scholarly journals Eversion technique versus conventional endarterectomy with patch angioplasty in carotid surgery: protocol for a systematic review with meta-analyses and trial sequential analysis of randomised clinical trials

BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e030503 ◽  
Author(s):  
Martijn S. Marsman ◽  
Jorn Wetterslev ◽  
Patrick W.H.E. Vriens ◽  
Ronald L.A.W. Bleys ◽  
Abdelkarime Kh. Jahrome ◽  
...  
Keyword(s):  
Systematic Review ◽  
Sequential Analysis ◽  
Risk Of Bias ◽  
Low Risk ◽  
Trial Sequential Analysis ◽  
Serious Adverse Events ◽  
Symptomatic Carotid ◽  
Patch Angioplasty ◽  
Symptomatic Carotid Stenosis ◽  
Meta Analyses

IntroductionTraditional carotid endarterectomy is considered to be the standard technique for prevention of a new stroke in patients with a symptomatic carotid stenosis. Use of patch angioplasty to restore the arterial wall after longitudinal endarterectomy is, to date, not unequivocally proven to be superior to eversion technique. A systematic review is needed for evaluation of benefits and harms of the eversion technique versus the traditional endarterectomy with patch angioplasty in patients with symptomatic carotid stenosis.Methods and outcomesThe review will be conducted according to this protocol following the recommendations of the ‘Cochrane Handbook for Systematic Reviews’ and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Randomised clinical trials comparing eversion technique versus endarterectomy with patch angioplasty in patients with a symptomatic stenosis of the internal carotid artery will be included. Primary outcomes are all-cause mortality rate, health-related quality of life and serious adverse events. Secondary outcomes are 30-day stroke and mortality rate, symptomatic arterial restenosis or occlusion and non-serious adverse events. The databases Cochrane Central Register of Controlled Trials, PubMed/MEDLINE and EMBASE will be searched (November 2019). We will primarily base our conclusions on meta-analyses of trials with overall low-risk of bias. We will use trial sequential analysis to assist the evaluation of imprecision in Grading of Recommendations, Assessment, Development and Evaluation. However, if pooled point estimates of all trials are similar to pooled point estimates of trials with overall low risk of bias and there is lack of a statistical significant interaction between estimates from trials with overall high risk of bias and trials with overall low risk of bias we will consider the trial sequential analysis adjusted precision of the estimate achieved in all trials as the result of our meta-analyses.Ethics and disseminationThe proposed systematic review will collect and analyse data from published studies, therefore, ethical approval is not required. The results of the review will be disseminated by publication in a peer-review journal and submitted for presentation at conferences.PROSPERO registration numberCRD42019119361.

scholarly journals Carotid endarterectomy with primary closure versus patch angioplasty in patients with symptomatic and significant stenosis: protocol for a systematic review with meta-analyses and trial sequential analysis of randomised clinical trials

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e026419 ◽  
Author(s):  
Martijn S Marsman ◽  
Jørn Wetterslev ◽  
Abdelkarime Khodadade Jahrome ◽  
Christian Gluud ◽  
Frans L Moll ◽  
...  
Keyword(s):  
Systematic Review ◽  
Primary Closure ◽  
Sequential Analysis ◽  
Risk Of Bias ◽  
Low Risk ◽  
Trial Sequential Analysis ◽  
Serious Adverse Events ◽  
Point Estimates ◽  
Patch Angioplasty ◽  
Meta Analyses

IntroductionUse of patch angioplasty in carotid endarterectomy (CEA) is suggested to reduce the risk of restenosis and recurrent ipsilateral stroke. The objective is to conduct a systematic review with meta-analysis and trial sequential analysis as well as Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessments comparing the benefits and harms of CEA with primary closure of the arterial wall versus CEA with patch angioplasty in patients with a symptomatic and significant carotid stenosis.Methods and analysisThe review shall be conducted according to this published protocol following the recommendations of the ‘Cochrane’ and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Randomised clinical trials comparing CEA with primary closure of the arterial wall versus CEA with patch angioplasty (regardless of used patch materials) in human adults with a symptomatic and significant carotid stenosis will be included. Primary outcomes are all-cause mortality at maximal follow-up, health-related quality of life and serious adverse events. Secondary outcomes are symptomatic or asymptomatic arterial occlusion or restenosis, and non-serious adverse events. We will primarily base our conclusions on meta-analyses of trials with overall low risk of bias. However, if pooled point estimates of all trials are similar to pooled point estimates of trials with overall low risk of bias and there is lack of a statistical significant interaction between estimates from trials with overall high risk of bias and trials with overall low risk of bias we will consider the precision achieved in all trials as the result of our meta-analyses.Ethics and disseminationThe proposed systematic review will collect and analyse secondary data from published studies therefor ethical approval is not required. The results of the systematic review will be disseminated by publication in a peer-review journal and submitted for presentation at relevant conferences.PROSPERO registration numberCRD42014013416.

