scholarly journals Ivermectin for the prevention of COVID-19: addressing potential bias and medical fraud

2021 ◽  
Author(s):  
Andrew Hill ◽  
Manya Mirchandani ◽  
Leah Ellis ◽  
Victoria Pilkington
Keyword(s):  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Group Analysis ◽  
Poor Quality ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Quality Of Data ◽  
Randomised Controlled ◽  
Post Hoc

Abstract Background Ivermectin is an antiparasitic drug being investigated in clinical trials for the prevention of COVID-19. However, there are concerns about the quality of some of these trials. Objectives To conduct a meta-analysis with randomised controlled trials of ivermectin for the prevention of COVID-19, while controlling for the quality of data. Methods We conducted a sub-group analysis based on the quality of randomised controlled trials evaluating ivermectin for the prevention of COVID-19. Quality was assessed using the Cochrane Risk of Bias measures (RoB 2) and additional checks on raw data, where possible. Results Four studies were included in the meta-analysis. One was rated as being potentially fraudulent, two as having a high risk of bias and one as having some concerns for bias. Ivermectin did not have a significant effect on preventing RT-PCR confirmed COVID-19 infection. Ivermectin had a significant effect on preventing symptomatic COVID-19 infection in one trial with some concerns of bias, but this result was based on post-hoc analysis of a multi-arm study. Conclusions This meta-analysis demonstrates that the currently available randomised trials evaluating ivermectin for the prevention of COVID-19 are insufficient and of poor quality.

Treating depression with physical activity in adolescents and young adults: a systematic review and meta-analysis of randomised controlled trials

2017 ◽  
Vol 48 (7) ◽  
pp. 1068-1083 ◽  
Author(s):  
A. P. Bailey ◽  
S. E. Hetrick ◽  
S. Rosenbaum ◽  
R. Purcell ◽  
A. G. Parker
Keyword(s):  
Physical Activity ◽  
Young Adults ◽  
Treatment Effect ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Adolescents And Young Adults ◽  
Controlled Trials ◽  
Randomised Controlled

AbstractWe aimed to establish the treatment effect of physical activity for depression in young people through meta-analysis. Four databases were searched to September 2016 for randomised controlled trials of physical activity interventions for adolescents and young adults, 12–25 years, experiencing a diagnosis or threshold symptoms of depression. Random-effects meta-analysis was used to estimate the standardised mean difference (SMD) between physical activity and control conditions. Subgroup analysis and meta-regression investigated potential treatment effect modifiers. Acceptability was estimated using dropout. Trials were assessed against risk of bias domains and overall quality of evidence was assessed using GRADE criteria. Seventeen trials were eligible and 16 provided data from 771 participants showing a large effect of physical activity on depression symptoms compared to controls (SMD = −0.82, 95% CI = −1.02 to −0.61, p < 0.05, I2 = 38%). The effect remained robust in trials with clinical samples (k = 5, SMD = −0.72, 95% CI = −1.15 to −0.30), and in trials using attention/activity placebo controls (k = 7, SMD = −0.82, 95% CI = −1.05 to −0.59). Dropout was 11% across physical activity arms and equivalent in controls (k = 12, RD = −0.01, 95% CI = −0.04 to 0.03, p = 0.70). However, the quality of RCT-level evidence contributing to the primary analysis was downgraded two levels to LOW (trial-level risk of bias, suspected publication bias), suggesting uncertainty in the size of effect and caution in its interpretation. While physical activity appears to be a promising and acceptable intervention for adolescents and young adults experiencing depression, robust clinical effectiveness trials that minimise risk of bias are required to increase confidence in the current finding. The specific intervention characteristics required to improve depression remain unclear, however best candidates given current evidence may include, but are not limited to, supervised, aerobic-based activity of moderate-to-vigorous intensity, engaged in multiple times per week over eight or more weeks. Further research is needed. (Registration: PROSPERO-CRD 42015024388).

scholarly journals Acupuncture for Vascular Mild Cognitive Impairment: A Systematic Review of Randomised Controlled Trials

2013 ◽  
Vol 31 (4) ◽  
pp. 368-374 ◽  
Author(s):  
Huijuan Cao ◽  
Yuyi Wang ◽  
Dennis Chang ◽  
Li Zhou ◽  
Jianping Liu
Keyword(s):  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Vascular Cognitive Impairment ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Randomised Controlled ◽  
State Examination

