Andreas Michalsen

Effects of Yoga Interventions on Pain and Pain-Associated Disability: A Meta-Analysis

UNLABELLED We searched databases for controlled clinical studies, and performed a meta-analysis on the effectiveness of yoga interventions on pain and associated disability. Five randomized studies reported single-blinding and had a higher methodological quality; 7 studies were randomized but not blinded and had moderate quality; and 4 nonrandomized studies had low quality. In 6 studies, yoga was used to treat patients with back pain; in 2 studies to treat rheumatoid arthritis; in 2 studies to treat patients with headache/migraine; and 6 studies enrolled individuals for other indications. All studies reported positive effects in favor of the yoga interventions. With respect to pain, a random effect meta-analysis estimated the overall treatment effect at SMD = -.74 (CI: -.97; -.52, P < .0001), and an overall treatment effect at SMD = -.79 (CI: -1.02; -.56, P < .0001) for pain-related disability. Despite some limitations, there is evidence that yoga may be useful for several pain-associated disorders. Moreover, there are hints that even short-term interventions might be effective. Nevertheless, large-scale further studies have to identify which patients may benefit from the respective interventions. PERSPECTIVE This meta-analysis suggests that yoga is a useful supplementary approach with moderate effect sizes on pain and associated disability.

Comparison of 4 neutrophil-derived proteins in feces as indicators of disease activity in ulcerative colitis

Background: To evaluate the diagnostic use of fecal concentrations of lactoferrin (Lf), calprotectin (Cal), polymorphonuclear neutrophil‐elastase (PMN‐e), and lysozyme (Lys) as indicators of disease activity in patients with active and inactive ulcerative colitis (UC). Methods: A total of 76 fecal specimens were collected from 31 patients with UC in times of active and inactive status of disease. Disease activity was determined with the colitis activity index (CAI; Rachmilewitz index), which includes a combination of laboratory parameters and clinical symptoms, with a score of at least 6 indicating active disease. Fecal Lf, Cal, PMN‐e, and Lys were measured and reported as micrograms per milliliter feces. Levels of more than 7.25, more than 6.00, at least 0.062, and at least 0.6 for Lf, Cal, PMN‐e, and Lys, respectively, were considered elevated as specified by the manufacturers. Results: Based on the CAI classification, 25 of the samples were from patients with active disease status and 51 were from patients with inactive status. Lf, PMN‐e, and Cal but not Lys showed increased levels in samples from patients in active disease compared with those in remission (median for Lf: 28.12 ± 110.86 versus 179.54 ± 334.09, P < 0.001; median for Cal: 15.13 ± 30.27 versus 116.23 ± 182.29, P < 0.001; median for PMN‐e: 0.21 ± 0.44 versus 1.02 ± 0.89, P < 0.001; median for Lys: 1.54 ± 2.39 versus 3.75 ± 5.39, P > 0.05). All 4 parameters correlated with the CAI (Lf: r = 0.441, P < 0.001; Cal: r = 0.505, P < 0.001; PMN‐e: r = 0.604, P < 0.001; Lys: r = 0.295, P < 0.05). Introducing a composite index based on Lf, Cal, and PMN‐e, the specificity was 72.5% and the sensitivity 88% compared with the CAI. Conclusions: Among the neutrophil‐derived proteins in feces, PMN‐e, Cal, and Lf represent useful markers of disease activity in patients with UC. Using all 3 markers in a composite index may be an additional noninvasive tool for the management of ambulant patients with UC.

Effects of Mind-Body Therapy on Quality of Life and Neuroendocrine and Cellular Immune Functions in Patients with Ulcerative Colitis

