Effects of Modified Ramadan Fasting on Mental Well-Being and Biomarkers in Healthy Adult Muslims - A Randomised Controlled Trial.

BACKGROUND: Ramadan fasting has seen increased attention in research, often with inconsistent findings. This study aims to investigate whether dietary and lifestyle modifications during Ramadan can improve well-being and health in healthy adult Muslims. METHOD: A randomised controlled trial with two parallel groups was conducted in an outpatient clinic of a university hospital in Essen, Germany, in 2016. Healthy adult Muslims (n = 114) aged 18-60 years were randomised to a modified fasting group; i.e., they received educational material prompting dietary and lifestyle modifications pre-Ramadan, and a control group who undertook Ramadan fasting as usual. Primary outcome was quality of life (WHO-5 Well-Being Index). Secondary outcomes included sleep quality, spirituality, and mindfulness (all self-report), body weight, body mass index, body fat, waist circumference, hip circumference, blood pressure, and heart rate, as well as blood serum biomarkers. Safety was examined via adverse events. RESULTS: The modified fasting group reported significantly higher quality of life (WHO-5) compared to the control after Ramadan (MD 5.9; 95% CI, 0.02-11.8; p < 0.05). Group differences in favour of the modified fasting were also found for satisfaction with health (MD 5.9, 95% CI 0.19-11.67), ease of life (MD 4.1, 95% CI 0.38-7.80) and mindfulness (MD 7.6, 95% CI 2.68-12.52), reductions in weight (MD, - 0.9 kg; 95% CI - 1.39 to - 0.42), BMI (MD - 0.3 kg/m2, 95% CI - 0.50 to - 0.15), hip circumference (MD - 0.3 kg/m2, 95% CI - 0.50 to - 0.15), and diastolic blood pressure (MD - 2.8 mmHg, 95% CI - 5.15 to - 0.43). About 60% of participants reported adverse events, mostly headaches/migraines, dizziness/fatigue, common cold, and gastrointestinal symptoms, with no group differences. One serious non-related adverse event each occurred in both groups. CONCLUSION: Pre-Ramadan dietary and lifestyle advice can lead to short-term improvements in mental and physical well-being of adult Muslims observing Ramadan. As such, this study demonstrates the potential benefits of culturally appropriate health interventions in a religious context. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier NCT02775175).

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.

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.

Mind-body medicine use by women diagnosed with breast cancer: results of a nationally representative survey.

PURPOSE: Worldwide breast cancer is the most commonly diagnosed cancer in women and often associated with a profound physiological stress reaction. Mind-body medicine modalities have been proven effective in reducing stress symptoms. This article will cover the prevalence of MBM use in women with and without breast cancer in the US population and detect predictors of MBM use in women diagnosed with breast cancer. METHODS: The 2017 National Health Interview Survey (NHIS) was used to study the prevalence of breast cancer and the use of mind-body medicine (MBM) among individuals with breast cancer in the US population. Using chi-squared tests and backward stepwise multiple logistic regression analyses, predictors of MBM use in women with breast cancer in the past 12 months were identified. RESULTS: The prevalence of breast cancer in women was 3.1%. Among women diagnosed with breast cancer, 25.2% had used MBM in the past 12 months. Spiritual meditation (14.3%), followed by yoga (9.6%), and mindfulness meditation (4.3%) were the most commonly used MBM approaches for women with breast cancer diagnosis. Only higher education independently predicted the use of MBM among them. CONCLUSIONS: In this nationally representative sample of the USA, the most common used MBM approach was spiritual meditation, while this approach is much less researched than the evidence based approaches of yoga and mindfulness meditation. Especially stressed individuals worldwide could benefit from MBM the literature suggests. Particularly in the acute survivorship stage, influencing the initial stress reaction could be beneficial.

Cancer, sleep problems, and mind-body medicine use: Results of the 2017 National Health Interview Survey.

