Wellness or medicine? Use and perception of Ayurveda in Germany: data from an online-representative cross-sectional study.

Introduction: Ayurveda, South Asia's largest and most relevant system of Traditional Medicine, holds a legal status akin to conventional Western medicine in India and elsewhere. There is an almost complete lack of data on the use of Ayurveda in Germany. The aim of this study was to investigate Ayurveda's utilization patterns, entry points, and factors influencing its use and the perception of Ayurveda among the German population. Methods: Basis of this manuscript was an online-representative survey which involved 4,065 participants aged 18-75 about the use and acceptance of Traditional, Complementary and Integrative Medicine (TCIM) in Germany. The survey was conducted online using Computer Assisted Web Interview (CAWI) in 2022. The dataset was analyzed descriptively and inferentially. Results: Altogether 9.3% (n = 377) of all survey participants (n = 4,065) had already used Ayurveda somehow, either more often (1.7%) or at least once in a lifetime (7.6%). Responders associated Ayurveda primarily with Indian Medicine (27.7%) and wellness (18%). Commonly used Ayurvedic services included non-medical treatments at wellness resorts/spas (48.3%), in outpatient practices (27.1%), and hotels (23.6%). 30.2% of the participants believe in Ayurveda's therapeutic potential. 76.7% of Ayurveda users find healthy nutrition important or very important. Nine predictors were found to classify Ayurveda users vs. non-users with spirituality and belief in Ayurveda's therapeutic efficacy as the most relevant ones. Ayurveda seems to be primarily used by well-educated and female individuals, often from higher-income groups and with a rather modern social milieu-orientation. Conclusion: Study results suggest that about every tenth German citizen has used Ayurveda in the past and about one third believes in its therapeutic potential. Because Ayurvedic therapies are often not evidence-based, there is an urgent need to perform high quality randomized controlled trials to investigate potential effects and safety of Ayurveda and how evidence-based Ayurveda treatments can be integrated into the German healthcare system.

Nature-based social prescribing programmes: opportunities, challenges, and facilitators for implementation.

BACKGROUND: Evidence on the health benefits of spending time in nature has highlighted the importance of provision of blue and green spaces where people live. The potential for health benefits offered by nature exposure, however, extends beyond health promotion to health treatment. Social prescribing links people with health or social care needs to community-based, non-clinical health and social care interventions to improve health and wellbeing. Nature-based social prescribing (NBSP) is a variant that uses the health-promoting benefits of activities carried out in natural environments, such as gardening and walking. Much current NBSP practice has been developed in the UK, and there is increasing global interest in its implementation. This requires interventions to be adapted for different contexts, considering the needs of populations and the structure of healthcare systems. METHODS: This paper presents results from an expert group participatory workshop involving 29 practitioners, researchers, and policymakers from the UK and Germany's health and environmental sectors. Using the UK and Germany, two countries with different healthcare systems and in different developmental stages of NBSP practice, as case studies, we analysed opportunities, challenges, and facilitators for the development and implementation of NBSP. RESULTS: We identified five overarching themes for developing, implementing, and evaluating NBSP: Capacity Building; Accessibility and Acceptability; Networks and Collaborations; Standardised Implementation and Evaluation; and Sustainability. We also discuss key strengths, weaknesses, opportunities, and threats for each overarching theme to understand how they could be developed to support NBSP implementation. CONCLUSIONS: NBSP could offer significant public health benefits using available blue and green spaces. We offer guidance on how NBSP implementation, from wider policy support to the design and evaluation of individual programmes, could be adapted to different contexts. This research could help inform the development and evaluation of NBSP programmes to support planetary health from local and global scales.

Effects of Prolonged Medical Fasting during an Inpatient, Multimodal, Nature-Based Treatment on Pain, Physical Function, and Psychometric Parameters in Patients with Fibromyalgia: An Observational Study.

