Integrative Medicine and Health 2nd World Congress Rome, September 20–23, 2023 (2025)

KS N 1.1 Aromatherapy: from bench to bedside

Giacinto Bagetta

Pharmacotechnology Documentation and Transfer Unit, Preclinical and Translational Pharmacology, Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, Rende, Italy

Some 97% of patients with dementia develop fluctuating neuropsychiatric symptoms before disease onset and during disease progression. Among these, agitation challenges. Its treatment uses neuroleptics that double the risk of death from cardiocerebrovascular accidents. Agitation may be caused, at least in part, by undiagnosed and inadequately treated pain due to impaired self‐report skills; in fact, agitation can be significantly reduced by appropriate analgesic treatment. Aromatherapy has demonstrated efficacy, but the quality of evidence is low due to methodological bias, making the results inconclusive. Therefore, the purpose of the present study is to provide the rationale to allow the clinical translation of bergamot essential oil (BEO) into studies able to provide high‐quality evidence of efficacy and safety. BEO has been deprived of the furocoumarins responsible for phototoxicity and encapsulated in the NanoBEO, a nanotechnological delivery system obtained through the use of solid lipid nanoparticles, tested in the preclinical setting in inflammatory and neuropathic pain models. NanoBEO confirms the strong antinociceptive and antiallodynic properties of BEO demonstrated invivo in experimental pain models relevant to chronic pain in the clinic (4). This fact allows further development of NanoBEO in treating agitation in dementia. The NanoBEO can: deliver known quantities of the phytocomplex; protect the active components from chemical‐physical and, therefore, pharmacological instability; encapsulate the terpenes responsible for the aroma, creating an odorless formulation for double‐blind clinical studies. NanoBEO was recently patented, and its efficacy on agitation and pain in severe dementia is being studied in a randomized, double‐blind, placebo‐controlled clinical trial, BRAINAID (NCT04321889).

KS N 2.1 Integrative Health: The challenges, and potential rewards, of moving beyond silos

Helene Langevin

Director of the National Center for Complementary and Integrative Health, USA

Throughout the world, we are witnessing an alarming rise in chronic non‐communicable diseases fueled by unhealthy diets, physical inactivity and chronic stress. A fragmented approach to treating conditions one at a time, once they occur, is contributing to this problem. In parallel, we are witnessing the deterioration of our environment that is threatening the planet as a whole. A solution to these problems will require the recognition that human health and planetary health are intrinsically linked. This presentation will address strategies to grow the research needed to move beyond silos and toward integrative health across biological, behavioral, social and environmental domains.

KS N 2.2 Importance of research in integrative medicine: Opportunities and challenges

Jianping Liu

Beijing University of Chinese Medicine, China

By incorporating traditional complementary medicine (T/CM) into conventional medicine, there is an opportunity to study the effect of integrative approaches in healthcare. The concept and model for this integration differ by country and region. The World Health Organization has encouraged the integration of T/CM into mainstream medicine in its 10‐year strategy for traditional medicine. More than 80% of world populations use some kind of T/CM and therapies, hence the importance of further research. T/CM could play a role in long‐term conditions where needs are unmet. The challenge is how to build up the evidence base on the benefits of T/CM and to identify the areas that conventional medicine is unable to meet but which T/CM could. Integration demonstrates optimal healthcare in practice, but it is important to build up research capacity and knowledge and skill in T/CM for both researchers and practitioners. Finally, developing research methodology that suits the unique feature of the complex interventions in T/CM is critical.

China has more than 60 years' experience in education, practice, and policy in integrative medicine of using both Traditional Chinese Medicine (TCM) and conventional medicine. In higher education, there are two types of universities/colleges: Western medicine and TCM. They cross over in their curricula, despite their different knowledge systems. In Chinese healthcare systems, there are two parallel healthcare services: Western medicine and integrative medicine. These are across different levels of healthcare from tertiary to primary care. Doctors, clinicians, and practitioners have to pass exams in order to obtain their respective licenses. Education in integrative medicine has been developed at bachelor, master, and PhD degree levels, as well as for continuous medical education. The Chinese Association of Integrative Medicine was established in 1981, and there are 66 specialty committees and more than 10 associated integrative medicine journals. T/CM services are provided at tertiary, secondary, and primary healthcare levels, including integrative medicine provision. These provide about 30% of health services across the country. In South Korea, integrative medicine began five years ago, with the government trying to set up integrative medicine models. Attempts have been made in providing cancer care, stroke, and obesity services by integrating Western medicine and Korean medicine in healthcare settings. The time is now right to research the effectiveness of this healthcare provision and validate the benefit to patients.

KS N 2.3 Using the ideals of Integrative Medicine to create the future of healthcare: from the sideline to leading

Amy Locke

Chair, Board of Directors, Academic Consortium for Integrative Medicine and Health

Professor and Chief Wellness Officer, University of Utah

The ideal future state of health for the world's populations is a cohesive model considering the synergistic roles of communities, public health and healthcare. This future state reaffirms the importance of the relationship between practitioner and patient, focuses on the whole person, is informed by evidence, and uses all appropriate therapeutic and lifestyle approaches, healthcare professionals and disciplines to achieve optimal health and healing.

We are far from this idealistic future. Healthcare costs continue to escalate while life expectancy declines. We train our future healthcare professionals in our current disease‐based model that prioritizes siloed pharmaceutical and interventional approaches over whole person prevention‐focused care. While exceptionally important, alone this approach does not provide a patient‐centered or health‐centered approach to whole person care. It does not effectively prevent disease. As healthcare professionals, we disregard our capacity to influence the leading risk factors for disease‐related death and disability, including health behaviors such as diet, social, economic and environmental drivers. This disconnect is partially responsible for burnout and increasing dissatisfaction with medicine as a career.

Rapid shifts are expected in the coming years as the current system collapses under financial stress. We need a sustainable future for healthcare. That means we must figure out how to re‐center on the patient, on a full spectrum of prevention and treatment, on how to influence public and community health opportunities. This future model must use systems thinking, be environmentally sustainable, and approach health from a population lens. It must take advantage of the wealth of expertise across our universities and communities. As we consider the role that Integrative Medicine may provide in the future, we must not be pulled back into the diagnosis and treatment paradigm, replacing medications with natural products.

This ideal future will require an ability to consider complex systems approaches to health and well‐being that focus on the patient and the healthcare team. Research strategies much not only evaluate effectiveness but also reach, implementation and institutionalization. They must do so in a multi‐dimensional capacity that looks at the whole person health as an outcome while looking at individuals in the context of where they live and work. We must take advantage of cross‐disciplinary work that branches across multiple fields to fully understand how to improve patients' health and preserve our future healthcare workforce. The healthcare systems of the world are reaching a breaking point. The Integrative Medicine community has an opportunity to lead the way to a more sustainable and health‐focused future.

KS N 2.4 TC+IM in times of limited resources

Vivian Lin

Executive Associate Dean and Professor of Public Health Practice, Faculty of Medicine, The University of Hong Kong

Traditional medicines have long and diverse histories around the world, relative to the short history of Western Medicine as we know it. However, these conventional practices and tools have been re‐emerging as part of our modern health systems, whether as traditional or complementary in some systems, or as part of an integrated approach to care and healing. In most countries, TC+IM is part of the frontline services, and thus part of the primary health care sector. As many service users need to pay out‐of‐pocket, it is clear that TC+IM is used either because it is trusted or because it is the only service available, and often both.

At a time when governments have adopted the goal of universal health coverage (UHC) as part of the 2030 Sustainable Development Agenda, it is timely to consider how TC+IM can help achieve the goal of UHC. With UHC defined as all people and communities having access to quality health services without undue financial hardship, any incorporation or integration of TC+IM into national health systems must consider how to assure access to affordable, people‐centred, integrated services and their quality and safety.

Expansion of primary health care is fundamental to achieving UHC, and incorporating TC+IM is an efficient approach to increasing service coverage. However, TC+IM would need to be put on a regulated platform – for both practitioners and products – to assure quality and safety. Systems also need to be put in place to assure continuity of care as well as safety with Western medicine, whether for referrals, specialist‐back up, or monitoring of adverse events. Financial coverage would need to be designed on similar basis of the rest of the health system.

For truly people‐centered integrated health care, mechanisms should be considered for individual user‐level integration. This may involve efforts to improve health literacy not only on the part of users to understand better how to manage their own care through different care systems but also amongst all health providers to understand how to support the patients' journeys and ensure best possible health outcomes.

System context is key to successful integration, so appropriate research and evaluation strategies should be embedded in an integrated health system.

KS N 2.5 Wellness Equity

Saper, Robert Bruce

Cleveland Clinic, Cleveland Clinic Community Care

Wellness can be defined as the active pursuit of optimal physical, mental, social, and spiritual health. Wellness equity is where everyone has equal opportunity and resources to pursue wellness. Wellness disparities exist when there are differences in wellness status between populations. Population characteristics associated with wellness disparities include many sociodemographic variables such as age, gender, race, ethnicity, religion, geography, sexual orientation, and socioeconomic status, to name just a few. Unfortunately, wellness disparities are widespread globally. The root causes of wellness disparities are complex and often include a history of structural, institutional, and individual discrimination. This root causes lead to differences in social determinants of health or wellness, i.e., housing, transportation, employment, income, food security, physical and psychological safety, ample space to be physically active, and social connection. These social determinants are more proximate drivers of wellness equity or disparities. Social determinants' impact on wellness is further mediated by individual and group behaviors, such as eating, drinking, moving, breathing, sleeping, responding to stressors, and interacting. Individual and group behaviors account for approximately a third of population health outcomes, whereas direct medical care accounts for approximately 10%. Given the complexity of wellness disparities, it is unsurprising that attempts to reduce disparities are often inadequate or partially adequate.

Creating wellness equity is an imperative for society and in particular, everyone involved in supporting the health and wellness of individuals and communities. We will discuss potential ways forward for how the complementary and integrative community can contribute and collaborate with others to strive towards this vision.

KS N 2.6 Glioblastoma: Genetics, epigenetics and holo‐genomics – Towards a systemic diagnostic‐therapeutic approach

Ernesto Burgio

ECERI – European Cancer and Environment Research Institute, Brussels, Belgium; ARTAC – Association for Research and Treatment Against Cancer, Paris, France

Rates of cancer have been dramatically increasing worldwide for several decades, along with those for chronic diseases. This increase mainly affects young people and children in whom cancer was a rare disease until the end of last century. This unexpected increase demonstrates the unfoundedness of the still‐dominant carcinogenesis model: the neo‐Darwinian model of stochastic DNA mutations promoted by natural selection. The rise in childhood and juvenile cancers should also be interpreted in the context of the dramatic increase in chronic pathologies (endocrine‐metabolic, immune‐inflammatory, neurodevelopmental and neurodegenerative, and precisely cancer) characterised by a reduction in age of onset. Some authors have called it an “epidemiological transition” between the 20th and 21st centuries, proposing an epigenetic (foetal programming) and hologenomic (altered microbiome would also play a significant role) rather than genetic origin. Cancer stemness and related epigenetic mechanisms of deregulation of cell proliferation and differentiation programmes were recently proposed to explain the increasingly early origin and resistance to traditional treatments.

With regard to childhood and juvenile cancer, the increase concerns not so much those that are traditionally more frequent at this age (e.g. acute lymphoblastic leukemia) but rather other previously rare types of cancer, especially those affecting the central nervous system (usually starting in the glia: astrocytomas, medulloblastomas, gliomas/glioblastomas [GBM]) and peripheral nervous system (neuroblastomas). Among the forms significantly increasing and characterised by a severe prognosis is GBM, a malignant neoplasm with unique features. Unlike most other cancers, where metastasis is the main cause of death, GBM rarely metastasises outside the neuraxis.

The high lethality index results from the tendency of neoplastic cells to invade the normal cerebral parenchyma, dispersing throughout the brain, due to the creation of an acidic environment through aerobic glycolysis (Warburg effect), which is toxic to other local cell populations and promotes degradation of the extracellular matrix, increasing the invasiveness of cancer cells. Furthermore, GBM tends to relapse rapidly after the first course of treatment due to the presence of subpopulations of brain tumour stem cells that express the neural precursor CD133 as a cell surface marker. The standard surgical and chemotherapeutic strategy is not effective because it tends to select stem cells not “ferried” by drugs, which remain even after surgery. On this basis, it is necessary to combine standard protocols with complementary strategies, to be implemented early, aimed at interrupting the hypoxia–glycolysis–acidosis cycle (ketogenic diets) and promoting the differentiation of neoplastic stem cells residual after surgical treatment.

KS N 2.7 Lifestyle factors and the hallmarks of cancer

Lorenzo Cohen, PhD

Richard E Haynes Distinguished Professor of Clinical Cancer Prevention

Director, Integrative Medicine Center, The University of Texas MD Anderson Cancer Center

The hallmarks of cancer have provided a much-needed blueprint for researchers to begin to understand the basic mechanistic features of cancer growth that have allowed all of us to approach cancer treatment with more effectiveness. Discoveries and treatment breakthroughs are now happening on many fronts as our understanding of the individual causal triggers of cancer growth becomes more sophisticated. This more individualized approach is so important because cancer is a master at variability, and this is why our one-size-fits-all approaches to treatment—especially treatment and control—often fall short.

We have known for some time now, thanks to the pioneering work by top scientists around the world, that certain lifestyle factors can profoundly affect the trajectory and outcome of cancer. Lifestyle factors including social and emotional support; managing stress; improving sleep, exercise, and diet; and minimizing exposure to environmental toxins work together to promote an optimal environment for health and well-being. Each of these factors have been scientifically linked to one or more key cancer hallmarks and gene expression profiles necessary for cancers to form, grow, and survive. Research also suggests that these lifestyle factors interact with and reinforce each other in both positive and negative ways.

Much emphasis has been placed on individual lifestyle factors such as diet, exercise, and reducing stressors (both psychological and biological), but an increasing body of research shows that the benefit of each lifestyle factor is enhanced and heightened when we make changes in more than one area. What these initial results tell us is that comprehensive lifestyle change can improve clinical outcomes and has substantial impact on key cancer hallmarks.

KS N 3.1 Integrative Surgery along the continuum of integrative oncology care

Eran Ben‐Arye

Director, Integrative Oncology Program, the Oncology Service, Lin, Zebulun, and Carmel Medical Centers, Clalit Health Services, Israel

The past two decades have seen a significant paradigm shift within the field of supportive cancer care, with the contextualization of 'integrative oncology', a concept whose goal is to introduce evidence‐based and patient‐centered complementary medicine modalities into mainstream conventional oncology care. In this lecture, we will present a number of the recent developments in integrative oncology within the surgical setting, exploring the methodologies and outcomes of clinical research on preoperative touch and mind‐body modalities, as well as the impact of intraoperative acupuncture during gynecological oncology surgery. The results of a randomized controlled trial assessing the impact of integrative therapies on perioperative pain and anxiety will be discussed, regarding both subjective patient‐reported outcomes and objective hemodynamic and anesthesiology‐related parameters such as heart rate, mean arterial pressure, and bispectral index. Finally, we will discuss the role of integrative surgical oncology and its contribution to ensuring continuity of care along the continuum of integrative oncology care.

KS N 3.2 Integrative Oncology: What Now and What Next?

Gary Deng

Integrative Medicine Service Memorial Sloan‐Kettering Cancer Center, New York

Integrative oncology has evolved over the last two decades since it emerged as a new field. It started rather organically, with various people working in the field developing their programs according to local conditions.

With the formation of a critical mass of professionals, institutions, and organizations, integrative oncology has become a more mature discipline with a clear definition, a theoretical framework, more standardized practices, robust research, and a pipeline of young clinicians and researchers.

In this presentation, Dr. Deng will review key milestones in clinical, research, and educational activities of integrative oncology in the United States, describe the current state of science, discuss progress achieved and obstacles encountered, and explore future directions to increase its impact on health care.

KS N 3.3 Cancer and psychoneuroendocrineimmunology

Francesco Bottaccioli

Founder and Honorary President of the Italian Society of Psychoneuroendocrineimmunology

Psychoneuroendocrineimmunology (PNEI) is the discipline that studies bidirectional relationships between the psyche and biological systems. PNEI is a new scientific paradigm that aims to replace the current reductionist paradigm, which has taken over since the second half of the nineteenth century.

In the last decade, this scientific project has found a new solid molecular basis in epigenetic research, which has revolutionised classical genetics. Epigenetics is the rapidly expanding science that studies the molecular mechanisms by which the environment and individual life act upon the information contained in the genome. This new research clarifies the relationships between the earliest stages of life, starting from conception, personality styles and the health of the child and adult. They also explain the molecular mechanisms with which the characteristics of our life (pollution, nutrition, sedentariness, stress, social position) and also our sex enter into the biology of the body, thus modifying it.

This provides the scientific basis for the integration of medicine with psychology. Integration is fundamental in general, but it is crucial for understanding and treating cancer. Today, we know that in addition to genome alterations that may undoubtedly be present, epigenetic alterations play a fundamental role.

Chronic stress and trauma cause the epigenetic signature in the brain and immune cells, determining neuroinflammation and immune dysregulation. Steve Cole from UCLA showed that chronic activation of the stress system induces a “conserved transcriptional response to adversity” in peripheral immune cells. This is characterised by increased expression of proinflammatory genes (i.e. interleukin (IL)‐1β, IL‐6 and tumour necrosis factor alpha) and decreased expression of antiviral‐ and antibody‐related genes (type 1 immune circuit). Inactivation of the type 1 immune circuit exposes cells to cancer and viral infections.

We have strong evidence of the relationship between stress and cancer from animal experimentation. Research on animals shows involvement of the immune system in controlling the beginning, growth and metastasis of cancer, involving immunity of cytotoxic lymphocytes and natural killer cells and forming the type 1 circuit. Increasing evidence from human studies is also disposable.

Stronger evidence is found in the post‐diagnosis phase. Several meta‐analysis link depression, loneliness and social isolation to a reduction in the survival rate of cancer patients. Other research has shown socially integrated women were found to have better survival after a cancer diagnosis (e.g. colorectal cancer).

According to Sullivan et al., “Cancer patients need better care, not just more technology”. Congress communication will detail this “better care” for patients with cancer.

KS N 3.4 The KIM experience: a model for implementation of Integrative Oncology‐services in hospitals and cancer centers

Thomas Breitkreutz

Senior Consultant Paracelsus Hospital, Unterlengenhardt, Germany

The Competence Network for Integrative Medicine (KIM), founded six years ago in southwest Germany under the patronage of the Minster of Health in the Federal State of Baden‐Wuerttemberg, is a best practice‐example for collaboration between hospitals that implement and develop I.O. services in interdisciplinary teams. With different professional working groups, the KIM develops treatment recommendations, including practices from different complementary traditions, focussing on the main symptoms of cancer patients, such as fatigue, loss of appetite/loss of weight, CIPN, or mucositis. Best practices are identified in an iterative Delphi process, including internal and external evidence and patient preferences. Today, leading cancer centers and university hospitals are part of the KIM network, and smaller hospitals with long‐lasting expertise in Integrative Medicine, thus covering all levels of hospital care. In July, the KIM was integrated into the southwestern branch of the German Cancer Society and continues its work to generate quality‐assured standards of care in Integrative Oncology. The lecture presents the structure, collaboration, methodology and results of implementation activities, focussing on important learnings of the KIM journey, and finally discusses strategic considerations concerning future quality standards of I.O.

KS N 3.5 Integrative Oncology: Present and Future

Ting Bao

Director, Integrative Breast Oncology Integrative Medicine and Breast Medicine Services ‐ Memorial Sloan Kettering Cancer Center, USA

Integrative oncology is a rapidly expanding field, driven by the growing interest among oncology patients and professionals alike in incorporating integrative medicine into cancer care. The primary aims are improving patients' quality of life and treatment adherence throughout their cancer journey. In this presentation, Dr. Bao will delve into the current state of integrative oncology practice, research, and education within two major cancer centers in the United States. She will also explore the potential advancement of integrative oncology and discuss the necessity for global collaboration to move the field forward.

KS N 3.6 Considering European Society for Integrative Oncology (ESIO) with the SIO: working together for a better future

Eran Ben‐Arye

Director, Integrative Oncology Program, The Oncology Service, Lin, Zebulun, and Carmel Medical Centers, Clalit Health Services, Israel

Chairman, Department of Family Medicine, Rappaport Faculty of Medicine

Integrative oncology (I.O.) programs across the globe are increasingly becoming part of supportive and palliative care, with many of these programs working in collaboration with the Society for Integrative Oncology (SIO) in the U.S. Over the last five years, the SIO has significantly expanded its activities across the globe, with an initiative led by the SIO Global Taskforce and the Ambassador Program, including a regional SIO Ambassador to Europe and the Middle East and SIO Ambassador to the U.K. The I.O. activities in Europe include important clinical and basic science research projects and medical education programs. European I.O. projects involve national organizations (e.g., Associazione Ricerca Terapie Oncologiche Integrate, ARTOI; and the British SIO, BSIO); with collaborative clinical research taking place in Tuscany (Italy) and the Competence Network on Integrative medicine (KIM, in Baden‐Württemberg, Germany). Other projects involve academic centers of excellence in Israel, Scandinavia (e.g., Norway's National Research Centre for Complementary and Alternative Medicine, NAFKAM); the Middle East (Middle East Research Group in Integrative oncology; and others. Many in the I.O. leadership in Europe are affiliated with the SIO, while others are organized in their own professional societies (e.g., Multinational Association of Supportive Care in Cancer, MASCC; International Federation of Anthroposophic Medical Associations, IVAA) and in leading academic centers.

In this session, we will explore the feasibility of launching the European Society for Integrative Oncology (ESIO), whose goal will be to facilitate and coordinate collaboration with the SIO, as well as launching regional medical education and research initiatives in 'Greater Europe': from the U.K., throughout the continent, to the Middle East and the Mediterranean.

KS N 3.7 Patients and Clinician's Perspectives about Cannabis Use While Receiving Cancer Treatment at a Comprehensive Cancer Center (CCC)

Richard T. Lee^1‐3, P. Mendiratta^2‐3, M. Farrell³, S. Finklea³, L. Huang³, E. Trapl³, S. Rao^2‐3, S. Gerson³, J. Cullen³

1. City of Hope Comprehensive Cancer Center

2. University Hospitals Seidman Cancer Center

3. Case Western Reserve University Comprehensive Cancer Center

Introduction: Cannabis is gaining popularity worldwide, including in the United States, with 37 states legalizing access to cannabis. Limited data exist regarding why patients are using cannabis while receiving anticancer treatments.

Methods: Patients with cancer who received treatment at National Cancer Institute (NCI) designated CCC were approached from August of 2021 to August of 2022 to participate in a cross‐sectional survey as part of a national NCI‐funded effort. Consenting patients completed a survey during a medical visit asking about cannabis use (past and present), reason for use (including if cancer‐related), type of cannabis, and frequency of use. A follow‐up phone call occurred within 30 days to confirm medications used, and details about cannabis use, if reported. A healthcare provider survey was also conducted to explore perspectives regarding patients' use of cannabis during active treatment.

Results: A total of 315 cancer patients completed the survey (43% response rate) with a median age of 60.7 (±12.8), 58% female, and a variety of cancer types (hematologic 21.3%, breast 17%, gastrointestinal 11.7%, lung 10.2%). The respondents were: White 61.6%, Black 22.5%, Other 7.3%, education (high school 27%, college 42.5%, post‐graduate 14.9%), and employment status (retired 35.2%, employed 25.7%, unemployed or disabled 21.9%). Among respondents, nearly half (48.4%) had used cannabis before, one‐third (32.1%) had used cannabis since their cancer diagnosis, and almost one in five (18.5%) were currently using cannabis. The forms used were smoked (31%), gummy (29%), liquid (19%), edible (7%), and pill (6%). The most commonly reported reasons for use by respondents were insomnia (79%), pain (72%), mood (68%), poor appetite (68%), and gastrointestinal symptoms (51%). A total of 165 completed surveys (25% response rate) were received for the clinician survey. Approximately half of the respondents were nurses (54% nurses, 22% advanced practice providers, and 21% physicians) and of White race (73%) with a mean age of 46 years. Approximately one‐fourth (24%) reported discussing the topic of cannabis and about half of these conversations (45%) were initiated by the respondent. The healthcare providers estimated 10% of patients with cancer overall were using cannabis and that one in four patients (23%) were using cannabis during cancer treatment. Four in ten (39%) clinicians felt comfortable in guiding patients about cannabis use, and only one in eight (13%) felt knowledgeable about the topic of cannabis.

Conclusions: Approximately one‐fifth of patients with cancer receiving treatment are actively using cannabis, despite limited data regarding the efficacy of cannabis. Management of cancer symptoms was among key reasons that cancer patients used cannabis.

KS N 3.8 Medicinal mushrooms in cancer care

Santhosshi Narayanan

Associate Professor Department of Palliative, Rehabilitative and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas

Purpose of Presentation: Patients seek clinical guidance on mushroom supplements that can be given alongside conventional treatments, but most research on such fungi has been preclinical. We present the results of a systematic review focused on clinical studies of mushrooms in cancer care conducted in the past 10 years. We searched Medline (Ovid), Embase (Ovid), Scopus (Wiley), and Cochrane Library to identify all mushroom studies conducted in humans published from January 2010 through December 2020. Two authors independently assessed papers for inclusion.

Findings: Of 136 clinical studies identified by screening 2349, 39 met inclusion criteria. The studies included 12 different mushroom preparations. A survival benefit was reported using Huaier granules (Trametes robiniophila Murr) in 2 hepatocellular carcinoma studies and 1 breast cancer study. A survival benefit was also found in 4 gastric cancer studies using polysaccharide‐K (polysaccharide‐Kureha; PSK) in the adjuvant setting. Eleven studies reported a positive immunological response. Quality‐of‐life (QoL) improvement and reduced symptom burden were reported in 14 studies using various mushroom supplements. Most studies reported adverse effects of grade 2 or lower, mainly nausea, vomiting, diarrhea, and muscle pain. Limitations included a small sample size and not using a randomized controlled trial design.

Summary: Many of the reviewed studies were small and observational. Most showed favorable effects of mushroom supplements in reducing the toxicity of chemotherapy, improving QoL, favorable cytokine response, and possibly better clinical outcomes. Nevertheless, the evidence is insufficient to recommend the routine use of mushrooms for cancer patients. More trials are needed to explore mushroom use during and after cancer treatment.

KS N 3.9 Prioritizing comprehensive lifestyle change to add years to life and life to years

Lorenzo Cohen, PhD

Richard E Haynes Distinguished Professor of Clinical Cancer Prevention

Director, Integrative Medicine Center, The University of Texas MD Anderson Cancer Center

We now know that we are not at the whim of our ancestry or our genes: we can positively influence the trajectory of our health, at any stage of life, regardless of the presence of disease, and this knowledge is changing the conversation about cancer. What is becoming increasingly clear is that it is not possible to treat or screen our way out of the cancer epidemic. Lifestyle factors including social and emotional support; managing stress; improving sleep, exercise, and diet; and minimizing exposure to environmental toxins work together to promote an optimal environment for health and well-being. Comprehensive lifestyle change can improve clinical outcomes at the same time as improving multiple aspects of quality of life. While billions of dollars are going toward more precision-based cancer treatments and early detection, cancer prevention through lifestyle change remains the cheapest and most effective method to prevent and improve outcomes for those with cancer. A true partnership of integrative medicine with a focus on comprehensive lifestyle change and precision medicine is the future of cancer care. It is time to finally move away from a model of disease care to one of true health care.

KS N 4.1 Integrative Pediatrics ‐ implementation and advocacy

Ines A. Von Rosenstiel

Department of Pediatrics, Rijnstate Hospital, Arnhem, the Netherlands

Patients seek integrative approaches to care and may incur substantial personal expenses in doing so. They need a pediatrician who can be a trusted advisor, guiding families incorporating lifestyle approaches, and non‐pharmacologic and/or pharmacologic therapies.

Pediatric integrative medicine involves the integration of complementary and conventional therapies based on the best available data to maximize therapeutic benefit to the patient.

Globally, healthcare is in the process of embracing whole‐person health with its focus on wellness and well‐being in addition to the treatment of clinical disorders.

Integrative Pediatrics (I.P.) has been recognized and introduced into global healthcare systems over the past two decades. Different countries have developed various models of I.P. with formalized interaction between the two medical paradigms of conventional medicine and complementary medicine.

Integrating complementary medicine into mainstream medicine includes leadership and governance, health system financing, health service delivery, health workforce, health Information systems, and health products, all with its challenges.

Despite the growing movement of I.P., many challenges to its successful implementation still need to be addressed, such as time, cost and reimbursement, body of research, trust by medical colleagues, knowledge, scalability, and access. Advocacy efforts for I.P. are crucial at all levels to push the philosophical tipping point to the implementation phase of whole child health, incorporating prevention, self‐care, holism, an individual approach, empowerment, and the optimal synthesis of complementary and conventional medicine.

Much work must be done to bring integrative pediatrics into reality for all our patients. One way to fulfill this promise strategically is by joining forces to establish a Society of Integrative Pediatrics.

KS N 4.2 Policy informed by evidence: Evidence Map of Systematic Reviews on Integrative Pediatrics

Ricardo Ghelman

Founding Chair of the Brazilian Academic Consortium for Integrative Health (CABSIN)

WHO Expert Advisory Traditional, Complementary and Integrative Medicine Panel (TCIM) and TCIM Americas Network/PAHO

Department of Medicine and Primary Care at the Federal University of Rio de Janeiro, Brazil

Ambassador of the Society of Integrative Oncology for Brazil and Chair of the Department of Integrative Medicine for Children and Adolescents of the São Paulo Pediatric Society

Introduction: The WHO Traditional Medicine Strategy proposes implementing evidence‐informed national policies. Since 2019, evidence gap maps have been developed by PAHO in partnership with the Brazilian Academic Consortium for Integrative Health. This evidence map describes interventional research on traditional, complementary, and integrative medicine (TCIM) in the pediatric population up to 18 years old, reporting health outcomes.

Methods: This evidence map is based on the 3iE evidence gap map methodology. We searched three electronic databases (PubMed, Embase, and VHL TCIM/PAHO), including systematic reviews. Systematic review quality was analyzed based on AMSTAR 2. We used Tableau to graphically display the confidence level reflecting the quality of the study (high, moderate, low, and critically low), the number of reviews, associating the different interventions (medical systems, products natural and non‐pharmacological interventions) to clinical outcomes and the effects (positive, potentially positive, inconclusive, negative) results in a broad estimate of evaluated effectiveness.

Results: 166 systematic review studies with and without meta‐analysis in publications up to May/2023 were included. We will present the effects of associations between interventions and clinical outcomes.

Conclusions: TCIM has been applied in different areas and this evidence map provides an easy visualization of valuable information for patients, health professionals and managers to promote complementary evidence‐based approaches for the pediatric population.

KS N 4.3 Pediatric integrative medicine research needs opportunities to build evidence with each patient seen

Sunita Vohra

Professor, Faculty of Medicine & Dentistry ‐ Pediatrics Dept ‐ University of Alberta, Canada

An international Delphi study identified priorities for research in pediatric integrative medicine. To meet these needs, Dr. Vohra will discuss two research methods that can help build evidence with each patient seen: N‐of‐1 trials to assess if treatments are effective and active surveillance to determine if treatments are safe. These research methods are flexible and adaptable across populations/conditions and interventions, making them broadly relevant across integrative health care for both adults and children, products, and practices.

KS N 5.1 Music in palliative care: The Schubert Treatment: clinical studies and reflections

Claire Oppert

Pain and Palliative Care Center CHU Sainte Périne AP‐HP, Paris

Palliative Care Unit of the Rives de Seine Hospital Center, Puteaux Maison Médical Jeanne Garnier, Paris, France

Claire Oppert, professional cellist and music therapist, shares her 14 years of experience in palliative care units.

The Schubert Treatment (2012‐2017) is a clinical study on the impact of live music (cello solo) during pain‐inducing care treatments, led by Claire Oppert and Dr Jean‐Marie Gomas with the healthcare team of the Palliative care unit of Hôpital Sainte Périne in Paris.

This innovative and creative protocol has confirmed the non‐medical analgesic effectiveness of music on end‐of‐life patients, reducing various symptoms such as pain and anxiety.

Additionally, live music has been seen to change caregivers' perception of their nursing care during procedures, improving the overall quality of the care and bettering the relations and communication within the multi‐disciplinary and medical team. The study also demonstrates how this new connection between patients, carers, and music therapists creates a relational dynamic suitable for relieving the patient's symptoms and the carers' psychological well‐being.

Claire Oppert expands her reflection on the impact of live music on the breathing of non‐conscious patients (in a coma or sedated) in a more recent study still in progress with Docteur Ségolène Perruchio in the Palliative Care Unit of Centre Hospitalier Rives de Seine in Puteaux.

Changes in the respiratory parameters of patients in 80% of the cases in reaction to the live music ‐all repertoires included, are experienced for most families of the patients like a palpable proof or an obvious sign that their loved one is “still there.”

Music at the bedside opens a possible non‐verbal communication channel, suggesting that psychic links can be maintained through musical vibration. Experiencing a “last sharing” is gratifying, relieving, and calming, providing psychological support for families.

All our studies seem to confirm that when the cello sings near the sickbed, for most patients, it stimulates a wealth of physical sensations, transforming, for a moment, the perception of a body of sickness and pain into one of feelings and emotions, a body of life regained.

The music focuses on the healthy and lively part of the person, even if that part only seems like a tiny part of health and life.

KS N 5.2 Contemporary Arts and Medicine

Iva Fattorini

Founder Artocene, former Executive Director and Global Chair of Cleveland Clinic Arts and Medicine Institute

The field of Arts and Health is growing exponentially, with the potential to improve health outcomes. Although it has ancient roots and is transforming healthcare systems globally, it needs to be defined better, and the uptake could be faster.

This talk will introduce the audience to the field by sharing the personal global journey of building one of the largest international arts and medicine programs, measuring its impact, and explaining the obstacles to scaling it. It will use the neuroscientific and social science lenses to inform the audience about the field and open the floor to discuss its future.

KS 5.3 Arts in medicine ‐ tradition, evidence, perspectives

Stefan N. Willich

Professor and Director of the Institute for Social Medicine, Epidemiology and Health Economics at Charité University Medical Center Berlin

Artistic aspects have had a long tradition in medicine including music, danse, visual and performing arts, literature, and architecture. However, evidence of therapeutic effectiveness of artistic interventions is still sparse. We will review the development of arts in medicine focussing on indications with scientific basis. We will also present some promising perspectives in the field. Further research and coordination will provide a basis to more systematic integration of arts therapies into routine clinical care of patients.

KS N 6.1 Chrono‐nutrition: An Ayurvedic perspective

Puthiyedath Rammanohar

MD (Ay), Director, Amrita Centre for Advanced Research in Ayurveda, Amrita Vishwa Vidyapeetham, Kollam, Kerala, India

Ayurveda is a system of healthcare indigenous to India. Ayurveda advocates a holistic approach to nurturing health and greatly emphasizes mindset, lifestyle, and diet for preventive and curative care. The body is a product of our food; a healthy and balanced diet has preventive and curative implications. Qualitative and quantitative parameters are considered essential to balance the diet in Ayurveda. However, the timing of a meal is paramount to ensure proper nutrition and health. The systematic approach to fixing the time of eating a meal is called kālabhojanaṃ in Ayurveda. There is a striking semblance of kālabhojanaṃ with the modern concept of chrono‐nutrition. In this talk, we will discuss chrono‐nutrition in light of the idea of kālabhojanam in Ayurveda. Ayurvedic texts point out that irregular eating habits are detrimental to metabolic health, even if food is nutritious.

For example, the same diet as morning and evening meals impacts metabolism differently, and modern scientific studies corroborate these observations in Ayurvedic texts. The ayurvedic concept of Kālabhojanam also correlates well with current ideas of Time Restricted Eating (TRE) and Time Restricted Feeding (TRF). It has been found that TRE/TRF can stimulate adipocyte thermogenesis. It has been found that feeding rhythms must be aligned with the circadian clocks and that misalignment can lead to metabolic aberrations and obesity. Evidence from animal studies and preliminary studies in humans indicate that Kālabhojanam (chromo‐nutrition), recommended by Ayurveda, is an optimal eating strategy that improves human health and prevents many metabolic disorders. There is a need for more rigorous studies on human beings. While Kālabhojanam (chrono‐nutrition) is considered foremost amongst practices that can enhance longevity and quality of life, Ayurveda also emphasizes the need to ensure food quality and regulate the quantity of food intake to optimize health benefits. The classical texts recommend that the timing of food must be decided based on the body's physiological state, diurnal variations in nature, and the seasons. Ayurvedic texts elaborate on a diet integrated into a well‐planned daily routine (dinacaryā) and seasonal routine (ṛtucaryā). There is a scope for a re‐examination of the kālabhojanaṃ (chromo‐nutrition) strategy elaborated in Ayurvedic texts in light of modern scientific research that has great potential to offer new leads for research in food and nutrition.

KS N 6.2 Food, Pesticides, Dysbiosis, and Chronic Inflammatory Diseases: The Autoimmune and Obesity Paradigms

Alessio Fasano

Mucosal Immunology and Biology Research Center, Massachusetts General Hospital for Children – Harvard Medical School, And Harvard T.H.

Improved hygiene leading to reduced exposure to microorganisms has been implicated as one possible cause for the recent 'epidemic' of chronic inflammatory diseases (CID) in industrialized countries.

That is the essence of the hygiene hypothesis that argues that the rising incidence of CID, may be, at least in part, the result of lifestyle and environmental changes that have made us too “clean” for our good. The gut microbiome consists of more than 100 trillion microorganisms, primarily bacteria. It has been recently recognized that there is a close bidirectional interaction between the gut microbiome and our immune system, and this cross‐talk is highly influential in shaping the host gut immune system function and, ultimately, shifting genetic predisposition to clinical outcome. This observation led to revisiting the possible causes of CID epidemics, suggesting a critical pathogenic role of microbiome composition. Several factors can influence microbiota composition, including diet and exposure to pollutants. Therefore, re‐shaping gut microbiota through dietary manipulation or decreasing the use of contaminants is becoming a highly active area of research for the prevention or treatment of a multitude of CID, including metabolic disorders involved in obesity and its complications.

KS N 6.3 Teaching Kitchens as Future Learning Laboratories

David M. Eisenberg

Director of Culinary Nutrition‐ Harvard T.H. Chan School of Public Health

It is worth imagining a world in which our children, and their children, learn to eat, cook, move, and think more healthfully. A world in which the relationships between food, human health, and planetary health are enhanced for the benefit of all. Simultaneously, there is a need to identify innovative strategies whereby individuals, families, and communities can learn to access and prepare affordable and nutritious foods combined with evidence‐based diet and lifestyle guidance. These approaches also need to address issues of health equity and environmental sustainability. Lastly, physicians now need enhanced nutrition education training to advise patients about improved food choices, thereby enabling them to reduce the risks of nutrition‐related chronic diseases.

Teaching Kitchens (T.K.s) are being created as educational classrooms and translational research laboratories to advance such strategies. Moreover, T.K.s can be used as revenue‐generating research sites in universities and hospitals performing sponsored research and, potentially, as instruments of cost containment. They can and are being built in partnership with terrestrial and (urban) high‐tech farmers. In this presentation, Dr. David Eisenberg, a physician, educator, researcher, and son and grandson of professional bakers, will describe the conceptual origins, growth, and potential of Teaching Kitchens to impact individual and societal health; and to be used as valued “learning laboratories” internationally. He will also provide updates concerning the relationship between Teaching Kitchens, and the more significant Food Is Medicine movement in the U.S. and internationally.

KS N 6.4 Healthy and sustainable diet for people and the planet

Gustav Dobos

Professor for Internal Medicine, Director Center for Integrative Medicine and Planetary Health, University Hospital Essen, Germany

The majority of non‐communicable chronic diseases are significantly influenced by nutrition. On the other hand, human food is also responsible for a high carbon footprint amplifying climate change. The concept of the Planetary Health Diet (PHDiet) developed by the EAT‐Lancet Commission headed by Walter Willett and Johan Rockström emphasizes a shift towards a predominantly plant‐based diet while reducing the consumption of animal‐based foods. The diet is designed to promote both human health and the sustainability of the planet's ecosystems. It allows adapting to all regions worldwide, providing humans with a healthy diet. It recommends increasing the intake of whole grains, legumes, fruits, vegetables, and nuts and reducing the consumption of red meat and animal‐based foods, sugar, and refined grains. The diet aims at providing all the necessary nutrients for optimal health while minimizing the environmental impact. By reducing the consumption of animal‐based foods, especially red meat (once a week at most), the PHDiet can help decrease the overall greenhouse gas emissions associated with food production and further land and water conservation, preserving biodiversity, reducing water usage, and mitigating deforestation. Planetary Health Diet can significantly mitigate climate change and create a more sustainable future.

The Mediterranean diet (MedDiet) is a variation of the PHDiet. According to multiple meta‐analyses, the MedDiet has numerous health benefits: it reduces the risk of heart disease as well as risk factors including obesity, hypertension, metabolic syndrome, and dyslipidemia, also type 2 diabetes, certain cancers (such as breast and colorectal cancer), as well as depression and neurodegenerative diseases, hence increased longevity. Furthermore, the relatively low environmental impact (water, nitrogen, and carbon footprint) of MedDiet is an additional positive aspect of the Mediterranean dietary model.

Combining a balanced plant‐based MedDiet/PHDiet with a mindful, environmentally conscious lifestyle, including physical activity, reduction in food waste, and social engagement, contributes to overall well‐being, longevity, and a healthy planet. Furthermore, we can make a significant change and impact immediately.

OS CIM N 2 How to reduce empathic distress and increase emotional skills in medical training? Experience of a Mindfulness‐Based stress reduction class vs. control group in France

Cloe Brami^1,3; Franck Zenasni¹; Liza Hettal¹; Serge Sultan¹

¹affiliated to LaPEA ‐ Université Paris Cité and Univ Gustave Eiffel, LaPEA, Boulogne Billancourt, France; ²CNRS UMR168, Institut Curie, Université PSL, Sorbonne Université, Paris, France; ³Department of Pediatrics, Université de Montréal, Québec, Canada. Centre de Recherche du CHU Sainte‐Justine, Montréal, France

Background: Improving student wellness through curricular activities is a topic of interest in medical school. Both distress and well‐being are related to medical student empathy. Numerous data suggest that learning mindfulness skills help to reduce anxiety, stress and overall psychological distress. Moreover, more data on the impact of MBSR on medical students' empathy and emotional skills still need to be collected.

Methods: We designed a controlled study including an intervention group (MBSR) and a wait‐list control group. We aimed to explore the impact of MBSR training in medical students on (1) empathy, (2) emotional skills (identification, understanding, acceptance) and (3) self‐care. Online assessments occurred at baseline and post‐intervention. We analyzed pre‐post changes and explored intervention effects using a generalized mixed model.

Results: Fifty‐one medical students were included. 80% of students attended all MBSR classes. When compared with the control group, the Personal Distress (PD) of the empathy subscale decreased significantly in the MBSR group (β = ‐3.55 [95%CI ‐5.09, ‐1.40], p < 0.005). No other significant change was observed for empathy subscales. Students in the MBSR group increased their emotional skills as the ability to identify (p < .005, Cohen's d = 0,52) and understand (p = .02, Cohen's d = 0.62) one's own emotion. Total Self‐Compassion Scale (SCS) increased significantly in the MBSR group (β = ‐25.5 [95%CI 18.16, 32.86], p < 0.001) assesses the ability to self‐care.

Conclusion: Results suggest that MBSR develops medical students' interpersonal resources and reduces empathy distress. Indeed, PD assesses the tendency to feel distress and discomfort in response to the distress of others and corresponds to a challenge in medical training. MBSR could be beneficially combined with other educational modalities to enhance each component of empathy.

OS CIM N 3 “Understanding students” motivations for participating in a mindfulness course: A qualitative analysis of medical students' views”

Cloe Brami¹; Franck Zenasni¹; Robieux Leonore³; Marie Aude Piot⁴; Serge Sultan²

¹affiliated to LaPEA ‐ Université Paris Cité and Univ Gustave Eiffel, LaPEA, Boulogne Billancourt, France; ²Department of Pediatrics, Université de Montréal, Québec, Canada. Centre de Recherche du CHU Sainte‐Justine, montreal, France; ³laboratory of psychology and process, paris, France; ⁴(4)Université de Paris‐Cité, AP‐HP, Necker Enfants malades hospital, Child and adolescent psychiatry unit, CESP, Inserm 1018, USQV Paris‐Saclay, PARIS, France

Background: Improving medical students' well‐being and empowerment through curricular activities is a topic of interest worldwide. Mindfulness‐based interventions (MBIs) are increasingly implemented in medical education, often as part of elective courses. To better understand training outcomes and adjust the curriculum to students' needs, we will explore why medical students will participate in meditation‐based education.

Methods: We analyzed 29 transcripts from the first session of an 8‐week MBSR program offered to medical students in French. Transcripts were coded and analyzed using a qualitative content thematic analysis and the constant comparison method.

Results: Analyses resulted in three themes describing students' motivation: (1) Medical education and the physician's role, i.e. improving interpersonal skills, acquiring skills oriented toward more integrative medicine, and being more productive in a highly competitive context. (2) Caring for my health, i.e., aiming at reducing stress, emotion regulation, and improving self‐compassion. (3) A quest for meaning, i.e. optimizing the meaning of care and life.

Conclusion: The results highlight the congruence between the perceived motivations and the evidence on the effect of mindfulness on self‐care, the development of humanistic medical skills, and the meaning of care. Some findings raise the issue of the limits of using mindfulness to enhance one's productivity. Notably, participants articulated the need for self‐care, as in mindfulness training, with the ability to care for others.

OS CIM N 4 Developing the Integrative Nursing Education Series Handbook for Teachers

Martine Busch¹; Anita Lunde²; Monique Van Dijk³; Thora Jenny Gunnarsdottir⁴; Torkel Falkenberg⁵; Marianne Van der Heijden⁶

¹Van Praag Instituut, Utrecht, Netherlands, ²VIA University College, Horssens, Denmark; ³Erasmus University Medical Center, Rotterdam, Netherlands; ⁴University of Iceland, Reykjavik, Iceland; ⁵Karolinska Institutet, Stockholm, Sweden; ⁶Erasmus University Medical Center, Rotterdam, Netherlands

Introduction: The Integrative Nursing Education Series (INES) project is a three‐year EU funded project that aims at improving education for nursing students on integrative nursing (IN) and the use of complementary non‐pharmacological interventions (NPIs). The third INES work package aimed to develop a framework for teaching about integrative nursing in Europe, in which we acknowledge the heterogeneity and medical pluralism in Europe whilst finding common ground in an approach to integrative nursing.

Methods: The INES Handbook is based on the results from the INES questionnaire and literature review, the INES SWOT analysis and the INES competency profile, which was developed through a two‐round Delphi study with experts on integrative nursing and/or nursing education from eight European countries. The INES Handbook is guided by the INES Dynamic Model of Integrative Nursing, that consists of varying combinations of selfcare/lifestyle, conventional care and complementary care, according to the needs and individual situation of the patient. The INES Handbook is built like a kaleidoscope: every teacher can choose which part of the series to teach, based on their cultural preferences and time limitations.

Results: The 168‐page long INES Handbook consists of eleven chapters presented over three series: ‘integrative nursing’; ‘integrative nursing within a conventional setting’; ‘integrative nursing and complementary and non‐pharmacological therapies’. Furthermore, in the INES Handbook we present a toolbox on various teaching methods, didactic reflections and resources. Narratives are added in every chapter to enhance students' engagement and to inspire the teacher.

Conclusions: The Integrative Nursing Handbook for Teachers in Nursing is the first evidence‐informed and expert‐supported educational framework for Integrative Nursing in Europe.

OS CIM N 5 Clinical Effectiveness of Apitherapy: Evidence Map

Erika Cardozo Pereira¹; Caio Fábio Schlechta Portella¹; Ricardo Ghelman¹; Mariana Cabral Schveitzer^3,1; Carmen Verônica Mendes Abdala²

¹Brazilian Academic Consortium for Integrative Health (CABSIn), São Paulo, Brazil; ²BIREME (Latin American and Caribbean Center on Health Sciences Information) ‐ Pan American Health Organization/World Health Organization (PAHO/WHO), São Paulo, Brazil; ³Department of Preventive Medicine, Universidade Federal de São Paulo, UNIFESP, São Paulo, Brazil

Introduction: Apitherapy is a therapeutic practice that uses honey bee products ‐ such as honey, propolis, royal jelly, pollen and apitoxin ‐ bee venom in the promotion of health, prevention and treatment of diseases in the general population. Its inclusion in the list of practices of the National Policy on Integrative and Complementary Practices in the Brazilian Health System occurred in 2018. It is necessary to map scientific evidence for its proper incorporation into health services. To map the scientific evidence on the effects of Apitherapy for different clinical and health conditions.

Method: This study is based on the methodology of evidence maps, which visually and graphically present an overview of the scientific production of medical interventions and therapeutic methods for specific health problems. The search included studies published up to 2021 in English, Portuguese and Spanish and was performed in four databases. The quality of the reviews was analyzed using the AMSTAR 2. Tableau was used to display the confidence level graphically, the number of reviews, health outcomes, and effects of interventions. Systematic review studies that could answer the following research question were eligible for inclusion in the Evidence Map: What is the clinical effectiveness of Apitherapy for health outcomes?

Results: 51 reviews were included, 26 systematic reviews with meta‐analysis, 16 systematic reviews, seven meta‐analyses and two systematic reviews of randomized clinical trials. The primary studies included in the reviews are mainly concentrated in countries such as Iran, India, Egypt, the United Kingdom and Pakistan. The studies evaluated the interventions of honey, propolis, apitoxin, royal jelly and pollen. Most evidence focuses on honey and applied intervention for mucositis and wound outcomes. The second most studied intervention was propolis applied for mucositis and dental plaque outcomes. We evaluated 57 health outcomes divided into eight main groups. Most studies reported a positive effect. Regarding methodological quality, the studies were classified into seven high‐level reviews, 15 low‐level reviews and 29 critically low‐level reviews.

Conclusions: Apitherapy has been applied in different areas, and this Evidence Map provides easy visualization of valuable information for patients, healthcare professionals and managers to promote evidence‐based Complementary and Integrative Medicine.

OS CIM N 6 Acupuncture: Traditional and Modern Medicine between genetics and epigenetics

Franco Cracolici

¹Oncology Department, Tuscany Region, Italy

Recent scientific studies highlight acupuncture's ability to regulate gene expression, activating or inhibiting various transcription factors through ancient formulas involving paths called 'Extraordinary Meridians'. Modern medicine, mainly thanks to Langevin's studies, has reconstructed how acupuncture affects epigenetics, contributing to an information chain that goes from stimulating fibroblasts involving integrins to coding new informational codes via the cell membrane. Through this action, acupuncture can restore a balance within the cell by reprogramming genetically altered codes or information given by the external environment of frank pathological significance. This report will describe scientific modalities and protocols that represent a valuable multidisciplinary bridge connecting our altered DNA to a new mode of observation and a profound therapeutic retouching. Concerning the action on the amygdala and hippocampus, memories impregnated with suffering, thanks to the meaning and use of points, switch pathological changes into physiological mode. Thanks to nuclear magnetic resonance and PET, these ancient hypotheses, which base their roots on millennial theories, have now become demonstrable realities.

OS CIM N 7 Acupuncture and Stroke

Franco Cracolici

Italian Federation of Acupuncture Societies (FISA), Bologna, Italy

Introduction: Stroke is the sudden loss of blood circulation to an area of the brain, resulting in a corresponding loss of neurologic function. Stroke is classified as either ischaemic (caused by thrombosis or embolisms) or haemorrhagic (caused mainly by rupture of blood vessel or aneurysm).

Acupuncture: The applied protocol focuses on the improvement of aphasia, dysphagia and hemiparesis, frequently associated with hemispatial neglect.

Acupuncture:

 1. Stimulates the prefrontal cortex

 2. Improves activation of brain functional areas

 3. Regulates cerebral blood flow

 4. Activates neurogenesis

 5. Activates angiogenesis

 6. Modulates vasoactive mediators

 7. Regulates neurochemistry (Neurotransmitters, Neurotrophic Factors, Antioxidants)

 8. Anti‐apoptoic action

 9. Activate the Insula

10. Activates the Spinal Cord

11. Action similar to Transcutaneous Spinal Stimulation

12. Informs the Somato‐Sensory cortex

13. Facilitates the Plasticity of Brain Connections

14. Activates the Basal Ganglia (Dopaminergic Action mediated by 20GV + Yamamoto Areas)

Low‐frequency electro‐stimulation is routinely applied

Experiments have proved that acupuncture has a positive impact on

1. morphology,

2. energy metabolism

3. nerve function

MECHANISM OF ACTION EBM

· reduces the infarcted area

· accelerates proliferation and repair of nascent capillaries and glial cells

· reduces edema around the necrotic area

· improves flow pattern of blood cells

· increases oxygen and blood supply to the brain tissue.

Conclusions: This report will highlight the therapy I have carried out for stroke outcomes in public and semi‐public centers that have combined allopathic medicine with acupuncture techniques, which will be shown and explained with traditional and complex formulas and related videos.

OS CIM N 8 Integrating complementary and alternative medicine within national healthcare: Professionals' experiences and views of the integration of complementary and alternative medicine within the UK's National Health Service in the context of ethics

Klara Dolakova

Faculty of Humanities, Charles University, Prague, Czech Republic

Introduction: Decision making in public health should be based not only on theoretical foundations and evidence for the specific approach but also on a thorough ethical consideration in the context of biomedical ethical principles. One of the areas that raises ethical discussion is the field of complementary and alternative medicine (CAM) and the possible integration of selected CAM methods into the public healthcare system. The high demand for CAM methods from the general public has contributed to the process of integrating selected CAM methods to some extent within the healthcare system in several countries (e.g. Switzerland, Germany and the UK, among others), as well as the fact that in the document WHO Strategy for Traditional Medicine 2014–2023, the World Health Organization recommends, where appropriate, the integration of selected CAM methods into national healthcare systems. As the UK is one of the countries that enables patients to access certain CAM approaches as a part of the National Health Service (NHS), the present study explored what ethical aspects play a role in the process of integrating a certain CAM method within healthcare. This qualitative study explores professionals' experiences and views of CAM integration within the NHS in the context of ethics. The main aim is to find out in which circumstances, according to professionals based in the UK, it is ethically acceptable to integrate a particular CAM method into healthcare.

Methods: Semi‐structured interviews were conducted with participants. Interviews were audio recorded, and field notes were taken. Audio recordings were transcribed verbatim. Transcripts were analysed thematically using framework methodology.

Results: A total of 21 participants (identified as researchers/academics, CAM practitioners and medical doctors) were interviewed. The study identified a number of key topics relating to participants' views on the integration of CAM within the NHS, including the perception of CAM in the context of healthcare, safety and regulation in healthcare and CAM, gaps in CAM research and education, or factors influencing CAM integration within the NHS.

Conclusions: This qualitative study identified key facilitators and barriers to CAM integration and the main ethical concerns both in the CAM field and within healthcare in general. Further research is needed to explore whether the identified factors are relevant in other countries as well.

OS CIM N 9 One Health, One Medicine

Bruno Galeazzi

FIAMO, Terni, Italy

Introduction: One Health is the holistic vision that the World Health Organization has been proposing since 2017, describing the interconnectedness and interdependence of humans, animals and the environment in the pursuit of global health. Since its inception, homeopathic medicine has shared this worldview. FIAMO includes medical homeopaths, veterinary homeopaths, pharmacists and agronomists as associates.

Methods: The evidence base of homeopathy was evaluated and compared to conventional medicine in order to investigate whether homeopathy can be a candidate to contribute to the One Health project.

Results: A 2007 Cochrane review analysed 1016 systematic reviews of conventional therapies. Of these, 44% concluded that the interventions studied were likely to be beneficial, of which 1% recommended no further research and 43% recommended additional research. Seven per cent of the reviews concluded that the interventions were likely to be harmful, and 5% recommended additional studies. Based on the results of the meta‐analyses published by Mathie in 2014, 2015, 2017, 2018 and 2019, homeopathy should be classified provisionally in the group of therapies which are effective but need further research, similar to 43% of the conventional therapies that, according to the Cochrane review, need additional research. The experiments of Baumgartner and Bellavite over the last 20 years on cellular and plant models have shown proof of effectiveness of the homeopathic verum compared to placebo. A review published by Bellavite in 2021 summarises the results, including more than 50 original studies by several authors. Fundamental research of homeopathic medicinal products has been summarised in a review by Tournier, in which 80% of the studies reveal that homeopathic solutions have peculiar physicochemical characteristics, different from the control.

Conclusions: Despite the explanation that the mechanism of action of homeopathic products is still under investigation, fundamental laboratory and clinical research supports the evidence base for homeopathy. The conceptual separation between conventional medicine and traditional, complementary and integrative medicine could be merged on the common ground of evidence‐based medicine, where the patient can benefit from the right therapy by the right therapist delivered at the right time. On this common ground, a One Medicine model is proposed as a modern adaptation of the Hippocratic bedside partnership between the similia and contrary principle.

OS CIM N 10 Evidence Map ‐ Clinical Effectiveness of Anthroposophic Medicine

Ricardo Ghelman^1,5; Kioshi Hosomi Jorge¹; Mariana Cabral Schveitzer^4,1; Caio Fábio Schlechta Portella^1,5; Ana Maria de Araújo Rodrigues¹; Edeltraud Johanna Lenk¹; Elaine Marasca Garcia da Costa¹; Giane Santana Alves Oliveira¹; Maurício Martins Baldissin¹; Nilo E. Gardin¹; Paulo Mauricio de Oliveira Vieira¹; Paulo Roberto Volkmann¹; Maristela Takeda¹; Carmen Verônica Mendes Abdala²

¹Brazilian Academic Consortium for Integrative Health (CABSIN), São Paulo, Brazil; ²The Latin American and Caribbean Center on Health Sciences Information of Pan American Health Organization/World Health Organization (BIREME/PAHO/WHO), São Paulo, Brazil; ³Universidade Paulista (UNIP), São Paulo, Brazil; ⁴Federal University of São Paulo (UNIFESP), São Paulo, Brazil; ⁵University of São Paulo (USP), São Paulo, Brazil

Introduction: This evidence map is part of a series on the clinical application of Traditional Complementary Integrative Medicines (TCIM). It presents an overview of the evidence on the effects of anthroposophic medicine, resulting from a collaboration between the Latin American and Caribbean Center for Information in Health Sciences (BIREME) and the Brazilian Academic Consortium for Integrative Health (CABSIN).

Methods: A comprehensive literature search was conducted (PubMed, BVS, EMBASE, and CINAHL). All studies were evaluated, characterized, and categorized by a group of researchers in anthroposophy in health.

Results: Were included 33 review studies (19 systematic reviews, one systematic review of randomized controlled trials, four systematic reviews with meta‐analysis, three meta‐analyses, one qualitative systematic review, and five scoping reviews. Primary studies were mainly from Germany, China, Italy, Russia, Bulgaria, South Korea, and Ukraine. Systematic reviews assess effectiveness, efficacy, and safety, including randomized clinical trials (RCTs), non‐randomized controlled trials, clinical trials and observational studies, and qualitative and quantitative studies. The AMSTAR2 tool was applied to assess the reliability level of the 33 reviews, resulting in 10 high‐level, two moderate‐level, eight low‐level, and seven critically low‐level reviews. This tool did not assess six reviews due to their qualitative or scoping nature. Interventions were organized into three groups (with subdivisions): Medications (Viscum album ‐ 22 reviews, General Medications ‐ 4 reviews), Non‐Medication Therapies (Eurythmy ‐ 2 reviews, General Therapies ‐ 1 review), and Multimodal Therapies (General ‐ 4 reviews). 63 outcomes were identified, grouped into Well‐being and Quality of Life, Cancer, Physiological and Metabolic Indicators, and Others. Most evidence focused on Cancer, followed by Well‐being and Quality of Life.

Conclusion: Positive effects (28 outcomes from 18 reviews) were mainly related to quality of life, patient safety, and chemotherapy and radiotherapy symptoms. Potentially positive effects (20 outcomes from 13 reviews) were identified for survival, chemotherapy and radiotherapy symptoms, and quality of life. Inconclusive/mixed effects were found in 15 outcomes from 11 reviews, indicating a need for more studies. No absence of effect or adverse effects were identified. This evidence map provides a comprehensive overview of the clinical effectiveness of anthroposophic medicine and can be used to inform future research and clinical practice.

OS CIM N 11 Evidence Mapping ‐ Clinical Effectiveness of Homeopathy

Ricardo Ghelman^1,5; Leoni Villano Bonamin^1,3; Holandino Quaresma Carla¹; Passos Adriana¹; Costa de Vilhena Edgard¹; Nascimento Coimbra Ednar¹; Adler Ubiratan¹; Takeda Maristela¹; Rocha Leandro¹; Schlechta Portella Caio Fábio^5,1; Cabral Schveitzer Mariana^1,4; Abdala Verônica²

¹Brazilian Academic Consortium for Integrative Health (CABSIN), São Paulo, Brazil; ²The Latin American and Caribbean Center on Health Sciences Information of Pan American Health Organization/World Health Organization (BIREME/PAHO/WHO), São Paulo, Brazil; ³Universidade Paulista (UNIP), São Paulo, Brazil; ⁴Federal University of São Paulo (UNIFESP), São Paulo, Brazil; ⁵University of São Paulo (USP), São Paulo, Brazil

Introduction: This evidence map presents an overview of the clinical effects of homeopathy. From an extensive literature search (PubMed, BVS, EMBASE, and CINAHL) conducted in February 2021, 51 review studies were included (31 systematic reviews, 13 systematic reviews with meta‐analysis, three systematic reviews of randomised controlled trials, and 13 meta‐analyses).

Method: Associations between interventions and outcomes were identified from data obtained in the primary studies included in the reviews. Each intervention was defined based on its category, type of medication, potency, and dosage. Interventions were only grouped if they were identical.

Results:

Conclusion: Considering all categories of interventions in primary studies, 49% showed positive or potentially positive effects, mainly for rhinitis and asthma outcomes. Individualised treatment showed 52% positive or potentially positive effects, complexes 54%, and Isotherapy 78%. Positive and potentially positive results were identified for respiratory tract infections in children, otitis, ADHD, irritable bowel syndrome, fibromyalgia, diarrhea, periodontitis, and postmenopausal syndrome in reviews classified as high confidence (AMSTAR 2).

OS CIM N 12 Meditation: Evidence Map of Systematic Reviews

Ricardo Ghelman^1,5; Caio Fábio Schlechta Portella^1,5; Rui Ferreira Afonso¹; Mariana Cabral Schveitzer^1,4; Verônica Abdala²

¹Brazilian Academic Consortium for Integrative Health (CABSIN), São Paulo, Brazil; ²The Latin American and Caribbean Center on Health Sciences Information of Pan American Health Organization/World Health Organization (BIREME/PAHO/WHO), São Paulo, Brazil; ³Universidade Paulista (UNIP), São Paulo, Brazil; ⁴Federal University of São Paulo (UNIFESP), São Paulo, Brazil; ⁵University of São Paulo (USP), São Paulo, Brazil

Introduction and Objective: Meditation is a contemplative practice with potential health benefits and therapeutic applications. This evidence map aims to provide an accessible, visual representation of evidence‐based information on meditation as a complementary therapy for various health conditions, benefiting patients, healthcare professionals, and managers.

Method: A search of four electronic databases from 1994 to November 2019 was conducted, including systematic reviews, meta‐analyses, meta‐syntheses, and integrative reviews. The 3iE evidence gap map methodology was utilized, with AMSTAR 2 for analyses. Tableau software was employed to graphically display confidence levels, the number of reviews, health outcomes, and intervention effects.

