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Background: There is an increasing range of mind-body medicine (MBM) courses in Germany to support university students in dealing with stress. The evaluation of these varies and often only has a small number of participants due to the limited group size of the courses. The aim of this project was the development of a quantitative basic evaluation that can be used across all sites that conduct MBM courses., Methods: In a consensus-based and systematic decision-making process, the learning objectives and various questionnaires for the evaluation of MBM courses were discussed and evaluated by experts according to defined criteria. The process was iterative, in which the reflection and definition of the learning objectives and the questionnaires were conditional and adapted if necessary. The recommendations for the basic evaluation of students' MBM courses were developed by consensus among the experts., Results: For the experts, the most important learning objectives of the MBM courses were stress reduction and self-experience with the exercises. A total of 21 questionnaires were evaluated from nine topics: mindfulness, empathy, self-reflection, self-efficacy, resilience, stress, sense of coherence, quality of life, and well-being. Finally, eight questionnaires were recommended by the expert group for use in a basic evaluation: stress (PSS-10), quality of life (WHOQOL-Bref), mindfulness (MAAS), self-efficacy (GSE), self-compassion (SCS), empathy (SPF), self-reflection (GRAS) and sense of coherence (SOC-13). Further questionnaires were recommended as "optional". An additional qualitative evaluation is recommended for a broader and deeper understanding of the quantitative results., Conclusions: The proposed basic evaluation is the central result of the iterative consensus-based decision-making process, which reflects the learning objectives of the underlying MBM courses. We hope that the basic evaluation will be integrated into other MBM courses so that results of various courses can be pooled and compared across sites in the future. This could increase the informative value of the evaluations. Furthermore, researchers could consider the use of the basic evaluation in clinically controlled trials on MBM., Trial Registration: The project was not registered in a clinical trial registry because no results from health care interventions on human participants have been analyzed or reported., Competing Interests: Declarations. Ethics approval and consent to participate: The members of the expert panel are the authors of this article. All the experts worked voluntarily in this project. No ethics approval or written informed consent was required as our institutional review board, the “Ethikkommission der Medizinischen Fakultät Charité – Universitätsmedizin Berlin”, does not advise any research which does not include human beings or human material, nor personal data. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests., (© 2024. The Author(s).)

Background: Increasing evidence has emerged for traditional, complementary and integrative medicine (TCIM) to treat COVID-19 which requires systematic summaries of the net benefits of interventions against standard care and one another. The study aims to conduct a systematic review and network meta-analysis (NMA) regarding TCIM therapies for treating mild/moderate acute COVID-19, potentially informing the WHO guideline development and clinical decision-making., Methods and Analysis: We will search Embase, MEDLINE, Virtual Health Library on Traditional Complementary and Integrative Medicine, Cochrane Central Register of Controlled Trials, WHO's International Clinical Trials Registry Platform with additional searches of Chinese and Korean literature sources for randomised controlled trials comparing TCIM with placebo, standard care, no treatment or with an alternate type of TCIM to treat COVID-19. We will limit the search dates from 2020 to 28 March 2024. Reviewers will, in duplicate, screen eligible articles, extract data and evaluate the risk of bias. We will conduct frequentist network meta-analyses for network comparisons and each outcome. We will assess the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation approach and classify interventions from most to least effective or harmful., Ethics and Dissemination: This NMA is based on the existing trials and data which is not subject to ethical approval. We will publish the NMA in a peer-reviewed journal. This may provide methodological reference and clinical evidence for TCIM on future epidemic-prone diseases., Prospero Registration Number: CRD42024517321., Competing Interests: Competing interests: We would like to disclose that Dr. Guyatt Gordon and Dr. Thabane Lehana are listed as members of the Editorial Board of BMJ Open, as noted on their website (https://bmjopen.bmj.com/pages/editorial-board). This association has been declared in accordance with the journal’s submission policies. All other authors have no potential conflicts of interest to declare related to this submission., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Over the last three decades, the number of randomized controlled trials (RCTs) using stimulation of auricular vagal sensory nerves by means of electrical stimulation, auricular acupuncture, or acupressure to support weight loss has increased markedly. This systematic review focuses on the effects of auricular stimulation (AS) on anthropometric parameters and obesity-related blood chemistry., Methods and Analysis: The following databases were searched until November 2021: MEDLINE (PubMed), EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), ISI Web of Science, and Scopus Database. Data collection and analysis were conducted by two reviewers independently. Quality and risk assessment of included studies was performed using the risk of bias tool of the Cochrane Handbook, and the meta-analysis of the effect of the most frequently assessed biomarkers was conducted using the statistical software RevMan., Results: The full texts of 1,274 studies were screened; 22 contained data on obesity-related outcomes, and 15 trials with 1,333 patients were included in the meta-analysis. The overall quality of the included trials was moderate. AS significantly reduced body mass index (BMI) (mean difference (MD) = -0.38 BMI points, 95% CI (-0.55 to -0.22), p  < 0.0001), weight (MD = -0.66 kg, 95% CI (-1.12 to -0.20), p  = 0.005), waist circumference (MD = -1.44 cm, 95% CI (-2.69 to -0.20), p  = 0.02), leptin, insulin, and HOMA insulin resistance compared to controls. No significant reduction was found in body fat, hip circumference, ratio of waist/hip circumference, cholesterol, LDL, triglycerides, adiponectin, ghrelin, and glucose levels. The AS was safe throughout the trials, with only minor adverse reactions., Conclusion: The study results suggest that a reduction of weight and BMI can be achieved by AS in obese patients; however, the size of the effect does not appear to be of clinical relevance. The effects might be underestimated due to active sham trials., Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display&#95;record.php?ID=CRD42021231885., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Hua, Usichenko, Cummings, Bernatik, Willich, Brinkhaus and Dietzel.)

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., Competing Interests: JS works self-employed as a nutritionist and alternative practitioner specializing in Ayurveda. She is also a lecturer at the “Sonne und Mond” Health Center in Berlin, training in Ayurvedic medicine. MJ received grants from the Karl and Veronica Carstens Foundation. CK is a lecturer at the “Sonne und Mond” Health Center, Berlin. He is on the scientific advisory board of the Bruno Zimmer company and a board member of the German Medical Association for Ayurveda (DÄGAM e.V.). BB and his working group were partly funded by the Kneipp-Bund e.V., by the Software AG foundation, by the BKK 24 health insurance company, by the Kneipp town Bad Wörishofen, by the Immanuel Albertinen Diakonie gGmbH and the Karl and Veronica Carstens Foundation. MO is a board member of the Berlin Brandenburg Medical Doctors’ Association for Naturheilkunde (Physiotherapy) (ÄN e.V.). ES works as a nutritionist and alternative practitioner specializing in Ayurveda. He is also a lecturer at the “Sonne und Mond” Health Center in Berlin, training in Ayurvedic medicine. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Schiele, Jeitler, Michalsen, Stapelfeldt, Ortiz, Sigl, Brinkhaus, Wischnewsky and Kessler.)

Background: With increased life expectancy, the coexistence of functional impairment and multimorbidity can negatively impact life quality and coherence in geriatric individuals. The self-report 10-item Internal Coherence (ICS) measures how individuals cope with and make sense of disease-specific life challenges. The aim of this study was to validate the ICS in a sample of geriatric individuals., Methods and Procedure: In a cross-sectional study, geriatric individuals with and without chronic diseases were recruited. A factor analysis with principal component extraction (PCA) and a structural equation model (SEM) was conducted to assess the ICS factor structure in a geriatric sample. To measure convergent validity, the following scales were used: Short Health Survey (SF-12), Karnofsky Performance Index (KPI), Trait autonomic regulation (Trait aR), Sense of Coherence Scale (SOC), and Geriatric Depression Scale (GDS)., Results: A sample of n = 104 (70-96 years of age) patients with Diabetes Mellitus Type 2 ( n = 22), cancer diseases ( n = 31) and healthy controls ( n = 51) completed the ICS. PCA and SEM yielded the original two-factor solution: 1. Inner resilience and coherence and 2. Thermo coherence. Overall internal consistency for this cohort was satisfying (Cronbach's α with r α = 0.72), and test-retest reliability was moderate ( r rt = 0.53). ICS scores were significantly correlated to all convergent criteria ranging between r = 0.22 * and 0.49 ** ( p < 0.05 *; p < 0.01 **)., Conclusion: Study results suggest that the ICS appears to be a reliable and valid tool to measure internal coherence in a geriatric cohort (70-96 years). However, moderate test-retest reliability prompts the consideration of potential age-effects that may bias the reliability for this specific cohort.

Background: There is evidence that patients' positive outcome expectations prior to study interventions are associated with better treatment outcomes. Nevertheless, to date, only few studies have investigated whether individual outcome expectations affect treatment outcomes in hypnosis., Objective: To examine whether outcome expectations to hypnosis prior to starting treatment were able to predict perceived stress, as measured on a visual analog scale (VAS), after 5 weeks., Methods: We performed a secondary data analysis of a multicenter randomized controlled trial of intervention group participants only. Study participants with stress symptoms were randomized to 5 weekly sessions of a group hypnosis program for stress reduction and improved stress coping, plus 5 hypnosis audio recordings for further individual practice at home, as well as an educational booklet on coping with stress. Perceived stress for the following week was measured at baseline and after 5 weeks using a visual analog scale (0-100 mm; VAS). Hypnosis outcome expectations were assessed at baseline only with the Expectations for Treatment Scale (ETS). Unadjusted and adjusted linear regressions were performed to examine the association between baseline expectations and perceived stress at 5 weeks., Results: Data from 47 participants (M = 45.02, SD = 13.40 years; 85.1% female) were analyzed. Unadjusted (B = 0.326, t  = 0.239, p  = 0.812, R  = 0.001) and adjusted (B = 0.639, 2  = 0.001) and adjusted (B = 0.639, t  = 0.470, p  = 0.641, R 2  = 0.168) linear regressions found that outcome expectations to hypnosis were not associated with a change in perceived stress between baseline and after 5 weeks in the intervention group., Conclusion: Our findings suggest that the beneficial effect of group hypnosis in distressed participants were not associated with outcome expectations. Other mechanisms of action may be more important for the effect of hypnosis, which should be explored in future research. Clinical trial registration : ClinicalTrials.gov, identifier NCT03525093., Competing Interests: MT and SF are both members of the Deutsche Gesellschaft für Hypnose und Hypnotherapy (DGH) and certified hypnotherapists who have received payments for teaching hypnosis within the hypnotherapy training programs of the DGH in the past. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Siewert, Teut, Brinkhaus, Fisch and Kummer.)