Fibromyalgia syndrome (FMS) is a common chronic pain disorder and often occurs as a concomitant disease in rheumatological diseases. Managing FMS takes a complex approach and often involves various non-pharmacological therapies. Fasting interventions have not been in the focus of research until recently, but preliminary data have shown effects on short- and medium-term pain as well as on physical and psychosomatic outcomes in different chronic pain disorders. This single-arm observational study investigated the effects of prolonged fasting (3-12 days, <600 kcal/d) embedded in a multimodal treatment setting on inpatients with FMS. Patients who were treated at the Department of Internal Medicine and Nature-Based Therapies of the Immanuel Hospital Berlin, Germany, between 02/2018 and 12/2020 answered questionnaires at hospital admission (V0) and discharge (V1), and then again three (V2), six (V3), and 12 (V4) months later. Selected routine blood and anthropometric parameters were also assessed during the inpatient stay. A total of 176 patients with FMS were included in the study. The Fibromyalgia Impact Questionnaire (FIQ) total score dropped by 13.7 ± 13.9 (p < 0.001) by V1, suggesting an improvement in subjective disease impact. Pain (NRS: reduction by 1.1 ± 2.5 in V1, p < 0.001) and quality of life (WHO-5: +4.9 ± 12.3 in V1, p < 0.001) improved, with a sustainable effect across follow-up visits. In contrast, mindfulness (MAAS: +0.3 ± 0.7 in V1, p < 0.001), anxiety (HADS-A: reduction by 2.9 ± 3.5 in V1, p < 0.0001), and depression (HADS-D: reduction by 2.7 ± 3.0 in V1, p < 0.0001) improved during inpatient treatment, without longer-lasting effects thereafter. During the study period, no serious adverse events were reported. The results suggest that patients with FMS can profit from a prolonged therapeutic fasting intervention integrated into a complex multimodal inpatient treatment in terms of quality of life, pain, and disease-specific functional parameters. ClinicalTrials.gov Identifier: NCT03785197.

Use and acceptance of traditional, complementary and integrative medicine in Germany-an online representative cross-sectional study.

Background: Older representative surveys show that Traditional, Complementary and Integrative Medicine (TCIM) is used by about 60% of the German population. However, no data exists for the current nationwide situation. The main aim of this cross-sectional study is to investigate the current use and acceptance of TCIM in Germany. Methods: This study is based on a representative sample of the German population aged 18-75 years. Participants were asked about the use and acceptance of TCIM. The survey was conducted online using Computer Assisted Web Interview (CAWI) in 2022 by three renowned German market research institutes on behalf of and in close coordination with the working group. The data set was analyzed descriptively and inferentially. Results: In total, 4,065 participants (52% female, 48% male, 0.4% diverse) responded completely (response rate: 21.5%). Among participants, 70% stated that they had used TCIM at some point in their lives, with 32% doing so in the last 12 months and 18% currently. The most common reason given (17%) was musculoskeletal pain. For their own health, 39% stated that TCIM is important. Traditional European Medicine was rated as very/mainly effective by 27% of participants and as partly effective by 44% (conventional medicine: 69% very/mainly effective, 19% partly effective). As a complementary treatment strategy to conventional medicine, 35% considered TCIM to be optimal ("Complementary Medicine"), 33% in combination with conventional medicine ("Integrative Medicine") and 5% without conventional medicine ("Alternative Medicine"). The majority of the participants were in favor of more research on TCIM and stated that the costs of TCIM services should be covered by health insurance companies (71% and 69%, respectively). Conclusion: These results from a representative online-population suggest that the use of TCIM in Germany remains at a high level. The nationwide relevance of TCIM should be given greater consideration in German health care policy making. TCIM should be systematically investigated using appropriate study designs and methods including high quality randomized clinical trials to investigate their effectiveness, efficacy, therapeutic safety and costs in the future.

The impact of cineole treatment timing on common cold duration and symptoms: Non-randomized exploratory clinical trial.