BACKGROUND: Sleep problems affect physical and emotional well-being as well as immune system function. Evidence has demonstrated an improvement in sleep problems in patients with cancer through the use of mind-body medicine (MBM). In the current study, the authors sought to elucidate the prevalence of sleep problems and the use of MBM in adult cancer survivors. METHODS: The authors analyzed data from the 2017 US National Health Interview Survey (NHIS) to estimate the prevalence of sleep problems and use of MBM in adult cancer survivors using means, standard deviations, weighted frequencies, and distributions. Backward stepwise multiple logistic regression analyses were used to identify independent predictors of MBM use within the past 12 months: age, sex, ethnicity, region, educational level, employment, and time since cancer diagnosis. RESULTS: A weighted total of 13,750,028 cancer survivors (59.2%) reported sleep problems. For the most part, survivors with sleep problems were aged ≥40 years, female, and non-Hispanic white. More survivors with (weighted N = 3,794,493; 27.6%) compared with without (weighted N = 1,695,435; 17.9%) sleep problems used MBM. Among cancer survivors with sleep problems, the most commonly used mind-body practice was spiritual meditation (weighted N = 1,972,578; 14.3%), followed by yoga (weighted N = 1,695,553; 17.9%). The use of MBM was independently predicted by being female, living in the western United States, having a higher educational level, and being employed. CONCLUSIONS: The high prevalence of sleep problems in cancer survivors is a major health issue that needs to be addressed. A considerable number of cancer survivors with sleep problems use MBM. This finding warrants the investigation of MBM concepts as treatment options for cancer survivors experiencing sleep problems.

Mindfulness-based stress reduction for treating chronic headache: A systematic review and meta-analysis.

BACKGROUND: Mindfulness-based stress reduction/cognitive therapy are frequently used for pain-related conditions, but their effects on headache remain uncertain. This review aimed to assess the efficacy and safety of mindfulness-based stress reduction/cognitive therapy in reducing the symptoms of chronic headache. DATA SOURCES AND STUDY SELECTION: MEDLINE/PubMed, Scopus, CENTRAL, and PsychINFO were searched to 16 June 2017. Randomized controlled trials comparing mindfulness-based stress reduction/cognitive therapy with usual care or active comparators for migraine and/or tension-type headache, which assessed headache frequency, duration or intensity as a primary outcome, were eligible for inclusion. Risk of bias was assessed using the Cochrane Tool. RESULTS: Five randomized controlled trials (two on tension-type headache; one on migraine; two with mixed samples) with a total of 185 participants were included. Compared to usual care, mindfulness-based stress reduction/cognitive therapy did not improve headache frequency (three randomized controlled trials; standardized mean difference = 0.00; 95% confidence interval = -0.33,0.32) or headache duration (three randomized controlled trials; standardized mean difference = -0.08; 95% confidence interval = -1.03,0.87). Similarly, no significant difference between groups was found for pain intensity (five randomized controlled trials; standardized mean difference = -0.78; 95% confidence interval = -1.72,0.16). CONCLUSIONS: Due to the low number, small scale and often high or unclear risk of bias of included randomized controlled trials, the results are imprecise; this may be consistent with either an important or negligible effect. Therefore, more rigorous trials with larger sample sizes are needed.

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.

Adverse effects of yoga: a national cross-sectional survey.