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., Competing Interests: MJ reports grants from the Karl and Veronica Carstens Foundation. MO is a board member of the Berlin Brandenburg Medical Doctors’ Association for Naturheilkunde (Physiotherapy; ÄN e.V.). AM reports grants from the Karl and Veronica Carstens Foundation and Stifterverband der Deutschen Wissenschaft. He receives honoraria for consulting from the Klosterfrau Foundation. BB and its working group were partly funded by the Kneipp-Bund e.V. MT reports grants from the Karl and Veronica Carstens Foundation. CK reports grants from the Karl and Veronica Carstens Foundation for conducting this study. He is a member of the scientific advisory board of the company Bruno Zimmer, board member of the German Medical Doctors’ Association for Ayurveda-Medicine (DÄGAM e.V.) and receives honoraria for lecturing Ayurveda at Sonne und Mond, Berlin. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Jeitler, Ortiz, Brinkhaus, Sigl, Hoffmann, Trübner, Michalsen, Wischnewsky and Kessler.)

Background: The Complementary and Alternative Health Belief Questionnaire (CHBQ) measures medical students' attitudes towards Complementary Medicine (CM). The aim of the study was to examine the validity and reliability of the German translation of the CHBQ., Methods: Data for the psychometric evaluation of the German translation were drawn from a study that investigated attitudes towards CM in (a sample of) medical students at Charité - Universitätsmedizin Berlin. Construct validity was determined via an exploratory factor analysis (EFA). Internal consistency was examined using Cronbach's alpha and split-half reliability., Results: The CHBQ was returned by 278 students, and was fully completed by 260 students (mean age 23.7 years; ± 4.3 SD), 69.2% were female). EFA revealed a single factor solution for all 10 items of the scale. All items, except one, had good item discrimination (range: 0.5-0.8), acceptable mean inter-item-correlation (0.39) and similar median correlation (0.38). Reliability was very good (α = 0.86) and further confirmed by split-half reliability (0.91)., Conclusions: The German version of the CHBQ is a valid and reliable instrument for measuring students' attitudes towards CM., (© 2024. The Author(s).)

Background: Breast cancer survivors often suffer from diagnosis- and therapy-related long-term side effects, such as cancer related fatigue, restricted stress resilience and quality of life. Walking as a physical activity and mindfulness practice have been shown to be helpful in studies. The aim of this study was to compare the individual experiences and subjectively perceived effects of walking in combination with mindfulness practice with moderate walking alone in breast cancer patients. This paper focuses on the qualitative results of a mixed-methods pilot study., Methods: Breast cancer patients who had finished their primary oncologic treatment at least 6 months ago were randomized to an 8-week group intervention program of either mindful walking or moderate walking. Within the qualitative study part, semi-structured focus group interviews (2 interviews per study arm) were conducted and analyzed using a qualitative content analysis approach. Audio recorded interviews were transcribed verbatim and pseudonymized. The subsequent data analysis was performed by using MAXQDA ® ., Results: A total of 51 women (mean age 55.8 [SD 10.9] years) were included in the RCT, among these 20 (mean age 56.7 [SD 12.0] years) participated in the focus group interviews (n = 11 patients of the mindful walking group; n = 9 patients of the walking group). Breast cancer patients in both groups described different effects in the complex areas of self-efficacy, coping, body awareness and self-reflection. While mindful walking primarily promoted body awareness and inner strength by mindfulness in breast cancer patients, moderate walking promoted self-efficacy by a confidence of their body and an easily integrated and accepted way of physical activity., Conclusions: Study interventions and the study setting triggered processes and reflections on one's own health and situation. However, mindful walking and moderate walking seem to address different resources. This important knowledge may help oncologists and other therapists to assess what type of interventions can best meet the needs and requirements of individual patients., Trial Registration: DKRS00011521; prospectively registered 21.12.2016; https://drks.de/search/de/trial/DRKS00011521., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Considering the analogies between the disruption in ecological systems and in individuals, the concept of integrative medicine is extended to the One Health concept and integrative medicine is introduced as an innovative model for guidance/correction in patients' therapy as well as in ecological realignment., Summary: The specific elements of integrative medicine that can be applied to human health as well as to environmental health are described (e.g. self-regulation, salutogenic healing processes, transdisciplinary multimodal approaches, methodological pluralism). The need for sustainable use of limited resources in medicine and pharmacy is pointed out. As examples for urgent action, the need of taking into account the whole life cycle of pharmaceutical products as well as the impact of diet for human and planetary health are mentioned., Key Message: Self-regulation plays a crucial role in human and environmental health; sustainable promotion of self-regulation enables people to become co-creators of their own health. Such a fundamental change requires transformation of one's inner relationship to nature and to oneself. The aim of the mini-review was to concretize individual fields of action and to investigate the question of whether the concepts of integrative medicine can be transferred from humans to the environment and thus to planetary health and whether this makes sense., (© 2024 The Author(s). Published by S. Karger AG, Basel.)

We aimed to assess DPNCheck's reliability for repeated sural nerve conduction (NC) parameters. This post hoc analysis used data from the randomized controlled ACUDPN trial assessing NC of the N. Suralis every eight weeks over a 6-month period in 62 patients receiving acupuncture against diabetic peripheral neuropathy (DPN) symptoms. The reliability of DPNCheck for nerve conduction velocity and amplitude was assessed using intraclass correlation coefficients (ICC) and was calculated using data from single time points and repeated measures design. The results of the NC measurements were correlated with the Total Neuropathy Score clinical (TNSc). Overall, for both nerve velocity and amplitude, the reliability at each measurement time point can be described as moderate to good and the reliability using repeated measures design can be described as moderate. Nerve velocity and amplitude showed weak correlation with TNSc. DPNCheck's reliability results question its suitability for monitoring DPN's progression. Given the limitation of our analysis, a long-term, pre-specified, fully crossed study should be carried out among patients with DPN to fully determine the suitability of the device for DPN progression monitoring. This was the first analysis assessing the reliability of the DPNCheck for DPN progression monitoring using data from multiple collection time points., (© 2023. The Author(s).)

Background: High stress during medical education and its detrimental effects on student health is well documented. This exploratory evaluation study assesses a 10-week Mind-Body-Medicine student course, created to promote student self-care at Charité Universitätsmedizin Berlin, Germany., Methods: During 2012-2019, uncontrolled quantitative and qualitative data were gathered from 112 student participants. Outcomes including changes in perceived stress (PSS), mindfulness (FMI/MAAS), self-reflection (GRAS), self-efficacy (GSE), empathy (SPF), and health-related quality of life (SF-12) were measured between the first (T0) and last sessions (T1). Qualitative data were obtained in focus groups at course completion and triangulated with quantitative data., Results: Quantitative outcomes showed decreases in perceived stress and increased self-efficacy, mindfulness, self-reflection, and empathy. In focus groups, students reported greater abilities to self-regulate stressful experiences, personal growth and new insights into integrative medicine. Triangulation grounded these effects of MBM practice in its social context, creating an interdependent dynamic between experiences of self and others., Conclusion: After completing an MBM course, students reported reduced perceived stress, increased self-efficacy, mindfulness, empathy and positive engagement with integrative concepts of doctor-patient relationships. Further research with larger randomized confirmatory studies is needed to validate these benefits., (© 2023. The Author(s).)