INTRODUCTION: Common cold (CC) symptoms arise from an inflammatory response treatable with cineole and generally peak within two days, which complicates research implementation. We therefore explored the benefits of early cineole administration with enrolment of participants prior to CC onset. METHODS: Out of 522 adults enrolled in our phase IV, open-label, non-randomized, exploratory clinical trial (EudraCT No. 2020-000860-51), 329 developed a CC and used 200 mg cineole (Soledum®, CNL-1976) t.i.d. for max. 15 (± 2) days. Primary endpoint was burden of disease based on the Wisconsin Upper Respiratory Symptom Survey (WURSS-11). RESULTS: Comparing three strata based on time to treatment (≤ 12 h, > 12 to ≤ 24 h and > 24 h), earliest treatment resulted in lowest AUC-WURSS (Spearman correlation coefficient of 0.36) and reduced the overall burden of disease by 38% (p < 0.0001). Earlier and lower symptom severity peak resulted, with shorter time to remission (average 8.9 vs. 10.7 days with latest treatment initiation, p < 0.05), and higher and faster recovering quality of life (p < 0.05). Tolerability was mostly rated as "very good", with adverse events of suspected causal relationship reported in 4.3% of participants. CONCLUSIONS: Early intervention shows clinical benefits relevant for the effective treatment of CC with cineole.

InterVFast-effectiveness and acceptance of intermittent fasting in cardiac rehabilitation patients: study protocol of a randomized controlled trial.

BACKGROUND: Research on intermittent fasting has shown that it can improve a variety of health outcomes, including blood sugar control, blood lipid levels and blood pressure. Only few studies document longer periods of fasting, especially in rehabilitation participants. Cardiac inpatient rehabilitation follows a multidisciplinary approach including change of health behaviour to reduce patients' risk of future cardiovascular events. To date, evidence suggests that intermittent fasting can be an effective way to improve health and well-being, but more research is needed to fully understand its long-term effects and factors that promote the implementation. Therefore, the aim of the ongoing InterVFast trial is to investigate the effectiveness of intermittent fasting amongst cardiac rehabilitation patients after 4-week inpatient rehabilitation as well as 3 and 12 months subsequently including patients' perspective. METHODS: This single-centre randomized controlled trial evaluates the effectiveness of the InterVFast intervention in weight loss (primary outcome). We also examine patients' acceptance and the effect on relevant outcomes as blood glucose and triglyceride levels, cholesterol and high-sensitivity C-reactive protein. Weight, blood samples and clinical data are collected as part of the initial and final examination during inpatient rehabilitation. During inpatient rehabilitation, participants daily note fasting intervals and meals eaten as well as practicability in a fasting diary. In addition, interviews about perceived advantages and disadvantages and acceptance are carried out with the participants in the IG. A standardized follow-up examination (weight, blood samples) will be carried out by the family doctor after 3 and 12 months (t2 and t3). DISCUSSION: Compared to other weight-loss intervention studies, our study addresses patients with coronary heart disease and includes patients' acceptance as well as long-term maintenance. It is hypothesized that participation in the InterVfast intervention will improve relevant health outcomes in a sample of cardiac rehabilitation patients and thus constitute a behavioural prevention strategy to reduce the risk of future cardiac events and improve overall health and quality of life. TRIAL REGISTRATION: ClinicalTrials.gov DRKS00023983. Registered on February 17, 2022.

Patients' perspectives on prescription cannabinoid therapies: a cross-sectional, exploratory, anonymous, one-time web-based survey among German patients.

Introduction: Since cannabinoids were partially legalized as prescription medicines in Germany in 2017, they are mostly used when conventional therapies do not suffice. Ambiguities remain regarding use, benefits and risks. This web-based survey explored the perspectives of patients whose experiences are not well enough known to date. Methods: In an anonymous, exploratory, cross-sectional, one-time web-based observational study, participants receiving cannabinoid therapy on prescription documented aspects of their medical history, diagnoses, attitudes toward cannabinoids, physical symptoms, and emotional states. Participants completed the questionnaires twice here: first regarding the time of the survey and then, retrospectively, for the time before their cannabinoid therapy. Participants were recruited in a stratified manner in three German federal states. Results: N = 216 participants (48.1% female, aged 51.8 ± 14.0) completed the survey, most of which (72%, n = 155) reported pain as their main reason for cannabinoid therapy. When comparing the current state with the retrospectively assessed state, participants reported greater satisfaction with their overall medical therapy (TSQM II: +47.9 ± 36.5, p < 0.001); improved well-being (WHO-5: +7.8 ± 5.9, p < 0.001) and fewer problems in PROMIS subscales (all p < 0.001). Patients suffering primarily from pain (72%, n = 155) reported a reduction of daily pain (NRS: -3.2 ± 2.0, p < 0.001), while participants suffering mainly from spasticity (8%, n = 17) stated decreased muscle spasticity (MSSS: -1.5 ± 0.6, p < 0.001) and better physical mobility (-0.8 ± 0.8, p < 0.001). Data suggests clinically relevant effects for most scores. Participants' attitudes toward cannabinoids (on a 5-point scale) improved (+1.1 ± 1.1, p < 0.001). Most patients (n = 146, 69%) did not report major difficulties with the cannabinoid prescription process, while (n = 27; 19%) had their cannabinoid therapy changed due to side effects. Discussion: Most participants experienced their therapy with cannabinoids as more effective than their previous therapy. There are extensive limitations to this cross-sectional study: the originally intended representativeness of the dataset was not reached, partly due to the SARS-CoV-2 pandemic; the sample has a larger proportion of privately insured and self-paying patients. Results does not suggest that cannabinoid patients belong to a particular clientele. Effect sizes observed for pain reduction, quality of life, social participation, and other outcomes suggest a therapeutic potential, particularly in the treatment of chronic pain.

