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

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

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

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

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.

The integration of yoga breathing techniques in cognitive behavioral therapy for post-traumatic stress disorder: A pragmatic randomized controlled trial.

Introduction: In trauma-focused Cognitive Behavioral Therapy (TF-CBT), stabilization techniques are used before confrontation ones to increase stress/affect tolerance and thus effectiveness of CBT. This study investigated the effects of pranayama, meditative yoga breathing and breath holding techniques, as a complimentary stabilization technique in patients with post-traumatic stress disorder (PTSD). Methods: Seventy-four PTSD-patients (84% female, 44.2 ± 13 years) were randomized to receive either pranayama at the beginning of each TF-CBT session or TF-CBT alone. The primary outcome was self-reported PTSD severity after 10 sessions of TF-CBT. Secondary outcomes included quality of life, social participation, anxiety, depression, distress tolerance, emotion regulation, body awareness, breath-holding duration, acute emotional reaction to stress, and adverse events (AEs). Intention-to-treat (ITT) and exploratory per-protocol (PP) analyses of covariance with 95% confidence intervals (CI) were performed. Results: ITT analyses revealed no significant differences on primary or secondary outcomes, except for breath-holding duration in favor of pranayama-assisted TF-CBT (20.81 s, 95%CI = 13.05|28.60). PP analyses of 31 patients without AEs during pranayama revealed significantly lower PTSD severity (-5.41, 95%CI = -10.17|-0.64) and higher mental quality of life (4.89, 95%CI = 1.38|8.41) than controls. In contrast, patients with AEs during pranayama breath holding reported significantly higher PTSD severity (12.39, 95%CI = 5.08|19.71) than controls. Concurrent somatoform disorders were found to be a significant moderator of change in PTSD severity (p = 0.029). Conclusion: In PTSD patients without concurrent somatoform disorders, the integration of pranayama into TF-CBT might reduce post-traumatic symptoms and increase mental quality of life more efficiently than TF-CBT alone. The results remain preliminary until they can be replicated by ITT analyses. Clinical trial registration: ClinicalTrials.gov, identifier NCT03748121.

The Interpretation of Verbal Probabilities: A Systematic Literature Review and Meta-Analysis.

INTRODUCTION: Verbal probabilities such as "likely" or "probable" are commonly used to describe situations of uncertainty or risk and are easy and natural to most people. Numerous studies are devoted to the translation of verbal probability expressions to numerical probabilities. METHODS: The present work aims to summarize existing research on the numerical interpretation of verbal probabilities. This was accomplished by means of a systematic literature review and meta-analysis conducted alongside the MOOSE-guidelines for meta-analysis of observational studies in epidemiology. Studies were included, if they provided empirical assignments of verbal probabilities to numerical values. RESULTS: The literature search identified 181 publications and finally led to 21 included articles and the procession of 35 verbal probability expressions. Sample size of the studies ranged from 11 to 683 participants and covered a period of half a century from 1967 to 2018. In half of the studies, verbal probabilities were delivered in a neutral context followed by a medical context. Mean values of the verbal probabilities range from 7.24% for the term "impossible" up to 94.79% for the term "definite". DISCUSSION: According to the results, there is a common 'across-study' consensus of 35 probability expressions for describing different degrees of probability, whose numerical interpretation follows a linear course. However, heterogeneity of studies was considerably high and should be considered as a limiting factor.