Results: The map includes 191 studies, with Mindfulness as the most prevalent keyword. Various meditation techniques were evaluated in different contexts, yielding high confidence levels in 22 studies, moderate in 84, and low in 82. Two meta‐syntheses and one integrative review were also included. The majority of studies reported positive effects and a beneficial potential of meditation practice. Health outcomes were divided into five groups, with mental health and vitality, and well‐being and quality of life comprising the largest number of studies.

Conclusion: Meditation has been applied in diverse areas, demonstrating its potential benefits for various populations and health conditions. This evidence map serves as a valuable visual tool to access information on meditation as a complementary therapy.

OS CIM N 13 Acupuncture for migraine prophylaxis and for patients recovering from stroke

Carlo Maria Giovanardi¹; Franco Cracolici¹; Alessandra Poini¹

¹Italian Federation of Acupuncture Societies (FISA), Bologna, Italy

Introduction and objective: The lecture will be divided into two parts to illustrate the efficacy and safety of acupuncture in migraine prophylaxis, compared with drug therapy and the role of acupuncture in the integrated management of the patient recovering from stroke with a focus on disorders such as dysphagia, aphasia, hypertonia.

Method and results: Discussion of a recent systematic review, which included 9 RCTs with 1484 patients and clinical experience within the integrative medicine department of a public hospital in Tuscany.

Conclusions: Regarding migraine, we found a slight reduction in favour of acupuncture for the number of days with migraine per month and response rate. We found a moderate effect in the reduction of pain intensity in favour of acupuncture and a significant reduction in acupuncture in both the dropout rate due to any reason and the dropout rate due to adverse events. Patients treated with acupuncture in post‐stroke rehabilitation showed high satisfaction, and the Integrative Medicine Department is now a benchmark for Tuscan healthcare.

OS CIM N 14 Use of Traditional Chinese Medicine (TCM) in facial nerve palsy

Carmelo Guido¹; Catia Vuono¹; Federica Sabatini¹; Tommaso Conti¹; Barbara Cucca¹

¹“Fior di Prugna”, Referral Center for TCM of the Tuscany Region– Local Health Unit Central Tuscany, Florence, Italy

Introduction and Objective. Facial nerve palsy (7th cranial nerve) is the most common acute mono‐neuropathy. It occurs rapidly and can result in paresis (limitation of movement) or paralysis (complete loss of movement). The latter involves the paralysis of any structure affected by the facial nerve and affects facial appearance. This condition can result from congenital, idiopathic, neoplastic, infection‐related, traumatic, malignant, diabetic, iatrogenic, and other inflammatory causes. The most frequent forms are Bell's palsy from idiopathic aetiology and Hunt's disease, resulting from herpes zoster infection with involvement and pathological manifestations also in the inner ear.

The literature confirms the efficacy of acupuncture and recommends its use, especially in the acute phase.

Methods. We report here our clinical experience on ten patients, seven women and three men, ranging in age from 10 to 86 years (mean 55 years). Sessions were conducted weekly with an average of nine treatments per patient.

The causes of seventh cranial nerve paresis were (III) H. Zoster, (II) Bell, (I) bereavement, (I) postoperative, (I) frigor, (I) tumour, (I) Guillain‐Barré. The treatment involved a combination of auricular therapy and acupuncture. In auricular therapy, semi‐permanent needles were applied to the following points: apex, trigeminal branches, thalamus, and mouth. In acupuncture, we used the following local points: ST2, ST6, ST7, TH22, LI20, SI 18, and remote points: LI4, TH5, LR3, VG20, KI3, ST36, SP6.

All treatments started at least two days after the onset of paresis up to a maximum of 6 months.

Conclusions. Our results are in agreement with the literature data. Seven patients had complete recovery and two 95% remission of symptoms. Only one patient did not show any improvement. That indicates that if treated promptly, facial paresis can be cured using acupuncture and auricular therapy, making people return to an excellent quality of life.

OS CIM N 15 Effects of flower therapy on anxiety state in climacteric women

Vanessa Damasceno Bastos; Neide Aparecida Titonelli Alvim; Talita Margonari Lazzuri

Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil

Introduction: The climacteric period corresponds to the time in a woman's life where the transition from the reproductive to non‐reproductive cycle occurs. It usually takes place between 40 and 65 years of age, constituting a period of numerous changes. Floral therapy in this phase of life can be used either as a single therapy or as complementary to conventional treatment. The objectives of this study were to analyze the clinical complaints of climacteric women and their relationship with the indicators of a diagnosis of anxiety and to evaluate the effects of floral therapy on self‐control of the anxiety status in women living in climacteric.

Method: This research reports the results of a doctoral thesis, which was carried out through individualized clinical, almost experimental, comparative clinical intervention of the before/after type using a quantitative approach, approved by the Research Ethics Committee. The field of research was the Center for Integrative and Complementary Health Practices of the municipality of Maricá, Rio de Janeiro, Brazil. The participants were women between 40 and 65 years old. Data collection was performed through individual nursing consultation, with follow‐up for six consecutive months, being a meeting each month. The individual interview was adopted, guided by a semi‐structured script, followed by the application of the Likert scale to classify nursing outcomes related to self‐control of anxiety, and this approach was used in all consultations. The vials containing the Saint Germain flower remedies were prepared by the researcher and delivered to the women from the third consultation. All consultations were recorded in magnetic medium and transcribed in full for further analysis.

Results: All nursing consultations followed the precepts of reception and integrality in healthcare. The results confirm the profile of the participants. Most (79.37%) participants did not engage in any physical activity. In addition to anxiety, women presented with sadness (100%), fatigue/tiredness (98.41%), joint pain (96.83%), hot flashes (95.24%), insomnia (93.65%), headache (88.89%), and numbness (88.89%). At the heart of climacteric care technologies, floral therapy has been gathering pace, since it meets the principles of integrality of women, raising their self‐esteem and well‐being.

Conclusion: After the development of three pre‐ and three post‐intervention consultations, the results of the research found that floral therapy allowed participants to respond to anxiety satisfactorily. There was a reduction in participants' anxiety levels of when using floral therapy, confirming the intended outcome.

OS CIM N 16 Current status and challenges of ancient TCM literature as evidence to support clinical decision‐making

Changhao Liang¹; Dingran Yin²; Jing Cui²; Yutong Fei¹

¹Centre for Evidence‐Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China; ²School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China

Background: Clinical practice guidelines for traditional Chinese medicine have become more standardized and widely accepted. The GRADE system is the most authoritative method; however, due to the unique mode of thinking and decision‐making in TCM, ancient literature and experience should be employed as evidence for clinical practice guidelines development.

Objectives: Investigate the current status and deficiencies of the ancient literature in China's clinical practice guidelines (CPGs) and expert consensus statements (ECSs) and offer methodological advice to facilitate using ancient literature evidence.

Methods: A systematic review approach was adopted. We searched seven databases (CNKI, Wanfang, VIP, SinoMed, PubMed, Embase and Cochrane) and six official websites of relevant societies to collect CPGs and ECSs in TCM published between January 1st,2018 and December 31st,2022. We used the predefined table to extract the general characteristics of the included studies, the involved ancient literature evidence usage and grading standards for descriptive analyses.

Results: The study found that most TCM guidelines and expert consensus did not refer to ancient literature when forming recommendations. Most of the guides that refer to ancient books are acupuncture guides, and there is much controversy in the literature about what kind of ancient books can be used as evidence.

Conclusions: This study systematically sorted through TCM guidelines and ECSs from 2018‐2022, analyzing their references in ancient literature evidence to explore their application's current situation and shortcomings. The scope and synthesis of ancient literature evidence should be clearly determined in future research.

OS CIM N 17 How well consensus methods apply in the development of guidelines for Traditional Chinese Medicine: A web‐based survey in China

Changhao Liang¹; Guanxiang Yin²; Jing Cui²; Ziyi Lin²; Yaqi Wang¹; Siqi Liu²; Yunzheng Chen²; Yutong Fei¹

¹Centre for Evidence‐Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China; ²School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China

Introduction: This study aimed to explore the opinions and attitudes of relevant application groups on the critical elements of the consensus methods during the guideline development process.

Methods: A cross‐sectional survey was used for this study. A structured questionnaire was distributed to stakeholders via the mobile phone application WeChat using purposeful and snowball sampling methods. People with experience of leading the development of clinical practice guidelines, participating in the consensus process in a guideline working group or expert panel, or being an external reviewer/examinator of guidelines were invited to take part. The questionnaire inquired about participants' demographic characteristics and the key issues in the consensus process related to the consensus method.

Results: A total of 2426 people participated in the survey. However, only 290 people met the eligibility requirements. The results came from 31 different provinces, with most coming from Beijing (n = 107; 36.9%). A total of 211 (72.76%) participants had senior professional titles, and 186 (64.14%) participants had guidelines ongoing. Regarding the most serious adverse aspects affecting the consensus process, the participants generally believed that the three most serious aspects were insufficient retrieval and evidence (30.7%), insufficient methodological training (19.83%), and overexpression of authority (11.16%).

Conclusions: Consensus methods are poorly standardized and are used inconsistently in the guideline development process. The results of this study provide consideration for different roles and better implementation of the consensus process in the guideline development process.

OS CIM N 18 Application of Response Adaptive Randomization and Simulations in Clinical Trials of Traditional Chinese Medicine

Tong Lin¹; Qiyou Ding²; Linhua Zhao¹; Ying Zhang³

¹Institute of Metabolic Diseases, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China; ²Beijing University of Chinese Medicine, Beijing, China; ³Center for Evidence‐based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China

Introduction: Response adaptive randomization (RAR) adjusts the randomization probability based on the treatment outcomes during the trial so that more subjects receive better therapies and can benefit from the clinical trial, which conforms to ethical requirements. This study aimed to review the research progress of RAR methods and outline their clinical application.

Methods: We retrieved articles in Pubmed, Embase, Cochrane Library and Web of Science databases from their inception to January 2023 to review the research progress of RAR methods. Doubly adaptive biased coin design (DBCD), one of the robust RAR algorithms, is more flexible with adjustable parameters and can target any allocation. We have developed the RAR platform for clinical application, which integrates data management, the DBCD algorithm and drug logistics.

Results: Through the comprehensive and systematic literature retrieval, 406 clinical trials were registered. Ninety‐six registered trials focused on psychological and mental illnesses (23.6%), followed by 57 studies on infectious diseases (14%), then respiratory diseases (54 trials, 13.3%), immune system diseases, cancers and other diseases. Only ten trials were completed with their results available, which were explicitly designed as superiority or equivalence studies to explore the effectiveness and safety of drugs and find the optimal drug dose. The sample size ranged from 88 to 501. The Bayesian RAR methods were employed in 6 trials, through which the frequent interim analysis was utilized to adjust randomization ratios based on emerging treatment outcomes to assign more subjects to the most successful groups. Four reported the number of interim analyses, and two reported early termination. The initial randomization ratios were prescribed in advance and usually not fixed with average distribution or any other clinical rational proportion. Our previous clinical research indicated that Gegen Qinlian Decoction, a classical, traditional Chinese medicine (TCM) prescription, lowered blood glucose more significantly than the control group. Simulation results showed that RAR methods assigned more patients to the TCM intervention (47 patients), superior to the previous study with 39 patients in the TCM group. In comparison, only 33 patients would receive conventional therapy. RAR methods can increase the chance of subject assignment to the superior treatment and reduce failures.

Conclusions: In conclusion, the RAR methods in clinical trials enable more subjects to receive superior interventions and satisfy ethical requirements by flexibly adjusting the randomization probability. The RAR methods and platform need generalization, providing technical and methodological support for clinical trials.

OS CIM N 19 Effectiveness and safety of Maxing Shigan Decoction for community‐acquired pneumonia: A systematic review and meta‐analysis of randomized controlled trials

Yutong Ling¹; Xuehan Liu²; Bingrui Zhang³; Qionghua Xiao¹; Zhihao Shuai¹; Rui Cai⁴; Han Bai³; Shuangsang Li³; Mingyi Yuan⁵; Yanxia Zhang¹

¹Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China; ²Centre for Evidence‐Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China; ³Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China; ⁴China‐Japan Friendship Hospital, Beijing, China; ⁵Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China

Background: Community‐acquired pneumonia (CAP) is one of the significant causes of morbidity and mortality worldwide. The standard treatment was antibiotic and symptomatic treatment. However, antibiotic resistance makes it increasingly challenging to treat CAP. Maxing Shigan (MXSG) Decoction has been reported to affect CAP positively. We aim to evaluate the effectiveness and safety of MXSG for CAP.

Methods: Eight databases (PubMed, Embase, the Cochrane Library, CNKI, Wanfang, VIP, Yiigle and Sinomed) were searched from their inception to December 21, 2022. Six reviewers independently screened studies, extracted data and used the Cochrane ROB tool to assess the risk of bias. We conducted a meta‐analysis using RevMan 5.4 when studies had high homogeneity.

Results: 68 RCTs involving 5675 participants were included. The methodological quality of included studies could have been more evident. Compared with WM, MXSG plus WM showed a beneficial effect in resolution time of fever (MD = ‐1.66 days, 95%CI ‐1.96 to ‐1.35; n = 24), cough (MD = ‐2.83 days, 95%CI ‐2.54 to ‐2.22; n = 18), phlegm (MD = ‐2.40 days, 95%CI ‐2.56 to ‐2.23; n = 9), dyspnea (MD = ‐2.73 days, 95%CI ‐3.32 to ‐2.13; n = 2), pulmonary crepitations (MD = ‐2.26 days, 95%CI ‐2.66 to ‐1.85; n = 19), absorption time of lung inflammation (MD = ‐2.93 days, 95%CI ‐3.39 to ‐2.47; n = 4) and length of hospital stay (MD = ‐1.38 days, 95%CI ‐2.54 to ‐0.23; n = 7). MXSG plus WM was superior to WM in the improvement rate of chest radiographs (RR = 1.17, 95%CI 1.14 to 1.21; n = 33). Moreover, MXSG plus WM showed positive effects on lung function, including FVC (MD = 0.25L, 95%CI 0.17 to 0.33; n = 2), FEV1(MD = 0.70L, 95%CI 0.44 to 0.96; n = 2) and PEF(MD = 14.00L/s, 95%CI 9.37 to 18.63; n = 1) compared with WM. There was no difference in All‐cause mortality (RR = 0.2, 95%CI 0.04 to 1.02, n = 1) between MXSG plus WM group and WM group. The incidence of adverse events in the MXSG plus WM group was lower than that in the WM group (RR = 0.62, 95%CI 0.41 to 0.96; n = 25). However, MXSG alone showed no difference in C‐reactive protein, white blood cells and improvement rate of chest radiograph compared with either the WM group or the placebo group.

Conclusions: Evidence of limited quality indicated that MXSG plus WM may shorten the duration of symptoms and improve the infection indices, chest radiograph and lung function. Meanwhile, adding MXSG may reduce the incidence of adverse events. Further, well‐designed RCTs should be required to confirm their effectiveness and safety.

OS CIM N 20 Methodological issues with Zelen's design and its applications in Traditional Chinese Medicine clinical trials

Run Lin¹; Tong Lin²; Xiankun Lu¹; Yingying Chen¹; Qiji Zhou¹; Ying Zhang¹

¹Beijing University of Chinese Medicine, Beijing, China; ²Guang'anmen Hospital, Beijing, China

Introduction: Classical randomized controlled trials often face difficulties in enrolment and compliance due to subjects' preference for the randomization scheme. Zelen's design can largely resolve these issues through randomizing subjects before the informing stage. This study systematically reviewed the progress of Zelen's design and its modifications in Traditional Chinese Medicine (TCM) clinical trials and clarified its methodological elements, advantages, and limitations.

Methods: A systematic literature search was conducted for Zelen's design from the inception of databases (PubMed, Cochrane Library, CNKI, WanFang, and VIP) to February 2023. Data extracted included sample size, population characters, length of follow‐up, Zelen's model, group shifting, and statistical methods.

Results: In total, eight trials were included. In these eight trials, the sample size ranged from 40 to 282. With regard to the participants' sex, the proportion of females ranged from 43.33% to 77.6%, except for one trial where the participants were all male. The average age was 54.76 years old. The follow‐up time ranged from 21 days to 18 months. Two trials were on allergic rhinitis, and two were on osteoarthrosis diseases. The remaining four trials were on cerebrovascular disease, chronic metabolic disease, digestive system disease, and muscular system disease. Regarding types of consent, half of the trials used double consent (n = 4; 50%). One trial used a modified Zelen's design nested within an observational study, which used two‐stage informed consent. Four trials switched groups. Three of them used single consent, in which participants assigned to the experimental group refused to accept the experimental treatment and changed to the control group. Two trials combined intention‐to‐treat analyses and as‐treated analyses. Three trials had no dropouts, and three trials excluded the data of participants who did not complete the trials.

Conclusions: Zelen's design has a broad application in clinical trials. Investigators of TCM clinical trials could increase participant compliance by using Zelen's design. However, it should be noted that there are still methodological issues that should be clarified in advance.

OS CIM N 21 Traditional Chinese Medicine for pain related to respiratory virus infection: an overview

Yueyi Zhang¹; Xuehan Liu¹; Bingrui Zhang¹; Yuhan Liu¹; Xinbin Zhang¹; Yutong Ling¹; Tian Zhang¹; Chunli Lu¹; Xinyan Jin¹; Jianping Liu¹

1Centre for Evidence‐Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China

Introduction: Pain is the most frequent symptom after COVID‐19, and the prevalence is 27.9%. Painkiller was the most common drug in pain, but it can cause gastrointestinal symptoms or other adverse events (AEs). Traditional Chinese medicine (TCM) showed potential effectiveness in pain management. We aimed to summarize the evidence of TCM for pain related to respiratory virus infection to support further clinical practice and research.

Methods: Eight databases (CNKI, Wanfang, VIP, Sinomed, Yiigle, PubMed, Cochrane Library, Embase) were searched from inception to July 13, 2022, to identify randomized controlled trial (RCTs), clinical controlled trials (CCTs), cohort studies and case‐control studies that evaluated TCM for pain related to respiratory virus infection. All types of pain and respiratory virus were considered. Reviewers independently selected studies. Information was extracted, including participants' characteristics, interventions, comparisons, and outcomes.

Results: 65 studies were included (involving 6828 participants), including 48 RCTs, 12 CCTs and five cohort studies. Only two publications were in English. All included studies focus on respiratory virus infection instead of pain. The most respiratory virus types were influenza (43 studies; 66.2%) and SARS‐CoV‐2 (8 studies; 12.3%). The types of pain were sore throat (57 studies; 87.7%), myalgia (30 studies; 46.2%), headache (27 studies; 41.5%), headache and body pain (3 studies; 4.6%), chest pain (3 studies; 4.6%) and abdominal pain (2 studies; 3.1%). The most common interventions were Chinese patent medicine (31 studies; 47.7%) and TCM decoction (31 studies; 47.7%). Only two studies (3.1%) used acupuncture and moxibustion. Thirty‐nine studies (60%) used TCM combined with conventional and basic treatments, while 26 (40%) used TCM alone. The most outcomes were pain symptom disappearance time (19 studies; 29.2%), remission time (17 studies; 26.2%) and disappearance rate (16 studies; 24.6%), remission rate and the score of general symptoms (14 studies; 21.5%). Half of the studies reported AEs but no serious AE.

Conclusions: Oral Chinese medicine was the most common intervention for pain related to respiratory virus infection. Our analysis may have been affected by the limited information provided in the studies, such as the need for a definition of symptom relief. In addition, all types of pain can affect the quality of life, so it is essential to research them to evaluate the effectiveness of TCM. Further well‐designed and reported studies are recommended to confirm the effects of TCM for relieving pain related to respiratory virus infection.

OS CIM N 22 Clinicians' and pharmacists' perceptions, attitudes, and clinical practices regarding herb‐drug interactions: a cross‐sectional survey

Chen Shen¹; Ming Yang¹; Lijiao Yan¹; Jingyi Xu^3,2; Jianping Liu¹

¹Beijing University of Chinese Medicine, Beijing, China; ²First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China; ³National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, China

Objective: This cross‐sectional survey aimed to explore the perspectives, attitudes, and practices of pharmacists and clinicians regarding herb‐drug interactions between Chinese and Western drugs.

Methods: A purposive sampling method was used to select hospital pharmacists, oncologists and clinicians with an internship in oncology as respondents for a web‐based questionnaire survey. The survey was conducted using the Wenjuanxing platform, which offers similar functions to Amazon Mechanical Turk, from March to April 2022. The questionnaire content was created based on a comprehensive literature review and expert evaluation. Respondents were carefully screened, and the questionnaire links were forwarded to corresponding clinicians' and pharmacists' WeChat groups. The questionnaire had four domains: baseline information, perceptions, attitudes, and clinical practice. We used SPSS 20.0 software to perform statistical analysis.

Results: We included 258 valid questionnaires, 176 completed by physicians and 82 by pharmacists. Our findings showed that over half of the clinicians (56.25%) and pharmacists (57.32%) indicate that their knowledge of the interactions between Chinese and Western medicine is average. Practitioners specializing in Traditional Chinese Medicine (TCM) and those in integrative Chinese and Western medicine had a significantly better understanding of such interactions than their Western medicine counterparts (F = 4.911, P = 0.008). There were significant differences in the attitudes of TCM practitioners, Western medicine practitioners, and integrated TCM‐Western medicine practitioners towards enhancing the effectiveness and reducing the toxicity of Chinese medicine (χ2 = 9.928, P = 0.010). In clinical practice, some practitioners (34.09%) and pharmacists (37.8%) only evaluate the interactions when they believe there are important issues or serious adverse reactions. Pharmacists believe that the current difficulties in the clinical application are mainly due to the interpretation of pharmacokinetics and pharmacodynamics of TCM‐Western medicine interactions and the unclear definition of their clinical significance. (χ2 = 3.877, P = 0.049).

Conclusion: Both clinicians and pharmacists have an average understanding of Chinese and Western drug interactions. However, some healthcare professionals may only evaluate a patient's prescription for potential problems if necessary, such as in cases of severe adverse reactions. Most studies on Chinese and Western drug interactions have focused on pharmacokinetic and pharmacodynamic aspects, and their clinical significance still needs to be determined. Therefore, there is a need for a more thorough investigation of the clinical relevance of these interactions, as well as efforts to increase awareness and improve current practices surrounding Chinese and Western drug interactions.

OS CIM N 23 Epigenetic breastfeeding

Eleonora Lombardi Mistura¹

¹SIPNEI, Bergamo, Italy

Introduction and objective: Breast milk is recognized by the most important Scientific Societies as an extremely beneficial food for the child and the nurse both in the short and long term and exclusive breastfeeding is recommended for at least the first six months of life. If the short‐term benefits can be traced back to the direct action of substances (nutrients and otherwise) present in breast milk, the long‐term ones have more complex roots of an epigenetic nature. The objective of our presentation is to understand if HU (Human Milk) can be called an “epigenetic regulator” for newborns in light of new scientific evidence.

Methods: Scientific Literature Review and insight into main “epigenetic breastfeeding's” discoveries from 2016 to 2023.

Results: The mechanisms through which breastfeeding acts epigenetically are essentially three; activation of enzymes that produce the tags, activation of nuclear receptors, and production of epigenetically active metabolites by the microbiota. Human milk contains maternal milk exosomes (MEX) with microRNAs, circular RNAs, and long coding RNAs, different from woman to woman. MEX has the power to cross the neonatal intestinal epithelium and arrive intact, with their information load, to all the infant's organs. They change in number and quality depending on whether the birth is preterm or at term and depending on the distance from the birth. They can be considered “ markers “ mediating the communication between mother and newborn. They are able to regulate enzymes that produce epigenetic marks such as DNMT1 (DNAmetyltransferase 1), to regulate genes that produce cells. growth or apoptosis, to promote or maintain intestinal tight junctions, and to promote the maturation of stamina cells also contained in human milk, Also the set of bacteria contained in human milk (MOM: Milk Oriented Microbiota) is important as an epigenetic regulator. Most of the MOM is made up of Bifidobacteria coming from the maternal gut. Scientific studies report that MOM contributes to the production of metabolities, such as SCFA (Short Chain Fatty Acids: acetoacetic, propionic, butyric acid), influencing the “epigenetic program” of the infant and epigenetic marks' enzymes.

Conclusions: In consideration of all the scientific data contained in the scientific literature we can say that the newborn is not only “breastfed” but also “breast programmed” by the epigenetic power of human milk.

OS CIM N 24 Clinical experience of Neuroacupuncture in Parkinson's Disease

Enrica Armienti¹; Cecilia Lucenti¹

¹Agopuntura Medica Integrata AMI, Pisa, Italy; ²Agopuntura Medica Integrata AMI, Siena, Italy

Introduction: Neuroacupuncture means the use of different specially developed techniques (including craniopunctures and French auriculotherapy) or specific modalities of point stimulation to achieve results in severe neurological pathology. The choice of points does not necessarily make use of energy or TCM diagnosis, but more specifically addresses anatomical districts, affected muscle chains or the Western neurofunctional diagnosis of the pathology to be treated (spasticity, dystonia, balance disorder, coordination disorder, dysarthria). Neuroacupuncture originated in the 1970s in both the East and the West and has seen numerous Masters develop different techniques in the light of neuroscience and today allows for great clinical efficacy in a relatively simple and cost‐effective way. Various experiences around the world, starting with the founders of the eponymous techniques Dr.Zhou and Dr.Yamamoto, have integrated treatments based on the principles of Neuroacupuncture to rehabilitation and therapeutic movement, achieving valuable results in terms of motor and functional improvement in patients with even severe and chronic neurological diseases, where it is the common domain of specialists that there is little margin for recovery.

Methods: This paper describes the clinical experience of ten Parkinson's disease patients with different’ stages and functional characteristics who underwent 10 sessions of neuroacupuncture, with or without rehabilitation training during treatment. Patients were assessed with functional scales for motor function (Timed Up and Go Test), balance (Berg Balance Scale) and the third section of the UPDRS before treatment and every 4 weeks during treatment to monitor improvements and were also asked to report their subjective well‐being.

Results: All patients experienced an improvement of subjective well‐being and capacities in daily living activities. No patient needed to increase drug therapy during the treatment period. No patients experienced a worsening of the functional scales, which remained stable or minimally improved. Slowing the progression of disability is a major goal in patients with Parkinson's disease.

Conclusions: It is necessary and interesting to perform long‐term follow‐up to consolidate conclusions about the use of these techniques in a systematic way in these patients.

OS CIM N 25 Neuroacupuncture is a feasible future for integrating acupuncture into physician training and clinical practice. A university training model experienced in Italy

Cecilia Lucenti¹; Barbara Spano'¹

¹AMI Agopuntura Medica Integrata, Siena, Italy

Introduction: Neurological diseases have an impact on the sustainability of the health and social system. The World Health Organization reported an increase in neurological diseases. New evidence for the benefits of acupuncture in various neurological disorders is emerging seemingly every week, suggesting that acupuncture's benefits in neurological conditions can be maintained long term. Neuro‐acupuncture is an emerging field as a contemporary acupuncture technique integrating traditional Chinese needling methods, auricular acupuncture and scalp acupuncture with western medical knowledge, neuroscience, and neurological rehabilitation. Neuro‐acupuncture produce rapidly remarkable results in the treatment of acute and chronic central nervous system disorders. These techniques have been developed in the modern era under the stimulus of neuroscience and can be learned in a relatively simple way by doctors and are easy to apply in all clinical contexts.

Objective: Thanks to its characteristics (proven clinical efficacy, advanced standardization, economic and practical feasibility) neuro‐acupuncture is an excellent opportunity to incorporate acupuncture into standard physician education and, thus, insert into real clinical pathways. Healthcare providers and neurologists in particular need to be educated to apply neuro‐acupuncture in order to have more patients treated precociously. Here we report our idea and experience at University of Siena (Italy) of an integrated and complete neuro‐acupuncture training to disseminate the clinic of neuro‐acupuncture.

Methods: At the University of Siena, AMI (Medical Integrated Acupuncture) association has promoted for 3 years a university post‐graduate course “principles and techniques of Acupuncture in Neurology” which has seen over 60 doctors trained in the various subjects of neuro‐acupuncture. In Italy acupuncture is provided only by doctors who usually need to go beyond the technique to include it in an overall medical thought and Neuroacupuncture allows for the creation of correlations that encourage daily clinical integration. The educational course included the mechanisms of action of acupuncture on nervous, vascular and metabolic systems, the uses of acupuncture on the central nervous system and the principles of neurofunctional rehabilitation with acupuncture. The main modern and traditional methods used in the world were analyzed to identify and use their specific neurophysiological contribution: bottom‐up brain stimulation, top‐down mechanisms of stimulus recognition, stimulation of the trigeminal system and the brainstem.

Results and Conclusion: All physicians with a relatively short study path have been enabled to effectively use these treatments in the daily clinic in neurological disorders and continued their technical study. Theoretical and clinical awareness among doctors improve access to treatments in neurological diseases.

OS CIM N 26 One Health model and Integrative Medicine

Francesco Macrì¹

¹SIOMI, Rome, Italy

Introduction: Can we assume a positive attitude towards those who say something different placing reasonableness at the basis of every evaluation? We are required to address concepts relating to the possibility of realizing the One Health project and its connections with the Homeopathy and the Integrative Medicine model in general, based on the observation of how the contrasts between defined conventional medicine and “different” medicines can be solved by changing our perspective on human health.

The diagnosis as well as the therapy corresponding guideline, should not be read in rigid procrustean terms in which to link the multiplicity of the disease, but cardinal points by which to orient oneself, bypassing the doctrinaire and instrumental method which believes it encompasses the patient's complessity, so to form an integrated, dynamic and open knowledge.

One Health wants consider the patient and his life experience in an area made up of rhythms and spaces, of body and mind, inserted in a system that provides for the balance between the health of the human being, of the animal and of the ecosystem.

Integrative Medicine, affirming the principles of interdisciplinarity, is the best representation of One Health's concepts, with repercussions not only at the patient's care level, but also in the research fields, leading to a type of research that is not only statistical but also clinical, not only quantitative but also qualitative.

OS CIM N 27 A comprehensive database of scientific evidence: a vital need for the homeopathic community

Francesco Marino¹

¹FIAMO (Federazione Italiana delle Associazioni e dei Medici Omeopati), Rome, Italy

Background: In the last decade Homeopathy suffered several worldwide attacks via media by skeptics because of its supposed “lack of evidence”. Statements and studies full of bias and prejudice were published to denigrate Homeopathy as a “pseudoscience”. Such a persecution provoked an incredible loss in terms of patients, new students and public consents. However, in the last 50 years evidence in favor of Homeopathy increased more and more. Therefore, a “comprehensive” and systematic database is imperative in order to collect all the reliable studies which were published and indexed in the scientific literature.

Materials and Methods: To evaluate references from main electronic databases (Pubmed, Embase, Core‐Hom, Google Scholar, Scopus) in order to systematize the best evidence at any level of research.

Results: Presently, a database has been created containing almost 1,146 reliable evidence. The results for Homeopathic research are encouraging, as regards the following studies:

SR: 101

Metanalises: 26

RCTs 247

Observational: 128

Veterinary: 109

Agro‐Homeopathy: 96

pre‐clinical: 219

Chemical‐Physical: 156

case Reports: 64

Thanks to special filters it is possible to select the studies according to year, author, journal, title, topic, page, condition, model, category.

The database has been implemented in the FIAMO website and protected by a password. Moreover, it will be updated every 3 months and shared with the whole (national and international) Homeopathic Community. It will be also available to patients, Institutions, stakeholders and media.

Conclusions: In the last 50 years evidence in Homeopathy has been increasing both at a quantitative and qualitative level. Unfortunately, it is neither well known by homeopaths themselves nor by the medical and scientific community. A comprehensive database is fundamental not only to defend but also to promote a worldwide recognition of Homeopathy as a significant field of Medicine. Finally, this database aims to be harmonized with all the other homeopathic databases already existing so that a unique “all inclusive” database can be created for e everyone.

OS CIM N 28 Understanding cerebro‐asthenia (Zuf al Dimagh): A rational approach for its assessment and treatment in clinical practice

Mohammad Nawab¹; Khan Javed Ali¹

¹National Research Institute of Unani Medicine for Skin Disorders, Opp ESI Hospital, Erragadda, 500038, Hyderabad, India

Introduction: Zuf al‐Dimagh (ZD) (Cerebroasthenia) may be defined as the clinical condition in which Quwwat‐i‐Hafiza (Faculty of Memory), Quwwat‐i‐Fikr (Power of Thinking) and Quwwat –i‐Takhayyul (Power of Imagination) are disturbed and may present as mild headache, anxiety, memory loss, speech impairment and impaired thoughts. Its manifestation may be correlated as mild to moderate cognitive impairment which represents the transition phase between the state of normal cognition and dementia. Early diagnosis and treatment of mild cognitive impairment may delay subsequent development of dementia. This study aimed to describe assessment criteria of ZD and to evaluate the efficacy of a Unani formulation Khamira Gawzaban Sada in its treatment.

Materials and methods: An open label single arm clinical trial was conducted to assess the efficacy and safety of a Unani formulation Khamira Gawzaban Sada (KZS) in ZD. The participants (n = 72) of both gender aged between 19 years and 70 years having Mini Mental State Examination (MMSE) score between 10 and 23 were included in the study. A Unani pharmacopoeial formulation (10 gm) was given once daily after breakfast in the morning for 6 weeks. The efficacy assessment criteria were post treatment difference in MMSE score from baseline and change in quality of life score from baseline to post treatment. Systemic safety was assessed on the basis of haematological and biochemical parameters. The data was analyzed as per protocol using paired t‐test for determination of safety and efficacy of the UF.

Results: An interim analysis of the study showed that the KZS significantly improved subjective parameters and cognitive impairment in 6 weeks post treatment. Out of 72 participants, 8 participants (11%) had excellent response, 30 participants (41.6%) had Good response and 34 participants (47.2%) had fair response to the treatment. The statistical analysis revealed that the change in MMSE score from baseline (23 ± 0.5) to post treatment (29.6 ± 0.5) was significant (p < 0.05). The quality of life score of the participants also improved significantly from 23 ± 2.2 to 40.6 ± 1.7. The baseline compared to post treatment haematological and biochemical parameters had not shown any significant change.

Conclusion: The Unani formulation KZS was found effective and safe in the treatment of ZD in the interim analysis of the study. The change in MMSE score and quality of life score was clinically and statistically significant. The issue of tolerability and compliance of KZS was not reported in any participant.

OS CIM N 29 How to overcome the fragmentation in the homeopathic world hampering the integration of homeopathy?

Antonella Ronchi¹

¹FIAMO, MIlan, Italy

Introduction: The integration process of homeopathy finds many obstacles. Some come from outside and arise mainly from the lack of recognition of the scientific value of homeopathic medicine: a prejudice that is hard to get rid of. But an important obstacle is also the fragmentation of the homeopathic world, unable to present itself with a coherent voice to the conventional medical community and patients.

The aim of this report is to review what has been done so far to overcome this internal obstacle and to propose possible solutions.

For many years I was President of FIAMO and in this role I tried to make a contribution by actively participating on behalf of the ECH in the drafting of European Standard 16872 'Services of Medical doctors with additional qualification in Homeopathy (MDQH)‐ Requirements for health care provision by MDQH' which defined the services offered by a doctor with additional competence in homeopathy, published in 2016.

Despite this important acquisition, the homeopathic world is still too fragmented.

The FIAMO Council has identified the Consensus Conference as the tool to overcome this impasse.

The general purpose of a Consensus Conference is to produce evidence‐based recommendations that are useful to assist practitioners and patients in the appropriate management of specific clinical situations on specific and controversial issues. These are issues on which there is no consensus of opinion and which often lead to a considerable lack of consistency in clinical, organizational and healthcare management behaviors. This distinguishes consensus conferences from guidelines, which instead refer to topics with fundamentally established knowledge, or at least that is how they are considered at the time of drafting.

The Consensus Conference could enable the homeopathic world to overcome differences of opinion and to base clinical decisions on the one hand on what constitutes the core of the homeopathic method, and on the other hand on what defines and enhances the richness of the different methodological approaches.

FIAMO has therefore promoted a Consensus Conference with the aim of defining the essential and common core of homeopathic medicine, but also the recognition of the different levels of intervention peculiar to each type of approach. Indeed, each practice has its own rationale that must be understood, justified and acknowledged.

The topics to be addressed will certainly be those that belong to the core of homeopathic medicine, such as similarity, experimentation on the healthy, single remedy, and those more amenable to discussion, such as modes of experimentation, case collection and case analysis, systematization and/or grouping of medicines according to various characteristics (periodic table, botanical and zoological families), etc.

Only this clarity will enable doctors and patients to make informed choices and to respond to the health needs of the population.

OS CIM N 30 Practical applications of pharmacogenetics in anticoagulant treatment

Ana Sabater¹

¹Eugenomic, Bacelona, Spain

Introduction: When treating patients with anticoagulants and/or antiplatelet medications, it is crucial to consider the patient's genetics and possible drug interactions. Failing to do so can have serious consequences, such as hemorrhage or thrombosis. The standard protocols for anticoagulation therapy are often inflexible, with no established algorithms for determining the most appropriate dose or medication(s) based on the patient's genetics.

To ensure the best outcomes, it is essential to first determine the patient's genetics and then select the most suitable drugs. Waiting until after an adverse event has occurred is not a reliable strategy. While hemorrhages and thrombosis can still occur even when taking into account genetic factors, the use of pharmacogenetics may be a powerful tool in preventing drug adverse reactions.

Linked to the world of health and the IT business for more than 14 years, Ana Sabater leads the EUGENOMIC project, a reference in genetics and pharmacogenetics in Europe. Her training in IT and marketing, as well as her commitment to personalized and quality healthcare, have led her to the development and commercialization of the innovative pharmacogenetic interpretation software g‐Nomic^®, a cutting‐edge tool for medical prescription.

In the field of training, Ana Sabater lectures on practical applications of pharmacogenetics at the University of Barcelona and has given more than 40 international presentations on pharmacogenetics.

OS CIM 31 Scientific evidence for the use of auriculotherapy in primary health care

Charles Tesser¹; Lucio José Botelho¹; Maria Gorete Monteguti Savi¹; Melissa Costa Santos¹; Emiliana Domingues Cunha Silva¹; Ari ojeda Ocampo Moré¹; João Eduardo Marten Teixeira¹; Marcos Lisboa Neves¹; Fátima Terezinha Pelachini Farias¹; Joyce Ribeiro Rothstein¹; Rina Dambi Yang Lee¹; Luciana Kiehl Noronha¹; Andrea Ruschel Träsel¹

¹Universidade Federal de Santa Catarina (UFSC), Florianópolis, Brazil

Introduction and objective: Auriculotherapy has been more used in primary health care (PHC) in Brazil. Our objective is to present a synthesis of 15 systematic reviews (SR) on the efficacy of auriculotherapy that supported recommendations of this technique for common problems in PHC.

Methods: We selected common problems in PHC for which there is evidence evaluating the use of auriculotherapy: anxiety, insomnia, obesity, low back pain, smoking, depression, headache, nausea/vomiting, dysmenorrhea, constipation, rhinitis, alcoholism, dental problems, osteoarthritis and chronic pain. We systematically searched 15 databases looking for clinical trials (CTs) for these problems in English, Spanish and Portuguese. Complementarily, systematic reviews (SRs) that included studies in other languages and expanded the empirical basis were analyzed. Quality was assessed as per the Scottish Intercollegiate Guidelines Network (SIGN 50, 2019) for CTs and RSs. CTs that compared auriculotherapy (with seeds, spheres or retention needles) with at least one control group were included. The selection of publications, quality assessment and data extraction were carried out by two independent researchers, accessing a third party in case of conflict. The main characteristics of the studies, outcomes and results were extracted.

Results: The searches produced 142 to 1928 publications from which 3 to 24 were included for each issue. 109 CTs were included: 11 high quality, 28 acceptable, 59 low quality and 11 unacceptable, leaving 98 CTs. 32 SRs were included: 11 high quality, 16 acceptable, 4 low quality and 1 unacceptable (excluded). Most of the people included had comorbidities, from hospitals or specialized clinics. Participant numbers ranged from 8 to 645 in CTs, and from 369 to 8204 in SRs. Treatment time ranged from 1 day to 12 weeks (generally 1 to 4 weeks), mostly without further follow‐up. There was a strong convergence of results between EC and RS: almost all studies showed clinically and statistically positive results, maintained after excluding the worst studies.

Conclusions: Despite the few studies on specific problems, the short follow‐up time, the few PHC participants and the low quality of the CTs, the convergence of results associated with the other three pillars of evidence‐based care (experience of therapists – favorable; institutional, clinical and sociocultural context of PHC associated with low cost and risk, simplicity and speed of application of auriculotherapy – favorable; patients' values and preferences – generally favorable) allows us to defend a strong and positive recommendation for the use of auriculotherapy as a complementary therapy in PHC.

OS CIM N 32 The core components of traditional Chinese medicine complex interventions and their connections: A qualitative study with Chinese clinicians

Xiaowen Zhang¹; Ma Sisi¹; Yu He¹; Liu Jianping¹

¹Beijing University of Chinese Medicine, Beijing, China

Introduction and objective: It is acknowledged that traditional Chinese medicine (TCM) could be regarded as a complex intervention, and qualitative interview has been applied into TCM to identify the deep context recently. However, most of the studies focused on one specific intervention or disease when choosing or using TCM as unique therapy rather than taking TCM as a whole system approach. This study aims to identify the core components of TCM intervention and their connections, and establish the framework of TCM complex interventions in the real world setting.

Methods: We applied purposive sampling to select TCM clinicians until thematic saturation was reached. All participants with informed consents were invited to take part in semi‐structured interviews on their experience and cognition of TCM intervention between March 2019 and January 2020. The transcribed interviews were coded by researchers in pairs using NVivo 12 plus. All the original words were analyzed using deductive and inductive coding approaches followed by thematic analysis based on grounded theory.

This study was approved by the Ethics Committee of Beijing University of Chinese Medicine (No. 2020BZHYLL0102).

Results: Forty‐four TCM clinicians were interviewed, and the recorded of interviews were transcribed into 452,293 Chinese characters. We extracted all the transcribed interviews into 2461 opening codes, and classified into 5 categories: medical therapies, psychology, practitioner's advice, social relationship, and behaviors. The first three categories, including medical therapies, psychology, practitioner's advice, were regarded as ‘hard’ intervention, which directly connected with etiology, the body status, and treatment effectiveness; the last two categories including social relationship and behaviors as ‘soft’ intervention, which may change with the communication between clinicians and patients, and play a potential role during the whole process of the intervention. Meanwhile, during the TCM complex intervention, multi‐therapies may apply, and social relationship may interact with the behaviors of clinicians‐patients. In addition, clinicians could improve their professional skill by studying classics, accumulating clinical experience, keeping morality and passion. Finally, it could be important to keep valid communication between clinicians and patients in order to establish mutual trust.

Conclusions: From the perspectives of clinicians, the core components of TCM complex intervention are medical therapies, psychology, practitioner's advice, social relationship, and behaviors. Each component matters in different degree in practice and interacts with each other. This study can be helpful to further understand the characteristics of TCM complex intervention and provide qualitative evidence for the future clinical trials on TCM.

OS CIM N 33 Traditional Chinese medicine for olfactory dysfunction: A bibliometric analysis of published clinical studies

Xiang‐yun Zou^1,2; Xue‐han Liu¹; Chun‐li Lu^3,1; Xin‐yan Jin¹; Bai‐xiang He^1,2; Yi‐lei Liao^1,4; Ting Liu^1,5; Yi‐dan Dai^1,5; Shi‐hao Qi^1,6; Zhu‐jun Sheng^1,7; Jian‐ping Liu^1,8

¹Centre for Evidence‐Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China; ²Department of Gastroenterology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China; ³Institute of Chinese medicine, Guangdong Pharmaceutical University, Guangzhou, China; ⁴Guanganmen Hospital, Beijing University of Chinese Medicine, Beijing, China; ⁵Beijing Hospital of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China; ⁶Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China; ⁷The Third Affiliated Hospital, Beijing University of Chinese Medicine, Beijing, China; ⁸The National Research Center in Complementary and Alternative Medicine (NAFKAM), Department of Community Medicine, Faculty of Health Science, UiT The Arctic University of Norway, Tromsø, Norway

Introduction and objective: Olfactory dysfunction (OD) is changed sense of smell. A population prevalence of 5 % was found for absence of anosmia and 15 % for hyposmia. Many studies have shown that traditional Chinese medicine (TCM) are effective in the treatment of OD. Therefore, we conducted a bibliometric analysis on TCM for OD to reveal trends and hot topics in the field.

Methods: We searched all types of clinical studies on OD treatment with all kinds of TCM modalities in eight databases (China National Knowledge Infrastructure, Chinese Scientific Journal Database, SinoMed, Wanfang,and Yiigle, PubMed, Cochrane Library and EMBASE) from their inception to May 5, 2022. Data were extracted and analyzed in Excel 2016 including study characteristics, type of diseases, treatments, comparisons, outcomes, efficacy, and adverse events.

Results: A total of 314 studies published from 1963 to 2022 were included, including 178 (56.69%) randomized controlled trials, 67 (21.34%) case reports, 46 (14.65%) case series, 15 (4.78%) non‐randomized controlled trials, five (1.59%) systematic reviews, two (0.64%) cohort studies and one (0.32%) case controlled study. There was an overall growth trend in the number of articles published, with the highest number of articles published in 2021 (n = 32, 10.16%). The top three common type of disease was chronic rhinosinusitis (ICD11: CA0A, n = 191, 60.83%), chronic rhinitis (ICD11: CA09.0, n = 92, 29.30%), nasal sinusitis disorder (ICD11: SC91, n = 41, 13.06%). And the most common type of OD was hyposmia (n = 187, 59.55%). The top three common TCM modalities were oral Chinese herbal medicine (n = 152, 48.41%), acupuncture (n = 81, 25.80%), and nasal irrigation used Chinese herbal medicine (n = 33, 10.51%). The most frequently used comparison was TCM combined western medicine vs western medicine (n = 97, 30.89%). And The most common outcome for OD was the effective rate of treatment (n = 135, 42.99%). In addition, 43 studies (13.69%) did not report the outcome of OD separately. Most of studies (n = 239, 76.11%) reported positive effects of TCM for OD, only 75 studies (23.89%) reported uncertain effects. No severe adverse events related to TCM were reported.

Conclusions: Chinese herbal medicine, nasal irrigation and acupuncture are effective for the treatment of OD. In additional, the current researches are mainly about respiratory system related OD, and more clinical studies on the TCM for OD caused by other diseases are needed to determine the effectiveness of TCM.

OS CIM 34 Effectiveness of Reflexology, and Sham Reflexology on Preoperative Anxiety in Patients Undergoing Laparoscopic Cholecystectomy: A Single‐Blinded Randomized Controlled Trial

Samuel Attias¹; Keinan Boker Lital¹; Schiff Elad¹

¹Bnai Zion Medical Center, Haifa, Israel

Background: Preoperative anxiety is a common phenomenon which is insufficiently addressed. The effectiveness of reflexology for reducing preoperative anxiety in comparison to sham‐reflexology and conservative treatment was assessed in this trial.

Methods: We conducted a randomized controlled single‐blinded trial with 300 patients undergoing elective laparoscopic cholecystectomy. Study subjects were randomly assigned to three groups of equal size: 1. Conservative treatment based on anxiolytic drugs as prescribed by an anesthesiologist. 2. Conservative treatment + reflexology. 3. Conservative treatment + sham‐reflexology.

Anxiety levels were assessed by means of the VAS‐A (Visual Analogue Scale for Anxiety) questionnaire, which patients used to rate their anxiety level between 0‐10. Anxiety levels were evaluated in the holding room (where patients wait ahead of surgery) before providing reflexology treatment (“pre”), and once again after treatment before entering surgery (“post”). The ANOVA test together with Post‐Hoc and a non‐parametric test were performed to examine the association between group assignment and the change in pre‐ and post‐intervention anxiety levels. analyze the data.

Results: A total of 300 patients were enrolled in the study. 101 patients were assigned to the reflexology group, 99 to the sham‐reflexology group, and 100 to the standard‐treatment‐only group. Across the entire sample, the mean anxiety score upon entering the holding room was 5.3, according to the VAS‐A questionnaire. The mean difference in the VAS‐A anxiety scores before and after the holding room intervention between the reflexology group and the sham‐reflexology group was 0.8, which is statistically (p = 0.022) but not clinically significant. In the subgroup classified as having medium‐to‐high anxiety level, the parallel difference was 1.3 points, which is clinically and statistically (p = 0.023) significant.

Conclusions: Reflexology treatment is more effective than sham‐reflexology and standard care alone in reducing preoperative anxiety in patients experiencing medium‐to‐high anxiety.

OS CIM 35 From Burnout to Breakthrough. Mental Health at German Hospitals: Grey Literature Review with Semi‐structured Interviews

Julia Katharina Schiele^1,2; Anna Katharina Koch¹; Daniela Adam³; Julia Berschick¹; Marleen Schröter¹; Sylvia Reschke¹; Wiebke Stritter¹; Sarah Blakeslee¹; Jalid Sehouli¹; Georg Seifert¹; Christian Kessler^3,2

¹Department of Paediatrics, Division of Oncology and Haematology, Charité Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt‐Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany; ²Department of Internal and Integrative Medicine, Immanuel Hospital Berlin, Berlin, Germany; ³Institute of Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt‐Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany

Introduction and Objective: Health care professionals are increasingly affected by stress and burnout. Therefore effective projects to support mental health and resilience are needed. Concepts such as Mind‐body medicine (MBM) approaches have been proven to contribute significantly in antagonizing the multidimensional construct of burnout. For a sustainable implementation of alike concepts, research about existing projects is necessary. This review evaluates current stress‐ and burnout‐prevention projects in German hospitals for healthcare professionals with the focus on content and implementation.

Method: A grey literature search was conducted in Google and Google Scholar search machines between March and April 2022, limited to the years ≥2017. Included projects targeted workplace health promotion for (1) nurses or/and physicians at German hospitals, (2) were conducted in presence, blended or hybrid, (3) modular or consecutive, that (4) explicitly aimed to reduce stress or to prevent burnout with resilience‐ or mindfulness‐based interventions. Project leads were interviewed about learnings, results, acceptance, content and formate between June and July 2022.

Results: Out of 55 projects identified, five were included; two at university hospitals and three at non‐university hospitals. Projects included 1) a peer‐based stress training; 2) an empathy‐based coaching concept; 3) a care‐focused webinar and on‐site behavioural prevention and healthy working support project; 4) a tailored nurse workshop project; 5) a blended weekly e‐learning online‐course on healthy routines and relaxation. Four out of five were scientifically evaluated. Interview results reported on the course design, target‐group orientation, didactic structure and institutional integration.

Conclusions: Stress‐ and burnout‐prevention projects exist at some German hospitals but vary significantly in content and scientific evaluation. This review reflects the importance of need‐based and low‐threshold approaches, utilising interpersonal potential and fostering incremental organisational changes beyond behavioural aspects on mental health among health care professionals.

OS CIM N 36 Exploring the process of health behaviour change in traditional acupuncture practice: A longitudinal qualitative study

Felicity Bishop¹; Jonquil Pinto¹; Katherine Bradbury¹; Dave Newell^2,1

¹University of Southampton, Southampton, United Kingdom; ²AECC University College, Bournemouth, United Kingdom

Introduction and Objective: Health behaviours (exercise/diet/alcohol/smoking) are a major public health concern. Traditional acupuncturists have an opportunity to support patients in adopting and maintaining healthier lifestyle behaviours and could thus make a valuable contribution to public health. This study explored health behaviour support provided to traditional acupuncture patients and aimed to (1) understand how clinical and psychosocial processes lead to behaviour change and (2) inform future behaviour change support in traditional acupuncture practice.

Methods: Longitudinal qualitative methods were used to capture experiences over time. Three traditional acupuncturists in private practice in the UK who participated in a previous nationwide survey were purposively sampled based on self‐reported provision of health behaviour support. Each acupuncturist recruited 3 patients, resulting in nine patient‐acupuncturist dyads. The final sample size was guided by the principle of information power.

Data comprised audio‐recordings of all consultations, in‐depth qualitative interviews with patients (two interviews each) and acupuncturists (one interview each). Interviews explored patients' and acupuncturists' experiences and perspectives on health behaviour support during a course of acupuncture treatment. Analysis was conducted concurrently with data collection. Reflexive thematic analysis focused primarily on patient interviews; each patient's experiences were interpreted within the context of the consultation and were related to their acupuncturist's experiences. Data was coded deductively (guided by previous work) and inductively, to explore new themes.

Results: Three themes were generated. Patients at different stages of readiness to change need different types of support – those overwhelmed by symptoms/stress need an approach which helps them gain control, whereas patients who are more ready to change need help sustaining motivation. Acceptance of health behaviour advice was related to establishing a cycle of mutually reinforcing trust in the practitioner, in their explanations and in their treatments. Decisions to enact a health behaviour change were based both on reasoned understanding (e.g. of how behaviours may contribute to illness) and changes in feelings and mood (e.g. calm, positivity, connecting to sensation of wellness).

Conclusions: Elements of traditional acupuncture practice including stress relief and symptom reduction, alternative experiential‐based explanations for illness, and strong therapeutic relationships may help patients to make health behaviour changes. Some of these elements have not been well theorised in the health behaviour change literature. Traditional acupuncturists may benefit from co‐creating training in health behaviour change techniques that could be delivered within their broader frameworks and clinical approach.

OS CIM N 37 Quantification of prevalence, clinical characteristics, co‐existence, and geographic variations of traditional Chinese medicine diagnostic patterns via latent tree analysis

Leonard Ho¹; Yulong Xu²; Nevin L Zhang³; Fai Fai Ho¹; Irene XY Wu⁴; Shuijiao Chen^5,6; Xiaowei Liu^6,5; Charlene HL Wong¹; Jessica YL Ching¹; Pui Kuan Cheong¹; Wing Fai Yeung⁷; Justin CY Wu¹; Vincent CH Chung¹

¹The Chinese University of Hong Kong, Shatin, Hong Kong (China); ²Henan University of Chinese Medicine, Zhengzhou, China; ³The Hong Kong University of Science and Technology, Clear Water Bay, Hong Kong (China); ⁴Central South University, Changsha, China; ⁵Xiangya Hospital, Changsha, China; ⁶Hunan International Scientific and Technological Cooperation Base of Artificial Intelligence Computer‐Aided Diagnosis and Treatment for Digestive Disease, Changsha, China; ⁷The Hong Kong Polytechnic University, Hung Hom, Hong Kong (China)

Background: Traditional Chinese Medicine (TCM) treatment strategies are guided by pattern differentiation, as documented in the eleventh edition of the International Classification of Diseases (ICD). However, no standards for pattern differentiation are proposed to ensure inter‐rater agreement. Without standardisation, research on associations between TCM diagnostic patterns, clinical features, and geographical characteristics is also not feasible. This diagnostic cross‐sectional study aimed to (i) establish the pattern differentiation rules of functional dyspepsia (FD) using latent tree analysis (LTA); (ii) compare the prevalence of diagnostic patterns in Hong Kong and Hunan; (iii) discover the co‐existence of diagnostic patterns; and (iv) reveal the associations between diagnostic patterns and FD common comorbidities.

Methods: A total of 250 and 150 participants with FD consecutively sampled in Hong Kong and Hunan, respectively, completed a questionnaire on TCM clinical features. LTA was performed to reveal TCM diagnostic patterns of FD and derive relevant pattern differentiation rules. Multivariate regression analyses were performed to quantify correlations between different diagnostic patterns and between diagnostic patterns and clinical and geographical variables.

Results: At least one TCM diagnostic pattern was differentiated in 70.7%, 73.6%, and 64.0% of the participants in the overall (n = 400), Hong Kong (n = 250), and Hunan (n = 150) samples, respectively, using the eight pattern differentiation rules derived. 52.7% to 59.6% of the participants were diagnosed with two or more diagnostic patterns. Cold‐heat complex (59.8%) and spleen‐stomach dampness‐heat (77.1%) were the most prevalent diagnostic patterns in Hong Kong and Hunan, respectively. Spleen‐stomach deficiency cold was highly likely to co‐exist with spleen‐stomach qi deficiency (adjusted odds ratio (AOR): 53.23; 95% confidence interval (CI): 21.77 to 130.16). Participants with severe anxiety tended to have liver qi invading the stomach (AOR: 1.20; 95% CI: 1.08 to 1.33).

Conclusions: Future updates of the ICD, textbooks, and guidelines should emphasize the importance of clinical and geographical variations in TCM diagnosis. Location‐specific pattern differentiation rules should be derived from local data using LTA. In future, patients' pattern differentiation results, local prevalence of TCM diagnostic patterns, and corresponding TCM treatment choices should be accessible to practitioners on online clinical decision support systems to streamline service delivery.

OS CIM N 38 Updating Hahnemann's Language

Tiziana Di Giampietro¹

1ECH, Pescara, Italy

Introduction: Hahnemann anticipated by 200 years what modern medicine is discovering today in the most advanced fields of research about the origin and evolution of diseases. One reason why conventional medicine does not recognize the homeopathic method is the difficulty in understanding archaic vocabulary. ECH has instigated a project to update this language so that homeopathy is understood, accepted and integrated into the One health approach that we wish for our patients.

Material and Methods: Hahnemann was a careful observer of the symptoms reported by his patients and of the evolution of the diseases. He noticed that disease was often triggered by an “accidental causality” (etiological cause or stressor) which altered the homeostatic balance, initiating suffering that was first acute, functional and reversible, and then chronic, lesioned and irreversible. The symptoms of the disease were an expression of a reaction to the insult suffered. He studied drugs that caused intoxication with “similar” symptoms to those of the patient and diluted them so that they lost their toxicity. He observed the effects of low dilutions on healing in acute diseases. He called this superficial disease, which causes inflammation of the skin and mucous membranes of the vascular microcirculation, “Psora”. Over time, this inflammation causes a slowing down of the circulation and of tissue drainage, with the formation of widespread oedema in the connective tissue between the skin and internal organs (metabolic syndrome). Hahnemann called this second phase “Sycosis”. If the environmental stressor persists, the vascular inflammation tends to localize in the innermost organs, with cell death and loss of function of the affected organ: glands (hypothyroidism, diabetes, Cushing's syndrome), mucous membranes (ulcerative colitis, Crohn's), alveoli (emphysema); and the disease then becomes chronic, lesioned and irreversible. He called this third stage “Luesinism”. Hahnemann identified these clinical stages of the disease in the most common pathologies of the time (scabies, blennorrhagia, syphilis) and called them “miasmas”. These arise from “accidental causality” (environment), are expressed according to the reactivity of the individual (genetics), and do not disappear with death but are transmitted to descendants as an acquired genomic alteration (epigenetics).

Results: This study aims to update homeopathic language by adapting it to the discoveries of medical science in order to interact in the future with the conventional scientific world without obstacles in the understanding of concepts and terms.

Conclusions: ECH promotes this “terms and concepts conversion” project in collaboration with other worldwide homeopathic organizations to create a useful lexicon. This will be structured in a planned initiative as a team of expert consensus conferences.

OS CIM N 39 Cardiovascular effects of auricular stimulation ‐ systematic review and metanalysis

Joanna Dietzel¹,Kevin Hua¹, Mike Cummings², Taras Usichenko^3,4, Miriam Bernatik⁵, Benno Brinkhaus¹, Joanna Dietzel¹

¹Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt‐Universität zu Berlin, Charitéplatz 1, 10117 Berlin, Germany

²British Medical Acupuncture Society, London, UK

³ Department for Anesthesiology, University Hospital Greifswald, Germany

⁴ Department of Anesthesia, McMaster University, Hamilton, ON, Canada

⁵ International Society of Chinese Medicine, Munich, Germany

Background: An abundant number of randomized controlled trials has evaluated auricular stimulation (AS) such as auricular acupuncture or acupressure or trans auricular vague nerve stimulation in experimental and clinical settings in the past. Objective parameters are often part of the outcomes in these trials. Aim was to evaluate the effects of auricular stimulation on cardiovascular parameters.

Methods and analysis: In this systematic review including a meta‐analysis only randomized controlled trials were included that compared AS to a control group. No restrictions on age or indications were made. Data collection and analysis was conducted by two reviewers independently. Quality and risk assessment of included studies was performed with the Risk of Bias Tool 1 and the meta‐analysis of the effect of the most frequently assessed biomarkers was conducted using the statistical software RevMan 5.4.

Results: Altogether, 76 studies were included: 38 studies assessed heart rate (HR), 19 studies analyzed heart rate variability (HRV), 31 studies analyzed blood pressure (BP) and 7 studies were identified that measured oxygen saturation (O2), 2 studies on baroreflex sensitivity and 2 studies on skin conductance were evaluated in this review. 26 studies contained continuous data and were eligible for meta‐analysis, 50 trials reported non continuous data and were evaluated descriptively. The overall quality of the studies was moderate. Acupressure lead to a clinically safe, significant reduction of HR with MD = ‐3.55, 95% CI (‐4.82 to ‐2.27), p < 0.00001, In HRV, AS was able to reduce the HF/LF ratio significantly compared to control procedures MD = ‐0.14, 95% CI (‐0.23 to 0.04), p = 0.007). No other cardiovascular parameters (blood pressure, Oxygen saturation, baroreflex sensitivity) were changed significantly.

Conclusion: This exploration of secondary parameters and safety values of RCTs with various research questions showed that AS leads to clinically safe reduction of HR and changes in the LF/HF ratio of the HRV. More research is needed to clarify whether AS can be used to treat cardiovascular diseases such as tachycardia or diseases with autonomic disbalance.

OS CIM N 40 Proposal of a diagnostic algorithm for myofascial trigger points based on a multiple correspondence analysis of cross‐sectional data

Petra Bäumler¹

¹Multidisciplinary Pain Center, Department for Anaesthesiology, University Hospital LMU Munich, Munich, Germany

Background: Myofascial trigger points (MTrPS), the morphological correlate of myfascial pain syndromes (MPS), contribute to the worldwide high chronic pain burden. However, uncertainty about MTrP diagnostic criteria remains. Aim of this cross‐sectional study was to characterize clusters of diagnostic criteria assessable during physical examination that might guide MTrP diagnosis.

Methods: Thirteen MTrP diagnostic criteria proposed in relevant literature were assessed by standardized examinations in the trapezius and levator scapulae muscles of 61 chronic pain patients undergoing an interdisciplinary pain assessment. Hierarchical cluster analysis from multiple correspondence analysis was applied to data of the four muscles separately. Examining physicians classified the findings as MTrP, sufficient for diagnosis of an MPS and/or relevant for the patients' pain condition.

Results: Taut bands, hypersensitive spots within a taut band, nodules within a taut band and referred pain (classical diagnostic criteria) were most frequent (28–66% M. trapezius, 8–21% M. levator scapulae). Restricted range of motion, pain during contraction, pain exacerbation during emotional stress, muscular weakness, jump sign, local twitch response and autonomic phenomena (complementary diagnostic criteria) occurred in 2–25% and hypersensitive spots and nodules outside of a taut band in 2–7% of the cases. Four clusters emerged: (1) no or just one diagnostic criterion, mostly a taut band alone; (2) a hypersensitive spot and/or nodule outside of a taut band partly in combination with complementary diagnostic criteria; (3) at least two classical diagnostic criteria (mostly a taut band containing a hypersensitive spot) partly in combination with complementary diagnostic criteria; (4) at least two, rather three, classical diagnostic criteria always in combination with complementary diagnostic criteria. Referred pain was specific to cluster 3 and 4. Among classical diagnostic criteria, palpable nodules within a taut band contributed least, and among complementary diagnostic criteria, restricted range of motion and pain during contraction contributed most to data representation.

Conclusion: We propose that the definite diagnosis of an MTrP requires a hypersensitive spot potentially felt as a nodule located within a taut band in addition to either referred pain, a local twitch response or at least two complementary diagnostic criteria, whereby signs of muscular dysfunction take on greater importance.