BACKGROUND: While yoga is increasingly used for health purposes, its safety has been questioned. The aim of this cross-sectional survey was to analyze yoga-associated adverse effects and their correlates. METHODS: A cross-sectional anonymous national online survey among German yoga practitioners (n = 1702; 88.9% female; 47.2 ± 10.8 years) was conducted from January to June 2016. Participants were queried regarding their yoga practice, i.e. yoga styles used, length and intensity of yoga practice, practice patterns, and whether they had experienced acute or chronic adverse effects of their yoga practice. Independent predictors of acute or chronic adverse effects were identified using multiple logistic regression analyses. RESULTS: Ashtanga yoga (15.7%), traditional Hatha yoga (14.2%), and Sivananda yoga (22.4%) were the most commonly used yoga styles. 364 (21.4%) yoga users reported 702 acute adverse effects, occurring after a mean of 7.6 ± 8.0 years of yoga practice. The most commonly reported yoga practices that were associated with acute adverse effects were hand-, shoulder- and head stands (29.4%). Using Viniyoga was associated with a decreased risk of acute adverse effects; practicing only by self-study without supervision was associated with higher risk. One hundred seventy-three participants (10.2%) reported 239 chronic adverse effects. The risk of chronic adverse effects was higher in participants with chronic illnesses and those practicing only by self-study without supervision. Most reported adverse effects concerned the musculoskeletal system. 76.9% of acute cases, and 51.6% of chronic cases reached full recovery. On average 0.60 injuries (95% confidence interval = 0.51-0.71) per 1000 h of practice were reported, with Power yoga users reporting the highest rate (1.50 injuries per 1000 h; 95% confidence interval = 0.98-3.15). CONCLUSIONS: One in five adult yoga users reported at least one acute adverse effect in their yoga practice, and one in ten reported at least one chronic adverse effect, mainly musculoskeletal effects. Adverse effects were associated with hand-, shoulder- and head stands; and with yoga self-study without supervision. More than three quarters of of cases reached full recovery. Based on the overall injury rate per 1000 practice hours, yoga appears to be as safe or safer when compared to other exercise types.

[18F]FDG PET/MR enterography for the assessment of inflammatory activity in Crohn's disease: comparison of different MRI and PET parameters.

PURPOSE: To evaluate the diagnostic performance of integrated whole-body positron emission tomography (PET)/magnetic resonance (MR) enterography in patients with Crohn's disease (CD). METHODS: Fifty patients with known CD and recurrent symptoms underwent ileocolonoscopy (reference standard) as well as PET/MR enterography. Seven ileocolonic segments were endoscopically analysed using the Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) and additionally classified into three categories of inflammation (none, mild to moderate and severe ulcerative inflammation). A total of 14 PET/MR parameters were applied for the assessment of inflamed segments. Contingency tables and the chi-squared test were used for the analysis of qualitative parameters, and the Mann-Whitney U test and receiver operating characteristic (ROC) curve for the analysis of quantitative parameters. The PET/MR parameters were ranked according to their diagnostic value by random forest classification. Correlations between PET/MR parameters and the severity of inflammation on endoscopy and SES-CD were tested using Spearman's rank correlation test. RESULTS: A total of 309 segments could be analysed. Based on multivariate regression analysis, wall thickness and the comb sign were the most important parameters for predicting segments with active inflammation of any type. SUVmax ratio of the bowel segment (relative to SUVmax of the liver) was the most important parameter for detecting segments with severe ulcerative inflammation. Wall thickness was the only parameter that moderately correlated with inflammation severity on endoscopy as well as with SES-CD (ρ = 0.56 and 0.589, both p < 0.001). CONCLUSION: PET/MR enterography is an excellent noninvasive diagnostic method, and both MR parameters and PET findings provided high accuracy in detecting inflamed segments.

Yoga for anxiety: A systematic review and meta-analysis of randomized controlled trials.

Yoga has become a popular approach to improve emotional health. The aim of this review was to systematically assess and meta-analyze the effectiveness and safety of yoga for anxiety. Medline/PubMed, Scopus, the Cochrane Library, PsycINFO, and IndMED were searched through October 2016 for randomized controlled trials (RCTs) of yoga for individuals with anxiety disorders or elevated levels of anxiety. The primary outcomes were anxiety and remission rates, and secondary outcomes were depression, quality of life, and safety. Risk of bias was assessed using the Cochrane tool. Eight RCTs with 319 participants (mean age: 30.0-38.5 years) were included. Risk of selection bias was unclear for most RCTs. Meta-analyses revealed evidence for small short-term effects of yoga on anxiety compared to no treatment (standardized mean difference [SMD] = -0.43; 95% confidence interval [CI] = -0.74, -0.11; P = .008), and large effects compared to active comparators (SMD = -0.86; 95% CI = -1.56, -0.15; P = .02). Small effects on depression were found compared to no treatment (SMD = -0.35; 95% CI = -0.66, -0.04; P = .03). Effects were robust against potential methodological bias. No effects were found for patients with anxiety disorders diagnosed by Diagnostic and Statistical Manual criteria, only for patients diagnosed by other methods, and for individuals with elevated levels of anxiety without a formal diagnosis. Only three RCTs reported safety-related data but these indicated that yoga was not associated with increased injuries. In conclusion, yoga might be an effective and safe intervention for individuals with elevated levels of anxiety. There was inconclusive evidence for effects of yoga in anxiety disorders. More high-quality studies are needed and are warranted given these preliminary findings and plausible mechanisms of action.