The coherence hypothesis assumes that sense of coherence (SOC) explains the positive link between religion/spirituality (R/S) and mental health. The aim of our meta-analysis is to evaluate the evidence for the association between SOC (sensu Antonovsky) and different aspects of R/S and thus to contribute to the verification of the coherence hypothesis. Eighty-nine English- and German-language primarily cross-sectional studies with 67,913 participants met the inclusion criteria. The R/S scales of all included studies were subjected to item-by-item qualitative content analysis in order to determine whether scales do actually measure religion or spirituality and which R/S aspects dominated the instrument. Based on this classification, overall and subgroup meta-analyses were conducted using a random effects model. The adjusted effect size between SOC and all positive R/S measures was r+ = .120, 95% CI [.092, .149]. Particularly significant (r+ < -.180 or > .180) were correlations with negative R/S scales (r+ = -.405, 95% CI [-.476, -.333]), R/S instruments measuring primarily positive emotions (r+ = .212, 95% CI [.170, .253]) or meaning-making (r+ = .196, 95% CI [.126, .265]). Both sample characteristics (age, culture, gender, health status, religious affiliation) and study characteristics (e.g., publication year) had a moderating effect on the R/S-SOC connection. The correlation was particularly high in studies from Southern Asia (r+ = .226, 95% CI [.156, .297]), the African Islamic cultural value zone (r+ = .196, 95% CI [.106, .285]), and in a small subgroup of Iranian studies (r+ = .194, 95% CI [.117, .271]). The results confirm that R/S and SOC are clearly associated and suggest that there are different religious/spiritual pathways to a strong SOC. The strength of the associations presumably depends not only on individual differences, but also on cultural embeddedness and social plausibility of R/S. Trial registration. PROSPERO registration number: CRD42021240380. https://www.crd.york.ac.uk/prospero/display&#95;record.php?ID = CRD42021240380., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Jeserich et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objective: Hydrotherapy is a traditional prevention and treatment strategy. This study's aim is to systematically review all available randomised controlled trials (RCTs) investigating clinical effects of hydrotherapy according to Kneipp which is characterised by cold water applications., Methods: RCTs on disease therapy and prevention with Kneipp hydrotherapy were included. Study participants were patients and healthy volunteers of all age groups. MEDLINE (via PubMed), Scopus, Central, CAMbase, and opengrey.eu were systematically searched through April 2021 without language restrictions and updated by searching PubMed until April 6th 2023. Risk of bias was assessed using the Cochrane tool version 1.ResultsTwenty RCTs (N=4247) 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 positive effects in favour of hydrotherapy on chronic venous insufficiency, menopausal symptoms, fever, cognition, emotional function and sickness absenteeism. However, 81 comparisons showed no differences between groups and 5 were in favour of the respective control group. Only half of the studies reported safety issues., Conclusion: Although RCTs on Kneipp hydrotherapy seem to show positive effects in some conditions and outcomes, it remains difficult to ascertain treatment effects due to the high risk of bias and heterogeneity of most of the considered studies. Further high-quality RCTs on Kneipp hydrotherapy are urgently warranted., Prospero Registration Number: CRD42021237611., Competing Interests: Competing interests: The authors MO, AKK, HC, GR, MT, HH and KL declare that they have no financial or other competing interests. BB was supported by the Kneipp Association in the context of his professorship at the Charité., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: 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, is used to treat patients with RLS; however, the clinical evidence is unclear. This study aims to investigate the effects and feasibility of self-administered hydrotherapy and acupressure in patients with RLS., Methods: This is a randomized, controlled, open-label, exploratory, clinical study with 3 parallel arms, comparing both self-applied hydrotherapy (according to the German non-medical naturopath Sebastian Kneipp) and acupressure 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 will be randomized. Patients in the hydrotherapy group will be trained in the self-application of cold knee/lower leg affusions twice daily for 6 weeks. The acupressure group will be trained in the self-application of 6-point-acupressure therapy once daily for 6 weeks. Both interventions take approximately 20 minutes daily. The 6-week mandatory study intervention phase, which is in addition to the patient preexisting routine care treatment, is followed by a 6-week follow-up phase with optional interventions. The waitlist group will not receive any study intervention in addition to their routine care before the end of week 12. Outcome parameters including RLS-severity, disease and health-related quality of life (RLS-QoL, SF-12), Hospital Anxiety and Depression Score in German version, general self-efficacy scale, and study intervention safety will be measured at baseline and after 6 and 12 weeks. The statistical analyses will be descriptive and exploratory., Conclusion: In the case of clinically relevant therapeutic effects, feasibility, and therapeutic safety, the results will be the basis for planning a future confirmatory randomized trial and for helping to develop further RLS self-treatment concepts., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc.)

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.

Background: Allergic diseases are common in the general population. Among the population of competitive athletes (hereafter referred to as athletes), previous studies have mostly focused on the prevalence of allergic diseases and further aspects of bronchial asthma. We aimed to examine the prevalence of allergic diseases and respective medication use in athletes in Germany., Methods: We performed a cross-sectional study in athletes from different sport disciplines between March 2012 and September 2013 in Munich, Bavaria. Allergic diseases and medication use were descriptively determined using the standardized Allergy Questionnaire for Athletes (AQUA). Allergic predisposition was defined at an AQUA Score (range 0 to 35) of at least 5., Results: In total, 560 athletes (mean age 20.4±6.7 years, males 73.4%, most frequent sport discipline soccer) were included in the analysis. The reported proportion of any allergic condition was 28%, and 46% of the athletes had an allergic predisposition. Sixteen percent of all athletes and 36% of athletes with an allergic predisposition reported the use of antiallergic or antiasthmatic medications., Conclusions: Athletes had a high rate of allergic diseases, and almost half of them reported an allergic predisposition. Further research is needed to validate our results and investigate the impact of allergic diseases in athletes on the performance and specific aspects of their sport, such as training intensity and duration.

Background : Diabetic polyneuropathy (DPN) is a common complication of diabetes, which presents with a loss of sensorimotor function or pain. This study assessed the effectiveness and safety of acupuncture as a treatment for DPN-related complaints. Methods : In this randomized controlled trial, patients with type II diabetes and symptoms of neuropathy in the lower limbs were included. A total of 12 acupuncture treatments were administered over 8 weeks. The waitlist control group received the same acupuncture treatment starting at week 16 (after baseline). Results : A total of 62 patients were randomized (acupuncture group n = 31; control group n = 31). The primary outcome was overall complaints, and it was reduced with a significant difference of 24.7 on a VAS (CI 95% 14.8;34.7, p < 0.001) between both groups in favor of acupuncture. Reductions were recorded for the secondary outcomes VAS pain, neuropathic pain symptom inventory (NPSI), emotional dimensions of pain, SF-12, and diabetic peripheral neuropathic pain impact (DPNPI) after the intervention and at the follow-ups in the acupuncture group. Adverse reactions were minor and transient. Conclusions : Acupuncture leads to a significant and lasting reduction in DPN-related complaints when compared to routine care and is well tolerated, with minor side effects.

Cancer-related fatigue (CRF) is a frequent long-term symptom in non-metastasized breast cancer patients (BC). This 4-year follow-up intended to compare the long-term effects of a 10-week multimodal therapy (MT: sleep education, psychoeducation, eurythmy- and painting therapy) and combination therapy [CT: MT plus aerobic training (AT)] to AT-control. BC-patients were randomized or allocated by preference to three arms in a comprehensive cohort study. Primary outcome was a composite score including Pittsburgh Sleep Quality Index (PSQI) and Cancer Fatigue Scale (CFS-D), captured at baseline, after 10 weeks of intervention (T1), 6 months later (T2), and after 4 years (T3). We exploratively tested for superiority of MT and CT versus AT after 4 years (T3) based on the statistical model of the main analysis. Of 126 (65 randomized) BC-patients included, 105 started treatments and 79 were re-assessed for long-term effects (T3). MT and CT were superior over AT after 4 years regarding PSQI/CFS-D and PSQI sum-score, respectively (all p < 0.05), but not for CFS-D. The multimodal and combination treatment for breast cancer patients with CRF indicates sustainable long-term superiority over aerobic training for the outcomes sleep quality and combined sleep quality/fatigue. A confirmative randomized controlled trial is warranted., (© 2023. The Author(s).)

Background: Patients with atopic dermatitis (AD) frequently use healthy lifestyle behaviors, although their benefits are unclear. This study's aim was to investigate the effectiveness of hypnotherapy, fasting with diet adjustments, and exercise in AD patients. Methods: In a four-armed randomized controlled monocenter open explorative clinical trial, adult patients with mild-to-moderate severe AD underwent, over 16 weeks, a five-session hypnotherapy group program (HTP), a five-session intermittent fasting with diet adjustment group program (IFDP), a five-session exercise group program (EP), or no study intervention (control) as add-on to topical corticosteroid use if required. Endpoints included subjectively perceived itching on a visual analogue scale (VAS, 0-100 mm); disease severity by SCORing Atopic Dermatitis (SCORAD); and adverse events (AEs). Endpoints were analyzed descriptively in the Full Analysis Set (FAS). Due to the coronavirus disease 2019 (COVID-19) pandemic, relevant changes to the study protocol included online in addition to "in-presence" group interventions, closing the study arm EP and premature trial termination before randomization of 120 intended patients. Results: During the COVID-19 pandemic, study recruitment was poor. The FAS included 20 patients (17 female) with 35.0 ± 12.1 (mean ± standard deviation [SD]) years of age. At baseline, mean ± SD for HTP ( n  = 6), IFDP ( n  = 4), EP ( n  = 1), and control ( n  = 9) were VAS itching 63.2 ± 18.0, 65.0 ± 13.9, 43.0 mm, 62.1 ± 17.3; SCORAD 43.0 ± 13.6, 47.0 ± 21.0, 60.3, 39.1 ± 15.6. After 16 weeks, endpoints were VAS itching 26.0 ± 16.4, 31.7 ± 9.9, 23.0 mm, 39.3 ± 27.0; SCORAD 24.1 ± 12.2, 29.1 ± 19.1, 49.1, 25.5 ± 14.4. No serious AEs related to the interventions were observed. Conclusion: Despite very small groups, study results indicated potential beneficial changes to baseline in perceived itching intensity, disease severity, and disease-specific quality of life for HTP and IFDP. Therefore, further clinical trials should be performed investigating the effectiveness and safety of all interventions. Clinical Trial Registration: January 31, 2020 German Clinical Trials Register (DRKS): DRKS00020557, Universal Trial Number (UTN): U1111-1247-1512.

Background: Complementary and Integrative Medicine (CIM), including self-care healthy life-style promotion strategies, is widely used in Germany. Aim of this study was to assess the use of self-care and lifestyle interventions as well as mental/emotional state experienced during the COVID-19 pandemic., Methods: An exploratory cross-sectional online study was conducted with adults in Germany through an online survey. Custom-developed questions in respiratory disease-status (including COVID-19), CIM-based self-care/lifestyle interventions and dietary patterns, and mental/emotional state as well as parameters for wellbeing (World Health Organization Well-Being Index, WHO-5) and self-efficacy (General Self-Efficacy Short Scale, GSE-3) were assessed. Data was analyzed using frequency and parametric measures., Results: The online survey was performed from January to March 2021 and included 1,138 participants (81.5% female; mean age: 49.2 ± 13.7 years; 54.9% holding a university degree) living in Germany, of which 62 had had a positive SARS-CoV-2 test, 4 an influenza infection and 375 participants other respiratory infections. The following individual health promotion strategies were reported: spending time in nature (90%; n = 1,024), physical activity (69.3%; n = 789), naturopathic remedies (63.1%; n = 718), plant-based diet (56.3%; n = 640), and Mind-Body interventions (54.7%; n = 623). No differences in strategies between individuals with respiratory diseases or the sample overall were found. Well-being had a mean value of 15.2 ± 5 (WHO-5) and self-efficacy 4.1 ± 0.6 (GSE-3). Nearly 8% reported a low mental/emotional state regarding the COVID-19 pandemic., Conclusion: Self-care and lifestyle interventions during the COVID-19 pandemic were reported by participants who were predominantly female, middle-aged, and well-educated. Most participants showed an overall balanced mental/emotional state. Further studies should include a representative control group from the general population., Clinical Trial Registration: clinicaltrials.gov, identifier NCT04653727., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Jeitler, Erehman, Koppold, Ortiz, Jerzynski, Stöckigt, Rotter, Blakeslee, Brinkhaus, Michalsen, Seifert, Cramer, Kandil and Kessler.)

