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.

Meditation-based lifestyle modification in mild to moderate depression-A randomized controlled trial.

OBJECTIVE: Depression is a global key challenge in mental health care. The implementation of effective, low-risk and cost-effective interventions to reduce its disease burden is a necessity. The aim of this study was to investigate the efficacy of the new Meditation-Based Lifestyle Modification (MBLM) program, a "second-generation" mindfulness-based intervention, in depressive outpatients. METHODS: Eighty-one patients with mild to moderate depression were randomized into three groups: intervention group (MBLM), control group (CONTROL), and treatment as usual group (TAU). The primary outcome was the change of depressive symptoms as administered by the Beck Depression Inventory-II (BDI-II) after 4 and 8 weeks. Secondary outcome variables included the Brief Symptom Checklist-18 and the Perceived Stress Scale-10. A 6-month follow-up was conducted. RESULTS: A greater reduction of depressive symptoms was found in MBLM participants compared to CONTROL (p < .001, ηp2 = 0.11, d = 0.70) and TAU ( p<.001,ηp2=0.10,d=0.67$p\lt .001,{\eta }_{{\rm{p}}}^{2}=0.10,d=0.67$ ) with a 13.15 points reduction of BDI-II score versus 1.71 points (CONTROL) and 3.34 points (TAU) after 8 weeks. Between-group post hoc tests for all secondary outcomes and at follow-up also yielded significant between-group differences with medium to large effect sizes in favor of MBLM. CONCLUSIONS: Study results showed beneficial effects of MBLM in depressed outpatients. Further high-quality controlled clinical studies including qualitative research are needed to investigate the specific and unspecific effects of the MBLM program in depression and other medical conditions.

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.

Acupuncture and its effect on cytokine and chemokine profiles in seasonal allergic rhinitis: a preliminary three-armed, randomized, controlled trial.

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.

Correction to: Impact of a combined multimodal-aerobic and multimodal intervention compared to standard aerobic treatment in breast cancer survivors with chronic cancer-related fatigue - results of a three-armed pragmatic trial in a comprehensive cohort design.

An amendment to this paper has been published and can be accessed via the original article.

[Acupuncture for pain and allergic rhinitis-from clinical experience to evidence]. / Akupunktur bei Schmerzerkrankungen und Allergien ­ von der klinischen Erfahrung zur Evidenz.

BACKGROUND: Acupuncture is a traditional Chinese medicine therapy method that is also frequently used in the western world. It has been the subject of intensive scientific research over the past two decades. AIM OF THE WORK: To describe the efficacy, therapy safety, and health economic relevance of acupuncture for chronic pain disorders and allergic diseases. MATERIAL AND METHODS: In the context of a review (narrative review) the relevant literature was selected, presented, and interpreted. RESULTS: Acupuncture is effective in chronic pain disorders such as chronic knee joint pain in osteoarthritis, migraine, tension headache, chronic lumbar spine pain, chronic cervical spine pain, shoulder pain, dysmenorrhea, and fibromyalgia under routine conditions. In addition, specific efficacy is shown in most chronic pain indications. Acupuncture is also effective in patients with allergic diseases. In large clinical studies, acupuncture has proven to be a relatively safe therapy, but severe complications (e.g. pneumothorax cases, hepatitis B) also occur in rare instances. Acupuncture is usually associated with higher therapy costs, but is considered a cost-effective treatment strategy for pain disorders. DISCUSSION: As a nonpharmacological procedure, acupuncture is becoming increasingly important in pain and allergy therapy and is therefore increasingly included in current guidelines. In further studies, the efficacy of acupuncture should be determined in other indications and the mechanisms of action of this therapy method should be investigated.

Effects of Osteopathic Manipulative Treatment on Musicians: A Systematic Review.

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.

Prophylactic acupuncture treatment during chemotherapy with breast cancer: a randomized pragmatic trial with a retrospective nested qualitative study.