Safety of acupuncture in oncology: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Acupuncture is frequently used to treat the side effects of cancer treatment, but the safety of this intervention remains uncertain. The current meta-analysis was conducted to assess the safety of acupuncture in oncological patients. METHODS: The PubMed, Cochrane Central Register of Controlled Trials, and Scopus databases were searched from their inception to August 7, 2020. Randomized controlled trials in oncological patients comparing invasive acupuncture with sham acupuncture, treatment as usual (TAU), or any other active control were eligible. Two reviewers independently extracted data on study characteristics and adverse events (AEs). Risk of bias was assessed using the Cochrane Risk of Bias Tool. RESULTS: Of 4590 screened articles, 65 were included in the analyses. The authors observed that acupuncture was not associated an with increased risk of intervention-related AEs, nonserious AEs, serious AEs, or dropout because of AEs compared with sham acupuncture and an active control. Compared with TAU, acupuncture was not associated with an increased risk of intervention-related AEs, serious AEs, or drop out because of AEs but was associated with an increased risk for nonserious AEs (odds ratio, 3.94; 95% confidence interval, 1.16-13.35; P = .03). However, the increased risk of nonserious AEs compared with TAU was not robust against selection bias. The meta-analyses may have been biased because of the insufficient reporting of AEs in the original randomized controlled trials. CONCLUSIONS: The current review indicates that acupuncture is as safe as sham acupuncture and active controls in oncological patients. The authors recommend researchers heed the CONSORT (Consolidated Standards of Reporting Trials) safety and harm extension for reporting to capture the side effects and better investigate the risk profile of acupuncture in oncology. LAY SUMMARY: According to this analysis, acupuncture is a safe therapy for the treatment of patients with cancer. Acupuncture seems to be safe compared with sham acupuncture and active controls.

Yoga for treating low back pain: a systematic review and meta-analysis.

ABSTRACT: Yoga is frequently used for back pain relief. However, the evidence was judged to be of only low to moderate certainty. To assess the efficacy and safety of yoga in patients with low back pain, a meta-analysis was performed. Therefore, MEDLINE/PubMed, Scopus, and the Cochrane Library were searched to May 26, 2020. Only randomized controlled trials comparing Yoga with passive control (usual care or wait list), or an active comparator, for patients with low back pain and that assessed pain intensity or pain-related disability as a primary outcome were considered to be eligible. Two reviewers independently extracted data on study characteristics, outcome measures, and results at short-term and long-term follow-up. Risk of bias was assessed using the Cochrane risk of bias tool. Thirty articles on 27 individual studies (2702 participants in total) proved eligible for review. Compared with passive control, yoga was associated with short-term improvements in pain intensity (15 RCTs; mean difference [MD] = -0.74 points on a numeric rating scale; 95% confidence interval [CI] = -1.04 to -0.44; standardized mean difference [SMD] = -0.37 95% CI = -0.52 to -0.22), pain-related disability (15 RCTs; MD = -2.28; 95% CI = -3.30 to -1.26; SMD = -0.38 95% CI = -0.55 to -0.21), mental health (7 RCTs; MD = 1.70; 95% CI = 0.20-3.20; SMD = 0.17 95% CI = 0.02-0.32), and physical functioning (9 RCTs; MD = 2.80; 95% CI = 1.00-4.70; SMD = 0.28 95% CI = 0.10-0.47). Except for mental health, all effects were sustained long-term. Compared with an active comparator, yoga was not associated with any significant differences in short-term or long-term outcomes.

Comprehensive Lifestyle Modification Influences Medium-Term and Artificially Induced Stress in Ulcerative Colitis-A Sub-Study within a Randomized Controlled Trial Using the Trier Social Stress Test.

