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Associated Factors and Consequences of Risk of Bias in Randomized Controlled Trials of Yoga: A Systematic Review.

ABSTRACT: Bias in randomized controlled trials (RCTs) of complementary therapy interventions seems to be associated with specific factors and to potentially distort the studies' conclusions. This systematic review assessed associated factors of risk of bias and consequences for the studies' conclusions in RCTs of yoga as one of the most commonly used complementary therapies.Medline/PubMed, Scopus, IndMED and the Cochrane Library were searched through February 2014 for yoga RCTs. Risk of selection bias was assessed using the Cochrane tool and regressed to a) publication year; b) country of origin; c) journal type; and d) impact factor using multiple logistic regression analysis. Likewise, the authors' conclusions were regressed to risk of bias.A total of 312 RCTs were included. Impact factor ranged from 0.0 to 39.2 (median = 1.3); 60 RCT (19.2%) had a low risk of selection bias, and 252 (80.8%) had a high or unclear risk of selection bias. Only publication year and impact factor significantly predicted low risk of bias; RCTs published after 2001 (adjusted odds ratio (OR) = 12.6; 95% confidence interval (CI) = 1.7, 94.0; p<0.001) and those published in journals with impact factor (adjusted OR = 2.6; 95%CI = 1.4, 4.9; p = 0.004) were more likely to have low risk of bias. The authors' conclusions were not associated with risk of bias.Risk of selection bias was generally high in RCTs of yoga; although the situation has improved since the publication of the revised CONSORT statement 2001. Pre-CONSORT RCTs and those published in journals without impact factor should be handled with increased care; although risk of bias is unlikely to distort the RCTs' conclusions.

SUBMITTER: Cramer H

PROVIDER: S-EPMC4668008 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Associated Factors and Consequences of Risk of Bias in Randomized Controlled Trials of Yoga: A Systematic Review.

Cramer Holger H Langhorst Jost J Dobos Gustav G Lauche Romy R

PloS one 20151202 12

<h4>Background</h4>Bias in randomized controlled trials (RCTs) of complementary therapy interventions seems to be associated with specific factors and to potentially distort the studies' conclusions. This systematic review assessed associated factors of risk of bias and consequences for the studies' conclusions in RCTs of yoga as one of the most commonly used complementary therapies.<h4>Methods</h4>Medline/PubMed, Scopus, IndMED and the Cochrane Library were searched through February 2014 for yo ...[more]

PMID: 26629905

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Project description:A growing number of randomized controlled trials (RCTs) have investigated the therapeutic value of yoga interventions. This bibliometric analysis aimed to provide a comprehensive review of the characteristics of the totality of available randomized yoga trials.All RCTs of yoga were eligible. Medline/PubMed, Scopus, the Cochrane Library, IndMED, and the tables of content of yoga specialty journals not listed in medical databases were screened through February 2014. Bibliometric data, data on participants, and intervention were extracted and analyzed descriptively.Published between 1975 and 2014, a total of 366 papers were included, reporting 312 RCTs from 23 different countries with 22,548 participants. The median study sample size was 59 (range 8-410, interquartile range?=?31, 93). Two hundred sixty-four RCTs (84.6%) were conducted with adults, 105 (33.7%) with older adults and 31 (9.9%) with children. Eighty-four RCTs (26.9%) were conducted with healthy participants. Other trials enrolled patients with one of 63 varied medical conditions; the most common being breast cancer (17 RCTs, 5.4%), depression (14 RCTs, 4.5%), asthma (14 RCTs, 4.5%) and type 2 diabetes mellitus (13 RCTs, 4.2%). Whilst 119 RCTs (38.1%) did not define the style of yoga used, 35 RCTs (11.2%) used Hatha yoga and 30 RCTs (9.6%) yoga breathing. The remaining 128 RCTs (41.0%) used 46 varied yoga styles, with a median intervention length of 9 weeks (range 1 day to 1 year; interquartile range?=?5, 12). Two hundred and forty-four RCTs (78.2%) used yoga postures, 232 RCTs (74.4%) used breath control, 153 RCTs (49.0%) used meditation and 32 RCTs (10.3%) used philosophy lectures. One hundred and seventy-four RCTs (55.6%) compared yoga with no specific treatment; 21 varied control interventions were used in the remaining RCTs.This bibliometric analysis presents the most complete up-to-date overview on published randomized yoga trials. While the available research evidence is sparse for most conditions, there was a marked increase in published RCTs in recent years.

