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.

Efficacy and safety of the Ayurvedic herbal preparation Maharishi Amrit Kalash: a systematic review of randomized controlled trials.

Background: Maharishi Amrit Kalash (MAK) 4 and 5 are Ayurvedic herbal nutritional supplements that are believed to have beneficial effects on overall health and wellbeing. This study aimed to systematically review all available randomized controlled trials (RCTs) investigating the clinical effects and safety of MAK. Methods: We included RCTs on therapy, health promotion, and prevention for patients and healthy volunteers of all ages. We systematically searched MEDLINE (via PubMed), EMBASE (via Ovid), the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library), DHARA, Clinicaltrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform, and Google Scholar from inception through 7 May 2023, with no time or language restrictions. The risk of bias was assessed using the Cochrane Risk of Bias Tool version 1. The protocol was registered with PROSPERO before conducting the review (CRD42023421655). Results: Three RCTs with 418 study participants were included. Two studies were on breast cancer patients and one on healthy adults. The two studies on cancer evaluated the efficacy of MAK in reducing the side effects of chemotherapy in women with breast cancer. The study on healthy adults evaluated whether MAK has an effect on an age-related alertness task as an indicator of cognitive aging. Both studies on breast cancer patients found beneficial effects on performance status, anorexia, vomiting, and body weight. One study reported positive effects regarding stomatitis. Regarding visual alertness, results showed that individuals who received MAK improved in performance. None of the three included studies reported adverse events. The risk of bias was mixed. Due to the small number and heterogeneity of the RCTs, no meta-analysis could be performed. Conclusion: There is evidence that MAK may have supportive effects in chemotherapeutic treatments for breast cancer patients and for healthy individuals regarding visual discrimination. However, it is difficult to verify treatment effects due to the small number of RCTs and the mixed risk of bias. Furthermore, none of the included studies recorded adverse events. Therefore, further high-quality studies are warranted to confirm the potential health benefits of MAK and to determine its optimal dosage and duration of use. Systematic review registration: PROSPERO, CRD42023421655.

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.

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.

Interventions to reduce stress and prevent burnout in healthcare professionals supported by digital applications: a scoping review.

Aim: Healthcare professionals are at increased risk of burnout, primarily due to workplace-related stressors. The COVID-19 pandemic has further increased this risk. Different interventions exist with varying degrees of effectiveness; little is reported on the content and implementation of such programs. This review fills this gap, with attention to recent programs using digital components. Methods: PubMed, Embase, PsycInfo, and Google Scholar were searched between January 24th and 28th, 2022, limited to the last 5 years (≥2017). Articles were included if they (1) focused on stress reduction or burnout prevention for nurses and medical doctors within workplace health promotion for nurses or medical doctors, (2) included a digital program component, (3) were conducted in high-income country contexts, and (4) were clinical studies published in English or German. Data was extracted using a priori designed spreadsheets. A group of at least 2 authors at each stage carried out the screening, selection, and data extraction. Results: The search strategy identified 153 articles, all except 7 were excluded. Two studies were conducted in the USA, two in Spain, one in the Netherlands, Poland, and Korea each. Four studies used a randomized study design, all but one had a control group. A wide range of outcome measures was used. The types of interventions included an adapted mindfulness-based stress reduction program combined with aspects of behavioral therapies, cognitive behavioral therapy, or acceptance and commitment therapy. The digital components used were apps (4 studies), a digital platform, blended learning, and a web-based intervention (1 study each). Six studies focused on individual interventions, one included organizational interventions. Conclusion: Despite an acute burnout crisis in the healthcare sector, only seven recent interventions were found that integrated digital components. Several problems emerged during the implementation of the interventions that made it clear that organizational support is urgently needed for successful implementation. Although interventions for stress reduction and burnout prevention should combine individual and organizational measures to be as successful as possible, this was only partially the case in one of the intervention programs. The results of this scoping review can be used to further develop or optimize stress and burnout prevention programs.

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.