Background: The aim of this study was to investigate the effects of mind-body therapy on neuroendocrine and cellular immune measures, health-related quality of life and disease activity in patients with ulcerative colitis (UC) in remission. Methods: Thirty UC patients in remission or with low disease activity were randomly assigned to an intervention group (n = 15) or a usual-care waiting control group (n = 15). Intervention consisted of a structured 60-hour training program over 10 weeks which included stress management training, moderate exercise, Mediterranean diet, behavioral techniques and self-care strategies. Quality of life, perceived stress and disease activity were assessed with standardized questionnaires (IBDQ, SF-36, PSS, CAI). In addition, the distribution of circulating lymphocytes and lymphocyte subsets as well as the β-adrenergic modulation of TNF-α production in vitro were analyzed. Urine catecholamines and plasma cortisol, prolactin and growth hormone were measured pre- and postinterventionally, and were compared with a healthy control group (n = 10). Results: In response to therapy, patients in the intervention group showed significantly greater improvement in the SF-36 scale Mental Health and the Psychological Health Sum score compared with changes observed in the usual-care waiting control group. Patients in the intervention group showed significantly greater improvement on the IBDQ scale Bowel Symptoms compared with the control group. However, no significant group differences in circulating lymphocyte subsets or endocrine parameters were observed in response to therapy. In addition, no significant effects of intervention on either the basal levels of TNF-α or the suppressive action of the β-adrenergic agonist isoproterenol on TNF-α production were observed. Conclusion: Mind-body therapy may improve quality of life in patients with UC in remission, while no effects of therapy on clinical or physiological parameters were found, which may at least in part be related to selective patient recruitment.

Effects of yoga on mental and physical health: a short summary of reviews.

This report summarizes the current evidence on the effects of yoga interventions on various components of mental and physical health, by focussing on the evidence described in review articles. Collectively, these reviews suggest a number of areas where yoga may well be beneficial, but more research is required for virtually all of them to firmly establish such benefits. The heterogeneity among interventions and conditions studied has hampered the use of meta-analysis as an appropriate tool for summarizing the current literature. Nevertheless, there are some meta-analyses which indicate beneficial effects of yoga interventions, and there are several randomized clinical trials (RCTs) of relatively high quality indicating beneficial effects of yoga for pain-associated disability and mental health. Yoga may well be effective as a supportive adjunct to mitigate some medical conditions, but not yet a proven stand-alone, curative treatment. Larger-scale and more rigorous research with higher methodological quality and adequate control interventions is highly encouraged because yoga may have potential to be implemented as a beneficial supportive/adjunct treatment that is relatively cost-effective, may be practiced at least in part as a self-care behavioral treatment, provides a life-long behavioural skill, enhances self-efficacy and self-confidence and is often associated with additional positive side effects.

Effects of Traditional Cupping Therapy in Patients With Carpal Tunnel Syndrome: A Randomized Controlled Trial

UNLABELLED We investigated the effectiveness of cupping, a traditional method of treating musculoskeletal pain, in patients with carpal tunnel syndrome (CTS) in an open randomized trial. n = 52 outpatients (58.5 +/- 8.0 years) with neurologically confirmed CTS were randomly assigned to either a verum (n = 26) or a control group (n = 26). Verum patients were treated with a single application of wet cupping, and control patients with a single local application of heat within the region overlying the trapezius muscle. Patients were followed up on day 7 after treatment. The primary outcome, severity of CTS symptoms (VAS), was reduced from 61.5 +/- 20.5 to 24.6 +/- 22.7 mm at day 7 in the cupping group and from 67.1 +/- 20.2 to 51.7 +/- 23.9 mm in the control group [group difference -24.5mm (95%CI -36.1; -2.9, P < .001)]. Significant treatment effects were also found for the Levine CTS-score (-.6 pts: 95%CI -.9; -.2, P = .002), neck pain (-12.6mm; 95%CI -18.8; -6.4, P < .001), functional disability (DASH-Score) (-11.1 pts; 95%CI -17.1; -5.1, P < .001), and physical quality of life (.3; 95%CI .0; .3, P = .048). The treatment was safe and well tolerated. We conclude that cupping therapy may be effective in relieving the pain and other symptoms related to CTS. The efficacy of cupping in the long-term management of CTS and related mechanisms remains to be clarified. PERSPECTIVE The results of a randomized trial on the clinical effects of traditional cupping therapy in patients with carpal tunnel syndrome are presented. Cupping of segmentally related shoulder zones appears to alleviate the symptoms of carpal tunnel syndrome.