Yoga for posttraumatic stress disorder - a systematic review and meta-analysis.

BACKGROUND: Yoga is increasingly used as a therapeutic treatment and seems to improve psychiatric conditions such as anxiety disorders and depression. The aim of this systematic review was to assess the evidence of yoga for reducing symptoms of posttraumatic stress disorder (PTSD). METHODS: The Cochrane Library, Medline/PubMed, PsycINFO, Scopus, and IndMED were searched through July 2017 for randomized controlled trials (RCTs) assessing the effects of yoga on symptoms of PTSD. Mean differences (MD) and standardized mean differences (SMD) with 95% confidence intervals (CI) were computed. The quality of evidence and the strength of recommendation were graded according to the GRADE recommendations. RESULTS: Seven RCTs (N = 284) were included. Meta-analysis revealed low quality evidence for clinically relevant effects of yoga on PTSD symptoms compared to no treatment (SMD = - 1.10, 95% CI [- 1.72, - 0.47], p < .001, I2 = 72%; MD = - 13.11, 95% CI [- 17.95, - 8.27]); and very low evidence for comparable effects of yoga and attention control interventions (SMD = - 0.31, 95%CI = [- 0.84, 0.22], p = .25; I2 = 43%). Very low evidence was found for comparable retention of patients in the trial for yoga and no treatment (OR = 0.68, 95%CI [0.06, 7.72]) or attention control interventions (OR = 0.66, 95%CI [0.10, 4.46]). No serious adverse events were reported. LIMITATIONS: Few RCTs with only limited sample size were available. CONCLUSIONS: Only a weak recommendation for yoga as an adjunctive intervention for PTSD can be made. More high quality research is needed to confirm or disconfirm these findings.

Mindfulness-Based Stress Reduction for Treating Low Back Pain: A Systematic Review and Meta-analysis.

BACKGROUND: Mindfulness-based stress reduction (MBSR) is frequently used to treat pain-related conditions, but its effects on low back pain are uncertain. PURPOSE: To assess the efficacy and safety of MBSR in patients with low back pain. DATA SOURCES: Searches of MEDLINE/PubMed, Scopus, the Cochrane Library, and PsycINFO to 15 June 2016. STUDY SELECTION: Randomized controlled trials (RCTs) that compared MBSR with usual care or an active comparator and assessed pain intensity or pain-related disability as a primary outcome in patients with low back pain. DATA EXTRACTION: Two reviewers independently extracted data on study characteristics, patients, interventions, outcome measures, and results at short- and long-term follow-up. Risk of bias was assessed using the Cochrane risk-of-bias tool. DATA SYNTHESIS: Seven RCTs involving 864 patients with low back pain were eligible for review. Compared with usual care, MBSR was associated with short-term improvements in pain intensity (4 RCTs; mean difference [MD], -0.96 point on a numerical rating scale [95% CI, -1.64 to -0.34 point]; standardized mean difference [SMD], -0.48 point [CI, -0.82 to -0.14 point]) and physical functioning (2 RCTs; MD, 2.50 [CI, 0.90 to 4.10 point]; SMD, 0.25 [CI, 0.09 to 0.41 point]) that were not sustained in the long term. Between-group differences in disability, mental health, pain acceptance, and mindfulness were not significant at short- or long-term follow-up. Compared with an active comparator, MBSR was not associated with significant differences in short- or long-term outcomes. No serious adverse events were reported. LIMITATION: The number of eligible RCTs was limited; only 3 evaluated MBSR against an active comparator. CONCLUSION: Mindfulness-based stress reduction may be associated with short-term effects on pain intensity and physical functioning. Long-term RCTs that compare MBSR versus active treatments are needed in order to best understand the role of MBSR in the management of low back pain. PRIMARY FUNDING SOURCE: None.