Background: Complementary and integrative medicine (CIM) is increasingly provided at university outpatient departments (OPDs) in Germany, but its scientific evaluation is sparse. Therefore, we aimed to investigate and evaluate feasibility, patients' characteristics and complaints at a university's CIM-OPD., Methods: A prospective evaluation included new patients without age restriction. At baseline, and after 6 and 12 months, patients filled out paper questionnaires. Patients rated their mean subjectively perceived severity of the main complaint within the last 7 days on a numerical rating scale (NRS) from 0 = no complaints to 10 = maximum complaints, their perceived resilience capacity in everyday life within the last 7 days (0 = not resilient to 10 = very resilient), and their contentment with the treatment (0 = not content to 10 = very content). Diagnoses were provided by physicians and coded according to the International Statistical Classification of Diseases and Related Health Problems, 10th revision. All data were analyzed descriptively., Results: During two years, 536 new patients {72.6% response, age (mean ± standard deviation [SD] and range) 49.6 ± 15.8 and 1-86 years, 75.7% female} chose to participate. The most frequent diagnosis groups were neoplasms (C00-C97, n = 143, 18.6%) and musculoskeletal diseases (M00-M99, n = 137, 17.9%). In n = 165 patients (30.8%), more than one diagnosis was provided. In a subgroup of 187 patients, who returned the questionnaire after 6 months, we compared baseline to 6-month values: severity of main complaint (mean ± SD) 5.2 ± 2.6 changed to 3.9 ± 2.6; resilience capacity 5.1 ± 2.6 to 5.6 ± 2.4. After 6 months, respondents rated their contentment with the treatment with (mean ± SD) 7.7 ± 2.6. Data after 12 months (n = 113) are comparable to data after 6 months., Conclusion: Patients of our CIM-OPD had a broad age range, were predominantly female, and suffered mostly from oncologic-related complaints and musculoskeletal diseases. In the responding subgroup after 6 months, patients were content with the treatment. These results should be verified by further prospective evaluations., Komplementäre und integrative Medizin (CIM) wird in Deutschland zunehmend in Hochschulambulanzen (OPDs) angeboten, deren wissenschaftliche Evaluation ist jedoch unzureichend. Deshalb war es unser Ziel, die Durchführbarkeit einer Evaluation, die Charakteristika und die Beschwerden der Patienten und Patientinnen an einer CIM-ODP zu untersuchen.Eine prospektive Evaluation schloss neue Patienten und Patientinnen ohne Altersbeschränkung ein. Zu Baseline sowie nach sechs und 12 Monaten füllten die Patienten und Patientinnen Papierfragebögen aus. Die Patienten und Patientinnen bewerteten ihre mittlere subjektiv empfundene Schwere der Hauptbeschwerden in den letzten sieben Tagen auf einer numerischen Ratingskala (NRS) von 0 = keine Beschwerden bis 10 = maximale Beschwerden, ihre mittlere subjektiv empfundene Belastbarkeit im Alltag in den letzten sieben Tagen (0 = nicht belastbar bis 10 = sehr belastbar) und ihre Zufriedenheit mit der Behandlung (0 = nicht zufrieden bis 10 = sehr zufrieden). Die Diagnosen wurden von den Ärzten und Ärztinnen gestellt und nach der International Statistical Classification of Diseases and Related Health Problems, 10. Revision, kodiert. Die Daten wurden deskriptiv ausgewertet.Im Laufe von zwei Jahren nahmen 536 neue Patienten und Patientinnen (72.6% Rücklauf, Alter (Mittelwert ± SD und Range) 49.6 ± 15.8 und 1–86 Jahre, 75.7% weiblich) teil. Die häufigsten Diagnosen waren Neoplasmen (C00-C97, n = 143, 18.6%) und Erkrankungen des Bewegungsapparates (M00-M99, n = 137, 17.9%). Bei n = 165 (30.8%) Patienten und Patientinnen wurde mehr als eine Diagnose vergeben. In einer Subgruppe von 187 Patienten und Patientinnen, die den Fragebogen nach 6 Monaten zurücksendeten, verglichen wir die Ausgangs-und 6-Monats-Werte: Schweregrad der Hauptbeschwerden (Mittelwert±SD) 5.2 ± 2.6 veränderte sich zu 3.9 ± 2.6; Belastbarkeit 5.1 ± 2.6 zu 5.6 ± 2.4. Nach sechs Monaten bewerteten die Befragten ihre Zufriedenheit mit der Behandlung mit (Mittelwert±SD) 7.7 ± 2.6. Die Daten nach 12 Monaten (n = 113) sind mit den Daten nach 6 Monaten vergleichbar.Die Patienten und Patientinnen unserer CIM-OPD hatten eine breite Altersspanne, überwiegend weiblich und litten zumeist unter onkologisch bedingten Beschwerden und Erkrankungen des Bewegungsapparates. Patienten und Patientinnen der nach sechs Monaten antwortenden Subgruppe waren mit der Behandlung zufrieden. Die Ergebnisse sollten durch weitere prospektive Evaluationen verifiziert werden., (© 2023 S. Karger AG, Basel.)

Background: Patients with seasonal allergic rhinitis (SAR) frequently use homeopathic therapy. Although there is some evidence that homeopathy may be effective in treating symptoms of SAR, there is a lack of high-quality clinical trials. Therefore, the aim of the homeopathy for SAR (HOMEOSAR) trial is to determine the efficacy of individualized or standardized homeopathic drug treatment compared to placebo regarding rhinitis-related quality of life in patients with SAR., Methods: This randomized, placebo-controlled, double-blind, three-armed intervention study will be conducted at two university hospital outpatient clinics for complementary and integrative medicine in Berlin and in 12 office-based practices specializing in homeopathic treatment in Germany. A total of 270 patients with clinical symptoms of SAR and positive allergy test to birch and grass pollen will receive homeopathic anamnesis and subsequently be randomized into (a) standardized homeopathic drug treatment with Galphimia Glauca (potency D6), (b) individualized homeopathic drug treatment (D6), or (c) placebo. All three groups can receive on-demand rescue medication as needed. Treatment will consist of two consultations and daily intake of the study medication for 4 weeks during the pollen season. The primary outcome is the mean overall score of the Rhinitis Quality of Life Questionnaire (RQLQ) in weeks 3 and 4, analyzed using analysis of covariance (adjusted for baseline RQLQ overall score and study center). A closed testing procedure will be used to control the overall type I error comparing the 3 treatment groups. Secondary outcomes include the overall RQLQ and its seven domain scores, responder status (decrease in RQLQ overall score of at least 0.5 points compared to the baseline value), use of rescue medication, intensity of total and individual SAR symptoms based on visual analog scale, generic health-related quality of life, safety, utilization of health care resources and associated costs. In addition, a qualitative data analysis is planned., Conclusion: The results of our study will contribute to clarifying the possible therapeutic effects of homeopathic drug treatment for patients with SAR., Trial Registration: This study has been registered in the German Clinical Trial Registry with trial ID DRKS00018081 on June 09, 2020., (© 2022. The Author(s).)

Background: Patients with atopic dermatitis (AD) frequently use acupuncture (ACU) and osteopathic medicine (OM), although their therapeutic benefits are unclear., Aim: To investigate the effectiveness of ACU and OM in patients with AD., Methods: In a three-armed, single-centre, randomized controlled open explorative clinical trial, adult patients with AD received ACU, OM or no study intervention (control group; CG) plus routine care. Outcomes included disease severity (SCORing Atopic Dermatitis; SCORAD), itching intensity (visual analogue scale; VAS), frequency of topical corticosteroid (TCS) use over 7 days and cost-effectiveness. Endpoints were analysed by analysis of covariance adjusted for the respective baseline value and TCS use., Results: Overall, 121 patients (92 women, 29 men) with a mean ± SD age of 31.4 ± 10.5 years were randomized. After 12 weeks, the adjusted means (95% CI) for ACU, OM and control were, respectively, 22.3 (18.3-26.3), 26.4 (22.6-30.2) and 23.7 (19.9-27.5) for SCORAD (P = 0.32); 27.9 (19.5-36.4), 35.0 (26.9-43.0) and 42.3 (34.7-50.0) for VAS itching (P < 0.05); and 2.3 (0.8-3.9), 1.9 (0.4-3.5) and 4.3 (2.6-6.0), for TCS use (P = 0.10). ACU and OM were not cost-effective compared with the CG., Conclusion: Although no differences in disease severity were found, our findings indicate that ACU might reduce itching in patients with AD. Furthermore, ACU and OM showed a trend towards reducing TCS use., (© 2022 The Authors. Clinical and Experimental Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.)