SAT0488 Comparative effectiveness of ayurveda and conventional care in knee osteoarthritis – a randomized controlled trial

Background Traditional Indian Medicine Ayurveda is used to treat knee osteoarthritis (OA) despite limited evidence. Objectives We aimed to evaluate the effectiveness of complex Ayurvedic treatment compared to complex conventional care in knee OA patients. Methods According to ACR criteria patients with knee OA were included in a multicenter randomized, controlled trial and treated in 2 hospital outpatient clinics and 2 private outpatient clinics in Germany with 5 physicians and 20 therapists participating. Patients received either Ayurvedic treatment (n=77) or conventional care (n=74) with 15 treatments over 12 weeks. Primary outcome was the change on the Western Ontario and McMaster University Osteoarthritis (WOMAC) Index after 12 weeks (validated German version). Secondary outcomes included the WOMAC subscales; a pain disability index, numeric rating scales for pain and sleep quality, a pain experience scale, a quality-of-life index, a profile of mood index, rescue medication use, and safety issues. Results A total of 151 patients (Ayurveda n=77, conventional care n=74) were included. Changes of the WOMAC Index from baseline to 12 weeks were more pronounced in the Ayurveda group (mean difference 61.0 [95% CI 52.4;69.6]) than in the conventional group (32.0 [95% CI 21.4;42.6]) resulting in a significant difference between groups (p<0.001) and a clinically relevant effect size (Cohens d 0.68 [95% CI 0.35;1.01]). Similar tendencies were observed for all secondary outcomes at week 12. Effects were sustainable at follow-ups after 6 and 12 months. Conclusions The results suggest that a complex Ayurvedic treatment might be clinically superior to a complex conventional intervention in the treatment of OA of the knee. Disclosure of Interest None declared

Amount of systemic steroid medication is a strong predictor for the use of complementary and alternative medicine in patients with inflammatory bowel disease: results from a German national survey.

Objectives: Previous studies have suggested that inflammatory bowel disease (IBD) patients rank high among users of complementary and alternative medicine (CAM). To further elucidate this phenomenon, we sent questionnaires to a large sample of IBD patients in Germany to determine the patterns and predictors of their CAM use. Methods: Pretested 73‐item questionnaires were mailed to a randomly selected representative sample of 1000 IBD patients from the approximately 16,000 members and associates of the German Crohns and Colitis Association. Predictors of CAM use were evaluated by logistic regression models. Results: Completed questionnaires were returned by 684 patients (female patients, 61.4%; Crohns disease patients, 58.3%; ulcerative colitis patients, 38.2%). Of the 671 adult respondents, 344 (51.3%) had experience with CAM, and significantly more of the ulcerative colitis patients (59.8%) than the Crohns disease patients (48.3%) had experience with CAM. There was no difference by gender. Homeopathy (52.9%) and herbal medicine (43.6%) were the most commonly used types of CAM. The most frequent personal reasons for CAM use were the search for an “optimum treatment” (78.9%) and the wish to stop taking steroids (63.8%). Using logistic regression, we found that total cortisone intake (P = 0.0077), but not duration of disease, was a strong predictor of CAM use. Other predictors were experience with psychosomatic and psychotherapeutic support (P = 0.0029), relaxation techniques (P = 0.0284), an academic education (P = 0.0173), a diet utilizing whole grains (P = 0.0123), and a normal body weight (P = 0.0215). Although 80% of patients indicated that they were interested in using CAM in the future, only 24.7% felt sufficiently informed about it. Conclusions: More than 50% of a large group of German IBD patients had used CAM. Prolonged or intensive steroid treatment, an academic education, active ways of coping, and a health‐conscious life‐style are associated with CAM use. Given the potential side effects and interactions, the treating physician should focus on thorough information about the benefits and limitations of conventional and complementary treatment options, especially for IBD patients who have received prolonged or intensive steroid treatment.

Effects of phlebotomy-induced reduction of body iron stores on metabolic syndrome: results from a randomized clinical trial