Project description:Intermittent fasting (IF) has gained attention as a promising diet for weight loss and dysmetabolic diseases management. This systematic review aimed to investigate the effects of IF on cardiometabolic risk factors (CMRFs). A systematic literature search was carried out using three electronic databases, namely PubMed, Embase, and the Cochrane Library, until October 2020. Randomized controlled trials that compared the IF intervention with a control group diet were included. Fourteen effect sizes were expressed as weighted mean difference (WMD) using a fixed-effects model and 95% confidence intervals (CI). Compared to the ones within control groups, participants exposed to the IF intervention reduced their body weight (WMD, -1.78 kg; 95% CI, -2.21 to -1.35; p <0.05), waist circumference (WMD, -1.19 cm; 95% CI, -1.8 to -0.57; p <0.05), fat mass (WMD, -1.26 kg; 95% CI, -1.57 to -0.95; p <0.05), body mass index (WMD, -0.58 kg/m2; 95% CI, -0.8 to -0.37; p <0.05), systolic blood pressure (WMD, -2.14 mmHg; 95% CI: -3.54 to -0.73; p <0.05), diastolic blood pressure (WMD: -1.38 mmHg, 95% CI, -2.35 to -0.41, p <0.05), fasting blood glucose (WMD: -0.053 mmol/L; 95% CI: -0.105 to 0.001; p <0.05), fasting insulin (WMD, -0.8 mIU/L; 95% CI, -1.15 to -0.44; p <0.05), insulin resistance (WMD, -0.21; 95% CI, -0.36 to -0.05; p <0.05), total cholesterol (WMD, -0.10 mmol/L; 95% CI, -0.17 to -0.02; p <0.05), and triglycerides (WMD, -0.09 mmol/L; 95% CI, -0.13 to -0.04; p <0.05). No effects were observed for low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, or glycosylated hemoglobin. This meta-analysis supports the role of IF in improving the component composition of CMRFs, including weight, waist circumference, fat mass, BMI, blood pressure, total cholesterol, triglycerides, fasting insulin, and insulin resistance, compared to a control group diet. Further research on IF interventions should take into account long-term and well-designed administration to draw definitive conclusions.

Project description:BackgroundThis systematic review evaluated the effectiveness of process interventions (education for clinicians, parent presence, education of parents [before and on day of vaccination], and education of patients on day of vaccination) on reducing vaccination pain, fear, and distress and increasing the use of interventions during vaccination.Design/methodsDatabases were searched using a broad search strategy to identify relevant randomized and quasi-randomized controlled trials. Critical outcomes were pain, fear, distress (when applicable), and use of pain management interventions. Data were extracted according to procedure phase (preprocedure, acute, recovery, combinations of these) and pooled using established methods. Analyses were conducted using standardized mean differences (SMD) and risk ratios (RR).ResultsThirteen studies were included. Results were generally mixed. On the basis of low to very low-quality evidence, the following specific critical outcomes showed significant effects suggesting: (1) clinicians should be educated about vaccine injection pain management (use of interventions: SMD 0.66; 95% confidence interval [CI]: 0.47, 0.85); (2) parents should be present (distress preprocedure: SMD -0.85; 95% CI: -1.35, -0.35); (3) parents should be educated before the vaccination day (use of intervention preprocedure: SMD 0.83; 95% CI: 0.25, 1.41 and RR, 2.08; 95% CI: 1.51, 2.86; distress acute: SMD, -0.35; 95% CI: -0.57, -0.13); (4) parents should be educated on the vaccination day (use of interventions: SMD 1.02; 95% CI: 0.22, 1.83 and RR, 2.42; 95% CI: 1.47, 3.99; distress preprocedure+acute+recovery: SMD -0.48; 95% CI: -0.82, -0.15); and (5) individuals 3 years of age and above should be educated on the day of vaccination (fear preprocedure: SMD -0.67; 95% CI: -1.28, -0.07).ConclusionsEducating individuals involved in the vaccination procedure (clinicians, parents of children being vaccinated; individuals above 3 y of age) is beneficial to increase use of pain management strategies, reduce distress surrounding with vaccination, and to reduce fear. When possible, parent presence is also recommended for children undergoing vaccination.

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Associated Factors and Consequences of Risk of Bias in Randomized Controlled Trials of Yoga: A Systematic Review.

Publications

Associated Factors and Consequences of Risk of Bias in Randomized Controlled Trials of Yoga: A Systematic Review.

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