scholarly journals Fever control interventions versus placebo, sham or no intervention in adults: a protocol for a systematic review with meta-analysis and Trial Sequential Analysis

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e032389 ◽  
Author(s):  
Naqash Sethi ◽  
Arushma Imran Naqash ◽  
Niklas Nielsen ◽  
Janus Christian Jakobsen
Keyword(s):  
Systematic Review ◽  
Sequential Analysis ◽  
Meta Analysis ◽  
Physiological Role ◽  
Risk Of Bias ◽  
Low Risk ◽  
Trial Sequential Analysis ◽  
Control Intervention ◽  
Registration Number ◽  
Meta Analyses

IntroductionFever is an integral part of the inflammatory response and has therefore likely a physiological role in fighting infections. Nevertheless, whether fever in itself is beneficial or harmful in adults is unknown. This protocol for a systematic review aims at identifying the beneficial and harmful effects of fever control interventions in adults.Methods and analysisThis protocol for a systematic review was conducted following the recommendations of Cochrane, GRADE and the eight-step assessment suggested by Jakobsen and colleagues for better validation of meta-analytical results in systematic reviews. We plan to include all relevant randomised clinical trials comparing any fever control intervention with placebo, sham or no intervention in adults. We plan to search CENTRAL, MEDLINE, Embase, LILACS, BIOSIS, CINAHL, Scopus and Web of Science Core Collection to identify relevant trials. Any eligible trial will be assessed and classified as either at high risk of bias or low risk of bias, and our primary conclusions will be based on trials at low risk of bias. We will perform our meta-analyses of the extracted data using Review Manager 5.3 and Trial Sequential Analysis. For all our outcomes, we will create a ‘Summary of Findings’ table based on GRADE assessments of the certainty of the evidence.Ethics and disseminationNo formal approval or review of ethics is required for this systematic review as individual patient data will not be included. This systematic review has the potential to highlight (1) whether one should believe fever to be beneficial, harmful or neither in adults; (2) the existing knowledge gaps on this topic; and (3) whether the recommendations from guidelines and daily clinical practice are correct. These results will be disseminated through publication in a leading peer-reviewed journal.PROSPERO registration numberCRD42019134006

scholarly journals Duloxetine versus ‘active’ placebo, placebo or no intervention for major depressive disorder; a protocol for a systematic review of randomised clinical trials with meta-analysis and trial sequential analysis

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Faiza Siddiqui ◽  
Marija Barbateskovic ◽  
Sophie Juul ◽  
Kiran Kumar Katakam ◽  
Klaus Munkholm ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Sequential Analysis ◽  
Citation Index ◽  
Trial Sequential Analysis ◽  
Random Errors ◽  
Major Depressive ◽  
Serious Adverse Events ◽  
Meta Analyses