Purpose: Numerous studies have demonstrated effectiveness for acupuncture in the treatment of seasonal allergic rhinitis (SAR). However, the underlying mechanism remains still unclear., Methods: 29 SAR patients were recruited from a large randomized, controlled trial investigating the efficacy of acupuncture in SAR. 16 patients were treated by acupuncture plus rescue medication (RM, cetirizine), 6 patients received sham acupuncture plus RM and 8 patients RM alone over 8 weeks. Patients were blinded to the allocation to real or sham acupuncture. At baseline and different time-points during intervention, plasma and nasal concentration of mediators of various biological functions were determined in addition to validated disease-specific questionnaires., Results: The concentration of biomarkers related to the Th1-, Th2-, and Treg-cluster was not changed in patients who received acupuncture, in neither plasma nor nasal fluid. However, with respect to eotaxin and some unspecific pro-inflammatory cytokines (IL-1b, IL-8, IP-10, MIP-1b, MCP-1), acupuncture led to a, partially significantly, lower nasal concentration than sham acupuncture or RM. Furthermore, the nasal symptom score was significantly reduced in patients only after real acupuncture., Conclusion: In SAR, acupuncture reduces the intranasal unspecific inflammation, but does not seem to act immunologically on the Th1-Th2-imbalance., (© 2022. The Author(s).)

Background: Complementary medicine (CM) is often used as an opportunity for preventive health measures and supportive self-care practices. This study aimed to explore the use of self-care practices and preventive health strategies and the aspects of the experienced emotions during the COVID-19 pandemic in a population with an affinity for CM. Methods: The authors conducted an exploratory cross-sectional study using an anonymous 41-item online survey in the German language. The survey respondents were recruited among adults with an affinity for CM (e.g., as targeted through their memberships in CM associations) from September 2020 to February 2021. A selection of self-care methods, mainly from CM, was presented in the questionnaire. Numerical rating scales (NRSs), ranging from 0 = minimum to 10 = maximum, were used to measure the intensity of different emotions experienced during the pandemic. Statistical analysis was carried out descriptively. Results: A total of 1605 participants (80.6% female; mean age: 55.4 ± 12.6 [SD] years; 43.9% holding a university degree) were included. The use of self-care methods for health promotion during the pandemic was reported by 86.8% of the respondents. Respondents favored staying in nature (85.6%), healthy nutrition (85.6%), and physical activities (83.6%). More than 60% of the respondents made use of vitamin C and/or D, herbal medicines, nutritional supplements, relaxation techniques, breathing exercises, homeopathy, or meditation for health promotion. The analysis of emotional status by NRS (0-10) revealed the lowest mean ± SD (standard deviation) for "feeling lonely" (2.6 ± 2.9) and "feeling anxious" (2.8 ± 2.6), and the highest mean for "feeling connected to others" (6.2 ± 2.5) and "well-being" (5.8 ± 2.4). Conclusions: Participants used a wide variety of self-care methods and prevention strategies to promote their health during the COVID-19 pandemic and showed, overall, a balanced emotional status. Further research should include a control group representative of the general population, to investigate the possible impact of self-care strategies. Clinical Trial Registration Number: "Deutsches Register Klinischer Studien" (German Clinical Trial Register); registration number: DRKS00022909.

Aim: The objective of this study was to investigate the effectiveness of a mindful walking program (MWP) in patients with chronic low back pain (CLBP). Methods: The trial was a two-armed, randomized, controlled single-center open clinical trial. The study was performed in the Outpatient Clinic for Integrative Medicine of the Charité-Universitätsmedizin Berlin. The participants were adults aged 18-65 years with CLBP (≥3 months) and an average low back pain within the past 7 days measured on a visual analog scale (VAS, 0 = no pain, 100 = worst imaginable pain) of at least 40 mm. The patients received either eight weekly MWP sessions or no intervention (control). The primary outcome was the perceived pain intensity assessed with a VAS (0-100 mm) after 8 weeks. The secondary outcomes included back function assessed by the Hannover Functional Questionnaire Backache (FFbH-R) and perceived stress assessed by the 14-item Cohen's Perceived Stress Scale (PSS-14). The results were obtained by analysis of covariance adjusted for the respective baseline values. Results: In total, 55 patients were randomized (MWP: n  = 29, 82.8% female, mean (±standard deviation) age: 52.5 ± 8.6 years, pain: 56.4 ± 14.1 mm; control: n  = 26, 84.6% female, 54.8 ± 7.5 years, pain: 55.4 ± 13.1 mm). After 8 weeks, compared with the control conditions, the MWP was not associated with a statistically significant benefit for pain (VAS), adjusted mean - 9.6 [-22.3 to 3.1], p  = 0.136, clinical benefits for back function (FFbH-R), adjusted mean 2.2 [-4.2 to 8.6], p  = 0.493, or stress (PSS-14), adjusted mean - 1.6 [-4.8 to 1.6], p  = 0.326. Conclusion: In conclusion, compared with no intervention, mindful walking did not significantly improve pain, back function, or perceived stress in patients with CLBP. Clinical Trial registration: ClinicalTrials.gov (NCT01893073).

Aim: Study aim was to investigate the effects of therapeutic phlebotomy on ambulatory blood pressure in patients with grade 1 hypertension. Methods: In this randomized-controlled intervention study, patients with unmedicated hypertension grade 1 were randomized into an intervention group (phlebotomy group; 500 mL bloodletting at baseline and after 6 weeks) and a control group (waiting list) and followed up for 8 weeks. Primary endpoint was the 24-h ambulatory mean arterial pressure between the intervention and control groups after 8 weeks. Secondary outcome parameters included ambulatory/resting systolic/diastolic blood pressure, heart rate, and selected laboratory parameters (e.g., hemoglobin, hematocrit, erythrocytes, and ferritin). Resting systolic/diastolic blood pressure/heart rate and blood count were also assessed at 6 weeks before the second phlebotomy to ensure safety. A per-protocol analysis was performed. Results: Fifty-three hypertension participants (56.7 ± 10.5 years) were included in the analysis ( n  = 25 intervention group, n  = 28 control group). The ambulatory measured mean arterial pressure decreased by -1.12 ± 5.16 mmHg in the intervention group and increased by 0.43 ± 3.82 mmHg in the control group (between-group difference: -1.55 ± 4.46, p  = 0.22). Hemoglobin, hematocrit, erythrocytes, and ferritin showed more pronounced reductions in the intervention group in comparison with the control group, with significant between-group differences. Subgroup analysis showed trends regarding the effects on different groups classified by serum ferritin concentration, body mass index, age, and sex. Two adverse events (AEs) (anemia and dizziness) occurred in association with the phlebotomy, but no serious AEs. Conclusions: Study results showed that therapeutic phlebotomy resulted in only minimal reductions of 24-h ambulatory blood pressure measurement values in patients with unmedicated grade 1 hypertension. Further high-quality clinical studies are warranted, as this finding contradicts the results of other studies.

Background: A large part of the population in Germany makes use of naturopathic, complementary and integrative medical treatments. There are now numerous scientific studies that provide evidence of efficacy for certain indications. At German medical faculties, selected procedures and their application are taught within the cross-sectoral unit called QB 12 and some elective courses, with a focus on specific aspects are offered. So far, however, there has been no structured curriculum that longitudinally anchors teaching across medical studies and enables all students to consider naturopathic and complementary medical options for patient care later on and to integrate them effectively into the diagnostic and treatment process., Objective: The aim of this position paper is to show the relevance of this topic for medical education, to clarify terminology and to present core competencies and possible implementation options for training., Method: The Integrative Medicine and Perspective Pluralism Committee of the German Association for Medical Education developed this position paper in a multi-stage consensual process, in cooperation with the Forum of University Work Groups on Naturopathic Treatment and Complementary Medicine., Results: First, different umbrella terms were discussed and an existing definition of integrative medicine and health was chosen for subsequent use. Building on this step, the status of education and its scientific foundation in Germany was considered in an international context. In the next step, a competency profile for medical training, consisting of seven areas of competency, was developed and described in detail with regard to naturopathic, complementary and integrative medicine. Implementation options were identified using possible starting points in the curriculum and using established examples of best practice., Conclusion: Despite different priorities at each faculty, it was possible to find an agreement on the development of competencies and anchoring them in medical education on the basis of a common definition of terms. Currently, the implementation in the mandatory and elective areas is very heterogeneous. As part of the current revision of the Medical Licensure Act, there are many possible starting points for the integration of naturopathic and complementary medical teaching content, especially in interprofessional and general practice courses. The implementation and accompanying research of targeted teaching settings should lay the foundations for a long-term and binding integration into medical education. Overall, it is clear that medical education in the field of naturopathy and complementary and integrative medicine has the potential to develop comprehensive core medical competencies., Competing Interests: The authors declare that they have no competing interests., (Copyright © 2022 Homberg et al.)

Competing Interests: Competing interests: All authors have completed the Unified Competing Interest form (available on request from the corresponding author) and declare: CW received a grant at the University of Zurich from the Kelm Foundation for a randomized controlled trial on acupuncture for dysgeusia during chemotherapy. CW is an unpaid board Member of the Society of Acupuncture Research. KJS received a grant from NIH (National Center for Complementary and Integrative Health). KJS seats on a Data Safety Monitoring Board or Advisory Board from NIH-DoD (Department of Defence)-VA(Veterans Affairs) Collaboratory DSMB, and Advisory Board of the National Center for Complementary and Integrative Health of the US NIH with honorarium. MC receives royalties from non commercially used Medical Acupuncture textbooks.MC works as the Medical Director of the British Medical Acupuncture Society (BMAS) full time. DPR is a volunteer vice president of the Canadian Arthritis Patient Alliance, a patient-led and run arthritis organization that accepts arms-length funding from pharma companies, and an employee of Five02 Labs Inc, under Clinical Trials Ontario to support its patient and public engagement efforts. DPR received an honorarium attend meetings and travel support from Eli Lilly Canada for her speech about living with arthritis and arthritis patient organizations in Canada. MW received grants from the NIH, Sanofi, Astrazeneca Teva, and Jin Hua Foundation Cohero. MW received consulting fees from AstraZeneca, Amgen, Glaxosmithkline, Sanofi, Genzyme, Regeneron, Boehringer Ingelheim, Novartis, genentech, Pulmatrix, Teva, Equillium, cytoreason , Restorbio, Cohero Health, cerecor, incyte, sound biologics, and kinaset. MW received grants for payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AstraZeneca, Glaxosmithkline, Sanofi, and Regeneron. PJD received grants from Abbott Diagnostics, Roche Diagnostics, and Siemens, the monitoring device of CloudDX, and the medical device of Philips Healthcare. PJD reports as a Member of the Scientific Advisory Board of Bayer and Quidel. The study was supported by the China Academy of Chinese Medical Sciences Innovation Fund (CI 2021A03503 & CI2021B011) and “The Belt And Road” Traditional Chinese Medicine Cooperation Project of China Academy of Chinese Medical Sciences; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; and no other relationships or activities that could appear to have influenced the submitted work of all authors.