Effects of an Online Meditation Course on Quality of Life and Positive Emotions: A Prospective Observational Study (EXPANSION Study).

Background: Several meditation interventions showed positive effects on physical and mental health. The aim of this study is a first evaluation of the (within-group) effects of a 21-day online meditation course of the "expansion method." Methods: For this exploratory observational study, parameters were assessed at baseline, at 1 month, and at a 3-month follow-up. Exploratory endpoints were health-related quality of life (PROMIS Preference Score), global health (PROMIS) with the subscales physical and mental health, stress perception (Perceived Stress Scale), positive and negative affect regulation (Positive and Negative Affect Schedule), flourishing (Flourishing Scale), self-efficacy (Short Scale for Measuring General Self-Efficacy Beliefs), gratitude and awe (Gratitude and Awe Questionnaire), resilience (Connor-Davidson Resilience Scale), spirituality (Aspects of Spirituality), and mysticism (Mysticism Scale) on validated inventories. In addition, self-constructed questions (NRS) assessed health status, lifestyle, and concept evaluation. Results: Data from 359 participants were included in this study (response rate: 68% at 1 month, 46% at 3 months). The main analysis was based on the complete cases at 1 month (n = 244 participants; 84% female; 51 ± 11 years; 89% German). Medium effect sizes were found for mental health (p < 0.0001; d = 0.6), flourishing (p < 0.0001; d = 0.63), and negative affect (p < 0.0001; d = 0.68) at 1 month. Small effect sizes were obtained for physical health, stress, positive affect, self-efficacy, spirituality, and mysticism at 3 months. In a sensitivity analysis, the strongest effects at 1 month were found in the subgroup that completed per-protocol (n = 140), followed by those with complete data at all time points (n = 159). Effects were lowest in the intention-to-treat analysis (n = 359). The content of the course was positively evaluated by the participants. Conclusions: The online meditation course based on the expansion method had potentially beneficial effects, especially on mental health parameters. Based on the feasibility results, further research using randomized controlled designs is warranted. Clinical Trial Registration: NCT04950543.

Meditation-Based Lifestyle Modification in Mild-to-Moderate Depression: Outcomes and Moderation Effects of Spirituality.