Abstract Background Major depression significantly impairs quality of life, increases the risk of suicide, and poses tremendous economic burden on individuals and societies. Duloxetine, a serotonin norepinephrine reuptake inhibitor, is a widely prescribed antidepressant. The effects of duloxetine have, however, not been sufficiently assessed in earlier systematic reviews and meta-analyses. Methods/design A systematic review will be performed including randomised clinical trials comparing duloxetine with ‘active’ placebo, placebo or no intervention for adults with major depressive disorder. Bias domains will be assessed, an eight-step procedure will be used to assess if the thresholds for clinical significance are crossed. We will conduct meta-analyses. Trial sequential analysis will be conducted to control random errors, and the certainty of the evidence will be assessed using GRADE. To identify relevant trials, we will search Cochrane Central Register of Controlled Trials, Medical Literature Analysis and Retrieval System Online, Excerpta Medica database, PsycINFO, Science Citation Index Expanded, Social Sciences Citation Index, Conference Proceedings Citation Index—Science and Conference Proceedings Citation Index—Social Science & Humanities. We will also search Chinese databases and Google Scholar. We will search all databases from their inception to the present. Two review authors will independently extract data and perform risk of bias assessment. Primary outcomes will be the difference in mean depression scores on Hamilton Depression Rating Scale between the intervention and control groups and serious adverse events. Secondary outcomes will be suicide, suicide-attempts, suicidal ideation, quality of life and non-serious adverse events. Discussion No former systematic review has systematically assessed the beneficial and harmful effects of duloxetine taking into account both the risks of random errors and the risks of systematic errors. Our review will help clinicians weigh the benefits of prescribing duloxetine against its adverse effects and make informed decisions. Systematic review registration PROSPERO 2016 CRD42016053931

scholarly journals The effects of adding glucocorticosteroids to standard care for children with sepsis. A systematic review of randomized clinical trials with meta-analysis and Trial Sequential Analysis

2021 ◽  
Author(s):  
Steven Kwasi Korang ◽  
Sanam Safi ◽  
Christian Gluud ◽  
Janus C Jakobsen
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Events ◽  
Standard Care ◽  
Sequential Analysis ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Trial Sequential Analysis ◽  
Serious Adverse Events ◽  
Meta Analyses

Abstract Background: Glucocorticosteroids are widely used to treat severe sepsis in pediatric intensive care units. However, the evidence on the clinical effects is unclear.Objective: To assess the benefits and harms of glucocorticosteroids for children with sepsis. Data Sources: We conducted a systematic review of randomized clinical trials with meta-analysis and Trial Sequential Analysis (TSA) (PROSPERO CRD42017054341). We searched CENTRAL, MEDLINE, Embase, LILACS, SCI-Expanded, and more. Study Selection: Randomized clinical trials assessing the effects of adding glucocorticosteroids to standard care for children with sepsis. Data Extraction: Two independent reviewers screened studies and extracted data. Evidence was assessed by GRADE according to our published protocol.Data Synthesis: We included 24 trials randomizing 3073 participants. Meta-analyses showed no evidence of an effect of adding glucocorticosteroids for children with sepsis with a mixed focus for any of our outcomes. Meta-analyses suggested evidence of a beneficial effect of dexamethasone for children with meningitis when assessing serious adverse events (risk ratio (RR) 0.68, 95% confidence interval (CI) 0.53 to 0.86; P = 0.001, very low certainty of evidence) and ototoxicity (RR 0.63, 95% CI 0.45 to 0.88; P = 0.007, low certainty of evidence). TSAs showed that we did not have sufficient data to confirm or reject these results. We found insufficient evidence to confirm or reject an effect on mortality or our other outcomes. No trials reported quality of life or organ failure. Most trials were at high risks of bias. We found high clinical heterogeneity between participants. None of our TSAs showed benefits, harms or futility. Conclusions: Generally, we found no evidence of an effect of glucocorticosteroids for children with sepsis without meningitis. Dexamethasone for sepsis in children due to meningitis may decrease serious adverse events and ototoxicity.

scholarly journals Vaccines to prevent COVID-19: a protocol for a living systematic review with network meta-analysis including individual patient data (The LIVING VACCINE Project)

2020 ◽  
Vol 9 (1) ◽  
Author(s):  
Steven Kwasi Korang ◽  
Sophie Juul ◽  
Emil Eik Nielsen ◽  
Joshua Feinberg ◽  
Faiza Siddiqui ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Individual Patient Data ◽  
Viral Vector ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Serious Adverse Events ◽  
Meta Analyses ◽  
Harmful Effects