PURPOSE: This study investigated the effect of additional prophylactic acupuncture during chemotherapy on quality of life and side effects compared to standard treatment alone in breast cancer patients. METHODS: In a pragmatic trial, newly diagnosed breast cancer patients were randomized to additional acupuncture treatments over 6 months or standard care alone (control group). The primary outcome was the disease-specific quality of life (FACT-B). Twenty qualitative semi-structured interviews were conducted with ten patients from each group regarding their subjective experiences. RESULTS: A total of 150 women (mean age 51.0 (SD 10.0) years) were randomized. For the primary endpoint, FACT-B total score after 6 months, no statistically significant difference was found between groups (acupuncture: 103.5 (95%, CI 88.8 to 107.2); control (101.4 (- 97.5 to 105.4); difference 2.0 (- 3.4 to 7.5) p = 0.458)). Qualitative content analyses showed that patients in the acupuncture group described positive effects on psychological and physical well-being. For both patient groups, coping strategies were more important than reducing side effects. CONCLUSIONS: Breast cancer patients receiving prophylactic acupuncture during chemotherapy did not show better quality of life in the questionnaires in contrast to the reported positive effects in the qualitative interviews. Coping strategies for cancer appear to be important. TRIAL REGISTRATION: clinicaltrials.gov; NCT01727362. Prospectively registered 11 July 2012; https://clinicaltrials.gov/ct2/show/NCT01727362 . The manuscript adheres to CONSORT guidelines.

Impact of a combined multimodal-aerobic and multimodal intervention compared to standard aerobic treatment in breast cancer survivors with chronic cancer-related fatigue - results of a three-armed pragmatic trial in a comprehensive cohort design.

BACKGROUND: Cancer-related fatigue (CRF) and insomnia are major complaints in breast cancer survivors (BC). Aerobic training (AT), the standard therapy for CRF in BC, shows only minor to moderate treatment effects. Other evidence-based treatments include cognitive behavioral therapy, e.g., sleep education/restriction (SE) and mindfulness-based therapies. We investigated the effectiveness of a 10-week multimodal program (MT) consisting of SE, psycho-education, eurythmy- and painting-therapy, administered separately or in combination with AT (CT) and compared both arms to AT alone. METHODS: In a pragmatic comprehensive cohort study BC with chronic CRF were allocated randomly or by patient preference to (a) MT, (b) CT (MT + AT) or (c) AT alone. Primary endpoint was a composite score of the Pittsburgh Sleep Quality Index and the Cancer Fatigue Scale after 10 weeks of intervention (T1); a second endpoint was a follow-up assessment 6 months later (T2). The primary hypothesis stated superiority of CT and non-inferiority of MT vs. AT at T1. A closed testing procedure preserved the global α-level. The intention-to-treat analysis included propensity scores for the mode of allocation and for the preferred treatment, respectively. RESULTS: Altogether 126 BC were recruited: 65 were randomized and 61 allocated by preference; 105 started the intervention. Socio-demographic parameters were generally balanced at baseline. Non-inferiority of MT to AT at T1 was confirmed (p < 0.05), yet the confirmative analysis stopped as it was not possible to confirm superiority of CT vs. AT (p = 0.119). In consecutive exploratory analyses MT and CT were superior to AT at T1 and T2 (MT) or T2 alone (CT), respectively. CONCLUSIONS: The multimodal CRF-therapy was found to be confirmatively non-inferior to standard therapy and even yielded exploratively sustained superiority. A randomized controlled trial including a larger sample size and a longer follow-up to evaluate multimodal CRF-therapy is highly warranted. TRIAL REGISTER: DRKS-ID: DRKS00003736 . Recruitment period June 2011 to March 2013. Date of registering 19 June 2012.

Effects of yoga on chronic neck pain: a systematic review and meta-analysis.