OS CIM N 41 Over‐the‐counter medicines, herbal medicines and dietary supplements for depression, anxiety and insomnia: A scoping review

Rachael Frost¹; Silvy Mathew¹; Verity Thomas¹; Sayem Uddin¹; Adriana Salame¹; Sukvinder Kaur Bhamra²; Juan Carlos Bazo Alvarez¹; Cini Bhanu¹; Tanya Cohen³; Christine Vial³; Michael Heinrich¹; Kate Walters¹

¹University College London, London, United Kingdom; ²University of Kent, Kent, United Kingdom; ³Patient and Public Involvement contributor, London, United Kingdom

Background: Depression, anxiety and insomnia are common and are associated with reduced quality of life, greater absence from work, greater risk of other health problems and increased use of healthcare services. There are known problems with access to standard psychological therapies (e.g. long waiting lists) and whilst prescription medications can be effective, they can also have side effects which discourage their use (e.g. increased falls risk in older people).

Aim: People often express a preference to self‐manage their mental health and may actively seek over‐the‐counter (OTC) medication, herbal medicines or dietary supplements prior to or whilst seeking support from a healthcare professional. Evidence for different products is currently reported as individual trials or reviews of individual products, which provides challenges for comparing products. We aim to map the evidence available for OTC medications, herbal medicines and dietary supplements for depression, anxiety and insomnia.

Method: We are carrying out a scoping review of randomized controlled trials evaluating oral OTC products in people aged over 18 years with symptoms of depression, anxiety or insomnia. We searched CENTRAL, MEDLINE, EMBASE, PsycInfo and AMED (inception to Dec 2022) and identified 15338 potentially relevant studies, of which 1367 full texts are currently being screened. Studies will not be limited by date or language. We will summarize studies according to age (under or over 60 years), condition, product and outcome, highlighting the volume and nature of the evidence available for each product. We will document where adverse effects have been recorded and where products have been evaluated alongside prescription medications.

Conclusions: Results will be presented at the conference. This review will provide a comprehensive guide as to the evidence available for over‐the‐counter products for treating common mental health disorders and identify gaps for future research.

OS CIM N 42 Intake of Hokkaido red wine reduces blood pressure and improves vascular function in healthy adult men

Prae Charoenwoodhipong¹; Roberta Holt¹; Carl Keen¹; Tomoyuki Sato²; Teruo Sone²; Robert Hackman¹

¹Department of Nutrition, University of California Davis, Davis, United States of America; ²Research Faculty of Agriculture, Hokkaido University, Sapporo, Japan

Introduction: Red wine intake is associated with lower cardiovascular risk and mortality, which may be partly due to polyphenolic anthocyanins and other phenolics that can vary with varietal, regional climate, production practices and bottle aging. This study assessed the vascular effects of 2015 and 2018 Zweigelt red wines produced by the same winery in Hokkaido, Japan.

Methods: A three‐arm crossover design enrolled ten healthy men, ages 50‐70 years, who randomly received either 240 mL of a 2015 or 2018 Zweigelt red wine containing 90 or 294 mg/L of total anthocyanins, respectively, or a calorie‐ and volume‐matched white grape juice control at least seven days apart. Systolic (SBP) and diastolic (DBP) blood pressure and vascular function measures (reactive hyperemia index [RHI], Framingham RHI [fRHI], augmentation index [AI], a measure of arterial stiffness, and AI at 75 beats/min [AI75]) were assessed at baseline and two and four hours after the intake of each beverage. Twenty‐four‐hour dietary recalls were collected before each study visit. Changes from baseline in vascular outcomes and BP were analyzed using a linear mixed model, and reported differences in food intake were assessed with a one‐way ANOVA.

Results: The mean age of participants was 58.6 years with a mean BMI of 27.5. The intake of both the 2015 or 2018 vintages significantly reduced the overall change in AI by 13% (p < 0.0001) and AI75 by 11% (p < 0.0013) compared to the control beverage. The overall change in SBP and DBP was lower after the intake of the 2018 wine (4.1 and 5.6 mmHg respectively; p = 0.018 for SBP and p = 0.019 for DBP) compared to the 2015 vintage or the control beverage. No significant differences were noted for RHI and fRHI in any of the groups compared to baseline values. No significant differences in dietary intake were noted for any of the three interventions.

Conclusion: The overall change in arterial stiffness was significantly lower with the intake of a single 250 mL portion of either the 2015 or 2018 Hokkaido Zweigelt red wine compared to a white grape juice control beverage. Overall, the change in SBP and DBP was significantly lower with the intake of the 2018 vintage compared to the 2015 wine or the control beverage. Future studies that explore the relationship between red wine composition on measures of vascular function are warranted.

OS CIM N 43 Defining and supporting a professional role for pharmacists associated with traditional and complementary medicines – a cross‐country study

Joanna Harnett¹; Carolina Oi Lam Ung²

¹University of Sydney, Sydney, Australia; ²University of Macau, Macau, Macau (China)

Introduction and Objective: An estimated 80% of the world's population use traditional and complementary medicine (T&CM) products as part of their healthcare, with many accessed through pharmacy. This cross‐cultural study posed a set of core responsibilities and actions to pharmacists related to T&CM products with a view towards developing consensus, about their role in guiding appropriate and safe use.

Methods: A cross‐sectional online survey reported in accordance with Strengthening the Reporting of Observational studies in Epidemiology (STROBE) guideline and the Checklist for Reporting Results of Internet E‐Surveys (CHERRIES). Twenty‐two researchers were involved in the recruitment of pharmacists across nine countries. The survey data was collected via the online survey tool Survey Monkey and data downloaded into SPSS statistical software for analysis.

Results: Of the 2341 participants representing pharmacists across nine low‐, middle‐ and high‐ income countries, most agreed (69%) that T&CM product use was common in the community they served but most did not have adequate training to support consumer's needs. Over 75% acknowledged there were known, and unknown safety risks associated with T&CM use. Of 18 professional responsibilities posed 92% agreed pharmacists should be able to inform consumers about the potential risks including T&CM side effects and drug‐herb interactions. The provision of accurate scientific information on the effectiveness of T&CM products, skills to guide consumers in making informed decisions, and communication with other healthcare professionals to support appropriate and safe T&CM product use were all ranked with high levels of agreement. To facilitate being effective in these responsibilities, pharmacists agreed regulatory reforms, development of T&CM education and training and access to quality products supported by high quality evidence to support their use were needed.

Conclusion: General agreement from across nine countries about eighteen professional responsibilities and several stakeholder actions serve as a foundation for discussion and development of international T&CM guidelines for pharmacists to play a role in promoting both the benefits and any harms associated with T&CM product use.

OS CIM N 44 An outpatient clinic for integrative mental health: patient characteristics and health outcomes based on patient reported routine outcome monitoring data

Rogier Hoenders¹; Ellen Visser²; Sanne Booij^1,3

¹Center for Integrative Psychiatry, Groningen, Netherlands (The); ²RGOc / UMCG, Groningen, Netherlands (The); ³University of Groningen, University Medical Center Groningen, Rob Giel Research Center, Groningen, Netherlands (The)

Background: There is an increasing interest in integrative (mental) health care / integrative psychiatry and a growth in centers offering such services, but a paucity of research on the type of patients and their symptoms, the effects of treatments and patient satisfaction.

Method: Analysis of patient characteristics, satisfaction and health outcomes were conducted, using routine outcome monitoring (ROM) data of questionnaires on psychopathology (OQ‐45), quality of life (MANSA), resilience (BRS), client satisfaction (CQI) and happiness (HI). Linear mixed models (with intention‐to‐treat) were used to examine change over time in the outcome measures. Multilevel version of Cohen's D was used to calculate effect sizes (ES).

Results: ROM data from 2012 to 2022 was included. A total of 1629 patients were assessed, of which 1333 received treatment and 296 consultation. Of these 1333 patients, 992 to 1039 filled in baseline questionnaires (81% responders). Of these, 69% was female, with a mean age of 41, mean treatment duration of 493 days, and on average 90 treatment hours. Baseline clinical characteristics indicated severe path pathology and impaired functioning: BRS 2.5, HI 4.7, MANSA 52 and OQ‐45 79. Compared to non‐responders, responders did not significantly differ in age, sex or diagnoses, but they had significant higher levels of psychopathology, and longer and more intensive treatments. A total of 688 (51%) completed all questionnaires at baseline and at follow‐up (completers). Compared to non‐completers they had significant higher levels of psychopathology, and longer and more intensive treatments. Linear mixed model analysis showed large and significant (p < .001) improvements in symptomatology (ES 1.25), quality of life (ES 1.11), resilience (ES 0.93), and happiness (ES 1.17) at discharge compared to baseline. Overall patient satisfaction (range 1‐10) was 7.9, satisfaction with treatment results 8.2, with being treated 9.2, shared decision making 7.9, treatment according to wishes 8.4 and being taken seriously 9.3.

Conclusions: Patients in this outpatient clinic for integrative psychiatry showed severe psychopathology and impaired functioning at baseline. During treatment they seem to improve in psychopathology, quality of life, happiness and resilience and client satisfaction seems high. Despite the large sample size and the high external validity, results should be interpreted with caution due to the lack of a control group, missing data and loss to follow up.

OS CIM N 45 Motivations, Training, and Practice Characteristics of Integrative Medical Doctors in Ontario, Canada: An Exploratory Study

Nadine Ijaz¹

¹Department of Law and Legal Studies, Carleton University, Ottawa, Canada

Introduction and Objective: A minority of Canadian medical doctors (MDs) employ an ‘integrative’ approach to clinical practice, characterized by the adoption of a ‘whole person health’ lens and the inclusion of ‘complementary’ therapeutic approaches that are neither taught in conventional medical schools nor widely accepted as standard practice. To date, however, little is known about the work of integrative MDs in the Canadian context. With reference to Canada's most populous province (Ontario), where ‘medically‐necessary’ MD care is obligatorily reimbursed by a government insurance program, the present study aims to investigate the range of motivations, postgraduate training backgrounds, practice characteristics and billing approaches engaged by integrative MDs.

Methods: The author undertook semi‐structured qualitative interviews, lasting 60 – 90 minutes each, with Ontario MDs who self‐identified as ‘integrative’ physicians. All respondents had held an active Ontario MD license and worked in clinical practice within the twelve months prior. All agreed to have their interviews audio recorded and transcribed following an informed consent process. Descriptive content and thematic analyses of verbatim transcripts proceeded concurrently with recruitment, which continued to the point of saturation with reference to the study aims.

Results: Fifteen Ontario MDs (nine women, six men) participated in the study; four identified as persons of color. All had completed medical school at least ten years prior; three had been MDs for over forty years. Twelve were qualified as general practitioners (family medicine); additional specialties included internal medicine, emergency medicine and obstetrics/gynecology. While some respondents had entered medical school intending to practice integrative care, others grew disillusioned with conventional biomedicine's limitations during or following medical training, leading them to explore unconventional therapeutic approaches. Others had become exposed to unconventional therapeutics within their families of origin, during their own experiences of ill health, or following patient inquiries. Most respondents had completed integrative medicine fellowships, functional medicine, and/or mind‐body medicine training programs in the United States. Some respondents had also undertaken acupuncture, yoga or meditation training, and/or extensive independent study. While practice structures varied, most MDs offered consultative integrative/functional medicine care addressing complex chronic disease, chronic pain, mental health, infertility and/or cancer. Six physicians exclusively billed Ontario's provincial health insurance plan for their services, five billed patients entirely privately (for provincially‐‘uninsured’ services), and four employed a hybrid public/private billing strategy.

Conclusions: This first exploratory study of Canadian integrative MDs provides key insights for medical educators and policymakers, and lays foundations for further research in this area.

OS CIM N 46 Patients' perceptions on non‐specific effects of acupuncture: Qualitative comparison between responders and non‐responders

Fai Fai Ho⁷; Robin S.T. Ho¹; Jon Adams²; Holger Cramer^3,2; Brenda Leung^2,4; Lesley Ward^5,2; Yan Zhang^2,6; Vincent C.H. Chung^2,7,1; Yue Jiang⁷

¹Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong, Hong Kong (China); ²Australian Research Center in Complementary and Integrative Medicine, University Technology Sydney, Sydney, Australia; ³Department of Internal and Integrative Medicine, Kliniken Essen‐Mitte, Faculty of Medicine, University of Duisburg‐Essen, Essen, Germany; ⁴Public Health, Faculty of Health Sciences, University of Lethbridge, Lethbridge, Canada; ⁵Department of Sport, Exercise and Rehabilitation, Faculty of Life Sciences, Northumbria University, Newcastle Upon Tyne, United Kingdom; ⁶Harris College of Nursing and Health Sciences, Texas Christian University, Fort Worth, United States of America; ⁷School of Chinese Medicine, The Chinese University of Hong Kong, Hong Kong, Hong Kong (China)

Background: Non‐specific effect of acupuncture constitutes part of the overall effect generated via clinical encounter beyond needle insertion and stimulation. It is unclear how responders and non‐responders of acupuncture experience non‐specific effects differently. We aimed to compare their experiences in a nested qualitative study embedded in an acupuncture randomized trial on functional dyspepsia.

Methods: Purposive sampling was used to capture experience of responders (n = 15) and non‐responders (n = 15) to acupuncture via individual in‐depth interviews. Design and analysis followed a framework analysis approach, with reference to an existing model on acupuncture non‐specific effects. Themes emerging outside of this model were purposefully explored.

Results: Responders had a more trusting relationship with acupuncturist in response to their expression of empathy. In turn they were more actively engaged in lifestyle modifications and dietary advice offered by acupuncturists. Non‐responders were not satisfied with the level of reassurance regarding acupuncture safety. They were also expecting more peer support from fellow participants, regarded that as an empowerment process for initiating and sustaining lifestyle changes.

Conclusions: Our results highlighted key differences in acupuncture non‐specific effect components experienced by responders and non‐responders. Positive non‐specific effects contributing to overall benefits could be enhanced by emphasizing on empathy expression from acupuncturists, trust‐building, offering appropriate explanations on safety, and organizing patient support groups. Further research on the relative importance of each component is warranted.

OS CIM N 47 Integrative Medicine in Treating Uncontrolled Diabetes in North Israel. A Proposal for Culture‐Tailored Approach

Sameer Kassem¹; Abedalhadi Zoabi²; Eran Ben‐Arye³

¹Department of Internal Medicine, Lady Davis Carmel Medical Center, Technion, Israel Institute of Technology, Haifa, Israel; ²Diabetes clinic, Clalit Health Services, Northern District, Israel; ³Oncology Program, Lin Medical center, Clalit Health Services, The Ruth and Bruce Rappaport Faculty of Medicine, Technion, Israel Institute of Technology, Haifa, Israel

Introduction and objective: Diabetes mellitus is a global pandemic affecting mainly developing societies and is associated with obesity, metabolic syndrome, cardiovascular disease, and cancer. Diabetes and obesity rates have been growing within the Arab countries, especially in modernly urbanized communities. The Arab society in Israel underwent lifestyle and dietary changes several years preceding neighboring countries and may serve a fruitful ground for predicting future trends of health and disease in the rest of the Arab world. Despite the advance in diabetes management, uncontrolled glycemia is still a major health issue in Arab society in Israel. We aim to introduce a new integrative medicine‐based approach that is tailored to the cultural, religious, and social aspects of this population. In this preliminary study, we evaluated the rates uncontrolled diabetes and obesity in the Arab society in North Israel and propose to apply integrative medicine modalities in treating the severely uncontrolled subset of this population.

Methods: Computerized electronic medical record screening for diabetes control and obesity in Clalit Health Services (CHS)‐ the major healthcare provider in Israel (∼52% of population). We evaluatedthe prevalence of diabetes and obesity (BMI >30) and the rates of severely uncontrolled diabetes (HbA1c>9%) within Arabs compared to the general population in Israel. We also evaluated the frequency of severely uncontrolled diabetes among Arabs in the northern district of Israel compared general Arab community in Israel.

Results: There are 1291678 (27%) Arabs insured in CHS of which 270697 (21%) reside in northern district. The prevalence of diabetes in Arabs and Jews in the north was quite similar (8.3% versus 8.2%, respectively). However, severely uncontrolled diabetes (HbA1c>9%) was more frequent among Arabs compared to Jews (13.3% versus 7.3%, respectively).

OS CIM N 48 Yoga as therapy for burnout: Health Technology Assessment Report on Efficacy, Safety, Economic, Social, Ethical, Legal and Organisational Aspects

Marleen Schröter¹; Holger Cramer^2,3; Heidemarie Haller⁴; Stefan Huster⁵; Ulrike Lampert⁶; Martin Schäfer^7,8; Gesa Janssen‐Schauer⁷; Friedhelm Meier⁹; Anja Neumann¹⁰; Silke Neusser¹⁰; Anna Katharina Koch¹

¹Department of Pediatrics, Division of Oncology and Hematology, Charité Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt‐Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany; ²Institute of General Practice and Interprofessional Care, University Hospital Tübingen, Tübingen, Germany; ³Bosch Health Campus, Stuttgart, Germany; ⁴Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg‐Essen, Essen, Germany; ⁵Ruhr‐University of Bochum, Bochum, Germany; ⁶Department Healthcare and Health Economy, Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany; ⁷Department of Psychiatry, Psychotherapy, Psychosomatics and Addiction Medicine, Kliniken Essen‐Mitte, Essen, Germany; ⁸Department of Psychiatry, Charité Campus Mitte, Charité Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt‐Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany; ⁹Institute for Ethics, Faculty of Protestant Theology, University of Tübingen, Tübingen, Germany; ¹⁰Research Institute for Medicine Management GmbH, Essen, Germany

Introduction and Objective: Burnout is a globally increasing problem. Yoga has proven to have a positive effect on a variety of stress‐related diseases. The effect of yoga as therapy on burnout has not been systematically studied yet. The aim of this health technology assessment (HTA) was to systematically assess and meta‐analyze the efficacy and safety of yoga as therapy for burnout. Economic, ethical, legal, social and organisational aspects were considered as well.

Method: The methodology of this HTA is in accordance with the general methods of the Institute for Quality and Efficiency in Healthcare (IQWIG), version 6.1. MEDLINE, Embase, Cochrane Central Register of Controlled Trials, PsycINFO, ClinicalTrials.gov, and the World Health Organization international clinical trials registry platform search portal were searched from their inception through November, 29^th 2021 for randomized controlled trials (RCTs) of yoga as therapy for individuals with burnout. Efficacy outcomes included severity of burnout, remission, subjective stress, depressive symptoms, self‐efficacy, health‐related quality of life, mortality and adverse events. Risk of bias was assessed using the IQWIG risk of bias appraisal.

Results: The search identified 776 articles. Five RCTs including 306 participants with burnout comparing yoga with active controls (mindfulness‐based cognitive therapy, cognitive behavioral therapy and group‐fitness classes) and passive controls (no treatment, treatment as usual, and waiting list) were included. Applied yoga interventions differed in terms of intervention length (3‐20 weeks) and content (traditional yoga, trauma‐informed Hatha Yoga, medical yoga + usual care, yoga + mindfulness and a structured yoga program). The potential for bias was rated as high for all included studies across all endpoints. This was mainly due to the impossibility of blinding patients and therapists. Meta‐analyses were carried out for burnout severity and subjective stress comparing yoga with passive controls. Meta‐analysis revealed no effects on burnout severity in general (Hedges´g = ‐0.41, p = .18, 95% confidence interval (CI) [‐1,29; 0,46]), whereas a positive effect on subjective stress emerged (Q = 10, p < .01, no pooled effect; prediction interval between ‐11.08 and 9.00; Hedges´g of individual studies ‐0.23/‐1.66/‐1.29, p = .45/<.001/<.001). Compared to active control, an effect on the burnout subscale depersonalization (p = .05) was evident on individual study level. No further effects were evident. Adverse events were reported insufficiently.

Conclusion: Yoga as a therapy may have positive effects on burnout but results are inconsistent. Common definitions, classifications and standardized diagnostic tools of burnout are necessary to improve scientific research on this topic and further assess yoga as a therapy method for burnout.

OS CIM N 49 Development and evaluation of a training program for interprofessional counseling on complementary and integrative health care for an as part of the CCC integrative study

Birgit Kröger¹; Ali Behzad³; Lioba Lohmüller¹; Regina Stolz¹; Markus Horneber²; Jan Valentini¹; Stefanie Joos¹; Cornelia Mahler⁴

¹Institute of General Practice and Interprofessional Care, University Hospital and Faculty of Medicine, Tübingen, Germany; ²Department of Internal Medicine, Division of Pneumology, Paracelsus Medical University, Clinical Nuernberg, Nuernberg, Germany; ³Clinic for Internal Medicine, Hematology and Internal Oncology, Erlangen University Hospital, Erlangen, Germany; ⁴Department of Nursing Science, University Tuebingen, Tubingen, Germany

Introduction and objective: Frequent use of complementary and integrative health care (CIH) is common among oncology patients, but it can also lead to side effects or interactions with conventional medicine. Therefore, there is a need for evidence‐based guidance to ensure patient safety. The main objective of the CCC integrative study is to implement and evaluate an interprofessional counseling intervention to improve patient activation in four Comprehensive Cancer Centers (CCC) in Baden‐Württemberg, Germany. This abstract describes the development and evaluation of an interprofessional training program for physicians and nurses within the CCC integrative study to mutually counsel patients on CIH measures

Methods: An interprofessional team of physicians, nurses, psychologists, and health scientists developed a blended learning approach with learning objectives to ensure a standardized training for the planned intervention. Asynchronous seminars on basic CIH aspects, such as nutrition, exercise, and relaxation techniques, were developed and uploaded to a learning platform. It also includes a database of applied CIH interventions, such as external applications, aromatherapy, and acupressure. Face‐to‐face seminars were planned for specific topics, e.g. motivational interviewing and interprofessional counseling. The training was planned over 10 months before beginning of the intervention and comprised 13 teaching days, equivalent to 64 teaching units à 45 minutes. Training sessions were evaluated via online survey after each session using self‐developed brief questionnaires. Additionally, as part of the study's overall process evaluation, insights on training and interprofessional counseling were collected through focus group discussions, and individual interviews with participating members of the counselling team at the end of the intervention phase.

Results: Twenty‐two participants (11 nurses, 11 physicians) among the four CCCs completed the training. A major hurdle in the course was the need to switch from in‐person to online training due to the pandemic. Planned in‐person seminars were therefore held as synchronous seminars via zoom. Initially, the participants expressed uncertainty regarding the technology which decreased over time (50% vs. 15% of particular participants).

Overall, the sense of being prepared for the intervention was high from the beginning (86%), and could be increased to 95% through direct adjustments after each training, e.g. specialization of topics according to the team's need.

Conclusion: The immediate evaluation of the teaching days made it possible to address the needs of the participants in the training program and to cover all topics relevant to the intervention. The program could be used as a template for future rollouts across sites.

OS CIM N 50 Acupuncture and low‐carb diet: an innovative and non‐invasive treatment for obesity

Giuseppe Lupi¹; Raymond Landgraaf¹; Massimo Fumagalli¹

¹Sinomedica, Lugano, Switzerland

Background: The obesity pandemic is a reality as worldwide obesity nearly tripled since 1975. Obesity rates are rising rapidly. In fact, in 2016, WHO reported that more than 1.9 billion adults were overweight (39% of world's adult population) and of these over 650 million were obese. Overall, obesity creates a substantial economic burden in both developed and developing countries. Furthermore, it represents a gateway to many diseases, especially type 2 diabetes mellitus, cardio‐vascular diseases, respiratory diseases, non‐alcoholic fatty liver disease (NAFLD), and some cancers.

Methods: Understanding the factors that influence obesity and weight loss has therefore become an important issue. It is a multidimensional problem and obesity is the result of a complex interaction of different factors. In this regard, factors such as (epi)genetics, environment, diet or lifestyle and neurohormonal factors have been identified, all of which being related to some extent to the weight gain in individuals. However, weight loss therapies are not always successful especially in the long run (diet), have side effects (medication) or are quite invasive (such as bariatric surgery).

Results: In recent years, acupuncture emerged as a safe and effective complementary treatment of obesity. Acupuncture is believed to induce loss of appetite, down‐regulates insulin and leptin resistance, while up‐regulating leptin receptor. It lowers ghrelin levels and decreases glucose levels. A review of the recent literature with these promising results from experimental studies and mounting clinical evidence will be presented. Also a “sneak preview” will be given of the results of our retrospective study where we explored the combined effect of low calory diet with acupuncture on weight reduction in over 11.000 patients with overweight or obesity. Results suggest that this combination of low caloric diet with acupuncture could be an effective (noninvasive) therapy that has long‐term sustainable effects on weight.

Conclusion: In conclusion, acupuncture may therefore be a new treatment modality to consider in obesity treatment.

OS CIM N 51 Does the effect of sham acupuncture differ according to the location of the needling point (verum or sham point) for chronic nonspecific low back pain? A systematic review and network meta‐analysis

Boram Lee¹; Chan‐Young Kwon²; Hye Won Lee³; Arya Nielsen⁴; L Susan Wieland⁵; Tae‐Hun Kim⁶; Stephen Birch⁷; Terje Alraek^8,7; Myeong Soo Lee¹

¹KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, Korea (Republic of); ²Department of Oriental Neuropsychiatry, Dong‐eui University College of Korean Medicine, Busan, Korea (Republic of); ³KM Convergence Research Division, Korea Institute of Oriental Medicine, Daejeon, Korea (Republic of); ⁴Department of Family Medicine & Community Health, Icahn School of Medicine at Mount Sinai, New York, United States of America; ⁵Center for Integrative Medicine, University of Maryland School of Medicine, Baltimore, United States of America; ⁶Korean Medicine Clinical Trial Center, Korean Medicine Hospital, Kyung Hee University, Seoul, Korea (Republic of); ⁷Kristiania University College, School of Health Sciences, Oslo, Norway; ⁸Department of Community Medicine, Faculty of Health Sciences, National Research Center in Complementary and Alternative Medicine (NAFKAM), Institute of Health Sciences, Tromsø, Norway

Introduction and objective: When setting sham acupuncture as controls to evaluate the efficacy of acupuncture, the sham needling technique is usually different from verum acupuncture. However, the sham procedure may either be often conducted at the same points that are used for verum acupuncture (verum points) or at non‐relevant points (sham points). We aimed to assess whether the effect of sham acupuncture is different according to whether a verum point or a sham point is utilized, using sham‐controlled trials of acupuncture for chronic nonspecific low back pain (cLBP) as an example.

Methods: The electronic databases including Medline, EMBASE, Cochrane Central Register of Controlled Trials, and Allied and Complementary Medicine Database were searched from their inception dates to February 12, 2023. Studies assessing the effect of acupuncture in sham acupuncture‐controlled or wait‐list‐controlled randomized trials on cLBP were included. Sham acupuncture was classified according to whether it was conducted at the same acupuncture points used in the verum acupuncture group (Sham AT(verum)) or at different points (Sham AT(sham)). After testing clinical similarity, transitivity, and statistical consistency, a frequentist network meta‐analysis was performed on pain and function outcomes. The risk of bias of the included studies and the certainty of evidence for main findings was evaluated.

Results: A total of 10 studies were included. On both pain and function outcomes, the comparative effectiveness of verum acupuncture was significantly better than Sham AT(sham) (pain: standardized mean difference (SMD) ‐0.31, 95% confidence interval (CI) ‐0.49 to ‐0.13; function: SMD ‐0.14, 95% CI ‐0.25 to ‐0.02). However, there were no differences between verum acupuncture and Sham AT(verum) (pain: SMD 0.06, 95% CI ‐0.27 to 0.39; function: SMD 0.19, 95% CI ‐0.01 to 0.38). The effect of Sham AT(verum) was borderline and significantly better compared with Sham AT(sham) on pain (SMD ‐0.37, 95% CI ‐0.73 to 0.00) and function (SMD ‐0.32, 95% CI ‐0.55 to ‐0.09), respectively (Figures 1 and 2). The risk of bias that could affect the interpretation of the results was usually low, and the quality of evidence was moderate to low.

Conclusions: Sham acupuncture needling at same points with verum acupuncture is not a true placebo control for assessing the efficacy of acupuncture for cLBP, underestimating the effectiveness of acupuncture in real‐world clinical settings.

OS CIM N 52 Effectiveness of Integrative Medical Care For Adult Depression: A Quasi‐Experimental Study

Anne Leis¹; Shirley Maltman¹; Wendy Verity¹; Marcus Ilesanmi¹; Vicky Holmes¹; Amanjot Kaur¹; Chrys Henry¹

¹University of Saskatchewan, Saskatoon, Canada

Introduction and Objective: Depression is one of the most common mental health issues worldwide. Antidepressants are usually the first line of standard treatment and often work in the short‐term. However, the long‐term management of depression may be difficult. This study compared the effectiveness of integrative medical care (IM care) to standard medical care (SM care) in depressed adults over one year.

Methods: After screening for depressive symptoms, 130 adults aged 17 to 73 years referred from family physician practices or self‐referred were non‐randomly allocated into SM care (n = 66) and IM care (n = 64) treatment arms. SM care participants received anti‐depressive treatments from their family physicians, and IM Care participants received individualized treatments from an integrative care physician. Both groups followed these treatment options for the 12‐month study protocol. Severity of depression assessed with the Beck Depression Inventory (BDI‐II), saliva samples and diaries were collected at baseline, 3, 6, 9 and 12 months. Only participants with 4+ data points were included in the analysis that compared change in means depression scores and cortisol levels. Descriptive analysis was used for self‐care as reported in the participants' diaries.

Results: After a similar initial reduction of BDI‐II scores in both groups, patients in the IM care group showed, on average, a more beneficial long‐term effect than the SM care group. The mean depression scores as compared with baseline were significantly different at 12 months (p = 0.0044) in favor of the IM care group. No statistically significant difference in cortisol levels was found between the two groups except at 9 months (p = 0.045) when the cortisol level of the SM care group was significantly higher. Over the study period, the most frequently reported modalities for managing depressive symptoms in the IM care group included: physical activity (80%), taking supplements (65%), professional counselling (43%), social connections (40%) deep breathing or mindfulness (38%) and spirituality practices (38%). The most frequently reported modalities for the SM care group were physical activity (72%), medications (61%), social connections (51%) art (29%) and recreation (24%).

Conclusion: This study showed that integrative medical care was as effective as standard medical care after 3 months. However, reduction in depressive symptoms was greater at one‐year in the IM care group, which suggests IM care may be an effective long‐term depression treatment modality. Whereas the frequency of physical activity was highest in both groups, their respective medical treatments for depression may have directly influenced other self‐care modalities. Additional research with a larger sample is warranted.

OS CIM N 53 Herbal medicines in Chile: views and experiences of healthcare providers

Katja Löbel¹; Sara Garfield¹; Michael Heinrich¹

¹UCL School of Pharmacy, London, United Kingdom

Introduction and objectives: Herbal medicine (HM) use has been increasing during the last decades in Chile, in line with a global trend towards using integrative (as well as alternative) medicines. Our previous research about HMs use in the Chilean population has shown that patients often initiate conversations with their healthcare providers about their use of HMs. However, we know little about the attitudes and experiences of healthcare providers in Chile toward their patient's use of HMs and their personal use.

This study aims to address this gap in knowledge by exploring the perspectives of healthcare providers in Chile on the use of HMs. Specifically, our study investigates how various healthcare providers, such as pharmacists, medical doctors, and nurses, among others, perceive and interact with patients who use HMs.

Methods: An online survey was developed based on previously published questionnaires to assess healthcare professionals' experiences with and attitudes towards patients using HMs. The survey also included questions about participants' personal use of HMs and their opinion. Participants were recruited through social media and were eligible to participate if they were healthcare professionals living in Chile who had worked directly with patients. Data was collected anonymously and analyzed using descriptive statistics. Ethical approval was obtained from UCL (UK) and USACH (Chile).

Results: One hundred and twenty‐four healthcare professionals have completed the survey to date, nearly half being pharmacists. Over half of the respondents reported encountering patients who take HMs in addition to their prescribed medicines on at least a weekly basis. When asked how likely they were to recommend herbal medicines to their patients, the majority responded positively, with over 60% indicating that they were 'slightly likely', 'likely', or 'very likely' to do so. Around 80% of respondents encouraged the use of herbal medicines when mentioned by patients. Less than 30% of respondents reported that their professional training in HMs was sufficient. In terms of personal use, the majority reported having used herbal medicine at some point, with more than fifty per cent having used it within the past week.

Conclusions: Our preliminary findings suggest that healthcare providers in Chile are aware of the widespread use of HMs among their patients and are open to integrating it into their practice. More education on HMs to provide better care for their patients is essential.

OS CIM N 54 The role of naturopathy for women with diminished ovarian reserve: surveys, a Delphi study and a feasibility randomised controlled trial

Alison Maunder¹; Carolyn Ee¹; Michael Armour¹; Arentz Susan¹; Costello Michael²

¹NICM Health Research Institute, Western Sydney Universit, Westmead, Australia; ²University of New South Wales, Sydney, Australia

Background: Women with diminished ovarian reserve (DOR) have fewer oocytes than would be expected at their age. DOR affects about 10% of women seeking medically assisted reproduction (MAR). However, the success rate of MAR is significantly lower in women with DOR than in women with normal ovarian reserve. Many women consult a naturopath to help them conceive but evidence for benefit of naturopathy in DOR is mostly anecdotal.

Aim: To investigate the health needs of women with DOR; describe naturopathic management of DOR and infertility; define a naturopathic intervention for evaluation in a randomized controlled trial (RCT); and investigate the feasibility, acceptability, and effect on fertility of naturopathy in women with DOR to inform an appropriately powered trial.

Method: We conducted (1) a survey of women with DOR to determine their usage and experience of traditional complementary integrative medicine (TCIM); (2) a survey of naturopaths to describe management of women with infertility and DOR; (3) a Delphi study of 12 practicing naturopaths to define an intervention for evaluation in a RCT; and (4) a two‐arm, parallel group, assessor‐blinded feasibility pilot RCT. Australian women with DOR and trying to conceive (either naturally or with MAR) were randomly assigned to naturopathy plus usual care or usual care alone for 16 weeks. Primary outcomes were feasibility (recruitment, adherence, retention rates) and acceptability. Secondary outcomes included ongoing pregnancy rates (OPR) and changes in health‐related questionnaires (mental health, quality of life, diet, exercise, sleep, weight). All p‐values are exploratory.

Results: Fertility and mental health were the main aspects of health affected in women with DOR. While MAR was most often recommended, TCIM practitioners, supplements and self‐care were commonly used alongside. Naturopaths approach treatment holistically, target well‐being and provide individualized treatment. Treatment includes dietary counselling, nutritional supplementation and herbal medicines. One hundred and fourteen women were approached to participate in the RCT between March and November 2022 of whom 41 (36%) consented. All 41 participants (100%) adhered to the intervention, 38 (93%) completed endpoint questionnaires and 32 (78%) found study participation to be acceptable. There was no difference in OPR between the 2 groups (RR = 1.36, 95% CI 0.25 – 7.34, p = 0.7181).

Conclusion: The evaluation of a naturopathic intervention through a RCT is feasible and acceptable to women with DOR. Outcomes from this study will inform sample size calculations powered for fertility outcomes for future definitive RCTs.

OS CIM N 55 A Bibliometric Analysis of the Research Literature Published in Traditional, Complementary, Alternative, and Integrative Medicine‐Categorized Journals

Jeremy Y. Ng^1,2

¹Centre for Journalology, Ottawa Methods Centre, Ottawa Hospital Research Institute, Ottawa, Canada; ²Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Canada

Introduction: The terms traditional, complementary, alternative, and integrative medicine (TCAIM) refer to a variety of medical and health care interventions, practices, products, or disciplines that are not regarded as being a part of conventional medicine. TCAIMs are a diverse group of therapies with widely varying safety and efficacy evidence profiles. Despite this fact, it is well established that globally various TCAIMs are used by many individuals on a regular basis for the prevention, management and/or treatment of disease. The present study details a bibliometric analysis of the research literature published in TCAIM journals.

Methods: On April 17, 2021, a search of all International Standard Serial Number of all journals categorized as “complementary and alternative medicine” (code 2707) based on the All Science Journal Classification was run on Scopus. No additional search restrictions were applied, and all publication types were included. The following bibliometric data were extracted: number of publications (in total and per year), authors and journals; open access status; journals publishing the highest volume of literature and their impact factors; language, countries, institutional affiliations, and funding sponsors of publications; most productive authors; and highest‐cited publications. Trends associated with this subset of publications were identified and presented, and bibliometric networks were created and visualized.

Results: Between 1938 and 2021, 219680 authors published 172466 papers in 143 journals, 42331 of which were published via an open access model. Since the 1940s, there has been an increase in the number of publications, with a sharp rise between the mid‐2000s and mid‐2010s. The Journal of Natural Products (n = 15144) was the periodical that published the highest number of articles. The most productive countries included China (n = 45860), the United States (n = 29523), and Germany (n = 10120); a number of the most common institutional affiliations and funding sponsors also originated from these three countries.

Conclusions: While many bibliometric analyses have been conducted on a specific TCAIM‐related topic to date, the present study represents the first of its kind and largest to date that captures the characteristics of the research literature published in TCAIM‐categorized journals. The total number of publications published in TCAIM journals is increasing. Future work should continue to investigate and track changes in the publication characteristics of the emerging research on this subject given the high prevalence of TCAIM use among patients, increased acceptance of TCAIM among conventional healthcare providers, and growing interest in TCAIM research.

OS CIM N 56 Collecting scientific data or herding cats? Lessons from integrative medicine interventions especially with children in real‐world settings.

Sarah Blakeslee¹; Gonza Ngoumou¹; Kristin Vieler¹; Judith Czakert¹; Wiebke Stritter¹; Georg Seifert¹

¹Charité ‐ Unversitätsmedizin Berlin, Berlin, Germany

Introduction: A growing body of knowledge has demonstrated the efficacy of many integrative medical practices for promoting health, especially with children. To build on the base of evidence and establish the effectiveness of health maintaining interventions in integrative medicine (IM), the collection of scientific data in a real‐world setting is essential. At the same time, conducting health promotion interventions in real‐world settings is complex and presents unique challenges. By highlighting the evidence‐based health interventions of an IM working group conducting research in real‐world settings, this work aims to identify barriers and opportunities in the planning and implementation of studies focusing on health promotion and well‐being for children and others.

Methods: Using a narrative, storytelling approach, we conducted a round table discussion and mapping session to illustrate and highlight experiences in conducting integrative health interventions in real‐world settings. Five experts in IM‐topics including nutrition, child health promotion, and aromatherapy participated. Findings were compared and contrasted and commonalities in experience were categorized into barriers and opportunities for lessons learned.

Results: Findings provide a first‐hand experience of conducting and implementing integrative medicine approaches within a real‐world context. Barriers were identified at every step of study design application and the experts described a range of strategic choices to maintain study rigor and data collection success. Opportunities highlighted existing structures or stakeholders that enabled individual adaptation to the real‐world setting to reach evidence‐based research objectives.

Conclusion: Scientific evidence is needed for many of the interventions geared toward health promotion. While a real‐world setting provides challenges to conducting studies for evidence‐based integrative medicine, experience shows that adaption and innovation in designs indicate promise for building scientific knowledge and methods for gathering evidence.

OS CIM N 57 Clinical Effects of Kneipp Hydrotherapy ‐ a Systematic Review of Randomized Controlled Trials

Miriam Ortiz¹; Anna K. Koch³; Holger Cramer^2,4; Klaus Linde⁶; Gabriele Rotter¹; Michael Teut¹; Benno Brinkhaus¹; Heidemarie Haller²

¹Institute of Social Medicine, Epidemiology and Health Economics, Charité ‐ Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt‐Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany; ²Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg‐Essen, Essen, Germany; ³Department of Pediatrics, Division of Oncology and Hematology, Charité Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt‐Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany, Berlin, Germany; ⁴Institute of General Practice and Interprofessional Care, University Hospital Tübingen, Tübingen, Germany, Tübingen, Germany; ⁵Bosch Health Campus, Stuttgart, Germany, Stuttgart, Germany; ⁶TUM School of Medicine, Institute of General Practice and Health Services Research, Technical University Munich, Munich, Germany

Introduction: Hydrotherapy is a traditional prevention and treatment strategy. The aim of this review is to systematically assess all available randomized controlled trials (RCTs) investigating clinical effects of “Kneipp” hydrotherapy which is characterised by cold‐water applications.

Methods: We included RCTs on therapy and prevention with hydrotherapy. Study participants were patients and healthy volunteers of all age groups. PubMed, Scopus, Central, CAMbase, opengrey.eu, and clinical trial registries (WHO German Clinical Trial Registry, ClinicalTrials.gov) were systematically searched through April 2021 without language restrictions. Risk of bias was assessed using the Cochrane tool.

Results: Twenty RCTs (N = 4.247) were included. Due to high heterogeneity of the RCTs, no meta‐analysis was performed. Risk of bias was rated as unclear in most of the domains. Of 132 comparisons, 46 showed significant effects in favor of hydrotherapy including chronic venous insufficiency, menopausal symptoms, fever, cognition, emotional function and sickness absenteeism. In contrast, 81 comparisons showed no differences between groups and 5 were in favor of the respective control group. Only half of the studies reported safety issues.

Conclusion: Kneipp Hydrotherapy showed some beneficial treatment effects in various conditions and outcome parameters. However, because of overall low study quality, further high‐quality RCTs are warranted.

OS CIM N 58 Cost‐Effectiveness of Chuna Manual Therapy and Usual Care, Compared with Usual Care Only for People with Neck Pain following Traffic Accidents: A Multicenter Randomized Controlled Trial

A‐La Park¹

¹Care Policy and Evaluation Centre, Department of Health Policy, London School of Economics and Political Science, London WC2A 2AE, UK, london, United Kingdom

Introduction: This is the first cost‐effectiveness analysis of Chuna manual therapy (CMT) plus usual Korean traditional medicine for traffic accident victims using a randomized controlled trial. The annual costs of Whiplash Associated Disorders (WAD) in Europe are EUR 10 billion . 60% of patients with acute WAD can develop chronicity with lingering pain and deteriorating quality of life and employability. The automobile compensation insurance scheme was expanded to include Korean traditional medicine, leading to an increase in use of complementary alternative medicine in 1999 in South Korea. With increasing car insurance claims for WAD, it is important to look at cost‐effectiveness of CMT as an adjunct therapy to usual care for WAD in a South Korean context to facilitate more optimal resource allocation decisions.

Methods: A total of 132 participants were equally assigned to the intervention group receiving 6‐11 sessions of CMT plus usual Korean traditional medicine care for 3 weeks or usual care including acupuncture, cupping, herbal medicine, moxibustion, and traditional physiotherapy at three hospitals. Cost‐effectiveness analysis was reported as recommended in the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) guidelines. Data on prescribed medications, emergency visits, inpatient days in conventional western and traditional Korean Medicine hospitals, day care, outpatient care, and diagnostic tests such as X‐rays were collected by patient self‐report, using an adapted version of the Client Service Receipt Inventory (CSRI) at baseline, 3, 6, and 12 weeks. This instrument is widely used to collect health services‐related resource use through self‐report. Intervention costs were estimated by examining electronic patient records.

Results: From a healthcare perspective, the intervention group had significantly higher costs (mean (SD), $778 (435) vs. $618 (318); difference, $160; 95% CI, $15 to $289; p = 0.005) at 12 weeks. From a societal perspective, total costs were insignificantly lower in the intervention group (mean (SD), $1077 (1081) vs. $1146 (1485); difference, $‐69; 95% CI, $‐568 to $377; p = 0.761). The intervention group dominated, with significantly higher QALYs gained at lower overall cost with a 72% chance of being cost‐effective. From a societal perspective, the intervention was cost saving for individuals who had neck pain after car accidents, although it was not cost‐effective from the healthcare perspective ($40,038 per QALY gained).

Conclusions: Our findings support use of CMT as an integrated care treatment for whiplash from a societal perspective. Further studies with larger sample sizes are needed to determine cost‐effectiveness in other cultural contexts.

OS CIM N 59 Interoceptive Awareness Training for Chronic Pain Treatment: A Pilot Implementation Science Study in an Integrative Health Clinic

Cynthia Price¹; Hanson Kathryn²; Blakeney Erin¹

¹University of Washington, Seattle, United States of America; ²Vanderbilt University, Nashville, United States of America

Introduction: Successful implementation of complementary and integrative health is important given that primary care and pain clinics are shifting to provide non‐pharmacological and interdisciplinary chronic pain care, a best‐practice to prevent and/or reduce use of opioid medications for pain. Mindful Awareness in Body‐oriented Therapy (MABT) is an evidence‐based mind‐body approach explicitly designed to reduce symptomatic distress through teaching interoceptive awareness and related development of skills for self‐care and emotion regulation. MABT, an 8‐week protocol, was delivered by licensed massage therapists trained in MABT; patients paid out‐of‐pocket for all sessions since massage therapy is not covered by insurance in the state where this clinic resides. While there is strong evidence for mind‐body interventions for chronic pain, the application of individually delivered approaches within the context of integrative health clinics has not been demonstrated. This mixed methods pilot implementation study examined the uptake of MABT within the clinic by examining key implementation outcomes of MABT acceptability, appropriateness, adoption, and penetration.

Methods: Data was collected through multiple data collection procedures, including a) surveys of clinic staff at 7 time points over 20 months to examine implementation outcomes, b) focus groups with different clinic staff stakeholders (e.g., integrative care providers, psychotherapists, massage therapists, and administrative staff), and c) electronic medical records to examine number of MABT referrals, source of referrals (provider discipline), and number of MABT sessions received.

Results: Clinic staff surveys (n = 190) showed high perceived MABT acceptability and appropriateness on all surveys following initial presentation of the MABT approach. High levels of acceptability and appropriateness were even more apparent in focus group results which highlighted MABT as addressing a perceived gap in symptom management for chronic pain. Adoption was high, with 70 patient referrals placed by clinicians, resulting in 42 patients attending MABT sessions; the majority of referrals were from integrative care providers (Nurse Practitioners). 71% of referred patients completed 6‐8 MABT sessions (at least 75% of the protocol). Primary barriers to referrals were identified as cost and availability of appointments.

Conclusions: The results demonstrate high implementation feasibility of MABT within an integrative health clinic for chronic pain. The findings suggest the need to better understand the unique value of interoceptive awareness for symptom management of chronic pain.

OS CIM N 60 Use of complementary and integrative health (CIH) in Finland: a cross‐sectional survey

Maija Pyykkönen¹; Pauliina Aarva²; Salla Ahola³; Matti Pasanen⁴; Kaija Helin⁵

1Socon Oy, Tampere, Finland; 2Faculty of Social Sciences, Tampere University, Tampere, Finland; 3Faculty of Management and Business, Tampere University, Tampere, Finland; 4Consultant in statistics, Tampere, Finland; 5Finnish Society for Integrative Medicine, Helsinki, Finland

Introduction: Population based studies have shown large differences in the estimated prevalence of complementary and integrative health (CIH) usage between studies. This is in part due to there being no golden standard definition for CIH. In Finland, an updated and internationally comparable study on CIH usage is needed. In the present study a modified Finnish version of the International Questionnaire to Measure Use of Complementary and Alternative Medicine (I‐CAM‐QFI) was utilised to examine prevalence of use of different CIH modalities and the experienced helpfulness in the general Finnish population.

Methods: Respondents (n = 3244) aged 16 and above were invited to take part in the I‐CAM‐QFI through an online panel in December 2022. The usage of CIH and the experienced helpfulness were described as the proportion of users per each modality. The data were weighted based on gender, age and place of residence.

Results: CIH was used by 51.1% (95% CI: 49.4 to 52.8) of the respondents in the 12 months prior to the survey. Self‐help practices were the most used category of CIH (28.8%; 27.3 to 30.4) compared to usage of CIH natural remedies excluding vitamins and minerals (27.0%; 25.5 to 28.6) and visiting a CIH provider (20.4%; 19.0 to 21.8). CIH was generally used more by women compared to men. The large majority found the modalities they used helpful.

Conclusions: The estimates of CIH usage are highly dependent on what is considered as CIH in different countries, and this should be paid attention to in future studies. Comparisons between countries reveal difficulties in using unified tools, as they need to be modified for the CIH fields in each country.

OS CIM N 61 Hydrotherapy and acupressure in restless legs syndrome – a randomized, controlled, three‐arm, explorative clinical trial

Julia Siewert¹; Julia Kubasch¹; Miriam Ortiz¹; Sylvia Binting¹; Ryan King¹; Joanna Dietzel¹; Rainer Nögel²; Josef Hummelsberger²; Stefan N. Willich¹; Benno Brinkhaus¹; Michael Teut¹

1Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt‐Universität zu Berlin, Institute of Social Medicine, Epidemiology and Health Economics, Charitéplatz 1, 10117 Berlin, Berlin, Germany; 2International Society for Chinese Medicine (SMS), Munich, Germany, Munich, Germany

Introduction: Restless legs syndrome (RLS) is a common neurological disease that has a significant impact on daily activities and quality of life, for which there is often no satisfactory therapy. Complementary medicine such as acupressure and hydrotherapy are used to treat patients with RLS, however with unclear clinical evidence. The aim of this study is to investigate the effects and the feasibility of self‐administered hydrotherapy according to Kneipp and acupressure in patients with RLS.

Methods: The study is a randomized controlled, open‐label, exploratory, clinical study with three parallel arms, comparing self‐applied daily hydrotherapy (according to the German non‐medical naturopath Sebastian Kneipp), and acupressure both in addition to routine care in comparison to routine care alone (waiting list control) in patients with RLS. Fifty‐one patients with at least moderate restless‐legs syndrome were included and randomized. Participants in the hydrotherapy group were trained in the self‐application of cold knee/lower leg affusions twice a day for 6 weeks. The acupressure group was trained in the self‐application of a 6‐point‐acupressure therapy once daily for 6 weeks. Both interventions took about 20 min daily. The 6‐week mandatory study intervention phase, which was in addition to the participant's pre‐existing routine care, was followed by a 6‐week follow‐up phase with optional interventions. The waiting list group did not receive any study intervention in addition to their routine care before the end of week 12. Outcome parameters include RLS‐severity (IRLSSG‐RS), disease and health‐related quality of life (RLS‐QoL, SF‐12), Anxiety and Depression scores (HADS‐D), self‐efficacy (GSE) and therapy safety at baseline, after 6 and 12 weeks. Statistical analyses will be descriptive and explorative.

Results/Conclusion: The study data is currently under statistical evaluation. The results will be presented and discussed on the congress for the first time.

OS CIM N 62 Bryophyllum pinnatum and improvement of nocturia and sleep quality in women: a multi‐centre, non‐randomised prospective trial

Nurlana Mirzayeva^1,2; Susanne Forst³; Daniel Passweg⁴; Verena Geissbühler⁵; Ana Paula Simões‐Wüst^6,7; Cornelia Betschart¹

1Department of Gynaecology, University Hospital and University Zurich, Zurich, Switzerland; 2Department of Obstetrics and Gynaecology, Cantonal Hospital Aarau, Aarau, Switzerland; 3Department of Obstetrics and Gynaecology, Cantonal Hospital Winterthur, Winterthur, Switzerland; 4Department of Obstetrics and Gynaecology, Triemli Hospital, Zurich, Switzerland; 5Department of Gynaecology, St. Claraspital, Basel, Switzerland; 6Department of Obstetrics, University Hospital Zurich, University of Zurich, Zurich, Switzerland; 7Klinik Arlesheim, Research Department, Arlesheim, Switzerland

Introduction: Nocturia is a pathologic condition that significantly affects the quality of sleep. Validated pharmaceutic treatment options exist but are, however, associated with marked side effects. Prospective clinical studies with tablets prepared from leaf press juice of the plant Bryophyllum pinnatum revealed a tendency towards reduction of micturition in patients with overactive bladder (OAB) and several improvements in sleep quality. These observations are in part supported by in vitro and invivo data. In the present study [see Mirzayeva et al, 2023, doi: 10.1155/2023/2115335], we investigated the effectiveness of Bryophyllum 50% chewable tablets in the treatment of nocturia and associated sleep disorders.

Methods: Altogether 49 women with idiopathic OAB and nocturia of ≥2 voids/night were treated with Bryophyllum 50% tablets for 3 weeks (350 mg chewable tablets, dosage 0‐0‐2‐2 oral tablets; WELEDA AG, Arlesheim, Switzerland). Nocturia, voiding volumes at night (ml), quality of life, sleep quality, and daily sleepiness were assessed before and after treatment with a 3‐day micturition diary, the International Consultation on Incontinence evaluating overactive bladder and related impact on quality of life (QoL) [ICIQ‐OAB], Pittsburgh Sleep Quality Index [PSQI], and Epworth Sleepiness Scale [ESS], respectively.

Results: Age of study population was 68.5 ± 11.6 y. After treatment, nocturia diminished from 3.2 ± 1.4 to 2.3 ± 1.3 (P < 0.001) and the PSQI score decreased from 7.7 ± 3.7 to 6.6 ± 3.4 (P = 0.004). Urgency, ICIQ‐Score and ESS lowered significantly, and the micturition volume showed a tendency towards increase. No serious adverse drug reactions were reported; compliance was good.

Conclusions: The results show a beneficial effect on the nocturnal voids and sleep quality of women with OAB. Bryophyllum 50% tablets can be regarded as a well‐tolerated alternative in the treatment of nocturia and broaden the repertoire of standard management.

OS CIM N 63 Becoming WHOLE: A Whole Health Operation for Learning and Empowerment for Caregivers across the University Hospitals Health System

Roshini Srinivasan^1,2; Samuel Rodgers‐Melnick^1,3; Jeffery A Dusek^1,3; Francoise Adan^1,3

¹University Hospitals Connor Whole Health, Cleveland, OH, United States of America; ²Duke University School of Medicine, Durham, NC, United States of America; ³Case Western Reserve University School of Medicine, Cleveland, OH, United States of America

Introduction: Frontline healthcare professionals (HCPs) are at high risk for burnout, which has been further exacerbated with the arrival of the COVID‐19 pandemic. Several complementary and expressive interventions have demonstrated effectiveness in addressing HCP wellbeing, including mindfulness, massage therapy, and group drumming. University Hospitals (UH) Connor Whole Health (CWH) has delivered many of these interventions in high volumes; however, comprehensive measures of the impact of these services have yet to be operationalized. The present study analyzes the feasibility and effectiveness of creating an integrated data repository to facilitate data collection on the immediate effects of whole health services delivered to HCPs across the UH health system.

Methods: A wide variety of CWH services were provided to employees of the UH health system across departments and facilities. Between January 13th to July 31st 2022, all UH caregivers presenting for CWH services were invited to participate in the study. Following consent, caregivers were invited to provide pre‐intervention measures, post‐intervention measures, and demographics in separate questionnaires. All data were collecting using REDCap. Data analysis included descriptive statistics of patient characteristics and means, standard deviations and paired t‐tests of single‐treatment effect on PROs where the pre‐session score was ≥1 for stress and tension or ≤9 for coping and relaxation. Brief thematic analysis was performed upon patient quotes.

Results: During the study period, there were 2023 participation units (instances of receiving a CWH service) by 1506 UH caregivers. Among these, 578 (28.6%) participation units by 485 (32.3%) caregivers consented to participate in the study. Of the 261 caregivers who provided demographic data, most were female (n = 228, 87.4%) and white (n = 190, 72.8%), with a mean age of 42.11 years. Most participants worked as Nurses (n = 88, 33.7%), Other Patient Care Professionals (n = 56, 21.5%) or Other (n = 54, 20.7%) at UH and worked in a community medical center location (n = 105, 40.2%). Most participants sought massage therapy (n = 176, 67.4%), followed by meditation (n = 112, 42.9%), yoga (n = 104, 39.8%), music therapy (n = 96, 36.8%), and acupuncture (n = 94, 36.0%), delivered in‐person (n = 197, 71.6%). For UH caregivers with moderate‐to‐high needs, defined as an initial stress/tension score ≥4, or initial coping/relaxation score ≤6, significant decreases in stress and tension and increases in coping and relaxation were observed post‐intervention.

Conclusions: Implementing an integrated data repository of whole services delivered to HCPs across a major academic healthcare system is feasible. These services are associated with positive effects upon wellbeing.

OS CIM N 64 Updating clinical prediction models for nonrecovery in older adults with back pain using only patient‐reported outcomes

Carina Staab¹; Andrew Humbert¹; Pradeep Suri¹; Sean Rundell¹

¹University of Washington, Seattle, United States of America

Introduction: Prior prognostic models developed by Van der Gaag et al. used both patient‐reported outcomes (PROs) and physical exam measures, which may limit use outside clinical encounters. This study aimed to examine the performance of updated prognostic models using only PROs from the Back Pain Outcomes Using Longitudinal Data (BOLD) study.

Methods: BOLD is a prospective cohort study with 5,239 patients aged 65 years or older with new episodes of back pain from 2010 to 2013. We defined persistent back pain as having a pain numerical rating (NRS) score of 3 or higher at both 6 and 12 months after baseline. Persistent disability was defined as having a Roland‐Morris Disability Questionnaire (RMDQ) score of 4 or higher at both 6 and 12 months after baseline. Our candidate predictors included PROs measures of demographics, symptom duration, pain, disability, anxiety and depression, expectations, and quality of life. We used logistic regression with LASSO penalization to develop updated, parsimonious prediction models for persistent pain and persistent disability. The final models' performance was evaluated with measures of calibration and discrimination (area under the curve [AUC]) using a split‐sample.

Results: Our analytical sample included 4,660 participants with complete outcomes. Both models performed well, displaying good overall performance during development and validation. The persistent back pain model contained age, sex, RMDQ, EuroQol five‐dimensional (EQ‐5D) – questions 1 & 3‐6, Patient Health Questionnaire‐4 (PHQ‐4) – anxiety and depression, pain expectation 3 months, back and leg pain NRS, college and vocational education, and back pain duration. It demonstrated good calibration (slope = 1.13) and acceptable discrimination (AUC 0.713). The persistent disability model contained age, sex, RMDQ, EQ‐5D – questions 1 & 6, pain expectation 3 months, back and leg pain NRS, and college education. It demonstrated good calibration (slope = 1.24) and discrimination (AUC 0.811).

Conclusions: These updated models utilized only PROs yet provided slightly better performance than the original models by Van der Gaag et al. applied to available variables in BOLD (AUC of 0.670 for pain and 0.778 for disability). It's important to note that we couldn't use Van der Gaag's exact models due to mismatch in available variables. These models should be externally validated before being used in a clinical, primary care setting.

OS CIM N 65 Development of a Burnout and Stress Prevention Intervention with Mind‐Body Medicine for Healthcare Professionals Using Critical Synthesis of Multi‐Method Research – Results of the Needs Assessment

Melanie Steinmetz¹; Julia Berschick¹; Julia K. Schiele¹; Marleen Schröter¹; Martin Bogdnski¹; Wiebke Stritter¹; Christian Kessler^2,3; Georg Seifert¹; Anna‐Katharina Koch¹

¹Department of Pediatrics, Division of Oncology and Hematology, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt‐Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany; ²Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt‐Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany; ³Department of Internal and Integrative Medicine, Immanuel Hospital Berlin, Berlin, Germany

Introduction: Burnout is a global threat with detrimental psychological and physiological consequences. Regarding healthcare professionals, it also effects patient safety and patient care. Mind‐body medicine has great potential to add effective measures to workplace health promotion (WHP). For a sustainable implementation of mind‐body medicine in WHP, a rigorous methodological approach to intervention development is needed. We aim to develop an evidence‐based, custom tailored, theory‐informed intervention with mind‐body medicine to foster stress‐ and burnout‐prevention in healthcare professionals working at Charité – Universitätsmedizin Berlin and the Immanuel Hospital Berlin. This abstract describes the needs assessment process as a basis for further intervention development.

Methods: We used the PRECEDE model by Green and Kreuter (2005) to analyze burnout, its causes, and its impact on the quality of life of the healthcare professionals. The model was informed by a scoping review, a grey literature review with semi‐structured interviews, on‐site observations including semi‐structured interviews at Charité – Universitätsmedizin Berlin and Immanuel Hospital Berlin, and the results of a ‘Think Experiment’ conducted at Charité – Universitätsmedizin Berlin. Various advisory boards including the employees for whom the intervention will be developed were involved in the process.

Results: The causes of burnout were divided into personal determinants, behavioral factors, and environmental factors. Behavioral factors were: not taking legally allowed breaks, doing overtime, low self‐care, neglecting basic needs, not asking for help, underutilization of existing health programs, skipping vacation or working during free time, and overly helping behavior. Environmental factors included factors on the interpersonal level (teams and leadership; e.g. missing appreciation by peers and leaders, lack of communication skills, and lacking feedback routines), on the organizational level (e.g. working conditions like increasing red tape, time pressure, and an optimizable open‐ear policy), and on the society level (e.g. lack of appreciation).

Conclusions: In view of the current burnout crisis in the healthcare sector, effective prevention measures must be an essential component of institutional policy. We identified a variety of factors at the individual and structural level that promote burnout among health professionals at Charité – Universitätsmedizin Berlin and Immanuel Krankenhaus Berlin. Based on this, an evidence‐based, individual, theory‐driven intervention for stress reduction and burnout prevention with mind‐body medicine will be developed in close collaboration with staff. Especially on an individual level, mind‐body medicine offers a variety of effective prevention measures here that can expand the spectrum of WHP. A broad participation of different stakeholders should ensure a sustainable implementation.

OS CIM N 66 Associations between using Chinese Herbal Medicine and both clinical outcome and gut microbiome in Eczema patients: A Prospective Observational Study

Yi Shun Tam¹; Oliver Chun ho Ma¹

¹The Hong Kong Tuberculosis Association ‐ The University of Hong Kong Chinese Medicine Clinic cum Training and Research Centre (Southern District), Hong Kong, Hong Kong (China)

Introduction: Eczema is a chronic, relapsing skin disease which influences patients' social life and mental well‐being. Currently, the major therapies include oral antihistamines or topical steroid ointment. Traditional Chinese Medicine (“TCM”) is frequently employed by patients who are worried about drug dependence and other negative consequences of long‐term steroid and antihistamine use. The relationship between gut microbes and allergic illnesses has come to light recently. Modifying the composition of gut microorganisms becomes an innovative idea for treating eczema. Thus far, not many studies have examined the connection between eczema and gut microbiome. Before we can offer any references and original ideas for the TCM treatment of eczema, further research must be done.

Study Design: An observational study of efficacy of TCM treatment in eczema patients.

Objective: This study aims to evaluate the effectiveness of TCM on the health condition of patients with eczema, particularly with Eczema Area Severity Index (EASI) score and the change of patients' gut microbiota.

Setting: The Hong Kong Tuberculosis Association ‐ The University of Hong Kong Chinese Medicine Clinic cum Training and Research Centre (Southern District).

Outcomes measures:

1. Clinician reported signs: EASI

2. Stool testing analysis indicating the gut microbiome profile

Methods:

Conclusion: This study provides a novel approach to quantifying the effectiveness of TCM treatment for eczema by clinical evaluation and changes in patients' gut microbes. Chinese Medicine Practitioners are more capable of formulating effective prescriptions according to the network analysis of the core herbs used in the treatment.

OS CIM N 67 The Yin and Yang of Cannabis in Medicine: Evidence‐Based, Practical Knowledge for the Busy Clinician

Leslie Mendoza Temple¹

¹Department of Family Medicine & Integrative Medicine, NorthShore University HealthSystem; University of Chicago Pritzker School of Medicine, Chicago, IL, United States of America

Introduction: This session will outline the basics of the system of cannabinoid receptors and endocannabinoids and review clinical situations (cancer symptom management) where cannabis may be a suitable, evidence‐based intervention.

Methods: Current evidence regarding the use of cannabis for the treatment of cancer itself will be included in the presentation. Clinical pearls on dosing, route, drug interactions, cannabinoid content, and the role of terpenes will be discussed. Risks of intoxication, addiction, driving impairment, occupational impacts, cannabis hyperemesis syndrome, and other risks will also be highlighted. Cannabis sativa is becoming more widely available as a medicine in the United States as well as throughout the world. The knowledge base regarding Cannabis' toxicity and addiction potential is well established, but its evidence as a therapeutic substance is still in development due to many barriers that hamper clinical trials in the U.S. and abroad. Although its medicinal use dates back thousands of years, health care providers trained in modern times during cannabis prohibition and stigmatization have insufficient knowledge regarding cannabis pharmacology, benefits, risks, and dosing recommendations. At present, patients are increasingly relying on internet testimonials or advice from trained (or poorly trained) laypersons in cannabis dispensaries to determine if cannabis may be useful for them. Recent surveys have shown a substantial gap between patients' need for quality medical advice on how to incorporate cannabis into their care and what their treating providers are able to discuss with them.