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19) which has rapidly spread worldwide. Several human randomized clinical trials assessing potential vaccines are currently underway. There is an urgent need for a living systematic review that continuously assesses the beneficial and harmful effects of all available vaccines for COVID-19. Methods/design We will conduct a living systematic review based on searches of major medical databases (e.g., MEDLINE, EMBASE, CENTRAL) and clinical trial registries from their inception onwards to identify relevant randomized clinical trials. We will update the literature search once a week to continuously assess if new evidence is available. Two review authors will independently extract data and conduct risk of bias assessments. We will include randomized clinical trials comparing any vaccine aiming to prevent COVID-19 (including but not limited to messenger RNA; DNA; non-replicating viral vector; replicating viral vector; inactivated virus; protein subunit; dendritic cell; other vaccines) with any comparator (placebo; “active placebo;” no intervention; standard care; an “active” intervention; another vaccine for COVID-19) for participants in all age groups. Primary outcomes will be all-cause mortality; a diagnosis of COVID-19; and serious adverse events. Secondary outcomes will be quality of life and non-serious adverse events. The living systematic review will include aggregate data meta-analyses, trial sequential analyses, network meta-analyses, and individual patient data meta-analyses. Within-study bias will be assessed using Cochrane risk of bias tool. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) and Confidence in Network Meta-Analysis (CINeMA) approaches will be used to assess certainty of evidence. Observational studies describing harms identified during the search for trials will also be included and described and analyzed separately. Discussion COVID-19 has become a pandemic with substantial mortality. A living systematic review assessing the beneficial and harmful effects of different vaccines is urgently needed. This living systematic review will regularly inform best practice in vaccine prevention and clinical research of this highly prevalent disease. Systematic review registration PROSPERO CRD42020196492

scholarly journals Effect of yoga on sleep quality and insomnia in women with sleep problems: a systematic review and meta-analysis

2019 ◽  
Author(s):  
Weili Wang ◽  
Kuang-Huei Chen ◽  
Ying-Chieh Pan ◽  
Szu-Nian Yang ◽  
Yuan-Yu Chan
Keyword(s):  
Systematic Review ◽  
Sleep Quality ◽  
Sleep Problems ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Control Group ◽  
Serious Adverse Events ◽  
Positive Effects ◽  
Meta Analyses

Abstract Objectives To examine the effectiveness and safety of yoga for women with sleep problems by performing a systematic review and meta-analysis.Methods Medline/PubMed, Clincalkey, ScienceDirect, Embase, PsycINFO, and the Cochrane Library were searched throughout the month of June 2019. Randomized controlled trials comparing yoga groups with control groups in women with sleep problems were included. Two reviewers independently evaluated risk of bias by using the risk of bias tool suggested by the Cochrane Collaboration for programming and conducting systematic reviews and meta-analyses. The main outcome measure was sleep quality or the severity of insomnia, which was measured using subjective instruments, such as the Pittsburgh Sleep Quality Index (PSQI), Insomnia severity index (ISI), or objective instruments, such as polysomnography, actigraphy, and safety of the intervention. For each outcome, standardized mean difference (SMD) and 95% confidence intervals (CIs) were determined. Results Nineteen studies including 1832 participants were included in this systematic review. Meta-analyses revealed positive effects of yoga using PSQI or ISI scores in 16 randomized control trials (RCTs) compared with the control group in improving sleep quality in women, PSQI (SMD = −0.54; 95% CI = −0.89 to −0.19 ; P = 0.003). However, three RCTs revealed no effects of yoga compared with the control group in reducing the severity of insomnia in women using ISI (SMD = −0.13; 95% CI = −0.74 to 0.48; P = 0.69). Seven RCTs revealed no evidence for effects of yoga compared with the control group in improving sleep quality for women with breast cancer using PSQI (SMD = −0.15 ; 95% CI = −0.31 to 0.01; P = 0.5). Four RCTs revealed no evidence for the effects of yoga compared with the control group in improving the sleep quality for peri-or postmenopausal women using PSQI (SMD = −0.31; 95% CI = −0.95 to 0.33; P = 0.34).Yoga was not associated with serious adverse events. Discussion This systematic review and meta-analysis found that yoga intervention in some groups of women was beneficial in managing sleep problems. Despite certain disadvantages in methodology in the included studies, yoga may be recommended as a complementary therapy to women.

scholarly journals Ivabradine added to usual care in patients with heart failure: a systematic review with meta-analysis and trial sequential analysis

2021 ◽  
pp. bmjebm-2021-111724
Author(s):  
Mathias Maagaard ◽  
Emil Eik Nielsen ◽  
Naqash Javaid Sethi ◽  
Ning Liang ◽  
Si-Hong Yang ◽  
...  
Keyword(s):  
Heart Failure ◽  
Adverse Events ◽  
Usual Care ◽  
Sequential Analysis ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Trial Sequential Analysis ◽  
Serious Adverse Events ◽  
All Cause Mortality