Study Objective: Previous randomized controlled trials (RCTs) suggest that auricular stimulation (AS) is safe and effective in treatment of preoperative anxiety; however, a systematic evaluation is lacking. The aim was to summarize the evidence on efficacy and safety of AS for preoperative anxiety, as well as for other outcomes., Design: We conducted a systematic review of RCTs including patients from all available populations. The search was done through MEDLINE (PubMed), EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), ISI Web of Science and Scopus Database from inception to June 2020. Study selection and data extraction were performed in by 2 independent reviewers with ability to resolve disagreements by a third author. Meta-analyses as well as the risk of bias and evidence quality assessments were performed according to the Cochrane 6.2, 2021 handbook recommendations., Interventions: We compared AS with pharmacological and non-pharmacological interventions for different outcomes., Measurements: We assessed the repercussion of the evaluated interventions over anxiety scores and their safety, physiological parameters, perioperative medications requirement and intensity of postoperative pain., Main Results: We have included 15 studies with 1603 patients. AS has presented reduced anxiety scores as compared to the sham control (Standardized Mean Difference (SMD) -0.72, 95% confidence interval (CI) -1.09 to -0.36, p < 0.0001; 8 trials; 701 patients; heterogeneity: I 2 80%; GRADE: moderate certainty) and to no intervention (SMD -1.01, 95% CI -1.58 to -0.45, p = 0.0004; 4 trials; 420 patients; heterogeneity: I 2 84%; GRADE: very low certainty). There was no difference between AS and benzodiazepines (SMD -0.03; 95% CI: -0.34 to 0.28; p = 0.84; 3 trials; 158 patients; heterogeneity: I 2 0%; GRADE: very low certainty). No trials reported serious adverse effects of AS., Conclusions: AS may be useful in treatment of preoperative anxiety. Due to heterogenous certainty in effect estimates, further research is needed to clarify the actual efficacy of AS for preoperative anxiety., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Introduction: Breast cancer (BC) survivors often suffer from disease- and therapy-related long-term side-effects. The study aim was to explore the feasibility, adherence, and individual experiences as well as possible effects of 2 different walking interventions in BC patients., Methods: This randomized controlled, pragmatic pilot trial included a qualitative study component. BC patients were randomized to either mindful walking (MFW) with mindfulness exercises and walking or moderate walking (MW) alone in weekly group sessions over 8 weeks. After 8 and 16 weeks, satisfaction, and self-perceived effectiveness as well as different health-related outcomes including health-related (WHOQOL-BREF) and disease-specific quality of life (FACT-G), perceived stress (PSQ) and cancer-related fatigue (CFS-D) were assessed. ANCOVA was used to evaluate differences in study outcomes. Qualitative data included 4 focus group interviews including 20 patients and were analyzed using a directed qualitative content analysis approach., Results: Altogether, 51 women (mean age 55.8 years (SD 10.9)) were randomized (n = 24 MFW; n = 27 MW). Both groups would recommend the course to other BC patients (MFW 88.9%; MW 95.2%) and showed possible improvements from baseline to week 8, without statistically significant difference between groups: WHOQOL-BREF (MFW: adjusted mean 65.4 (95% confidence interval (CI), 57.1-73.7); MW: 61.6 (53.6-69.6)); FACT-G (MFW: 76.0 (71.5-80.5); MW: 73.0 (68.5-77.4)); PSQ (MFW: 45.3 (40.5-50.1); MW: 45.4 (40.8-50.0)); CFS-D (MFW: 24.3 (20.8-27.8); MW: 25.5 (22.1-28.8)). Improvements lasted until the 16-weeks follow-up. The qualitative analysis suggested that MFW primarily promoted mindfulness, self-care, and acceptability in BC patients, whereas MW activated and empowered the patients as a result of the physical exercise., Conclusion: Both study interventions were positively evaluated by patients and showed possible pre-post effects in disease-specific health-related outcomes without differences between groups. The qualitative analysis results indicate that different resources and coping strategies were addressed by the 2 study interventions., Trial Registration: DKRS00011521; prospectively registered 21.12.2016; https://www.drks.de/drks&#95;web/navigate.do?navigationId=trial.HTML&TRIAL&#95;ID=DRKS00011521.

Background and Aim: Patients with chronic musculoskeletal pain diseases (CMPDs) often use osteopathic medicine (OM), although the changes in patients with pain diseases are still insufficiently investigated. This study aimed to observe changes along and after OM in addition to routine care on pain, functioning, and quality of life in patients with four CMPDs., Methods: In this observational trial with follow-up, patients suffering from chronic neck pain (CNP, n = 10), chronic low back pain (CLBP, n = 10), chronic shoulder pain (CSP, n = 10), or chronic knee pain (CKP, n = 10) received up to six OM sessions in addition to routine care., Results: A total of 40 patients (73% female, mean age 47.7 ± 8.3 years, mean pain intensity 59.4 ± 12.5 mm, measured by a visual analog scale [VAS] 0-100 mm) were included. After 26 weeks, there was an improvement in the VAS pain score in the whole population (mean difference to baseline -33.1 mm [95% CI -40.5 to -25.7]), as well in the patients with the four diseases: CNP (-33.7 mm [-54.7 to -12.6]), CLBP (-28.2 mm [-47.9 to -8.4]), CSP (-32.4 [-46.8 to -18.0]), and CKP (-38.1 mm [-49.1 to -27.0]). Regarding disease-specific outcomes, we found improvements in CNP, as measured by the neck disability index (scale 0-50; mean difference -3.6 [-9.0 to 1.9]), CLBP, as measured by the low back pain rating scale (scale 0-60; -3.4 [-12.5 to 5.7]), CSP, as measured by the disabilities of the arm, shoulder and hand score (scale 0-100; -13.4 [-23.1 to -3.7]), and CKP, as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (scale 0-96; -13.0 [-23.5 to -2.5]). These improvements persisted through week 52. No adverse events were observed., Conclusion: The study observed beneficial changes along and after the OM treatment in addition to routine care in patients with four different CMPDs. High-quality, multicenter randomized controlled trials are strongly needed to compare the effectiveness of OM and standard care interventions in treating CMPDs in the future. We have provided sufficient data for sample size calculations for these trials., (© 2021 The Author(s) Published by S. Karger AG, Basel.)

Background: The severity of atopic dermatitis (AD) is associated with lifestyle behaviors such as exercise, relaxation techniques, and dietary or nutritional adjustments., Objective: The aim of this study was to investigate the frequency of self-initiated exercise, relaxation techniques, and dietary or nutritional adjustments and their perceived benefits in patients with AD., Methods: An exploratory cross-sectional study was performed in May 2019 with 115 AD patients who participated in a threearmed randomized controlled trial (the CAMATOP study). Data on lifestyle behaviors in the three domains of exercise, relaxation techniques, and dietary or nutritional adjustments and their perceived benefits were collected anonymously by a questionnaire and exploratively evaluated., Results: A total of 58 (50.4%) patients responded and were included in the analyses. Within the previous 4 months, 54 (93.1%) respondents had performed exercise, and 24 (41.4%) respondents had used a relaxation technique. A total of 44 (75.9%) respondents had adjusted their diet or nutrition intake due to AD. Exercise, relaxation techniques, and dietary or nutritional adjustments were rated as helpful by most respondents (57.4%, 87.0%, and 95.1%, respectively). Overall, 54 (93.1%) respondents adopted at least one lifestyle factor, and 13 (22.4%) adopted a lifestyle factor in all three domains., Conclusion: In our sample, AD patients often adopted lifestyle behaviors such as exercise, relaxation techniques, diet and nutrition and perceived relaxation techniques and nutritional adjustments as helpful. Further high-quality cohort studies and prospective clinical trials should evaluate the benefits and possible risks of potentially healthy lifestyle behaviors in AD patients., (© 2022 S. Karger AG, Basel.)

Background: Acupuncture has shown beneficial effects for seasonal allergic rhinitis (SAR); however, it is time and cost intensive. We investigated feasibility and effects of self-administered body acupressure as a self-care technique that stimulates acupuncture points with manual pressure in SAR patients., Methods: We conducted a two-armed randomized controlled exploratory trial to compare effects of self-administered acupressure over 4 weeks at five acupuncture points plus rescue medication (RM) with cetirizine compared to RM alone in SAR patients. Among other outcome parameters, we assessed disease-related quality of life (Rhinitis Quality of Life Questionnaire [RQLQ]), overall SAR symptoms by a visual analogue scale (VAS) and a rescue medication score (RMS) after 4 and 8 weeks., Results: Forty-one SAR patients (mean age 38.5 ± 10.0 years, n = 21, 51.2% women) were randomized. Compared to RM alone (n = 21), acupressure plus RM (n = 20) was associated with relevant improvements after 4 weeks, shown by the difference between groups in adjusted means of RQLQ: - 0.9 points (95% CI - 1.6 to - 0.2; p = 0.011) and VAS overall SAR symptoms: - 21.6 mm (95% CI - 36.3 to - 6.8; p = 0.005). The RMS was lower in the acupressure group than in the control group: 1.9 points (95% CI - 3.8 to - 0.1; p = 0.120). Group differences decreased slightly until week 8. The acupressure was feasible and safe., Conclusion: Results of this exploratory study indicate that self-applied acupressure is feasible, may improve disease-specific quality of life and reduce disease-related symptoms as well as anti-allergic medication intake in SAR patients. High-quality confirmatory studies including a sham-control group are needed in the future. Trial registration DRKS-ID: DRKS00014310. Date of registration in DRKS: 2018/04/24. Investigator sponsored/initiated trial (IST/IIT): yes. Ethics approval/approval of the ethics committee: Approved (leading) Ethics Committee No. EA1/033/18, Ethik-Kommission der Charité -Universitätsmedizin Berlin. URL: https://www.drks.de/drks&#95;web/navigate.do?navigationId=trial.HTML&TRIAL&#95;ID=DRKS00014310., (© 2021. The Author(s).)