Background Vascular mild cognitive impairment (VMCI) is the most common type of vascular cognitive impairment induced by cerebrovascular disease. No effective medicines are currently available for VMCI. Objective To assess the effectiveness and safety of acupuncture for VMCI. Methods Seven electronic databases were searched for randomised controlled trials which investigated the effects of acupuncture compared with no treatment, placebo or conventional therapies on cognitive function or other clinical outcomes in patients with VMCI. The quality of the trials selected was evaluated according to the ‘risk of bias’ assessment provided by the Cochrane Handbook for Systematic Reviews of Interventions. RevMan V.5.1 software was employed for data analysis. Results Twelve trials with 691 participants were included. The methodological quality of all included trials was unclear and/or they had a high risk of bias. Meta-analysis showed acupuncture in conjunction with other therapies could significantly improve Mini-Mental State Examination scores (mean difference 1.99, 95% CI 1.09 to 2.88, random model, p<0.0001, 6 trials). No included trials mentioned any adverse events of the treatment. Conclusions The current clinical evidence is not of sufficient quality for wider application of acupuncture to be recommended for the treatment of VMCI, and further large, rigorously designed trials are warranted.

scholarly journals Antibiotic therapy for pelvic inflammatory disease: an abridged version of a Cochrane systematic review and meta-analysis of randomised controlled trials

2018 ◽  
Vol 95 (1) ◽  
pp. 21-27 ◽  
Author(s):  
Ricardo F Savaris ◽  
Daniele G Fuhrich ◽  
Rui V Duarte ◽  
Sebastian Franik ◽  
Jonathan D C Ross
Keyword(s):  
Systematic Review ◽  
Pelvic Inflammatory Disease ◽  
Inflammatory Disease ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Quality Of Evidence ◽  
Randomised Controlled

ObjectiveTo assess the effectiveness and safety of antibiotic regimens used to treat pelvic inflammatory disease (PID).DesignThis is a systematic review and meta-analysis of randomised controlled trials (RCTs). Risk of bias was assessed using the criteria outlined in the Cochrane guidelines. Quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation.Data sourcesEight electronic databases were searched from date of inception up to July 2016. Database searches were complemented by screening of reference lists of relevant studies, trial registers, conference proceeding abstracts and grey literature.Eligibility criteriaRCTs comparing the use of antibiotics with placebo or other antibiotics for the treatment of PID in women of reproductive age, either as inpatient or outpatient treatment.ResultsWe included 37 RCTs (6348 women). The quality of evidence ranged from very low to high, the main limitations being serious risk of bias (due to poor reporting of study methods and lack of blinding), serious inconsistency and serious imprecision. There was no clear evidence of a difference in the rates of cure for mild-moderate or for severe PID for the comparisons of azithromycin versus doxycycline, quinolone versus cephalosporin, nitroimidazole versus no use of nitroimidazole, clindamycin plus aminoglycoside versus quinolone, or clindamycin plus aminoglycoside versus cephalosporin. No clear evidence of a difference between regimens in antibiotic-related adverse events leading to discontinuation of therapy was observed.ConclusionsWe found no conclusive evidence that one regimen of antibiotics was safer or more effective than any other for the treatment of PID, and there was no clear evidence for the use of nitroimidazoles (metronidazole) compared with the use of other drugs with activity against anaerobes. More evidence is needed to assess treatments for women with PID, particularly comparing regimens with or without the addition of nitroimidazoles and the efficacy of azithromycin compared with doxycycline.

scholarly journals Effects of traditional Chinese exercise on cardiac rehabilitation after percutaneous coronary intervention: study protocol for network meta-analysis of randomised controlled trials

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e023096 ◽  
Author(s):  
Chuanjin Luo ◽  
Junmao Wen ◽  
Weipeng Sun ◽  
Ting Li ◽  
Xiaojiang Yu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trials ◽  
Tai Chi ◽  
Meta Analysis ◽  
Coronary Intervention ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Percutaneous Coronary ◽  
Randomised Controlled