OBJECTIVE: The present study presents long-term results of stress-related outcomes of a prospective RCT that evaluated effects of a ten-week comprehensive lifestyle-modification program (LSM) in patients with inactive ulcerative colitis (UC). In addition, exploratory results of a sub-study applying a laboratory stress protocol (Trier Social Stress Test; TSST) conducted within the RCT are reported. METHODS: Ninety-seven patients with inactive UC were randomized to LSM (n = 47; 50.28 ± 11.90 years; 72.3% female) or self-care (n = 50; 45.54 ± 12.49 years; 70% female). Patients' perceived stress, anxiety, flourishing and depression were assessed at week 0, 12, 24 and 48. After the respective intervention, 16 female patients (LSM: n = 8; 44.6 ± 14.3 years; Self-care: n = 8; 49.25 ± 4.30 years) additionally underwent the TSST. State anxiety, blood pressure, pulse, complete blood counts, adrenocorticotropic hormone (ACTH), cortisol, adrenalin and noradrenalin were measured at baseline (-15 min), stress (+10 min), recovery1 (+20 min) and recovery2 (+55 min). Statistical significance was set at p < 0.05; for the exploratory sub-study using the TSST, p-values < 0.10 were considered significant. RESULTS: Patients' perceived stress declined significantly after the LSM (p < 0.001) compared with control. This lasted until week 24 (p = 0.023) but did not persist until week 48 (p = 0.060). After 48 weeks, patients' flourishing was significantly increased compared with control (p = 0.006). In response to the TSST, significant group differences were evident for pulse (p = 0.015), adrenaline (p = 0.037) and anxiety (p = 0.066). After 55 min, group differences were found for ACTH (p = 0.067) and systolic blood pressure (p = 0.050). CONCLUSIONS: LSM has a medium-term positive effect on perceived stress. First indications show that it is promising to investigate these effects further under laboratory conditions. It is also desirable to find out how the effects of LSM can be maintained in the long term.

A systematic review and meta-analysis of acceptance- and mindfulness-based interventions for DSM-5 anxiety disorders.

This meta-analysis systematically reviewed the evidence on standardized acceptance-/mindfulness-based interventions in DSM-5 anxiety disorders. Randomized controlled trials examining Acceptance and Commitment Therapy (ACT), Mindfulness-Based Cognitive Therapy (MBCT), and Mindfulness-Based Stress Reduction (MBSR) were searched via PubMed, Central, PsycInfo, and Scopus until June 2021. Standardized mean differences (SMD) and 95% confidence intervals (CI) were calculated for primary outcomes (anxiety) and secondary ones (depression and quality of life). Risk of bias was assessed using the Cochrane tool. We found 23 studies, mostly of unclear risk of bias, including 1815 adults with different DSM-5 anxiety disorders. ACT, MBCT and MBSR led to short-term effects on clinician- and patient-rated anxiety in addition to treatment as usual (TAU) versus TAU alone. In comparison to Cognitive Behavioral Therapy (CBT), ACT and MBCT showed comparable effects on both anxiety outcomes, while MBSR showed significantly lower effects. Analyses up to 6 and 12 months did not reveal significant differences compared to TAU or CBT. Effects on depression and quality of life showed similar trends. Statistical heterogeneity was moderate to considerable. Adverse events were reported insufficiently. The evidence suggests short-term anxiolytic effects of acceptance- and mindfulness-based interventions. Specific treatment effects exceeding those of placebo mechanisms remain unclear. Protocol registry: Registered at Prospero on November 3rd, 2017 (CRD42017076810).

Efficacy and Safety of Auricular Acupuncture for the Treatment of Insomnia in Breast Cancer Survivors: A Randomized Controlled Trial.

Among women, breast cancer is the most commonly diagnosed cancer worldwide. Sleep problems impair 40-70% of breast cancer survivors. This randomized controlled trial evaluates the effect of auricular acupuncture on sleep quality in breast cancer survivors suffering from insomnia. Fifty-two female breast cancer survivors with insomnia (mean age 55.73 ± 8.10 years) were randomized either to 10 treatments of auricular acupuncture within five weeks (n = 26), or to a single session of psychoeducation plus an insomnia advice booklet (n = 26). The primary outcome was sleep quality (measured by the Pittsburgh Sleep Quality Index) at week 5. Secondary outcomes were inflammation parameter (interleukin-6), stress, anxiety, depression, quality of life, and fatigue at week 5, and sleep quality, stress, anxiety, depression, quality of life, and fatigue 17 and 29 weeks after randomization. Intention-to-treat analysis showed a significantly stronger increase in sleep quality in the auricular acupuncture group compared to the psychoeducation group (p = 0.031; η2p = 0.094) at week 5. Furthermore, auricular acupuncture improved stress (p = 0.030; η2p = 0.094), anxiety (p = 0.001; η2p = 0.192), and fatigue (p = 0.006; η2p = 0.148) at week 5 compared to psychoeducation. No significant group difference was found concerning the other outcomes at week 5, or in any outcome at week 17 or week 29. No serious adverse events occurred during the study period. In conclusion, a semi-standardized group auricular acupuncture might be an effective and safe intervention in treating insomnia in breast cancer survivors in the short term, and may reduce stress, anxiety, and fatigue as well. Long-term effects remain questionable.