Introduction: Complementary medicine (CM) is often used by patients and offered by physicians. The attitude of medical students toward CM in Germany has been given little research attention. The aim was to assess the attitude of medical students toward CM in general and their opinion about the importance of CM university research and teaching. Methods: An exploratory cross-sectional study among medical students at the Charité-Universitätsmedizin Berlin was performed at the beginning of the summer term 2019 using an online survey. The attitude toward CM was assessed by the Complementary and Alternative Medicine Health Belief Questionnaire (CHBQ, range 10-70, neutral at 40; a higher score indicates a more positive attitude toward CM). Furthermore, students rated their own CM use and the perceived importance of CM university research and teaching (range 1-7; a higher score indicates more agreement). The study was approved by the Charité Ethics Committee (institutional review board). Results: Out of 1256 contacted students, 349 (27.8%) students (mean age 23.7 ± 4.3 years, 69.0% female) participated. The attitude toward CM based on the CHBQ was rather neutral (mean 44.2 ± 10.7) and more positive among females than males (mean 46.1 ± 10.7 vs. 40.6 ± 9.5, p  < 0.001). Medical students favored CM university research (mean 5.4 ± 1.5) and mostly did not agree that CM is currently taught sufficiently at the university (mean 3.4 ± 1.7). The lifetime prevalence of student's own CM use was 48.4% of respondents (79.1% females). Conclusion: Although medical students, in this sample with a high percentage of females, reported a rather neutral attitude toward CM, the authors' findings indicate that medical students promoted research and teaching in CM. Further multicenter cross-sectional studies in German and European medical universities should be undertaken to explore students' attitudes and wishes regarding the integration of CM in university teaching, research, and patient care.

The aim of this study is to explore experiences and perceived effects of the Rosary on issues around health and well-being, as well as on spirituality and religiosity. A qualitative study was conducted interviewing ten Roman Catholic German adults who regularly practiced the Rosary prayer. As a result of using a tangible prayer cord and from the rhythmic repetition of prayers, the participants described experiencing stability, peace and a contemplative connection with the Divine, with Mary as a guide and mediator before God. Praying the Rosary was described as helpful in coping with critical life events and in fostering an attitude of acceptance, humbleness and devotion., (© 2021. The Author(s).)

Importance: In observational studies, patients' treatment outcome expectations have been associated with better outcomes (ie, a placebo response), whereas concerns about adverse side effects have been associated with an in increase in the negative effects of treatments (ie, a nocebo response). Some randomized trials have suggested that communication from clinicians could affect the treatment outcomes by changing patients' expectations., Objective: To investigate whether treatment outcome expectations and reported adverse side effects could be affected by different briefing contents before a minimal acupuncture treatment in patients with chronic low back pain (CLBP)., Design, Setting, and Participants: This randomized single-blinded clinical trial was conducted among patients with CLBP at 1 outpatient clinic in Switzerland who had a pain intensity of at least 4 on a numeric rating scale from 0 to 10. Different recruitment channels were used to enroll patients. Data were collected from May 2016 to December 2017 and were analyzed from June to November 2018., Interventions: Patients were randomized to receive either a regular expectation briefing or a high expectation briefing (effectiveness) and either a regular adverse side effect briefing or an intense adverse side effect briefing (adverse side effect) in a 2 × 2 factorial design. The intervention (briefing sessions and written materials) was standardized and delivered before the acupuncture treatment, with additional booster informative emails provided during the 4-week, 8-session acupuncture course., Main Outcomes and Measures: The primary end point was the patients' expectations regarding the effectiveness of the acupuncture treatment (Expectation for Treatment Scale [ETS]) after the briefing and the subsequent pain intensity (numeric rating scale). The primary end point for the adverse side effect briefing was the adverse side effect score at the end of the acupuncture treatment, derived from session-by-session assessments of adverse side effects., Results: A total of 152 patients with CLBP (mean [SD] age, 39.54 [12.52] years; 100 [65.8%] women) were included. The estimated group difference (regular vs high) for the ETS was -0.16 (95% CI -0.81 to 0.50, P = .64), indicating no evidence for a difference between intervention groups. There was also no evidence for a difference in pain intensity at the end of the acupuncture treatment between the groups with different expectation briefings. The adverse side effects score in the group with the intense adverse side effect briefing were estimated to be 1.31 times higher (95% CI, 0.94 to 1.82; P = .11) than after a regular adverse side effect briefing, but the finding was not statistically significant., Conclusions and Relevance: In this study, suggestions regarding treatment benefits (placebo) and adverse side effects (nocebo) did not affect treatment expectations or adverse side effects. Information regarding adverse side effects might require more research to understand nocebo responses., Trial Registration: German Clinical Trials Register Identifier: DRKS00010191.

Background: Acupuncture is used to treat patients with diabetic peripheral neuropathy; however, the evidence is unclear. We present the design and methodology of the ACUDPN (ACUpuncture in Diabetic Peripheral Neuropathy) trial, which investigates the effectiveness of acupuncture for the treatment of diabetic peripheral neuropathy (DPN) symptoms. The aim of this study is to investigate whether acupuncture is effective for the treatment of DPN symptoms., Methods: This study is a two-armed, randomized, controlled, parallel group, open-label, confirmatory, multicenter trial (8-week intervention period plus 16 weeks of follow-up). Physicians in outpatient units in Germany who specialize in acupuncture treatment will treat 110 diabetes type II patients with clinical symptoms of peripheral neuropathy in the feet and legs with signs of neuropathy according to nerve conduction testing. The patients will be randomized in a 1:1 ratio to one of the following two groups: (a) semi-standardized acupuncture plus routine care or (b) routine care alone. Acupuncture will consist of 12 treatments per patient over 8 weeks. The primary outcome will be the overall DPN-related complaints in the extremities after 8 weeks as measured by the Visual Analog Scale (VAS). Further outcome measures will include DPN-related pain, the Neuropathic Pain Symptom Inventory (NPSI), Diabetic Peripheral Neuropathic Pain Impact (DPNPI) scores, and nerve conduction parameters of the sural nerve at weeks 8, 16, and 24., Discussion: The results of this trial will be available in 2021 and will help clarify whether acupuncture can be considered effective for the treatment of DPN with regard to the subdimensions of the neuropathic clinical picture., Trial Registration: ClinicalTrials.gov NCT03755960 . Registered on 11 August 2018.

Background: Although complementary medicine is frequently used in Germany, there is almost no information about complementary medicine use in competitive sports. The aim was to assess the use of complementary medicine among elite athletes in Germany., Patients and Methods: A cross-sectional study among athletes was performed between March 2012 and September 2013. Athletes of both sexes who visited a sports medical outpatient clinic in Munich, Bavaria were included. Data about the use of complementary medicine were collected by means of a standardized measurement instrument, the German version of the international complementary and alternative medicine questionnaire., Results: Of the 334 athletes (female 25%, mean age 20.2 ± 6.6 years) who completed all 4 sections of the questionnaire, 69% reported the use of at least one type of complementary medicine within the last 12 months. 505 athletes (female 26%, mean age 20.5 ± 7.0 years) completed at least one section of the questionnaire entirely. Within 12 months, the osteopath (11%), herbal medicine (17%), vitamins/minerals (32%), and relaxation techniques (15%) were the most frequently visited/used in relation to the respective sections of the questionnaire., Conclusion: Complementary medicine is frequently used by athletes in Germany. The efficacy, safety, and costs of complementary medicine should be investigated in clinical trials among athletes in the future., (© 2020 The Author(s) Published by S. Karger AG, Basel.)

Background: During the COVID-19 pandemic people are facing risks of adverse health effects due to the restrictions implemented such as quarantine measures, reduced social contact, and self-isolation. In this qualitative review, we collected data on potential preventive and therapeutic health benefits of Complementary and Integrative Medicine (CIM) that might be useful during the COVID-19 pandemic. We have reviewed the scientific literature to summarize CIM practices that could be beneficial for improving physical and mental health and well-being of the population under the current pandemic circumstances. It must be noted that this review is not SARS-CoV-2 specific and we explicitly do not intend to make any SARS-CoV-2 specific health claims in this article. Methods and Findings: A qualitative, non-systematic literature review was conducted in Medline to identify literature describing preventive and therapeutic CIM approaches for strengthening mental and physical health. For a variety of CIM approaches clinical evidence was identified, indicating beneficial effects. CIM approaches include specific dietary measures and selected micronutrients, physical activity, techniques from Mind-Body Medicine, single botanicals or botanical compounds, and spending time in nature among others. The effects of CIM measures on conditions like obesity and hypertension are of special relevance here, as these conditions are considered as risk factors for a severe course of COVID-19. Moreover, a possibly direct effect of CIM approaches on immune functions and clinical parameters in respiratory tract infections, such as influenza, were identified. The findings of this review could be helpful for clinicians, patients, and the general population during the current pandemic when discussing and/or considering CIM options. Conclusions: CIM offers a variety of preventive and therapeutic options for strengthening physical and mental resilience, which could also be useful in the current COVID-19 pandemic. The evidence of CIM approaches with a potential benefit in the COVID-19 pandemic in different areas is worth to be analyzed. While this qualitative review has several obvious limitations, it might serve as useful starting point for further research on this topic., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2020 Seifert, Jeitler, Stange, Michalsen, Cramer, Brinkhaus, Esch, Kerckhoff, Paul, Teut, Ghadjar, Langhorst, Häupl, Murthy and Kessler.)