IntroductionCoronary heart disease (CHD) is the most common cause of death worldwide. Percutaneous coronary intervention (PCI) has been shown to reduce mortality in patients with CHD. However, there are still recurrences of cardiovascular events after PCI. Cardiac rehabilitation (CR) in patients with established CHD is associated with reductions in cardiovascular mortality and hospital admissions, as well as improved quality of life. More and more clinical trials suggest that traditional Chinese exercise (TCE) plays a positive role in patients post-PCI. The primary purposes of the current study are to conduct a network meta-analysis of randomised trials to determine the effects of TCE in patients after PCI, and to separately compare the effects of tai chi, baduanjin and yijinjing on CR after PCI.Methods and analysisStudies will be retrieved from the following databases: PubMed, Embase, Cochrane Library, Chinese National Knowledge Infrastructure, Wanfang Data, Chinese BioMedical Database and Chinese Science and Technology Periodicals Database, from inception to December 2018. We will include randomised controlled trials that are related to the effects of TCE therapies in patients after PCI. The primary outcomes will be all-cause mortality, revascularisations, health-related quality of life and hospitalisations. Two reviewers will independently select eligible articles. For each included article, two reviewers will independently extract the data and assess the risk of bias by using the Cochrane risk of bias tool. Bayesian network meta-analyses will be conducted to pool all treatment effects. The ranking probabilities for the optimal intervention of various treatments (tai chi, baduanjin or yijinjing) will be estimated by the mean ranks and surface under the cumulative ranking curve. The Grading of Recommendations Assessment, Development and Evaluation System will be used to assess the quality of evidence.Ethics and disseminationThe results will be disseminated through peer-reviewed publications. They will provide consolidated evidence to inform clinicians on the potential functions of TCE in CR, and to provide reliable evidence for the application of TCE.Trial registration numberCRD42018088415.

scholarly journals The methodological quality of individual participant data meta-analysis on intervention effects: systematic review

BMJ ◽  
2021 ◽  
pp. n736
Author(s):  
Huan Wang ◽  
Yancong Chen ◽  
Yali Lin ◽  
Julius Abesig ◽  
Irene XY Wu ◽  
...  
Keyword(s):  
Methodological Quality ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
A Priori ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Individual Participant ◽  
Randomised Controlled ◽  
Meta Analyses

Abstract Objective To assess the methodological quality of individual participant data (IPD) meta-analysis and to identify areas for improvement. Design Systematic review. Data sources Medline, Embase, and Cochrane Database of Systematic Reviews. Eligibility criteria for selecting studies Systematic reviews with IPD meta-analyses of randomised controlled trials on intervention effects published in English. Results 323 IPD meta-analyses covering 21 clinical areas and published between 1991 and 2019 were included: 270 (84%) were non-Cochrane reviews and 269 (84%) were published in journals with a high impact factor (top quarter). The IPD meta-analyses showed low compliance in using a satisfactory technique to assess the risk of bias of the included randomised controlled trials (43%, 95% confidence interval 38% to 48%), accounting for risk of bias when interpreting results (40%, 34% to 45%), providing a list of excluded studies with justifications (32%, 27% to 37%), establishing an a priori protocol (31%, 26% to 36%), prespecifying methods for assessing both the overall effects (44%, 39% to 50%) and the participant-intervention interactions (31%, 26% to 36%), assessing and considering the potential of publication bias (31%, 26% to 36%), and conducting a comprehensive literature search (19%, 15% to 23%). Up to 126 (39%) IPD meta-analyses failed to obtain IPD from 90% or more of eligible participants or trials, among which only 60 (48%) provided reasons and 21 (17%) undertook certain strategies to account for the unavailable IPD. Conclusions The methodological quality of IPD meta-analyses is unsatisfactory. Future IPD meta-analyses need to establish an a priori protocol with prespecified data syntheses plan, comprehensively search the literature, critically appraise included randomised controlled trials with appropriate technique, account for risk of bias during data analyses and interpretation, and account for unavailable IPD.

scholarly journals Comparative efficacy and safety of interventions for treating head lice: a protocol for systematic review and network meta-analysis

2021 ◽  
Vol 5 (1) ◽  
pp. e001129
Author(s):  
Bill Stevenson ◽  
Wubshet Tesfaye ◽  
Julia Christenson ◽  
Cynthia Mathew ◽  
Solomon Abrha ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Grey Literature ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Head Lice ◽  
Efficacy And Safety ◽  
Randomised Controlled ◽  
Meta Analyses