Are Protective Activities and Limitations in Practical Skills of Daily Living Associated with the Cognitive Performance of People with Mild Cognitive Impairment? Baseline Results from the BrainFit-Nutrition Study.

Limitations in daily living have not yet been described adequately for mild cognitive impairment (MCI). In this study, we investigated first, time spent on protective activities (social, mental, and physical) and second, limitations in practical skills of daily living, both for people with MCI. We used baseline data from 270 individuals who participated in the randomized controlled trial BrainFit-Nutrition. The Montreal Cognitive Assessment (MoCA) was used to identify people with MCI. Participants were asked how much time they spent engaged in social, mental, and physical activities each week. Furthermore, the Bayer-ADL scale was used to quantify deficits in activities of daily living (ADLs). Regarding protection, the number of hours spent engaged in the three activity areas was significantly correlated with the cognitive performance in people with MCI. Social activities were positively associated with current cognitive performance. Concerning the limitations in practical skills of daily living, older and more cognitively impaired individuals were affected. Memory and orientation appear to be among the first practical skills of daily living that become impaired in people with MCI. Treatment recommendations for people with MCI include an increase in social, mental, and physical activities as well as the promotion of a healthy lifestyle.

[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.

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.

A Case Report of Acute Hepatitis Involving the Medicinal Herb Tinospora cordifolia Along with Other Variables.

This is a 54-year-old woman from Germany of central European origin who developed an acute hepatitis while orally taking Ayurvedic herbal remedies, among those was the medicinal herb Tinospora cordifolia. She took the plant powders from July 1, 2021, to October 1, 2021, with the intention of relieving the symptoms of her subjectively irritated gastrointestinal tract. The patient's main symptoms of acute hepatitis were progressively increasing general fatigue, nausea, and exhaustion. During an inpatient hospital admission from November 4, 2021, to November 9, 2021, she was under clinical observation, but no specific therapeutic measures were deemed necessary; however, blood chemistry showed an acute toxic hepatitis. There was no clinical or laboratory evidence of acute liver failure. Aminotransferase values decreased to normal values on December 14, 2021, by themselves. This case report contributes to the ongoing discussion about the potential risks of triggering an acute hepatitis due to the intake of herbal remedies from the Tinospora genus in rare cases, differentiating other involved risk factors. The case also shows that causality assignments are not trivial in the context of multivariate clinical scenarios. In the case of known hepatic metabolism-associated risk factors, T. cordifolia should be used with more caution based on available case reports. At the same time, no hasty and exaggerated prejudgments should be made about this medicinal herb, which has been very successfully used in traditional South Asian systems of medicine for many centuries.

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.

Knowledge, Attitudes and Application of Critical Nutrient Supplementation in Vegan Diets among Healthcare Professionals-Survey Results from a Medical Congress on Plant-Based Nutrition.

Plant-based diets are associated with numerous health benefits but also bear risks of micronutrient deficiencies if inadequately planned. The risk of nutrient deficiencies can be reliably reduced by supplementation but requires risk-awareness. We distributed a paper-and-pencil questionnaire to n = 902 healthcare professionals attending a congress on plant-based nutrition (VegMed 2018, Berlin). On the day of the survey (21 April 2018), n = 475 questionnaires were returned and analyzed descriptively. Of the n = 213 strict vegan participants, 2% (n = 5) took no supplements at all. All supplementing vegans reported taking vitamin B12. Almost three-quarters of vegans (73%, n = 152) took vitamin D, and 22% (n = 45) reported taking omega-3 fatty acids. Iron was supplemented by 13% (n = 28), iodine by 12% (n = 25), calcium by 11% (n = 22), zinc by 7% (n = 14), magnesium by 5% (n = 11), and selenium by 4% (n = 9). For 11%, a supplement other than vitamin B12 was subjectively most important. Nearly 50% had their vitamin B12 levels laboratory tested at least once a year; nearly one-quarter reported testing every two years, and another one-quarter rarely or never. Participants following a vegan diet were better informed about institutional recommendations of the German Nutrition Society and the Academy of Nutrition and Dietetics for vegan diets than participants following vegetarian or omnivorous diets. Vegan nutrition in pregnancy/lactation period and childhood was considered most appropriate by vegans. Despite a high awareness of potential health risks associated with vitamin B12 deficiency on a strict vegan diet and a comprehensive understanding of the official dietary recommendations of nutrition societies, use of supplements and performance of regular laboratory tests were only moderate among vegan healthcare professionals. Considering the paramount importance of adequate supplementation of critical nutrients to avoid nutrient deficiencies, scientific and public discourse should be further facilitated. Further investigation of the supplementation behavior of vegan health professionals could be of particular interest, as a possible correlation with the quality of their own nutrition counseling is not inconceivable.