Background: Nonspecific chronic neck pain (cNP) is common in adult violinists and violists and is often treated with osteopathic medicine (OM), although the effectiveness of this treatment has not been determined to date. This study aimed to evaluate the effectiveness and safety of OM in adult violinists and violists with cNP., Methods: In a two-armed randomized controlled single-center open trial, adult violinists and violists, including music students, with cNP (⩾12 weeks) were randomized to either five individualized OM sessions (OM group) or to no intervention (control group, CG) in the outpatient clinic for integrative medicine, Charité - Universitätsmedizin Berlin, Germany. All patients received a musicians' medicine consultation and paracetamol on demand. The primary outcome parameter was the neck pain intensity on a visual analog scale (VAS, 0-100 mm, 0 = no pain, 100 = worst imaginable pain) after 12 weeks. Secondary outcomes included neck pain disability (Neck Disability Index, NDI, 0-100%) after 12 weeks. The last follow-up visit was after 52 weeks. Statistical analysis included analysis of covariance adjusted for respective baseline value., Results: Altogether, 62 outpatients were included [OM group ( n  = 28), CG ( n  = 34); 81% female; mean age, 41.6 ± 11.1 years; mean baseline neck pain, 55.9 ± 11.6 mm]. After 12 weeks, OM was associated with an improvement in the OM group versus the CG in neck pain on the VAS [14.6 mm (95% confidence interval 8.0; 21.2) versus 40.8 mm (34.7; 46.9), p  < 0.001, Cohen's d  = 1.4], and neck pain disability as determined by the NDI [8.8% (6.7; 10.8) versus 17.2% (15.3; 19.1), p  < 0.001]. Some improvements were maintained until 52 weeks of follow-up. No serious adverse events were observed., Conclusions: The results of this study suggest that OM might be effective in reducing pain intensity in adult violinists and violists with nonspecific cNP. Further studies should investigate the efficacy of OM in comparison with a sham procedure and with other effective therapy methods in high-quality multicenter trials., Trial Registration: WHO Trial Registration https://apps.who.int/trialsearch/NoAccess.aspx?aspxerrorpath=/trialsearch/Trial2.aspx by German Clinical Trials Register DRKS00009258, Universal Trial Number (UTN): U1111-1173-5943., Competing Interests: Conflict of interest statement: Gabriele Rotter receives irregular lecture fees for teaching in osteopathic medicine and musicians’ medicine. She is a board member of the European Register for Osteopathic Physicians (EROP). The other authors declare no conflicts of interest regarding this study., (© The Author(s), 2020.)

Background: Preoperative anxiety causes profound psychological and physiological reactions that may lead to a worse postoperative recovery, higher intensity of acute and persistent postsurgical pain and impaired quality of life in the postoperative period. Previous randomized controlled trials (RCTs) suggest that auricular acupuncture (AA) is safe and effective in the treatment of preoperative anxiety; however there is a lack of systematic evidence on this topic. Therefore, this protocol was developed following the PRISMA guidelines to adequately evaluate the existing literature regarding the value of AA for the reduction in anxiety in patients in a preoperative setting, compared to other forms of acupuncture, pharmacological, or no control interventions and measured with questionnaires regarding anxiety and fear. Methods: The following databases will be searched: MEDLINE (PubMed), EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), ISI Web of Science, and Scopus Database. RCTs will be included if an abstract is available in English. Data collection and analysis will be conducted by two reviewers independently. Quality and risk assessment of included studies will be done using the Cochrane 5.1.0 handbook criteria and meta-analysis of effectiveness and symptom scores will be conducted using the statistical software RevMan V.5.3. Conclusions: This systematic review will evaluate the efficacy and safety of AA for preoperative anxiety. Since all data used in this systematic review and meta-analysis have been published, this review does not require ethical approval. The results may be published in a peer-reviewed journal or be presented in relevant conferences. Registration number: PROSPERO ID CRD42020.

Background: The aim of the trial was to investigate the effect of a hypnotherapeutic group program in healthy persons with increased levels of perceived stress., Methods: In a randomized controlled multicenter trial participants with a self-assessed subjective stress level ≥ 40 mm on a visual analogue scale (0-100 mm; VAS) for the previous week and a stable state of health were randomized to either 5 weekly sessions of 120-min duration of a hypnotherapeutic group program for stress reduction and improved stress coping plus 5 hypnosis audiorecords for individual practice at home plus an educational booklet for stress coping (hypnosis group) versus an educational booklet only (control group). The primary outcome parameter was the VAS stress level for the previous week after 5 weeks. Secondary outcome parameters included the VAS stress level after 12 weeks, perceived stress (CPSS), depression (ADS-K), self efficacy (SWE) and quality of life (SF 36) after 5 weeks and 12 weeks. Analysis of covariance with a significance level of 5% using the full analysis set was used for analysis; the model included treatment (fixed effect), VAS baseline value (fixed covariate), and center (random effect)., Results: A total of 95 participants were randomized; 47 (40 female, 45 ± 13.4 years of age) were allocated to the hypnosis group, and 48 (41 female, 46.9 ± 14.3 years) were allocated to the control group. Regarding VAS stress level after 5 weeks, the adjusted VAS mean in the hypnosis group was 41.8 mm [95% confidence interval (CI): 35.2; 48.4] compared to 62.9 mm [56.2; 69.7] in the control group, and the group difference was - 21.2 mm [- 30.1; - 12.2] (P < 0.001). After 12 weeks, the stress intensity on the VAS showed a between-group difference of - 14.7 mm [- 25.1; - 4.4] (P = 0.006), and the adjusted means were 41.1 mm [33.4; 48.8] in the hypnosis group and 55.9 mm [48.4; 63.5] in the control group. Improvements were also reported for CPSS, SF-36, SWE and ADS-K after 5 and 12 weeks., Conclusion: Compared to the control group, the hypnosis group showed reduced perceived stress after 5 and 12 weeks., Trial Registration: ClinicalTrials.gov NCT03525093 ; date of registration: May 15, 2018.

The aim of this study was to develop a standardized hypnotherapeutic group program for stress reduction, test its feasibility, and measure its preliminary pre- to postintervention effects. In this prospective, single-arm feasibility study, healthy adult participants with self-assessed increased stress levels received 5 weekly group hypnosis sessions plus audio recordings. Twelve persons (10 females, mean (SD) age 48.9 (11.8) years participated. The mean (SD) intensity of perceived stress on a 0-to-100 mm VAS was reduced from 75.5 (11.5) mm at baseline to 33.9 (18.8) mm after 5 weeks. Cohen's perceived stress scale was reduced from 20.8 (5.7) to 13.8 (5.4). Focus group interviews showed that the study intervention was feasible and well accepted. Confirmatory testing of the intervention in a randomized controlled trial is necessary.

There is a growing interest in nonpharmacological pain treatment options such as cupping. This meta-analysis aimed to assess the effectiveness and safety of cupping in chronic pain. PubMed, Cochrane Library, and Scopus were searched through November 2018 for randomized controlled trials on effects of cupping on pain intensity and disability in patients with chronic pain. Risk of bias was assessed using the Cochrane risk of bias tool. Of the 18 included trials (n =1,172), most were limited by clinical heterogeneity and risk of bias. Meta-analyses found large short-term effects of cupping on pain intensity compared to no treatment (standardized mean difference [SMD] = -1.03; 95% confidence interval [CI] = -1.41, -.65), but no significant effects compared to sham cupping (SDM = -.27; 95% CI = -.58, .05) or other active treatment (SMD = -.24; 95% CI = -.57, .09). For disability, there were medium-sized short-term effects of cupping compared to no treatment (SMD = -.66; 95% CI = -.99, -.34), and compared to other active treatments (SMD = -.52; 95% CI = -1.03, -.0028), but not compared to sham cupping (SMD = -.26; 95% CI = -.57,.05). Adverse events were more frequent among patients treated with cupping compared to no treatment; differences compared to sham cupping or other active treatment were not statistically significant. Cupping might be a treatment option for chronic pain, but the evidence is still limited by the clinical heterogeneity and risk of bias. Perspective: This article presents the results of a meta-analysis aimed to assess the effectiveness and safety of cupping with chronic pain. The results suggest that cupping might be a treatment option; however, the evidence is still limited due to methodical limitations of the included trials. High-quality trials seem warranted., (Copyright © 2020 United States Association for the Study of Pain, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Professional musicians frequently suffer from musculoskeletal complaints and disorders (MCD), which can be treated by osteopathic manipulative treatment (OMT). The aim of this systematic review was to evaluate the effectiveness and efficacy of OMT in adult musicians., Methods: A systematic literature search included the electronic databases PubMed/MEDLINE, Medpilot, EBSCOhost, BioMedCentral, OSTMED-Dr, osteopathic-research.com, PEDro, hand searches, and contact to European osteopathic academies. Interventional and observational studies published between January 1999 and January 2019, of professional or amateur musicians who were either healthy or had MCD treated by OMT, were included. The quality of the randomized controlled trials (RCTs) was assessed by the Physiotherapy Evidence Database (PEDro) Scale ranging between 0 and 10 points., Results: Only 5 studies were identified investigating OMT in musicians, including 1 RCT (cross-over design), 3 clinical controlled trials, and 1 case report. The internal validity of the RCT was assessed as 6 points. OMT was reported to have a positive impact on healthy singers, improving phonation time, voice quality, and voice range. It also improved the cervical range of motion in violinists. No adverse events were observed, although only the cross-over RCT reported partly an assessment of adverse events., Conclusions: The evidence for OMT in adult musicians is very limited. Prospective controlled clinical trials investigating OMT in musicians are required.