The INTREST registry: protocol of a multicenter prospective cohort study of predictors of women's response to integrative breast cancer treatment.

BACKGROUND: Cancer registries usually assess data of conventional treatments and/or patient survival. Beyond that, little is known about the influence of other predictors of treatment response related to the use of complementary therapies (CM) and lifestyle factors affecting patients' quality and quantity of life. METHODS: INTREST is a prospective cohort study collecting register data at multiple German certified cancer centers, which provide individualized, integrative, in- and outpatient breast cancer care. Patient-reported outcomes and clinical cancer data of anticipated N = 715 women with pTNM stage I-III breast cancer are collected using standardized case report forms at the time of diagnosis, after completing neo-/adjuvant chemotherapy, after completing adjuvant therapy (with the exception of endocrine therapy) as well as 1, 2, 5, and 10 years after baseline. Endpoints for multivariable prediction models are quality of life, fatigue, treatment adherence, and progression-based outcomes/survival. Predictors include the study center, sociodemographic characteristics, histologic cancer and comorbidity data, performance status, stress perception, depression, anxiety, sleep quality, spirituality, social support, physical activity, diet behavior, type of conventional treatments, use of and belief in CM treatments, and participation in a clinical trial. Safety is recorded following the Common Terminology Criteria for Adverse Events. DISCUSSION: This trial is currently recruiting participants. Future analyses will allow to identify predictors of short- and long-term response to integrative breast cancer treatment in women, which, in turn, may improve cancer care as well as quality and quantity of life with cancer. TRIAL REGISTRATION: German Clinical Trial Register DRKS00014852 . Retrospectively registered at July 4th, 2018.

The use and benefits of Craniosacral Therapy in primary health care: A prospective cohort study.

BACKGROUND: Patients frequently use treatments complementary to standard primary care. This prospective cohort-study examined the use, benefits, and safety of Craniosacral Therapy (CST). METHODS: Consecutive out-patients utilizing CST from 2015 to 2019 were asked to provide anonymized data on symptom intensity, functional disability, and quality of life before and after treatment using an adapted 11-point numerical rating scale (NRS) version of the Measure Yourself Medical Outcome Profile (MYMOP). Treatment expectations were assessed as were concurrent therapies/medication and safety. Mean differences were analyzed using paired sample t-tests with 95 % confidence intervals (CI), predictors of treatment response using linear regression modelling. RESULTS: CST therapists submitted 220 patient records (71.4 % female) including 15.5 % infants and toddlers, 7.7 % children, and 76.8 % adolescents and adults. Patients received on average 7.0 ± 7.3 CST sessions to treat 114 different, acute and chronic conditions. Symptom intensity significantly decreased by -4.38 NRS (95 %CI=-4.69/-4.07), disability by -4.41 NRS (95 %CI=-4.78/-4.05), and quality of life improved by 2.94 NRS (95 %CI = 2.62/3.27). Furthermore, CST enhanced personal resources by 3.10 NRS (95 %CI = 1.99/4.21). Independent positive predictors of change in the adapted total MYMOP score included patients' expectations (p = .001) and therapists' CST experience (p = .013), negative predictors were symptom duration (p < .002) and patient age (p = .021); a final categorical predictor was CST type (p = .023). Minor but no serious adverse events occurred. CONCLUSIONS: In primary care, patients and parents of underage children use CST for preventive and therapeutic purposes. Considering the design limitations, CST appears to be overall effective and safe in infants, children, and adults.