The goal of this presentation is to impart a well‐rounded knowledge base for participants on the potentially “good” and “evil” aspects of this complex plant, with useful takeaways on the clinical incorporation of cannabis in a patient's treatment plan.

A discussion on the impact of regulation and patient access, as well as medical education in this burgeoning field will also occur.

OS CIM N 68 Evaluation of the Integrative Medicine in Intensive Care program ‐ External Applications as a Complementary Medicine Supplement for Intensive Care Patients

Eliane Timm¹; Jana Ertl¹; Ottilia Rohrer²; Ursula Wolf¹

¹Institute of Complementary and Integrative Medicine, University of Bern, Bern, Switzerland; ²Department of Intensive Care Medicine, Bern University Hospital and University of Bern, Bern, Switzerland

Introduction: External applications (compresses, rubs, wraps, embrocation) have been used for centuries in medicine. They support the body's own regulatory ability and are complementary to conventional treatments. Due to the method of application and low dosage effects, these applications are non‐invasive and can be safely used alongside conventional prescribed medications in selected patient populations. As part of the program “Integrative Medicine in Intensive Care”, in 2022, several external applications (such as oils and ointments against insomnia, fever, etc.) were applied in the Department of Intensive Care Medicine (ICM) of the University Hospital of Bern, Switzerland. The aim of this evaluation was to access the implementation of this program from the perspective of nursing professionals by using the standard methodology of focus groups.

Methods: Nursing professionals working in the ICM department took part in focus groups about the implementation of the program. They were asked about their general opinions, their experiences so far, barriers to use the applications, and about their ideas and thoughts to improve the program. Participation was voluntary. Here we report on the main points of the comments voiced by the nurse professionals.

Results: Four, 40‐50min, focus interviews were conducted with 50 ICM health professionals. Participants viewed these external applications as positive and rated it as good addition to the conventional treatment. They stated that their experience with them were positive, particularly in reference to the so‐called feverwash (the most used application). Some voiced that effects of some applications were, given the different therapeutic components in an ICU, difficult to measure. By far the most mentioned barrier in using these applications was time constrains, where they did not feel they had the time to treat patients with such methods, followed by not remembering to use them during shifts. One specific barrier for the intermediate care was the inconvenient storage location of the material. To prevent or reduce these challenges, participants suggested a laminated sheet with a short manual as quick reminder during shifts, someone specifically trained to help with the applications on patients, and the option for more training in this area.

Conclusions: The nursing staff welcomes the use of external applications as a good addition to their established methods and treatments. Barriers of the program were mainly organizational. It is important that everyone involved is informed about the new applications. Additionally, particularly in the introductory phase, being regularly reminded supports remembering to use the external applications.

OS CIM N 69 Associations between Chinese Herbal Medicine for different syndrome differentiation and clinical outcome in Eczema patients: A Retrospective Cohort study

Pak Yin Tse¹; Oliver Chun ho Ma¹; Long Ching Tang¹

¹The Hong Kong Tuberculosis Association ‐ The University of Hong Kong Chinese Medicine Clinic cum Training and Research Centre (Southern District), Hong Kong, Hong Kong (China)

Introduction: In recent years, there has been a notable increase in the prevalence of eczema. At present, standard therapeutic modalities include topical steroid ointments and oral antihistamines. A significant number of patients opt for Traditional Chinese Medicine (TCM) in lieu of conventional treatments due to concerns over drug dependency and potential adverse effects associated with prolonged steroid use. The Eczema Area and Severity Index (EASI) has been widely used for measuring eczema severity. Efficacy of Chinese medicine can be evaluated by comparing the EASI score before and after treatment. Preliminary findings from our research indicate that TCM can be effective in treating eczema. Further analysis of the results is currently underway.

Study design: Retrospective cohort study will be adopted to investigate the association between using Chinese Herbal Medicine (CHM) for different syndrome differentiation and the change of EASI in eczema patients.

Objectives: This study aims to evaluate the effectiveness of TCM by examining the association of CHM use among different syndrome differentiation and the change of EASI in eczema patients. Additionally, prescriptions used will be analyzed to reveal the treatment principle and core CHM for eczema.

Setting: The Hong Kong Tuberculosis Association ‐ The University of Hong Kong Chinese Medicine Clinic cum Training and Research Centre (Southern District)

Outcomes measures:

1. Clinician reported signs: EASI

2. Dependence on topical steroid ointments or oral antihistamines etc

Methods: Between June 2019 and December 2022, the Southern District Chinese Medicine Clinic conducted pre‐ and post‐treatment EASI assessments on 1,169 eczema patients. Basic information (age, gender, age of onset, previous medication history) was collected after obtaining informed consent. All participants were evaluated with EASI and categorized into different syndrome differentiation by registered TCM Practitioners. Differences in EASI between different types of TCM syndromes will be analyzed to understand the distribution and conditions prognostic relationship. Furthermore, association rule mining will be used to find out the common CHM combinations. Social network analysis will be used to graphically demonstrate and analyze the Chinese herbal medicine network. It helps disclose the treatment principle and core CHM used for eczema from the large‐scale clinical data.

Conclusion: The findings of this study is significant for the advancement of clinical guidelines and treatment protocols for eczema, and thus help to maximize the advantages of TCM in prevention and treatment in atopic dermatitis.

OS CIM N 70 A Dutch national research agenda on integrative medicine: results of a consensus‐based strategy

Herman van Wietmarschen^1,2; Annemarie Kapteijns^1,2; Erik Baars^1,2; Martine Busch^1,3; Art Vreugdenhil^1,4; Ines von Rosenstiel^1,5; Anne Speckens^1,6; Rogier Hoenders^1,7

¹Consortium for Integrative Care and Health, Veldhoven, Netherlands (The); ²Louis Bolk Institute, Bunnik, Netherlands (The); ³van Praag Institute, Utrecht, Netherlands (The); ⁴Department of Internal Medicine, Maxima Medical Centre, Eindhoven, Netherlands (The); ⁵Department of Pediatrics, Rijnstate Hospital, Arnhem, Netherlands (The); ⁶Department of Psychiatry, Radboud University Medical Center, Nijmegen, Netherlands (The); ⁷Center for Integrative Psychiatry, Lentis, Groningen, Netherlands (The)

Introduction: The WHO has stressed several times, for instance in its traditional medicine strategy 2014‐2023, the importance of traditional and complementary medicine for global health and wellbeing, and the need for the integration of medical systems. Most member states now have national policy, programs and or research institutes for traditional and complementary medicine (WHO 2019). However, despite these calls from WHO and public interest in the Netherlands, there is no national program or research institute established yet. Initiated by the national institute of health research (ZonMw), in 2018 a consortium for integrative care and health (CIZG) was founded. It consists of 1 academic medical center, 3 large teaching hospitals, 2 mental health care institutes and 1 research institute. The consortium issued the development of a national research agenda with research priorities for the Netherlands.

Methods: A consensus‐based strategy was followed. A survey was developed based on the literature and two focus group sessions. The survey was conducted amongst stakeholders interested in or connected to integrative medicine (IM). Snowball sampling was used.

Results: 92 stakeholders (conventional health care professionals 28%, IM professionals 17%, patients 15%, researchers 13%, managers 4%, policymakers 3%, other 18%) completed the survey. According to respondents, the most promising research areas for the Netherlands are oncology (77%), pain management (64%) and palliative care (54%). Besides, studies of effectiveness (75%) and cost‐effectiveness (57%) of IM interventions have the highest priority, followed by establishing best practices of collaboration between complementary and conventional health care professionals (53%). Mind‐body interventions (64%), biological interventions (49%) and whole medical systems (42%) were also mentioned as important fields for research. Furthermore, developing high quality information tools for patients (71%) was recommended. Positive developments for integrative medicine in the Netherlands were the increased attention for lifestyle and prevention (76%), the increase of chronic diseases (71%) and the shift from disease towards health (75%). Identified barriers were lack of knowledge about integrative medicine (71%), lack of reimbursement of complementary treatments (67%) and existing administrative structures of health care organisations.

Conclusions: A research agenda for IM research in the Netherlands was established. The research priorities will be presented to the Dutch government and Dutch funding organisations as well as to the stakeholders and the public. The research priorities will be developed into research lines and project for the CIZG and Louis Bolk Institute to further the development towards integrative medicine in the Netherlands.

OS CIM N 71 Co‐creation of an evidence‐based toolkit to facilitate communication on complementary medicine between general and complementary care practitioners in the Netherlands

Louise Mulder¹; Martine Busch²; Armelle Demmers³; Herman van Wietmarschen¹

¹Louis Bolk Institute, Bunnik, Netherlands (The); ²van Praag Institute, Utrecht, Netherlands (The); ³RBCZ, Zeist, Netherlands (The)

Introduction: In 2016‐2019 the authors developed a first version of a toolkit to facilitate communication between conventional and complementary care professionals. A register for complementary care therapists (the RBCZ) representing 28 professional organisations covering 9000 therapists was interested to adopt, expand and implement the tools. The aim was to improve the communication and collaboration between member therapists of the RBCZ and conventional health care professionals. The first set of tools was targeted towards primary care physicians. In this project the reach was expanded to include mental health professionals, occupational physicians, physiotherapists, and nurse practitioners. Furthermore, there was more focus on the implementation of the tools.

Methods: The toolkit was expanded and new tools were developed in a co‐creation process with conventional (RC) and complementary care (CC) professionals in three field labs, one in Utrecht, one in Amsterdam and one in the North of the Netherlands. Thematic focus group discussions were held to define the content of the toolkit. Pragmatic evidence‐based cards for possible referral to the respective complementary care modalities were developed based on systematic literature assessment and Strength Of Recommendation Taxonomy (SORT) criteria. Guidelines for implementation of the tools were developed and presented in a symposium for all RBCZ members.

Results: The evidence‐based toolkit consists of eight items. 1) Recommendations to enhance regional collaboration and communication between RC and CC professionals, 2) recommendations for CC practitioners how to get in touch with RC professionals, 3) recommendations for professional CC associations how to get in touch with RC professionals, 4) instructions on how to report results of complementary treatments of patients to RC professionals, 5) evidence‐based cards for RC professionals on referral to CC professionals for: pain (neck, lower back), depression, medically unexplained physical symptoms, irritable bowel syndrome, burnout and fatigue, 6) instructions on how to construct an overview of qualified CC practitioners in a region, 7) ethical guidelines about safe and effective use of CC to support decision making of GPs together with patients, 8) guideline for the use of SORT criteria to assess evidence for professional organisations. Furthermore, a guideline for professional organisations and CC professionals was developed for implementing the tools.

Conclusions: The evidence‐based toolkit was expanded and further developed. Next step is to further support the field labs with implementing the tools and evaluating the effects on collaboration and communication.

OS CIM N 72 Feasibility of clinical trials on herbal medicines in UK primary care: lessons learned

Merlin Willcox¹; Hu Xiao‐Yang¹; Michael Moore¹

¹University of Southampton, Southampton, United Kingdom

Introduction: The National Institute for Health and Care Excellence (NICE) makes recommendations on treatments in the UK National Health Service (NHS) based on evidence from systematic reviews of randomised controlled trials. At present very few herbal medicines are mentioned because of “insufficient evidence”. To assess the feasibility of conducting double‐blind randomised placebo‐controlled clinical trials of herbal medicines in UK primary care.

Methods: We have conducted four feasibility trials and one definitive randomised controlled trial of herbal medicines in UK general practice (Pelargonium sidoides for acute bronchitis; Andrographis paniculata for acute respiratory infections; Shufeng Jiedu (a complex Chinese medicine) for acute exacerbations of COPD), Individualised Chinese medicine for recurrent urinary tract infections, and Arctostaphylos uva‐ursi for acute urinary tract infections.

Results: All the trials were able to recruit and retain patients from GP practices, although they faced varying challenges, mainly concerning recruitment and trial procedures. Most patients and GPs were open to trying herbal medicines. Lessons learned include the need to work closely with manufacturers to source GMP products which can be taken through to definitive trials, and which patients can easily be advised to purchase. It was easier to recruit and retain patients from Chinese Medicine Practitioners than from GPs for the trial of Individualised Chinese Herbal Medicine, but this may not easily be scaled up.

Conclusion: It was feasible to recruit patients from UK general practice to clinical trials of herbal medicines. Progress to definitive trials is difficult because of a lack of UK‐GMP preparations on the market.

OS CIM 73 Evidence‐based clinical Chinese medicine: the whole‐evidence approach

Xue Charlie¹; Zhang Tony¹; CAIRCCM On behalf of²

¹RMIT University, Melbourne, Australia; ²China‐Australia International Research Centre for Chinese Medicine (CAIRCCM), RMIT and GPHCM, Melbourne, Australia

Introduction: Chinese medicine has been used for centuries to treat many common health conditions and is supported by an extensive literature base, accumulated over more than 2,000 years. However, health practitioners often lack the time, resources and knowledge to find and evaluate relevant clinical evidence. This means it may be difficult for them to make informed clinical decisions based on current best evidence. Comprehensive systematic reviews, like those in the clinical evidence monograph series, provide this information and help practitioners make informed clinical decisions. In response to this, the China‐Australia International Research Centre for Chinese Medicine developed a ‘whole‐evidence approach’ and has applied this methodology to systematically evaluate the current best available evidence on Chinese medicine for 29 common clinical conditions.

Results: Information from each component is collated and analyzed to provide users including practitioners a comprehensive understanding of classical and contemporary Chinese medicine interventions for a particular condition. The Centre has produced evidence‐based clinical Chinese medicine monographs on 29 commonly health conditions. These are published bilingually by the World Scientific Publishing House Singapore and the People's Medical Publishing House China.

Conclusions: Practitioners, academics, researchers and policy makers can use monographs as the best available, up‐to‐date clinical evidence in their practice, in combination with their expertise and patients' treatment preferences, to make better informed clinical decisions. By using the whole‐evidence approach, practitioners can be confident that their decisions are based on current best evidence.

OS CIM N 74 Effects and mechanisms of Tai Chi on mild cognitive impairment and early‐stage dementia: A scoping review

Nibras Jasim¹; Darsiha Balakirishnan²; Han Zhang³; Genevieve Z. Steiner‐Lim⁴; Diana Karamacoska⁴; Guoyan (Emily) Yang⁴

¹School of Psychology, Western Sydney University, Sydney, Australia; ²School of Medical Science, Western Sydney University, Sydney, Australia; ³School of Acupuncture and Massage, Beijing University of Chinese Medicine, Sydney, Australia; ⁴NICM Health Research Institute, Western Sydney University, Sydney, Australia

Introduction: Health benefits of Tai Chi have been documented in people with mild cognitive impairment (MCI). However, the effects of Tai Chi and its underlying mechanisms among this population have not yet been fully understood. This study aimed to: (1) identify the neurocognitive, psychological, and physical health benefits of Tai Chi on people with mild cognitive impairment, and (2) explore the underlying mechanisms of these effects.

Methods: We searched systematic reviews (SRs) and randomised control trials (RCTs) on Tai Chi for mild cognitive impairment (MCI) from Medline, PubMed, Cochrane Library, EMBASE, and four Chinese databases. The methodological quality of included SRs was assessed with the critical appraisal tool A Measurement Tool to Assess systematic Reviews (AMSTAR 2), and RCTs with the Cochrane risk of bias tool.

Results: A total of 8 SRs with meta‐analyses and 6 additional RCTs were included. The findings were inconsistent about Tai Chi in improving global cognitive function, attention and executive function, memory and language, and perceptual‐motor function. Tai Chi was beneficial in improving depressive symptoms but not superior to stretching, cognitive behavior therapy or usual care. Results from the RCTs also showed that Tai Chi can reduce arthritis pain and slow the progress of dementia. No studies investigating the potential mechanisms of Tai Chi among people with MCI were identified. Instead, 9 mechanistic studies on healthy adults demonstrated that Tai Chi may improve memory and cognition via increasing regional brain activity, network functional connectivity, and regional grey matter volume.

Conclusion: The effects of Tai Chi on neurocognitive outcomes in people with MCI are still inconclusive. Further high‐quality clinical trials and mechanistic studies are needed to understand if and how Tai Chi may be applied as a successful intervention to delay deterioration and improve quality of life in people with increased risk of cognitive decline.

OS CIM N 75 Ginkgo Biloba for Mild Cognitive Impairment and Alzheimer's Disease: An Updated Systematic Review and Meta‐Analysis of Randomized Controlled Trials

Guoyan (Emily) Yang¹; Yuyi Wang²; Nibras Jasim¹; Fathima Nuska Mohamed Nawas¹; Jinzhou Tian³; Dennis Chang¹; Jian‐Ping Liu⁴

¹Western Sydney University, Sydney, Australia; ²Chongqing Hospital of Traditional Chinese Medicine, Chongqing, China; ³Dongzhimen Hospital, Beijing, China; ⁴Beijing University of Chinese Medicine, Beijing, China

Introduction: Ginkgo biloba is a natural medicine that is potentially beneficial for mild cognitive impairment (MCI) and Alzheimer's disease (AD). The is an update of a systematic review published in 2015 to evaluate the effectiveness and safety of Ginkgo biloba in treating MCI and AD.

Methods: We searched Medline, Embase, Cochrane Library, Chinese Scientific Journals Database (VIP), China Network Knowledge Infrastructure (CNKI), Sino‐Med Database and Wan Fang Database for randomized clinical trials on Ginkgo biloba in treating MCI or AD published between December 2014 and December 2022. Meta‐analyses were performed by RevMan 5.4.1 software. Subgroup analyses were conducted based on dosage forms. We evaluated the methodological quality by Cochrane's revised risk of bias tool (RoB 2) and appraised certainty of evidence with GRADE.

Results: We included six new trials and a total of 27 trials involving 2772 people with MCI or AD. The general methodological quality of included trials was poor. Compared with placebo, Ginkgo biloba was superior in improving the Short Cognitive Performance Test (SKT) in people with AD. Compared with conventional medicine, the tablet form of Ginkgo biloba was superior in improving the Mini‐Mental State Examination (MMSE) scores at the end of the interventions, and the Activity of Daily Living (ADL) at 4 weeks of tablet and injection forms of Ginkgo biloba in people with AD. In addition, compared with conventional medicine alone, Ginkgo biloba, of tablet or injection dosage form, in combination with conventional medicine was superior in improving MMSE scores, HDS and the ADL at the end of the interventions for people with AD, and the tablet dosage form of Ginkgo biloba for MCI. Ginkgo biloba group experienced less adverse events when compared with conventional medicine (OR 0.52, 95% CI 0.29 to 0.94, P = 0.03, I² = 79%) or when used in combination with conventional medicine versus conventional medicine alone (OR 0.29, 95% CI 0.10 to 0.80, P = 0.02, I² = 88%). There was no significant between‐group difference in Ginkgo biloba and placebo groups.

Conclusions: Ginkgo biloba seems beneficial for the improvement of cognitive function, activities of daily living, and global clinical assessment in patients with MCI or AD. Ginkgo biloba induced less adverse events than conventional medicine. However, there still has been no strong evidence in the past eight years to confirm the effectiveness and safety of ginkgo biloba in treating MCI and AD. Large sample size and rigorously designed trials are needed.

OS CIM N 76 Evidence‐based clinical Chinese medicine for vascular dementia: the whole‐evidence approach and the current best evidence

Xue Charlie¹; Zhang Tony¹; May Brian¹; CAIRCCM On behalf of²

¹RMIT University, Melbourne, Australia; ²China‐Australia International Research Centre for Chinese Medicine (CAIRCCM), RMIT and GPHCM, Melbourne, Australia

Introduction: Vascular dementia (VaD) is a chronic disorder that is associated with cerebrovascular disease (CVD) and manifests as declines in memory and intellectual abilities that cause impaired functioning in daily living. VaD is the second most common form of dementia after Alzheimer Disease. In modern Chinese medicine, the main term for vascular dementia is xue guan xing chi dai. Health practitioners often lack the time, resources and knowledge to find and evaluate relevant clinical evidence. This means it may be difficult for them to make informed clinical decisions based on current best evidence. Comprehensive systematic reviews, like those in the clinical evidence monograph series, provide this information and help practitioners make informed clinical decisions. In response to this, the China‐Australia International Research Centre for Chinese Medicine developed a ‘whole‐evidence approach’. We use vascular dementia to illustrate the approach and present the key findings.

Methods: The whole‐evidence approach evaluates all types and levels of clinical evidence, and has four main components:

• diagnosis, differentiation and treatment of clinical conditions, based on published textbooks and clinical guidelines

• analysis of conditions and their historical context, based on systematic searches of the full texts of more than 1,000 classical Chinese medical books

• assessment of evidence from modern clinical studies of Chinese medicine, based on established Cochrane Collaboration methods and Grading of Recommendations, Assessment, Development and Evaluation (GRADE)

• examination of potential mechanisms of action of key herbs.

Results: Searches of English and Chinese language biomedical databases for clinical trials identified 180 randomised controlled trials (RCTs) of Chinese herbal therapies in participants diagnosed with VaD. Syndrome differentiation was used in 52 studies. The database searches found 47 RCTs of acupuncture therapies in participants diagnosed with VaD including 4 RCTs of scalp acupuncture and 2 RCTs of moxibustion. Ten RCTs reported syndrome differentiation. Searches of over 1,000 classical books in the database Zhong Hua Yi Dian located 126 references to treatments for VaD including 92 commonly used herbal formulae and 34 references to acupuncture therapies.

Conclusions: VaD was an identifiable clinical presentation in the Chinese medicine classical literature. Many of the traditional medicines frequently used as ingredients in classical formulae for VaD‐like symptoms/signs were consistent with contemporary clinical use. Also, experimental studies suggest biological activities relevant to VaD. Practitioners can use the VaD monograph as the best available, up‐to‐date clinical evidence in their practice, in combination with their expertise and patients' treatment preferences, to make better informed clinical decisions.

OS INTEGRATIVE ONCOLOGY N 1 Role of Acupuncture in the management of orphan symptoms related to the antitumour treatments: experience of the multidisciplinary oral therapy outpatient clinic of the “Giuseppe Mazzini” Hospital, Teramo, Italy

Maria Abad Arranz¹; Federica Aielli¹; Azzurra Irelli¹; Leonardo Patruno¹; Silvana Ciccone¹; Alessia Di Giacobbe¹; Giovanni Cianci¹; Luca Napoleoni¹; Francesco Martella¹; Armida D'Incecco¹; Secondo Scarsella²; Katia Cannita¹

¹Medical Oncology Unit, Department of Oncology, Mazzini Hospital, Teramo, Italy; ²Italian Academy of Chinese Medicine, L'Aquila, Italy

Introduction: The multidisciplinary oral therapy outpatient clinic was set up in September 2022 at the Medical Oncology Unit of the “Giuseppe Mazzini” Hospital, Teramo (Italy). This outpatient clinic involved oncologists, nurses, acupuncturists, psychologists, nutritionists and music therapists, thus moving towards Integrative Medicine. Orphan symptoms are not systematically evaluated in clinical practice and need to be studied and appropriately treated. Acupuncture could play a role in their treatment.

Methods: From October 2022 to March 2023, a prospective observational study was conducted to enrol consecutive cancer patients with orphan symptoms related to hormone therapy or oral chemotherapy. Patients were selected by the oncologist and recruited for the visit with the acupuncturist.

Results: Twenty‐nine cancer patients were evaluated: 24 women (83%) and five men (17%). The mean age was 56 for women (range 41‐77) and 61 for men (range 55‐78). ECOG PS was 1 (86%) and 2 (14%). Primary tumours were: breast, 24 (83%); colon, 3 (11%); prostate, 1 (3%); liver, 1 (3%). Twenty‐one of 29 patients evaluated (72%) were enrolled in the acupuncture series: 17 women (71%) and four men (1%). Among men, cancer treatment‐related symptoms eligible for acupuncture were: peripheral neuropathy 3 (75%) and hot flushes 1 (25%). Among women, cancer treatment‐related symptoms eligible for acupuncture were: fatigue, 12 (71%); joint stiffness, 8 (47%); insomnia, 3 (18%) and swelling sensation in lower limbs, 2 (12%). Some patients had co‐occurring symptoms. Each patient takes an average of 7 acupuncture treatments (2‐12). Patients with hot flashes and chemotherapy‐induced peripheral neuropathy were treated with 4Hz continuous wave electroacupuncture and a TDP lamp. Patients with joint stiffness were also treated with a TDP lamp. No adverse events were reported. At the end of the treatment cycle, patients treated with acupuncture were more likely to experience improvements in symptoms related to cancer treatment measured by numeric scales for symptoms and in quality of life (QoL) measured by the QLQ‐C30 QoL subscale. The feedback questionnaires highlighted the efficacy of the acupuncture procedure and the improvement of QoL. All patients interviewed expressed the will to continue the acupuncture therapy.

Conclusions: This single‐centre study offers a real‐life acupuncture experience in patients undergoing hormone therapy or oral chemotherapy. Acupuncture impacts perceived well‐being, improves QoL and reduces orphan symptoms, improving patient compliance with the antitumour treatments.

OS INTEGRATIVE ONCOLOGY N 2 Don't eat what you want! 10 reasons why it is necessary to give the utmost importance to nutrition in colorectal cancer

L. Anelli¹; M. Bonucci¹

1‐ Foundation ARTOI

Introduction: Colorectal cancer is considered a significant malignancy worldwide, involving genetic and environmental factors. Significant evidence indicates that nutrition and intestinal microbiota have a role in the development and progression of this disease. The idea that you can “eat what you want” without consequences for colon health is losing ground.

Objective: The present study aims to indicate ten reasons, based on the latest scientific evidence, why it is important to have good nutrition in patients with colon cancer. The study would identify some fundamental points to take the importance of nutrition in the oncological field.

Methods: Some reviews on the importance of nutrition in colon cancer in various fields, from preventive to curative, were analysed.

Results: Ten reasons have been identified for giving importance to nutrition and the microbiota in colon cancer.

 1. In colon cancer, we have changes in the oral microbiome with a risk marker for colon cancer development.

 2. Cigarette smoke induces gut microbiota dysbiosis with a protumorigenic role in CRC altering and impairing gut barrier function.

 3. Weight loss and physical activity have been related to a reduced incidence of CRC; obese individuals should be screened for CRC and bring weight reduction, diet, and exercise.

 4. The microbial combination has been changed in colorectal lesions and colorectal cancer. Also, dysbiosis in gut microbiota has been found in CRC patients compared with healthy controls.

 5. The gut microbial metabolite Urolithin A (UroA) and its structural analogue UAS03, produced from ellagic acid‐containing foods such as pomegranates, berries, and walnuts, chemosensitized the 5FUR colon cancers for effective 5‐fluorouracil chemotherapy.

 6. Changes in the microbiome at different parts of the GI tract are responsible for the progression of colorectal adenoma and colorectal cancer.

 7. Antibiotics can induce antibiotic resistance in bacteria through selection of mutators. The stress caused by antibiotics on human cells could let the selection of dMMR colon cells mimic the selection of bacterial mutators.

 8. The intestinal microbiota influences the microenvironment of colon cancers by targeting microRNA (miRNA).

 9. The intestinal microbiome of cancer patients who developed a fever in the setting of neutropenia was enriched in mucin‐degrading bacteria.

10. Microbiota interactions with the host may influence responsiveness to cancer immunotherapies by modulating innate and adaptive immunity.

Conclusion: We must promote widespread awareness of a balanced diet and a healthy lifestyle to prevent this disease. We need to develop new therapeutic strategies based on nutrition and microbiota to improve the clinical outcome of colon cancer patients. When the patient asks about the diet to follow, it seems appropriate to avoid answering, “Eat what you want”.

OS INTEGRATIVE ONCOLOGY N 3 Homeophatic recommendations in integrative oncology by expert consensus methodology: user friendly clinical guidelines for best practice

Bagot Jean‐Lionel¹; Theunissen Ingrid²; Lavallee Véronique³; Fischer Isabelle⁴; KARP Jean‐Claude¹

¹Groupe Hospitalier Saint Vincent, Outpatient department of Integrative Health, Strasbourg, France; ²Chirec‐Delta Clinic, Brussels, Belgium; ³Centre Hospitalo‐Universitaire Dupruytren 1, Pôle cancer service oncologie médicale, Limoges, France; ⁴Private surgery, Montigny‐ le‐ Bretonneux, France; ⁵Centre Hospitalier de Troyes, Department of Oncology ‐ radiotherapy, Troyes, France

Introduction: Homeopathy is the complementary medicine most widely used by cancer patients in France. A recent study of oncological patients showed that 30% of users. They indicated a high level of satisfaction. Gradually, a converging body of evidence suggests the benefit of homeopathy to help cancer patients cope with their disease and the secondary effects of cancer treatments.

However, supportive care guidelines for this therapy are not yet available. The International Homeopathic Society of Supportive Care in Oncology intended to propose integrative oncology homeopathic treatment recommendations to all health professionals. A prescription tool respecting the principles of individualisation specific to homeopathy would be easy to implement in all clinical settings.

Methods: We used the expert consensus methodology proposed by the French High Health Authority. This method applies when writing a small number of concise, unambiguous recommendations for specific issues. It applies to new clinical management strategies when there is insufficient data in scientific studies on the subject, which is the case in homeopathic supportive cancer care.

Seven steering groups studied cancer disclosure, surgery, chemotherapy, targeted therapies, radiation therapy, hormone therapy, and the post‐cancer period. A draft prescription proposal was made after a critical and synthetic analysis of available bibliographical data and a discussion of existing practices. These recommendations were presented during the annual congress attended by physicians, pharmacists, oncologists or surgeons specialising in homeopathic integrative oncology (around fifty participants). Each year in June, these recommendations are upgraded using the same consensus method.

Results: Thirty recommendations were discussed, amended, adopted or rejected. They are handy for side effects, such as fatigue, pain, digestive problems, sleep disorders, sadness, and neuropathy which are common to cancer patients and often challenging to alleviate. On the other hand, problems at the time of disclosure, palliative care or post‐cancer period require an individualised homeopathic consultation. We will present clinical cases and the 2023 recommendations focused on pain management.

Conclusion: These recommendations are part of a program to improve good practice in supportive care. Homeopathic treatment is very safe since there is no risk of medical interaction or significant side effects. The low cost of homeopathy makes them accessible to all. This is the first time such expert consensus recommendations have been proposed for homeopathic practitioners. Five years' hindsight has shown its efficiency and usefulness for the patients and the care givers, even those who are not trained homeopaths.

OS INTEGRATIVE ONCOLOGY N 4 Effectiveness of a mindfulness and relaxation app on distress in people with cancer (CanRelax)

Jürgen Barth¹; Sonja Schläpfer¹; Fabien Schneider⁴; Tobias Kowatsch^5,6,4; Claudia Witt¹

¹Institute for Complementary and Integrative Medicine, University Hospital Zurich and University of Zurich, Zurich, Switzerland; ²IUFRS Institute of Higher Education and Research in Healthcare, Faculty of Biology and Medicine, University of Lausanne and Lausanne University Hospital, Lausanne, Switzerland; ³Departement of Oncology, CHUV, Lausanne, Switzerland; ⁴Center for Digital Health Interventions, Department of Management, Technology, and Economics, Zurich, Switzerland; ⁵Institute for Implementation Science in Health Care, Zurich, Switzerland; ⁶School of Medicine, University of St. Gallen, St Gallen, Switzerland

A mixed‐methods feasibility study with our mindfulness and relaxation app for people with cancer (CanRelax app 1.0) showed good acceptance of the app, adherence to the exercises, and changes in distress (Mikolasek et al., 2018, 2021). Participants' feedback also revealed areas for improvement which have been addressed in the revised CanRelax app 2.0. The effectiveness of the CanRelax app on distress has to be investigated.

The study aimed to evaluate the effectiveness of the CanRelax app 2.0 to reduce distress in people with cancer compared with a waitlist control group in a randomized controlled trial.

Adults diagnosed with any type of cancer within the last five years and elevated levels of distress were eligible. The CanRelax app (www.canrelax.org) was designed as a fully automated, stand‐alone intervention. The app provides weekly coaching sessions with a chatbot and applies nearly 40 distinct behavior change techniques to increase app engagement and support regular relaxation practice. The primary outcome is the level of distress after 10 weeks (PHQ‐ADS). Participant recruitment began in July 2022 and ended in February 2023. Registration: DRKS00027546.

We enrolled 210 participants in the trial. The full dataset will be available by summer 2023, so results about the effectiveness will be available at the meeting.

Our findings will contribute to the evidence about the effectiveness of digital interventions for reducing distress in people with cancer with a large sample and a comprehensive dataset.

Funding: Swiss Cancer Research foundation, KFS 4556‐08‐2018

Mikolasek, M., Witt, C. M., & Barth, J. (2018). Adherence to a mindfulness and relaxation self‐care app for cancer patients: mixed‐methods feasibility study. JMIR mHealth and uHealth, 6(12), e11271.

Mikolasek, M., Witt, C. M., & Barth, J. (2021). Effects and implementation of a mindfulness and relaxation app for patients with cancer: Mixed methods feasibility study. JMIR cancer, 7(1), e16785.

OS INTEGRATIVE ONCOLOGY N 5 Viscum album Lipophilic Extract in Actinic Keratosis, Cutaneous Squamous Cell Carcinoma and Basal Cell Carcinoma: A Retrospective Case Series

Karolina Königsberger^1,2; Wilfried Tröger²; Konrad Urech²; Reif Marcus³; David Martin¹; Stephan Baumgartner^1,2

¹University of Witten/Herdecke, Witten, Germany; ²Society for Cancer Research, Arlesheim, Switzerland; ³Society for Clinical Research, Berlin, Germany

Introduction: Cutaneous squamous cell carcinoma (cSCC) and basal cell carcinoma (BCC) belong to the group of non‐melanoma skin cancers (NMSC). Actinic keratosis (AK) is a precursor lesion of cSCC. The incidences of cSCC, BCC and AK are currently strongly increasing. Different standard therapies exist for these conditions but are not always applicable or successful. Hydrophilic mistletoe extracts have been used in anthroposophic cancer therapy since 1917. Viscum album Lipophilic Extract (VALE) is prepared by means of supercritical CO₂ extraction. This retrospective case series assessed the safety and clinical effects of a topical application of 10% VALE in individual cases of cSCC, BCC and AK.

For this retrospective case series, a positive vote was obtained from the ethics committee of the University of Witten/Herdecke (No. 146/2020). Eligible patients signed a declaration of consent prior to inclusion in the study. The main outcome parameters were the clinical response to treatment with VALE and adverse drug reactions. Risk factors, concomitant therapies and diseases, further diagnostic and therapeutic information were documented where available. Data analysis was performed on the level of patients and of individual lesions.

Methods: The study population consisted of 55 patients with 74 skin lesions. Individual case analysis accompanied by photographic documentation revealed typical and promising treatment courses.

Results: Clinical response rates (complete + partial remissions) for individual lesions were 78 % for cSCC, 70 % for BCC, and 71 % for AK. Complete remission rates for individual lesions were 56 % for cSCC, 35 % for BCC, and 15 % for AK. In cSCC and BCC, shorter times to best clinical response were observed. Adverse drug reactions were reported in five patients including erythema and inflammatory reactions of mostly moderate severity that resolved completely. In one case, therapy was temporarily paused, in four cases it was continued without interruption.

Conclusions: The results of this study suggest that VALE is a safe and tolerable extract under whose application complete and partial remissions of NMSC could be observed. To improve and assess the efficacy of VALE, prospective investigations are necessary.

OS INTEGRATIVE ONCOLOGY N 6 Integrating conventional and complementary treatments in cancer care: the process within the public healthcare system of the region of Tuscany, Italy

Elio Rossi¹; Mariella Di Stefano¹; Francesca Bosinelli¹; Cristina Noberasco¹; Linda Nurra¹; Gianni Amunni²; Katia Belvedere²

¹Clinic of Complementary medicine and diet in oncology, Tuscan Local Health Unit North‐West, Lucca, Italy; ²Institute Cancer Prevention Research and Oncological Network (ISPRO), Florence, Italy

Introduction. According to a European multicenter study, 32.2% of the population uses complementary therapies, with percentages ranging from 5% to 74.8%. Furthermore, an estimated 40% of Italian cancer patients use these therapies in addition to anticancer therapies. In April 2021, the Manual for Breast Cancer Services issued by the European Commission Initiative on Breast Cancer Quality Assurance Development Group (QASDG) stated that Breast Cancer services must have a written policy to ask the patient about and discuss the use of complementary and integrative medicine (CIM) for breast cancer.

Methods: In 2009, the Tuscan Tumor Institute (now ISPRO) and the Tuscan Center Integrative Medicine (TCIM) established a working group of experts in CIM and medical oncologists to review the literature on using CIM in oncology. From 2013‐2015, the TCIM participated in the European Partnership for Action against Cancer‐EPAAC, aiming to collect evidence on using CIM in cancer and mapping the European centres offering integrative oncology services. In 2018, the Memorial Sloan Kettering Cancer Centre of New York, US, signed a Memorandum of Understanding of international collaboration for research and professional training.

Results: In 2015, a Resolution of the Tuscan Regional Government stated to develop the use of some CM to manage cancer‐related symptoms and side effects of conventional anticancer therapy. They were acupuncture for nausea and post‐chemotherapy and post‐surgery vomiting, cancer pain, hot flashes of iatrogenic menopause, xerostomia; homeopathy for hot flashes of iatrogenic menopause and side effects of radiotherapy; herbal medicine for pain, nausea and vomiting, anxiety and depression. Subsequently, a Panel of CIM experts and oncologists defined how to apply this Resolution. In 2019, Tuscany Region approved a regional Guideline (Diagnostic and Therapeutic Care Pathway) on breast cancer, which included a section on CIM as supportive cancer care. The most recent step of this innovative process is the document 'Diagnostic, therapeutic and care pathways ‐ Integrative medicine for cancer patients', approved by the regional Decree no. 19664/21. The aim is to promote evidence‐based CIM treatments in regional cancer Departments, reduce the side effects of anticancer therapy, ensure effective, safe, high quality and uniform treatments, and improve patient's quality of life in a multidisciplinary approach to anticancer therapy.

Conclusions. Including evidence‐based complementary treatments as part of a Comprehensive Cancer Care Network helps respond effectively to cancer patients' demands combining safety and equity of access in public healthcare systems.

OS INTEGRATIVE ONCOLOGY N 7 Benefits of homeopathic complementary treatment in breast cancer patients: A retrospective cohort study based on the French nationwide healthcare database (SNDS)

Medioni Jacques^2,8; Sciemeca Daniel³; Lopez‐Marquez Yecenia⁴; Leray Emmanuelle⁵; Dalichampt Marie⁶; Hoertel Nicolas^8,9; Bennani Mohammed⁶; Trempat Pascal⁷; Boujedaini Naoual⁷

²APHP Hôpital Européen Georges Pompidou, Paris, France; ³., Maisons‐Alfort, France; ⁴Service d'Hépatogastroentérologie, Hôpital de la Croix Rousse, Lyon, France; ⁵Univ Rennes, EHESP, CNRS, Inserm, Rennes, France; ⁶Nantes, France; ⁶Qualees, Paris, France; ⁷Boiron, Messimy, France; ⁸Université Paris Cité, Paris, France; ⁹APHP Corentin Celton, Paris, France

Introduction: There is a growing use of complementary therapies in oncology and homeopathy features prominently. Their purpose is to help patients better cope with the illness and the side effects (SEs) of cancer treatments that mainly affect the quality of life (QOL). However, there are few comparative studies. The French Health Insurance database, SNDS, is emerging as one of Europe's largest and most comprehensive sources of health data. SNDS database includes anonymized data on socio‐demographics, diagnosis, drugs, medical characteristics, hospitalizations, and mortality. This study aimed to assess the benefits of homeopathy treatment on the QOL for patients with non‐metastatic breast cancer (BC), prescribed in post‐surgical complementary therapy, compared to treatment without homeopathy.

Methods: An extraction from the SNDS database targeted all patients who underwent mastectomy for newly diagnosed BC during 2012‐2013. QOL was assessed through proxies, primarily the use of medication palliating the SEs of cancer treatments. Exposure to homeopathy and use of SEs medication or medications prescribed for treating anxiety, depression, and sleeping disorders were measured by the number of dispensing. The association was assessed using a Random Effect Poisson Count Model, with adjustment for co‐factors: patients' characteristics at inclusion (sex, age, comorbidities, surgery, adjuvant therapy) and those of the physician implied in cancer care (socio‐demographic, localization, type of activity, volume of prescription).

Results: 98,009 patients were included (mean age 61 ± 13). Patients taking homeopathy appeared to have fewer cardiovascular and diabetes comorbidities. Homeopathy was used in 11%, 26%, and 22% of patients, respectively, during the 7 to 12 months before surgery, the six months before, and the six months after, then stable at 15% for four years. During the six months after surgery, there was a significant overall decrease (RR = 0.88, CI95 = [0.87; 0.89]) in the dispensing of SEs medication for patients with ≥3 homeopathy dispensing vs none. Decrease appeared to be greater for immunostimulants (RR = 0.79, CI95 = [0.74; 0.84]), corticosteroids (RR = 0.82, CI95 = [0.79; 0.85]), antidiarrheals (RR = 0.83, CI95 = [0.77; 0.88]), systemic antifungals (RR = 0.86, CI95 = [0.8; 0.92]), and antiemetics (RR = 0.9, CI955 = [0.87; 0.93]). There was no difference in dispensing medications for treating anxiety, depression, and sleeping disorders after surgery between patients receiving homeopathy vs no homeopathy.

Conclusion: The study showed increasing use of homeopathy in patients with BC following diagnosis. This use was sustained after surgery and seemed to play an important role in helping to tolerate SEs of cancer treatments better.

OS INTEGRATIVE ONCOLOGY N 8 Radiotherapy and Hospice: an integrated multidisciplinary organizational approach

Gaetana Giuseppa Saita²; Pieralba Chiarlone²; Silvio Giono Calvetto²; Giovanni Moruzzi²; Bonanno Salvatore¹

¹Azienda Sanitaria Provinciale 8, UOC Radioterapia, Siracusa, Italy; ²Azienda Sanitaria Provinciale 8, UOSD Hospice, Siracusa, Italy

Introduction: According to Italian Law, Hospice is a residential facility where terminally oncological patients no longer eligible for active treatment are admitted. Our aim in the Hospice in Siracusa was to improve The quality of life by better control of pain symptoms of those oncological patients admitted with unfavourable short‐term prognosis ( 60 days) by applying a simultaneous combination of Palliative Care and Radiotherapy (RT), the last one being in the same medical structure.

Methods: The prospective cohort study was carried out with a sample of 267 enrolled patients (en‐rolling period from 2020 to 2022) admitted with a cancer diagnosis in the terminal phase with pain, dyspnea, bleeding, dysphagia symptomatology unresponsive to standard treatment. The assessment scales used were: ECOG, KPS, PaPscore, ESAS, PPI and VAS. Patients were evaluated at different time points: admission (T0), after one week of supportive care (T1), RT treatment, post‐RT (T2) and VAS pre‐ and post‐treatment and death. Palliative radiotherapy (PRT) was performed using conventional 3D RT (3DCRT). The median RT applied dose was 20 Gy.

Results: From 2020 to 2022, a group of 65 patients were selected among the oncological patients with a 60‐day prognosis admitted to hospice to receive palliative radiotherapy treatments. Among these patients, 41 survived beyond 60 days after admission and after simultaneous multidisciplinary treatment (PRT). The overall response rate was 90.8%. The symptomatic response to these treatments was evaluated by mean VAS, resulting in 9.8 and 3.2, respectively, at T0 and T2. Moreover, the patients with locally advanced diseases showed a higher rate of symptomatic response than metastatic patients (95.3% vs 87.0%).

Conclusions: These results showed that an appropriate multidisciplinary organizational approach allows for overcoming some logical problems and allows clinical and care continuity for in‐patients. Our experience based on improved clinical response suggests that cancer patients with moderate to severe pain should be treated with palliative RT. Therefore, an enhanced synergistic relationship between hospices and hospitals and creation of a multidisciplinary team available to terminally ill patients may improve their quality of life.

OS INTEGRATIVE ONCOLOGY N 9 Integrative therapy in triple‐negative breast cancers: observational study in 48 patients

Massimo Bonucci¹; Cristina Villiva'¹; BiancaMaria Bonucci¹; Lorenzo Anelli¹; Francesca Andreazzoli¹

¹Artoi Foundation, Rome, Italy

Introduction: Triple‐negative breast cancer is particularly aggressive, with a higher incidence of relapse and increased mortality. Current therapies (surgery, chemotherapy, radiotherapy and immunotherapy) fail to improve these data. Furthermore, there are currently no adequate treatments to prevent recurrences and metastases. Increasingly, attempts are being made to help patients with advice on improving their diet and lifestyle. Studies in basic research have shown that natural substances have specific anti‐inflammatory, anti‐proliferative and pro‐apoptotic actions.

Methods: In order to evaluate the effect of nutrition and natural substances on triple‐negative breast cancer, 48 breast cancer patients (11 with metastases and 37 with only the primary tumour) who, during and after conventional antiblastic treatment, used certain natural substances such as polydatin, curcumin, Indole‐3 carbinol and sulforaphane and followed a specific diet were followed for five years (from 2013 to 2018).

Results: All patients were treated with surgery, standard chemotherapy, or radiotherapy at the beginning and during the observational period. In the group of patients with metastases at the study's beginning, only four deaths occurred. In the group with only a primary tumour at the beginning of the study, one patient had a local recurrence, which was treated with surgery.

Conclusions: Triple‐negative breast cancer is an aggressive pathology, and there are no protocols for preventing relapses. The study showed that in patients with triple‐negative breast cancer, integrative therapy could be a help for improving QoL and prevention. We need more data to confirm this result.

OS INTEGRATIVE ONCOLOGY N 10 Patients refusing anticancer treatments and Complementary and Integrative Medicine

Elio Rossi¹; Mariella Di Stefano¹; Cristina Noberasco¹; Marco Picchi¹; Francesca Bosinelli¹

¹Clinic of Complementary medicine and diet in oncology, Tuscan Local Health Unit North‐West, Lucca, Italy

Introduction and aim: A number of cancer patients refuse conventional anticancer treatments for various reasons. To fill an important knowledge gap, this study, conducted at the Clinic for Complementary Medicine (CM) and Diet in Oncology, Campo di Marte Hospital, Lucca (Italy) aimed at clarifying why, when, and how a few patients who accessed the clinic refuse oncological treatments.

Methods: It is an observational prospective study. Medical records of cancer patients visited were thoroughly analysed, in order to understand the reasons for their refusal. The data concerned 35 (6.3%) out of 552 cancer patients, aged 39‐79 years (mean age 56.9 years), who were consecutively visited from 2013 to 2019 and refused conventional anticancer treatments.

Results: From September 2013 to December 2019, at the Public Clinic of CM and Diet in Oncology of Lucca 552 cancer patients, 467 (84.1%) female and 88 (15.9%) male, with a median age of 57 years (19–89 years), were consecutively visited. Among all the patients who attended the clinic, 35 (6.3%) refused to undergo or continue one or more conventional treatments against their oncologist's recommendations. Of them, 33 patients were women, and the mean age was 56 (range 33–81) years; 41.2% had a primary school diploma, 23.5% had a high school diploma, and 5.9% had a degree. In terms of occupation, they were mainly clerks (41.2%), followed by housewives (11.8%), students (5.9%), and other workers (5.9%). Cancer patients refusing anticancer therapy were distributed as follows: 7/35 (20%) refused all kinds of anticancer treatment, 14 (40%) specifically refused chemotherapy, 7 (20%) specifically refused endocrine therapy, 2 (5.7%) refused surgery and 1 (2.8%) refused radiotherapy. Four patients (11.4%) refused other kinds of anticancer treatment (i.e. radioiodine, chemoembolization, growing factors, and immunotherapy). The most popular treatments were artemisine (Artemisia vulgaris L.), Potassium Ascorbate and Viscum Album. Thirty‐one patients (88.6%) completed at least one follow‐up visit; of them 18 (58.1%) are still in good conditions, 4 (12.9%) are in a disease progression phase, and 9 (29%) passed away. Interestingly, after their baseline integrative oncology visit, 15 out of 31 patients visited at follow‐up (48.4%) turned out to accept conventional treatments.

Conclusions: An Integrative Oncology Clinic may contribute to improve the communication with patients, especially with those who initially refuse conventional treatments, and play a positive role in treatment refusal management.

OS INTEGRATIVE ONCOLOGY N 11 Spiritual Care as part of Integrative Medicine approaches requires documentation of patients´ existential and spiritual needs: Implementation of the Spiritual Needs Screener in Palliative Care Counseling

Arndt Büssing¹; Dickmann Anja⁴; Scheer Karin²; Tewes Mitra³; Niesert Wolfgang⁴; Büntzel Jens⁵; Rentschler Jochen⁶

¹Professorship Quality of Life, Spirituality and Coping, Witten/Herdecke University, Herdecke, Germany; ²University Hospital Essen, Hospice work and Palliative Medicine consultation, Clinic for Internal Medicine, Essen, Germany; ³University Hospital Essen, Department of Palliative Medicine, University of Duisburg‐Essen, Essen, Germany; ⁴Clinic for Palliative Care Medicine, Evangelische Kliniken Essen‐Mitte, Essen, Germany; ⁵Palliative Care Unit, Südharz Clinic Nordhausen, Nordhausen, Germany; ⁶Department Hematology and Internistic Oncology, Palliative Medicine, Ortenau Clinic, Offenburg, Germany

Introduction: Several Integrative Medicine (IM) approaches regard patients´ spirituality as important in principle, but rarely address what patients expect and need. Their spiritual distress, wellbeing and needs are usually not addressed during the medial anamnesis. In order to apply Spiritual Care competently and reliably, patients´ existential and spiritual needs have to be documented in order to respond to them as a multi‐professional team. As it is often argued that there is not enough time for further documentation, the 10 item Spiritual Needs Screener (Cronbach's alpha = 0.86) was developed on the basis of the internationally established Spiritual Needs Questionnaire (SpNQ).

Aim: The SpNeeds Screener was applied in four palliative care centers in Germany enrolling 134 patients (97% cancer, 62% women, mean age 71 ± 12 years). As the Screener is intended to facilitate documentation of patients´ needs and to facilitate reactions of a multiprofessional team, these were cross‐sectionally documented and evaluated.

Results: The SpNQ Screener scores were significantly higher in the Southern center compared to the West and East centers (Eta² = 0.15; p < 0.0001). These differences refer mainly to Religious and Inner Peace needs rather than Existential needs. Women had higher needs than men (Eta² = 0.36; p = 0.029). Moderate to strong needs for psychological support were stated by 41%, and for pastoral care support by 27%.

First reactions towards documented needs were talks with medical doctors (94%), palliative care nurses (89%) and psychologists (89%), while chaplains were consulted in 41%. In 39% psychotherapeutic support was initiated, in 48% psychological and pastoral care support, and in 13% none of them.

Using the screener was often the cause for long talks with the patients which appreciated that their needs were regarded as relevant by the team. This may finally improve their satisfaction with the team support and own wellbeing. However, some nurses had reservations about working with the screener, while psychologists and chaplains appreciated it. In many cases there were clear misjudgments of the team in relation to the needs expressed. They often assumed that there was no need for psychological or pastoral support, although strong needs were expressed by the patients.

Conclusions: The SpNeeds Screener may sensitize for an important topic which is often a matter of chance whether it is addressed or not. It facilitates easier documentation and thus reactions by the palliative care team. It is recommended to implement it in routine processes to support patients´ existential and spiritual needs, care satisfaction and psychological wellbeing.

OS INTEGRATIVE ONCOLOGY N 12 Effects of electroacupuncture on postoperative complications of gastrointestinal cancers: A systematic review and meta‐analysis

Yiqing Cai¹; Xueer Yan²; Cheng Tan²; Jianping Liu¹

¹Beijing University of Chinese Medicine, Beijing, China; ²Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing, China

Background: This study aimed to evaluate the effects of electroacupuncture on postoperative complications of gastrointestinal cancers, and to assess the methodological quality of the included trials.

Methods: Only randomized controlled trials (RCTs) in English or Chinese languages were searched in the six databases including PubMed, Web of science, the Cochrane Library, Chinese Scientific Journals Database, China National Knowledge Infrastructure, and the Wanfang Database from inception to April 2022. The reference lists of all the related studies were screened to supplement the missing trials. The study selection and data extraction were performed by two authors independently. We assessed the methodological quality of the included RCTs independently using the Risk of Bias tool. The meta‐analyses were conducted to explore the effects of electroacupuncture using Revman 5.3 software.

Results: A total of 14 RCTs were included, with 1428 participants. Among these RCTs, six RCTs involved patients with colorectal cancer, four involved patients with gastric cancer, two involved patients with colon cancer, one involved patients with pancreaticoduodenal cancer, one involved patients with rectal cancer, and one involved patients with pancreatic cancer. The intervention in all 14 RCTs were electroacupuncture combined with usual care, the comparisons in 11 RCTs were usual care, while in 3 RCTs were sham acupuncture. All the 14 RCTs were of unclear risk of bias. The meta‐analysis showed a significant improvement from electroacupuncture for the time of first exhaust (‐13.14 [‐19.89, ‐6.39] hours, P < 0.00001), time of first defecation (‐17.64 [‐26.06, ‐9.23] hours, P < 0.0001), time to recovery of bowel sounds (‐10.39 [‐13.41,‐7.36] hours, P < 0.0001). In terms of pain, the result of the meta‐analysis showed that the score of visual analog scale was significantly decreased by electroacupuncture (‐0.65 [‐0.86, ‐0.43], P < 0.0001). The meta‐analysis showed that electroacupuncture significantly shortens the time to return to independent activity (‐0.33 [‐0.51, ‐0.14] hour, P < 0.0001) and length of postoperative hospital stay (‐0.37 [‐0.55, ‐0.19] day, P < 0.0001).

Conclusion: Low certainty of evidence shows that electroacupuncture may improve gastrointestinal function (shorter time of first exhaust, time of first defecation and time to recovery of bowel sounds), relieve pain, decrease the time to return to independent activity and length of hospital stay compared with the controls. Given the overall unclear risk of bias and poor methodological quality of the included RCTs, these findings should be validated in future trials.

OS INTEGRATIVE ONCOLOGY N 13 Factors Influencing the Implementation of Integrative Oncology Interventions in Cancer Care: A Systematic Review Guided by the Theoretical Domains Framework

Leonard Ho¹; Ming Hong Kwong¹; Angus SC Li¹; Per Nielsen²; Fai Fai Ho¹; Claire CW Zhong¹; Vincent CH Chung¹

¹The Chinese University of Hong Kong, Shatin, Hong Kong (China); ²Linköping University, Linköping, Sweden

Background: The incorporation of Integrative Oncology (IO) into cancer care appears to be beneficial, but the implementation of IO remains a challenge. Guided by the analytical framework based on the Theoretical Domains Framework (TDF) and the Capability–Opportunity Motivation–Behavior (COM‐B) model, this systematic review identified the barriers to and facilitators of IO implementation in conventional cancer care settings.

Methods: We searched eight electronic databases from their inception until February 2022 for qualitative, quantitative, or mixed‐methods empirical studies that reported the implementation outcomes for IO services. Critical appraisal approach was tailored according to study types. The identified implementation barriers and facilitators were mapped onto TDF domains and then to the COM‐B model.

Results: We included twenty‐eight studies (11 qualitative, six quantitative, nine mixed‐methods, and two Delphi studies) of satisfied methodological quality. The main implementation barriers were a lack of knowledge about IO, the absence of funding for IO services, and clinicians' and nurses' low level of IO receptiveness. The key implementation facilitators were the dissemination of positive evidence on IO clinical benefits, the equipping of providers with IO service delivery skills, and the provision of a supportive organizational climate.

Conclusion: Multifaceted implementation strategies are needed to address the determinants that influence IO service delivery. Based on our findings, the following generic strategies should be applied to local adoption of IO: (i) promotion of effective IO communications between healthcare professionals and patients; (ii) creation of a supportive organizational climate conducive to IO service delivery; and (iii) improvement of operational procedures and logistical arrangements.

OS INTEGRATIVE ONCOLOGY N 14 The multidisciplinary reality of the oncology department of the Tuscany Health Authority USL Sud Est

Franco Cracolici; C. Bocci; A. Martignetti; C. Bengala

Oncology Department of the Tuscany Health Authority USL Sud Est, Tuscany, Italy

A total of 538 cancer patients were referred in the decade of activity (2011–2020) to the Center for Integrated Medicine of Pitigliano to the Homeopathy clinic of Pitigliano Hospital. Of these, 228 were followed in the Homeopathy and Integrated Medicine Clinic of Grosseto (at the beginning of the 2018 clinic). A total of 500 cancer patients were followed in the Oncology Acupuncture Clinic (Grosseto + Lenitherapy/Campostaggia, which started a few months ago). This is all thanks to a vast multidisciplinary network that has seen the commitment of various oncologists and experts in integrated medicine who have been involved in various stages of a territorial oncology network that has carried out a wide range of initiatives, including: the creation of the Integrated Oncology network (2020) within the oncology department; the USLSUDEST procedure “integrated oncology pathway”, approved on 14 August 2020; the training project “1st level of integrated medicine in oncology: theoretical part” (2021); the USL project “Acupuncture in support of cancer patients” (February 2021–February 2022) at UOSD Oncologia Valdarno; the regional project “Improving the quality of life of cancer patients with complementary and integrated medicine techniques” held in Campostaggia from April 2021 to April 2022 and continued with the creation of an acupuncture clinic for cancer patients; the USL project “Wellness techniques and lifestyles for cancer patients” (30 March–30 September 2022) at the PO Misericordia in Grosseto; the FAIRAC research project (Tuscany 2020 research call); and the CHEMOCIN research project (Tuscany 2020 research call).

OS INTEGRATIVE ONCOLOGY N 15 The Effects of Acupuncture on Treatment‐Related Symptoms & Symptom Interference in Patients with Head and Neck Cancer Experiencing Chronic Radiation‐Induced Xerostomia (RIX): Wake Forest NCI Community Oncology Research Program Research Base (WF NCORP RB) Randomized, Sham‐controlled Trial WF‐97115

Suzanne Danhauer¹; Emily V. Dressler¹; Glenn J. Lesser¹; David I. Rosenthal²; Mark S. Chambers²; M. Kay Garcia²; Andrew Cusimano²; W. Mark Brown¹; Jewel Ochoa²; Peiying Yang²; Joseph Chiang²; Ora K. Gordon³; Rhonda Crutcher⁴; Jung K. Kim⁵; Michael P. Russin⁶; Joshua Lukenbill⁷; Mercedes Porosnicu¹; Kathleen J. Yost⁸; Kathryn E. Weaver¹; Lorenzo Cohen²

¹Wake Forest University School of Medicine, Winston Salem, NC, United States of America; ²The University of Texas MD Anderson Cancer Center, Houston, TX, United States of America; ³Providence Research Network, St. John Cancer Institute, University of California Los Angeles, Los Angeles, CA, United States of America; ⁴Providence Health & Services, Los Angeles, CA, United States of America; ⁵The Living Acupuncture, Burbank, CA, United States of America; ⁶Kaiser Permanente Diablo Service Area, Martinez, CA, United States of America; ⁷Iowa‐Wide Oncology Research Coalition NCORP, Des Moines, IA, United States of America; ⁸Cancer Research Consortium of West Michigan NCORP, Spectrum Health at Butterworth Campus, Grand Rapids, MI, United States of America

Introduction: The majority of head/neck (HN) cancer patients who undergo radiotherapy (RT) develop RIX. Existing treatments for RIX show limited benefit and have side effects. Initial small studies suggest acupuncture may treat chronic RIX. A multicenter, phase III, randomized, sham‐controlled trial (NCT02589938) compared true acupuncture (TA) with sham acupuncture (SA) and wait list control (WLC) in treating RIX and improving treatment‐related symptoms/interference.

Methods: HN patients with chronic RIX ≥12 months post‐bilateral RT with grade 2‐3 xerostomia were recruited through the WF NCORP RB network (2UG1CA189824, U10CA045809, R01CA160880). All received standard oral hygiene and were randomized to TA, SA, or WLC. TA and SA groups were treated 2x/week for 4 weeks. Those reporting a minor response (10‐19 point decrease on the Xerostomia Questionnaire (XQ)) received another 4 weeks of treatment. Patients with no response (increase/decrease of <10 points on XQ), partial response (≥20 point decrease on XQ), or complete response (XQ score = 0) received no further treatment. The MD Anderson Symptom Inventory – Head/Neck (MDASI‐HN), XQ, and FACT‐G (quality of life) were collected at baseline, 4, 8, and 12 weeks. Primary outcomes for this abstract were MDASI‐HN core symptoms (CS) and symptom interference (SI) at 12 weeks. Repeated measures ANCOVA models were used to adjust for baseline outcome, treatment group, time, and interaction of treatment*time using unadjusted covariance structure. Post hoc comparisons were adjusted via Bonferroni correction.

Results: 258 patients from >30 sites participated (mean age = 65 years, 78% male, 67% AJCC stage IVa,b disease). At 4 weeks, there were significant between‐group differences between TA and SA versus WLC on MDASI‐HN CS (p = 0.001; TA = 23.4; SA = 23.4; WLC = 31.0) and SI (p = 0.005; TA = 8.2, SA = 8.1, WLC = 12.0); pattern was similar at 8 weeks. CS and SI were also different between TA and WLC at 12 weeks (CS: p = 0.026; TA = 23.9, WLC = 29.5; SI: p = 0.004; TA = 6.9, WLC = 10.8). The XQ (Week 4) revealed statistically significant group differences between TA and WLC, marginal group differences between TA and SA, and no differences between SA and WLC (similar patterns seen at Weeks 8 and 12). FACT‐G score (and subscales) was significantly improved for TA at 12 weeks compared to both SA and WLC (p = 0.001; TA = 102.1; SA = 98.4; WLC = 97.4).

Conclusions: True acupuncture was more effective than sham acupuncture and standard oral hygiene alone in improving treatment‐related symptoms/interference ≥12 months after the end of RT. True acupuncture was also better than both sham acupuncture and standard oral hygiene at improving quality of life.

OS INTEGRATIVE ONCOLOGY N 16 Effect of the use of Saint Germain flower essences as a complementary integrative practice in the modulation of inflammatory markers in women with breast cancer associated with the use of tamoxifen

Marcela Martins Furlan de Leo; Leoni Terezinha Zenevicz; Gabriela Gonçalves de Oliveira; Jose Afonso Pena Paes; Leonardo Barbosa Leiria

Federal University of Fronteira Sul, Chapecó, Brazil

Introduction: Breast cancer (BC) is a malignant neoplasm that affects women and men worldwide. It has a high prevalence in females, with high severity and biopsychosocial impact. Of multifactorial origin, BC has high morbidity and mortality, and its treatment, whether surgical or pharmacological, generates several undesirable physical and psychological effects. In this context, the Association of Complementary Integrative Practices (PICS), through the application of Saint Germain flower essences, aims to contribute to the reduction of proinflammatory molecules, acting as an adjuvant in mitigating the negative effects generated by the different treatments. In the present study, the relationship between the levels of two inflammatory markers, interleukin 6 (IL‐6) and tumour necrosis factor alpha, and a hepatic marker, alkaline phosphatase, was verified in patients who used or did not use Saint Germain flower therapy as an adjuvant treatment with tamoxifen and who did not undergo hormone replacement.