Postural awareness and its relation to pain: validation of an innovative instrument measuring awareness of body posture in patients with chronic pain.

BACKGROUND: Habitual postural patterns are associated with musculoskeletal pain, and improving a maladaptive posture requires postural awareness in order to lead to clinical improvements. This study aimed to develop and evaluate the psychometric properties of an innovative postural awareness scale. METHODS: A 12-item Postural Awareness Scale (PAS) was developed and administered to 512 chronic pain patients (50.3 ± 11.4 years, 91.6% female, 37.1% spinal/shoulder pain) to assess its factor structure and reliability. To determine convergent validity, measures of body awareness, body responsiveness, body image, and mindfulness were correlated with the PAS, as were clinical measures of pain intensity, disability, and mental health. Sensitivity to change was assessed in 202 outpatients participating in a 10-week multimodal mind-body program. RESULTS: Factor analysis revealed two factors (Ease/Familiarity with Postural Awareness and Need for Attention Regulation with Postural Awareness) that explained 50.8% of the variance. Cronbach's alpha for the complete scale was 0.80; Spearman-Brown coefficient of split-half reliability was 0.67; and intra-class correlation was ICC2,1 = 0.75 (95% confidence interval = 0.71, 0.78). Significant positive correlations were found for body awareness (r = 0.23), body responsiveness (r = 0.41), body image (r = 0.22-0.32), and mindfulness (r = 0.38); negative correlations for pain intensity (r = - 0.14), disability (r = - 0.12), depression (r = - 0.23), and stress (r = - 0.29). Postural awareness scores increased with a mind-body program (p < 0.001); changes in the PAS were negatively correlated with changes in pain intensity (r = - 0.35) in patients with spinal/shoulder pain. CONCLUSION: Self-reported postural awareness is associated with clinical symptoms in chronic pain patients; improvements in postural awareness are longitudinally associated with reduced pain in patients with spinal/shoulder pain.

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.

Yoga for improving health-related quality of life, mental health and cancer-related symptoms in women diagnosed with breast cancer.