BackgroundHead lice infestation is a major public health problem around the globe. Its treatment is challenging due to product failures resulting from rapidly emerging resistance to existing treatments, incorrect treatment applications and misdiagnosis. Various head lice treatments with different mechanism of action have been developed and explored over the years, with limited report on systematic assessments of their efficacy and safety. This work aims to present a robust evidence summarising the interventions used in head lice.MethodThis is a systematic review and network meta-analysis which will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement for network meta-analyses. Selected databases, including PubMed, Embase, MEDLINE, Web of Science, CINAHL and Cochrane Central Register of Controlled Trials will be systematically searched for randomised controlled trials exploring head lice treatments. Searches will be limited to trials published in English from database inception till 2021. Grey literature will be identified through Open Grey, AHRQ, Grey Literature Report, Grey Matters, ClinicalTrials.gov, WHO International Clinical Trials Registry and International Standard Randomised Controlled Trials Number registry. Additional studies will be sought from reference lists of included studies. Study screening, selection, data extraction and assessment of methodological quality will be undertaken by two independent reviewers, with disagreements resolved via a third reviewer. The primary outcome measure is the relative risk of cure at 7 and 14 days postinitial treatment. Secondary outcome measures may include adverse drug events, ovicidal activity, treatment compliance and acceptability, and reinfestation. Information from direct and indirect evidence will be used to generate the effect sizes (relative risk) to compare the efficacy and safety of individual head lice treatments against a common comparator (placebo and/or permethrin). Risk of bias assessment will be undertaken by two independent reviewers using the Cochrane Risk of Bias tool and the certainty of evidence assessed using the Grading of Recommendations, Assessment, Development and Evaluations guideline for network meta-analysis. All quantitative analyses will be conducted using STATA V.16.DiscussionThe evidence generated from this systematic review and meta-analysis is intended for use in evidence-driven treatment of head lice infestations and will be instrumental in informing health professionals, public health practitioners and policy-makers.PROSPERO registration numberCRD42017073375.

Acupuncture for Amnestic Mild Cognitive Impairment: A Meta-Analysis of Randomised Controlled Trials

2016 ◽  
Vol 34 (5) ◽  
pp. 342-348 ◽  
Author(s):  
Min Deng ◽  
Xu-Feng Wang
Keyword(s):  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Methodological Quality ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Scientific Journal ◽  
Adjunctive Treatment ◽  
Controlled Trials ◽  
Randomised Controlled

Objective Mild cognitive impairment (MCI) is a pre-dementia state; 5–10% of cases per year will evolve into dementia. MCI can be amnestic (AMCI) or non-amnestic. AMCI is associated with a higher risk of progression. In recent years, interest in acupuncture as a potential treatment for AMCI has grown. The aim of this meta-analysis was to estimate the clinical effectiveness and safety of acupuncture for AMCI. Methods Randomised controlled trials (RCTs) of acupuncture versus medical treatment for AMCI were identified using the following databases from inception to July 2015: PubMed; Medline; CENTRAL; Chinese Scientific Journal Database; The Chinese Acupuncture Trials Register; China National Knowledge Infrastructure (CNKI); and Wanfang database. Data were extracted from RCTs meeting the inclusive criteria according to Cochrane methods. Meta-analyses were conducted using Rev Man V.5.3 software. Results Five trials involving 568 subjects were included. Meta-analysis showed that participants receiving acupuncture had better outcomes than those receiving nimodipine with greater clinical efficacy rates (odds ratio (OR) 1.78, 95% CI 1.19 to 2.65; p<0.01), mini-mental state examination (MMSE) scores (mean difference (MD) 0.99, 95% CI 0.71 to 1.28; p<0.01), and picture recognition score (MD 2.12, 95% CI 1.48 to 2.75; p<0.01). Meta-analysis also showed acupuncture in conjunction with nimodipine significantly improved MMSE scores (MD 1.09, 95% CI 0.29 to 1.89; p<0.01) compared to nimodipine alone. Three trials reported adverse events. Methodological quality of the included studies was judged to be generally poor. Conclusions Acupuncture appears effective for AMCI when used as an alternative or adjunctive treatment; however, caution must be exercised given the low methodological quality of included trials. Further, more rigorously designed studies are needed.