Methods: This was a double‐blind pilot clinical trial, with 30 Brazilian women with breast cancer participating during a six‐month follow‐up. Participants consumed the prescribed doses of the flower therapy: two drops a day for the six‐month study period. The placebo group received only the diluent (brandy). Blood samples were taken for enzyme levels before and six months after using the flower therapy or placebo. The levels of IL‐6 and TNF‐α were assessed using enzyme‐linked immunosorbent assay, and the alkaline phosphatase level with the colorimetric enzymatic kinetic method.

Results: All groups of patients had high levels of inflammatory markers, which was expected, given the clinical condition of these patients. The results showed a significant difference between the group that received the flower therapy and the group that used the placebo, with a reduction in the serum levels of IL‐6 and alkaline phosphatase in the group that used the placebo where there was no difference.

Conclusions: The use of Saint Germain flower essences can help reduced serum inflammatory levels by reducing IL‐6 and alkaline phosphatase levels. Combined with conventional treatment, it can improve the conditions and lifestyle of patients with breast cancer. As the study with these essences is pioneering, more studies are needed, since the differences found may be related to the use of flower therapies.

OS INTEGRATIVE ONCOLOGY N 17 Ozone therapy in the management of collateral effects related to the use of hormone therapy in prostate cancer.

Annamaria Di Palma¹

¹Ospedale S. Pietro FBF Roma, Italy

Purpose: Using Androgen deprivation therapy (ADT) for prostate cancer exposes patients to adverse effects—hand joint symptoms, one of which is rarely reported. We describe the benefits of Intravenously Ozonetherapy and direct to tissue Ozontherapy to mitigate the symptoms.

Material and Methods: We perform Ozonetherapy Intravenously and Directly to the tissue in patients suffering hand joint symptoms during ADT. Patients completed a three‐item self‐administered Stanford Health Assessment Questionnaire (HAQ) questionnaire developed to assess the functional disability in rheumatoid arthritis. After initiating ADT, 1, 2 e 3 and 6 months after local and intravenously Ozone therapy.

Conclusion: Our study demonstrated the usefulness of Ozone therapy for patients receiving ADT who are showing significant hand joint symptoms.

OS INTEGRATIVE ONCOLOGY N 18 A qualitative exploration of the facilitators and barriers affecting the implementation of a counseling program on complementary and integrative healthcare: Perceptions of patients and counselors.

Helena Dürsch¹; Ursula Boltenhagen²; Cornelia Mahler²; Stephanie Joos³; Joachim Szencsenyi¹; Nadja Klafke¹

¹Department of General Practice and Health Services Research, University Hospital Heidelberg, Heidelberg, Germany; ²Department of Nursing Science, University Hospital Tuebingen, Tuebingen, Germany; ³Institute of General Practice and Interprofessional Care, University Hospital Tuebingen, Tuebingen, Germany

Background: The CCC‐Integrative study (trial registration number DRKS00021779) aims to develop and implement an interprofessional counseling program at four German Comprehensive Cancer Centers (CCCs) for cancer patients seeking information on complementary and integrative healthcare (CIH). In parallel with the implementation study, a mixed‐method process evaluation was conducted to examine the mechanisms of implementation. This paper reports on the patients' and counselors' perspectives on the factors affecting the implementation of the counseling program.

Method: Forty problem‐centered interviews with patients who participated in the CIH counseling program and twelve interviews with physicians and nurses of the counseling teams were conducted. All interviews were audio‐recorded, transcribed verbatim, and analyzed using deductive‐inductive content analysis following Kuckartz and Rädiker.

Results: A synthesis of the analysis of the patient and counselor interviews revealed three overlapping facilitating and two hindering factors affecting the implementation of the counseling intervention. Patients reflected positively on the organization and flexibility in scheduling appointments for counseling sessions and the ability to conduct follow‐up consultations online or by telephone if needed. However, regarding the accessibility of the CIH counseling service, some participants pointed out that the program is not yet sufficiently well publicized and may not reach all patients who need CIH counseling. Both participants and counselors perceived the interprofessional approach to counseling as beneficial as the different professions complemented each other, which was particularly valuable in complex patient cases. It was also perceived as positive that multiple consultations were offered within this new counselling structure, as side effects and symptoms change over the course of treatment, and thus lifestyle recommendations can be adapted. Nevertheless, some participants would have liked longer‐term support from the counseling teams, as they experienced the CIH approach as a sound complement to conventional therapy. Counselors were also concerned about the permanence of the counseling service and recognized the urgent need to offer patients consistent regular CIH counseling on‐site in the clinic.

Conclusion: The findings highlight the complexity of factors that promote and impede innovative CIH counseling structures and which future interventions could target to support patients and their consultation teams in providing high‐quality supportive care. Flexibility, and thorough coordination in organizing consultations, interprofessional patient care, and repeated consultations were conducive factors in the CCC Integrative study. Publicity and accessibility, as well as the continuity of the CIH consultation program, represent areas that require further development and should be recognized early when translating this healthcare structure into other settings.

OS INTEGRATIVE ONCOLOGY N 19 Severity of radiodermatitis in breast cancer patients with preventive treatment with homeopathic/integrative protocol compared with a control group with standard care

Elio Rossi¹; Cristina Noberasco¹; Marco Picchi¹; Marialessandra Panozzo¹; Anna Lida Elia¹

¹Clinic of Complementary medicine and diet in oncology, Tuscan Local Health Unit North‐West, Lucca, Italy

Background: To deal with the adverse effects of anti‐cancer treatment, the Homeopathic Clinic of Lucca, in collaboration with the Oncology Department, has set up an Integrative Oncology Outpatient Unit in the Public Hospital Campo di Marte of Lucca (Italy).

Aims: To present the preliminary results of homeopathy and complementary integrative medicine treatment targeted towards reducing the radiodermatitis and other adverse effects of radiotherapy.

Methods: This is a retrospective observational study conducted on consecutive 102 breast cancer patients undergoing radiotherapy from September 2018 to December 2022. In the case of radiodermatitis, the number of RT sessions was also divided into four groups (‘‘to be started,’’ ‘‘from 1 to 9,’’ ‘‘from 10 to 19,’’ and ‘‘from 20 to 29’’). The severity of radiodermatitis was evaluated with the Radiation Therapy Oncology Group (RTOG) scale. In particular one group of patients was treated with Radium bromatum 6 CH before, then Belladonna 6 CH after RT, and also with application local an alkalinizing agent and Calendula ointment. The control group undergoing RT without integrative treatment used only standard care, keratoplastic ointments as standard care to promote tissue repair and healing.

Results: The severity of radiodermatitis was evaluated at the beginning and at the end of the treatment in a group of 77 consecutive breast cancer patients; 40 patients with a homeopathic integrative protocol during RT were compared with a control group of 37 patients without treatment. Preliminary results show that 36 patients with homeopathic integrative treatment had G0/G1; 1 patient G2; 2 patients G3, and finally 1 patients G4, meanwhile in the group of no‐treated patients, 16 patients had G0/G1; 7 patients G2; 2 patients G3, and finally 8 patients G4. The results showed a statistically significant reduction in the severity of radiodermatitis in the group of patients treated with the homeopathic/integrated protocol (Mann‐Whitney U test: two‐tailed significance p ≤ 0.01). Furthermore 9 patients with other cancers than breast cancer, were successfully treated (G1) with the same homeopathic/integrative protocol and finally 8 patients began the treatment protocol after having already started RT sessions, had similar good results. Finally, 4 patients were positively treated at the end of RT for long‐term consequences.

Conclusion: The integration of evidence‐based homeopathy and complementary treatments allows for an effective response to the demand coming from cancer patients to reduce many side effects of anti‐cancer therapies, in particular dermatitis due to RT, as well as to improve their quality of life.

OS INTEGRATIVE ONCOLOGY N 20 Integrative hyperthermia versus chemotherapy in patients with locally advanced pancreatic cancer: a multicenter retrospective observational comparative study on 217 patients

G. Fiorentini¹, D. Sarti², A. Mambrini³, G. Ranieri⁴, I. H. Ferri¹, M. Bonucci ⁵, P. Giordano Sciacca ⁶, M. Ballerini ⁷, S. Bonanno ⁸, C. Milandri ⁹, R. Nani ¹⁰, S. Guadagni ¹¹, P. Dentico ¹²

1. IHF Integrative Oncology Outpatient Clinic, Bologna, Italy

2. Oncology Department, Santa Maria de37lla Misericordia Hospital, Urbino, Italy

3. Department of Oncology ‐ ASL Toscana Nord Ovest, Massa Carrara Hospital, Massa, Italy

4. Interventional Oncology Unit with Integrated Section of Translational Medical Oncology, National Cancer Research Centre, Istituto Tumori “Giovanni Paolo II”, Bari, Italy.

5. Association Research for Integrative Oncology Treatments (ARTOI) Foundation, Roma, Italy

6. Complementary Medicine Service, District Hospital of Merano,Italy

7. Hyperthermia Unit, Bellessere Medical Center, Terni, Italy

8. Radiotherapy Unit, A. Rizza Hospital, Siracusa, Italy

9. Medical Oncology Unit, San Donato Hospital, Arezzo, Italy.

10. Interventional Radiology Unit, Humanitas Gavazzeni, Bergamo, Italy

11. Department of Applied Clinical Sciences and Biotechnology, Section of General Surgery, University of L'Aquila, L'Aquila, Italy.

12. Hyperthermia Service, Medical Oncology Unit, San Giuseppe Hospital, Empoli (Florence), Italy

Background: Modulated Electro Hyperthermia (mEHT) is combined with chemotherapy offering therapeutic effects in pancreatic cancer. Objective: to assess survival, tumour response and toxicity of mEHT for locally advanced or metastatic pancreatic tumour therapy.

Methods: This was a retrospective data collection on patients affected by locally advanced pancreatic cancer performed in 9 Italian centres, members of the International Clinical Hyperthermia Society‐Italian Network (ICHS‐IT). This study included 217 patients; 128 (59%) of them were treated with chemotherapy (no‐mEHT), and 89 (41%) patients received mEHT alone or in association with chemotherapy. mEHT treatments were performed, applying a power of 60–150 watts for 40‐90 minutes.

Results: median patients' age was 67 years (range 31–92 years). mEHT group had a median overall survival (OS) greater than non‐mEHT group (20 months, range 1,6‐24, vs nine months, range 0.4‐56.25, p < 0,001). mEHT group showed a higher number of partial responses (PR) (45% vs 24%, p = 0,0018) and a lower number of progressions (PD) (4% vs 31%, p < 0,001) than the no‐mEHT group at the three months follow‐up. Adverse events were observed in 2,6% of mEHT sessions.

Conclusions: mEHT seems safe and benefits survival and tumour response of stage III‐IV pancreatic tumour treatment. Further studies are warranted.

OS INTEGRATIVE ONCOLOGY N 21 Urtica comp. gel is highly effective in reducing the need for rescue care in breast cancer patients undergoing radiation therapy.

Jodie Freeman¹; Wolf Ursula¹

¹Institute of Complementary and Integrative Medicine, University of Bern, Bern, Switzerland

Introduction and objective: Radiation dermatitis is one of the most common side effects of radiotherapy for cancer and affects around 95 % of patients receiving radiotherapy. Skin lesions bear a marked risk of infection and have a profound impact on the patient's quality of life, due to pain and discomfort. These issues may be the cause of interruption of radiation therapy, resulting in inadequate disease treatment. The aim of this study is to compare Urtica. comp. gel with the institutional standard skin care of radiation dermatitis.

Patients and Methods: This randomized open‐label pilot study was performed to test if Urtica comp. gel would reduce the incidence and severity of radiation dermatitis, reduce the need for additional therapy, decrease pain and improve the quality of life compared with the standard skin care, Excipial‐Hydrolotion Patients were assessed at baseline, at weekly assessments and up to 6 weeks after radiotherapy.

Results: A total of 28 patients were randomly assigned. There was no statistically significant difference in maximum acute radiation dermatitis between the Urtica comp. gel and Excipial‐Hydrolotion. Yet, Urtica comp. gel significantly reduced the need for rescue care for radiation dermatitis with only 31 % of the 13 patients needing additional therapy compared to 69 % using Excipial‐Hydrolotion. A chi‐square test of independence found that the relationship between the treatment group and patients requiring additional therapy is highly significant, X² (1, N = 28) = 5.073, p = 0.02. There were no major differences in pain, itching, and skin‐related quality of life.

Conclusion: Urtica comp. gel is shown to be highly effective in reducing the need for rescue care in patients with breast cancer. These results highlight an urgent need to validate these results in larger double‐blind trials and to further explore more potential benefits.

OS INTEGRATIVE ONCOLOGY N 22 Nanoemulsified fungal actives emerge as natural immunoadjuvants for cancer prevention and treatment in ongoing clinical trials

Pere Gascón¹; Esteban Sinde²; Vanessa Núñez Cruz²; Arturo Rodríguez Blanco²; Catalina Fernández de Ana²

¹Laboratory of Translational and Molecular Oncology, University of Barcelona, Barcelona, Spain; ²Hifas da Terra S.L., Pontevedra, Spain

Introduction: Gut microbiota modulation and targeting STAT3/NF‐KB activation through proinflammatory cytokine regulation are novel strategies in clinical oncology, mainly if innovative biotechnologies applied to mushroom nutraceuticals are intended to achieve these goals. Strain‐specific nano‐emulsified fungal actives of extracts of Ganoderma lucidum HdT488, Hericium erinaceus HdT1428, fermented Cordyceps sinensis and Grifola frondosa HdT1178 used presently in nutraceuticals have shown in vitro prebiotic, immunomodulatory and proapoptotic activity, and no interaction with cytochrome P450 enzymes.

The main objective is to determine if specific formulations based on nano‐emulsified fungal actives are good candidates for clinical trials in colorectal cancer (CRC) and breast cancer (BC) patients, respectively, and can show gut microbiota modulation activity and the capacity to reduce inflammation markers.

Methods: The effect of 2 fungal nano‐emulsified formulas specifically developed as adjuvants in CRC and BC were tested. CRC formulation effect on gut microbiota and inflammation was evaluated invivo in 41 murine. BC formulation was tested in an ex vivo study using the microbiota of 10 recently diagnosed BC patients of an ongoing clinical trial. Analysis of gut microbiota modulation was performed using 16S rRNA and phylogenetic beta‐diversity comparative analysis of both samples. IL‐6 and TNF‐α levels in serum were quantified with ELISA.

Results: A 3 % reduction of proteobacteria was observed after three months of treatment using the CRC formulation in CRC murine models. The composition of gut microbiota compared to control groups in the Bifidobacteriaceae, Erysipelotrichaceae and Clostridiaceae families showed statistically significant differences (beta‐diversity) in CRC models treated with the formula, indicating a potential shift towards a healthier and younger microbiome. Gut microbiota composition of BC patients after BC formula supplementation varied vs the control group (Bray Curtis and Unweighted Unifrac: Adonis2 p < 0,001***). BC formula showed clinically relevant prebiotic properties by increasing the relative abundance of Bifidobacterium and Lactobacillus and decreasing the total relative abundance of the proinflammatory genus Escherichia‐Shigella in BC microbiota. CRC formulation tended to reduce inflammatory markers such as serum IL‐6 (p < 0,05*).

Conclusions: Innovative formulations based on a synergy of strain‐specific nano‐emulsified fungal actives for CRC and BC modulate gut microbiota and are validated candidates in ongoing phase II randomized, double‐blind, placebo‐controlled studies. Both emerge as natural immunoadjuvants in CRC and BC treatments, respectively, helping to improve the quality of life and also capable of significantly being used in the prognosis of CRC and BC patients through the interaction with gut microbiota in non‐responders.

OS INTEGRATIVE ONCOLOGY N 23 Integrative oncology and the terrain approach in Traditional European Medicine (TEM): a Swiss perspective

Anne Gimalac¹; Ludivine Colas¹; Nora Everli¹

¹Navi, Research in Integrative Health, Epalinges, Switzerland

Introduction and Background: In integrative oncology, the support and balancing of each patient's individual functioning plays a crucial role in the prevention of disease and relapse, as well as in the support of the side effects of treatment. The notion of terrain is a fundamental basis of the approaches of Naturopathy in Traditional European Medicine (TEM) in cancer treatment.

Objective: The Integrative Oncology Unit (IOU) at Navi was a collaborative project that brought together different exploratory research projects in TEM and oncology, between 2021 and 2023. Its objective was to enable clinicians to articulate naturopathic terrain approaches and prevention and care follow-ups in oncology, in a Swiss integrative health perspective. The unit aimed to evaluate whether and how the patient's specific terrain guides the choice of lifestyle practices and remedies proposed by practitioners in oncology follow-up.

Methods: The IOU was able to produce research results through the completion of four research projects: 1. a study of adapted strategies in TEM for breast cancer care. 2. a qualitative study on TEM assessment profiles for the prevention of cervical cancer. 3. a study of the beneficial effects of forest bathing (shirin yoku) in integrative oncology. 4. a systematic review of the literature using artificial intelligence to research dietary supplements and naturopathic approaches to cancer prevention and treatment. For each project, an appropriate methodology was deployed, from qualitative surveys by questionnaires or fieldwork, to systematic literature reviews thanks to innovative specialized research tools. Regular meetings of the working group allowed for exchanges and syntheses between the different projects.

Results: While on the applied therapy side, new innovative tools allow to easily identify some scientifically validated remedies for the prevention and the accompaniment of cancer, they do not shed light on personalized dosage or galenic. Also, we observed that the question of adapting and individualizing these remedies to the patient’s terrain, or individual functioning, is more difficult to grasp from a research perspective.

Conclusion: This project has identified the need to build new research methodologies and tools reflecting TEM theories and their clinical finesse. This is necessary in order to identify the traditional profiles that are most at risk of developing certain cancers, as well as to justify the rationale for choosing individualized care interventions or lifestyle practices to strengthen or balance the patients’ terrain. A project to assess the terrain according to the principles of traditional Greek medicine has been created for this purpose.

OS INTEGRATIVE ONCOLOGY N 24 Integrative Oncology Research Program at an Australian Cancer Hospital

Suzanne Grant; Judith Lacey; Ki Kwon; Margery Hellman; Chris Dickson; Maria Gonzalez

¹NICM Health Research Institute, Western Sydney University, Sydney, Australia; ²Chris O'Brien Lifehouse, Sydney, Australia

Introduction: A small number of cancer hospitals in Australia have incorporated complementary therapies into supportive care or as an “integrative oncology” service. Modalities commonly adapted for use in a hospital setting include acupuncture, yoga, meditation or mindfulness, and oncology massage. This presentation will report on the integrative oncology research program within one comprehensive cancer center in Australia.

Conclusion: This research program snapshot will provide the opportunity to highlight domains which affect the research, such as stakeholder engagement, clinician led research, and strategies and challenges for growing an integrative oncology research program.

OS INTEGRATIVE ONCOLOGY N 25 Medicinal Mushrooms and Cancer: Scoping Reviews

Suzanne Grant¹; Xun Li²; Ping Wang²; Huidi Lan²; Guoyan Yang^1,2; Honglin Li²; Duanhong Yang²; Jianping Liu²

¹NICM Health Research Institute, Western Sydney University, Sydney, Australia; ²Beijing University of Chinese Medicine, Beijing, China

Introduction: Mushroom and mushroom products are considered to be helpful for cancer, with considerable invivo and in vitro work, and incorporation of mushroom supplements in cancer care in China and Japan. To date, there has been little systematic work to identify the scope of existing clinical evidence in treating or supporting people with cancer. We conducted scoping reviews to understand the scope of research that has been undertaken to examine the effectiveness and safety of different types of mushrooms and mushroom extracts in people with breast cancer, and lung cancer.

Method: We searched Cochrane, MEDLINE (1980‐2021), EMBASE (1982‐2021), EBSCOhost (All), CINAHL, and LILACS (1997‐2021); Chinese databases; Japanese databases and Korean databases. We included all relevant randomized controlled trials (RCTs) and clinical controlled trials (CCTs), which included quasi‐randomized and quasi‐experimental designs with comparative controls (controlled before‐and‐after studies), including Phase I/II studies on the use of mushrooms in women with breast cancer and people with lung cancer.

Results: Lung cancer. We included 138 (135 Chinese and 3 English, Japanese publication analysis is on‐going) randomized and non‐randomized trials involving 9934 participants published from 1981 to 2022. A total of 82 studies focused on lung cancer itself, while 41 focused on pleural effusion, 6 on complications, 6 on comorbidity and 3 others. The majority of mushroom product preparations were Chinese patent medicine (128 studies), followed by compound decoction (8 studies) and single mushroom (2 studies). Among 128 Chinese patent medicines, lentinan injection was the most common (103 studies) type. Breast cancer. We included 36 randomized and non‐randomized trials with 2009 participants. Studies focused on effects on side effects during and after treatment such as fatigue, nausea, seroma and quality of life; effects on immunological parameters; and safety. Most common mushroom intervention was lentinan (16 studies) derived from the mycelium of the shiitake mushroom.

Conclusion: Medicinal mushrooms are used as dietary supplements globally, and in Japan and China they have been used clinically for over 30 years. The global functional mushroom market is estimated at $15.3 billion in 2022 and is expected to reach $23.3 billion by 2030. The results of our review in two solid cancers show diverse outcome measures and heterogeneity in the interventions. Given the global investment in products, and prevalent usage by people with cancer, a targeted.

OS INTEGRATIVE ONCOLOGY N 26 Prehabilitation and Integrative Oncology for Women with Cancer receiving Chemotherapy: Co‐design and Qualitative Study

Suzanne Grant^1,2; Susannah Graham¹; Lacey Judith^2,1; Gonzalez Maria^1,2; Kerrin‐Ayres Kim¹

¹Chris O'Brien Lifehouse, Sydney, Australia; ²NICM Health Research Institute, Western Sydney University, Sydney, Australia

Background: Proactively addressing modifiable cardiovascular risk factors and potential treatment impact from diagnosis rather than post‐treatment is novel. We sought to codesign a multimodal program to commence at diagnosis and continue through treatment for women undergoing neoadjuvant chemotherapy for breast cancer. We undertook a qualitative study to codesign a program which is currently being piloted.

Methods: Phase 1 Codesign: Interviews and focus groups with women with breast cancer and healthcare professionals were conducted in 2022 using ZOOM. Three researchers agreed on a set of codes within categories, each with a brief description, forming an analytical framework. Coding was performed using NVivo. Phase 2 Feasibility Study: A program was developed (Figure 1: Program) and a feasibility, mixed‐method study is underway. The aim of the study is to explore effectiveness, identify the costs and the moderators that influence the success (or failure) of the program using the RE‐AIM framework.

Results: Codesign: Eleven women with breast cancer and 11 healthcare professionals (4 nurses, 2 surgeons, 2 medical oncologists, 1 radiation oncologist and allied participated in focus groups and interviews. Key themes for consumers included need for a single point of contact (navigation), preference for a “package”, being “organized”, individualized and engagement of oncologist. Strong support from healthcare professionals, wanting to be on the front foot (proactive), belief in the benefit of exercise for treatment tolerability and minimizing side effects and providing support. Pilot study: 19 of 30 women have enrolled, 5 women have completed the program. Interim analysis will be presented at the conference.

Conclusion: Results of this study will not only provide insight into the appropriateness of a multi‐modal rehabilitation program for women receiving chemotherapy for breast cancer but provide an understanding of the implementation framework which may facilitate such a program. Results of this study will not only provide insight into the appropriateness of a multi‐modal rehabilitation program for women receiving chemotherapy for breast cancer but provide an understanding of the implementation framework which may facilitate such a program.

OS INTEGRATIVE ONCOLOGY N 27 Impact of acupuncture on acute dysphagia in patients treated with radio‐chemotherapy for squamous‐cell carcinoma of the head‐neck area: prospective randomized phase 2 study. Preliminary data

Carmelo Guido¹; Pierluigi Bonomo²; Federica Sabatini¹; Catia Vuono¹; Elisabetta Barbara Cortesi¹; Barbara Cucca¹

¹“Fior di Prugna”, Referral Center for TCM of the Tuscany Region – Local Health Unit Central Tuscany, Florence, Italy; ²Department of Cancer Radiotherapy, Careggi University Hospital, Florence, Italy

Introduction: Squamous‐cell carcinoma of the head and neck (SCC‐HN) accounts approximately for 6% of all malignant neoplasms. Currently, concomitant radiochemotherapy treatment is the standard of care for patients with advanced SCC‐HN in case of unresectable disease or when an organ‐preservation approach is pursued. Such treatment is burdened by high toxicity, has a severe impact on acute treatment tolerance and may cause late complications. Acute dysphagia is one of the most frequent adverse effects of treatment after oral mucositis and dermatitis, causing significant deterioration in the patient's quality of life.

Aim: To evaluate the effect of acupuncture on swallowing function in patients with locally advanced SCC‐HN undergoing RT/RTCT treatment and its correlation with quality of life.

Methods: This is a prospective multicenter randomized controlled phase 2 study. The participating centers are 6, located in various areas of Italy (i.e. Florence, Rome, Reggio Emilia, Ferrara, Verbania, and Merano/Bolzano).

Ninety patients are randomized in a 1:1 ratio between:

‐ Experimental arm: 1 session of acupuncture (combined with auricular electrostimulation) on a weekly basis 2 weeks before RT/RTCT until +2 weeks after completion of RT (11 sessions)

‐ Standard arm: standard RT/RTCT treatment with IMRT technique.

Assessment of acupuncture efficacy on dysphagia symptoms by MD Anderson Dysphagia Inventory (MDADI) questionnaire and of quality of life by EORTC QLQ‐C30 and EORTC QLQ‐HN43 scales at 2, 12 and 24 weeks after RT.

Results: Patients' enrolment began in June 2021 and will end in December 2023; currently 68 patients have been enrolled and treated.

Preliminary results have shown an improvement in dysphagia symptoms during the acupuncture session, although the persistence of the improvement over time and the impact on patients' quality of life still need to be evaluated. At present, no serious adverse effects (SAEs) have occurred among the enrolled patients.

OS INTEGRATIVE ONCOLOGY N 28 Effectiveness of Mind‐Body Medicine on reducing side effects of endocrine therapy in breast cancer patients: a randomized controlled trial

Heidemarie Haller¹; Zeynep Özdemir¹; Anna Paul²; Silke Lange^3,2; Felix J. Saha²; Sonja L. Seibt^2,3; Reinisch Mattea^4,5; Gustav Dobos¹; Sherko Kuemmel^5,4; Petra Voiss³

¹Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg‐Essen, Essen, Germany; ²Department of Internal and Integrative Medicine, Evang. Kliniken Essen‐Mitte, Essen, Germany; ³Department for Integrative Oncology and Supportive Medicine, Evang. Kliniken Essen‐Mitte, Faculty of Medicine, University of Duisburg‐Essen, Essen, Germany; ⁴Breast Unit, Evang. Kliniken Essen‐Mitte, Essen, Germany; ⁵Department of Gynecology with Breast Center, Charité – Universitätsmedizin Berlin, Berlin, Germany

Introduction: Women undergoing endocrine therapy for breast cancer frequently report side effects often accompanied by irregular medication intake. In order to manage side effects and improve quality of life while taking endocrine medication, the MICOM group concept consisting of Mind‐Body Medicine (mindfulness training, yoga, moderate exercise, nutrition, complementary self‐help strategies, cognitive restructuring) and auricular acupuncture was developed and tested for its effectiveness.

Methods: Sixty‐eight women undergoing endocrine therapy for breast cancer (54.7 ± 9.3 years, TNM I‐III) were randomized to either receive 11 weekly 6.5‐hour MICOM group sessions in addition to treatment as usual (TAU) or waitlist in addition to TAU. The primary outcome was operationalized by the Menopause Rating Scale (MRS) at week 11. Secondary outcomes included general cancer‐related quality of life, fatigue, spiritual health, stress, anxiety and depression, adherence to endocrine medication, and adverse events (AE). Intention‐to‐treat analyses of covariance with respective baseline values and expectation as linear covariates and 95% confidence intervals (CI) were performed. Additional mediator analyses of mindfulness and social support were executed to identify possible mechanisms of treatment allocation on change in MRS severity.

Results: ITT analyses at week 11 revealed significant between group differences on menopausal symptoms (‐5.63 MRS, 95%CI = ‐8.13|‐3.13) as well as on cancer‐related quality of life (9.06 FACT‐G, 95%CI = 3.63|14.49), fatigue (9.19 FACIT‐F, 95%CI = 5.82|12.57), spiritual health (3.16 FACIT‐SP, 95%CI = 0.14|6.17), stress (‐2.50 PSS, 95%CI = ‐4.32|‐0.68), anxiety (‐2.01 HADS, 95%CI = ‐2.92|‐1.09), and depression (‐2.59 HADS, 95%CI = ‐4.00|‐1.17). Endocrine medication adherence was very high in both groups with no significant differences between groups (‐0.03 MARS, 95%CI = ‐0.33|0.28). Beside one serious AE (local cancer recurrence) in the control group, study participation was not associated with further AEs or AEs related dropouts. Mediator analyses identified change in mindfulness (p < .001) but not change in perceived emotional or informational social support as a significant mediator of the effect of treatment allocation on change in MRS severity.

Conclusion: In women experiencing side effects from endocrine therapy of breast cancer, adding Mind‐Body Medicine and auricular acupuncture to usual care can significantly reduce menopausal symptoms, fatigue, stress, anxiety and depression and enhance cancer related quality of life and spirituality. Mindfulness seem to mediate short‐term effects of MICOM. Further studies investigating longer‐term effects are needed.

OS INTEGRATIVE ONCOLOGY N 29 Cannabis‐drug interactions: what do Australian pharmacists and health care professionals need to know?

Joanna Harnett¹; Jocelin Chan¹; Jennifer Hunter¹; Joel Siciliano¹; Haohan Qi¹

¹University of Sydney, Sydney, Australia

Background: In Australia, cannabis‐based products are most frequently prescribed as adjunctive medicines for chronic pain, followed by anxiety, sleep disorders and other mental health problems. Most patients who are using medicinal cannabis will be taking other medicines including those for the management of the conditions. Cannabis constituents, tetrahydrocannabinol (THC) and cannabidiol (CBD), inhibit cytochrome P450 (CYP) enzymes and are highly protein bound. Therefore, pharmacists and other health professionals need to be aware of potential cannabis–drug interactions (CDIs).

Objectives: To summarize the available evidence into an article to build pharmacists' knowledge about clinically significant CDIs according to drug classes that are commonly used for mental health or pain management.

Methods: Rapid review methods were used to systematically search for human studies in Medline, Embase and CINAHL databases using two key concepts ‐ cannabis and CDIs. Data from CDI studies involving neurological, psychotropic or analgesic drug classes were summarized and agreed risk ratings and recommendations provided.

Results: 54 articles reporting potential CDIs were reviewed in detail, of which 51 articles reported potential drug‐pair interactions. A total of 34 CDIs were identified. Inhibition of cytochrome P450 (CYP) enzymes, including CYP2C19 and CYP3A4, were the most common mechanism of CDIs. A bidirectional CDI between the benzodiazepine clobazam was reported, with increased plasma levels of metabolites for both compounds observed, reductions in risk of seizures but increased risk of somnolence and over sedation. While no changes in plasma levels of Valproate and CBD/Epidiolex were identified an increased risk of herb induced liver injury necessitating discontinuation of the CBD were reported. Numerous drugs used in the treatment of anxiety, pain and depression combined with the activity of cannabis on adrenergic, cholinergic, and dopaminergic neurons was another prominent CDI mechanism. Cannabis combined with the anticholinergic effects of tricyclic antidepressants can lead to an increased drug effect resulting in tachycardia and delirium. Cannabis induced renal dysfunction was implicated in a CDI that reported reduced renal excretion of lithium. Increased plasma levels of buprenorphine associated with concurrent recreational cannabis use was associated with opioid toxicity.

Conclusion: The evidence synthesis that informed a continuing professional education article has identified most of the literature explored CDIs in people living with conditions concurrently treated with neurological, psychotropic and/or analgesic properties. The form, dose and duration of cannabis compound are important considerations in predicting the likelihood and severity of CDIs.

OS INTEGRATIVE ONCOLOGY N 30 Exploring the Challenges of Communicating about Complementary and Alternative Medicine When Cancer Patients Decline Conventional Treatment: A Qualitative Study of Patients

Johanna Hök Nordberg^1,2,3; Kathrin Wode^4,5,1; Lena Sharp^1,5; Per Fransson⁴

¹Regional Cancer Centre Stockholm Gotland, Stockholm, Sweden; ²Karolinska Institutet, Department of Neurobiology, Caring Sciences and Society, Stockholm, Sweden; ³Karolinska Institutet, Department of Physiology and Pharmacology, Stockholm, Sweden; ⁴Umeå University, Department of Radiation Sciences/Oncology, Umeå, Sweden; ⁵Umeå University, Department of Nursing, Umeå, Sweden

Background: The effective communication between cancer patients and their care team regarding the use of complementary and alternative medicine (CAM) is crucial for ensuring patient safety and building mutual trust. While the communication regarding CAM use alongside conventional cancer treatment has been relatively well explored, less is known about such communication when patients opt for CAM instead of conventional treatment.

Aim: This study aims to explore the experiences of patients and physicians in situations where patients decline recommended cancer treatment and consider using CAM.

Methods: Qualitative interviews were conducted with seven CAM‐using cancer patients who declined some or all conventional treatment and ten physicians from oncology and palliative care. The data was analyzed using framework analysis.

Results: The results indicate a difference in the reasoning of patients and physicians regarding treatment choices. While physicians focus on medical reasoning, patients' reasoning reflects complex values. The use of CAM by patients seems to have added to the difficulty of physicians in understanding patients' views, sometimes leading to a power struggle where both parties risked being pushed into hierarchical roles with inflexible standpoints. Despite the challenges in communication, both parties aimed for an open and respectful dialogue.

Conclusion: This study highlights the complexity of shared decision‐making in practice and calls for greater awareness of these challenging situations. It emphasizes the need to acknowledge patient's values and improve the knowledge of health care professionals regarding CAM.

OS INTEGRATIVE ONCOLOGY N 31 Teaching Swedish oncology health care professionals about complementary and integrative medicine: course design & evaluation

Johanna Hök Nordberg^1,2; Kathrin Wode^1,4

¹Regional Cancer Centre Stockholm Gotland, Stockholm, Sweden; ²Karolinska Institutet, Department of Neurobiology, Caring Sciences and Society, Stockholm, Sweden; ³Karolinska Institutet, Department of Physiology and Pharmacology, Stockholm, Sweden; ⁴Umeå University, Department of Radiation Sciences/Oncology, Umeå, Sweden; ⁵Umeå University, Department of Nursing, Umeå, Sweden

Background: Despite extensive use of complementary and alternative medicine (CAM) among cancer patients in Sweden, healthcare professionals receive no official education on the topic, leading to a knowledge gap. Therefore, the Regional Cancer Center Stockholm Gotland has initiated a course on complementary and integrative medicine (CIM) for cancer care professionals with the goal to promote informed dialogue between patients, significant others, and healthcare professionals.

Method: Since 2020 we have been offering this three‐day hybrid course for cancer care professionals twice a year. The course includes blended learning activities and involves approximately 20 international experts in the field covering e.g. regulation, evidence on effectiveness and safety, and tools for knowledge‐based dialogue. Since its inception, 159 cancer care professionals, including oncology and palliative medicine specialists, oncology nurses, palliative specialist nurses, physiotherapists, dieticians, and patient representatives, have participated. We collected feedback from all 159 participants and present results from the course evaluations as mean scores on a scale of 1‐5 (1 = very bad, 5 = very good). Participants were asked before and after the course, how confident they were with asking and answering patients' questions about CAM. Open‐ended feedback was analyzed by means of content analysis.

Results: With an average response rate of 90%, the overall impression of the course received a score of 4.7 out of 5. Clinical applicability received a score of 4.1 out of 5 and the recommendation of the course to colleagues received a score of 4.7 out of 5. Regarding asking and answering questions, the results suggest an increase in confidence after the course; scores increased from 3.3 to 4.3 for asking questions and from 2.5 to 3.8 for answering questions.

Conclusion: The implementation of a multi‐professional national course for cancer care professionals about CIM in Sweden is feasible and well received.

OS INTEGRATIVE ONCOLOGY N 32 A feasibility trial of Self‐Acupuncture for Chemotherapy Cancer patients

John Hughes¹; Lallita Carballo³; Saul Berkovitz²; Catrina Davy¹; Sosie Kassab²; Mike Cummings⁴; Katie Ruane⁵; Alex Molassiotis⁶; Beverley de Valois⁷; Felicity Bishop⁸

¹Royal London Hospital for Integrated Medicine UCLH NHS Trust and University of West London, London, United Kingdom; ²Royal London Hospital for Integrated Medicine UCLH NHS Trust, London, United Kingdom; ³UCH Macmillan Cancer Centre, London, United Kingdom; ⁴British Medical Acupuncture Society, London, United Kingdom; ⁵Patient representative, London, United Kingdom; ⁶University of Derby, Derby, United Kingdom; ⁷Mount Vernon Cancer Centre, London, United Kingdom; ⁸University of Southampton, Southampton, United Kingdom

Introduction and objective: Acupuncture has been used extensively for symptom management in cancer, with evidence suggesting acupuncture may be an effective intervention for various cancer related symptoms. Self‐acupuncture involves teaching patients to insert a limited number of acupuncture needles into points on their own body to enable them to self‐manage their own symptoms. Self‐acupuncture is known to have been taught to UK National Health Service patients since the 1970's. Despite its long use within the NHS, there remains a dearth of published research which has evaluated the safety or effectiveness of the intervention. The present study aims to evaluate the feasibility of delivering self‐acupuncture to chemotherapy cancer patients undergoing treatment in a routine clinical care NHS setting. This will include preliminary data on the size of any effect, participants' views on the design of the trial, and for those allocated to the self‐acupuncture intervention, their views on the intervention.

Methods: The feasibility trial employs a pragmatic mixed methods randomized parallel‐group exploratory design. Feasibility trial aims to recruit 80 participants, using a ratio of 1:3 standard care to standard care plus self‐acupuncture. Participants randomized to self‐acupuncture attend a 1.5 hour group workshop led by two experienced acupuncturists. Participants taught to safely apply acupuncture bilaterally using traditional acupuncture needles to the acupuncture point Stomach 36, and if appropriate Spleen 6 and/or Liver 3 (maximum six points in total). Participants asked to needle the points 2‐3 times a week throughout their cancer treatment and for 3 months post treatment. Participants complete baseline outcome measures and follow up outcomes measures at end of chemotherapy treatment, and 3 months post chemotherapy treatment. Outcome measures include EORTC QLQ‐C30, MFI and Memorial Symptom Assessment Scale. At end of chemotherapy treatment participants also take part in qualitative telephone interviews. At 3 months post chemotherapy treatment those allocated to self‐acupuncture invited to participate in a second qualitative interview. Participants allocated to standard care offered training in self‐acupuncture once trial is complete. Quantitative data entered into Statistical Packages for Social Sciences (SPSS). Analysis will include descriptive statistics, appropriate tests for statistical significance and statistical power calculation. Data from qualitative interviews analysed thematically using Framework methodology.

Results: Feasibility trial ongoing, preliminary findings will be presented at the conference.

Conclusions: If self‐acupuncture were found to be safe and effective it could provide cancer patients with an inexpensive self‐management tool to help manage their symptoms.

OS INTEGRATIVE ONCOLOGY N 33 The Mistletoe And Breast cancer (MAB) study: a UK pilot RCT.

Alyson Huntley¹; Lorna Duncan¹; Susan Bryant¹; Gene Feder¹

¹University of Bristol, Bristol, United Kingdom

Objective: To test the feasibility of a pilot, RCT of mistletoe with an embedded qualitative study in the UK National Health Service (NHS) setting.

Methods: The aim was to recruit 45 patients via an NHS oncology centre with a diagnosis of early/locally advanced breast cancer. Trial groups were: Iscador^® Maleus, Iscador^® Pinus or saline (placebo). A diary was used to record their therapy. Questionnaires EORTC QLQ‐C30, EORTC QLQ‐BR23, FACT‐N, CFS, ARS‐State, and CAMBI were applied. Qualitative interviews were undertaken with participants, oncologists, and nurses.

Results: 67 patients were approached and 15 gave consent. One participant dropped out prior to randomization. Two participants withdrew during the trial. Ten participants and 5 staff were interviewed.

Barriers to recruitment were extra treatment and time, extra injections, and the possibility of placebo allocation. COVID‐19 had a negative impact on recruitment and caused stress for some participants.

Adherence to the therapy was good. However, diaries and interviews indicated participants struggled with injections, and in some cases, the skin reactions. The interviews highlight a positive approach by participants; devising ways to cope with self‐injection. Adverse events were low.

7/14 participants did not know their therapy allocation. All participants described their decision on how they felt, and not on therapy appearance.

Conclusion: This pilot shows it is feasible in the UK to recruit breast cancer patients into a randomized controlled trial of mistletoe versus placebo, for them to adhere to treatment and provide follow‐up data.

OS INTEGRATIVE ONCOLOGY N 34 Treatment of cancer patients at the “Dr Spinedi” clinic: therapeutic model and timing of interventions with classic homeopathy in cancer treatment in a complex case of colon carcinoma

Antonietta Iasiello¹; Daniela Cremonini¹; Paul Muttathukunnel¹

¹Clinica Dr. Spinedi, Orselina, Switzerland

Background: Cancer is a multifactorial pathology that requires an integrated approach with attention to all phases of the treatment, from diagnosis to recovery, but also in state of chronicity, palliation and end life. Homeopathy has proven to be a valid resource in accompanying oncological treatments along their entire course and in particular for the following conditions: side effects of diagnostic tests, emotional reaction to diagnosis, current symptoms, side effects of allopathic treatments, short, medium and long term consequences of surgery, pain, complications of the disease, palliation but also treatment of the predisposing terrain on a genetic basis, possible causes (even decades after their action) and prevention of relapses .

Objectives: The aim of our work is to show how the clinic “Dr. Spinedi” practically applies the principles of Classical Homeopathy to the integrative treatment of cancer patients with the timing of all interventions during both hospitalization and following outpatient treatment.

Methods: A case of colon carcinoma in a patient with colon polyposis, previous right breast infiltrating ductal carcinoma, recurrent rectal adenoma and right ovarian androblastoma will show how in “Dr. Spinedi” clinic Classical Homeopathy is used to treat complex oncological cases (six years follow up).

OS INTEGRATIVE ONCOLOGY N 35 A mixed method randomized controlled pilot study assessing the feasibility, safety, and impact of a wilderness experience for adolescent and young adult cancer survivors: the WAYA study

Miek Jong¹; Trine Stub¹; Helene Dahlqvist²; Mats Jong²

¹Arctic University of Norway, NAFKAM, Tromsø, Norway; ²Mid Sweden University, Sundsvall, Sweden

Introduction and objective: Childhood and adolescent and young adult (AYA) cancer survivors suffer from chronic health issues such as psychological distress, pain, and fatigue. Given the multitude of these issues among them and given that there are few interventions that have the potential to impact multiple factors, it is critical to investigate promising interventions. Exposure to nature may be such a promising intervention. However, randomized controlled studies (RCTs) of nature/wilderness interventions for cancer survivors are lacking. This study investigated whether it is feasible to conduct an RCT of a wilderness experience and assessed its impact on AYA cancer survivors.

Methods: Inclusion criteria were individuals aged 16–39 years surviving from any type of cancer. They were randomized to a wilderness intervention (n = 19) or a comparison intervention (n = 23). The wilderness program involved an 8‐day wilderness expedition with backpacking, camping, sea kayaking, gorge climbing, and mindfulness‐practices. With 3 months in between, it was followed by a 4‐day basecamp intervention. The comparison was an 8‐day holiday program at a Spa‐hotel, followed by a 4‐day holiday program after 3 months. The primary outcome was study feasibility and safety. A qualitative approach through individual interviews with participants in the wilderness program (n = 17) allowed deeper understanding about the impact of such a wilderness experience on AYA cancer survivors.

Results: All participants completed the study after one year. The majority was female (70%) and represented different types of cancers. Clinical characteristics were similar between the two groups, except age at cancer diagnosis which was higher in the wilderness program (age 19.1 vs. 12.5 years; p = 0.024). Adherence to the program and data completeness was high (> 90%) in both groups. The relative risk for adverse effects (AEs) was similar in both groups (1.0, 95% Confidence Interval 0.8‐1.3), and all were mild to moderate in severity. Nature connectedness was significantly increased in the wilderness group compared to the holiday program for up to one year (p < 0.001). No differences were found between the two groups regarding the quality of life. Qualitative content analysis revealed 5 themes captured in an overarching theme “supporting personal growth through challenges in nature”.

Conclusion: It is feasible and safe to conduct an RCT on such a complex intervention as a wilderness experience for AYA cancer survivors. This pilot study lays the foundation for a larger RCT to investigate the effectiveness of wilderness programs on the health of AYA cancer survivors.

OS INTEGRATIVE ONCOLOGY N 36 Prevalence of late and long‐term effects of cancer (treatment) and use of complementary and alternative medicine in Norway

Agnete Egilsdatter Kristoffersen¹; Barbara Wider¹; Jorunn V. Nilsen⁴; Mona Bjelland⁴; Dana C. Mora¹; Johanna Hök Nordberg^3,5; Ann Ragnhild Broderstad²; Kiwumulo Nakandi¹; Trine Stub¹

¹UiT The arctic university of Noray, NAFKAM, Tromsø, Norway; ²UiT The arctic university of Norway, Centre for Sami Health Research, Tromsø, Norway; ³Regional Cancer Center Stockholm Gotland, Stockholm, Sweden; ⁴The Norwegian Cancer Society, Oslo, Norway; ⁵Karolinska Institutet, Dept Neurobiology, Care Sciences & Society, Stockholm, Sweden

Background: The increasing number of patients surviving cancer leads to more people experiencing late and long term‐effects from the disease and its treatment. Fatigue, sleep disorders, early menopause, pain, and nerve damage are commonly reported. Methods helping people to recover after cancer treatment are therefore essential. The aims of this study were threefold; (1) to determine the level of cancer patients suffering from late and long‐term effects of cancer diagnosis and treatment in Norway, (2) explore complementary and alternative medicine (CAM) modalities used for managing these adversities, and (3) describe self‐perceived benefits and harms of the CAM interventions.

Methods: The study was conducted in cooperation with the Norwegian Cancer Society (NCS) and consisted of an online cross‐sectional study among members of the NCS user panel with present or previous cancer (n = 706). The study was carried out in September/October 2021 using a modified cancer‐specific version of the International Questionnaire to Measure Use of Complementary and Alternative Medicine (I‐CAM‐Q). A total of 315 women and 153 men agreed to participate, resulting in a response rate of 67%.

Results: Most of the participants (83%) suffered from late and long‐term effects of cancer or cancer treatment; mostly fatigue (59.2%), sleep disorder (41.5%), hot flashes (39.2%), nerve damage (polyneuropathy, 38.0%), and pain (36.6%) with a median number of 5 different late and long‐term effects reported. Late and long‐term effects were positively associated with younger age and college/university education. Nearly half of the participants experiencing late and long‐term effects reported having used CAM to treat these complaints (43%). Most frequently used were self‐help practices (26%) such as relaxation therapy (19%), yoga (14%) and meditation (13%), but also visits to CAM providers were reported by 22%. Herbal‐ and other natural remedies to treat late and long‐term effects were used by 13%. A high percentage of CAM users reported self‐perceived improvements of their symptoms (86% for self‐help practices, 90% for visits to CAM providers). Few experienced adverse effects of the CAM treatment.

OS INTEGRATIVE ONCOLOGY N 37 Patients and Clinicians Perspectives about Cannabis Use While Receiving Cancer Treatment at a Comprehensive Cancer Center (CCC)

Richard Lee¹; Prateek Mendiratta^2,3; Megan Farrell³; Shalena Finklea³; Lauren Huang³; Erika Trapl³; Santosh Rao^3,2; Stanton Gerson³; Jennifer Cullen³

¹City of Hope Comprehensive Cancer Center, Orange County, United States of America; ²University Hospitals Seidman Cancer Center, Cleveland, United States of America; ³Case Western Reserve University Comprehensive Cancer Center, Cleveland, United States of America

Introduction: Cannabis is gaining popularity worldwide including in the United States with 37 states legalizing access to cannabis. Limited data exist regarding why patients are using cannabis while receiving anticancer treatments.

Methods: Patients with cancer who received treatment at a National Cancer Institute (NCI) designated CCC were approached from August of 2021 to August of 2022 to participate in a cross‐sectional survey as part of a national NCI‐funded effort. Consenting patients completed a survey during a medical visit asking about cannabis use (past and present), reason for use (including if cancer‐related), type of cannabis, and frequency of use. A follow‐up phone call occurred within 30 days to confirm medications used, and to collect further details about cannabis use, if reported. A healthcare provider survey was also conducted to explore perspectives regarding patients' use of cannabis during active treatment.

Results: A total of 315 cancer patients completed the survey (43% response rate) with a median age of 60.7 (±12.8), 58% female, and a variety of cancer types (hematologic 21.3%, breast 17%, gastrointestinal 11.7%, lung 10.2%). The respondents were of a diverse racial/ethnic backgrounds (White 61.6%, Black 22.5%, Other 7.3%) education (high school 27%, college 42.5%, post‐graduate 14.9%), and employment status (retired 35.2%, employed 25.7%, unemployed or disabled 21.9%). Among respondents, nearly half (48.4%) had used cannabis before, one‐third (32.1%) had used cannabis since their cancer diagnosis, and almost one in five (18.5%) were currently using cannabis. Among current or past users of cannabis the forms used were smoked (31%), gummy (29%), liquid (19%), edible (7%), and pill (6%). The most common reported reasons for use by respondents were insomnia (79%), pain (72%), mood (68%), poor appetite (68%), and gastrointestinal symptoms (51%). For the clinician survey, a total of 165 completed surveys (25% response rate) were received. Approximately half of respondents were nurses (54% nurses, 22% advance practice providers, and 21% physicians) and of White race (73%) with a mean age of 46 years. Approximately one‐fourth (24%) reported discussing the topic of cannabis and about half of these conversations (45%) were initiated by the respondent. The healthcare providers estimated 10% of patients with cancer overall were using cannabis and that one in four patients (23%) were using cannabis during cancer treatment. Four in ten (39%) clinicians felt comfortable in providing guidance to patients about cannabis use, and only one in eight (13%) felt knowledgeable about the topic of cannabis.

Conclusions: Approximately one‐fifth of patients with cancer receiving treatment are actively using cannabis, despite limited data regarding the efficacy of cannabis. Management of cancer symptoms were among key reasons that cancer patients used cannabis.

OS INTEGRATIVE ONCOLOGY N 38 Safety and efficacy of acupuncture for symptom management in breast cancer patients

Ye‐Seul Lee¹

¹Jaseng Medical Foundation, Seoul, Korea (Republic of)

Introduction: Acupuncture is often used to manage treatment‐related symptoms in breast cancer (BC) patients. To investigate the effect of acupuncture during different phases of breast cancer patient's survival, this study examined the association between acupuncture and severe complications such as breast cancer‐related lymphedema (BCRL), treatment‐related cardiovascular events, and chemotherapy‐induced peripheral neuropathy (CIPN).

Methods: Three different analyses were conducted using a nationwide cohort from Korea. First, acupuncture during post‐operative period of three to six months after surgery on the risk of BCRL was examined. Second, acupuncture during adjuvant chemotherapy on the 5‐year risk of coronary artery diseases (CAD), stroke, congestive heart failure (CHF), cardiomyopathy, and overall survival were investigated. Third, the effect of acupuncture on the use of prescribed medications including tramadol, gabapentin, pregabalin, imipramine, amitriptyline, valproic acid, and duloxetine for CIPN patients was examined. Logistic regression model and survival analyses using Kaplan Meier curve and multivariable Cox proportional hazards ratio model were conducted on propensity score‐matched cohort.

Results: A total of 44,216 patients were identified with newly diagnosed BC and records of BC surgery between 2011 and 2013 in Korea. The risk of BCRL was not influenced by acupuncture during the post‐operative period (Hazard Ratio (HR) = 1.015, 95% Confidence Interval (CI) = 0.87–1.19). The risk of treatment‐related cardiovascular diseases was not influenced by acupuncture (CAD: HR = 1.05, CI = 0.79‐0.40; stroke: HR = 1.18, CI = 0.77‐1.80; CHF: HR = 1.11, CI = 0.77‐1.62). Tramadol use in CIPN patients tended to decrease after receiving acupuncture, though it was not statistically significant (HR 0.86, 95% CI 0.58‐1.27).

Conclusion: Acupuncture was not associated with severe treatment‐related complications of BC in both short‐term and long‐term periods, and it showed potential of reduced risk of prescribed medications for peripheral neuropathy. Dosage response was observed between number of acupuncture sessions and health outcomes. Overall, acupuncture is a safe option for BC patients seeking additional help to address their symptoms.

OS INTEGRATIVE ONCOLOGY N 39 Acupuncture as integrative medicine in breast cancer patients: An italian feasibility study in Emilia‐Romagna oncology hospital settings

Grazia Lesi¹; Giorgia Razzini²; Elisa Stivanello³; Guido Giarelli⁴; Stefania Florindi⁴; Muriel Assunta Musti³; Chiara Petrucci¹; Silvia Princivalle⁵; Maria Bernadette Ligabue⁶; Anna Fedeli⁷; Lucia Angeloni⁸; Milena Sabadini⁸; Roberto Riva⁸; Roberto Martini⁸; Paolo Pandolfi³

¹Primary Care and Family Planning Clinic Departments, Bologna Local Health Authority, Bologna, Italy; ²Unit of Medical Oncology Civil Hospital, Modena Local Health Autorithy, Carpi, Italy; ³Department of Public Health, Bologna Local Health Authority, Bologna, Italy; ⁴Asclepiadi Service Onlus, University “Magna Graecia”, Catanzaro, Italy; ⁵Radiotherapy and Oncology Unit, S. Anna Hospital, Local Healt Authority, Ferrara, Italy; ⁶Oncology Department, Reggio Emilia IRCCS, Reggio Emilia, Italy; ⁷Oncology Department IRCCS Meldola, Meldola, Italy; ⁸Mediorer Project, RER, Bologna, Italy

Introduction: Despite the best research evidence that acupuncture could be used to reduce climateric symptoms in women with breast cancer during cancer treatment, its integration within the Italian National Health Service is still in the very early stage. We conducted a feasibility study aiming to evaluate the integration of acupuncture within the oncological settings of the local health authorities of Emilia‐Romagna to reduce climacteric syndrome in women with breast cancer.

Methods: The following outcomes were analysed: patients' compliance with acupuncture treatment, referral frequency by cancer care team, patients and cancer care team satisfaction, and enablers and barriers in implementing integrated cancer care. Both quantitative and qualitative methods were used. Six cancer centres participated in this study.

Results: The implementation of integrative medicine space was anticipated in all six centres by a one‐year preparatory phase which included: (1) focus groups to explore the needs and expectations of patients and cancer clinic staff and to identify enablers and barriers for integration; (2) training courses on the principles of Traditional Chinese Medicine and project information campaigns to all stakeholders; and (3) the organisation of the integrative medicine clinic, including room space, staff and referral systems. During a one‐year acupuncture treatment phase, 228 women with breast cancer accessed the integrative medicine clinics, covering up to 80% of the waiting list and up to 50% of all the potential beneficiaries. Patients' compliance in terms of the 10 acupuncture sessions performed was 78%. Cancer centre professionals participated actively in the referral process. At the end of the study, acupuncture was reported to be effective in reducing climateric symptoms and was therefore highly requested, as confirmed by the participants during in‐depth interviews and by the cancer team during focus groups. No adverse events or interruption of cancer therapy due to acupuncuture were reported.

Conclusions: Our study shows that implementation of integrative therapy such as acupuncuture treatment for climateric symptoms in women with breast cancer is feasible, effective and safe within the Italian cancer centre health service.

OS INTEGRATIVE ONCOLOGY N 40 Efficacy of Homoeopathy in advanced metastatic cancer pain management

Farokh Master¹

¹King Edward Memorial Hospital, Mumbai, India

Aim: The aim of this prospective study was to uncover the efficacy of Homoeopathic drugs in controlling the pain and overall quality of life of cancer patients who were already on heavy doses of opiates and non‐opiate painkillers.

Methods: We selected 30 patients who regularly attended our cancer clinic for a minimum period of 9 months. The evaluation was based on their type of pain, e.g. burning, stabbing, spasmodic, etc. The duration of the pain was noted along with its pathophysiology, e.g. somatic, visceral, neuropathic, etc. Most importantly the pain score from 0 to 10 was used to label the intensity of pain. Furthermore, every patient was evaluated using the Karnofsky Performance Scale, European Organization for Research and Treatment of Cancer QLC ‐C30 (Version 3) and The Short Form (36) Health Survey. Before starting Homoeopathy the total use of opiates and non‐opiate painkillers tablets was evaluated and their respective dosage was noted. In the first two weeks, the dosage was unchanged but subsequently, the dosage was reduced to see the effect of Homoeopathic medicine on cancer pain. Detailed homoeopathic evaluation of the patient was done, determining his past and family history, his physical constitution, his physical general symptoms, his mental symptoms and his life space. Single homoeopathic drugs were selected in different potencies and administered by a special 5‐cup method dose and patients were observed over a minimum period of 9 months. Evaluation after the remedy was done using the Karnofsky Performance Scale, European Organization for Research and Treatment of Cancer QLC ‐C30 (Version 3) and the Short Form (36) Health Survey.

Results: The results were very encouraging. More than 70% of the patients irrespective of the type of cancer and type of pain felt improvement in their pain. More than 60% of the patients reduced their opiates and non‐opiate painkillers by more than 60%. They felt their energy levels and feeling of well‐being improved by almost 80%.

Conclusions: From this study, we could positively conclude that Homoeopathic medicines could provide cancer patients with significant relief in their pain without causing any adverse effects. In fact, they were able to improve the overall condition of the patient and give them a sense of well‐being along with an improvement in their energy levels.

OS INTEGRATIVE ONCOLOGY N 41 Efficacy of Homeopathy in Advanced Solid Tumours of Brain and Spinal cord

Farokh Master¹

¹King Edward Memorial Hospital, Mumbai, India

Aim: The aim of this prospective study was to uncover the efficacy of Homoeopathic drugs in controlling the growth of solid tumors in the brain and spinal cord in two cases solved with classical homeopathy.

Methods: Two cases diagnosed with Intramedullary Sol from C1 TO C3, Right thalamic pilomyxoid astrocytoma. Detailed homeopathic case‐taking was done according to Hahnemann as mentioned in aphorisms 84‐104. Cases were repertorised using RadarOpus synthesis. Both cases were treated constitutionally with different medicines but during acute episodes, patients were given small remedies. Patients were monitored every month. Based on the totality of the symptoms in both cases following medicines were used‐ Heroinum, Taxus baccata, Gelsemium, Terminalia chebula, Iodum, and Temozolomide. The patients were under homeopathic treatment for two years.

Results: The results were very encouraging. In both cases, irrespective of the type of cancer and type of pain felt improvement in the size of the tumor. They felt their energy levels and feeling of well‐being improved by almost 80%. There was a complete reduction in the size of the tumor and complete resolution of intramedullary sol.

Conclusions: From this study, we could positively conclude that Homoeopathic medicines could provide cancer patients with significant relief in their pain without causing any adverse effects. In fact, they were able to improve the overall condition of the patient and give them a sense of well‐being along with an improvement in their energy levels.

OS INTEGRATIVE ONCOLOGY N 42 High dosage supplementation with pharma grade CBD in ovarian cancer patients, a study proposal

Marco Mitidieri¹

¹2. Città della Salute e della Scienza di Torino, TORINO, Italy

Introduction and objective: Cannabidiol (CBD) is one of the extensively studied phytocannabinoids produced by the Cannabis sativa L. plant. It belongs to the terpenophenolic class of molecules broadly known as “cannabinoids”. Its active form is a result of non‐enzymatic decarboxylation of its precursor CBD‐A during the drying step of the drug's manufacturing process. CBD has been widely investigated for its therapeutic effects on human health and its complete lack of psychoactivity, making it a highly promising compound. Numerous studies have reported its anti‐inflammatory and antioxidant activities, as well as its anxiolytic and antidepressant properties. Recent research has focused on the potential pharmacological activity of CBD in certain cancers such as endometrial or ovarian cancer. In a 2010 study, Falasca et al. reported CBD's antagonist activity towards the GPR55 receptor, which is expressed in some ovarian and prostatic cancer cell lines and plays a key role in cancer cell proliferation.

Methods: Our study proposal aims to evaluate the clinical impact of a supplementation of 1000 mg of 99.9% pure CBD in addition to conventional cancer treatments. The CBD supplementation will be administered to a cohort of 20‐40 female patients suffering from ovarian cancer at any FIGO stage. The cohort will be divided into two groups: one group receiving actual CBD and the other group receiving a placebo. The study design will be either single or double‐blind. Wolff‐Parkinson‐White Syndrome and major arrhythmias will be absolute exclusion criteria. The primary outcome assessments will include quality of life assessment (HRQoL), pain assessment (VAS), and self‐reported benefits on cancer treatment side effects. The secondary outcome assessment will involve a critical review of oncological medical documentation (CT scans, MRI, X‐rays, surgical outcomes, etc.). Statistical analysis will be performed using software such as SPSS to determine the statistical significance between the two study groups.

Results and Conclusions: This study aims to contribute to the growing body of knowledge regarding the potential benefits of CBD supplementation in cancer treatment. The results will shed light on the clinical implications and therapeutic potential of CBD in the context of ovarian cancer.

OS INTEGRATIVE ONCOLOGY N 43 Singular and combined effects of Nordic Walking practice and Acupuncture on bioelectrical impedance vector of breast cancer survivors

Massimo Rinaldi^2,3; Teresa Morano²; Sofia Serafini¹; Pascal Izzicupo¹; Anna D'Eugenio^2,3; Laura Masini^3,2; Ettore Cianchetti²; Francesca Di giandomenico²; Simona Grossi²; Andrea Di Blasio^2,3

¹integrative medicine, Ortona, Italy; ²Eusoma Breast Cancer, Ortona, Italy; ³Department of medicine age, Chieti, Italy

Introduction and objective: Acupuncture and physical exercise are complementary treatments for breast cancer survivors (BCS). Acupuncture has been shown to hamper negative effects of oncological treatments, also through the balance the bodily fluids between extra and intracellular fields. Also, physical exercise has an important influence on bodily fluid balance, not only through sweating and metabolic processes but also through the effects of body movements. Nordic walking (NW) is being given attention as a useful treatment for BCS since it actively involves myofascial chains which mirror traditional Chinese meridians. The bioelectrical impedance vector analysis (BIVA) approach, proposed by Piccoli et al. (1994), interpolates resistance (R) and reactance (Xc), standardized for the subject height, on the RXc graph, as a single vector assessing soft tissues and bodily fluids. The study aimed to evaluate singular and combined effects of Nordic Walking practice and Acupuncture on bioelectrical impedance vector of breast cancer survivors.

Methods: Eighty BCS (53.24 ± 5.50 years), including 38 women not practising neither physical exercise nor NW (NW‐) and 42 Nordic walkers (NW+), were recruited and investigated, in a random order, for bodily R and Xc immediately before and after (a) acupuncture treatment (Acu+) and (b) supine rest without acupuncture (Acu‐). The BIVA software (Piccoli, 2002) was used to: (a) characterize the distribution model of bioelectrical vector (BIA vector) in each group, (b) execute statistical analysis, based on the T² Hotelling test for groups and paired samples, investigating the linear distance between vectors on the RXc graph, calculated as the Mahalanobis distance.

Results: The BIA vector showed statistically significant differences between the NW‐ and NW+ before and after Acu+ (T = 10.6, P = 0.0073, D = 0.73; T = 14.3, P = 0.0015, D = 0.85) and also between NW‐ and NW+ before and after Acu‐ (T = 7.3, P = 0.0321, D = 0.6; T = 10.2, P = 0.0088, D = 0.72). Furthermore, all the conditions affected BIA vectors, although NW+ coupled with Acu+ showed higher and additive effects (T² = 40.7, P = 0.00, D = 1.03; T² = 229.3, P = 0.00; D = 2.34; T² = 206.8, P = 0.00, D = 2.33; T² = 498, P = 0.00, D = 3.44 for NW‐ Acu‐, NW + Acu‐, NW‐ Acu+, NW+ Acu+, respectively).