To eat or not to eat-an exploratory randomized controlled trial on fasting and plant-based diet in rheumatoid arthritis (NutriFast-Study).

Background: Fasting is beneficial in many diseases, including rheumatoid arthritis (RA), with lasting effects for up to 1 year. However, existing data dates back several decades before the introduction of modern therapeutic modalities. Objective: This exploratory RCT compares the effects of a 7-day fast followed by a plant-based diet (PBD) to the effects of the dietary recommendations of the German society for nutrition (Deutsche Gesellschaft für Ernährung, DGE) on RA disease activity, cardiovascular (CV) risk factors, and well-being. Methods: In this RCT we randomly assigned 53 RA patients to either a 7-day fast followed by an 11-week PBD or a 12-week standard DGE diet. The primary endpoint was the group change from baseline to 12 weeks on the Health Assessment Questionnaire Disability Index (HAQ-DI). Further outcomes included other disease activity scores, body composition, and quality of life. Results: Of 53 RA patients enrolled, 50 participants (25 per group) completed the trial and were included into the per-protocol analysis. The primary endpoint was not statistically significant. However, HAQ-DI improved rapidly in the fasting group by day 7 and remained stable over 12 weeks (Δ-0.29, p = 0.001), while the DGE group improved later at 6 and 12 weeks (Δ-0.23, p = 0.032). DAS28 ameliorated in both groups by week 12 (Δ-0.97, p < 0.001 and Δ-1.14, p < 0.001; respectively), with 9 patients in the fasting but only 3 in the DGE group achieving ACR50 or higher. CV risk factors including weight improved stronger in the fasting group than in the DGE group (Δ-3.9 kg, p < 0.001 and Δ-0.7 kg, p = 0.146). Conclusions: Compared with a guideline-based anti-inflammatory diet, fasting followed by a plant-based diet showed no benefit in terms of function and disability after 12 weeks. Both dietary approaches had a positive effect on RA disease activity and cardiovascular risk factors in patients with RA. Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT03856190, identifier: NCT03856190.

Does a Plant-Based Diet Stand Out for Its Favorable Composition for Heart Health? Dietary Intake Data from a Randomized Controlled Trial.

A plant-based diet (PBD) can provide numerous health benefits for patients with cardiovascular risk factors. However, an inadequately planned PBD also bear the potential for deficiencies in certain macro- and micronutrients. The present study analyzed nutrient profiles of individuals who adopted a PBD as part of the CardioVeg study. Participants with cardiovascular risk factors were randomly assigned to either a whole-food PBD intervention (n = 36; eight 90 min group meetings including two 120 min cooking sessions) or a control group asked to maintain an omnivorous diet (n = 34) for eight weeks. Food intake data were collected using three-day weighed food records and analyzed with NutriGuide software, including the German Nutrient Data Base (German: Bundeslebensmittelschlüssel). Nutrient intake was compared before and after eight weeks as well as between the groups. The results for both groups were then contrasted to the current dietary recommendations published by the societies for nutrition in Germany, Austria, and Switzerland. Moreover, anthropometric/laboratory data and ambulatory blood pressure monitoring were determined at baseline and after 8 weeks. Data of a subsample (n = 18 in the PBD group and n = 19 in the control group) were used for the present analyses of the dietary intake data. A PBD yielded several benefits including (but not limited to) a lower energy density, a lower intake of cholesterol and saturated fat, an increased consumption of fiber, and a lower intake of salt. Recommended intakes of most vitamins and minerals were generally met, except for vitamin B12 in the PBD group. A low intake of several other critical nutrients (vitamin D, iodine) was observed in both groups. Compared with the control group, PBD resulted in a significant decrease in body weight, body mass index, waist circumference, HbA1c, and fasting blood glucose after 8 weeks. Overall, it can be concluded that a PBD had a more favorable nutrient composition for cardiovascular health than the omnivorous dietary pattern of the control group.