ObjectivesTo assess the beneficial and harmful effects of adding ivabradine to usual care in participants with heart failure.DesignA systematic review with meta-analysis and trial sequential analysis.Eligibility criteriaRandomised clinical trials comparing ivabradine and usual care with usual care (with or without) placebo in participants with heart failure.Information sourcesMedline, Embase, CENTRAL, LILACS, CNKI, VIP and other databases and trial registries up until 31 May 2021.Data extractionPrimary outcomes were all-cause mortality, serious adverse events and quality of life. Secondary outcomes were cardiovascular mortality, myocardial infarction and non-serious adverse events. We performed meta-analysis of all outcomes. We used trial sequential analysis to control risks of random errors, the Cochrane risk of bias tool to assess the risks of systematic errors and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) to assess the certainty of the evidence.ResultsWe included 109 randomised clinical trials with 26 567 participants. Two trials were at low risk of bias, although both trials were sponsored by the company that developed ivabradine. All other trials were at high risk of bias. Meta-analyses and trial sequential analyses showed that we could reject that ivabradine versus control reduced all-cause mortality (risk ratio (RR)=0.94; 95% CI 0.88 to 1.01; p=0.09; high certainty of evidence). Meta-analysis and trial sequential analysis showed that ivabradine seemed to reduce the risk of serious adverse events (RR=0.90; 95% CI 0.87 to 0.94; p<0.00001; number needed to treat (NNT)=26.2; low certainty of evidence). This was primarily due to a decrease in the risk of ‘cardiac failure’ (RR=0.83; 95% CI 0.71 to 0.97; p=0.02; NNT=43.9), ‘hospitalisations’ (RR=0.89; 95% CI 0.85 to 0.94; p<0.0001; NNT=36.4) and ‘ventricular tachycardia’ (RR=0.59; 95% CI 0.43 to 0.82; p=0.001; NNT=212.8). However, the trials did not describe how these outcomes were defined and assessed during follow-up. Meta-analyses showed that ivabradine increased the risk of atrial fibrillation (RR=1.19; 95% CI 1.04 to 1.35; p=0.008; number needed to harm (NNH)=116.3) and bradycardia (RR=3.95; 95% CI 1.88 to 8.29; p=0.0003; NNH=303). Ivabradine seemed to increase quality of life on the Kansas City Cardiomyopathy Questionnaire (KCCQ) (mean difference (MD)=2.92; 95% CI 1.34 to 4.50; p=0.0003; low certainty of evidence), but the effect size was small and possibly without relevance to patients, and on the Minnesota Living With Heart Failure Questionnaire (MLWHFQ) (MD=−5.28; 95% CI −6.60 to −3.96; p<0.00001; very low certainty of evidence), but the effects were uncertain. Meta-analysis showed no evidence of a difference between ivabradine and control when assessing cardiovascular mortality and myocardial infarction. Ivabradine seemed to increase the risk of non-serious adverse events.Conclusion and relevanceHigh certainty evidence shows that ivabradine does not seem to affect the risks of all-cause mortality and cardiovascular mortality. The effects on quality of life were small and possibly without relevance to patients on the KCCQ and were very uncertain for the MLWHFQ. The effects on serious adverse events, myocardial infarction and hospitalisation are uncertain. Ivabradine seems to increase the risk of atrial fibrillation, bradycardia and non-serious adverse events.PROSPERO registration number: CRD42018112082.

scholarly journals Self-determination theory interventions versus usual care in people with diabetes: a protocol for a systematic review with meta-analysis and trial sequential analysis

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Anne Sophie Mathiesen ◽  
Mette Juel Rothmann ◽  
Vibeke Zoffmann ◽  
Janus Christian Jakobsen ◽  
Christian Gluud ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Usual Care ◽  
Patient Engagement ◽  
Sequential Analysis ◽  
Self Determination Theory ◽  
Risk Of Bias ◽  
Self Determination ◽  
Trial Sequential Analysis