OBJECTIVE: The aim of this review was to systematically assess and meta-analyze the effectiveness of yoga in relieving chronic neck pain. METHODS: PubMed/MEDLINE, the Cochrane Library, Scopus, and IndMED were screened through January 2017 for randomized controlled trials assessing neck pain intensity and/or neck pain-related disability in chronic neck pain patients. Secondary outcome measures included quality of life, mood, and safety. Risk of bias was assessed using the Cochrane tool. RESULTS: Three studies on 188 patients with chronic non-specific neck pain comparing yoga to usual care were included. Two studies had overall low risk of bias; and one had high or unclear risk of bias for several domains. Evidence for short-term effects was found for neck pain intensity (standardized mean difference (SMD) = -1.28; 95% confidence interval (CI) = -1.18, -0.75; P < 0.001), neck pain-related disability (SMD = -0.97; 95% CI = -1.44, -0.50; P < 0.001), quality of life (SMD = 0.57; 95% CI = 0.17, 0.197; P = 0.005), and mood (SMD = -1.02; 95% CI = -1.38, -0.65; P < 0.001). Effects were robust against potential methodological bias and did not differ between different intervention subgroups. In the two studies that included safety data, no serious adverse events occurred. CONCLUSION: Yoga has short-term effects on chronic neck pain, its related disability, quality of life, and mood suggesting that yoga might be a good treatment option.

Acupuncture for the prevention of episodic migraine.