Objective: Understanding the relevance of religion or spirituality (R/S) in the treatment of mental disorders is central to clinical and academic psychiatry. In this secondary analysis, associations of R/S with depression were investigated with respect to a new second-generation mindfulness-based intervention, the Meditation-Based Lifestyle Modification (MBLM) program. Methods: Different aspects of spirituality, spiritual coping, and spiritual engagement were assessed in 81 patients with a diagnosis of mild-to-moderate depression. Treatment effects on R/S postscores and predictor and moderation effects of depression severity and stress change-scores were evaluated at 8 weeks (MBLM vs. CONTROL [drug continuation therapy] vs. TAU [inpatient treatment as usual]) and 6 months (TAU+MBLM vs. TAU). Results: At both time points, significant differences between MBLM versus TAU and CONTROL were found in a range of spiritual outcomes, most of them with a medium-to-large effect size and in favor of MBLM. Baseline interest in spirituality (p = 0.001) and baseline spiritual mind-body practice (p = 0.017) were identified as independent predictors of change in depression severity at 6 months. Moreover, moderation analyses found that patients reporting often/regular spiritual mind-body practice at 6 months did not benefit differently from TAU+MBLM versus TAU (p = 0.437) regarding their change in depression severity and stress, while those reporting no/seldom spiritual mind-body practice at 6 months benefited significantly worse from TAU than from TAU+MBLM (p = 0.002). Conclusions: Participation in the MBLM program resulted in significantly greater increases in spirituality in depressed patients than standard therapy. Interest in spirituality and engagement in spiritual mind-body practices at baseline were positive predictors of clinical outcome in both groups. Patients of any group who regularly performed spiritual mind-body practices benefited equally in terms of antidepressant outcomes, underlining the benefit of these practices within a general therapeutic framework. ClinicalTrials.gov Identifier: NCT03652220.

Effects of an Integrative Day Care Clinic Program with a Focus on Nature Therapy in a Hospital Park Setting on Quality of Life in Oncological Patients-A Non-Randomized Controlled Study.

Cancer often causes long-term physical and psychological impairments. Lifestyle modification and nature-based interventions (NBIs) can have a positive impact on patients' quality of life (QOL). This participants-blinded, non-randomized controlled study assessed parameters at weeks 0, 12, and 24, including, as a primary endpoint, QOL in cancer patients on the Functional Assessment of Cancer Therapy-General (FACT-G) at week 12. QOL in breast cancer patients, fatigue, well-being, stress, anxiety/depression, socio-psychological well-being, benefits of nature interaction, insomnia, self-efficacy, mindfulness, and self-compassion were assessed as secondary endpoints. N = 107 cancer patients (96.3% women; 52.5 ± 9.3 years, 80.4% breast cancer) were assigned to either a 12-week nature-based (NDC; n = 56) or conventional (DC; n = 51) oncology day care clinic program, whereby the assignment group was not known to the participants. There was no significant group difference for the primary endpoint. At week 24, QOL, fatigue, mindfulness and self-compassion scores were significantly higher, and at weeks 12 and 24, the insomnia score was significantly lower in NDC compared to DC. In conclusion, this study indicates positive and clinically relevant effects of the program on QOL, fatigue, and psychological parameters. NBIs seem to have a more pronounced effect.

Protocol for a multicentre cross-sectional, longitudinal ambulatory clinical trial in rheumatoid arthritis and Parkinson's disease patients analysing the relation between the gut microbiome, fasting and immune status in Germany (ExpoBiome).

INTRODUCTION: Chronic inflammatory diseases like rheumatoid arthritis (RA) and neurodegenerative disorders like Parkinson's disease (PD) have recently been associated with a decreased diversity in the gut microbiome, emerging as key driver of various diseases. The specific interactions between gut-borne microorganisms and host pathophysiology remain largely unclear. The microbiome can be modulated by interventions comprising nutrition.The aim of our clinical study is to (1) examine effects of prolonged fasting (PF) and time-restricted eating (TRE) on the outcome parameters and the immunophenotypes of RA and PD with (2) special consideration of microbial taxa and molecules associated with changes expected in (1), and (3) identify factors impacting the disease course and treatment by in-depth screening of microorganisms and molecules in personalised HuMiX gut-on-chip models, to identify novel targets for anti-inflammatory therapy. METHODS AND ANALYSIS: This trial is an open-label, multicentre, controlled clinical trial consisting of a cross-sectional and a longitudinal study. A total of 180 patients is recruited. For the cross-sectional study, 60 patients with PD, 60 patients with RA and 60 healthy controls are recruited at two different, specialised clinical sites. For the longitudinal part, 30 patients with PD and 30 patients with RA undergo 5-7 days of PF followed by TRE (16:8) for a period of 12 months. One baseline visit takes place before the PF intervention and 10 follow-up visits will follow over a period of 12 months (April 2021 to November 2023). ETHICS AND DISSEMINATION: Ethical approval was obtained to plan and conduct the trial from the institutional review board of the Charité-Universitätsmedizin Berlin (EA1/204/19), the ethics committee of the state medical association (Landesärztekammer) of Hessen (2021-2230-zvBO) and the Ethics Review Panel (ERP) of the University of Luxembourg (ERP 21-001 A ExpoBiome). The results of this study will be disseminated through peer-reviewed publications, scientific presentations and social media. TRIAL REGISTRATION NUMBER: NCT04847011.