AbstractBackgroundMetabolic syndrome (METS) is an increasingly prevalent but poorly understood clinical condition characterized by insulin resistance, glucose intolerance, dyslipidemia, hypertension, and obesity. Increased oxidative stress catalyzed by accumulation of iron in excess of physiologic requirements has been implicated in the pathogenesis of METS, but the relationships between cause and effect remain uncertain. We tested the hypothesis that phlebotomy-induced reduction of body iron stores would alter the clinical presentation of METS, using a randomized trial.MethodsIn a randomized, controlled, single-blind clinical trial, 64 patients with METS were randomly assigned to iron reduction by phlebotomy (n = 33) or to a control group (n = 31), which was offered phlebotomy at the end of the study (waiting-list design). The iron-reduction patients had 300 ml of blood removed at entry and between 250 and 500 ml removed after 4 weeks, depending on ferritin levels at study entry. Primary outcomes were change in systolic blood pressure (SBP) and insulin sensitivity as measured by Homeostatic Model Assessment (HOMA) index after 6 weeks. Secondary outcomes included HbA1c, plasma glucose, blood lipids, and heart rate (HR).ResultsSBP decreased from 148.5 ± 12.3 mmHg to 130.5 ± 11.8 mmHg in the phlebotomy group, and from 144.7 ± 14.4 mmHg to 143.8 ± 11.9 mmHg in the control group (difference -16.6 mmHg; 95% CI -20.7 to -12.5; P < 0.001). No significant effect on HOMA index was seen. With regard to secondary outcomes, blood glucose, HbA1c, low-density lipoprotein/high-density lipoprotein ratio, and HR were significantly decreased by phlebotomy. Changes in BP and HOMA index correlated with ferritin reduction.ConclusionsIn patients with METS, phlebotomy, with consecutive reduction of body iron stores, lowered BP and resulted in improvements in markers of cardiovascular risk and glycemic control. Blood donation may have beneficial effects for blood donors with METS.Trial registrationClinicalTrials.gov: NCT01328210 Please see related article: http://www.biomedcentral.com/1741-7015/10/53

Psychological and quality-of-life outcomes from a comprehensive stress reduction and lifestyle program in patients with coronary artery disease: results of a randomized trial.

Background: Stress reduction and comprehensive lifestyle modification programs have improved atherosclerosis and cardiac risk factors in earlier trials. Little is known about the impact of such programs on quality-of-life (QoL) and psychological outcomes. Given recent significant improvements in cardiac care, we evaluated the current benefit of stress reduction/lifestyle modification on QoL and emotional distress in patients with coronary artery disease (CAD). Methods: 101 patients (59.4 ± 8.6 years, 23 female) with CAD were randomized to a 1-year lifestyle/stress management program (n = 48) or written advice (n = 53). QoL and psychological outcomes were assessed with the SF-36, Beck Depression, Spielberger State/Trait Anxiety, Spielberger State/Trait Anger and Perceived Stress Inventories. Group repeated-measures analyses of variance were performed for all measures. Results: Adherence to the program was excellent (daily relaxation practice 39 ± 5vs. 5 ± 8 min, respectively; p < 0.001). Both groups improved comparably in most dimensions of QoL, and significantly greater improvements for the lifestyle group were found for physical function and physical sum score (p = 0.046 and p = 0.045). Depression, anxiety, anger and perceived stress were reduced similarly in both groups. However, intervention × gender interaction effects revealed greater benefits among women in the lifestyle intervention vs. advice group for depression and anger (p = 0.025 and p = 0.040), but no effects for men. Conclusions: A comprehensive lifestyle modification and stress management program did not improve psychological outcomes in medically stable CAD patients. The program did appear to confer psychological benefits for women but not men. Further trials should investigate gender-related differences in coronary patient responses to behavioral interventions.

Checklist for the qualitative evaluation of clinical studies with particular focus on external validity and model validity

BackgroundIt is often stated that external validity is not sufficiently considered in the assessment of clinical studies. Although tools for its evaluation have been established, there is a lack of awareness of their significance and application. In this article, a comprehensive checklist is presented addressing these relevant criteria.MethodsThe checklist was developed by listing the most commonly used assessment criteria for clinical studies. Additionally, specific lists for individual applications were included. The categories of biases of internal validity (selection, performance, attrition and detection bias) correspond to structural, treatment-related and observational differences between the test and control groups. Analogously, we have extended these categories to address external validity and model validity, regarding similarity between the study population/conditions and the general population/conditions related to structure, treatment and observation.ResultsA checklist is presented, in which the evaluation criteria concerning external validity and model validity are systemised and transformed into a questionnaire format.ConclusionThe checklist presented in this article can be applied to both planning and evaluating of clinical studies. We encourage the prospective user to modify the checklists according to the respective application and research question. The higher expenditure needed for the evaluation of clinical studies in systematic reviews is justified, particularly in the light of the influential nature of their conclusions on therapeutic decisions and the creation of clinical guidelines.