Effects of an Integrative Mind-Body-Medicine Group Program on Breast Cancer Patients During Chemotherapy: An Observational Study.

BACKGROUND: Breast cancer is one of the leading cancers in women in the Western world. Cancer treatment, especially chemotherapy, is often associated with physical and psychosocial side effects. OBJECTIVE: To improve the quality of life and manage side effects, a new integrative mind-body-medicine group concept for breast cancer patients receiving chemotherapy was developed and pilot tested. METHODS: Breast cancer patients participated in a 66 hours mind-body-medicine group program tailored to the needs of cancer patients during chemotherapy. The program was integrated into standard care encompassing mindfulness training, yoga, moderate exercise, nutrition, complementary self-help strategies, cognitive restructuring, and acupuncture. Quality of life (EORTC QLQ-C30), depression and anxiety (HADS), stress (PSS-10), and fatigue (BFI) were assessed before and after the program, as well as satisfaction and safety. Analyses were carried out on exploratory basis with paired samples t-tests. RESULTS: Fifty-seven female patients, aged 51.3±10.5 years, with breast cancer diagnoses were enrolled. After completing the program, global EORTC quality of life was improved (D=9.5; 95%-CI=[2.9|16.1]; p=.005), although the EORTC-symptom scales assessing fatigue (D=9.9; 95%-CI=[1|18.8]; p=.030), nausea (D=7.1; 95%- CI=[0.6|13.6]; p=.031), and dyspnea (D=12.5; 95%-CI=[2.9|22.1]; p=.011) were found to be increased. Stress (D=-3.5; 95%-CI=[-5|-2.1]; p=.000), anxiety (D=-3.8; 95%-CI=[-4.9|-2.7]; p=.000) and depression (D=-3.9; 95%-CI=[-4.9|-2.8]; p=.000) were also found to be significantly reduced. Regarding the severity of (D=0.2; 95%- CI=[-0.8|0.5]; p=.644) and the impairment due to fatigue (D=0.1; 95%-CI=[-0.8|0.6]; p=.696), no significant worsening was observed. Patients were satisfied with the program. No serious adverse events were reported. CONCLUSION: Breast cancer patients benefit from an integrative mind-body-medicine group program during chemotherapy regarding the quality of life and psychological symptoms. Randomized controlled trials are warranted.

Comparative efficacy of different exercise interventions in chronic non-specific low back pain: protocol of a systematic review and network meta-analysis.

INTRODUCTION: Chronic non-specific low back pain is a major public health problem. Evidence supports the effectiveness of exercise as an intervention. Due to a paucity of direct comparisons of different exercise categories, medical guidelines were unable to make specific recommendations regarding the type of exercise working best in improving chronic low back pain. This network meta-analysis (NMA) of randomised controlled trials aims to investigate the comparative efficacy of different exercise interventions in patients with chronic non-specific low back pain. METHODS AND ANALYSIS: MEDLINE, Scopus, Cochrane Central Register of Controlled Trials, Physiotherapy Evidence Database, SPORTDiscus, Clinicaltrials.gov and the WHO International Clinical Trials Registry Platform search portal were searched on November 2019 and without language restrictions. The search will be updated after data analysis. Studies on adults with non-specific low back pain of at least 12 weeks duration comparing exercise to either no specific intervention (ie, no treatment, wait-list or usual care at the treating physician's discretion) and/or functionally inert interventions (ie, sham or attention control interventions) will be eligible. Pain intensity and back-specific disability are defined as primary outcomes. Secondary outcomes will include health-related physical and mental quality of life, work disability, frequency of analgesic use and adverse events. All outcomes will be analysed short-term, intermediate-term and long-term. Data will be extracted independently by two review authors. Risk of bias will be assessed using the recommendations by the Cochrane Back and Neck Group and be based on an adaptation of the Cochrane Risk of Bias tool. ETHICS AND DISSEMINATION: This NMA will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses_NMA checklist. The results will be presented in peer-reviewed journals, implemented in existing national and international guidelines and will be presented to health care providers and decision makers. The planned completion date of the study is 1 July 2021. PROSPERO REGISTRATION NUMBER: CRD42020151472.