[Fasting - a potent modern therapy]. / Fasten ­ ein potentes Therapeutikum der Moderne.

Therapeutic fasting has found its way into modern medicine in the last decade through a multitude of experimental work and animal studies as well as increasing clinical research. It is a procedure with a tradition dating back thousands of years and thus comes with a variety of different practices. What they all have in common, is the reduction of daily food intake for a limited period of time. This has a variety of effects on metabolism, cells and organ systems, which can make it a potent tool in medical practice.

Intestinal Microbiota Reduction Followed by Fasting Discloses Microbial Triggering of Inflammation in Rheumatoid Arthritis.

Rheumatoid arthritis (RA) synovitis is dominated by monocytes/macrophages with inflammatory patterns resembling microbial stimulation. In search of triggers, we reduced the intestinal microbiome in 20 RA patients (open label study DRKS00014097) by bowel cleansing and 7-day fasting (≤250 kcal/day) and performed immune monitoring and microbiome sequencing. Patients with metabolic syndrome (n = 10) served as a non-inflammatory control group. Scores of disease activity (DAS28/SDAI) declined within a few days and were improved in 19 of 20 RA patients after breaking the fast (median ∆DAS28 = -1.23; ∆SDAI = -43%) or even achieved remission (DAS28 < 2.6/n = 6; SDAI < 3.3/n = 3). Cytometric profiling with 46 different surface markers revealed the most pronounced phenomenon in RA to be an initially increased monocyte turnover, which improved within a few days after microbiota reduction and fasting. Serum levels of IL-6 and zonulin, an indicator of mucosal barrier disruption, decreased significantly. Endogenous cortisol levels increased during fasting but were insufficient to explain the marked improvement. Sequencing of the intestinal microbiota indicated that fasting reduced potentially arthritogenic bacteria and changed the microbial composition to species with broader metabolic capabilities. More eukaryotic, predominantly fungal colonizers were observed in RA, suggesting possible involvement. This study demonstrates a direct link between the intestinal microbiota and RA-specific inflammation that could be etiologically relevant and would support targeted nutritional interventions against gut dysbiosis as a causal therapeutic approach.

[The potential of nutrition for pain management and planetary health]. / Das Potenzial der Ernährung für Schmerztherapie und planetare Gesundheit.

The consumption of western diets that are often rich in animal-source foods and low in wholesome, plant-based foods, has grave implications for public health. This is expressed in a growing prevalence of obesity as well as high rates of cardiovascular and metabolic diseases and some cancers. At the same time, current global dietary patterns are major contributors to global environmental challenges, i.e. the climate and the biodiversity crisis, and are thereby a major threat to planetary health. Shifting to more plant-based diets, e.g. in line with the "Planetary Health Diet", provides a major opportunity to improve individual and planetary health. Plant-based dietary patterns with an increase in the consumption of anti-inflammatory and a decrease in pro-inflammatory substances can also lead to improvements in pain symptoms, especially in inflammatory or degenerative joint diseases. In addition, dietary shifts are a prerequisite to achieve global environmental targets and thereby ensure a livable and healthy future for everyone. Medical professionals therefore have a special responsibility to actively promote this transformation.

How Does Meditation-Based Lifestyle Modification Affect Pain Intensity, Pain Self-Efficacy, and Quality of Life in Chronic Pain Patients? An Experimental Single-Case Study.