Abstract Background Existing self-management and behavioural interventions for diabetes vary widely in their content, and their sustained long-term effectiveness is uncertain. Autonomy supporting interventions may be a prerequisite to achieve ‘real life’ patient engagement and more long-term improvement through shared decision-making and collaborative goal setting. Autonomy supportive interventions aim to promote that the person with diabetes’ motivation is autonomous meaning that the person strives for goals they themselves truly believe in and value. This is the goal of self-determination theory and guided self-determination interventions. Self-determination theory has been reviewed but without assessing both benefits and harms and accounting for the risk of random errors using trial sequential analysis. The guided self-determination has not yet been systematically reviewed. The aim of this protocol is to investigate the benefits and harms of self-determination theory-based interventions versus usual care in adults with diabetes. Methods/design We will conduct the systematic review following The Cochrane Collaboration guidelines. This protocol is reported according to the PRISMA checklist. A comprehensive search will be undertaken in the CENTRAL, MEDLINE, EMBASE, LILACS, PsycINFO, SCI-EXPANDED, CINAHL, SSCI, CPCI-S and CPCI-SSH to identify relevant trials. We will include randomised clinical trials assessing interventions theoretically based on guided self-determination or self-determination theory provided face-to-face or digitally by any healthcare professional in any setting. The primary outcomes will be quality of life, mortality, and serious adverse events. The secondary will be diabetes distress, depressive symptoms and adverse events not considered serious. Exploratory outcomes will be glycated haemoglobin and motivation. Outcomes will be assessed at the end of the intervention and at maximum follow-up. The analyses will be performed using Stata version 16 and trial sequential analysis. Two authors will independently screen, extract data from and perform risk of bias assessment of included studies using the Cochrane risk of bias tool. Certainty of the evidence will be assessed by GRADE. Discussion Self-determination theory interventions aim to promote a more autonomous patient engagement and are commonly used. It is therefore needed to evaluate the benefit and harms according to existing trials. Systematic review registration PROSPERO CRD42020181144

scholarly journals The effect of yoga on sleep quality and insomnia in women with sleep problems: a systematic review and meta-analysis

2020 ◽  
Author(s):  
Weili Wang ◽  
Kuang-Huei Chen ◽  
Ying-Chieh Pan ◽  
Szu-Nian Yang ◽  
Yuan-Yu Chan
Keyword(s):  
Systematic Review ◽  
Sleep Quality ◽  
Sleep Problems ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Control Group ◽  
Serious Adverse Events ◽  
Positive Effects ◽  
Meta Analyses

Abstract Background: To examine the effectiveness and safety of yoga of women with sleep problems by performing a systematic review and meta-analysis. Methods: Medline/PubMed, ClinicalKey, ScienceDirect, Embase, PsycINFO, and the Cochrane Library were searched throughout the month of June, 2019. Randomized controlled trials comparing yoga groups with control groups in women with sleep problems were included. Two reviewers independently evaluated risk of bias by using the risk of bias tool suggested by the Cochrane Collaboration for programming and conducting systematic reviews and meta-analyses. The main outcome measure was sleep quality or the severity of insomnia, which was measured using subjective instruments, such as the Pittsburgh Sleep QualityIndex (PSQI),Insomnia Severity Index (ISI), or objective instruments such as polysomnography, actigraphy, and safety of the intervention. For each outcome, a standardized mean difference (SMD) and confidence intervals (CIs) of 95% were determined. Results: Nineteen studies in this systematic review included 1832 participants. The meta-analysis of the combined data conducted according to Comprehensive Meta-Analysis showed a significant improvement in sleep (SMD =−0.327, 95% CI=−0.506 to −0.148,P<0.001).Meta-analyses revealed positive effects of yoga using PSQI scores in 16 randomized control trials (RCTs), compared with the control group in improving sleep quality among women usingPSQI (SMD = −0.54; 95% CI = −0.89 to −0.19; P = 0.003). However, three RCTs revealed no effects of yoga compared to the control groupin reducing insomnia among women using ISI (SMD = −0.13; 95% CI = −0.74 to 0.48; P = 0.69).Yoga was not associated with any serious adverse events. Discussion: This systematic review and meta-analysis demonstrated that yoga intervention in women can be beneficial whencompared to non-active control conditions in term of managing sleep problems.The moderator analyses suggest that participants in the non-breast cancer subgroup and participants in the non-peri/postmenopausal subgroup were associated with greater benefits, with a direct correlation of total class time with quality of sleep among other related benefits.

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