Complementary therapies for clinical depression: an overview of systematic reviews.

OBJECTIVES: As clinical practice guidelines vary widely in their search strategies and recommendations of complementary and alternative medicine (CAM) for depression, this overview aimed at systematically summarising the level 1 evidence on CAM for patients with a clinical diagnosis of depression. METHODS: PubMed, PsycInfo and Central were searched for meta-analyses of randomised controlled clinical trials (RCTs) until 30 June 2018. Outcomes included depression severity, response, remission, relapse and adverse events. The quality of evidence was assessed according to Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) considering the methodological quality of the RCTs and meta-analyses, inconsistency, indirectness, imprecision of the evidence and the potential risk of publication bias. RESULTS: The literature search revealed 26 meta-analyses conducted between 2002 and 2018 on 1-49 RCTs in major, minor and seasonal depression. In patients with mild to moderate major depression, moderate quality evidence suggested the efficacy of St. John's wort towards placebo and its comparative effectiveness towards standard antidepressants for the treatment for depression severity and response rates, while St. John's wort caused significant less adverse events. In patients with recurrent major depression, moderate quality evidence showed that mindfulness-based cognitive therapy was superior to standard antidepressant drug treatment for the prevention of depression relapse. Other CAM evidence was considered as having low or very low quality. CONCLUSIONS: The effects of all but two CAM treatments found in studies on clinical depressed patients based on low to very low quality of evidence. The evidence has to be downgraded mostly due to avoidable methodological flaws of both the original RCTs and meta-analyses not following the Consolidated Standards of Reporting Trials and Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Further research is needed.

Hypoglossal acupuncture for acute chemotherapy-induced dysgeusia in patients with breast cancer: study protocol of a randomized, sham-controlled trial.

BACKGROUND: Distortion of taste sensations is a common chemotherapy-induced side effect; however, treatment evidence is limited. Pilot data indicated that acupuncture might be able to improve symptoms of dysgeusia. Thus, the aim of this study is to investigate the effects and side effects of hypoglossal acupuncture in the treatment of dysgeusia in patients with breast cancer undergoing chemotherapy. METHODS/DESIGN: The study is a randomized controlled trial comparing a single verum acupuncture treatment with two active comparators: sham acupuncture and dietary recommendations. Sample size calculation revealed a total of 75 patients pending an alpha of 0.05, a power of 0.8, and an estimated effect size of 0.80. Patients with breast cancer undergoing platinum- or taxane-based chemotherapy will be included if they present with phantogeusia (abnormal taste sensations without an external oral stimulus) with an intensity of 4 points or above on an 11-point numeric rating scale (NRS). The primary outcome is phantogeusia; secondary outcomes include parageusia (abnormal taste of food), hypogeusia (reduced taste sensations), hypergeusia (increased taste sensations), xerostomia (dry mouth), stomatitis, appetite, and functional impairment. All outcomes will be assessed at baseline and prior to the next chemotherapy administration using an 11-point NRS for each. All adverse events will be recorded. DISCUSSION: The results of this study will demonstrate the extent to which hypoglossal acupuncture may influence the intensity of and functional impairment due to chemotherapy-induced dysgeusia. TRIAL REGISTRATION: Clinical Trials.gov, NCT02304913 . Registered on 19 November 2014.

The risks and benefits of yoga for patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis.