Conclusions: From the bioimpedance vector analysis, it is assumed that NW and Acu treatments improve cell integrity and balance bodily water distribution between the extra and intracellular fields; their effects are better when combined.

OS INTEGRATIVE ONCOLOGY N 44 A Randomized Controlled Trial addressing cancer‐related cognitive impairment (chemobrain) in a sample of breast cancer patients undergoing rehabilitation exercises, diet, and add‐on complementary medicine: Preliminary findings.

Elio Rossi¹; Stefania Tocchini²; Matilde Luchi²; Anna Lida Elia¹; Cristina Noberasco¹; Marco Picchi¹; Francesca Bosinelli²

¹Clinic of Complementary medicine and diet in oncology, Tuscan Local Health Unit North‐West, Lucca, Italy; ²Clincal Neuropsychology, Tuscan Local Health Unit North‐West, Lucca, Italy

Background: In the last decade, despite the increasing of 5‐year survival rates in breast cancer (BC) patients, cancer and its conventional treatments were often associated with several side effects. In particular, there is a growing interest in cancer‐related cognitive impairment (CRCI), which encompasses mental fatigue and an impairment in multiple domains, including attention, processing speed, and memory that could be increased by anxiety/depressive symptoms.

Aim: Our controlled and randomized study will evaluate the effectiveness of an add‐on integrative treatment (including acupuncture and/or homeopathy) compared to a standard care in relieving CRCI.

Materials and methods:

Sample: We aim at enrolling a total of 320 patients according to the following criteria. Inclusion criteria: females; age: 18‐65 years; primary diagnosis of early BC (stages I‐III A); being treated with adjuvant chemotherapy and/or endocrine therapy; provided written informed consent; cognitive complaints. Exclusion criteria: metastatic BC; previous history of other cancer types; personal and/or family history of severe neurological and/or psychiatric disorders; use of concurrent psychoactive drugs; severe needle phobia; pregnancy.

Randomization: Patients will be randomised and assigned to one of 4 groups: 1) rehabilitation exercises and dietary advices plus acupuncture/auriculotherapy; 2) rehabilitation exercises and dietary advices plus homeopathy; 3) rehabilitation exercises and dietary advices plus acupuncture/auriculotherapy and homeopathy; 4) rehabilitation exercises and dietary advices (i.e, active control group).

Assessment: Patients will undergo a broad neuropsychological and clinical battery at the baseline and at a 11‐months follow‐up. Plus, they will undergo a shorter neuropsychological and clinical battery during treatments (3 months) and after treatment completion. Moreover, they will undergo hematologic tests both at the baseline and at a 10‐month follow‐up.

Treatments: Acupuncture: specific 8‐week protocol consisting of standard a personalised points, repeated for two sessions (baseline‐3 months and 3‐6 months). Homeopathy: specific 8‐week protocol consisting of two magistral preparations, repeated for two sessions (baseline‐3 months and 3‐6 months).

Plus, all patients will receive dietary advices aimed at reducing inflammation and will undergo a computerised cognitive rehabilitation program (i.e., COGMED Working Memory Training).

Results: An initial qualitative observation in a small number of patients (N = 15) reveals the presence of discrepancies mainly in the mnemonic and executive domain added to mild to moderate anxiety‐depressive symptoms. The preliminary results of this study will be presented during the congress in Rome.

Conclusions: Our preliminary findings suggest that an Integrative Complementary treatment of cognitive symptoms induced by anticancer therapy may play a promising role in promoting patients' wellbeing.

OS INTEGRATIVE ONCOLOGY N 45 Integrative oncology in the Public Hospital of Lucca (Italy): Outcome results of 10 years of activity

Elio Rossi¹; Marco Picchi¹; Cristina Noberasco¹; Marialessandra Panozzo¹; Francesca Bosinelli¹; Linda Nurra¹; Mariella Di Stefano²

¹Clinic of Complementary medicine and diet in oncology, Local Health Unit Tuscany North West, Lucca, Italy; ²Tuscan Regional Center of Integrative Medicine, Florence, Italy

Background: The Clinic for Complementary Medicine and Diet in Oncology was opened, in collaboration with the Oncology Department, at the Hospital of Lucca (Italy) in 2013 to address the side effects of anti‐cancer treatments.

Aim: To present the results of complementary medicine treatment targeted towards reducing the adverse effects of anti‐cancer therapy and cancer symptoms and improving patient's quality of life. Dietary advice was aimed at the reduction of foods that promote inflammation, in favor of those with anti‐oxidant and anti‐inflammatory properties.

Methods: Retrospective observational study on 914 patients consecutively visited from September 2013 until December 2022. The intensity of symptoms was evaluated according to a grading system from G0 (absent) to G1 (slight), G2 (moderate), and G3 (strong). The severity of radiodermatitis was evaluated according to the Radiation Therapy Oncology Group (RTOG) scale.

Results: The main types of cancer observed were: breast (57.1%), colon (7.3%), lung (5.0%), ovary (3.9%), stomach (2.5%), prostate (2.2%), and uterus (2.5%). The comparison of clinical conditions before and after treatment showed a significant amelioration of nausea, insomnia, depression, anxiety, fatigue, mucositis, hot flashes, joint pain, dysgeusia, neuropathy, and the totality of the observed symptoms. Moreover, in a subgroup of 77 breast cancer patients in radiotherapy undergoing integrative treatment, 40 patients with a homeopathic integrative protocol during RT were compared with a control group of 37 patients without treatment. The data showed a statistically significant reduction in the severity of radiodermatitis in the group of patients treated with the homeopathic/integrated protocol (Mann‐Whitney test: two‐tailed significance p ≤ 0.01).

Among all the patients who attended the clinic, 35 (6.3%) refused to undergo or continue one or more conventional treatments against their oncologist's recommendations; 7/35 (20%) refused all kinds of anti‐cancer treatment, 14 (40%) specifically refused chemotherapy, 7 (20%) specifically refused endocrine therapy, 2 (5.7%) refused surgery and 1 (2.8%) refused radiotherapy. Four patients (11.4%) refused other kinds of anti‐cancer treatment (i.e. radioiodine, chemoembolization, growing factors, and immunotherapy). Thirty‐one patients (88.6%) completed at least one follow‐up visit. Eighteen of them (58.1%) are still in good conditions, 4 (12.9%) are in a disease progression phase, and 9 (29%) passed away. After their baseline integrative oncology visit, 15 out of 31 patients visited at follow‐up (48.4%) turned out to accept conventional treatments.

Conclusions: An integrative oncology clinic may contribute to reduce the adverse effects of anti‐cancer therapy and improve the quality of life of cancer patients.

OS INTEGRATIVE ONCOLOGY N 46 Improvement of quality of life in lung cancer patients receiving radiotherapy in combination with Viscum album L. –a real‐world data study

Friedemann Schad^1,2; Diana Steinmann³; Shiao Li Oei¹; Anja Thronicke¹; Christian Grah⁴

¹Research Institute Havelhöhe at the Hospital Gemeinschaftskrankenhaus Havelhöhe, Berlin, Germany; ²Interdisciplinary Oncology and Palliative Care, Hospital Gemeinschaftskrankenhaus Havelhöhe, Berlin, Germany; ³Department of Radiotherapy and Special Oncology, Hannover Medical School, Hannover, Germany; ⁴Lung Cancer Centre, Hospital Gemeinschaftskrankenhaus Havelhöhe, Berlin, Germany

Introduction: Lung cancer (LC) is associated with high mortality and poor quality of life (QoL). The disease as well as oncological treatments such as radiation and chemotherapy with adverse effects can impair the QoL of cancer patients. Add‐on treatment with extracts of Viscum album L. (white‐berry European mistletoe, VA) has been shown to be feasible and safe, has only mild side effects, and can improve the QoL of cancer patients. The objective of this study was to evaluate the changes in self‐reported QoL of LC patients 12 months after their primary LC diagnosis, treated in a real‐world setting, according to oncology guidelines and additional VA treatment.

Methods: A real‐world data study was conducted using registry data. Self‐reported QoL was assessed by the evaluation of the European Organization of Research and Treatment Health‐Related Quality of Life Core Questionnaire scale (EORTC QLQ‐C30). Multivariate linear regression analyses adjusted for age, gender, year of LC diagnosis, and targeted therapy received were performed to analyze factors associated with changes in QoL at 12 months after primary LC diagnosis.

Results: A total of 112 primary LC patients (all stages, 92% non‐small‐cell lung cancer, median age 70 (ICR: 63‐75)), answered the questionnaires at first diagnosis and 12 months later. For longitudinal analysis of different treatment combinations of radiotherapy and VA treatment, patients were assigned to four different groups depending on the treatments they received during the 12 months. 32 patients receiving radiotherapy (Rad) without VA were allocated to the Rad group, 29 patients receiving VA applications without Rad were allocated to the VA group, 24 patients received Rad and VA and were allocated to the RadVA group, while 27 patients receiving neither Rad nor VA served as reference group. Adjusted multivariate regression analyses revealed significant improvements of 27 points for pain (p = 0.006) and 17 points for nausea/vomiting (p = 0.005) in patients of the combined RadVA group. In addition, significant improvements of 15 to 21 points for role (p = 0.03), physical (p = 0.02), cognitive (p = 0.04), and social functioning (p = 0.04) were observed in the VA group, receiving VA applications without Rad.

Conclusions: Add‐on VA therapy reveals supportive effects for the QoL of lung cancer patients. Patients receiving VA therapy reported improved QoL 12 months after LC diagnosis. Particularly in combination with radiotherapy a significant reduction in pain and nausea/ vomiting has been observed.

OS INTEGRATIVE ONCOLOGY N 47 Naturopathic herbal management of lung, colorectal and skin cancer: International practitioner survey

Ilma Imtiaz¹; Andrea Bugarcic¹; Janet Schloss¹; Amie Steel²; Rebecca Redmond^1,2; Jessica Browne³; Cathrina Geldard¹

¹Southern Cross University, Lismore, Australia; ²University of Technology Sydney, Sydney, Australia; ³Southern Cross University, Bilinga, Australia

Introduction: Cancer is one of the leading causes of death worldwide and is predominantly managed by anti‐cancer drugs. Over 80% of cancer patients also choose to use natural medicine in conjunction with conventional treatments. While there is clear evidence of anticancer activities of herbal medicines and the use of these in the general population, there has been little research on contributions of naturopaths and their treatments for certain cancers with a focus on the traditional use and preparation of herbal medicines. This survey aimed to collate information primarily on herbal medicines that naturopaths and herbal medicine practitioners use in lung, colorectal and skin cancer management in current clinical practice.

Methods: This cross‐sectional practitioner survey recruited naturopaths world‐wide with clinical experience in cancer management through the World Naturopathic Federation and Australian and New Zealand naturopathic associations (ANTA, ATMS, NHAA, and NMHNZ). Data collection was conducted through an online self‐administrated questionnaire on Qualtrics made available in English, German, Spanish, French, Portuguese and Greek languages. The ethics approval numbers are 2022/076 (Southern Cross University) and ETH22‐7385 (University of Technology Sydney). The questions included naturopath demographics, practice characteristics, naturopathic treatment for cancer (types of herbs recommended, single or multiple therapies, herb name, plant part used, preparation method, administration type, dosage), and concomitant use of pharmaceutical medicines and other naturopathic modalities used for cancer management (Questionnaire link: https://scuau.qualtrics.com/jfe/form/SV_5tmp2ra0W8XMIjI).

Results: A total of 13 naturopaths from Australia, Canada, USA, Columbia, New Zealand, Portugal and France participated in the survey. Lung and skin had most responses (n = 11) followed by colorectal cancers (n = 9). The survey identified 52 different herbal species with Astragalus membranaceus (Astragalus), Curcuma longa (Turmeric) and Pittosporum phylliraeoides (Gumby gumby) being the only herbs used across all three cancers.

Conclusion: The data from this survey provides some insights into what herbal medicines naturopaths prescribe for these cancers. In addition, what form and how these herbs were administered was captured with different countries using various methods. The results of this survey form a basis to investigate the potential anti‐cancer properties of the herbs as used in clinical practice through in vitro testing.

OS INTEGRATIVE ONCOLOGY N 48 Traditional and Contemporary Herbal Medicines in Management of Cancer: A Scoping Review

Ilma Imtiaz¹; Janet Schloss¹; Andrea Bugarcic¹

¹Southern Cross University, Lismore, Australia

Introduction: Cancer is one of the leading causes of death worldwide and is primarily managed by chemotherapy, radiation and surgery. Traditional medicine is widely used worldwide due to availability, affordability, wide applicability and accessibility. While potential for traditional medicines in management of cancer is well‐documented, there is limited literature that collates traditional knowledge and contemporary herbal medicine practice. To collate available evidence on herbal medicines used in the management of all cancers from traditional world‐wide sources, and the management of lung and colorectal cancers in contemporary practice.

Methods: JBI methodology for scoping reviews was used and the protocol registered with the Open Science Framework (https://doi.org/10.17605/OSF.IO/4QCZS) was followed. Medicinal plants with anti‐cancer properties were identified through a search of the following sources: Trove, Archive.Org, and Henriette's herbal medicine page (traditional texts: 1800‐1945), book list available from World Naturopathic Federation white paper (contemporary naturopathic texts: 1945 ‐ 2021), and in PubMed, MEDLINE, SCOPUS, ScienceDirect, AMED and JSTOR (case studies: across all time periods). Data extracted included the name of herbs, type of cancer treated, plant part used, preparation method, single or poly herbal preparation, administration method and expected outcome.

Results: Of the 1973 citations retrieved, 38 traditional texts, 3 contemporary naturopathic texts and 10 case studies were included in the review. The traditional texts (n = 110) noted the highest number of different anti‐cancer herbal species, followed by case reports (n = 52) and contemporary texts (n = 13). Most frequently mentioned herbs in traditional medicine included Hydrastis canadensis, Echinacea angustifolia, and Thuja occidentalis, and in contemporary medicine included Curcuma longa, Calendula officinalis, and Hydrastis canadensis. In case studies Atractylodis sp., Ginseng, and Astragalus sp. were reported to be the most frequently used. From traditional herbs (n = 111), Calendula officinalis, Hydrastis canadensis, and Cannabis sativa are the only herbs used in contemporary clinical practice (n = 3).

Conclusion: This review identified various herbal medicines used to treat cancer traditionally which are distinct to those found in contemporary use. Moreover, this review discovered the use of herbs from other native medical systems around the world in the contemporary Australian naturopathic practice and individual case management. This is in line with the movement of herb use from the traditional Anglo‐American system to the contemporary mixed system. The evidence presented in the review could be utilized in pre‐clinical settings to research traditional preparations of herbs.

OS INTEGRATIVE ONCOLOGY N 49 Increased Survival Rate in High Grade Glioma patients with Medicinal Cannabis

Janet Schloss¹; Judith Lacey²; Sinclair Justin³; Steel Amie⁴; Sibbritt David⁴

¹National Centre for Naturopathic Medicine, Faculty of Health, Southern Cross University, Lismore, Australia; ²Supportive Care, Chris O'Brien Lifehouse Cancer Hospital, Sydney, Australia; ³NICM Health Research Institute, Westmead Campus, Western Sydney University, Sydney, Australia; ⁴ARCCIM, UTS City Campus, The University of Technology Sydney, Sydney, Australia

Introduction: Cannabis has been used for cancer‐related symptoms, but few trails have assessed quality of life (QoL) or tolerability. The tolerability of a delta‐9 tetrahydrocannabinol (THC) containing cannabis product, and their effect on symptoms and QoL in patients with recurrent or inoperable high‐grade gliomas is poorly defined but is essential before efficacy trials can be conducted.

Methods: We conducted a randomised, double‐blind trial assessing the tolerability of two oral oil‐based preparations of medicinal cannabis in 88 patients with high grade gliomas. The two preparations used different cannabidiol (CBD) and THC ratios (THC:CBD): 1:1 (5.8mg/ml:5.6mg/ml) and 4:1 (15mg/ml:2.8mg/ml). A single daily dose given in the evening were individually titrated. Outcomes included disease response by the Functional Assessment of Cancer Therapy for Brain Cancer (FACT‐Br), magnetic resonance imaging (MRI) at baseline and 12 weeks, blood pathology, National Cancer Institute of Common Terminology Criteria (NCI‐CTC) and clinical monitoring. Symtom assessments were performed 4‐weekly for 12 weeks.

Results: Nine hundred and twenty‐one (n = 921) people volunteered for screening across Australia, with 642 excluded, 92 recruited and 88 enrolled. Sixty‐one (n = 61) participants completed 12‐week follow‐up (attrition 30%). Both cannabis oils were well tolerated. Total FACT‐Br was similar for both preparations, however, statistical significance was found for physical (p = 0.025) adn functional (p = 0.014) wellbeing, identifying the 1:1 ratio to be more appropriate. Comparing the groups to baseline, participants reported improvements in sleep (p = 0.009), improved energy (p = 0.015) and contentment with QoL (p = 0.006). There was no major adverse events attributable to the cannabis with main side effects noted as dizziness, drowsiness, tiredness and dry mouth. Pharmacokinetic data is also completed. Two and half years post‐trial, 47% of participants are still alive with equates to patients surviving 5‐7 years post diagnosis for a disease that has a survival rate of 6‐12 months.

Conclusion: A single nightly oral dose of THC‐containing cannabis oil was well tolerated in patients in both groups with high grade gliomas and significantly improved sleep, functional wellbeing and QoL compared to baseline. Medicinal cannabis may support and potentially increase survival in patients with high grade gliomas.

OS INTEGRATIVE ONCOLOGY N 50 Long‐Term effect of Fractional CO2 Laser Therapy for Genitourinary Syndrome of Meno‐ pause (GSM) in Breast Cancer Survivors: mono‐central perspective study.

Roberto Senatori¹; Lucia Merlino²

¹ARTOI Foundation, Rome, Italy; ²Sapienza University, Rome, Italy

Objective: The aim of this study was to determine the long‐term efficacy of fractional CO2 laser therapy (CLT) in women with previous diagnosis of breast cancer.

Methods: Our study design was a single‐arm study on a population of breast cancer survivors (BCS). The enrolled women received a CO2 laser treatment once a month for 3 sessions. Participants were contacted for follow‐up at twelve‐weeks and after one year from the end of the treatment. The Vaginal Assessment Scale (VAS), the Female Sexual Function Index (FSFI), the Female Sexual Distress Scare Revised (FSDS‐R), the International Consultation on Incontinence Questionnaire‐Urinary Incontinence Short Form (ICIQ‐UISF), the Quality of Life Questionnaire (QOLQ) and adverse events were collected and reported for the 12 months follow‐up. The changes in scores were compared between the twelve‐weeks and one‐year follow‐ups using paired t‐tests.

Results: Among 82 BCS assessed, 63 women (mean [SD] age, 51.6 [8.2] years) were deemed eligible for CLT; 52 completed treatments and were reassessed twelve‐weeks after the end of treatment.; 43 participated in the one‐year follow‐up. We recorded an initial improvement in the VAS score and in QOLQ score from baseline to the twelve‐weeks follow‐up; there was no statistically significant difference in the VAS score (p = 0.180) and QOLQ score (p = 0,150), between the twelve‐weeks follow‐up and the one‐year follow‐up.At the one‐year follow‐up, the FSFI and FSDS‐R scores remained improved from baseline and there was no statistically significant change in the FSFI score (p = 0.681) or the FSDS‐R score (p = 0.457) from the twelve‐weeks to the one‐year follow‐up. The ICIQ‐UISF scores were baseline at the one‐year follow‐up; howe‐ ver, the change between the twelve weeks and the one‐year follow‐ups was not statistically significant (p = 0.12). No adverse effects were recorded.

Conclusions: Our findings suggest that fractional CO2 laser therapy appear to be effective in treatment of GSM in a specific population of patients with a potential long‐term benefit. However, literature evidences concerning long term effects are scarce and incomplete. Randomized clinical trials that can investigate diffe‐ rent therapeutic protocols of CLT, with different intensity, duration and frequency of treatment have become necessary.

OS INTEGRATIVE ONCOLOGY N 51 Development of self‐care eLearning courses for cancer patients: An implementation research project with broad stakeholder engagement

Anita V. Thomae¹; Sarah Brüllmann¹; Zhang Linxin¹; Huber Christine¹; Canella Claudia^1,2; Barth Jürgen¹; Gabban Mario⁸; Hellberg‐Nägele Matthias^4,8; Meier Schnorf Helga^5,8; Siebenhüner Alexander^6,8; Weis Joachim^7,8; Witt Claudia M.¹

¹Institute for Complementary and Integrative Medicine, University Hospital Zurich and University of Zurich, Zurich, Switzerland; ²Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt‐Universität zu Berlin, and Berlin Institute of Health, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, Germany; ³Advisory Board, Zurich, Switzerland; ⁴Kantonsspital St. Gallen, St. Gallen, Switzerland; ⁵GIST‐group, Zug, Switzerland; ⁶Clinic for Hematology and Oncology, Hirslanden Zurich AG, Zurich, Switzerland; ⁷Comprehensive Cancer Center Freiburg, University of Freiburg, Freiburg, Germany; ⁸Advisory Board, Zurich, Switzerland

Introduction: Cancer related fatigue and sleep problems have a high prevalence occurring in 50 to 70% of all people with cancer. Relating to these symptoms, there is positive evidence as well as recommendations in clinical practice guidelines for Mind Body Medicine (MBM) self‐care techniques, such as acupressure and mindfulness. eLearning courses provide an innovative and standardized way to learn those techniques in a flexible manner. We will present the scientific development of eLearning courses for cancer patients to learn and apply MBM self‐care techniques.

Methods: The eLearning was developed iteratively integrating patients' needs and expectations. Using principles of implementation research (Implementation Research Logic Model) and a participatory approach, we involved relevant stakeholders and applied qualitative and quantitative methods. A stakeholder advisory board including a cancer patient, a cancer patients' advocate, an oncologist, a clinical nurse specialist and a researcher for self‐help research participated in the complete development process and were involved in key decisions. The findings from patients' interviews and pilot testing were included throughout the development process.

Results: Focus groups with stakeholders such as clinicians (n = 6) and MBM‐experts (n = 7) provided important insights in information to be given as well as Q&A's and pitfalls that should be addressed in the eLearning. Online assessments were developed with MBM‐Experts (n = 7) and teaching experts (n = 5) to ensure the correct application of both interventions (acupressure and mindfulness). Health professionals assessed the relevance of the information provided in the eLearning for patients. They rated it as good to very good (acupressure: 4.7 ± 0 (n = 41 raters); mindfulness: 4.6 ± 0.7 (n = 17); all numeric results on a scale from 1 (strongly disagree) to 5 (strongly agree)). The comprehensibility of the eLearning courses was rated by health professionals as good to very good (acupressure: 4.9 ± 0.4 (n = 41); mindfulness: 4.5 ± 0.7 (n = 17)). Face‐to‐face control assessments revealed that 85% of persons can apply acupressure correctly after the eLearning (health professionals, n = 39). Health professionals had a positive impression on patients' ability to apply the respective self‐care techniques taught in the eLearning (acupressure: 4.5 ± 0.7 (n = 41); mindfulness: 4.1 ± 1.0 (n = 13)). A pilot testing with cancer patients confirmed these results.

Conclusion: Involving different stakeholder groups in an interactive process resulted in eLearning courses for acupressure and mindfulness that were feasible for patients, and provided a positive learning experience while teaching correct application of self‐care techniques. The courses will serve as interventions in a randomized controlled trial.

OS INTEGRATIVE ONCOLOGY N 52 The French Society of Integrative Oncology (SFOI): an Integrative Oncology à la française

Alain Toledano¹; Violaine Forissier²; Cloé Brami³; Bénédicte Mastroianni⁴; Jean‐Loup Mouysset⁵; Jean‐Lionel Bagot⁶

¹Institut Rafael, Conservatoire Nationale des Arts et Métiers chaire‐ Santé Integrative, Paris, France; ²Clinique de Bonneveine, Marseille, France; ³GIS tep care ‐ Reso Université paul valéry, Montpellier, France; ⁴Medical Oncology Department and Interdisciplinary Department of Oncology Support Care, Leon Berard Cancer Center, Lyon, France; ⁵centre Ressource, AIX EN PROVENCE, France; ⁶Groupe Hospitalier Saint Vincent, Department of Integrative Medicine, Strasbourg, France

Introduction and objectives: To meet the demand for holistic care of people faced with multi‐dimensional damage to their integrity by the ordeal of cancer, integrative oncology (IO) has gradually been implemented in France.

The international definition of IO has been recognized and practiced in France for several years in various but isolated forms. The development of knowledge and care, as well as the chronicisation of the cancerous disease in a metastatic situation, requires a response that meets patients' basic needs.

Enriched by new data on changing needs and behaviors, we want to contribute to implementing and structuring a French IO, a fundamental paradigm shift in the context of health.

Methods: We have formed a group of experts and founding members to federate and implement IO in France. It comprises oncologists, organ specialists, general practitioners, researchers, dentists, and psychologists already practicing IO in France to define its foundations and a common position.

Results: As a result of our different experiences in private and public initiatives in France: the Rafaël Institute in Paris, the eight “Ressource” Centers, the IO Outpatients department in Saint Vincent de Paul Hospital in Strasbourg, the IO practice in Marseille, the IO consultation at the Leon Berard Cancer Center in Lyon, the Flanders House in Dunkirk, IO liberal practice in Montpellier and elsewhere… we have formalized the approach of IO in France in April 2023 with the creation of the French Society of Integrative Oncology (SFIO). This approach brings together people involved in this new field of medicine to develop the practice, teaching, research, and promotion of IO.

Our first acts are defining our common values and objectives by writing a founding article, an annual national congress, a reflection on the various paramedical practices, and creating a university diploma in IO.

Conclusion: To support all the needs of the cancer patient, we must find the best answers to their problems, whether physical, psychological, emotional, spiritual, existential, or social.

The new paradigm will require a common language and values leading to a consensus currently being built. We face many challenges to bring the implementation of integrative oncology to France and to promote its accessibility to the most significant number. Through our sharing of experience and our future work, we wish to contribute to bringing about a positive change to this new medical paradigm.

OS INTEGRATIVE ONCOLOGY N 53 Systematic review: Evidence for high‐dose intravenous vitamin C in oncology

Claudia Vollbracht¹; Karin Kraft²

¹Medical Science Department, Pascoe Pharmazeutische Präparate GmbH, Giessen, Germany; ²Department of Internal Medicine, University Medicine Rostock, Rostock, Germany

Introduction: Vitamin C deficiency in oncology patients has been documented in many studies and is often exacerbated by treatment (surgery, radiation, chemotherapy, etc.). Vitamin C deficit correlates with decreased quality of life, poorer rates of survival and markers of tumour progression such as oxidative stress, hyper‐inflammation, immunodeficiency, increased levels of hypoxia‐induced factor (HIF) and decreased activity of the TET2‐enzyme family.

Methods: For the systematic review, the Medline and Cochrane Central databases were searched for trials that investigated intravenous vitamin C (> 3g daily) in patients with cancer. In addition, experimental data were included for a plausibility analysis.

Results: 6 controlled trials (4 randomised and 2 retrospective cohort studies) and 4 observational studies met the inclusion criteria. Quality of life was assessed in 4 controlled and 3 observational studies. Compared with the control group, patients treated with vitamin C had significantly lower symptom scores for fatigue, pain, insomnia, and depression. In the observational studies, a significant decrease in symptoms was observed over the course of the various studies. In addition, vitamin C treatment was associated with less myelosuppression (retrospective cohort trial) and a significant and clinically relevant increase in the lymphocyte count in lymphopenia (observational trial). Survival was evaluated in 4 randomised and 1 retrospective cohort study. In 3 studies, significantly longer survival was observed in the vitamin C group. Data from experimental studies indicate that high systemic levels of vitamin C act primarily on three vulnerable sites of many cancer cells: redox imbalance, epigenetic reprogramming and regulation of oxygen sensitivity. This involves the generation of hydrogen peroxide (H₂O₂), a shift in the epigenetic profile towards tumour suppression (TET2 ↑, HIF ↓) and a decrease in metastasis‐related processes (epithelial‐mesenchymal transition ↓, collagen ↑).

Conclusions: The treatment of vitamin C deficiency closes an important therapeutic gap in oncological patients. High‐dose intravenous vitamin C appears to be a well‐tolerated supportive therapy option with a positive impact on quality of life. Its chemotherapeutic potential should be further investigated in clinical trials.

Note: The review is not yet published.

OS INTEGRATIVE ONCOLOGY N 54 The Transdiagnostic Oncology Program (TOP), a combined lifestyle intervention for improving the quality of life of cancer survivors: a controlled before‐and‐after pilot study in the primary care setting

Sanne Booij^1,2; Amy Pieper¹; Christianne Wester¹; Ute Bultmann³; Elkana Waarsenburg⁴; Rogier Hoenders¹

¹Center Integrative Psychiatry, Groningen, Netherlands (The); ²University of Groningen, University Medical Center Groningen, Groningen, Netherlands (The); ³Department of Health Sciences, Community and Occupational Medicine, University of Groningen, University Medical Center Groningen, Groningen, Netherlands (The); ⁴Primary Care Facility Kloosterveen, Assen, Netherlands (The)

Introduction: There is a need for interdisciplinary primary care‐led aftercare programs for the common (transdiagnostic) problems cancer survivors experience to increase their quality of life. The aim of this controlled before‐and‐after pilot study was to examine the feasibility and effectiveness of a transdiagnostic, family doctor‐led interdisciplinary program to increase quality of life in a heterogeneous group of cancer survivors.

Methods: The intervention group (N = 19) followed a 12‐month interdisciplinary aftercare program in the primary care setting, consisting of: family doctor consultation, physical exercise, mind‐body therapy, sleep hygiene, dietary recommendations, and optional psychological therapy. Eligible cancer survivors who declined participation, were included as controls (N = 16). The primary outcome was quality of life, as measured with the EORTC‐QOL‐C30, covering global health status, and various forms of functioning and symptoms. Secondary outcomes included assessments of fatigue, mental health, happiness, and work ability. Assessments took place at baseline (T0), and 6 months (T1) and 12 months post‐baseline (T2). Intention‐to‐treat multilevel analyses were conducted.

Results: At baseline, the intervention group scored significantly worse on several indices of quality of life, and on secondary outcomes, compared to controls. Regarding overall satisfaction with the program, participants scored an 8 out of 10 (SD = 0.80). On top of this, participants scored 8 out of 10 (SD = 1.12) on experiencing an improved quality of life and a 9 out of 10 (SD = 1.09) on whether they found the combined lifestyle‐interventions offer an added value. The participants were also satisfied with the program content (course material and information meetings); 4 out of 5. Most participants found the frequency of the meetings with the physiotherapy (61%), FD (92%) and dietician (85%) just right, while the majority found the frequency of the relaxation (mind‐body) meetings too low (55%). The intervention group showed significantly larger increases at T2 in physical and social functioning, and decreases in fatigue and anxiety, compared to the control group.

Conclusion: TOP seems feasible and seems to increase the quality of life and related aspects in cancer survivors over 1 year. A randomized controlled trial is warranted.

OS INTEGRATIVE ONCOLOGY N 55 Quality of life in breast cancer patients treated with mistletoe extract: A systematic review and meta‐analysis

Walach Harald^1,2; Loef Martin¹; Paepke Daniela³

¹Change Health Science Institute, Berlin, Germany; ²Kazimieras Simonavicius University, Vilnius, Lithuania; ³Spital Zollikerberg, Zürich, Switzerland

Introduction: Breast cancer is the most common cancer type in women and quality of life an essential part of the patients' well‐being. It is a matter of debate whether the pharmacological treatment with mistletoe extracts (ME) can improve the quality of life of breast cancer patients.

Methods: This systematic review included randomized clinical trials (RCTs) and non‐randomized intervention studies (NRSIs) comparing breast cancer patients treated with ME to control groups. We searched previous systematic reviews and multiple databases until January 2023. We conducted a meta‐analysis and assessed the risk of bias via RoB 2 and ROBINS‐I and the certainty of evidence via GRADE, respectively.

Results: Nine RCTs and seven NRSIs with 833 and 2831 participants, respectively, were included. They received ME of different manufactures (e.g. Iscador, Helixor) with or without additional treatments as compared with multiple controls (e.g. no control, placebo). The pooled standardized mean difference for RCTs was SMD = 0.61 (95% CI 0.47 to 0.75; p < 0.0001) and for retrospective NRSIs was SMD = 0.46 (95% CI 0.10 to 0.82; p = 0.01). The risk of bias was medium to high for the RCTs and serious for all NRSIs. The GRADE was medium for RCTs and very low for NRSIs.

Conclusions: The evidence is mainly limited due to the risk of bias. Our results indicate a clinically relevant, moderate‐sized effect of ME on the quality of life in breast cancer patients. Further RCTs and real‐world evidence need to confirm this result and should make clear distinctions between different breast cancer subgroups and stages.

OS INTEGRATIVE ONCOLOGY N 56 Acupuncture Reduces Insomnia in Lung Cancer Survivors: A Retrospective Cohort Study

Ruifang Yu¹; Yingqi Wang¹; Yue Chen¹; Canyang Zhang¹; Xinfeng Guo^1,2

¹Guangzhou University of Chinese Medicine, Guangzhou, China; ²Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China

Introduction and Objective: Insomnia is a common complication among lung cancer survivors, but effective long‐term treatments are lacking. Acupuncture's multi‐channel and multi‐target regulation properties make it a promising intervention for preventing insomnia while used for alleviating other complications such as pain. However, real‐world evidence of its effectiveness is limited. To promote the use of acupuncture and improve the quality of life for lung cancer patients, we conducted a retrospective cohort study.

Methods: Using data from the GDHCM electronic medical record database from 2012 to 2021 (with a mean follow‐up of 14.4 months), we conducted a 1:1 propensity‐score matching and multivariate Cox regression model to explore whether acupuncture can reduce the risk of insomnia and identify independent risk factors for insomnia among lung cancer patients. A directed acyclic graph was used to guide the modelling strategy, and exploratory stratified analysis was performed. The Kaplan‐Meier method and log‐rank test were used to compare the cumulative incidence of insomnia between the acupuncture and non‐acupuncture groups. We also calculated the E‐value to assess the impact of potential unmeasured confounders on the robustness of the results.

Results: Our study included 1295 lung cancer survivors (mean [SD] age 63.2[10.4]; 904 males; 559 patients received acupuncture) who met the study criteria. After propensity‐score matching, we analyzed 466 matched pairs. Acupuncture reduced the risk of insomnia (adjusted HR 0.72, 95%CI 0.54‐0.96). Our results also revealed that a higher ECOG PS score, radiotherapy, opioid analgesics, and mental disorder increased the risk of insomnia in lung cancer patients. The cumulative incidence of insomnia was significantly lower in the acupuncture group (log‐rank test, P = 0.014). An unmeasured confounder could fully account for the association of acupuncture with the occurrence of insomnia in lung cancer patients if it were associated with the exposure and outcome by an HR of 1.82 (lower confidence limit, 1.20).

Conclusions: In conclusion, our study provides real‐world evidence supporting the use of acupuncture to alleviate cancer‐related symptoms such as pain because it has the long‐term effect of reducing the risk of insomnia in lung cancer survivors. We recommend that clinicians consider acupuncture as a complementary therapy for improving the quality of life of their patients.

OS PEDIATRIC DISEASE N 1 Osteopathic manipulative treatment (OMT) in pediatrics and neonatology: a scoping review

Andrea Manzotti^1,2; Matteo Galli^1,2; Adele Alberti^1,2; Chiara Leva^1,2; Francesco Cerritelli¹; Gianluca Lista³

¹COME Collaboration Onlus, Pescara, Italy; ²SOMA Istituto Osteopatia Milano, Milano, Italy; ³Division of Neonatology, “V. Buzzi” Children's Hospital, ASST‐FBF‐Sacco, Milano, Italy

Introduction: Osteopathy is increasing interest in pediatrics and neonatology in research and clinical practice. Numerous studies have demonstrated a significant reduction in the most common early‐life symptoms in children treated with OMT, implying that OMT during the neonatal and pediatric years may be beneficial in various musculoskeletal problems. Numerous authors have reported that OMT benefits premature infants improves physiological parameters and other clinical conditions, reduces hospital stays and increases costs for neonatal intensive care units (NICUs). This scoping review aims to comprehend the current research landscape, identify critical points for a practical and rigorous osteopathic approach, and identify new frontiers for the future of osteopathic research in the pediatric and neonatal fields.

Methods: Following databases were investigated: OVID, Medline, ScienceDirect, Cochrane, Clinicaltrials.gov, Osteomed.dr, Scopus, Web of Science, Publons, Scholar Google, Europe PMC, Embase, CINHAIL and the grey literature will be combed. Languages will be limited to English, Italian, German, Spanish, Portuguese, and French. All types of studies will be included. The grey literature will be combed for presentations, conference proceedings, conference abstracts, and reports. After two researchers screen titles, abstracts and full texts for eligibility, the remaining references will be exported to a software program for managing citation screening (Covidence, 2019).

Results: 101 study were admitted to the data extraction. Considering studies with different internal age stratification, many were conducted in early babies' life: 41 in newborns, 42 in infants and 27 in premature. The primary clinical condition where osteopathic intervention was suggested or investigated are prematurity (15 studies), neurological/behavioral disorders (11 studies), musculoskeletal disorders (10 studies), otolaryngology disease (9 studies), respiratory disease (8 studies) and positional plagiocephaly (7 studies). Most osteopathic studies in pediatric and neonatology were conducted in the USA (49 studies) or in Italy (27 studies), with significant distance from the other countries. The OMT techniques most investigated are cranial techniques, which are present in the OMT protocol of 44 studies, followed by myofascial release (39 studies) and functional techniques (33 studies).

Conclusions: Osteopathy in pediatric and neonatal field is growing in interest, particularly in early children's life. The effect of osteopathic treatment is well studied in specific pediatric conditions such as neurological/behavioral disorders, musculoskeletal disorders, otolaryngology disease and respiratory disease, using a wide range of delicate.

OS PEDIATRIC DISEASE N 2 Historical background of Integrative Pediatrics in Europe

Catharina Amarell

Children 's Hospital St. Marien Landshut, Germany

Introduction: Complementary and alternative medicine (CAM) can support and amplify traditional therapies, especially in children. However, they are barely being used in in‐patient treatment.

Methods: The children's hospital St. Marien integrated CAM methods into routine pediatric care of the hospital in in‐house and outpatient treatments. Complementary treatments are not only provided for acute illnesses but are also offered as a supportive treatment to children with chronic illnesses.

Different modalities were implemented: using wraps and poultices and aromatherapy, herbal medicine, relaxation techniques, hypnotherapy, methods of acupressure.

Conclusions: Over the last years it became clear that the biggest challenges for a lasting implementation are: lack of financing by health‐insurances; skepticism of other physicians, lack of trained professionals and time‐consuming therapies in a short‐time focused medicine. Regular training, integration in general pediatric guidelines and in the education of residents and nurses will be needed to implement these therapies in a medical care routine.

OS PEDIATRIC DISEASE N 3 Watering sprouts. Barriers, hurdles and opportunities to implementing a health and lifestyle concept with preschool children – qualitative observations and lessons learned.

Sarah Blakeslee¹; Martin Bogdanski¹; Farid I. Kandil¹; Michael Jeitler¹; Angela Tekath¹; Wiebke Stritter¹; Georg Seifert¹

¹Charité ‐ Unversitätsmedizin Berlin, Berlin, Germany

Background: Health and well‐being in early childhood give a foundation for health and prevent chronic illness with healthy nutrition, regular exercise, reduction of stress and building resilience. European holistic health and lifestyle systems start integrative health and healing practices early in childhood. One such system, the 200‐year‐old Kneipp Health System (KHS) known for cold‐water applications, is practiced in kindergartens with a preschool concept. Little research has explored how the KHS concept is implemented and practiced in kindergartens.

Implementing a health and lifestyle system in a preschool setting, with many stakeholders and a strict study timeline, is challenging. The Kita Kneipp Study is a kindergarten‐based observational study to evaluate the effect of a KHS on preschool children's sick days. Within the Kita Kneipp Study, we detail lessons learned, barriers, hurdles, and opportunities to implementing KHS as compared to existing Kneipp‐certified kindergartens.

Methods: First, we conducted qualitative expert interviews with seven Kneipp‐certified kindergarten directors in Berlin. Field notes recorded the salient themes and detailed the visits. Insights from these interviews were embedded in the study design of the Kita Kneipp Study. Then, during the study KHS implementation, field notes of observed interactions between parents and educators, informal interviews during kindergarten site visits, and participant observation during a 4‐day educator KHS training were documented. Themes from field notes were deductively analyzed for barriers, hurdles, and opportunities and compared with the previous interviews with Kneipp‐certified kindergartens.

Results: Holistic approaches to child health and development through KHS fit well into existing kindergarten structures. Barriers to implementing the KHS in certified kindergartens differed from study kindergartens. Time was needed to acclimate to a health and lifestyle concept by parents and staff and this was seen to affect concept implementation. Accepting and implementing a health promotion and lifestyle change concept in the kindergartens was dependent on the resources and support available at the kindergarten. Both certified and study kindergartens recognized the opportunity to innovatively and individually adapt the concept to the needs of a kindergarten or combine them with other program concepts.

Conclusion: Implementing health promotion and lifestyle changes in a kindergarten setting benefits from a framework such as KHS for kindergartens to playfully introduce and individually tailor an integrated health promotion concept. However, in order for the long‐term benefits of concepts promoting health in early childhood to be useful, barriers to implementation must be adequately addressed.

OS PEDIATRIC DISEASE N 4 Empathy at school project (ESP). Effects of didactics of emotions® on psycho‐biological variabilities among primary school children: results of a controlled longitudinal study and implications for further research perspectives

A G Bottaccioli 1 2, U Mariani 3, R Schiralli 3, M G Mari 3, M Pontani 3, M Bologna 1 4, P Muzi 4, S D Giannoni 4, V Ciummo 4, S Necozione 4, V Cofini 4, L Chiariotti 5, M Cuomo 5, D Costabile 5, F Bottaccioli 1 4

1 Società Italiana di Psiconeuroendocrinoimmunologia (SIPNEI), Rome, Italy

2 Department of Medical Sciences, University of Turin, Italy

3 Emotional Training Center, Viterbo, Italy

4 L'Aquila University‐ Department of Life, Health and Environmental Sciences, Italy

5 Federico II University of Naples ‐ Department of Medical Biotechnology, and Molecular Medicine, Italy

Background: There is mounting evidence of chronic stress among primary school children leading to anxiety, irritability and sleeping problems, with negative consequences on scholastic climate. Promoting emotion regulation within school environment through innovative didactic methodologies is a valuable tool for teachers and parents to reduce emotional distress and associated risk behaviours and to promote wellbeing.

Aim: To explore psychological and biological consequences of teaching emotional training in an experimental group of Italian Primary School children.

Methods: 81 children (6 to 8 years) were divided into an experimental (33) and a control group (30). A further advanced group of 18 subjects, who experienced the method in the previous school year, was also included. The experimental study lasted 1 school year. The following psychological tests were administered to all groups: TEC (Test of Emotion Comprehension) to measure children's emotional abilities and the Projective test (PT) 'A person in the rain', to identify children coping skills in stressful conditions. Morning salivary cortisol, IL‐6 and TNF‐alpha assays were conducted in all groups. Psychological and biological tests were administered at the beginning and at the end of the study.

Results: The MR‐Anova model for TEC score pairwise comparisons showed that mean score significantly increased only in the experimental group (pB <0.001); at the end of the project there was a significant difference between experimental and control group (pB = 0.012). The mean score of PT test increased significantly from baseline to the end of project for the experimental group (pB <0.001) and for the advanced group (pB = 0.004). At the end of project, there were significant differences between the experimental and the control group (pB = 0.004) and between the advanced group and the control group (pB <0.001). Salivary cortisol pairwise comparisons showed that cortisol levels decreased significantly over time in the experimental group (pB <0.001). IL‐6 and TNF‐alpha levels did not show significant difference.

Conclusion: In the experimental groups who experienced didactics of emotion for at least 1 school year there was a significant increase in children's ability to cope with reality, stress and anxiety, and improvement of emotional competence. Moreover, a significant reduction in the amount of salivary cortisol was observed in the experimental group and also a stable reduced amount of salivary cortisol in the advanced group. These findings show that an intervention through emotional education program can regulate interpersonal skills and the stress axis response.

OS PEDIATRIC DISEASE N 5 Effectiveness of an intervention method on the treatment habits of paediatric patients

Claudio Farinelli¹; Manuel Rossi²; Marina Aimati³; Giuseppe Stefano Morino⁴

¹Pediatrician – Vice‐President SIPPS Lazio, Latina, Italy; ²Pharmacist, Latina, Italy; ³Foundation ARTOI, Rome, Italy; ⁴Paediatrician, Researcher IRCCS O.B.G., Rome, Italy

Introduction: Periodic administration of the phytotherapeutic substances polydatin, elderberry and beta‐glucans reduces the administration of antibiotics according to a comparison of 132 children aged two to six years with daily phytotherapy and 168 children aged two to six years without phytotherapy over five months. This study aimed to counteract influenza and parainfluenza viral symptoms with phytotherapic drugs by monitoring antibiotic administration in those on therapy and those not on therapy.

Methods: The study used a phytotherapeutic supplement of galenic nature containing 98% polytadine 200 mg and a phytotherapeutic product of pharmaceutical origin based on elderberry, titrated 7%–8% in anthocyanins and 8%–15% in polyphenols. The preparations contained a total of 56.3 mg of elderberry and 78.8 mg of beta‐glucans. An age‐adjusted dose of 2–5 mL of the galenical preparation (polytadine) was administered daily to 88 children aged two to six years. The phytotherapeutic pharmaceutical preparation at a dose of 1 gtt/kg per day was administered to 48 children aged two to six years. Daily administrations were given continuously from October 2022 to February 2023.

Results: Out of the 48 children supplemented with pharmaceutical phytotherapy in five months, 30 did not take antibiotics, 12 took one course of antibiotic therapy and six took two courses of antibiotic therapy. Out of 88 children supplemented with galenic phytotherapy, 64 did not take antibiotic therapy at all in five months, 23 took only one course of antibiotic therapy and one child took two courses of antibiotic therapy. Out of the 168 children who did not take any phytotherapeutic supplementation in five months, 63 took one course of antibiotics and 15 took two or more courses of antibiotic therapy.

Conclusions: Of the children taking phytotherapeutic supplementation, only 32% received antibiotic therapy compared to 46.5% of untreated children.

OS PEDIATRIC DISEASE N 6 The Impact of Screen Use on Children

Monica Galanti

Integrative Medicine Unit, Roberto del Río Hospital

University of Chile

Member and Co‐founder of the MTCI Americas Network

The use of screens has become a global reality, with a significant increase observed as a result of the pandemic. This trend has raised concerns among educators, parents, and health professionals regarding the potential effects of excessive screen time on children's development and well‐being. While there is increasing information available on the use of screens by children, there is a lack of comprehensive guidelines and recommendations regarding parental involvement in digital control. This work aims to provide an in‐depth analysis of the use of screens in children, exploring both the potential benefits and drawbacks associated with screen use, as well as establishing family guidelines for responsible screen use. Screens can be valuable educational tools, providing access to a vast array of information and interactive learning platforms. Educational applications and programs have been shown to enhance children's cognitive skills, including problem‐solving, critical thinking, and language development. Screens also foster creativity and imagination through interactive storytelling and digital art tools, and they facilitate social connections, particularly in situations where physical presence is not feasible. However, prolonged screen time has been linked to sedentary behavior and a decline in physical activity, increasing the risk of obesity and associated health problems. Excessive screen use can disrupt sleep patterns, negatively impacting children's overall well‐being. Research also suggests that excessive exposure to screens, especially during critical developmental stages, may contribute to attention difficulties, impaired social skills, and decreased academic performance. To strike a balance, it is crucial to promote healthy media habits and encourage alternatives to screen time, such as outdoor play, reading, and engaging in creative activities. Establishing clear family guidelines for screen use can help mitigate potential negative effects and empower children to navigate the digital landscape safely and responsibly.

Conclusion: Striking a balance and promoting healthy media habits are essential in today's increasingly digital world to ensure the well‐being and development of children. Establishing guidelines for responsible screen use, along with encouraging diverse activities, will help children thrive in a technology‐driven society.

OS PEDIATRIC DISEASE N 7 Osteopathic manipulative treatment (OMT) in pediatrics and neonatology: a scoping review

Andrea Manzotti^1,2; Matteo Galli^1,2; Adele Alberti^1,2; Chiara Leva^1,2; Francesco Cerritelli¹; Gianluca Lista³

¹COME Collaboration Onlus, Pescara, Italy; ²SOMA Istituto Osteopatia Milano, Milano, Italy; ³Division of Neonatology, “V. Buzzi” Children's Hospital, ASST‐FBF‐Sacco, Milano, Italy

Introduction: Osteopathy is increasing interest in pediatrics and neonatology in research and clinical practice. Numerous studies have demonstrated a significant reduction in the most common early‐life symptoms in children treated with OMT, implying that OMT during the neonatal and pediatric years may be beneficial in various musculoskeletal problems. Numerous authors have reported that OMT benefits premature infants improves physiological parameters and other clinical conditions, reduces hospital stays and increases costs for neonatal intensive care units (NICUs). This scoping review aims to comprehend the current research landscape, identify critical points for a practical and rigorous osteopathic approach, and identify new frontiers for the future of osteopathic research in the pediatric and neonatal fields.

Methods: Following databases were investigated: OVID, Medline, ScienceDirect, Cochrane, Clinicaltrials.gov, Osteomed.dr, Scopus, Web of Science, Publons, Scholar Google, Europe PMC, Embase, CINHAIL and the grey literature will be combed. Languages will be limited to English, Italian, German, Spanish, Portuguese, and French. All types of studies will be included. The grey literature will be combed for presentations, conference proceedings, conference abstracts, and reports. After two researchers screen titles, abstracts and full texts for eligibility, the remaining references will be exported to a software program for managing citation screening (Covidence, 2019).

Results: 101 study were admitted to the data extraction. Considering studies with different internal age stratification, many were conducted in early babies' life: 41 in newborns, 42 in infants and 27 in premature. The primary clinical condition where osteopathic intervention was suggested or investigated are prematurity (15 studies), neurological/behavioral disorders (11 studies), musculoskeletal disorders (10 studies), otolaryngology disease (9 studies), respiratory disease (8 studies) and positional plagiocephaly (7 studies). Most osteopathic studies in pediatric and neonatology were conducted in the USA (49 studies) or in Italy (27 studies), with significant distance from the other countries. The OMT techniques most investigated are cranial techniques, which are present in the OMT protocol of 44 studies, followed by myofascial release (39 studies) and functional techniques (33 studies).

Conclusions: Osteopathy in pediatric and neonatal field is growing in interest, particularly in early children's life. The effect of osteopathic treatment is well studied in specific pediatric conditions such as neurological/behavioral disorders, musculoskeletal disorders, otolaryngology disease and respiratory disease, using a wide range of delicate.

OS PEDIATRIC DISEASE N 8 Multi‐cancer detection based on pattern formation in drying body fluids: a systematic review and meta‐analysis of diagnostic test accuracy studies

Maria Olga Kokornaczyk^1,2; Marcus Reif³; Martin Loef⁴; Harald Walach^4,5; Natalia Borisovna Bodrova⁶; Paul Doesburg^7,1; João Vitor da Costa Battista^1,8; Jürgen Pannek^10,9; Devika Shah¹; Stephan Baumgartner^7,1,2

¹Society for Cancer Research, Arlesheim, Switzerland; ²University of Bern, Institute of Complementary and Integrative Medicine, Bern, Switzerland; ³Society for Clinical Research, Berlin, Germany; ⁴Change‐Health‐Science Institute, Berlin, Germany; ⁵Next Society Institute, Kazimieras Simonavicius University, Vilnius, Lithuania; ⁶International Research Group on Very Low Dose and High Dilution Effects (GIRI), Dornach, Switzerland; ⁷Institute for Integrative Medicine, University of Witten/Herdecke, Herdecke, Germany; ⁸Federal University of Rio de Janeiro, Multidisciplinary Laboratory of Pharmaceutical Sciences, Faculty of Pharmacy, Rio de Janeiro, Brazil; ⁹Neuro‐Urology, Swiss Paraplegic Center, Nottwil, Switzerland; ¹⁰Department of Urology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

Introduction and objectives: Cancer detection sensitivity towards multiple cancer types might shorten the diagnosis time and enhance cancer treatment outcomes. Our aim was to provide a systematic review and meta‐analysis of the accuracy of a little‐known group of diagnostic tests using patterns formed in drying body fluids for the detection of different cancer types (diagnostic patterning tests; DPTs).

Methods: PubMed, Web of Science, eLibrary Russia, and other sources were searched. The quality of the eligible publications was evaluated by means of the QUADAS‐2 tool. Data were extracted separately for cases with (i) untreated cancers, (ii) treated cancers, and (iii) precancerous conditions; controls were divided into (iv) healthy and (v) non‐cancer patients. Meta‐analyses were conducted according to Cochrane recommendations.

Results: In total 610 records were collected, out of which 40 were included describing 41 diagnostic test accuracy studies. The studies involved 15.969 participants, including 5.265 cancer cases with over 50 different cancer types, and 189 precancerous condition cases. In 27 studies, the reference standard was a histopathological or clinical examination. The publications concerned in total six different DPTs, involving different experimental protocols. Pooled sensitivity and specificity (95% confidence intervals, CI) overall studies and DPTs amounted to 0.89 (0.83 to 0.93) and 0.90 (0.84 to 0.93), respectively. Because of the high heterogeneity of the collected publications, a comparative analysis of only two DPTs (copper‐chloride biocrystallization applied to blood and the Bolen test) was possible. As shown in Figure 1 the copper‐chloride biocrystallization showed sensitivity and specificity values of 0.93 (95% CI 0.87 to 0.96) and 0.93 (0.85 to 0.97) and the Bolen test of 0.86 (0.77 to 0.92) and 0.89 (0.80 to 0.94), respectively; however, without a significant difference between the two tests (‐2LL = 2.561; df = 3; p = 0.464). Both DPTs were more accurate for detecting untreated cancers than those under treatment.

Conclusions: Overall, the diagnostic tests based on pattern formation in drying body fluids revealed satisfying accuracy for the detection of more than 50 different cancers. The potential of these tests should be evaluated further, especially regarding early cancer detection.

OS PEDIATRIC DISEASE N 9 Complementary Medicine in pediatric oncology ‐ Trainings needs of pediatric oncologists ‐ Development and evaluation of a blended learning training

Alfred Längler

Institute for integrative medicine, Witten/Herdecke University, Witten, Germany and Department of Pediatrics

Director of WHO/Unicef Initiative Baby friendly Hospital Germany

Introduction: The Competence Network Complementary Medicine in Oncology (KOKON), funded by the German Cancer Aid, aimed to develop information, communication, counseling and training concepts for complementary medicine (CM) in oncology. Results of the first funding phase (2012‐2015) showed that oncological patients want to be advised by their oncologists on CM. Oncologists often feel not confident about this. In the second funding phase (2016 – 2020) CM training programs for oncologists, pediatric oncologists (POs) as well as for general practitioners were developed and evaluated. At the start we, as experts in integrative cancer treatment, aimed to examine information and training needs of POs on CM, while simultaneously identifying preference patterns regarding information and training content. Following that we developed and evaluated a blended learning training for POs based on these results.

Methods: The e‐learning for POs consisted of three courses with a duration of six hours. Content was an overview of CM in pediatric oncology and specific treatments (e.g. holistic medical systems, specific diets, yoga, relaxation methods, aromatherapy). Aim of the workshops was to promote professional skills relevant for physician‐patient interaction related to CM. The workshops included role plays with simulation patients, impulse lectures, and exchange of experience.

Results: A total of 101 POs completed the survey. Only 11.4% agreed to being sufficiently informed of CM. They considered an overview of CM therapies and information about relaxation methods and herbal remedies for cancer‐related symptoms such as lack of appetite, nausea, or vomiting as most important in training material, and also the topics of adverse effects and summary of evidence. 32 POs completed the e‐learning. After the project the e‐ learning was made available again for interested POs. 34 further applications were received 22 out of the 32 registered POs participated in a workshop. The POs agreed that they had received professionally relevant content during the e‐learning. The feedback from the participants on the workshop was very positive.

Conclusions: Although counseling on CM affects several professional groups, no interdisciplinary approach was pursued, as the project was intended to explicitly prepare Pos to address these issues as part of their usual medical consultation, if the family so wishes. We received several requests to participate in the blended learning from other professional groups, which shows that this program is of importance for all members of the treatment team in pediatric oncology. The results of the project should be expanded, updated and adapted so that other professional groups can benefit.

OS PEDIATRIC DISEASE N 10 PIONEERING INTEGRATIVE PEDIATRIC ONCOLOGY UNIT IN SPAIN: ADVANCING CARE MODELS and CLINICAL OBJECTIVES

Esther Martínez García,¹; Cristina López de San Román Fernández¹; M Betina Nishishinya Aquino,

¹Pediatric Cancer Center Barcelona, Barcelona, Spain

Background and aims: Pediatric cancer patients and their families are increasingly combining conventional treatment with complementary therapies to control symptoms. Spanish public healthcare system does not cover them. To address this need, the Hospital Sant Joan de Déu in Barcelona established the first integrative pediatric oncology unit (UOPI) in 2019, the unique care model in Spain. We want to show the feasibility of the implementation of a pediatric integrative oncology unit as well as the data of the care activity

Methods: Describe complementary treatments (acupuncture, nutrition, aromatherapy and massage) and feasibility analysis based on the rate of therapeutic rejection of the treatments offered by the integrative pediatric oncology unit. Retrospective analysis of the most frequent indications for pediatric oncology acupuncture.

Results: We aim to bridge the gap between conventional cancer treatments and complementary approaches like acupuncture, massage, and nutritional support; we seek to optimize treatment outcomes and minimize side effects. In two years, in our integrative oncology unit have evaluated more than 300 patients and performed more than 1,210 acupuncture treatments in patients undergoing active treatment and survivors. The most frequent reasons for consultation are: gastrointestinal motility disorders, such as nausea, vomiting, diarrhea and constipation; pain such as tumor, neuropathic, scar pain, functional, musculoskeletal, headache and abdominal pain; mood disorders such as psychophysical asthenia, anxiety, insomnia or night terrors; and others such as loss of appetite, allergic reactions or hot flashes. The mean age of the patients is 9.5 years, and the rate of therapeutic rejection is 2.3%. Each child's cancer journey is unique, and we recognize the importance of tailoring treatment plans to their individual needs. Our multidisciplinary team collaborates closely to develop personalized treatment strategies, ensuring that every aspect of the child's well‐being is considered.

Conclusions: The first integrative pediatric oncology unit in Spain aims to redefine the care model for pediatric cancer patients by combining conventional and complementary therapies within a holistic framework. Represents an innovative approach to provide comprehensive care for children and young people with cancer. By combining conventional medical treatments with complementary therapies and holistic support, our center aims to revolutionize the standard of care. Through our comprehensive approach, personalized care plans, and emphasis on patient and family well‐being, we aspire to improve treatment outcomes and enhance the overall quality of life for children and adolescents with cancer. An integrative oncology unit covers the medical and social demand for comprehensive cancer care. Key elements of our care model include: individualized care plans, family‐centered care, continuity of care independent of the prognosis and promote research and innovation.

OS PEDIATRIC DISEASE N 11 Pediatric Integrative Medicine in Residency (PIMR) Program

Hilary McClafferty

Pediatric Emergency Medicine at Tucson Medical Center, USA

Pediatric Integrative Medicine in Residency

Founder of the Academy of Pediatric Integrative Medicine

American Academy of Pediatrics (AAP)

Introduction: The field of integrative pediatrics has developed relatively slowly in comparison to adult integrative medicine, in part due to an historical paucity of research in children. Over time, as pediatric research has accumulated, demand for evidence‐based integrative pediatric care has outstripped supply, revealing an educational gap and a pressing need for more trained pediatric specialists in the field.

Methods: Existing IM fellowships in the United States cover only a small percentage of integrative pediatric material. The Pediatric Integrative Medicine in ReAn Overview of Pediatric Integrative Medicine. McClafferty, HH. Pediatr Ann. 2019 Jun 1;48(6): e216‐e219.sidency program developed by Dr. McClafferty in 2012 at the University of Arizona was the first program of its kind, embedding integrative pediatrics into conventional pediatric residency programs.

Conclusions: A brief overview of this program, and programs it subsequently catalyzed, will be discussed and a snapshot of pediatric IM training programs in the US will be reviewed. In response to ongoing need, development of the Academy of Pediatric Integrative Medicine was undertaken in 2022, offering a specialty certificate to international physicians and qualified advanced practice nurses desiring concentrated study in the field. A brief overview of this program and its projected goals, and a vision for growth for the field will be reviewed.

OS PEDIATRIC DISEASE N 12 Training the Next Generation of Integrative Pediatricians: A Novel Pediatric Integrative Medicine Clinical Fellowship

Ann Ming Yeh:

Pediatric Gastroenterology and Integrative Medicine ‐ Stanford University

Andrew Weil Center for Integrative Medicine Associate Director for the Academy Scholars ‐ Academy of Integrative Pediatrics

Introduction: Integrative Pediatrics is an emerging subspecialty in Pediatrics. While virtual training opportunities exist for distance‐learning fellowships, until recently, no clinical training opportunities existed for pediatricians to learn integrative pediatric modalities.

Methods: In 2017, we created a 1‐ year clinical fellowship at Stanford Medicine Children's Health. Fellows rotate through clinics in pediatric integrative subspecialties (gastroenterology, pulmonary, rheumatology, pain, and neurodevelopmental) and learn pediatric specific modalities such as hypnosis, food as medicine, and auricular acupressure, supplements, and botanicals. Noon conferences occur weekly and are open to the Pediatric Integrative Medicine community. Fellows also simultaneously train through the distance‐learning fellowship with the Andrew Weil Center for Integrative Medicine. A limited research or scholarly project is also required. To date we have successfully graduated 5 fellows (at time of conference).

OS PEDIATRIC DISEASE N 13 Outpatient integrative‐medicine options in pediatric palliative care

Mercedes Ogal

Integrative Medicine, Pediatric Clinic‐ Brunnen, Switzerland

Introduction: Overall, few children and adolescents have a life‐shortening disease (about 5000 in Switzerland), but those affected usually have a high need for therapy and care. The goal of pediatric palliative care is to enable them and their families to fill their shortened lives with as much quality of life as possible. The families need a supporting network with coordinated case management and loving, empathic care. The necessary structures for this are mostly missing in Switzerland. In contrast to nearby countries, palliative care as a structured care offer is not legally established in Switzerland.

Methods: This presentation aims to show the opportunities offered by the integration of various complementary medicine methods in outpatient pediatric palliative care and how these methods enable to improve the quality of life of patients and their families. For this purpose, proven therapeutic methods are considered, examined for possible evidence and illustrated with practical examples (acupuncture, phytotherapy, aromatherapy, Bach flower therapy, homeopathy, massage therapy, rubs, medical hypnosis, relaxation methods, music and sound therapy, orthomolecular medicine, balneotherapy, animal‐assisted therapies and, last but not least, spiritual guidance).

Results/Experience: Often these methods can also be used by family members with the patient, reducing the feeling of helplessness in the relatives and strengthening self‐efficacy.

Conclusion: The use of complementary medicine therapies in pediatric palliative care is extremely useful and helpful in many ways ‐ while strengthening the family system.