INTRODUCTION: Chronic pain is a growing worldwide health problem and complementary and integrative therapy options are becoming increasingly important. Multi-component yoga interventions represent such an integrative therapy approach with a promising body of evidence. METHODS: The present study employed an experimental single-case multiple-baseline design. It investigated the effects of an 8-week yoga-based mind-body intervention, Meditation-Based Lifestyle Modification (MBLM), in the treatment of chronic pain. The main outcomes were pain intensity (BPI-sf), quality of life (WHO-5), and pain self-efficacy (PSEQ). RESULTS: Twenty-two patients with chronic pain (back pain, fibromyalgia, or migraines) participated in the study and 17 women completed the intervention. MBLM proved to be an effective intervention for a large proportion of the participants. The largest effects were found for pain self-efficacy (TAU-U = 0.35), followed by average pain intensity (TAU-U = 0.21), quality of life (TAU-U = 0.23), and most severe pain (TAU-U = 0.14). However, the participants varied in their responses to the treatment. CONCLUSION: The present results point to relevant clinical effects of MBLM for the multifactorial conditions of chronic pain. Future controlled clinical studies should investigate its usefulness and safety with larger samples. The ethical and philosophical aspects of yoga should be further explored to verify their therapeutic utility.

Effects of Prolonged Fasting during Inpatient Multimodal Treatment on Pain and Functional Parameters in Knee and Hip Osteoarthritis: A Prospective Exploratory Observational Study.

Preliminary clinical data suggest that pain reduction through fasting may be effective for different diagnoses. This uncontrolled observational clinical study examined the effects of prolonged modified fasting on pain and functional parameters in hip and knee osteoarthritis. Patients admitted to the inpatient department of Internal Medicine and Nature-based Therapies of the Immanuel Hospital Berlin between February 2018 and December 2020 answered questionnaires at the beginning and end of inpatient treatment, as well as at 3, 6, and 12 months after discharge. Additionally, selected blood and anthropometric parameters, as well as subjective pain ratings, were routinely assessed during the inpatient stay. Fasting was the only common intervention for all patients, being performed as part of a multimodal integrative treatment program, with a daily caloric intake of <600 kcal for 7.7 ± 1.7 days. N = 125 consecutive patients were included. The results revealed an amelioration of overall symptomatology (WOMAC Index score: -14.8 ± 13.31; p < 0.001; d = 0.78) and pain alleviation (NRS Pain: -2.7 ± 1.98, p < 0.001, d = 1.48). Pain medication was reduced, stopped, or replaced by herbal remedies in 36% of patients. Improvements were also observed in secondary outcome parameters, including increased quality of life (WHO-5: +4.5 ± 4.94, p < 0.001, d = 0.94), reduced anxiety (HADS-A: -2.1 ± 2.91, p < 0001, d = 0.55) and depression (HADS-D: -2.3 ± 3.01, p < 0.001, d = 0.65), and decreases in body weight (-3.6 kg ± 1.65, p < 0.001, d = 0.21) and blood pressure (systolic: -6.2 ± 15.93, p < 0.001, d = 0.43; diastolic: -3.7 ± 10.55, p < 0.001, d = 0.43). The results suggest that patients with osteoarthritis of the lower extremities may benefit from prolonged fasting as part of a multimodal integrative treatment to improve quality of life, pain, and disease-specific functional parameters. Confirmatory randomized controlled trials are warranted to further investigate these hypotheses.

[Recommendations of the committee on complementary medicine and nutrition in ayurvedic medicine, homeopathy, nutrition and Mediterranean diet]. / Empfehlungen der Kommission Komplementäre Heilverfahren und Ernährung zu ayurvedischer Medizin, Homöopathie, Ernährung und mediterraner Kost.

Methods of complementary and alternative medicine (CAM) are appealing for many patients with rheumatic diseases. The scientific data are currently characterized by a large number of publications that stand in contrast to a remarkable shortage of valid clinical studies. The applications of CAM procedures are situated in an area of conflict between efforts for an evidence-based medicine and high-quality therapeutic concepts on the one hand and ill-founded or even dubious offers on the other hand. In 2021 the German Society of Rheumatology (DGRh) launched a committee for CAM and nutrition, which aims to collect and to evaluate the current evidence for CAM applications and nutritional medical interventions in rheumatology, in order to elaborate recommendations for the clinical practice. The current article presents recommendations for nutritional interventions in the rheumatological routine for four areas: nutrition, Mediterranean diet, ayurvedic medicine and homeopathy.