OBJECTIVES: To determine the effectiveness and safety of yoga interventions on disease symptoms, quality of life and function in patients diagnosed with chronic obstructive pulmonary disease (COPD). DATA SOURCES: Medline/PubMed, Scopus, and CENTRAL (Cochrane Central Register of Controlled Trials) were searched through 6 June 2019. REVIEW METHODS: Randomized controlled trials assessing the effects of yoga on quality of life, dyspnea, exercise capacity, and pulmonary function (FEV1) in patients with COPD were included. Safety was defined as secondary outcome. Mean differences (MD) and standardized mean differences (SMD) with 95% confidence intervals (CIs) were computed. Risk of bias was assessed using the Cochrane tool. RESULTS: Eleven randomized controlled trials with a total of 586 patients were included. Meta-analysis revealed evidence for effects of yoga compared to no treatment on quality of life on the COPD Assessment Test (MD = 3.81; 95% CI = 0.97 to 6.65; P = 0.009, I2 = 70%), exercise capacity assessed by the 6-minute walk test (MD = 25.53 m; 95% CI = 12.16 m to 38.90 m; P = 0.001, I2 = 0%), and pulmonary function assessed by FEV1 predicted (MD = 3.95%; 95% CI = 2.74% to 5.17%; P < 0.001, I2 = 0%). Only the effects on exercise capacity and pulmonary function were robust against methodological bias. Effects were only present in breathing-focused yoga interventions but not in interventions including yoga postures. Adverse events were reported infrequently. CONCLUSION: This meta-analysis found robust effects of yoga on exercise capacity and pulmonary function in patients with COPD. Yoga, specifically yoga breathing techniques, can be an effective adjunct intervention for patients with COPD. Yoga's safety needs to be assessed in more depth in future studies.

Craniosacral therapy for chronic pain: a systematic review and meta-analysis of randomized controlled trials.

OBJECTIVES: To systematically assess the evidence of Craniosacral Therapy (CST) for the treatment of chronic pain. METHODS: PubMed, Central, Scopus, PsycInfo and Cinahl were searched up to August 2018. Randomized controlled trials (RCTs) assessing the effects of CST in chronic pain patients were eligible. Standardized mean differences (SMD) and 95% confidence intervals (CI) were calculated for pain intensity and functional disability (primary outcomes) using Hedges' correction for small samples. Secondary outcomes included physical/mental quality of life, global improvement, and safety. Risk of bias was assessed using the Cochrane tool. RESULTS: Ten RCTs of 681 patients with neck and back pain, migraine, headache, fibromyalgia, epicondylitis, and pelvic girdle pain were included. CST showed greater post intervention effects on: pain intensity (SMD = -0.32, 95%CI = [- 0.61,-0.02]) and disability (SMD = -0.58, 95%CI = [- 0.92,-0.24]) compared to treatment as usual; on pain intensity (SMD = -0.63, 95%CI = [- 0.90,-0.37]) and disability (SMD = -0.54, 95%CI = [- 0.81,-0.28]) compared to manual/non-manual sham; and on pain intensity (SMD = -0.53, 95%CI = [- 0.89,-0.16]) and disability (SMD = -0.58, 95%CI = [- 0.95,-0.21]) compared to active manual treatments. At six months, CST showed greater effects on pain intensity (SMD = -0.59, 95%CI = [- 0.99,-0.19]) and disability (SMD = -0.53, 95%CI = [- 0.87,-0.19]) versus sham. Secondary outcomes were all significantly more improved in CST patients than in other groups, except for six-month mental quality of life versus sham. Sensitivity analyses revealed robust effects of CST against most risk of bias domains. Five of the 10 RCTs reported safety data. No serious adverse events occurred. Minor adverse events were equally distributed between the groups. DISCUSSION: In patients with chronic pain, this meta-analysis suggests significant and robust effects of CST on pain and function lasting up to six months. More RCTs strictly following CONSORT are needed to further corroborate the effects and safety of CST on chronic pain. PROTOCOL REGISTRATION AT PROSPERO: CRD42018111975.

Emotional release and physical symptom improvement: a qualitative analysis of self-reported outcomes and mechanisms in patients treated with neural therapy.