OS INTEGRATIVE ONCOLOGY N 14 An Unit of Integrative Pediatrics in Brazil: Present and Future

Paula Pasqualucci¹; Danton de Souza¹; Rita Polastrini¹; Georg Seifert²; Vicente Odone Filho³

¹Unit of Integrative Pediatrics, Department of Pediatrics, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil, Sao Paulo, Brazil; ²Department of Pediatrics, Division of Oncology and Hematology, Charité‐Universitätsmedizin Berlin, Berlin, Germany, Berlin, Germany; ³Department of Pediatrics, Division of Oncology and Hematology, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil, São Paulo, Brazil

Introduction and Objective: Complementary and integrative healthcare practices (CIHP) have not been systematically institutionalized in pediatric hospital care in Brazil so far. The Unit of Integrative Pediatrics (UPI) of the Pediatric Department of the Faculty of Medicine, University of Sao Paulo, Brazil was created to update the healthcare model for pediatric patients with chronic and complex conditions in a tertiary hospital. The Unit's clinical framework is focused on four major clinical conditions: mental health promotion, child‐family care, reduction of medication use and patient self‐care skills promotion. We aim to describe the clinical activities adopted by the UPI present the data collected after 2 years of activity. We also want to discuss possibilities for the future.

Method: to describe the activity of the UPI in Brazil after 2 years of practice.

Results: The UPI implementation concept was developed based on clinical care, teaching and scientific research. Over the last 2 years (2021‐2022), CIHP were systematically integrated into routine pediatric care of a tertiary hospital in Sao Paulo, Brazil in an inpatient as well as outpatient setting, in addition to conventional medical treatments. The patients were actively recruited by a pediatric leader with basic knowledge in integrative health. In the inpatient setting, music therapy was indicated for patients in long term hospitalizations who showed communication and socialization impairments and anthroposophic external therapy and acupuncture were indicated for symptoms control (pain, anxiety, insomnia). In the outpatient setting, an 8‐sessions mindfulness‐based program was delivered by remote online sessions for patients with stress symptoms referred by the healthcare professional or self‐referred. A total of 213 patients were assisted in 1,5 years of activity, the mean age of patients was 10,8 years old, 59,6% were female and 52,1% were self‐referred white. Of all patients assisted, 27,6% were assigned to music therapy, 43,6% to antroposophic external therapy, 15% to acupuncture and 28,6% to mindfulness. Of these, 53,9% were oncologic patients.

Conclusions: The adoption of systematically patient‐centered care that focuses on wellness and health promotion and treats the child‐family unit as a whole is a necessary path for the future of pediatric healthcare.

OS PEDIATRIC DISEASE N 15 A Quest for Healthy Childhood in German‐speaking Countries: challenges, and research contributions of integrative medicine and future trends

Georg Seifert

Charité Universitätsmedizin Berlin, Department of Pediatrics, Division of Oncology and Hematology, Germany.

• Holder of Endowed Chair (W2) of Integrative Medicine in Paediatrics at the Charité Medical School, Berlin Germany

• Senior Consultant Department of Paediatric Oncology/Haematology

• Visiting Professor, Universidade de São Paulo, Brazil

• Continuing education and professional development officer of the department

• Spokesperson of the informal working group Integrative Medicine and Complementary Medicine in Paediatrics (corporate membership of the German Society of Paediatrics and Adolescent Medicine (DGKJ) as working group planned)

This talk focuses on the health challenges that children face today regarding the field of prevention and therapy. Against this background, research contributions will present the current innovative projects being undertaken within integrative medicine in German‐speaking countries and at the Charité‐Universitätsmedizin Berlin. These include new approaches such as digital health applications to monitor and promote children's health, the integration of prevention and integrative therapies into school programs, and the introduction of new interdisciplinary concepts for the integrative medicine care of children with chronic diseases. By looking at improvements that these trends can offer for prevention and therapeutic applications to child health and their impact, the future of integrative medicine will be highlighted.

OS PEDIATRIC DISEASE N 16 Investigating the experience of an audio‐based mindfulness vs. control program for mothers with infants in the neonatal intensive care unit at Johns Hopkins School of Medicine

Erica Sibinga (USA)

Associate Professor of Pediatrics at Johns Hopkins School of Medicine

National Advisory Council for Complementary and Integrative Health

American Academy of Pediatrics' Section on Integrative Medicine

Introduction: Mothers with an infant in the neonatal intensive care unit (NICU) are at increased risk for depression, anxiety, and trauma symptoms, with negative implications for maternal‐infant bonding, maternal wellbeing, and infant development. Few interventions to promote NICU mothers' mental health, however, have been developed or tested. Our previous work suggests that mindfulness programming is promising in this setting.

Objective: This study examined the perceived impact of a mindfulness‐based intervention on the experience of mothers with infants in the NICU.

Methods: This qualitative sub‐study was embedded in an on‐going parent pilot RCT of a mindfulness program vs. general infant health education program for mothers with infants in the NICU, delivered via audio and video, designed to enhance accessibility. We sought to interview participants up to two times each (two weeks after receiving program materials and one month after transitioning home from the NICU). Analysis of the text was conducted using an iterative, thematic comparison process informed by grounded theory.

Results: We conducted 37 interviews with 26 mothers (15 intervention, 11 control), in which feasibility and acceptability was generally high and four themes emerged. The mindfulness intervention was perceived to impact the mothers' NICU experience by: 1) calming the chaos; 2) finding comfort in non‐judgmental acceptance; 3) gaining perspective; and 4) facilitating self‐care.

Conclusion: In a sample of mothers of infants in the NICU, this audio‐video mindfulness intervention shows promising results related feasibility and acceptability, as well as improving maternal stress and NICU experience. Mindfulness programming initiated during the NICU stay has promise, with potential for improvements in important long‐term maternal‐child outcomes.

OS PEDIATRIC DISEASE N 17 Supporting the Human Spirit through Transpersonal Integrative Medicine

David Steinhorn¹, Jana Din², Al Striplen³

1‐ Integrative Medicine Initiative in Chicago

1‐ Capital Caring Health, Washington, DC. USA

2‐ Tao Healing Center, Sacramento, CA. USA

3‐ Native American Counselor, Sacramento, CA. USA

Introduction: Most integrative medicine practitioners acknowledge that optimal well‐being is achieved through care of the body, mind, emotions, and spirit. Our approach to integrative medicine focuses on supporting the human spirit in our hospitalized patients, who are often unable to participate in conventional counseling due to advanced illness, dementia, or developmental limitations. In contrast to spiritual care delivered by chaplains or religious leaders, our work has been non‐religious, non‐theological. It rests upon an acknowledged universal spirituality common to all people, recognizing that we are all part of something bigger than ourselves. We call our approach “Transpersonal Medicine” which guides individuals to connect with their inner healing resources and spirit. By guiding patients to a mindful, peaceful inner state, they can connect also with tutelary energies that may offer new insights and opportunities for healing trauma and wounds incured in the process of living.

Methods: A physician and practitioner trained in transpersonal healing methods, created a partnership in a university hospital to offer transpersonal healing to patients and their families. The physician identified patients/families who assented to the experience. The healer's intention was to alleviate existential suffering and reduce pain by guiding individuals from their heads to their hearts, creating a mindful, peaceful inner state. Infants were offered the intervention to calm and soothe them. Using rhythmic drumming or rattle, the practitioner guided the participants to a quiet inner space, similar to one achieved through mindfulness training. In the mindful quietude, some sought answers to clinical decisions, which their chaotic minds and emotions prevented them from finding.

Results: Over 100 sessions have been provided for adults and children with serious medical conditions, including advanced cancers, coma, and fatal brain injury. While many of the patients died, others recovered well. Families of those patients who died found meaning and comfort in the transpersonal process. No individuals experienced adverse consequences. Family comment: “Your work supported us in going deeper into ourselves, our hearts and our connecting with [our son]”

Conclusion: Transpersonal medicine utilizing drum or rattle is feasible and acceptable to many patients/families with serious illness. As a complement to the standard medical care, this work provides non‐verbal, comforting support for the human spirit to accept conventional medical interventions optimally. Spiritual healing can take place even without cure of the body. Our approach also complements conventional chaplain support and allows individuals to connect more deeply with their intrinsic healing resources.

OS PEDIATRIC DISEASE N 18 A qualitative study among healthcare providers on risks associated with the use of supportive care for cancer treatment‐related symptoms in children and adolescents

Dana C. Mora¹; Agnete E. Kristoffersen¹; Miek C. Jong¹; Jill A. Hervik²; Trine Stub¹

¹NAFKAM, UiT The Arctic University of Norway, Tromsø, Norway; ²Department of Anaesthesia, Pain Clinic, Vestfold Hospital Trust, Tønsberg, Norway

Introduction: Although more than 300,000 children and adolescents are diagnosed with cancer yearly, little research has been conducted investigating how healthcare providers consider risk and patient safety connected with supportive care (including complementary and alternative medicine (CAM)) in this age group. This study aimed to explore how different healthcare providers perceive and evaluate risk when patients combine supportive care and conventional medicine in clinical practice and how they communicate and inform parents about the use of these modalities.

Methods: In‐depth semi‐structured interviews were conducted with 22 healthcare providers with expertise in treating pediatric oncology patients from five countries. Systematic content analysis was conducted using Nvivo 1.61. The analysis resulted in three themes and eight subthemes.

Results: Generally, participants were conservative when recommending supporting care modalities to parents of children and adolescents with cancer. The most important criterion when recommending a modality was evidence for safety based on a risk/benefit evaluation. Negative interactions with conventional medicine were avoided by using the half‐life of a drug approach (the time it takes for a drug's active substance in the body to reduce by half). Depending on the patient's health status, less invasive modalities were used. To enhance safety, participants practiced open and egalitarian communication with parents.

Conclusion: Healthcare providers used a variety of approaches to achieve a safe practice when parents wanted to combine supportive care and conventional cancer treatment. They emphasized that these modalities should be foremost safe and not become an extra burden for the patients. Providers highlighted patient‐centered care to meet the individual's specific health needs and desired health outcomes. A lack of national and regional standardized training programs for supportive care in pediatric oncology was considered a hazard to patient safety.

OS PEDIATRIC DISEASE N 19 Speaking the unspeakable: The Power of Dance & Movement with Children for Healing and Wellness

Suzie Tortora

Memorial Sloan Kettering Cancer Center, NYC, USA

Introduction/description: Early childhood research demonstrates that initial perception is registered through the baby's bodily‐felt engagement with their surroundings, perceived through multisensory experiences and informed by secure interactions with primary caregivers. Trauma research explains that early memory is somatic, multisensory and kinesthetic, and can be triggered by sensory experiences reminiscent of elements of the original event throughout a lifetime. Stress physiology and a sense of disempowerment and loss of control of one's body creates a wide variety of emotional experiences that are felt but difficult to verbalize. The term embodiment, describing this interrelatedness between the body, mind and emotions, is a prominent focus of research in trauma, psychology, neuroscience, affect neuroscience, somatics, and dance/movement therapy. The goal of trauma treatment is to support an individual to create a coherent narrative of their lived experience to promote healing.

Method: Dance/movement therapy (DMT) is a treatment modality fostering the individual's embodied experience using nonverbal analysis, dance, movement and music to support the expression of feelings that are difficult to express in words. DMT is uses to promote both a healthy lifestyle and resilience and healing from crisis situations.

Aims: This presentation addresses how to support babies, children, teens and their families through vulnerable times, bridging infant mental health; nonverbal movement analysis; and dance/movement psychotherapy. It demonstrates how to help children voice their experiences using nonverbal observation, play, songs, dance, movement, breathe and mindfulness activities to create an embodied coherent narrative. How DMT is use to encourage wellness and healing from potential traumatic reactions to natural and political disasters, and medical illness will be discussed.

Conclusions: Through an innovative lens dance/movement psychotherapy addresses the psychic and somatic aspects of experience used along the spectrum from wellness to the trauma, providing a window into the individual's emotional “felt‐story”.

OS PEDIATRIC DISEASE N 20 Pollution and non‐communicable disease

Jan Vagedes

Department of Pediatrics, Filderklinik,

ARCIM Institute (Academic Research in Complementary and Integrative Medicine)

Tübingen University

Introduction: Children's health is crucial for the future of our planet and it is important to promote healthy lifestyles and prevent environmental non‐communicable diseases (NCDs). Environmental pollution, which includes air, water, and soil, threatens children's health and causes many non‐communicable diseases such as asthma, allergies, and cardiovascular disease.

Methods: The development of health promotion strategies should focus on creating environments that promote physical activity, healthy eating, and clean air and water. By providing safe spaces for physical activity, healthy eating, and positive mental health, schools, families, and communities can play an important role in promoting healthy lifestyles. To prevent environmental pollution (NCDs), measures should be taken to reduce exposure to environmental pollutants, such as reducing industrial emissions and automobile traffic, promoting green spaces, and using renewable energy sources.

Conclusions: In summary, promoting healthy lifestyles and preventing pollution‐related health disorders are critical to children's health and well‐being, especially in times of crisis. Addressing the complex environmental, social, and economic factors that influence children's health requires intersectoral collaboration and policy action to create a healthy and sustainable environment for future generations.

OS PEDIATRIC DISEASE N 21 Can homeopathy reduce antibiotic use while maintaining symptom control for acute otitis media? A systematic review

Rachel Perry¹; Alyson Huntley²; Michael Teut³; Nai Ming Lai⁴; David Martin^5,6; Esther van der Werf^2,7

¹Bristol Heart Institute and Bristol Trials Centre, Bristol Medical School, Bristol, United Kingdom; ²Centre For Academic Primary Care, Bristol Medical School, Bristol, Bristol, United Kingdom; ³Institute for Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Berlin, Germany; ⁴School of Medicine, Faculty of Health and Medical Sciences, Taylor's University, Kuala Lumpur, Malaysia; ⁵Tübingen University Children's Hospital, Tübingen University, Tübingen, Germany; ⁶Institute of Integrative Medicine, Department of Medicine, University of Witten/Herdecke, Witten, Germany; ⁷Homeopathy Research Institute, London, United Kingdom

Introduction: Effective and safe non‐antibiotic treatment may contribute to reducing antibiotic use and antimicrobial resistance (AMR), and meeting doctors' and patients' desire for symptom relief in Acute Otitis Media (AOM). This systematic review aims to assess whether homeopathy can effectively reduce AOM symptoms and the use of antibiotics.

Methods: A search of Pubmed, Embase, Cochrane Central Register of Controlled Trials, Web of Science, AMED, CINAHL, CORE‐Hom and CAM‐QUEST was conducted to identify all controlled trials (randomised (RCTs) and non‐randomised (nRCTs) on individualised homeopathy (IH) and non‐individulaised homeopathy (non‐IH)) in patients with AOM. Data analysis and quality appraisal will be according to the Cochrane Handbook for Systematic Reviews of Interventions. Primary outcomes are symptom relief (severity and duration) and antibiotic use. Secondary outcomes include antibiotic prescribing, hearing loss, recurrence, health service and medication use, quality of life, re‐consultation and adverse events. Meta‐analyses are planned to be performed on the highest level of available evidence available only (PROSPERO 2022 CRD42022367188).

Results: The search identified 507 records. 84 full‐text papers were screened for eligibility. 9 studies were identified, of which 4 reported on the effectiveness of IH (n = 1: homeopathy vs placebo; n = 3: homeopathy vs standard care and 5 on the effectiveness of non‐IH (n = 1: homeopathy vs placebo; n = 4: homeopathy vs standard care. The effect of homeopathy on symptom relief and antibiotic use, and whether effects can be demonstrated over and above those expected with placebo, will be presented. Additionally, we will present findings on secondary outcomes.

Conclusion: This systematic review will give the most up‐to‐date evidence for the effectiveness and safety of homeopathy for AOM. It will also guide the conduct of further clinical trials in the important topic area of the role of homeopathy in AMR.

OS PEDIATRIC DISEASE N 22 Historical development and application of traditional/complementary medicine in children's health care: a prospective from China

Darong Wu

‐State Key Laboratory of Dampness Syndrome of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou

‐Outcome assessment research team in Chinese medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou

‐Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou

Introduction: Since more than 2400 years ago, traditional medicine has been applied to prevent and treat children's diseases in China. It has been defined that based on the theory of traditional Chinese medicine (TCM), paediatrics of TCM is a clinical medicinal knowledge, primary in growing development, pathophysiology, feeding, health protection or prevention and treatment of a variety of diseases from infant, childhood to adolescence, through traditional methods, interventions or therapies.

The imperial medical bureau in Tang Dynasty (618‐907 AD) developed a regulation for five years of regular training of pediatricians. In China, from Sui Dynasty (581‐617 AD) to Song Dynasty (960‐1279 AD), the medical system of paediatrics of TCM had been well and comprehensively developed. Research showed promising or potential effects for alternative, complementary, or integrative applications of TCM in treating viral diseases, immunological diseases, digestive system diseases, acute diseases/symptoms, and diseases of newborns, etc.

Types of interventions or therapies commonly adopted include herbal medicine, Chinese patent medicine, pediatric Tuina/massage, acupuncture, bloodletting, moxibustion, etc. In China, based on the Government's policy to facilitate medical integration, these interventions are carried out not only in TCM hospitals but also in the TCM departments that belong to Western medicine or integrative medicine hospitals or some community health care centres.

Conclusions: Integration of paediatrics of TCM into health services has been strengthened and extended in China, especially over the past several decades. Further development in this area may face both opportunities and challenges.

OS PEDIATRIC DISEASE N 23 Effect of pediatric Tuina(massage) on children's recurrent acute respiratory tract infections: a retrospective cohort study in Southern China

Lingjia Yin^1,2; Cecilia Lundborg¹; Darong Wu²; Jinghua Yang²; Helle Alvesson¹; Jianxiong Cai²; Taoying Lu²; Qianwen Xie²; Gaetano Marrone¹

¹Karolinska Institutet, Stockholm, Sweden; ²The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China

Introduction: Children are vulnerable to recurrent acute respiratory tract infections (ARTIs), which are associated with significant morbidity and mortality. Pediatric Tuina (massage) has been utilized as a clinical prevention for children in China, but it is unknown whether this massage approach is associated with decreased ARTI recurrence. The aim of this study was to determine the effectiveness of pediatric Tuina (PT) in preventing recurrent ARTIs in children.

Method: This is a retrospective cohort study based on the electronic medical records of children with recurrent ARTIs in 2016. Children were divided into a PT group or a non‐PT group, according to whether they had received PT or not in 2016. The primary outcome was the number of ARTI episodes in 2017 and 2018. The secondary outcomes were the number of ARTIs leading to outpatient department visits and outpatient antibiotic prescriptions due to ARTIs in the same time period. Negative binomial regressions were used to detect the association between PT and the outcomes.

Result: A total of 2,303 children were included in the analysis, including 94 in the PT group and 2,209 in the non‐PT group. Children who received PT six or more times in 2016 had fewer episodes of ARTIs in 2017 (incidence rate ratio: 0.59, 95% CI: 0.42‐0.84) and 2018 (IRR: 0.58, 95% CI: 0.36‐0.94) and fewer outpatient department visits due to ARTIs in 2017 (IRR: 0.56, 95% CI: 0.38‐0.83) than children who had not received PT in 2016. There was no significant difference in the number of outpatient antibiotic prescriptions between the two groups.

Conclusion: Receiving PT six or more times within one year is associated with a decrease in recurrent ARTIs in children in the following two years. Randomized controlled trials are needed for effect evaluation prior to establishing PT as a method for preventing recurrent ARTIs among children.

OS NUTRITION AND LIFESTYLE N 1 The effects of brainwave entrainment associated with the Mediterranean diet on clinical symptoms of depression: a randomized controlled trial

Francisco Cidral‐Filho^1,3; Taynah de Oliveira Galassi¹; Rafaela Hardt da Silva¹; Gabriela de Souza¹; Nayara Medeiros¹; Heidi Lenny Paasch²; Luisa Pereira Gonçalves²; Arthur Pereira Ruiz Camara²; Steffani Horstmann Goedert²; Victor Juchem de Brito²; Brenda Canatto de Paiva²; Patrick Porter³; Daniel Fernandes Martins¹

¹Experimental Neuroscience Laboratory (LaNEx), Postgraduate Program in Health Sciences, University of Southern Santa Catarina ‐ UNISUL, Palhoça, Brazil; ²Health Sciences Graduation Program, University of Southern Santa Catarina ‐ UNISUL, Palhoça, Brazil; ³Integrative Wellbeing Institute, Orlando, United States of America

Background: Major depressive disorder (MDD) is a multidimensional illness that alters mood and impairs quality of life. The Mediterranean diet (MD) is effective in reducing depressive symptoms. Additionally, reduced stress, anxiety, and improved sleep have been observed with brainwave entrainment (BE). This study evaluated symptoms of depression (Hamilton Depression Rating Scale ‐ HAMD), resilience, and quality of sleep (Brief Resilience Scale ‐ BRS and Pittsburgh Sleep Quality Index ‐ PSQI) in individuals with MDD.

Methods: This is a randomized, double‐blind, placebo‐controlled study conducted at the Experimental Neuroscience laboratory of the Universidade do Sul de Santa Catarina (UNISUL), Brazil. 29 female patients with MDD were randomly assigned to: MD+BE (n = 15) or MD+BE Placebo (n = 14) group. Clinical assessments were conducted at baseline and after 30 and 60 days. Participants underwent daily 20‐minute BE sessions: one audiovisual session with a BrainTap headset (New Bern, NC) at the university clinic on MON, WED and FRI and one audio BE session with an Mp3 file on TUE, THU and SAT. Sessions consisted of Binaural beats and Isochronic Tones varying in the alpha (8 to 12 Hz), theta (4 to 7 Hz) or delta rages (0.5 to 3 Hz); visual Entrainment was delivered through a light‐emitting diode at 470 nanometers (nm) flickering at the same rate. Placebo BE sessions were delivered in the Beta range (13 to 30 Hz).

Results: HAMD scores decreased in both groups: on day 30 (MD+BE mean: 7.35 ± 4.90, p = 0.001; MD+BE Placebo mean: 11.87 ± 9.14, p = 0.001) and 60 (MD+BE mean: 5.00 ± 4.13, p = 0.001; MD+BE Placebo mean: 6.73 ± 5.87, p = 0.001) when compared to baseline evaluation (two‐way ANOVA and Bonferroni post hoc test). Both groups improved the PQSI (MD+BE mean: 8.28 ± 3.42, p = 0.001 vs MD+BE Placebo mean: 9.20 ± 4.69, p = 0.127) on day 60. BRS score increased only in the MD+BE group (MD+BE mean: 131.40 ± 28.77, p = 0.149; MD+BE Placebo mean: 104.70 ± 44.10, p > 0.999) on day 60.

Conclusions: Both MD and BE effectively decreased the clinical symptoms of depression. The association of BE to MD produced more pronounced results. These data suggest that BE may be an effective adjunct to treating depression.

OS NUTRITION AND LIFESTYLE N 2 Superiority of an IgG‐guided elimination‐rotation diet compared to FODMAP diet and classic dietary recommendations in the management in patients with a mixed form of irritable bowel syndrome

Camille Lieners

Department of Dietetics and Clinical Nutrition, Medical University of Bialystok, Bialystok, Poland

Institute of Microecology, Poznan, Poland

Introduction: Irritable bowel syndrome (IBS) is a chronic disease characterised by recurrent abdominal pain, disturbed bowel emptying and change in stool consistency. Numerous studies have shown good results in the management of IBS by applying different nutritional therapy approaches. The aim of the study was to compare the effectiveness of three different diet plans: G1‐FM, the low‐FODMAP diet; G2‐IP, the immunoglobulin G (IgG)‐based elimination‐rotation diet and, as a control group, G3‐K, a classic diet recommended by an attending gastroenterologist experienced in treating patients with mixed IBS.

Methods: Seventy‐three women were enrolled in the study (M_age = 41.7 ± 14.8 years; range 18–74 years), who met the criteria for inclusion in the study (mixed IBS according to Rome Criteria III). The diet of each patient in group 1 (G1‐FM) and group 2 (G2‐IP) was determined individually during a meeting with a dietitian. In group 1 (G1‐FM), each patient received individual dietary advice. In group 2 (G2‐IP), an individual IgG elimination‐rotation diet was applied, including nutritional counselling regarding the use of the elimination‐rotation diet. Patients in group 3 (G3‐K) received nutrition advice from a leading gastroenterologist.

Results: Significant differences in the reduction of IBS symptoms were found between groups. All IBS symptoms as well as co‐morbid symptoms such as headache, skin conditions, constant tiredness/weakness significantly improved or disappeared completely in the G2‐IP group (p < 0.008), while in the G1‐FM group, only some IBS symptoms such as bloating and gastric fullness significantly improved. Idiopathic abdominal pain (p = 0.12), abdominal pain after a meal (p = 0.06), abdominal pain during defecation (p = 0.25) and sensation of incomplete defecation (p = 0.25) and co‐morbid symptoms (p = 1.0) did not significantly improve in G1‐FM. In group, G3‐K no significant improvement was seen.

Conclusions: The most effective diet in the treatment of patients with mixed IBS was the elimination‐rotation diet based on an IgG‐dependent food hypersensitivity test.

OS NUTRITION AND LIFESTYLE N 3 Prolonged modified fasting for osteoarthritis: a prospective observational study

Daniela Koppold^1,2; Ixquic Alvardo‐Rupflin^1,2; Farid Kandil¹; Sara Meiß^1,2; Carolin Breinlinger¹; Nico Steckhan³; Andreas Michalsen^1,2; Christian Keßler^2,1

¹Charité Universitätsmedizin Berlin, Berlin, Germany; ²Immanuel Krankenhaus Berlin, Berlin, Germany; ³Hasso‐Plattner‐Institut, Potsdam, Germany

Background and Objective: Preliminary experimental and clinical data suggest pain reducing properties of therapeutic fasting. This uncontrolled, observational study investigated effects of prolonged fasting on functional parameters and pain in hip and knee osteoarthritis.

Patients and Methods: Patients of the inpatient department of internal and integrative medicine at the Immanuel Hospital Berlin between 02/02/2018 and 12/03/2020 completed questionnaires at the beginning and end of the inpatient treatment, and 3, 6, and 12 months after discharge. In addition, selected blood and anthropometric parameters were collected during the inpatient stay. The therapeutic fast (daily caloric intake <600 kcal ) was part of a multimodal integrative treatment program.

Results: N = 125 patients were included. They fasted for a mean of 7.7 ± 1.7 days. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) showed a reduction in pain (NRS: ‐2.7 ± 1.98, p < 0.0001, d = 1.48) and a decrease in functional limitations (WOMAC total score: ‐14.8 ± 13.31; p < 0.0001; d = 0.78). Pain medication was reduced, discontinued, or replaced with herbal remedies in one‐third of patients. Improvements were also observed in secondary outcome parameters, including higher quality of life (WHO‐5: +4.5 ± 4.94, p < 0.0001, d = 0.94), less anxiety (HADS‐A: ‐2.1 ± 2.91, p < 0.0001, d = 0. 55) and depression (HADS‐D: ‐2.3 ± 3.01, p < 0.0001, d = 0.65), and a decrease in body weight (‐3.6 kg ±1.65, p < 0.0001, d = 0.21) and blood pressure (systolic: ‐6.2 ± 15.93, p < 0.0001, d = 0.43; diastolic: ‐3.7 ± 10.55, p < 0.0003, d = 0.43).

Conclusions: Prolonged modified fasting could potentially benefit patients with knee or hip osteoarthritis as part of a multimodal integrative treatment approach in terms of quality of life, pain, and disease‐specific functional parameters. Further randomized controlled trials are needed to confirm these findings.

OS NUTRITION AND LIFESTYLE N 4 Individual breastfeeding experience in an anthroposophic hospital: a mixed methods study

Theresa Ertlmaier¹; Anja Borgmann‐Staudt^1,2; Nike Rieker¹; Monika Berns³; Paula Böhmig¹; Oana Popa‐Costea¹; Wiebke Stritter¹; Georg Weikert⁴; Magdalena Balcerek^1,5

¹Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt‐Universität zu Berlin, Department of Paediatric Oncology and Haematology, Berlin, Germany; ²Gemeinschaftskrankenhaus Havelhöhe, Maternity Clinic, Berlin, Germany; ³Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt‐Universität zu Berlin, Clinic for Neonatology, Berlin, Germany; ⁴DRK Klinikum Westend, Clinic for Neonatology, Berlin, Germany; ⁵Berlin Institute of Health, BIH, Berlin, Germany

Introduction: Breastfeeding has short and long‐term health benefits for both the mother and the infant. Therefore, the World Health Organization recommends exclusive breastfeeding for 6 months with continued breastfeeding along with introducing complementary foods until 2 years of age or longer. Despite the introduction of initiatives to support breastfeeding, such as baby‐friendly (BF) hospitals, only 55.8% of children born in Germany in 2018/2019 were breastfed exclusively for 4 months. In 2018, in an anthroposophical BF hospital with a holistic individual treatment 100% of mothers attempted breastfeeding after delivery.

Objective: Our study aims to identify individual needs of families to support breastfeeding duration, including barriers and facilitators. In this context, we compare the sustained breastfeeding rate of an anthroposophical BF hospital (A) to another BF clinic (B) and a non‐BF maximum care provider (C).

Methods: In our mixed methods study we conduct semi‐structured parental interviews (2 months postpartum) as well as questionnaire surveys at 4 time points within the first year of the child's life (first days in hospital and 2, 6 and 12 months postpartum) with primipara mothers whose child was born at full term (≥37 + 0 weeks of gestation) and cared for in the postpartum ward. Parents are being recruited since November 2022 in three hospitals (A, B, C*) in Berlin, Germany. Interviews are audio‐recorded, transcribed verbatim and analysed according to the Qualitative Content Analysis by Mayring. Questionnaires are analysed with descriptive and multivariate methods. Qualitative and quantitative results are combined and triangulated.

Results: In total, 296/347 (85%) mothers filled out our first questionnaire in the first days postpartum. Almost all mothers stated to have a very high motivation to breastfeed (A: 93%, B: 93%, C: 93%). In A, 93% of the mothers received sufficient breastfeeding counselling without remaining questions in comparison to 77% in B and 59% in C. Advice was offered actively by the health care providers to 90% of participating mothers in A, as well as to 85% and 58% in B and C, respectively. In Rome, we present further results, including the transverse comparison as well as the longitudinal course up to the second questionnaire.

*ongoing recruitment

Conclusion: Initial results indicate that offering breastfeeding counselling more broadly and actively in the anthroposophic BF clinic leads to more satisfactorily informed mothers.

OS NUTRITION AND LIFESTYLE N 5 Defining fasting: an international consensus process on fasting terminology

Carolin Breinlinger⁷; Christian Kessler^1,2; Holger Cramer^6,3; Anika Hartmann^1,5; Etienne Hanslian^3,2; Andreas Michalsen^1,2; Daniela A. Koppold^8,2

¹Institute of Social Medicine, Epidemiology and Health Economics, Charité ‐ Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt‐Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany; ²Department of Internal and Integrative Medicine, Immanuel Krankenhaus Berlin, Berlin, Germany; ³Institute of Social Medicine, Epidemiology and Health Economics, Charite University, Berlin, Germany; ³Institute for General Practice and Interprofessional Care, University Hospital Tübingen, Tübingen, Germany; ⁵Department of Dermatology, Venereology and Allergology, Charité‐Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt‐Universität zu Berlin, Berlin, Germany; ⁶Bosch Health Campus, Stuttgart, Germany; ⁷Charité‐Universitätsmedizin Berlin, Berlin, Germany; ⁸Institute of Social Medicine, Epidemiology and Health Economics & Clinic for Pediatrics, Charité‐Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt‐Universität zu Berlin, Berlin, Germany

Introduction and Objective: To define various forms of fasting in a translational, cross‐sectional expert panel, an international, multidisciplinary consensus process was conducted.

Methods: Frequently cited authors in the field and clinicians with at least five years' expertise in medical fasting were invited. Five online survey rounds were complemented by a live online conference conducted after the third round. Items receiving ≥70% votes were accepted, those obtaining <70% votes recirculated or rejected when ≥50% voted for exclusion.

Results: Overall, thirty‐nine participated, and n = 25 (Europe (n = 12), North America (n = 12), and Australia (n = 1)) completed all five survey rounds. 24 terms, including “fasting”, “modified fasting”, “fluid‐only fasting”, “alternate‐day fasting”, “short‐term fasting”, “prolonged fasting” and “religious fasting” were defined. “Intermittent Energy Restriction”, “Intermittent fasting”, “time‐restricted eating” and “fasting‐mimicking diet” were discussed most.

Conclusions: This study provides expert recommendations on definitions around fasting to be used in future publications and fasting treatments, facilitating communication and cross‐referencing in the field.

OS NUTRITION AND LIFESTYLE N 6 Mediterranean diet adaptations to traditional cultural eating paradigms: a realist synthesis

Kieran Cooley^1,2,3; Nana‐Adjoa Bourne¹; Gursharan Mangat¹; Prabhjot Chohan¹; Yumna Farooq¹; Herpreet Singh¹

¹The Canadian College of Naturopathic Medicine, Toronto, Canada; ²National Centre for Naturopathic Medicine at Southern Cross University, Lismore, Australia; ³Australian Research Centre in Complementary & Integrative Medicine, University of Technology Sydney, Ultimo, Australia

Background: The Mediterranean Diet (MD) has been studied for its benefits in metabolic risk factors since the 1950s. In recent years, debates around barriers to access within cultural, socioeconomic, and environmental fields have arisen within non‐Eurocentric cultural backgrounds. Using data on the effects of dietary components with health benefits, this realist synthesis will produce a map of the evidence for modifications to the MD that match various cultural eating patterns.

Methods: Foods and constituents of the MD were compared and analyzed to assess benefits for both healthy and metabolic disease states using both empirical and theoretical approaches. Databases (PubMed and Cochrane) were searched using terms for cultural diets (eg. “standard American diet,” “Mediterranean diet,” “Japanese diet”) and metabolic disease outcomes associated with the MD (eg. HbA1C, cholesterol, waist circumference, weight, AST and ALT). A cultural affinity diet database was used to identify culturally‐specific foods that match components of the MD (eg. Foods with high soluble fiber that have been shown to have impact on HbA1c).

Results: Cultural alternatives to foods and components of the MD exist, however there is modest research on the specific health effects of most culturally‐adapted diets as alternatives. Five major cultural regions are identified in research with traditional diets and foods that promote similar effects to the MD. Cooking methods, food storage/preservation may vary for same food in different regions/cultures, and some sociological factors appear influence adherence to traditional diet (religion; socioeconomic status/ access to; involvement in community; physical activity). Some limitations to this research exist including that research done on specific tribes/regions/ethnic group may not be applicable across the country. There is also a paucity of specific evidence relative to other culturally competent diets eaten in North America and their metabolic health benefits.

Conclusion: Whilst some evidence‐gaps exist, it is feasible to translate most components of the MD to various diets of cultural affinity based on evidence that supports the effects of dietary constituents. Future study is needed to examine the overall effects of cultural adaptations to the MD, the design and effectiveness of healthcare practitioner training and resources for implementation, and the barriers and facilitators to cultural inclusion or health access for a broader range of dietary behaviors.

OS NUTRITION AND LIFESTYLE N 7 Older adults' views and experiences of using herbal medicines and dietary supplements to promote health in later life: A qualitative study

Patricia Belton¹; Rachael Frost¹

¹University College London, London, United Kingdom

Background: Surveys show that the herbal medicines and dietary supplements are commonly used by older people. However, whilst previous studies have documented what is being used, there is a gap in understanding how and why these products are used by older people.

Aims: We aimed to develop an in‐depth understanding of the experiences, beliefs and attitudes of UK‐based older adults towards their use of herbal medicines and dietary supplements.

Method: We carried out semi‐structured, one‐to‐one interviews by telephone or video call. Interviews asked about reasons for their use, their purchasing habits, their wellbeing behaviors, conversations held with health care professionals (HCPs) and awareness of drug interactions between prescribed medications and herbal medicines or dietary supplements. Interviews were recorded, transcribed verbatim and analyzed using thematic analysis.

Results: We recruited 20 older adults aged 65‐87 years who mostly took dietary supplements, along with a small range of herbal medicines. We found that older adults took a proactive approach to their wellbeing, with a particular focus on a good diet and adequate exercise. The use of dietary supplements was preventative, both for general health and targeted use for specific health concerns (e.g. cardiovascular disease). Both dietary supplements and herbal medicines were also used for a range of common problems for older people, such as joint problems or cognitive problems, in order to avoid the need for medication or healthcare consultations. Purchasing habits were aligned to brand loyalty, with a preference for telephone ordering and/or human interaction. Older people made choices whether to continue taking a herbal medicine or dietary supplement based on their own empirical experiences, but struggled to find support for checking medication interactions. Disclosure of supplement use to healthcare professionals depended on how negative previous healthcare professional reactions to disclosure had been.

Conclusions: Use of herbal medicines and dietary supplements represents a positive method of proactive self‐care for older people. Further information needs to be provided on interactions with medication and healthcare professionals need to ask about their use.

OS NUTRITION AND LIFESTYLE N 8 A Combined Lifestyle Intervention for Psychiatric Outpatients (CHAPTER): Results of a Pilot Randomized Controlled Trial

Charlie Schillemans^1,2; Rogier Hoenders¹; Sanne Booij^3,1; Stynke Castelein^1,2

¹CIP Lentis, Groningen, Netherlands (The); ²University of Groningen, Groningen, Netherlands (The); ³University Medical Center Groningen, Groningen, Netherlands (The)

Introduction and objective: The lifestyle and somatic health of psychiatric patients are concerning, resulting in a life expectancy of 15‐20 years lower compared to the general population. Effects of combined lifestyle interventions (CLI) on the overall health of psychiatric patients are promising, but require further investigation. This pilot aims to evaluate the feasibility, acceptability, and preliminary effectiveness of a CLI consisting of 11 group sessions on exercise, nutrition, relaxation, sleep, meaning and substance use.

Methods: Outpatients were randomized to intervention (n = 10) or control group (n = 10). Feasibility and acceptability were assessed through records, evaluation forms and qualitative interviews. Effect sizes and precision were investigated by estimating eta‐squared and 95% CIs for changes in quantitative outcomes. Preliminary effectiveness was investigated for mental health (OQ‐45), wellbeing (WEMWBS), luck (Happiness Index), self‐efficacy (MHCS), subjective physical health (VAS‐scale), quality of life (QoL; WHOQOL‐BREF), daily functioning (WHODAS 2.0), meaning (MLQ), general stress (DASS‐S), sleep (ISI), workability (WAI) and general health (EQ‐5D‐5L) using self‐report questionnaires. Somatic measurements included body weight, resting blood pressure, breath frequency and heart frequency, hip and waist circumference, fat percentage and visceral fat. Experience sampling methodology was used to assess lifestyle behavior and affect. Sleep and physical activity were captured using accelerometers. Subjective effects were assessed in interviews.

Results: Patients were diagnosed with severe chronic mood, personality, anxiety, somatic symptoms and attention deficit hyperactivity disorders with a mean treatment duration of 20 years. The mean attendance rate of the intervention completers was 84%. There were 3 (out of 10) intervention drop‐outs, who completed on average 23% of the intervention. Overall experiences with the intervention were positive, also among drop‐outs. Participants suggested more attention to group processes, shorter and more interactive sessions, guidance in maintenance, no online sessions and adjusting the information level. Subjective effects on self‐compassion, lifestyle awareness and overall recovery were the most reported. Preliminary moderate to large effects were found on body weight (η2 = 0,152), QoL subdomain social relationships (η2 = 0,156) and mental health (η2 = 0,084), general health (η2 = 0,058) and self‐efficacy (η2 = 0,056), while other outcomes showed negligible to small effects (η2 ranging from <0.01 to 0.03).

Conclusions: The applicability of the lifestyle intervention in this complex psychiatric patient population leaves room for improvement, which may have resulted in the few measurable effects in this pilot, although satisfaction with the CLI‐intervention was moderate to high. This CLI should be adjusted according to these patients' recommendations and outcomes measurements should be reconsidered.

OS NUTRITION AND LIFESTYLE N 9 Feasibility and Effects of repetitive cycles of a Fasting Mimicking Diet on Subfertile Men – A qualitative data analysis

Katharina May¹; Jocelyn Behling¹; Wiebke Stritter²; Christian Kessler^3,1; Andreas Michalsen^1,3; Daniela Koppold^3,1

¹Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt‐Universität zu Berlin, Berlin, Germany, Berlin, Germany; ²Charité ‐ Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt‐Universität zu Berlin, and Berlin Institute of Health, Department of Pediatrics, Division of Oncology and Hematology, Charitéplatz 1, 10117 Berlin, Germany, Berlin, Germany; ³Immanuel Hospital Berlin, Department of Internal and Integrative Medicine, Berlin, Germany, Berlin, Germany

Introduction and objective: Approximately 15% of couples in Germany are sub fertile. About 50% of this subfertility can be attributed to the male partner. Lifestyle factors are known to have a considerable impact on sperm quality. Pre‐clinical studies have demonstrated that fasting alters hormones such as testosterone, elevates insulin sensitivity and reduces oxidative stress, which affects male spermatogenesis. This mixed method study is the first to investigate feasibility of a Fasting Mimicking Diet (FMD) in the context of subfertility. This abstract focuses on the qualitative analysis of the mixed method study. The research question guiding the qualitative analysis referred to feasibility, usability and possible resulting lifestyle changes of three FMD cycles.

Methods: 23 participants aged 18‐50 years were recruited at fertility centers and outpatient urology clinics between May 2021 and March 2023. They were randomized into a fasting and a control group. The fasting group followed a FMD with a daily maximum caloric intake of 500 kcal for 5 days thrice within 6 months. The FMD used was provided by the company “Salufast”, including complete FMD‐boxes for convenience and a mobile application with motivational elements. 10 semi structured interviews were conducted with subjects from the intervention group regarding their fasting experience in an iterative process. They were evaluated in the style of structured content analysis according to Kuckartz.

Results: Qualitative analysis show that the FMD is feasible, also during work. Some men got the impulse for sustainable changes in their lifestyle, others described a feeling of self‐empowerment concerning their fertility. All men were satisfied by the accompaniment offered by the fasting team and the mobile application. Most of the patients reported a habituation effect, meaning that the third FMD cycle was perceived as easier than the first one. Yet, several participants described difficulties with the recurring food options of the provided FMD.

Conclusion: The FMD, accompanied by a mobile application, might be a tool in the context of lifestyle changes to improve sperm quality. Especially with regards to self‐efficacy and gaining new impulses, fasting might be a promising intervention to support fertility in men. The quantitative data are still to be evaluated to complement the qualitative data.

OS NUTRITION AND LIFESTYLE N 10 Green Hospital Food: Implementation of sustainable, plant‐based foodservices at the University Hospital Essen

Rebeca Montejano Vallejo¹; Kristin Hünninghaus¹; Gustav Dobos¹; Heidemarie Haller¹

¹Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg‐Essen, Germany, Essen, Germany

Introduction: Sustainability is not just an individual responsibility. Sustainability requires structural changes that invite people's commitment to human and planetary health. The transformation of hospital foodservices is a key multiplier for both long‐term recovery of patients and the reduction of the ecological footprint of a hospital. The purpose of this study is to develop and test strategies for redesigning foodservices at the University Medicine Essen (UME), Germany, according to the Planetary Health Diet approach recommended by the EAT‐Lancet Commission.

Methods: At the beginning of the transformation process, a baseline survey was conducted to evaluate the status quo of objective and subjective quality criteria of the existing UME foodservices. This included food content and food waste analyses as well as the evaluation of hospital employees' and patients' satisfaction with the current UME foodservices and their willingness to make healthier and more sustainable food choices.

Results: Baseline analyses revealed significant differences between the current UME foodservices and the recommendations of the Planetary Health Diet approach with regard to insufficient amount of low‐processed plant‐based foods and the high amount of animal components, especially red meat. Total food waste was measured within a period of 4 weeks with the goal of 50% reduction by 2025. Subjective responses from 571 employees and 439 patients showed that 7.7% of the patients and 18.6% of the UME employees followed a vegetarian or vegan diet. A total of 69.6% of the patients and 78.3% of the UME employees already reduced or are willing to reduce their meat intake because of, health issues, animal welfare, and climate change. 74.8% of employees were willing to pay more for a better taste and quality of canteen foods.

Conclusion: Results of the baseline evaluation of UME hospital foodservices showed deviations from the Planetary Health Diet approach and high food waste, both of which have a negative impact on the carbon footprint. Patients as well as employees reported the need and their commitment for further foodservice transformation.

OS NUTRITION AND LIFESTYLE N 11 Evaluation of an innovative two weeks course on nutrition in the context of planetary Health in medical education at Charité University Medicine Berlin.

Gonza Ngoumou¹; Daniela A. Koppold^1,2; Laetitia Wenzel¹; Julia Schiele¹; Wiebke Stritter¹; Christian Kessler²; Georg Seifert¹

¹Charité Universitätsmedizin Berlin, Working group for Integrative Medicine in Peadiatrics, Berlin, Germany; ²Charité Universitätsmedizin Berlin, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, Germany

Introduction: Nutrition is of fundamental importance in the context of human and planetary Health. Health professionals, particularly doctors, could be essential multipliers for healthy food habits. Nonetheless, nutrition is barely covered in the medical school curriculum in Germany. A didactically innovative two weeks course covering the versatile applications of nutrition in medicine was developed and evaluated.

Methods: The course' concept is based on four core components: (1) content and scientific backgrounds of nutrition in the Health of humans and the planet; (2) social, political, ecological and economical environments of food; (3) communicating and motivating for healthy eating and (4) self‐experience and culinary medicine. These components are interwoven and addressed using mixed didactic features, emphasizing participative, immersive, group and peer‐to‐peer learning. The flipped classroom, multimedia displays, topic‐related station work, simulation games, practical training in motivational interviewing, playful quizzes, as well as self‐experience (specific diets, fasting) and shared cooking, are some elements included in the program. The module took place in two consecutive semesters and ran through an evaluation each time. The evaluation consists of quantitative (questionnaires) and qualitative (observation and individual interviews) data. Here, the results are presented descriptively.

Results: Eighteen medical students participated in the first module, from which 80‐100% took part in the quantitative data collection. The average rating of the module was 1,42 on a German school rating scale (scale of 1‐6, 1 very good and 6 very bad). Interestingly, only 6/18 students (33,3%) were initially convinced that nutrition has a high level of evidence in the medical context. At the end of the module, 11/14 (78,6%) were convinced of this statement. Four participants were chosen for the qualitative interviews. The selection was based on the principle of maximum variation sampling according to high and low participation. The result shows a differentiated picture of the module, which guided a series of course improvements for the following semester. The group‐learning atmosphere was highlighted as particularly positive.

Conclusion: The evaluation showed the medical students' hunger for knowledge and great motivation for nutrition. The variety of methods and content was well received and rated valuable for deepening and practising.

OS NUTRITION AND LIFESTYLE N 12 Long term tube feeding enteral nutrition with Italian quality product Arthrospira Platensis

Giorgio Noera¹; Cheti Serafini¹; Morena Gaddoni¹

¹Nursing Home Giardino St Lucia, Massa Lombarda (Ra), Italy

Introduction: Long‐term term nasogastric tube feeding enteral nutrition is defined as a medical nutritional therapy (NGEN) that is provided for more 4 months. The incidence rates are 79 per million inhabitants. Approximately 58% to 87% patients aged ≥75 years died within 730 days after initiation for micronutrient deficiency.

Objective: A high‐level overview of the safety and efficiency of Arthrospira Platensis micronutrients (Spirulina) is at the forefront of the NGEN indication and the goal is to meet the state of need.

Methods: We tested and monitored in 5 frail elderly people over 92 yr assisted with ENGE total Spirulina quality production, for a cumulative survival period of 1750 days. The Critical Quality Attributes and Quality Target Product Profile of patient‐centered care were tested in a multi‐state survival analysis.

Results: The tipping point of sensitivity analysis by Weibull probability density and cumulative function resulted in a Altman's benefit of 5.552 per patient treated and observed likelihood benefit in decreased risk of death by 3.505‐ to‐13.349 fold.

Conclusion: Certified high quality Arthrospira Platensis micronutrients play a key role in the safety and efficacy of long‐term enteral nutrition with permanent pharyngeal nasal tube. The high ratio to procedural advantage, makes it possible to propose it to the above line for the guideline.

OS ART AND MEDICINE N 1 I have seen the life dancing: End‐of‐life stories – A narrative analysis

Pieralba Chiarlone; Giuseppa Gaetana Saita; Flavia Lena; Tuzza Azzurra; Giono Calvetto Silvio; Moruzzi Giovanni

Azienda Sanitaria Provinciale 8, U.O.S.D. Hospice Kairos, Siracusa, Italy

Introduction: Since 2010, Hospice Kairos in Siracusa has offered inpatients, their families, volunteers and caregivers the opportunity to write down their thoughts, experiences and emotions in a single and shared notebook located in the living room. This work explored the human experience of the end of life by analysing the written memories of hospice patients and caregivers.

Methods: A qualitative epistemological analysis model (grounded theory) was chosen to evaluate the written memories collected from 2010 to 2022, during which 1732 patients were admitted to Hospice Kairos in Siracusa. Analysis of the collected memories was carried out by (1) reading all narratives, (2) categorising and quantifying by selected keywords (open coding), (3) creating labels from the meaning units and (4) creating categories containing similar labels.

Results: The study was carried out on 575 written memories. Sixty examples of open coding were identified, and then 24 labels were created, which in turn were categorised into six focused coding categories identified as gratitude, bequest, spirituality, struggle, life journey and bereavement. These six categories represent the main topics of the end‐of‐life experiences analysed in this study.

Conclusions: Interpretation of the focused coding revealed the benefits that writing at the end of life had in terms of the personal evolution of being able to give new meaning to the essence of life.

OS ART AND MEDICINE N 2 Crisis, creativity and finitude: Experiences with expressive therapy in hospice patients

Cristina Endrizzi; Sabina Teresa Mediani; Rosanna Barbaro; Paolo Fumagalli; Francesco Apicella; Ivan Battistin

Unità Cure Palliative, ASST‐Pavia, Mede, Italy

Introduction: A growing body of research is addressing the role of embodied resonance in intersubjective relationships. In embodied therapies, embodied resonance is about the posture, bodily sensations, emotional perception and expressive movement of each partner in reaction to the other (Fuchs and Kock, 2014). Embodied resonance is behind kinaesthetic empathy and sustains the process focalised to one's own awareness and countertransference experience in the therapeutic setting. Attention to patient spirituality is the topic of several consensus‐based recommendations and is an essential element of care in cases of serious illness. Art therapy (music, art and dance) is included among spiritual health interventions (Puchalsky, 2019). Using preverbal instruments, the creative process emphasises the ability to symbolise. Expressive therapies are included in the interventions in order to support end‐of‐life conversations about spiritual issues. To face impending death constitutes a crisis. By focusing on ontological representations of death as transformation or passage (instead of annihilation), the person in crisis can develop an attitude of resilience (Testoni, 2015). In these experiences, the underlying goal is to offer a transformative place where patients can shape their deepest concerns about the topic of transcendence.

Methods: In the hospice setting, patients facing death are invited to engage in dance movement therapy, musical instruments, and artistic tools to describe their thinking and feelings about spiritual issues. By attunement and mirroring, therapists can adjust their responses according to their patients' feelings. Therefore, a motor dialogue proceeds. A transition phase involving drawing is then offered before the verbal narration.

Results: The aesthetic graphical and motor products of patients are collected and compared with interventions carried out by healthcare professionals during training courses about end‐of‐life themes.

Conclusion: A philosophical interpretation concerning the phenomenology of crossing the threshold is suggested, and how patients and healthcare professionals feel about it. This also implies a different vision of temporality.

OS ART AND MEDICINE N 3 The effect of active visual art therapy on health outcomes: A systematic review and meta‐analysis of randomised controlled trials

Ronja Joschko, Caroline Klatte, Weronika A. Grabowska, Stephanie Roll, Stefan N. Willich, Anne Berghöfer,

Institute for Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, Germany

Introduction: Art therapy has a longstanding tradition in patient treatment. In recent years, there has been a noticeable surge in research publications exploring its efficacy. To provide a comprehensive overview of the field, our objective was to conduct a systematic review including all randomized controlled trials (RCTs).

Methods: We focused on active visual art therapy (AVAT), during which a patient manipulates any kind of material (for example clay, paint, etc.) with the aim of receiving a therapeutic effect. We included all control groups that utilized interventions other than AVAT. Using a peer reviewed search strategy we conducted a systematic literature search of the Cochrane Library, EMBASE (via Ovid), MEDLINE (via Ovid), CINAHL, ERIC, APA PsycArticles, APA PsycInfo, and PSYNDEX (all via EBSCOHost) and the clinical trials registry ClinicalTrials.gov. We evaluated the study quality using the Cochrane Risk of Bias tool ROB2. Publication bias was addressed using funnel plots. We synthesized the results through narrative summaries and forest plots. Additionally, we performed a meta‐analysis with multiple subgroups and conducted a meta‐regression.

Results: Our review included 74 reports from 69 studies, with 60 studies analysed quantitatively in a meta‐analysis. The studies included a total of 3951 participants. In the majority of studies, art therapy was used to treat patients with mental health issues. The most commonly studied outcomes were anxiety, depression, well‐being, self‐esteem and social adjustment. Overall, art therapy tended to have positive effects, but the general quality of the studies is low.

Conclusions: Art therapy seems to be associated with therapeutic benefit. However, further good quality studies are needed to establish guidelines, standards, best practice models of art therapy and to provide better evidence of its potential efficacy.

OS ART AND MEDICINE N 4 Pain‐ting: The act of painting as a pain reliever

Sharon Benraf Moses

Rehabilitation Complementary Medicine Unit, Reuth TLV Rehabilitation Hospital, Tel Aviv, Israel

What is the impact of painting as a way of self‐medicating? How does it help us, and why is it similar to stand‐up comedy as a therapeutic method, even when its content is very dark? Can the process of painting change our course from self‐destructive behaviour such as “cutting”, using drugs or self‐induced vomiting?

Fifteen years ago, I made the decision to deal with my own eating disorder. I was an art student back then, and the four years that I dedicated to painting my pain saved my live. At the end of those four years, I changed the direction of my life from an art teacher to a practitioner and teacher of Traditional Chinese Medicine.

This lecture shares my insights and is spiced with images from my own life (including the drawing series “Zang Fu” based on Traditional Chinese Medicine], from patients' lives, and from famous artists – artists who had to deal with chronic or terminal illness and expressed their struggles on canvas.

OS ART AND MEDICINE N 5 How healthcare clowns can contribute to more supportive hospital environments: RED NOSES Partnerships in the Healthcare System

Monica Culen¹

¹RED NOSES International, Vienna, Austria

Introduction and objective: RED NOSES is an artistic organization engaging with different vulnerable groups (children in hospitals, children with disabilities, elderly people, and refugees) through the art of clowning. RED NOSES carried out an Evaluation, examining how the relationships between RED NOSES and its healthcare partners have developed, and how they are perceived by healthcare staff.

Methods: The evaluation was conducted in 2021 by external evaluator, PhD Diana Harper, following a mixed‐method approach. A survey was conducted among hospitals that regularly collaborate with RED NOSES (729 surveys in 10 countries), as well as two case studies in hospitals in German and Jordan, and focus groups and key informant interviews with RED NOSES team members and external experts.

Results: The question “During an emergency situation, do you think clowns should be considered essential workers as part of the healthcare team?” received mixed responses. Around one‐third answered yes (36%), most respondents weren't sure (43%), and a minority answered no (21%), confirming the different opinions among partners on the role of healthcare clowns.

Conclusions: The common goal between the healthcare sector and RED NOSES is to create more supportive environments in hospitals. To achieve this, both sides must apply an integrated and cross‐sectoral care approach. Based on the results of the evaluation, a Partnership Compass was developed to provide a common understanding of what makes partnerships between RED NOSES and healthcare institutions successful and how these can be further developed.

Some recommendations of the evaluation are to work on better defining and communicating the role of clowns in hospitals. Another recommendation is to co‐create more opportunities for clowns to support the healthcare partners, especially in more acute and stressful situations.

To increase the sustainability of the cross‐sectoral collaboration, there is a need to look beyond individual partnerships and seek systemic change. An important part of these efforts is to raise awareness for the positive impact of using artistic and humorous approaches in healthcare settings.

OS ART AND MEDICINE N 6 The powerful experience. Emotion regulation and self‐image in personality disorders in arts & psychomotor therapies

Suzanne Haeyen^1,2; Susan Van Hooren³

¹HAN University of Applied Sciences, Nijmegen, Netherlands (The); ²GGNet Centre of Mental Health, Apeldoorn, Netherlands (The); ³Open University, Heerlen, Netherlands (The)

Introduction and objective: Arts & psychomotor therapies are experience‐based and use tools like drama, dance, images, exercise, movement or music. Multidisciplinary treatment programs for people diagnosed with personality disorders often include these forms of therapies. Personality disorders are complex mental disorders and people with this diagnosis are often difficult to reach from an emotional perspective. But how are these therapies perceived, what are the effects and what are the working mechanisms? How are these therapies perceived by patients? In this presentation from the research group for Arts & Psychomotor therapies in Personality Disorders we will introduce the use of arts & psychomotor therapies within this target group and point out core themes of art therapy: the powerful experience, emotion regulation and self‐image regulation.

Methods: An overview of recent quantitative (RCTs) as well as multiple qualitative studies will be presented and discussed.

Results: The available studies show promising results regarding effects of arts and psychomotor therapies. Patients perceive these therapies as a positive and effective way to improve the felt connection with their emotions, gain self‐insight and improve personal behavior and social functioning.

Conclusion: Arts & psychomotor therapies may help people diagnosed with a personality disorder to gain access to their emotions, to be able to regulate their emotions and to develop a stable, more positive self‐image. Although the evidence base is growing there is still a considerable need for more knowledge on this topic ‐ theoretical, scientific and practical.

OS ART AND MEDICINE N 7 Approaching artistic expression through the therapist's eye and patient's self‐reported Inner Correspondence. A conceptual framework to evaluate and better understand the impact of anthroposophic painting‐ and eurythmy therapy on clinical outcome

Annette Mehl¹; Dagmar Brauer²; Katharina Gerlach³; Hans‐Broder von Laue⁴; Marcus Reif⁵; Roland Zerm¹; Christoph Gutenbrunner⁶; Matthias Kröz^7,8,1

¹Research Institute Havelhöhe, Berlin, Germany; ²Medical Section, School of Spiritual Science/Goetheanum, Dornach, Switzerland; ³Institute for Eurythmy Therapy, Research Institute of Arts Therapy, Alanus Hochschule, Alfter, Germany; ⁴AnthroMed Öschelbronn – Centre for Integrative Medicine, Niefern‐Öschelbronn, Germany; ⁵Society for Clinical Research, Berlin, Germany; ⁶Clinic for Rehabilitative Medicine, Hannover Medical School, Hannover, Germany; ⁷Hospital Arlesheim, Research Department, Arlesheim, Switzerland; ⁸Institute for Integrative Medicine, University Witten/Herdecke, Witten‐Herdecke, Germany

Introduction: Among the artistic anthroposophic therapies (ATs) painting therapy and eurythmy therapy, a mindful artistic therapy, are of prominent importance to treat a range of somatic, psychosomatic and psychiatric conditions. To better understand the possible impact of artistic expression during ATs on clinical outcome, we associated the level of therapists' evaluated watercolor images and movement entities with patients' self‐reported therapy immersion using the Inner Correspondence Questionnaire with Painting Therapy (ICPTh) and Inner Correspondence and Peacefulness with Practice (ICPH). Introduced is a conceptual framework to investigate possible interactions between ATs and patients' inner correspondence.

Methods: In two nested validation studies we examined pictorial expression with the Anthroposophic AART Therapy Paint (AART‐ASSESS‐P) and eurythmy gestures with the Anthroposophic AART Therapy Eurythmy Move (AART‐ASSESS EuMove). In a second step we correlated therapists' evaluations with the ICPTh for painting therapy and the ICPH for eurythmy therapy.

Results: Sufficient to good reliability was found for the five subscales of the AART‐ASSESS‐P (r_α = 0.60 – 0.81) and the total score (comprising three subscales) of the AART‐ASSESS EuMove (r_α = 0.89). Low Spearman rho correlations were found between the AART‐ASSESS‐P subscale 'color quality' and the ICPTh (r = 0.25, p = 0.058), and between the AART‐ASSESS EuMove subscale ‘Mindfulness in Movement’ and the ICPH (r = 0.32, p < 0.05). The ICPTh is associated with lower distress, depression, affective fatigue (r = ‐0.26 – ‐0.29, p < 0.05) and better rest/activity regulation (r = 0.26, p < 0.05). The self‐report questionnaires on Inner Correspondence (ICPH and ICPTh) are correlated with internal coherence (r = 0.29, 0.32, both p < 0.05).

Conclusion: The two peer‐report instruments give insight in how therapists evaluate patients' painting expression and eurythmy therapy gestures during APT and ET. Additionally, low associations with patients' Inner Correspondence and therapeutic evaluations could be detected. Further studies should investigate the impact of artistic expression and patient's Inner Correspondence on clinical outcome.

OS ART AND MEDICINE N 8 Medicine is Art and Art Medicine – The impact of Art for Cancer Patients

Oliver Micke¹; Büntzel Jens²

¹Department of Radiotherapy and Radiation Oncology, Franziskus Hospital, Bielefeld, Germany; ²Department of Otolaryngology, Südharz Hospital, Nordhausen, Germany

Introduction: Arts in medicine programs have significant impacts on patients and staff in long‐term care environments, but the literature lacks evidence of effectiveness on cancer patients.

Methods: An art in medicine program was initiated, consisting of art therapy, workshops, lectures on art, visiting art exhibitions and reading art books. The qualitative study used individual structured interviews to assess the impact of the art programming on satisfaction, stress, coping, feeling of support, quality of life in 20 breast cancer patients.

Results: The study confirmed that the art program can positively affect satisfaction, stress, coping, feeling of support, quality of life in breast cancer patients. Significant insights related to distraction and relaxation, self‐expression and communication, and supportive community, and the art program were found.

Conclusion: While positive impacts of the art program are clear, potential negative effects also need to be considered in the development of practice protocols. Overall, art can provide cancer patients with a range of benefits, from emotional support and relaxation to opportunities for self‐expression and community building.

OS ART AND MEDICINE N 9 Arts Therapies in Forensic Psychiatric Care: a review on effects, active elements, and mechanisms of change

Susan Van Hooren¹; Annemarie Abbing^2,3; Wim Waterink¹; Peter Verboon¹; Sashank Nyapati²; Suzanne Haeyen^5,3,4

¹Open University of the Netherlands, Heerlen, Netherlands (The); ²Hogeschool Leiden, Leiden, Netherlands (The); ³KenVaK Research centre for the Arts Therapies, Heerlen, Netherlands (The); ⁴HAN University of Applied Sciences, Nijmegen, Netherlands (The); ⁵GGNet Centre of Mental Health, Apeldoorn, Netherlands (The)

Introduction: Mental health care in forensic settings consists of a broad range of treatments, including arts therapies. Arts therapies consist of (visual) art therapy, music therapy, drama therapy and dance (movement) therapy. Despite positive experience in practice, there remains little research on the effects, active elements, and mechanisms of change of arts therapies in forensic settings.

Methods: We performed a systematic review. Meta‐analyses were performed to investigate the effects of arts therapies among adult patients in forensic settings. ‘Principles of Realist Review’ was applied to identify relations between active elements, its effects, and mechanisms of change. In addition, PRISMA Guidelines were used. Studies were search in PubMed, CINAHL, APA PsycInfo, Web of Science Core Collection and EMBASE. Included were Randomised Controlled Trials, Controlled Clinical Trials, case control studies, cohort studies, and multiple case studies. Only peer‐reviewed articles, published in English, Dutch or German language were included. The types of participants and setting were restricted to adult patients in forensic settings, aged 18‐65 years, from any gender or ethnicity. The studies need to investigate arts therapies provided by an arts therapist. Type of outcome measures were restricted to quantitative measures of psychosocial outcomes. These outcomes were clustered in risk‐ and protective factors for recidivism. Quality and risk of bias was assessed using Effective Public Health Practice Project.