Stress Reduction by Yoga versus Mindfulness Training in Adults Suffering from Distress: A Three-Armed Randomized Controlled Trial including Qualitative Interviews (RELAX Study).

Distress is a growing public health concern. In this three-armed randomized controlled trial, n = 102 adults with elevated stress levels and stress-related symptoms were randomly assigned to (1) "integrative" yoga classes which combined physical exercises, mindfulness training, and ethical/philosophical aspects of traditional yoga; to (2) Iyengar yoga classes which entailed primarily physical exercises; or to (3) mindfulness training without physical training. We hypothesized the synergistic effects of physical yoga exercises, mindfulness, and ethical/philosophical aspects. The primary outcome was the group difference on Cohen's Perceived Stress Scale (PSS) after 12 weeks. Secondary outcomes included burnout, quality of life, physical complaints, depression, anxiety, mindfulness, interoceptive awareness, self-regulation, spirituality, mysticism, and posttraumatic stress. All outcomes were evaluated at baseline (V0), after 12 weeks (V1), and after 24 weeks (V2). A subset of participants took part in qualitative interviews. A lasting and clinically relevant stress reduction was observed within all groups (PSS ΔV0−V1Integrative Yoga = −6.69 ± 6.19; ΔV0−V1Iyengar Yoga = −6.00 ± 7.37; ΔV0−V1Mindfulness = −9.74 ± 7.80; all p < 0.00). Effect sizes were also statistically large at the end of the follow-up period (Cohen's d Integrative Yoga = 1.41; d Iyengar Yoga = 1.37; d Mindfulness = 1.23). There were no significant group differences or evidence of relevant synergistic effects from combining mindfulness and physical yoga exercises. All three interventions were found to be equally effective methods of stress reduction. Their use in practice should be based on availability and patient preference.

A Randomized Controlled Trial of Fasting and Lifestyle Modification in Patients with Metabolic Syndrome: Effects on Patient-Reported Outcomes.

Lifestyle interventions can have a positive impact on quality of life and psychological parameters in patients with metabolic syndrome (MetS). In this randomized controlled trial, 145 participants with MetS (62.8% women; 59.7 ± 9.3 years) were randomized to (1) 5-day fasting followed by 10 weeks of lifestyle modification (F + LM; modified DASH diet, exercise, mindfulness; n = 73) or (2) 10 weeks of lifestyle modification only (LM; n = 72). Outcomes were assessed at weeks 0, 1, 12, and 24, and included quality of life (Short-Form 36 Health Survey Questionnaire, SF-36), anxiety/depression (Hospital Anxiety and Depression Scale, HADS), stress (Cohen Perceived Stress Scale, CPSS), mood (Profile of Mood States, POMS), self-efficacy (General Self-Efficacy Scale, GSE), mindfulness (Mindfulness Attention Awareness Scale, MAAS), and self-compassion (Self-Compassion Scale, SCS). At week 1, POMS depression and fatigue scores were significantly lower in F + LM compared to LM. At week 12, most self-report outcomes improved in both groups-only POMS vigor was significantly higher in F + LM than in LM. Most of the beneficial effects within the groups persisted at week 24. Fasting can induce mood-modulating effects in the short term. LM induced several positive effects on quality of life and psychological parameters in patients with MetS.