BACKGROUND: Acupuncture is often used for migraine prevention but its effectiveness is still controversial. We present an update of our Cochrane review from 2009. OBJECTIVES: To investigate whether acupuncture is a) more effective than no prophylactic treatment/routine care only; b) more effective than sham (placebo) acupuncture; and c) as effective as prophylactic treatment with drugs in reducing headache frequency in adults with episodic migraine. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL: 2016, issue 1); MEDLINE (via Ovid, 2008 to January 2016); Ovid EMBASE (2008 to January 2016); and Ovid AMED (1985 to January 2016). We checked PubMed for recent publications to April 2016. We searched the World Health Organization (WHO) Clinical Trials Registry Platform to February 2016 for ongoing and unpublished trials. SELECTION CRITERIA: We included randomized trials at least eight weeks in duration that compared an acupuncture intervention with a no-acupuncture control (no prophylactic treatment or routine care only), a sham-acupuncture intervention, or prophylactic drug in participants with episodic migraine. DATA COLLECTION AND ANALYSIS: Two reviewers checked eligibility; extracted information on participants, interventions, methods and results, and assessed risk of bias and quality of the acupuncture intervention. The primary outcome was migraine frequency (preferably migraine days, attacks or headache days if migraine days not measured/reported) after treatment and at follow-up. The secondary outcome was response (at least 50% frequency reduction). Safety outcomes were number of participants dropping out due to adverse effects and number of participants reporting at least one adverse effect. We calculated pooled effect size estimates using a fixed-effect model. We assessed the evidence using GRADE and created 'Summary of findings' tables. MAIN RESULTS: Twenty-two trials including 4985 participants in total (median 71, range 30 to 1715) met our updated selection criteria. We excluded five previously included trials from this update because they included people who had had migraine for less than 12 months, and included five new trials. Five trials had a no-acupuncture control group (either treatment of attacks only or non-regulated routine care), 15 a sham-acupuncture control group, and five a comparator group receiving prophylactic drug treatment. In comparisons with no-acupuncture control groups and groups receiving prophylactic drug treatment, there was risk of performance and detection bias as blinding was not possible. Overall the quality of the evidence was moderate. Comparison with no acupunctureAcupuncture was associated with a moderate reduction of headache frequency over no acupuncture after treatment (four trials, 2199 participants; standardised mean difference (SMD) -0.56; 95% CI -0.65 to -0.48); findings were statistically heterogeneous (I² = 57%; moderate quality evidence). After treatment headache frequency at least halved in 41% of participants receiving acupuncture and 17% receiving no acupuncture (pooled risk ratio (RR) 2.40; 95% CI 2.08 to 2.76; 4 studies, 2519 participants) with a corresponding number needed to treat for an additional beneficial outcome (NNTB) of 4 (95% CI 3 to 6); there was no indication of statistical heterogeneity (I² = 7%; moderate quality evidence). The only trial with post-treatment follow-up found a small but significant benefit 12 months after randomisation (RR 2.16; 95% CI 1.35 to 3.45; NNT 7; 95% 4 to 25; 377 participants, low quality evidence). Comparison with sham acupunctureBoth after treatment (12 trials, 1646 participants) and at follow-up (10 trials, 1534 participants), acupuncture was associated with a small but statistically significant frequency reduction over sham (moderate quality evidence). The SMD was -0.18 (95% CI -0.28 to -0.08; I² = 47%) after treatment and -0.19 (95% CI -0.30 to -0.09; I² = 59%) at follow-up. After treatment headache frequency at least halved in 50% of participants receiving true acupuncture and 41% receiving sham acupuncture (pooled RR 1.23, 95% CI 1.11 to 1.36; I² = 48%; 14 trials, 1825 participants) and at follow-up in 53% and 42%, respectively (pooled RR 1.25, 95% CI 1.13 to 1.39; I² = 61%; 11 trials, 1683 participants; moderate quality evidence). The corresponding NNTBs are 11 (95% CI 7.00 to 20.00) and 10 (95% CI 6.00 to 18.00), respectively. The number of participants dropping out due to adverse effects (odds ratio (OR) 2.84; 95% CI 0.43 to 18.71; 7 trials, 931 participants; low quality evidence) and the number of participants reporting adverse effects (OR 1.15; 95% CI 0.85 to 1.56; 4 trials, 1414 participants; moderate quality evidence) did not differ significantly between acupuncture and sham groups. Comparison with prophylactic drug treatmentAcupuncture reduced migraine frequency significantly more than drug prophylaxis after treatment ( SMD -0.25; 95% CI -0.39 to -0.10; 3 trials, 739 participants), but the significance was not maintained at follow-up (SMD -0.13; 95% CI -0.28 to 0.01; 3 trials, 744 participants; moderate quality evidence). After three months headache frequency at least halved in 57% of participants receiving acupuncture and 46% receiving prophylactic drugs (pooled RR 1.24; 95% CI 1.08 to 1.44) and after six months in 59% and 54%, respectively (pooled RR 1.11; 95% CI 0.97 to 1.26; moderate quality evidence). Findings were consistent among trials with I² being 0% in all analyses. Trial participants receiving acupuncture were less likely to drop out due to adverse effects (OR 0.27; 95% CI 0.08 to 0.86; 4 trials, 451 participants) and to report adverse effects (OR 0.25; 95% CI 0.10 to 0.62; 5 trials 931 participants) than participants receiving prophylactic drugs (moderate quality evidence). AUTHORS' CONCLUSIONS: The available evidence suggests that adding acupuncture to symptomatic treatment of attacks reduces the frequency of headaches. Contrary to the previous findings, the updated evidence also suggests that there is an effect over sham, but this effect is small. The available trials also suggest that acupuncture may be at least similarly effective as treatment with prophylactic drugs. Acupuncture can be considered a treatment option for patients willing to undergo this treatment. As for other migraine treatments, long-term studies, more than one year in duration, are lacking.

Acupuncture for the prevention of tension-type headache.

