The relevance of outcome expectations in group hypnosis for stress reduction: a secondary analysis of a multicenter randomized controlled trial.

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, R2 = 0.001) and adjusted (B = 0.639, t = 0.470, p = 0.641, R2 = 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.

Implementation of a Mindful Walking Intervention in Breast Cancer Patients After Their Primary Oncologic Treatment: Results of a Qualitative Study Within a Randomized Controlled Trial.

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.

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

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

German translation and validation of the complementary and alternative medicine health belief questionnaire (CHBQ).

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.

Self-care strategies for medical students: an uncontrolled mixed-methods evaluation of a mind-body-medicine group course.

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.

Cardiovascular effects of auricular stimulation -a systematic review and meta-analysis of randomized controlled clinical trials.

Background: The number of randomized controlled trials using auricular stimulation (AS) such as transauricular vagus nerve stimulation, or other auricular electrostimulation or auricular acupuncture or acupressure, in experimental and clinical settings, has increased markedly over the last three decades. This systematic review focusses on cardiovascular effects of auricular stimulation. Methods and analysis: The following databases were searched: MEDLINE (PubMed), EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), ISI Web of Science, and Scopus Database. RCTs were reviewed that had been published in English and European languages. Data collection and analysis was conducted by two reviewers independently. Quality and risk assessment of included studies was performed and the meta-analysis of the effect of the most frequently assessed biomarkers. Results: Altogether, 78 trials were included. 38 studies assessed heart rate (HR), 19 studies analyzed heart rate variability (HRV), 31 studies analyzed blood pressure (BP) and 7 studies were identified that measured oxygen saturation (O2), 2 studies on baroreflex sensitivity and 2 studies on skin conductance were evaluated in this review. 26 studies contained continuous data and were eligible for meta-analysis, 50 trials reported non continuous data and were evaluated descriptively. The overall quality of the studies was moderate to low. AS leads to a significant reduction of HR, the changes though were not considered an adverse reaction. Furthermore, when looking at HRV, AS was able to reduce the LF/HF ratio significantly compared to control procedures. No other cardiovascular parameters (blood pressure, oxygen saturation, baroreflex sensitivity) were changed significantly. AS produced only minor side effects in all trials. Conclusion: AS can lead to clinically safe reduction of HR and changes in the LF/HF ratio of the HRV, which is presumably via an increase in vagal activity. More research is needed to clarify whether AS can be used to modulate tachycardia or indications with autonomic imbalance. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=231885 PROSPERO, ID CRD42021231885.

Sense of coherence and religion/spirituality: A systematic review and meta-analysis based on a methodical classification of instruments measuring religion/spirituality.

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_record.php?ID = CRD42021240380.

Clinical effects of Kneipp hydrotherapy: a systematic review of randomised controlled trials.

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.

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

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

Hydrotherapy and acupressure in restless legs syndrome: A randomized, controlled, 3-armed, explorative clinical trial.

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.

Acupuncture in Patients with Diabetic Peripheral Neuropathy-Related Complaints: A Randomized Controlled Clinical Trial.

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.

Characteristics of Patients Presenting at a University Outpatient Department for Complementary and Integrative Medicine.

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 1­86 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.

Hypnotherapy, Intermittent Fasting, and Exercise Group Programs in Atopic Dermatitis: A Randomized Controlled Explorative Clinical Trial During the COVID-19 Pandemic.

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.

Allergic diseases in German competitive athletes: results of a cross-sectional study.

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.

Acupuncture in diabetic peripheral neuropathy-neurological outcomes of the randomized acupuncture in diabetic peripheral neuropathy trial.

BACKGROUND: Diabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus and can lead to serious complications. Therapeutic strategies for pain control are available but there are few approaches that influence neurological deficits such as numbness. AIM: To investigate the effectiveness of acupuncture on improving neurological deficits in patients suffering from type 2 DPN. METHODS: The acupuncture in DPN (ACUDPN) study was a two-armed, randomized, controlled, parallel group, open, multicenter clinical trial. Patients were randomized in a 1:1 ratio into two groups: The acupuncture group received 12 acupuncture treatments over 8 wk, and the control group was on a waiting list during the first 16 wk, before it received the same treatment as the other group. Both groups received routine care. Outcome parameters were evaluated after 8, 16 and 24 wk and included neurological scores, such as an 11-point numeric rating scale (NRS) 11 for hypesthesia, neuropathic pain symptom inventory (NPSI), neuropathy deficit score (NDS), neuropathy symptom score (NSS); nerve conduction studies (NCS) were assessed with a handheld point-of-care device. RESULTS: Sixty-two participants were included. The NRS for numbness showed a difference of 2.3 (P < 0.001) in favor of the acupuncture group, the effect persisted until week 16 with a difference of 2.2 (P < 0.001) between groups and 1.8 points at week 24 compared to baseline. The NPSI was improved in the acupuncture group by 12.6 points (P < 0.001) at week 8, the NSS score at week 8 with a difference of 1.3 (P < 0.001); the NDS and the TNSc score improved for the acupuncture group in week 8, with a difference of 2.0 points (P < 0.001) compared to the control group. Effects were persistent in week 16 with a difference of 1.8 points (P < 0.05). The NCS showed no meaningful changes. In both groups only minor side effects were reported. CONCLUSION: Study results suggest that acupuncture may be beneficial in type 2 diabetic DPN and seems to lead to a reduction in neurological deficits. No serious adverse events were recorded and the adherence to treatment was high. Confirmatory randomized sham-controlled clinical studies with adequate patient numbers are needed to confirm the results.

Lifestyle Behaviors in Patients with Atopic Dermatitis: Results of a Cross-Sectional Study following a Randomized Controlled Trial.

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.

Health-Related Self-Care Strategies and Coping Resources During the COVID-19 Pandemic: An Online-Based Cross-Sectional Study.

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.

Acupuncture and osteopathic medicine for atopic dermatitis: a three-armed, randomized controlled explorative clinical trial.

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.

Naturopathy, complementary and integrative medicine in medical education - position paper by the GMA Committee Integrative Medicine and Perspective Pluralism.

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.

Mindful Walking in Patients with Chronic Low Back Pain: A Randomized Controlled Trial.

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).