Patient Experiences With Prescription Cannabinoids in Germany: Protocol for a Mixed Methods, Exploratory, and Anonymous Web-Based Survey.

BACKGROUND: Medical cannabinoids are controversial. Their use is comparatively rare, but it is rising. Since 2017, cannabinoids can be prescribed in Germany for a broader range of indications. Patient surveys on these drugs are hampered by the stigmatization of cannabinoids and their (still) low prevalence in medical contexts. Against this background, patients' willingness to provide information is limited. Moreover, it is logistically challenging to reach them with a survey. A thorough knowledge of currently ongoing therapies and their effects and side effects, however, is important for a more appropriate and effective use of cannabinoids in the future. OBJECTIVE: This study is an exploratory data collection using a representative sample. The main goal is to provide a detailed picture of the current use of medical cannabinoids in Germany. It is intended to identify subgroups that may benefit particularly well or poorly. METHODS: We are conducting a representative, anonymous, cross-sectional, one-time, web-based survey based on mixed methods in 3 German federal states. Health conditions under cannabinoid therapy and before are documented with validated, symptom-specific questionnaires. This allows an estimation of the effect sizes of these therapies. The selection of parameters and questionnaires was based on the results of independent qualitative interviews in advance. Representative samples of the hard-to-reach study population are obtained by cluster sampling via contracted physicians of the statutory health insurance companies. RESULTS: Recruitment was ongoing until the end of June 2022, with 256 enrolled participants. Validated questionnaires on pain, spasticity, anorexia or wasting, multiple sclerosis, nausea or vomiting, depression, and attention deficit hyperactivity disorder (ADHD) were selected. Symptom scores are being assessed for both current conditions under cannabinoid therapy and conditions prior to this therapy (in retrospect). Validated questionnaires are also used for treatment satisfaction and general quality of life. These are supplemented by existing diagnoses, a detailed medication history, any previous experiences with cannabis or illegal substances, experiences with the prescription process, and sociodemographic data. Based on the results of the previous qualitative interviews, questions were added regarding prior experience with relaxation methods and psychotherapy, personal opinions about cannabinoids, pre-existing or symptom-related psychological trauma, and different experiences with different cannabis-based therapies. CONCLUSIONS: The exploratory mixed methods approach of this project is expected to provide valid and relevant data as a basis for future clinical research. The study design may be representative for a large proportion of outpatients treated with cannabinoids in the German federal states studied. It may have less bias toward social desirability and may provide valuable information in addition to existing studies. Due to the observational and cross-sectional nature of this study, various limitations apply. Causal relations cannot be drawn. TRIAL REGISTRATION: German Clinical Trials Register DRKS00023344; https://drks.de/search/en/trial/DRKS00023344. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38814.

Post Hoc Analysis of a Randomized Controlled Trial on Fasting and Plant-Based Diet in Rheumatoid Arthritis (NutriFast): Nutritional Supply and Impact on Dietary Behavior.

This study aimed at comparing the nutrient supply and dietary behaviors during a plant-based diet (PBD) combined with time-restricted eating (TRE) to standard dietary recommendations in rheumatoid arthritis patients. In this open-label, randomized, controlled clinical trial, patients were assigned to either a 7-day fast followed by an 11-week PBD including TRE (A) or a 12-week anti-inflammatory diet following official German guidelines (German Nutrition Society, DGE) (B). Dietary habits were assessed by 3-day food records at weeks -1, 4 and 9 and food frequency questionnaires. 41 out of 53 participants were included in a post-hoc per protocol analysis. Both groups had similar energy, carbohydrate, sugar, fiber and protein intake at week 4. Group A consumed significantly less total saturated fat than group B (15.9 ± 7.7 vs. 23.2 ± 10.3 g/day; p = 0.02). Regarding micronutrients, group B consumed more vitamin A, B12, D, riboflavin and calcium (each p ≤ 0.02). Zinc and calcium were below recommended intakes in both groups. Cluster analysis did not show clear group allocation after three months. Hence, dietary counselling for a PBD combined with TRE compared to a standard anti-inflammatory diet does not seem to lead to two different dietary clusters, i.e., actual different dietary behaviors as expected. Larger confirmatory studies are warranted to further define dietary recommendations for RA.