BACKGROUND: Acupuncture is often used for prevention of tension-type headache but its effectiveness is still controversial. This is an update of our Cochrane review originally published in Issue 1, 2009 of The Cochrane Library. OBJECTIVES: To investigate whether acupuncture is a) more effective than no prophylactic treatment/routine care only; b) more effective than 'sham' (placebo) acupuncture; and c) as effective as other interventions in reducing headache frequency in adults with episodic or chronic tension-type headache. SEARCH METHODS: We searched CENTRAL, MEDLINE, EMBASE and AMED to 19 January 2016. We searched the World Health Organization (WHO) International Clinical Trials Registry Platform to 10 February 2016 for ongoing and unpublished trials. SELECTION CRITERIA: We included randomised trials with a post-randomisation observation period of at least eight weeks, which compared the clinical effects of an acupuncture intervention with a control (treatment of acute headaches only or routine care), a sham acupuncture intervention or another prophylactic intervention in adults with episodic or chronic tension-type headache. DATA COLLECTION AND ANALYSIS: Two review authors checked eligibility; extracted information on participants, interventions, methods and results; and assessed study risk of bias and the quality of the acupuncture intervention. The main efficacy outcome measure was response (at least 50% reduction of headache frequency) after completion of treatment (three to four months after randomisation). To assess safety/acceptability we extracted the number of participants dropping out due to adverse effects and the number of participants reporting adverse effects. We assessed the quality of the evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation). MAIN RESULTS: Twelve trials (11 included in the previous version and one newly identified) with 2349 participants (median 56, range 10 to 1265) met the inclusion criteria.Acupuncture was compared with routine care or treatment of acute headaches only in two large trials (1265 and 207 participants), but they had quite different baseline headache frequency and management in the control groups. Neither trial was blinded but trial quality was otherwise high (low risk of bias). While effect size estimates of the two trials differed considerably, the proportion of participants experiencing at least 50% reduction of headache frequency was much higher in groups receiving acupuncture than in control groups (moderate quality evidence; trial 1: 302/629 (48%) versus 121/636 (19%); risk ratio (RR) 2.5; 95% confidence interval (CI) 2.1 to 3.0; trial 2: 60/132 (45%) versus 3/75 (4%); RR 11; 95% CI 3.7 to 35). Long-term effects (beyond four months) were not investigated.Acupuncture was compared with sham acupuncture in seven trials of moderate to high quality (low risk of bias); five large studies provided data for one or more meta-analyses. Among participants receiving acupuncture, 205 of 391 (51%) had at least 50% reduction of headache frequency compared to 133 of 312 (43%) in the sham group after treatment (RR 1.3; 95% CI 1.09 to 1.5; four trials; moderate quality evidence). Results six months after randomisation were similar. Withdrawals were low: 1 of 420 participants receiving acupuncture dropped out due to adverse effects and 0 of 343 receiving sham (six trials; low quality evidence). Three trials reported the number of participants reporting adverse effects: 29 of 174 (17%) with acupuncture versus 12 of 103 with sham (12%; odds ratio (OR) 1.3; 95% CI 0.60 to 2.7; low quality evidence).Acupuncture was compared with physiotherapy, massage or exercise in four trials of low to moderate quality (high risk of bias); study findings were inadequately reported. No trial found a significant superiority of acupuncture and for some outcomes the results slightly favoured the comparison therapy. None of these trials reported the number of participants dropping out due to adverse effects or the number of participants reporting adverse effects.Overall, the quality of the evidence assessed using GRADE was moderate or low, downgraded mainly due to a lack of blinding and variable effect sizes. AUTHORS' CONCLUSIONS: The available results suggest that acupuncture is effective for treating frequent episodic or chronic tension-type headaches, but further trials - particularly comparing acupuncture with other treatment options - are needed.

Acupuncture in patients with seasonal allergic rhinitis: a randomized trial.