BACKGROUND: Neural Therapy (NT) is a common complementary treatment approach using injections with short-acting local anesthetics to treat pain and chronic diseases. However, little is known about the underlying mechanisms and the domains of treatment response. This study therefore analyzed patient experiences following NT injections with procaine. METHODS: Maximum variation sampling was used to collect data from semi-structured interviews conducted with 22 hospital inpatients aged 59.6 ± 14.9 years (81.8% female). Each had multiple (9.4 ± 6.9) diagnoses. They were undergoing two weeks of integrative treatment, which included individualized NT. The interview data were analyzed in MAXQDA using qualitative content analysis. RESULTS: With injection, patients first described local anesthetic effects including temporary blocking of pain and increased local warmth. Second, patients reported on vegetative reactions frequently leading to turmoil within the body like initial aggravation of existing symptoms or the appearance of new, concealed or phantom symptoms. This often required the need for rest to deal with the treatment stimulus. As a third step, many patients could gain physical and emotional release and relief in symptoms, mood and functioning. Emotional release was often accompanied by weeping and initially overwhelmed affected patients with dissociated memories. However, in cases where patients were able to experience those memories with a new distance, a fourth step of integration was achievable. It included reframing processes as well as a gain in pain perception and body-awareness. As a possible fifth step, patients experienced improved mood, increased pain acceptance and empowerment. Adverse events of NT included pain from the injections, vegetative complaints and emotional turmoil that lasted for minutes or hours, with a maximum of two days. CONCLUSIONS: Patients treated with procaine injections reported different psychophysiological outcomes contributing to the understanding of the mechanisms underlying NT. Further efficacy studies should separate specific NT from non-specific/placebo effects. TRIAL REGISTRATION: DRKS00004567 .

Mindfulness-based interventions for women with breast cancer: an updated systematic review and meta-analysis.

BACKGROUND: The aim of this meta-analysis was to systematically update the evidence for mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT) in women with breast cancer. MATERIAL AND METHODS: In October 2016, PubMed, Scopus, and Central were searched for randomized controlled trials on MBSR/MBCT in breast cancer patients. The primary outcome was health-related quality of life. Secondary outcomes were fatigue, sleep stress, depression, anxiety, and safety. For each outcome, standardized mean differences (SMD/Hedges' g) and 95% confidence intervals (CI) were calculated. Risk of bias was assessed by the Cochrane risk of bias tool. RESULTS: The Literature search identified 14 articles on 10 studies that included 1709 participants. The overall risk of bias was unclear, except for risk of low attrition bias and low other bias. Compared to usual care, significant post-intervention effects of MBSR/MBCT were found for health-related quality of life (SMD = .21; 95%CI = [.04-.39]), fatigue (SMD = -.28; 95%CI = [-.43 to -.14]), sleep (SMD = -.23; 95%CI = [-.40 to -.05]), stress (SMD = -.33; 95%CI = [-.61 to -.05]), anxiety (SMD = -.28; 95%CI = [-.39 to -.16]), and depression (SMD = -.34; 95%CI = [-.46 to -.21]). Up to 6 months after baseline effects were significant for: anxiety (SMD = -.28; 95%CI = [-.47 to -.09]) and depression (SMD = -.26; 95%CI = [-.47 to -.04]); and significant for anxiety (SMD = -.21; 95%CI = [-.40 to -.03]) up to 12 months after baseline. Compared to other active interventions, significant effects were only found post-intervention and only for anxiety (SMD = -.45; 95%CI = [-.71 to -.18]) and depression (SMD = -.39; 95%CI = [-.65 to -.14]). However, average effects were all below the threshold of minimal clinically important differences. Effects were robust against potential methodological bias. Adverse events were insufficiently reported. CONCLUSIONS: This meta-analysis revealed evidence for the short-term effectiveness and safety of mindfulness-based interventions in women with breast cancer. However, their clinical relevance remains unclear. Further research is needed.