Results: Twenty‐six studies were included in the review. The included studies were heterogeneous in type of outcome measures, intervention characteristics, and described mechanisms. The meta‐analyses indicated significant effects on both risk factors (psychiatric symptoms, addiction) and protective factors for criminal behaviour (social functioning, psychological functioning). Effects on criminal and/or antisocial behaviour were not significant, but this outcome measure was scarcely used among the studies. The analyses of mechanisms of change resulted in a description of regulatory processes which are stimulated by the applied interventions during arts therapies.

Conclusions: The systematic review showed that arts therapies in forensic settings yields effects on psychiatric symptoms, social functioning, and psychological functioning. Furthermore, these findings give insight in how arts therapies results in these effects in forensic psychiatric patients.

OS BASIC AND TRASLATIONAL RESEARCH N 1 Phytotherapy and Anthroposophic medicine as a treatment option for allergic rhinitis: A systematic review

Céline Braunwalder¹; Eliane Timm¹; Matteo Wullschleger¹; Jana Ertl¹; Ursula Wolf¹

¹Institute of Complementary and Integrative Medicine, University of Bern, Bern, Switzerland

Introduction and objective: Allergic rhinitis is a common disease that affects a person's quality of life and leads to loss of productivity at work. Traditional, complementary, and integrative medicine is highly accepted and frequently used among individuals with allergic rhinitis. An overview of the current state of research on the effect of medications from Western phytotherapy and anthroposophically extended medicine (AeM) would be useful to inform affected individuals about potential treatment options. The main objective of this article is to systematically summarize evidence on the efficacy, effectiveness, and safety of Western phytotherapy and AeM in individuals with allergic rhinitis.

Methods: Four electronic databases (i.e. PubMed, Ovid Embase, Ovid AMED, Anthromedics) were screened for clinical studies published between 1990 and April 2022. All types of study designs were considered to capture the full range of evidence, providing a comprehensive overview for further research and the use of medication. Findings from included studies were qualitatively synthesized, separately for Western phytotherapy and AeM. Study quality was assessed by the integrated quality criteria for the review of multiple study designs (ICROMS) tool.

Results: 27 studies were included in this systematic review, 19 studies on Western phytotherapy (13 randomized controlled trials (RCTs); 6 with a pre‐post design) and 8 studies on AeM (3 RCTs; 6 with a pre‐post design). Study results on Western phytotherapy showed beneficial effects on nasal and ocular symptoms and quality of life. The most frequently studied herbs were Petasites hybridus and Nigella sativa. Studies on AeM reported beneficial effects on nasal and ocular symptoms. A nasal spray based on Citrus/Cydonia and Euphrasia eye drops were the most reported medications in AeM. The medications studied were rated to be safe in studies that reported on safety. The majority of RCTs were of high quality, whereas observational studies were rated to be of low quality.

Conclusions: Findings from this systematic review suggest several medications from Western phytotherapy and AeM that are beneficial and safe in the treatment of allergic rhinitis. The results support physicians and pharmacists in advising individuals with allergic rhinitis on potential treatment options.

OS BASIC AND TRANSLATIONAL RESEARCH N 2 Aromatherapy, Dental Fear and Anxiety: Influence of essential‐oil vaporization in dental practices on acute anxiety ‐ a multicenter, cluster‐randomized, controlled, single‐blinded study (AROMA_dent)

Judith Czakert¹; Farid Kandil¹; Wiebke Stritter¹; Georg Seifert¹

¹Charité ‐ Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt‐Universität zu Berlin, Department of Pediatric Oncology and Hematology, Integrative Medicine in Pediatric Oncology, Berlin, Germany

Background: Dental fear and anxiety (DFA) is known as a great challenge in oral healthcare, which can result in compromised oral health, dental pain, and uncomfortable treatment. Although the need for strategies to prevent DFA is apparent and addressed by various approaches, the evidence of effects of essential‐oil vaporization in dental practices and their potential to address DFA is limited.

Objective: Subsequently, the primary aim of this study was to investigate the effect of stress‐reducing essential‐oil vaporization in dental practices on acute anxiety of patients.

Methods: Four dental practices underwent 5 conditions (vaporization of mono essential oils Orange, Swiss Pine, blended essential oils Forest Walk, Good Mood, and control group) in 5 consecutive weeks in a block randomized design. The sample included patients between 18 and 65 years for treatment routine examination, acute pain or planned intervention. The primary outcome measured was the acute anxiety with the State‐Trait‐Anxiety Inventory (STAI‐S) in the validated German version. Prior to dental treatment the STAI‐S was measured and compared between the four essential‐oil conditions and the control condition. Independent ANCOVAs were calculated to estimate the contribution of five confounders: age, gender, trait anxiety and practice.

Results: 486 patients completed the STAI‐S and could be included in the analysis. Across all patients, STAI‐S was slightly higher in the control group (40.7 ± 11.6) than in the intervention groups (38.4 ± 10.5), but this difference was not significant. We confined an additional analysis on the subpopulation (n = 131 patients) with an increased level of trait anxiety (STAI‐T scores ≥42 = cut‐off). For this group, the difference in acute anxiety between the control group (51.1*11.9, n = 30) vs. the groups treated with essential oils (46.8*9.6, n = 118) was significant (T = 4.39, p = 0.0379), however, not clinical relevant.

Conclusion: The results of the additional analysis confirm the general potential of essential‐oil vaporization to alleviate acute anxiety in dental patients with a high trait anxiety. The stress‐reducing effect is also confirmed by anecdotic statements of the dental‐practice staff, as well as a generally positive effect on the atmosphere and mood in the practice. Further research should consider using multimethod approaches and including the dental office staff in the target population. It might also be of interest for future research to investigate the anxiety‐reducing role of essential‐oil vaporization as one part of a combination of techniques against DFA.

OS BASIC AND TRANSLATIONAL RESEARCH N 3 Evidence‐Based Medicine in the context of Complementary and Integrative Traditional Medicines: a critical analysis

Rafael Dall'Alba¹; Charles Tesser²; Mariana Sato³

¹Pan American Health Organization (PAHO), Brasilia, Brazil; ²Federal University of Santa Catarina, Florianópolis, Brazil; ³University of São Paulo, São Paulo, Brazil

Introduction: The dynamics of knowledge permeate social, cultural, and political instances where science stands out as a tool for interpreting and systematising knowledge. In this epistemological construction, some paradigms are more or less prominent and are based on specific knowledge totems. In the health field, it is no different, the dominance of the hegemonic biomedical paradigm captures the way of doing science, dictating what is and is not evidence. For example, we can cite evidence‐based medicine (EBM) as an element of knowledge validation based on its four pillars: clinical expertise, research evidence, the patient's values and circumstances, and the practice context. However, other paradigms interpret health differently, such as the vitalistic paradigm, which brings together complex medical systems from Complementary and Integrative Traditional Medicines (TCIM) that are disseminated and recommended by the World Health Organization. However, when biomedical scientific standards scrutinise these TCIMs, they are often criticised for lack of efficacy and effectiveness.

Methods: This analysis aims to problematise the construction of evidence from its established method ‐EBM ‐ within its application in the context of TCIM, highlighting strengths and captures. This approach is based on the literature review of the themes of TCIM and EBM, referencing the Critical Theory of Technologies.

Results: The results are derived from Horton's (2014) reflection, which questions whether science is in the right place to understand the meaning and efficacy of one of the most widespread TCIMs, mindfulness. It is necessary to highlight that EBM predominantly arises from the pillar of evidence and that, after successive criticisms, “incorporated” subjective dimensions such as the circumstance in which the practice is carried out, the user's perspective, and the context from the professional who uses them. However, these subjective elements were not valued in this dynamic of information validation in health decision‐making. Moreover, it is precisely these pillars that emerge in the TCIM. Although TCIM has some evidence formatted to hegemonic standards, its holistic approach presents a challenge, especially since these undervalued pillars of EBM deal with central themes in promoting effective healthcare, such as greater clinical sensitivity of professionals, clinical conduct adjusted to circumstances and contexts of social determinants of health, greater patient adherence (including in allopathic therapies), promotion of self‐care, rational use of medications (patient and professional) among many others.

Conclusions: In conclusion, this imbalance generated by the misapplication of EBM, disregarding the pillars related to subjectivity, presents itself as one of the significant challenges for the scientific development of this vitalistic paradigm. Recognising these elements means promoting epistemological justice and the practical possibility of strengthening science as a fundamental element of the social transformation of health care.

OS BASIC AND TRANSLATIONAL RESEARCH N 4 Protective Effect of Limosilactobacillus fermentum ME‐3 against the Increase in Paracellular Permeability Induced by Chemotherapy or Inflammatory Conditions in Caco‐2 Cell Models

Ivano Hammarberg Ferri

IHF, Bologna, Italy

Introduction: Chemotherapy‐ or inflammation‐induced increase in intestinal permeability represents a severe element in disease evolution in patients with colorectal cancer and gut inflammatory conditions. Emerging data strongly support the gut microbiota's role in preserving intestinal barrier integrity, whilst chemotherapy and gut inflammation alter microbiota composition. Some probiotics might have a strong re‐balancing effect on the gut microbiota, positively affecting intestinal barrier integrity.

Methods: In this study, we asked whether Limosilactobacillus fermentum ME‐3 can prevent the intestinal paracellular permeability increase caused by the chemotherapeutic drug Irinotecan or by inflammatory stimuli, such as lipopolysaccharide (LPS). As an intestinal barrier model, we used a confluent and polarized Caco‐2 cell monolayer and assessed the ME‐3‐induced effect on paracellular permeability by transepithelial electrical resistance (TEER) and fluorescent‐dextran flux assays. The integrity of tight and adherens junctions was examined by confocal microscopy analysis. Transwell co‐cultures of Caco‐2 cells and U937‐derived macrophages were used as models of LPS‐induced intestinal inflammation to test the effect of ME‐3 on the release of the pro‐inflammatory cytokines Tumor Necrosis Factor α, Interleukin‐6, and Interleukin‐8, was measured by ELISA.

Results: The results demonstrate that ME‐3 prevents the IRI‐induced increment in paracellular permeability, possibly by modulating the expression and localization of cell junction components. In addition, ME‐3 inhibited the increase in paracellular permeability and the release of pro‐inflammatory cytokines in the co‐culture model of LPS‐induced inflammation.

Conclusions: Our findings sustain the validity of L. fermentum ME‐3 as a valuable therapeutic tool for preventing leaky gut syndrome, still currently without an available specific treatment.

OS BASIC AND TRANSLATIONAL RESEARCH N 5 Bojungikki‐Tang Enhances the Efficacy of Pembrolizumab Treatment in Human PBMC‐Injected H460 Tumor‐Bearing Mice

Se Won Na¹; Jin‐Mu Yi¹; Jaemoo Chun¹; Mi‐Kyung Jeong¹

¹KM Convergence Research Division, Korea Institute of Oriental Medicine, Daejeon, Korea (Republic of)

Introduction and objective: Immune checkpoint inhibitors (ICIs) have become a major treatment option for non‐small cell lung cancer (NSCLC), but their efficacy is still limited because only a subset of patients responded to ICIs. Bojungikki‐Tang (BJIKT), a widely used herbal medicine extracted from 10 medicinal plants, has been largely investigated as a combined treatment with anticancer agents. In this study, we examined the potential anti‐tumor effect of co‐administration of BJIKT and pembrolizumab in human PBMC‐injected H460 tumor‐bearing MHC I/II double knockout (dKO) NSG mice.

Methods: Human PBMC‐injected MHC I/II dKO NSG mice were injected with H460 cells to induce lung tumor formation and were given injection of pembrolizumab and BJIKT, respectively or both.

Results: We found that combination treatment with BJIKT and pembrolizumab significantly suppressed tumor growth by regulating the activation of immune cells. Immunohistochemistry and flow cytometry analysis showed that the combination therapy decreased the exhausted proportion of CD8(+) and CD4(+) T cells expressing PD‐1 and LAG‐3 markers in the tumor tissues. Additionally, gene expression analysis using RNA‐Seq suggested that combination treatment regulates immune‐related pathways with anti‐tumor effects.

Conclusions: Taken together, we found that combination therapy altered immune cells and regulated anti‐tumor immune response, paving the way for a more effective understanding of the role of BJIKT in the tumor microenvironment.

OS BASIC AND TRANSLATIONAL RESEARCH N 6 AroMaDem ‐ Aroma oil massage with lavender oil for residents in nursing homes with agitated dementia

Carina Klocke¹; Birgit Kröger¹; Regina Stolz¹; Elke Kaschdailewitsch¹; Holger Mauch¹; Bettina Noack¹; Stefanie Joos¹; Jan Valentini¹

¹University Hospital and Faculty of Medicine, Tübingen, Germany. ¹Institute for General Practice and Interprofessional Care, University Hospital and Faculty of Medicine, Tübingen, Germany

Introduction and objective: With life expectancy steadily increasing, the number of people living with dementia is also rising. The quality of life of those affected as well as their family caregivers is often severely impaired by psychological and behavioral symptoms of dementia (BPSD). Symptomatic treatment by pharmacological approaches frequently causes severe side effects and rarely is of sufficient effectiveness. Aroma massages with lavender oil (Lavandula angustifolia) represent a promising complementary medicine approach to alleviate symptoms, as it is the most researched essential oil to date in terms of reducing agitation in people with dementia. The aim of this this study (AroMaDem) is to investigate a standardized intervention including a training curriculum on aroma massage for people with agitated dementia in a nursing home setting.

Methods: Within the framework of an explorative randomized‐controlled trial, the feasibility in everyday care and the clinical benefits will be evaluated. Approximately n = 120 nursing home residents will receive either a hand and forearm rub with lavender oil (2%) (intervention group) or additional, non‐olfactory or non‐sensory stimulating single activities (control group) four times a week over 8‐12 weeks. Changes in agitation (clinical benefit) will be assessed using the Cohen‐Mansfield Agitation Inventory (CMAI) and Neuropsychiatric Inventory (NPI‐NH); documentation and evaluation of indication‐related medication will also occur. The feasibility will be investigated via retention rate, documentation of side effects and on the basis of a qualitative process evaluation (interviews) with the professional groups and relatives involved.

Results: To date, there are n = 9 nursing homes enrolled into the study and within their process of recruiting residents. We gained first insights concerning the feasibility of the intervention during trainings and supervision of the study teams. It shows that motivation within the teams is high and both interventions are feasible for every care when conducted by trained specific dementia caregivers of the nursing homes.

Conclusions: First results concerning the feasibility and clinical benefits are expected shortly and will be presented at the congress. If the evaluation is as positive as expected, the low‐threshold approach and safe use of 2% lavender oil could be transferred in a home setting by family caregivers.

OS BASIC AND TRANSLATIONAL RESEARCH N 7 Strategy change in oncology‐ an individual adaptation of conventional and complementary therapy strategies based on tumor gene expression and sensitivity of circulating tumor cells

Martin Landenberger¹

¹Praxis Dr. Landenberger, Munich, Germany

Introduction: Our conventional cancer treatment is determined by guidelines „one sized fits all“ and not tailor‐made a soften requested, after a series of rigid therapy staging will show where the therapy was beneficial or in vane.

In tailor‐made sensitivity tests like in blood harvested circulating cancer cells responsivness for conventional and complementary therapy such as plant extracts can be tested and the therapy therefore is selective.

In tumor tissue‐ fresh or formalin fixed FFPE the gene expression can be measured to allow us to select to most matching therapy.

Materials and methods: EDTA blood samples are used to harvest circulating tumor cells CTC to measure the response to conventional and complementary therapies such as misteltoe, curcumin, resveratrol, shogaol, and others. Often plant extracts can improve conventional therapies and reduce immunosuppressive effects.

A differential chemo and biological sensitivity test with fresh tissue or in formalin‐fixed tissue FFPE allows us to evaluate the therapeutic efficiency of 40 chemotherapies and 20 natural plant extracts due to the actual gene expression in changing cancer tissue. The therapy can be adapted to different changing cancer tissue.

Results: In tailor‐made conventional and complementary tissue, a higher response with eventually lower side effects on bone marrow or gut tissue can be observed, and the life span, as well as the life quality, can be improved sometimes dramatically.

Impressive cases will be demonstrated.

Discussion/ conclusion: As tailor‐made diagnostics to response of conventional as well as complementary therapies from examination of CTC‐sensitivity and tumor gene expression tests is available the therapy can be improved in favor of survival rates as well as therapy responses or complete remissions.

Reasons for change from normal tissue into cancer tissue (endogenous disruptors/xenoestrogens) will be presented.

Cases of how to treat well and successfully will be presented step by step.

OS BASIC AND TRANSLATIONAL RESEARCH N 8 Machine learning model to predict short‐term outcomes following acupuncture and manual therapy for lumbar disc herniation using electronic health records

Ye‐Seul Lee¹

¹Jaseng Medical Foundation, Seoul, Korea (Republic of)

Introduction: The development of electronic health records (EHR)‐based machine learning models has advanced in the recent years with the aim of enhancing the quality and efficacy of healthcare. This study examined the ability of machine learning models to predict results following acupuncture treatment for lumbar disc herniation (LDH).

Methods: A total of 7,969 patient records between May 2016 to April 2021 from five Korean Medicine hospitals were used to develop and validate a prognosis‐predictive machine learning model. A total of 137 features including demographics, patient history, test results, patient‐reported outcomes on pain and quality of life, and magnetic resonance imaging (MRI) interpretations were preprocessed and included in the model. Using numeric rating scale (NRS), a minimal clinically important difference (MCID) of 1.6 was considered as “improved.” Random forest, XGBoost, Gradient Boosting Model (GBM), and a traditional logistic regression model were used to develop prediction models.

Results: The mean age of patients in the improved and unimproved groups were 50.0 and 48.5, respectively. Average days since onset in the improved and unimproved groups were 351 and 324 days, respectively. The model predicted improvement after acupuncture and manual therapy with an area under the receiver operating characteristic curve of 0.918. Pain ratings in the back and legs, use of non‐steroidal anti‐inflammatory drugs (NSAIDs), height and weight, degeneration of lumbar discs in MRI interpretations were important features in predicting the improved short‐term outcome of LDH patients after a minimum of 14‐days acupuncture and manual therapy treatment.

Conclusion: This study proposes a set of machine learning models for predicting outcomes of acupuncture and manual therapy treatments for LDH patients, taking into account demographic, disease‐related, and radiologic features. Further studies are warranted to ensure external validity across different populations and follow‐up periods. The results can contribute to patient consultations and risk adjustment for non‐pharmaceutical LDH management.

OS BASIC AND TRANSLATIONAL RESEARCH N 9 Gelsemium Low Doses Increases Bioenergetics and Neurite Outgrowth

Imane Lejri^1,2; Amandine Grimm^1,2; Pascal Trempat³; Naoual Boujedaini³; Anne Eckert^1,2

¹Transfaculty Research Platform Molecular & Cognitive Neuroscience, Neurobiology Laboratory for Brain Aging and Mental Health, University of Basel, Basel, Switzerland, Basel, Switzerland; ²Psychiatric University Clinics, Basel, Switzerland, Basel, Switzerland; ³Laboratoire Boiron, Messimy, France, Messimy, France

Introduction and objective: Gelsemium sempervirens (GS) is medicinal plant, traditionally used in homeopathy as a remedy for a variety of psychological and behavioral symptoms of anxiety and depression. Changes in neural plasticity have been shown to play a significant role in the onset and development of those mental illnesses. Mitochondria play an extremely important role in the central nervous system by being the main energy producer through oxidative phosphorylation and being involved in the regulation of cell survival and death, as well as synaptic plasticity. Neurite outgrowth is the differentiation process by which neurons establish synapses through the protrusion of neurons and their extension. Because the effects of GS dynamized dilutions on mitochondrial function and neuroplasticity remain elusive, we aimed to investigate whether a treatment with GS at 3C and 5C (C, centesimal dilutions) improved bioenergetic parameters such as ATP production, mitochondrial respiration, cellular glycolysis, and neurite outgrowth.

Methods: The effects of the 3C and 5C GS dynamized dilutions were investigated on human SH‐SY5Y neuroblatoma cells. Nerve growth factor (NGF), which is known as a promotor of cell growth and survival, was used as a positive control. ATP levels and cell survival were evaluated by bioluminescence and MTT assays, respectively. Cells were treated for 24h either with medium alone (untreated control condition, CTRL), NGF, vehicle control or the different dynamized dilutions. Bioenergetic phenotype (OCR/ECAR profiles) and effect on neurite outgrowth on 2D or 3D cell cultures were investigated for the CTRL, NGF, or GS dynamized dilutions treatment conditions after 24h or 3 days, respectively.

Results: Our results demonstrate that GS dynamized dilutions (3C and 5C) efficiently ameliorated the bioenergetics of SH‐SY5Y neuroblastoma cells by increasing cellular ATP level and mitochondrial respiration as well as promoting cell survival. In addition, GS dilutions significantly improved neurite extension in 2D as well as 3D culture models after 3 days of treatment. 3C and 5C dilutions showed similar functional effects to those obtained with the positive control NGF.

Conclusions: These findings indicate that GS dilutions modulate mitochondrial bioenergetic phenotype and improve neurite formation. The mitochondrial function‐improving properties of GS dynamized dilutions may represent one possible pathway contributing to their neuroprotective effects.

OS BASIC AND TRANSLATIONAL RESEARCH N 10 Exploring the pivotal variables of tongue coating metabolites between patients with type 2 diabetes from healthy controls

Lun‐Chien Lo^1,6; Pei‐Yung Liao^1,2; Po‐Chi Hsu^1,3; Der‐Yen Lee¹; John. Y. Chiang^5,4

¹China Medical University, Taichung, Taiwan (China); ²Changhua Christian Hospital, Changhua, Taiwan (China); ³Kuang Tien General Hospital, Taichung, Taiwan (China); ⁴Kaohsiung Medical University, Kaohsiung, Taiwan (China); ⁵National Sun Yat‐sen University, Kaohsiung, Taiwan (China); ⁶China Medical University Hospital, Taichung, Taiwan (China)

Introduction: Diabetes mellitus (DM) is a public problem closely associated with numerous oral complications, such as coated tongue, xerostomia, salivary dysfunction, etc. The observation of tongue coating, a foundation for clinical diagnosis and treatment in traditional Chinese medicine (TCM), is a significant indicator of a disease's occurrence, development, and prognosis. The biological basis of tongue diagnosis and the relationship between the metabolites and biomarkers of the tongue coating remains elusive. This study aims to evaluate the tongue coating metabolites and tongue features between patients with type 2 diabetes mellitus (DM), pre‐diabetes and individuals without DM.

Methods: This study is a case‐controlled and prospective cohort study from July 2020 to Dec 2021. Detailed information about the participants, including general information, history of diabetes, and tongue diagnosis, was collected from the interview. We have applied the automatic tongue diagnosis system to assess the tongue feature differences in TCM diagnosis. Nine primary tongue features will be extracted and analyzed, including tongue shape, tongue colour, tooth mark, tongue fissure, fur colour, fur thickness, saliva, ecchymosis, and red spots. After collecting the tongue coating and analyzing the metabolite composition using liquid chromatography‐mass spectrometry (LC‐MS), the data will be used to establish the metabolite signature for diabetes.

Results: We have enrolled 169 participants, comprising 123 participants with type 2 diabetes, 13 participants with pre‐diabetes, and 24 non‐diabetes participants. There are 340 metabolite signals detected to differentiate DM stages further. The difference of metabolite intermediates in several pathways was observed in tongue fur samples (see the heat map). The top impact pathways were linked to lipid metabolism. The differential lipid composition may be resulted from aberrant diabetic conditions and could be used to represent the characteristics of diabetes.

Discussion: This study aims to identify the tongue features of DM using TCM diagnostic tools and to investigate the pattern differences and treatment. Current results only compare the difference of metabolites in tongue coating between DM and non‐DM (pre‐DM plus normal subjects).

OS BASIC AND TRANSLATIONAL RESEARCH N 11 Counteracting gemcitabine+nab‐paclitaxel induced dysbiosis in KRAS wild type and KRASG12D mutated pancreatic cancer invivo model

Valerio Pazienza¹; Concetta Panebianco¹; Federica Pisati¹; Annacandida Villani¹; Annapaola Andolfo¹; Marynka Ulaszewska¹; Ferro Carmelapia¹; Tizianapia Latiano¹; Francesco Perri¹

¹Gastroenterology Unit IRCCS “Casa Sollievo della Sofferenza” Hospital, SAN GIOVANNI ROTONDO, Italy; ²Gastroenterology Unit IRCCS “Casa Sollievo della Sofferenza” Hospital, SAN GIOVANNI ROTONDO, Italy; ³Histopathology Unit, Cogentech S.C.a.R.L, FIRC Institute of Molecular Oncology, Milan, Italy; ⁴Gastroenterology Unit IRCCS “Casa Sollievo della Sofferenza” Hospital, SAN GIOVANNI ROTONDO, Italy; ⁵IRCCS San Raffaele Scientific Institute, Milan, Italy; ⁶IRCCS San Raffaele Scientific Institute, Milan, Italy; ⁷Gastroenterology Unit IRCCS “Casa Sollievo della Sofferenza” Hospital, SAN GIOVANNI ROTONDO, Italy; ⁸Gastroenterology Unit IRCCS “Casa Sollievo della Sofferenza” Hospital, SAN GIOVANNI ROTONDO, Italy; ⁹Gastroenterology Unit IRCCS “Casa Sollievo della Sofferenza” Hospital, SAN GIOVANNI ROTONDO, Italy

Introduction and objective: Pancreatic cancer (PC) has a very low survival rate mainly due to late diagnosis and refractoriness to therapies. The latter also cause adverse effects negatively affecting the patients' quality of life, often requiring dose reduction or discontinuation of scheduled treatments, compromising the chances of cure.

Methods: We explored the effects of a specific probiotic blend on PC mice xenografted with KRAS wild‐type or KRASG12D mutated cell lines alone or together with gemcitabine+nab‐paclitaxel treatment to then assess tumor volume and clinical pathological variables. Beside a semi‐quantitative histopathological evaluation of murine tumor and large intestine samples, histochemical and immunohistochemical analyses were carried out to evaluate collagen deposition, proliferation index Ki67, immunological microenvironment tumor‐associated, DNA damage markers and also mucin production. Blood cellular and biochemical parameters and serum metabolomics were further analyzed. 16S sequencing was performed to analyze the composition of fecal microbiota. Gemcitabine+nab‐paclitaxel treatment impaired gut microbial profile in KRAS wild‐type and KRASG12D mice.

Results: Counteracting gemcitabine+nab‐paclitaxel‐ induced dysbiosis through the administration of probiotics ameliorated chemotherapy side effects and decreased cancer‐associated stromatogenesis. Milder intestinal damage and improved blood count were also observed upon probiotics treatment as well as a positive effect on fecal microbiota, yielding an increase in species richness and in short chain fatty acids producing‐ bacteria. Mice’ serum metabolomic profiles revealed significant drops in many amino acids upon probiotics administration in KRAS wild‐type mice while in animals transplanted with PANC‐1 KRASG12D mutated all treated groups showed a sharp decline in serum levels of bile acids with respect to control mice.

Conclusions: These results suggest that counteracting gemcitabine+nab‐paclitaxel‐ induced dysbiosis ameliorates chemotherapy side effects by restoring a favourable microbiota composition. Relieving adverse effects of the chemotherapy through microbiota manipulation could be a desirable strategy in order to improve pancreatic cancer patients' quality of life and to increase the chance of cure.

OS BASIC AND TRANSLATIONAL RESEARCH N 12 Identifying predictive bacterial markers from cervical swab microbiota on pregnancy outcome in woman undergoing assisted reproductive technologies

Valerio Pazienza¹; Annacandida Villani¹; Andrea Fontana³; Silvia De Stefani⁴; Stefano Barone⁵; Simone Palini⁶; Concetta Panebianco¹

¹Gastroenterology Unit IRCCS “Casa Sollievo della Sofferenza” Hospital, SAN GIOVANNI ROTONDO, Italy; ²Gastroenterology Unit IRCCS “Casa Sollievo della Sofferenza” Hospital, SAN GIOVANNI ROTONDO, Italy; ³Bisotatistic Unit IRCCS “Casa Sollievo della Sofferenza” Hospital, SAN GIOVANNI ROTONDO, Italy; ⁴Clinica Nuova Ricerca, Rimini, Italy; ⁵Fisiopatologia della Riproduzione dell'Ospedale Cervesi, Cattolica, Italy; ⁶Fisiopatologia della Riproduzione dell'Ospedale Cervesi, Cattolica, Italy; ⁷Gastroenterology Unit IRCCS “Casa Sollievo della Sofferenza” Hospital, SAN GIOVANNI ROTONDO, Italy

Introduction and objective: Failure of the embryo to implant causes about three‐fourths of lost pregnancies. Female genital tract microbiota has been associated to Assisted Reproductive Technologies (ART) outcomes. The objective of this study was to analyze the microbiota of human cervical swab and to correlate these findings with the ART outcomes.

Methods: In this study, 88 cervical swabs were collected from women undergoing ART cycles, with various causes of infertility, at the beginning of the ART protocols. After microbial DNA extraction, V3‐V4 variable regions of the 16S rRNA gene were amplified and sequenced on the Illumina MiSeq platform. PEnalized LOgistic Regression Analysis (PELORA) was performed to identify clusters of bacterial populations with differential abundances between patients with unfavorable and favorable pregnancy outcome groups, respectively.

Results: We identified a core of microorganisms at lower taxonomic levels that were predictive of women's pregnancy outcomes. Statistically significant differences were identified at species levels with Lactobacillus salivarius, Lactobacillus rhamnosus among others. Moreover the abundance of Lactobacillus crispatus and iners, respectively increased and decreased in favorable group as compared to unfavorable group, resulted within the core of microorganisms associated to positive ART outcome. Although the predominance of lactobacilli is generally considered to be advantageous for ART outcome, we found that also the presence of Bifidobacterium (together with the other lactobacilli) was more abundant in the favorable group.

Conclusions: Cervix is colonized by microorganisms which can play a role in ART outcomes as seen by an overall decrease in embryo attachment rates and pregnancy rates in both fertile and infertile women. If confirmed in a larger cohort, the abundance of these bacteria can be useful not only as a marker of unfavorable pregnancy outcome but also they may open the way to new interventional strategies based on genital tract microbiota manipulation in order to increase the pregnancy rates in woman undergoing assisted reproductive technologies.

OS BASIC AND TRANSLATIONAL RESEARCH N 13 Investigating the Potential Anti‐Inflammatory Effects of an Herbal Mixture Preparation on Inflammatory Bowel Disease

Maria‐Riera Piqué‐Borràs¹; Johann Röhrl¹; Gerald Künstle¹

1Weleda, Switzerland

Introduction: Patients suffering from inflammatory bowel disease (IBD) have been found to experience compromised motility due to mucosal inflammation. The herbal mixture preparation (contained in a registered product) is traditionally used for the treatment of gastrointestinal dysmotility disorders. This study aimed to investigate the anti‐inflammatory properties of the herbal mixture and its four individual extracts (Dryopteris filix‐mas (Df), Phyllitis scolopendrium (Ps), Polypodium vulgare (Pv), and Salix mixture with alba/purpurea/viminalis (Sm).

Methods: Dry extracts were prepared from the commercial medicinal product. The production of pro‐inflammatory leukotrienes and prostaglandins, along with the activation of the NF‐κB pathway, are typical markers of an inflammatory response. The activation of NF‐κB was evaluated through a reporter assay using the human Jurkat cell line. To assess the suppression of pro‐inflammatory and pain‐related enzymes 5‐lipoxygenase (5‐LOX) and cyclooxygenase‐2 (COX‐2), recombinant human enzymes were used.

Results: The herbal mixture extract and the individual extracts Ps and Sm strongly suppressed 5‐LOX enzyme (IC50: 12.6, 60.6, 16.6 μg/mL, respectively), whereas Pv and Df showed a lower inhibition effect (IC50: 223.8 and 648.6 μg/mL, respectively). On the other hand, the COX‐2 enzyme was suppressed by the herbal mixture, and all single extracts (IC50: 12.6 (mixture), 25.5 (Df), 14.3 (Ps), 7.9 (Pv), 2.7 (Sm) μg/mL). In addition, NF‐κB activation was inhibited by the whole mixture extract and only by the Sm individual extract (IC50: 223.1 and 79.6 μg/mL).

Conclusion: The results of this study suggest that the herbal extract mixture, with its effective anti‐inflammatory and analgesic properties, could be a promising therapeutic option for individuals suffering from IBD.

OS BASIC AND TRANSLATIONAL RESEARCH N 14 Implementation of New Global Integrated 35‐Minor/1‐Major‐IMH‐Theoretical‐Knowledge‐Matrix‐Research‐Model Based on Transcontinental Multidisciplinary‐Multidimensional‐Multimodal Eastern‐&Western‐Medicine‐Mindsets Related‐to Integrative‐Oncology, Evidence‐Based Cancer‐Health‐Care‐Therapy‐Systems & Patient‐Centred Cancer‐Health‐Status‐Value‐Added‐Creation/Optimisation

Yannick Pots¹; Christel Fontaine¹

¹Global Centre for Integrative Medicine and Research, Ghent, Belgium

Introduction: Cancer is 2^e‐leading‐cause(9.6mio) of all‐deaths(56.9mio)‐worldwide(2018). With an increase from13% in2012 to17% in2018, cancer will account for about one‐fourth of all‐deaths by‐2030. With estimated‐financial cost of $1.16 trillion and estimated‐increase of 0.66%/year, cancer will cause significant health&pharmaceutical costs. Implementation of a New Global 35‐Minor/1‐Major‐IMH(Integrative Medicine&Health)Matrix‐Research‐Model(M‐R‐M) Based on Eastern‐&‐Western‐Medicine‐Mindsets Related‐to Integrative‐Oncology, Evidence‐Based Health‐Care & Patient‐Centred HealthValue‐Added‐Creation/Optimisation.

Methods: Eastern M‐R‐M, based on Inclusion of 1°Ayurveda‐Medicine‐Mindset, 2°Energetic‐Medicine‐Mindset, 3°Lifestyle‐Medicine‐Mindset, & 4° Chinese‐Medicine‐Mindset Integrated with the Western M‐R‐M, and WHO‐ICD11‐Mindset, Creating a New Global Integrative 35‐Minor/1‐Major‐IMH M‐R‐M Resulting in an Optimized Cancer‐Health‐Care Systems.

Results: First, related to Patho‐Physiology‐of Primary‐Cancers, we found: 1°the least frequent number of cancers in the Vata Dosha Pillar (26.09%), the most frequent number in the Pitta Dosha Pillar (43.48%), compared to the Kapha Dosha Pillar (30.43%); 2°Ether SubDosha Level: 4.35%, at the Air SubDosha Level: 17.39%, at the Fire SubDosha Level: 10.87%, at the Water SubDosha Level: 30.43%, at the Earth SubDosha Level: 36.96%; Insight into Physiology of Meridians(Mrds): in the Vata Dosha Pillar, we found five Mrds (2Yang&3Ying), in the Pitta Dosha Pillar five Mrds (4Yang&1Yin), in the Kapha Dosha Pillar two Mrds (0Yang&2Ying). Re‐Stimulation of the Circle of the Mrds, 2, i.e.,RenMai‐&DuMai, plus 12, i.e.,1°Lungs(Mrd,3‐5) – 2°Colon(Mrd,5‐7) – 3°Stomach(Mrd,7‐9) – 4°Spleen(Mrd,9‐11) – 5°Heart(Mrd,11‐13) – 6°Small Intestine(Mrd,13‐15) – 7°Bladder(Mrd,15‐17) – 8°Kidneys(Mrd,17‐19) – 9°Pericard(Mrd,19‐21) – 10°Duodenum(Mrd,21‐23) – 11°Gallbladder(Mrd,23‐1) – 12°Liver(Mrd,1‐3) – Will Lead to a ReBalancing of Left‐Side‐Energy (Female/Yin) and Right‐Side‐Energy (Male/Yang). Together with the Healthy‐Life‐Rules this will Restore the Secretion in “papilla vateri”, at Chakra3.5, i.e. Source of Health/Energy, resulting in a Decrease of different Diseases, and Health Conditions.

Conclusion: Implementation of the New Global 35‐Minor/1‐Major‐IMH Matrix‐Research‐Model Based on Integration of the two Multimodal Eastern‐&‐Western‐Mindsets is Essential to Advance in CIM Clinical Practice, Research and Education, Related‐to Integrative‐Oncology. This will not just be a Benefit for the Cancer Patient's Global Health, but also for the Private & Public, at Low(er) Health‐Care‐&Pharmaceutical Costs.

OS BASIC AND TRANSLATIONAL RESEARCH N 15 Differentially manufactured Arnica montana L. extracts mediate anti‐inflammatory effects on human T cells via different signaling pathways

Karina Berschneider¹; Bernhard Wetterauer²; Christian Orlik¹; Beate Jahraus¹; Henning Kirchgessner¹; Anastasilia Zuieva²; Stefan Wölfl²; Guido Wabnitz¹; Michael Schmiech³; Yvonne Samstag¹

¹Heidelberg University Hospital, Institute of Immunology, Heidelberg, Germany; ²Heidelberg University, Institute of Pharmacy and Molecular Biotechnology, Heidelberg, Germany; ³Ulm University, Institute of Pharmacology of Natural Products & Clinical Pharmacology, Ulm, Germany

Introduction: The immune system plays a key role in wound healing/tissue repair and in protecting humans from pathogens. While the activity of T lymphocytes (T cells) is crucial for normal healing processes in response to trauma, prolonged T cell activation ‐ going along with sustained inflammation ‐ is involved in delayed tissue repair. Arnica montana L. (Arnica) has a long tradition of use for the treatment of blunt injuries and inflammation. In this study, we have characterized the mode of action of differentially prepared Arnica extracts on primary human T cells.

Methods: Arnica montana L. extracts were prepared from different plant parts (root or whole plant) and by different manufacturing processes. HPLC‐MS/MS analysis was used to determine the main phytochemical compounds in all tested extracts. Primary T cells were freshly isolated from human blood. Then T cells were activated by costimulation through the antigen specific T cell receptor plus the costimulatory molecule CD28, which mimicks physiological antigen recognition. Fluorescent staining combined with flow cytometry was used to determine the viability, activation and proliferation of these T cells. The molecular mechanisms of Arnica action were investigated by determining the translocation of transcription factors from the cytoplasm into the cell nucleus using imaging flow cytometry. Moreover, transcription factor activity was determined by reporter assays. The influence of the different Arnica extracts on gene expression was characterized by broad multiplexed analysis using the nCounter technology.

Results: All Arnica extracts prepared from different plant parts (root or whole plant) inhibited T cell activation and proliferation. This could be traced back to diminished IL‐2 production and diminished IL‐2 responsiveness due to reduced CD25 (IL‐2R α‐chain) expression. HPLC‐MS/MS analysis identified caffeoylquinic acids as the main phytochemical compound group in all tested extracts. The extract effects on T cell functions were, however, not mimicked by isolated caffeoylquinic acids underlining the importance of multiple components in these extracts. Interestingly, the three tested extracts were found to mediate their effects via interfering with different T cell receptor signaling pathways.

Conclusion: The characterized molecular mechanisms and anti‐inflammatory properties of Arnica extracts on human T cells contribute to explain the mode of action of Arnica montana L., and support their application in the context of delayed wound healing/tissue repair. Furthermore, our findings make them interesting candidates to be studied as potential treatment options for other T cell‐driven inflammatory diseases.

OS BASIC AND TRANSLATIONAL RESEARCH N 16 The diet‐induced differences in gut microbiota determines the responder / non‐responder of Daiokanzoto (Da‐Huang‐Gan‐Cao‐Tang)

Kento Takayama^1,2; Chiho Takahara¹; Masanori Iseki²; Katsuhiko Ishihara²; Takashi Tanaka³; Nonaka Gen‐ichiro⁴; Hirofumi Inoue¹

¹Pharm. Sci., Fukuyama Univ., Hiroshima, Japan; ²Kawasaki Medical School, Okayama, Japan; ³Grad. Sch. Biomed. Sci., Nagasaki Univ., Nagasaki, Japan; ⁴Usaien Pharmaceutical Co., Ltd, Saga, Japan

Introduction: Daiokanzoto (da‐huang‐gan‐cao‐tang: DKT) is a traditional medicine consisting of rhubarb and glycyrrhiza. It is often used clinically to treat constipation. The purgative action of DKT is generally attributed to sennoside A (SA) (the main laxative constituent in rhubarb) which is transformed to an active metabolite by gut microbiota. It is widely accepted that the state of the gut microbiota is influenced by dietary habits. Therefore, we hypothesize that dietary habits may alter gut microbiota, influencing the purgative activity of DKT, and thereby categorizing an individual as a responder or non‐responder to DKT treatment.

Methods: In this study, we manipulated gut microbiota in mice by feeding them a high‐carbohydrate or high fiber diet. We then categorized them into laxative responders and non‐responders. To assess the relationship between laxatives and gut microbiota, we monitored the gut microbiota before and after administering laxatives.

Results: In the mice fed a high‐carbohydrate diet, DKT exerted significantly higher purgative activity than SA alone, and rhein 8‐O‐β‐D‐glucopyranoside (RG) contributed to this activity. The administration of DKT and SA+RG increased the abundance of the family Enterobacteriaceae, leading to increased purgative activity. In contrast, DKT effects were significantly suppressed by a high‐fiber diet, which we attribute to gallate and tannin activity.

Conclusion: These results demonstrate that diet‐induced differences in gut microbiota determined the effect of DKT. This is interesting, considering that Oriental medicines are usually formulated for a specific functional state or “pattern.” These results reveal that the usefulness of DKT is based on multiple constituents. Furthermore, dietary habits affect the state of gut microbiota that influences the success of this traditional medicine.

OS BASIC AND TRANSLATIONAL RESEARCH N 17 Fundamental research in homeopathy: considerations and recommendations

Alexander Tournier^1,2,3; Bonamin Leoni⁴; Buchheim‐Schmidt Susann⁵; Cartwright Steven⁶; Dombrowsky Christoph¹; Doesburg Paul⁷; Holandino Carla⁸; Kokornaczyk Maria Olga^1,7; van de Kraats Everine⁹; López‐Carvallo Jesús Antonio¹⁰; Nandy Papiya¹¹; Mazón‐Suástegui José Manuel¹⁰; Mirzajani Fateme¹²; Poitevin Bernard¹³; Scherr Claudia⁷; Thieves Karin¹⁴; Würtenberger Sandra¹⁵; Baumgartner Stephan^1,2,7

¹Institut für Komplementäre und Integrative Medizin, Bern, Switzerland; ²Institute of Integrative Medicine, Witten/Herdecke University, Herdecke, Germany; ³Homeopathy Research Institute, London, United Kingdom; ⁴Universidade Paulista ‐ UNIP. Graduation Program on Environmental and Experimental Pathology, Sao Paolo, Brazil; ⁵Medical Science, Deutsche Homöopathie‐Union, Karlsruhe, Germany; ⁶Cherwell Laboratory for Fundamental Research in Homeopathy, Oxford, United Kingdom; ⁷Society for Cancer Research, Arlesheim, Switzerland; ⁸Universidade Federal do Rio de Janeiro, Laboratório Multidisciplinar de Ciências Farmacêuticas, Rio de Janeiro, Brazil; ⁹World Water Community, Rotterdam, Netherlands (The); ¹⁰Centro de Investigaciones Biológicas del Noroeste S.C., La Paz, Mexico; ¹¹Centre for Interdisciplinary Research and Education, Kolkata, India; ¹²Protein Research Center, Shahid Beheshti University, Tehran, Iran (Islamic Republic of); ¹³Société Savante d'Homéopathie, Paris, France; ¹⁴Sola Salus, Institute for Homeopathic Research, Vienna, Austria; ¹⁵Scientific Society for Homeopathy, Köthen, Germany

Introduction: The homeopathic potentisation procedure, involving successive steps of dilution and succussion to arrive at pharmaceutical preparations with specific biomedical effects, is a core tenet of homeopathy. Dilution levels generated during the homeopathic manufacturing process often exceed well beyond Avogadro's limit. Accordingly, the scientific assessment of the potentisation procedure is of high importance. However, until now no specific guidelines in this research area existed. To provide recommendations to promote highest quality, statistically sound, and reproducible basic research into specific effects of homeopathic preparations. Also, to provide a more uniform base upon which research protocols can be designed and discussed so as to make best use of existing knowledge and understanding in this field of research.

Methods: Input was gathered from experts (members of scientific societies dealing with homeopathic basic research) in a structured process seeking consensus as what the most important aspects and considerations are when it comes to creating high‐quality research into homeopathic potentisation.

Results: We present a series of recommendations on a number of topics such as: experimental controls, system stability, blinding and randomisation, environmental influences, and procedures for the production of homeopathic samples and controls, thereby taking specific challenges of the research field into account.

Conclusions: Different key aspects of homeopathy research are discussed. All together these provide a strong foundation for building meaningful research protocols, which take account of the latest thinking in the field and provide a backdrop for meaningful comparison of research protocols.

OS BASIC AND TRANSLATIONAL RESEARCH N 18 Identifying target organs of Radix Achyranthis Bidentatae: A bioinformatics approach on active compounds and genes

Nhat‐Minh Tran^1,2,3; Su‐Jin Baek¹; Hyeong Joon Jun¹; Sanghun Lee^1,2

¹Korea Institute of Oriental Medicine, Daejeon, Korea (Republic of); ²University of Science and Technology, Daejeon, Korea (Republic of); ³Hue University of Medicine and Pharmacy, Thua Thien Hue, Viet Nam

Introduction: Herbal medicines traditionally target organs for treatment based on medicinal properties, and this theory is widely used in prescriptions. However, the scientific evidence to explain how herbs act on specific organs by biological methods has been still limited. This study used bioinformatics tools to identify the target organs of Radix Achyranthis Bidentatae (RAB), a blood‐activating herb that nourishes the liver and kidney, strengthens bones, and directs prescription to the lower body.

Methods: RAB's active compounds and genes were collected and predicted through databases such as TCMSP, HIT2.0, and BATMAN‐TCM. Next, the RAB's gene list was analyzed based on two approaches to obtain target organs. DAVID and Gene ORGANizer enrichment‐based approaches were used to enrich an entire gene list, and the BioGPS and HPA gene expression‐based approaches were used to analyze the expression of core genes.

Results: RAB's genes were found to be involved in whole blood, blood components, and lymphatic organs across all four tools. Each tool indicated a particular aspect of RAB's target organs: DAVID‐enriched genes showed a predominance in blood, liver, and kidneys; Gene ORGANizer showed the effect on low body parts and bones and joints; and BioGPS and HPA showed high gene expression in bone marrow, lymphoid tissue, heart muscle, and smooth muscle.

Conclusion: The results of bioinformatics‐based target organ prediction can serve as a modern interpretation tool for the target organ theory of traditional medicine. Future studies should predict therapeutic target organs in complex prescriptions rather than single herbs and conduct experiments to verify predictions.

OS BASIC AND TRANSLATIONAL RESEARCH N 19 Duckweed (Lemna gibba L.) as test organism in homeopathic basic research

Annekathrin Ücker^1,2; Claudia Scherr²; Bianka Lutz³; Stephan Baumgartner^1,2,4

¹Institute of Integrative Medicine, University of Witten/Herdecke, Witten, Germany; ²Society for Cancer Research, Arlesheim, Switzerland; ³Research Institute of Organic Agriculture, Frick, Switzerland; ⁴Institute of Complementary and Integrative Medicine, University of Bern, Bern, Switzerland

Introduction: Looking back over the last 20 years, duckweed (Lemna gibba L. clone number 9352) has proven to be a valuable test organism in basic homeopathic research. In the early 2000s, an ISO‐certified duckweed bioassay from ecotoxicology was implemented to investigate influences of homeopathic preparations on growth rate of duckweed.

Methods: In general plants were cultivated in modified Steinberg medium for seven days prior to an experiment. Duckweed was sorted according to its surface area and symmetry before being allocated into blinded and randomised treatment groups. After six or seven days growth under controlled conditions, growth rates were calculated from frond surface determined by computer‐based image analysis. Different pre‐treatments for 48h prior to sorting of plants were used. The different pre‐treatments included calcium‐deficiency and heavy metal stress. In all settings (with/without pre‐treatment) the test system stability was investigated by systematic negative control (SNC) experiments.

Results: Unimpaired duckweed treated with potentised gibberellic acid (14x‐30x) showed significant differences between treatment and control groups (5 experiments, p < 0.001). A replication trial also found significant effects (5 experiments, p = 0.0085) if the plant were in the state of gibbosity (enlargement of aerenchym). In the replication trial, the effect direction was inverted, however. Similar results were obtained with unimpaired duckweed treated with Arg‐nitr (14x‐30x). Based on the interpretation of gibbosity as a stress situation, test systems with artificial stress were developed. After a calcium‐deficiency pre‐treatment, Calc‐carb (15x‐30x) induced growth‐promoting effects (11 experiments, p = 0.01). After a pre‐treatment with arsenic, a stabilisation of effect direction (increase of growth rate by treatment by Ars‐alb (eight potencies between 17x‐33x)) was achieved (original 5 experiments with 156 mg/L arsenic, p < 0.001; replication series 1 with 156 mg/L arsenic, p = 0.097; replication series 1 with 250 mg/L arsenic, p = 0.044). The influence of the stress level was further investigated in experiments with Merc‐corr 24x‐30x: mild mercury stress (2.5 mg/L HgCl₂ pre‐treatment) led to a growth rate increase, severe mercury stress (5mg/L HgCl₂ pre‐treatment) led to a growth rate reduction. All SNC experiments indicated stable test systems.

Conclusion: Effects of potentised substances are detectable in duckweed bioassays that cannot be allocated to placebo effects. Stress induced by gibbosity, nutrient deficiency or heavy metals seems to sensitize the plants to the treatment with homeopathic preparations. Further investigations of the relationship between stress and effects size might lead to formulation of hypotheses on the mode of action of potentised treatments.

OS BASIC AND TRANSLATIONAL RESEARCH N 20 Aromatherapy Clinical Effectiveness Evidence Map

Adriana Wolffenbüttel^1,2; Lissandra Fogaça³; Vivian Malva^4,1; Priscila Pereira¹; Caio Portella^1,5; Carmen Verônica Abdala⁶; Ricardo Ghelman¹; Mariana Schveitzer^1,7

¹Brazilian Academic Consortium for Integrative Health (CABSIn), São Paulo, Brazil; ²Postgraduate Program in Pharmaceutical Sciences, Toxicology Laboratory, Federal University of Rio Grande do Sul, Porto Alegre, Brazil; ³Departamento de Medicina Preventiva, Escola Paulista de Medicina, Universidade Federal de São Paulo ‐ Unifesp, São Paulo, Brazil; ⁴Anhembi Morumbi University, São Paulo, Brazil; ⁵Faculty of Medicine of the University of São Paulo, São Paulo, Brazil; ⁶Latin American and Caribbean Center on Health Sciences Information BIREME ‐ PAHO – WHO, São Paulo, Brazil; ⁷Faculdade de Ciências Médicas da Santa Casa de Misericórdia de São Paulo – FCMSCSP, São Paulo, Brazil

Introduction and objective: This Map is part of the Evidence Maps on the clinical application of Medicine Traditional, Complementary, and Integrative (TCIM) integrating the Brazilian National Policy on Integrative and Complementary Practices (PNPIC). This is a product of the Cooperation Project amongst BIREME/PAHO/WHO, the Brazilian Ministry of Health, and the Brazilian Academic Consortium for Integrative Health (CABSIn).

Methods: From a broad bibliographic search carried out in VHL, PUBMED, EMBASE and CINAHL, 73 review studies were selected and included in the Map (33 systematic with meta‐analysis, 1 systematic review of randomized controlled studies, 35 systematic reviews and 4 meta‐analyses). Based on the methodological quality assessment (AMSTAR Tool 2) the studies were classified by level of confidence for the reported results: High (n = 07), Moderate (n = 06), Low (n = 10) and Critically Low (n = 06). = 50). All studies were evaluated, characterized and categorized by the group of researchers in the field of Aromatherapy.

Results: The 73 studies included in the Aromatherapy Map gather evidence for interventions with essential oils (49 essential oils), vegetable oils (06 fatty vegetable oils), mixtures (66 synergies) and 01 hydrosol, using five forms of application: bath, inhalation, ingestion, massage, in management or topic. Each intervention was related to 55 health outcomes classified into 7 groups: Pain; Metabolic and Physiological Indicators; Noncommunicable Diseases; Well‐Being, Vitality and Quality of Life; Mental health; Infectious Diseases; and Reproductive Health totaling 420 associations (Figure 1). Were included effects for each intervention/outcome reported, as positive, potentially positive, no effect, inconclusive effect, noting that there were no negative and potentially negative effects. Lavender (Lavandula angustifolia) was the most researched essential oil. The Roses (Rosa damascena) was the second most researched essential oil. Regarding the country in focus, which indicates where the primary studies included in the reviews were conducted, 38 countries appear indicated in most of the 73 studies included in the Map.

Conclusions: There are diverse possibilities of therapeutic interventions with Aromatherapy, where the focus is on the person, as an integral and unique being, without neglecting the health outcomes. The researchers consider advertising that adequate training is important for a professional to work with clinical applications of Aromatherapy in humans. Noteworthy most authors' 73 reviews included concluded their heterogeneity in the Aromatherapy clinical trials, interfering with systematizing systematic reviews and meta‐analyses.

OS BASIC AND TRANSLATIONAL RESEARCH N 21 Gengnianshou Decoction Increases Estrogen Level without Side Effects on Reproductive Tissues in Ovariectomized Rats

Qiyou Ding^1,2; Tong Lin¹; Linhua Zhao¹; Wei Zhang³

¹Institute of Metabolic Diseases, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China; ²Beijing University of Chinese Medicine, Beijing, China; ³Gansu University of Chinese Medicine, Lanzhou, China

Introduction and objective: The menopausal syndrome is experienced by 80% of menopausal women and seriously affects their life quality. Hormone replacement therapy has been considered the mainstay therapy for menopausal syndrome, but it not only has strict indications but also can increase the risk of endometrial hyperplasia, carcinoma, stroke and venous thromboembolism, especially for long‐term therapy. Gengnianshou decoction (GNS) is a traditional Chinese medicine (TCM) prescription that has shown promise for alleviating menopausal symptoms. In this study, we aimed to investigate the biological mechanism, estrogen‐like action properties and the reproductive system safety of GNS using both in vitro and invivo models.

Methods: The effects of GNS were investigated in ovariectomized (OVX) rats as well as KGN cells. Thirty‐six 12‐week‐old female Sprague‐Dawley rats were randomly divided into the following groups: Sham operation group, OVX group, estrogen group, high‐dose GNS group, medium‐dose GNS group and low‐dose GNS group. After 9 weeks of administration, samples were taken and the blood plasma levels of hormones, lipids, and aromatase were measured through enzyme‐linked immunosorbent assays. The histological morphologies of the uterus were investigated by HE staining. The estrogen‐like effects of the GNS were also analyzed in vitro using the MTT assays and Luciferase reporter gene assays.

Results: The invivo results showed GNS significantly had increased estradiol, and decreased follicle‐stimulating hormone and luteinizing hormone in the circulation of OVX rats, but the loss of estrous cycle and uterine atrophy caused by ovariectomy could not be restored. HE staining showed that, unlike estrogen intervention, GNS did not increase endometrial thickness. But GNS also ameliorated menopausal‐derived lipid metabolism dysfunction and reduced the weight gain associated with estrogen reduction in OVX rats. The in vitro results showed that GNS could promote the conversion of testosterone into estrogen, and significantly induce ER‐estrogen response element (ERE) luciferase activity, but in the presence of aromatase inhibitor letrozole, it could not stimulate the proliferation of KGN cells and exert estrogen activity.

Conclusions: These data demonstrate that GNS mainly relies on aromatase to increase estrogen levels and showed estrogen‐like effects. It can ameliorate ovariectomy‐derived obesity and lipid metabolism dysfunction without the risk of promoting endometrial hyperplasia.

OS BASIC AND TRANSLATIONAL RESEARCH N 22 Development of a synergistic combination for endothelial dysfunction in cardiovascular diseases

Xian (Phoebe) Zhou¹; Yanfang Zheng²; Chunguang Li¹; Dennis Chang¹

¹NICM Health Research Institute, Western Sydney University, Westmead, NSW, 2145, Australia, Westmead, Australia; ²Fujian Key Laboratory of Chinese Materia Medica, College of Pharmacy, Fujian University of Traditional Chinese Medicine, Fuzhou, China, Fuzhou, China

Introduction: Cardiovascular disease (CVD) consist of a group of disorders such as hypertension, hyperglycaemia, and atherosclerosis, that are often inter‐related. Cardiovascular patients often take multiple medications concurrently to manage their multimorbid conditions. As a result, polypharmacy has become an increasing issue that may lead to reduced efficaciousness and jeopardising patient's safety. Chinese herbal medicine with a multi‐component and multi‐target approach may provide a novel therapeutic strategy for the prevention and management of CVDs. The current study incorporating silico analysis, in vitro and invivo experiments aimed to develop a synergistic combination of curcumin (Cur) and baicalein (Bai), bioactive phytochemicals derived from Chinese herbal medicine, to protect vascular function against oxidative stress, hyperglycaemia and hyperlipidaemia.

Methods: The cellular protective effects of Cur and Bai alone and in combination were tested in H₂O₂ (2.5 mM) impaired human endothelial EA. hy926 cells. Network pharmacology analysis was conducted to understand the molecular mechanisms of these two bioactive targeting endothelial dysfunction. High‐fat diet‐induced Goto‐Kakizaki rats (n = 5 each group) were treated via oral gavage with Cur (150 mg/kg), Bai (150 mg/kg) and Cur‐Bai (75 mg/kg Cur +75 mg/kg Bai, OG) over 4 weeks. The changes in endothelial function, blood glucose and lipids, blood vessel structures, and protein expressions of nuclear factor erythroid 2–related factor 2 (Nrf2) and related antioxidant genes were examined compared to the control. The interactions between two bioactive phytochemicals were determined by the combination index (CI) model.

Results: Cur‐Bai (1:1, w/w) synergistically (CI <1) restored the endothelial cell survival and exhibited a greater effect on lowering the fasting blood glucose and blood lipids in rats comparing to the two chemicals when used alone. Cur‐Bai repaired the blood vessel structure in the aortic arch and mid thoracic aorta. The Nrf2 and related antioxidant genes were highly relevant to the multi‐targeted action of the Cur‐Bai combination as demonstrated in network pharmacology. Both of our in vitro and invivo results demonstrated the significantly increased protein expressions of Nrf2 and HO‐1, as well as SOD enzymatic activity.

Conclusion: The Cur‐Bai combination demonstrated synergistic activity in attenuating endothelial dysfunction in diabetic angiopathy rats and could provide therapeutic benefits in protecting vascular endothelia function in CVDs. Further research to investigate the pharmacokinetic interaction of these two compounds is warranted.

OS BASIC AND TRANSLATIONAL RESEARCH N 23 The effect of reflexology on anxiety and the use of epidural anasthesia during advanced stages of labour: a randomized control trial

Bat Zion Zidenberg¹

¹Bnai Zion Medical Center, Haifa, Israel

Introduction: Foot reflexology reduces anxiety and may affect the course of labor. We evaluated the effect of reflexology on the level of anxiety and the use of epidural anaesthesia in primigravida with moderate to severe anxiety.

Methods: In this open‐label randomized controlled trial, primigravida with moderate to severe anxiety (VAS‐A (Visual Analog Scale for Anxiety) >4) were randomized to one of two groups: addition of reflexology to standard‐of‐care (SOC), or SOC alone. Women in the reflexology group received foot reflexology according to a treatment protocol which was approved by five experienced reflexologists, based on a literature review and on clinical experience. The primary outcome was the decrease in the level of anxiety at end‐of‐treatment in the reflexology group as compared with SOC only, 30 minutes after randomization. Secondary outcome included decrease in the use of epidural anesthesia.

Results: Overall, 154 women were included in the study: 79 women were assigned to reflexology treatment while 76 received SOC only. No between‐group differences were found concerning socio‐demographic or medical/obstetrical characteristics, and the percentage of primiparas whose labor was induced was similar in both groups. Greater relief of VAS anxiety was observed immediately after reflexology treatment compared to the SOC group during the first 30 minutes after group assignment (p = 0.002). The use of epidural block was lower in the reflexology group (N = 66 (83%)) as compared to the control group (N = 72 (95%)), p = 0.037.

Conclusion: Foot reflexology had a short‐term anxiety‐reducing effect during labor in primigravida with moderate to severe anxiety. Moreover, anxious primigravida receiving reflexology tended to use less epidural, although the causal relationship of this finding cannot be evaluated according to the current data. Further studies should assess the duration of reflexology treatment effect and its impact on the use of epidural anaesthesia. In addition, sham control studies should be conducted to evaluate the specific effects of reflexology.

OS COVID‐19 AND OTHER DISEASES N 1 The characteristics and outcomes of dyspnea in studies of Traditional Chinese Medicine for Respirovirus‐related diseases: Evidence from randomized clinical trials

Zhuojia An; Xuehan Liu; Chunli Lu; Xinyan Jin; Jianping Liu

Centre for Evidence‐Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China

Introduction: Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) is a class of viruses that can be transmitted through the respiratory tract, which can cause respiratory symptoms such as dyspnea in the acute and sequelae stages. There is a long history of the use of Traditional Chinese Medicine (TCM) for the relief of respiratory symptoms. Our aim is to review trials of TCM for Respirovirus‐related dyspnea in order to provide information for clinical practice.

Methods: We searched databases including CNKI, Wanfang, VIP, SinoMed, Yiigle, the Cochrane Library, Embase, and PubMed from their inception to June 2022 to identify randomized controlled trials (RCTs) that intended to treat Respirovirus‐related dyspnea with TCM. The participants, diagnosis, interventions, and outcomes were extracted.

Results: Ninety‐five RCTs were included, of which 76 were in Chinese and 19 in English. The common respiratory viruses were respiratory syncytial virus (n = 29; 30.5%), SARS‐CoV‐2 (n = 25; 26.3%), and influenza virus (n = 12; 12.6%). The descriptions of dyspnea were diverse. The most common descriptions in Chinese were Huxikunnan (dyspnea; n = 34; 44.7%), Qicu (shortness of breath; n = 33; 43.4%), and Chuanbie (asthma; n = 31; 40.8%). In English, the most common descriptions were shortness of breath (n = 12; 63.2%) and dyspnea (n = 10; 52.6%). Imaging (n = 40, 52.6%; n = 15, 78.9%) and etiology (n = 37, 48.7%; n = 18, 94.7%) were commonly used to diagnose the related disease. Scales were used as outcomes to evaluate the improvement of dyspnea in 56.8% (54/95) of RCTs. Among them, 55.3% (42/76) of Chinese RCTs and 42.1% (8/19) of English RCTs used the TCM syndrome score scale, but the grading scales were inconsistent, including ranges of 0–3, 0–6 and 0–9. The Borg (n = 3; 15.8%), mMRC (n = 3; 15.8%), VAS (n = 2; 10.5%), and SGRQ (n = 2; 10.5%) scales were also used in English RCTs. Imaging (n = 45, 59.2%; n = 9, 47.4%), etiology (n = 21, 27.6%; n = 7, 36.8%), and other auxiliary tests were common for effectiveness evaluation. Furthermore, symptom improvement time (n = 20; 26.3%) was used in Chinese RCTs, and improvement rate (n = 6; 31.6%) was used in English RCTs as outcomes.

Conclusions: Differences in symptom descriptions and scales affect the consistency of studies and lead to research waste. TCM scales are not effective in evaluating symptom improvement due to the lack of testing of validity, reliability, and consistency. Future studies should be conducted using normative descriptions, standardized diagnostic criteria, and international outcome indicators.