UNLABELLED: Chinese translation BACKGROUND: Acupuncture is frequently used to treat seasonal allergic rhinitis (SAR) despite limited scientific evidence. OBJECTIVE: To evaluate the effects of acupuncture in patients with SAR. DESIGN: Randomized, controlled multicenter trial. (ClinicalTrials.gov: NCT00610584) SETTING: 46 specialized physicians in 6 hospital clinics and 32 private outpatient clinics. PATIENTS: 422 persons with SAR and IgE sensitization to birch and grass pollen. INTERVENTION: Acupuncture plus rescue medication (RM) (cetirizine) (n = 212), sham acupuncture plus RM (n = 102), or RM alone (n = 108). Twelve treatments were provided over 8 weeks in the first year. MEASUREMENTS: Changes in the Rhinitis Quality of Life Questionnaire (RQLQ) overall score and the RM score (RMS) from baseline to weeks 7 and 8 and week 16 in the first year and week 8 in the second year after randomization, with predefined noninferiority margins of -0.5 point (RQLQ) and -1.5 points (RMS). RESULTS: Compared with sham acupuncture and with RM, acupuncture was associated with improvement in RQLQ score (sham vs. acupuncture mean difference, 0.5 point [97.5% CI, 0.2 to 0.8 point; P < 0.001]; RM vs. acupuncture mean difference, 0.7 point [97.5% CI, 0.4 to 1.0 point; P < 0.001]) and RMS (sham vs. acupuncture mean difference, 1.1 points [97.5% CI, 0.4 to 1.9 points; P < 0.001]; RM vs. acupuncture mean difference, 1.5 points [97.5% CI, 0.8 to 2.2 points; P < 0.001]). There were no differences after 16 weeks in the first year. After the 8-week follow-up phase in the second year, small improvements favoring real acupuncture over the sham procedure were noted (RQLQ mean difference, 0.3 point [95% CI, 0.03 to 0.6 point; P = 0.032]; RMS mean difference, 1.0 point [95% CI, 0.2 to 1.9 points; P = 0.018]). LIMITATION: The study was not powered to detect rare adverse events, and the RQLQ and RMS values were low at baseline. CONCLUSION: Acupuncture led to statistically significant improvements in disease-specific quality of life and antihistamine use measures after 8 weeks of treatment compared with sham acupuncture and with RM alone, but the improvements may not be clinically significant.

Complementary medicine in nursing homes--results of a mixed methods pilot study.

BACKGROUND: 'Kneipp Therapy' (KT) is a form of Complementary and Alternative Medicine (CAM) that includes a combination of hydrotherapy, herbal medicine, mind-body medicine, physical activities, and healthy eating. Since 2007, some nursing homes for older adults in Germany began to integrate CAM in the form of KT in care. The study investigated how KT is used in daily routine care and explored the health status of residents and caregivers involved in KT. METHODS: We performed a cross-sectional pilot study with a mixed methods approach that collected both quantitative and qualitative data in four German nursing homes in 2011. Assessments in the quantitative component included the Quality of Life in Dementia (QUALIDEM), the Short Form 12 Health Survey (SF-12), the Barthel-Index for residents and the Work Ability Index (WAI) and SF-12 for caregivers. The qualitative component addressed the residents' and caregivers' subjectively experienced changes after integration of KT. It was conceptualized as an ethnographic rapid appraisal by conducting participant observation and semi-structured interviews in two of the four nursing homes. RESULTS: The quantitative component included 64 residents (53 female, 83.2 ± 8.1 years (mean and SD)) and 29 caregivers (all female, 42.0 ± 11.7 years). Residents were multimorbid (8 ± 3 diagnoses), and activities of daily living were restricted (Barthel-Index 60.6 ± 24.4). The caregivers' results indicated good work ability (WAI 37.4 ± 5.1), health related quality of life was superior to the German sample (SF-12 physical CSS 49.2 ± 8.0; mental CSS 54.1 ± 6.6). Among both caregivers and residents, 89% considered KT to be positive for well-being.The qualitative analysis showed that caregivers perceived emotional and functional benefits from more content and calmer residents, a larger variety in basic care practices, and a more self-determined scope of action. Residents reported gains in attention and caring, and recognition of their lay knowledge. CONCLUSION: Residents showed typical characteristics of nursing home inhabitants. Caregivers demonstrated good work ability. Both reported to have benefits from KT. The results provide a good basis for future projects, e.g. controlled studies to evaluate the effects of CAM in nursing homes.