Comparative efficacy and acceptability of psychotherapies for panic disorder with or without agoraphobia: systematic review and network meta-analysis of randomised controlled trials

2021 ◽  
pp. 1-13
Author(s):  
Davide Papola ◽  
Giovanni Ostuzzi ◽  
Federico Tedeschi ◽  
Chiara Gastaldon ◽  
Marianna Purgato ◽  
...  
Keyword(s):  
Systematic Review ◽  
Panic Disorder ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Psychodynamic Therapy ◽  
Controlled Trials ◽  
First Line ◽  
Short Term ◽  
Randomised Controlled

Background Psychotherapies are the treatment of choice for panic disorder, but which should be considered as first-line treatment is yet to be substantiated by evidence. Aims To examine the most effective and accepted psychotherapy for the acute phase of panic disorder with or without agoraphobia via a network meta-analysis. Method We conducted a systematic review and network meta-analysis of randomised controlled trials (RCTs) to examine the most effective and accepted psychotherapy for the acute phase of panic disorder. We searched MEDLINE, Embase, PsycInfo and CENTRAL, from inception to 1 Jan 2021 for RCTs. Cochrane and PRISMA guidelines were used. Pairwise and network meta-analyses were conducted using a random-effects model. Confidence in the evidence was assessed using Confidence in Network Meta-Analysis (CINeMA). The protocol was published in a peer-reviewed journal and in PROSPERO (CRD42020206258). Results We included 136 RCTs in the systematic review. Taking into consideration efficacy (7352 participants), acceptability (6862 participants) and the CINeMA confidence in evidence appraisal, the best interventions in comparison with treatment as usual (TAU) were cognitive–behavioural therapy (CBT) (for efficacy: standardised mean differences s.m.d. = −0.67, 95% CI −0.95 to −0.39; CINeMA: moderate; for acceptability: relative risk RR = 1.21, 95% CI −0.94 to 1.56; CINeMA: moderate) and short-term psychodynamic therapy (for efficacy: s.m.d. = −0.61, 95% CI −1.15 to −0.07; CINeMA: low; for acceptability: RR = 0.92, 95% CI 0.54–1.54; CINeMA: moderate). After removing RCTs at high risk of bias only CBT remained more efficacious than TAU. Conclusions CBT and short-term psychodynamic therapy are reasonable first-line choices. Studies with high risk of bias tend to inflate the overall efficacy of treatments. Results from this systematic review and network meta-analysis should inform clinicians and guidelines.

scholarly journals The Effect of Vitamin D Supplementation on Glycaemic Control in Women with Gestational Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomised Controlled Trials

2019 ◽  
Vol 16 (10) ◽  
pp. 1716 ◽  
Author(s):  
Omorogieva Ojo ◽  
Sharon M. Weldon ◽  
Trevor Thompson ◽  
Elisabeth J. Vargo
Keyword(s):  
Diabetes Mellitus ◽  
Vitamin D ◽  
Glycaemic Control ◽  
Gestational Diabetes ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Vitamin D Supplementation ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Randomised Controlled

Vitamin D deficiency is highly prevalent amongst pregnant women and is linked to a range of adverse complications, including gestational diabetes. However, there is no consensus among researchers regarding the impact of vitamin D supplementation in alleviating adverse effects in gestational diabetes. The objective of this systematic review and meta-analysis was to determine whether supplementation of vitamin D given to women with gestational diabetes can promote glycaemic control. EMBASE and PubMed were searched up to November, 2018. The selection criteria included randomised controlled trials of the effect of vitamin D supplementation (1000–4762 IU/day) on pregnant women with gestational diabetes mellitus. Study data and outcome measures (fasting blood glucose, glycated haemoglobin and serum insulin) were extracted from included studies. Random-effects models were used for meta-analyses. Heterogeneity tests, and analysis of the risk of bias were conducted. Most of the studies were graded as having either low risk or moderate risk of bias although two studies had a high risk of bias in the areas of blinding of participants and personnel, and incomplete outcome data. On the other hand, the heterogeneity statistic (I2) ranged from 0–41% in the studies included. Five randomised controlled trials were selected for this review and meta-analysis (involving a total of 173 participants supplemented with vitamin D and 153 participants as control drawn from the studies). Vitamin D supplementation was associated with a decrease in fasting blood glucose by a mean of 0.46 mmol/L (−0.68, −0.25) (p < 0.001), glycated haemoglobin by a mean of 0.37% (−0.65, −0.08) (p < 0.01) and serum insulin concentration by mean of 4.10 µIU/mL (−5.50, −2.71) (p < 0.001) compared to controls. This review shows evidence that vitamin D supplementation has the potential to promote glycaemic control in women with Gestational Diabetes Mellitus (GDM). However, due to the limited number of studies in the meta-analysis, the conclusion should be interpreted with caution. Further studies are needed to fully understand the exact mechanism by which vitamin D influences glucose metabolism.

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