BACKGROUND: Breast cancer is the cancer most frequently diagnosed in women worldwide. Even though survival rates are continually increasing, breast cancer is often associated with long-term psychological distress, chronic pain, fatigue and impaired quality of life. Yoga comprises advice for an ethical lifestyle, spiritual practice, physical activity, breathing exercises and meditation. It is a complementary therapy that is commonly recommended for breast cancer-related impairments and has been shown to improve physical and mental health in people with different cancer types. OBJECTIVES: To assess effects of yoga on health-related quality of life, mental health and cancer-related symptoms among women with a diagnosis of breast cancer who are receiving active treatment or have completed treatment. SEARCH METHODS: We searched the Cochrane Breast Cancer Specialised Register, MEDLINE (via PubMed), Embase, the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 1), Indexing of Indian Medical Journals (IndMED), the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal and Clinicaltrials.gov on 29 January 2016. We also searched reference lists of identified relevant trials or reviews, as well as conference proceedings of the International Congress on Complementary Medicine Research (ICCMR), the European Congress for Integrative Medicine (ECIM) and the American Society of Clinical Oncology (ASCO). We applied no language restrictions. SELECTION CRITERIA: Randomised controlled trials were eligible when they (1) compared yoga interventions versus no therapy or versus any other active therapy in women with a diagnosis of non-metastatic or metastatic breast cancer, and (2) assessed at least one of the primary outcomes on patient-reported instruments, including health-related quality of life, depression, anxiety, fatigue or sleep disturbances. DATA COLLECTION AND ANALYSIS: Two review authors independently collected data on methods and results. We expressed outcomes as standardised mean differences (SMDs) with 95% confidence intervals (CIs) and conducted random-effects model meta-analyses. We assessed potential risk of publication bias through visual analysis of funnel plot symmetry and heterogeneity between studies by using the Chi2 test and the I2 statistic. We conducted subgroup analyses for current treatment status, time since diagnosis, stage of cancer and type of yoga intervention. MAIN RESULTS: We included 24 studies with a total of 2166 participants, 23 of which provided data for meta-analysis. Thirteen studies had low risk of selection bias, five studies reported adequate blinding of outcome assessment and 15 studies had low risk of attrition bias.Seventeen studies that compared yoga versus no therapy provided moderate-quality evidence showing that yoga improved health-related quality of life (pooled SMD 0.22, 95% CI 0.04 to 0.40; 10 studies, 675 participants), reduced fatigue (pooled SMD -0.48, 95% CI -0.75 to -0.20; 11 studies, 883 participants) and reduced sleep disturbances in the short term (pooled SMD -0.25, 95% CI -0.40 to -0.09; six studies, 657 participants). The funnel plot for health-related quality of life was asymmetrical, favouring no therapy, and the funnel plot for fatigue was roughly symmetrical. This hints at overall low risk of publication bias. Yoga did not appear to reduce depression (pooled SMD -0.13, 95% CI -0.31 to 0.05; seven studies, 496 participants; low-quality evidence) or anxiety (pooled SMD -0.53, 95% CI -1.10 to 0.04; six studies, 346 participants; very low-quality evidence) in the short term and had no medium-term effects on health-related quality of life (pooled SMD 0.10, 95% CI -0.23 to 0.42; two studies, 146 participants; low-quality evidence) or fatigue (pooled SMD -0.04, 95% CI -0.36 to 0.29; two studies, 146 participants; low-quality evidence). Investigators reported no serious adverse events.Four studies that compared yoga versus psychosocial/educational interventions provided moderate-quality evidence indicating that yoga can reduce depression (pooled SMD -2.29, 95% CI -3.97 to -0.61; four studies, 226 participants), anxiety (pooled SMD -2.21, 95% CI -3.90 to -0.52; three studies, 195 participants) and fatigue (pooled SMD -0.90, 95% CI -1.31 to -0.50; two studies, 106 participants) in the short term. Very low-quality evidence showed no short-term effects on health-related quality of life (pooled SMD 0.81, 95% CI -0.50 to 2.12; two studies, 153 participants) or sleep disturbances (pooled SMD -0.21, 95% CI -0.76 to 0.34; two studies, 119 participants). No trial adequately reported safety-related data.Three studies that compared yoga versus exercise presented very low-quality evidence showing no short-term effects on health-related quality of life (pooled SMD -0.04, 95% CI -0.30 to 0.23; three studies, 233 participants) or fatigue (pooled SMD -0.21, 95% CI -0.66 to 0.25; three studies, 233 participants); no trial provided safety-related data. AUTHORS' CONCLUSIONS: Moderate-quality evidence supports the recommendation of yoga as a supportive intervention for improving health-related quality of life and reducing fatigue and sleep disturbances when compared with no therapy, as well as for reducing depression, anxiety and fatigue, when compared with psychosocial/educational interventions. Very low-quality evidence suggests that yoga might be as effective as other exercise interventions and might be used as an alternative to other exercise programmes.

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.

Gynecologic oncologists' attitudes and practices relating to integrative medicine: results of a nationwide AGO survey.

PURPOSE: The growing popularity and acceptance of integrative medicine is evident both among patients and among the oncologists treating them. As little data are available regarding health-care professionals' knowledge, attitudes, and practices relating to the topic, a nationwide online survey was designed. METHODS: Over a period of 11 weeks (from July 15 to September 30, 2014) a self-administered, 17-item online survey was sent to all 676 members of the Research Group on Gynecological Oncology (Arbeitsgemeinschaft Gynäkologische Onkologie) in the German Cancer Society. The questionnaire items addressed the use of integrative therapy methods, fields of indications for them, advice services provided, level of specific qualifications, and other topics. RESULTS: Of the 104 respondents (15.4%) using integrative medicine, 93% reported that integrative therapy was offered to breast cancer patients. The second most frequent type of tumor in connection with which integrative therapy methods were recommended was ovarian cancer, at 80% of the participants using integrative medicine. Exercise, nutritional therapy, dietary supplements, herbal medicines, and acupuncture were the methods the patients were most commonly advised to use. CONCLUSION: There is considerable interest in integrative medicine among gynecological oncologists, but integrative therapy approaches are at present poorly implemented in routine clinical work. Furthermore there is a lack of specific training. Whether future efforts should focus on extending counseling services on integrative medicine approaches in gynecologic oncology or not, have to be discussed. Evidence-based training on integrative medicine should be implemented in order to safely guide patients in their wish to do something by themselves.