High prevalence but limited evidence in complementary and alternative medicine: guidelines for future research.

The use of complementary and alternative Medicine (CAM) has increased over the past two decades in Europe. Nonetheless, research investigating the evidence to support its use remains limited. The CAMbrella project funded by the European Commission aimed to develop a strategic research agenda starting by systematically evaluating the state of CAM in the EU. CAMbrella involved 9 work packages covering issues such as the definition of CAM; its legal status, provision and use in the EU; and a synthesis of international research perspectives. Based on the work package reports, we developed a strategic and methodologically robust research roadmap based on expert workshops, a systematic Delphi-based process and a final consensus conference. The CAMbrella project suggests six core areas for research to examine the potential contribution of CAM to the health care challenges faced by the EU. These areas include evaluating the prevalence of CAM use in Europe; the EU cititzens' needs and attitudes regarding CAM; the safety of CAM; the comparative effectiveness of CAM; the effects of meaning and context on CAM outcomes; and different models for integrating CAM into existing health care systems. CAM research should use methods generally accepted in the evaluation of health services, including comparative effectiveness studies and mixed-methods designs. A research strategy is urgently needed, ideally led by a European CAM coordinating research office dedicated to fostering systematic communication between EU governments, the public, charitable and industry funders, researchers and other stakeholders. A European Centre for CAM should also be established to monitor and further a coordinated research strategy with sufficient funds to commission and promote high quality, independent research focusing on the public's health needs and pan-European collaboration. There is a disparity between highly prevalent use of CAM in Europe and solid knowledge about it. A strategic approach on CAM research should be established to investigate the identified gaps of knowledge and to address upcoming health care challenges.

A randomised multicentre trial of acupuncture in patients with seasonal allergic rhinitis--trial intervention including physician and treatment characteristics.

BACKGROUND: In a large randomised trial in patients with seasonal allergic rhinitis (SAR), acupuncture was superior compared to sham acupuncture and rescue medication. The aim of this paper is to describe the characteristics of the trial's participating physicians and to describe the trial intervention in accordance with the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) guidelines, to make details of the trial intervention more transparent to researchers and physicians. METHODS: ACUSAR (ACUpuncture in Seasonal Allergic Rhinitis) was a three-armed, randomised, controlled multicentre trial. 422 SAR patients were randomised to semi-standardised acupuncture plus rescue medication (RM, cetirizine), sham acupuncture plus RM or RM alone. We sent a questionnaire to trial physicians in order to evaluate their characteristics regarding their education about and experience in providing acupuncture. During the trial, acupuncturists were asked to diagnose all of their patients according to Chinese Medicine (CM) as a basis for the semi-standardised, individualized intervention in the acupuncture group. Every acupuncture point used in this trial had to be documented after each session RESULTS: Acupuncture was administered in outpatient clinics by 46 (mean age 47 ± 10 years; 24 female/ 22 male) conventionally-trained medical doctors (67% with postgraduate specialization such as internal or family medicine) with additional extensive acupuncture training (median 500 hours (1st quartile 350, 3rd quartile 1000 hours with 73% presenting a B-diploma in acupuncture training (350 hours)) and experience (mean 14 years in practice). The most reported traditional CM diagnosis was 'wind-cold invading the lung' (37%) and 'wind-heat invading the lung' (37%), followed by 'lung and spleen qi deficiency' (9%). The total number of needles used was higher in the acupuncture group compared to the sham acupuncture group (15.7 ± 2.5 vs. 10.0 ± 1.6). CONCLUSIONS: The trial interventions were provided by well educated and experienced acupuncturists. The different number of needles in both intervention groups could be possibly a reason for the better clinical effect in SAR patients. For future trials it might be more appropriate to ensure that acupuncture and sham acupuncture groups should each be treated by a similar number of needles. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00610584.

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.

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.

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

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