Effect of Yoga in the Therapy of Irritable Bowel Syndrome: A Systematic Review.

BACKGROUND & AIMS: This review aims to systematically survey the effects of yoga on symptoms of irritable bowel syndrome (IBS), pain, quality of life, mood, stress, and safety in patients with IBS. METHODS: MEDLINE/Pubmed, Scopus, the Cochrane Library, CAM-QUEST, CAMbase, and IndMED were screened through November 2015. Randomized controlled trials comparing yoga with usual care, nonpharmacologic, or pharmacologic interventions were analyzed for patients with IBS. Primary outcomes included gastrointestinal symptoms, quality of life, and pain. Anxiety, mood, and safety were defined as secondary outcomes. Risk of bias was assessed according to the Cochrane Collaboration recommendations. RESULTS: Six randomized controlled trials with a total of 273 patients were included in the qualitative analysis. There was evidence for a beneficial effect of a yogic intervention over conventional treatment in IBS, with significantly decreased bowel symptoms, IBS severity, and anxiety. Furthermore, there were significant improvements in quality of life, global improvement, and physical functioning after yoga compared with no treatment. Two randomized controlled trials reported safety data stating that no adverse events occurred. Overall, risk of bias of the included studies was unclear. CONCLUSIONS: The findings of this systematic review suggest that yoga might be a feasible and safe adjunctive treatment for people with IBS. Nevertheless, no recommendation can be made regarding yoga as a routine intervention for patients with IBS because of major flaws in study methods. More research is needed with respect to a high-quality study design and consensus in clinical outcome measurements in IBS. ClinicalTrials.gov number, NCT02721836.

A randomized controlled bicenter trial of yoga for patients with colorectal cancer.

OBJECTIVE: The aim of this trial was to evaluate the effects of yoga on health-related quality of life in patients with colorectal cancer. METHODS: Patients with non-metastatic colorectal cancer were randomly assigned to a 10-week yoga intervention (90 min once weekly) or a waitlist control group. Primary outcome measure was disease-specific quality of life (Functional Assessment of Cancer Therapy - Colorectal [FACT-C]) at week 10. Secondary outcome measures included FACT-C subscales: spiritual well-being (FACT - Spirituality); fatigue (FACT - Fatigue); sleep disturbances (Pittsburgh Sleep Quality Inventory); depression and anxiety (Hospital Anxiety and Depression Scale); body awareness (Scale of Body Connection); and body-efficacy expectations (Body-Efficacy Expectations Scale). Outcomes were assessed at week 10 and week 22 after randomization. RESULTS: Fifty-four patients (mean age 68.3 ± 9.7 years) were randomized to yoga (n = 27; attrition rate 22.2%) and control group (n = 27; attrition rate 18.5%). Patients in the yoga group attended a mean of 5.3 ± 4.0 yoga classes. No significant group differences for the FACT-C total score were found. Group differences were found for emotional well-being at week 22 (∆ = 1.59; 95% CI = 0.27,2.90; p = 0.019), sleep disturbances at week 22 (∆ = -1.08; 95% CI = -2.13, -0.03; p = 0.043), anxiety at week 10 (∆ = -1.14; 95% CI = -2.20, -0.09; p = 0.043), and depression at week 10 (∆ = -1.34; 95% CI = -2.61, -0.8; p = 0.038). No serious adverse events occurred in the yoga group, while liver metastases were diagnosed in one patient in the control group. CONCLUSION: This randomized trial found no effects of yoga on health-related quality of life in patients with colorectal cancer. Given the high attrition rate and low intervention adherence, no definite conclusions can be drawn from this trial.