scholarly journals Oral Pre-exposure prophylaxis (PrEP) to prevent HIV: a systematic review and meta-analysis of clinical effectiveness, safety, adherence and risk compensation in all populations

2021 ◽  
Author(s):  
Eamon O Murchu ◽  
Liam Marshall ◽  
Catherine Hayes ◽  
Patricia Harrington ◽  
Patrick Moran ◽  
...  
Keyword(s):  
Systematic Review ◽  
Sex Workers ◽  
Rate Ratio ◽  
Meta Analysis ◽  
Risk Groups ◽  
Risk Compensation ◽  
Controlled Trials ◽  
List Type ◽  
Serodiscordant Couples ◽  
Exposure Prophylaxis

AbstractBackgroundThe objective of this study was to conduct a systematic review and meta-analysis of randomised controlled trials (RCTs) of the effectiveness and safety of oral Pre-Exposure Prophylaxis (PrEP) to prevent HIV.MethodsDatabases (PubMed, Embase and the Cochrane Register of Controlled Trials) were searched up to 5/7/2020. RCTs were included that compared oral tenofovir-containing PrEP to placebo, no treatment or alternative medication/dosing schedule. The primary outcome was the rate ratio (RR) of HIV infection using a modified intention-to-treat analysis. All analyses were stratified a priori by population: men who have sex with men (MSM), serodiscordant couples, heterosexuals and people who inject drugs (PWID).The quality of individual studies was assessed using the Cochrane Risk-of-Bias tool and the certainty of evidence was assessed using GRADE.ResultsOf 2,803 unique records, 15 RCTs met our inclusion criteria. Over 25,000 participants were included, encompassing 38,289 person-years of follow-up data.PrEP was found to be effective in MSM (Rate Ratio [RR] 0.25, 95% CI: 0.1-0.61; Absolute Rate Difference [ARD] -0.03, 95% CI: -0.01 to -0.05), serodiscordant couples (RR 0.25, 95% CI: 0.14-0.46; ARD -0.01, 95% CI: -0.01 to -0.02) and PWID (RR 0.51, 95% CI: 0.29-0.92; ARD - 0.00, 95% CI: -0.00 to -0.01), but not in heterosexuals (RR 0.77, 95% CI: 0.46-1.29).Efficacy was strongly associated with adherence (p<0.01). PrEP was found to be safe, however unrecognised HIV at enrolment increased the risk of viral drug mutations. Evidence for risk compensation or an increase in STIs was not found.DiscussionPrEP is safe and effective in MSM, serodiscordant couples and PWID. Additional research is needed prior to recommending PrEP in heterosexuals. Data were limited by poor adherence in several studies. No RCTs were identified for other high-risk groups, such as trangender women and sex workers.PROSPERO IDCRD42017065937Article SummaryStrengths and limitations of this studyA systematic review and meta-analysis of RCTs was conducted of the efficacy and safety of oral PrEP to prevent HIV following best practice guidelines (PRISMA guidelines and GRADE framework)Observational studies were excluded from this review, and as such, PrEP effectiveness may be lower in real-world settingsChange in sexual behaviour, or ‘risk compensation’, is difficult to ascertain based on RCT evidence aloneDue to substantial variation in adherence across studies, findings should be interpreted with caution.

scholarly journals Randomized Controlled Trials of Early Ambulatory Hydroxychloroquine in the Prevention of COVID-19 Infection, Hospitalization, and Death: Meta-Analysis

2020 ◽  
Author(s):  
Joseph A. Ladapo ◽  
John E. McKinnon ◽  
Peter A. McCullough ◽  
Harvey Risch
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Side Effects ◽  
Fixed Effects ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Randomized Controlled ◽  
Exposure Prophylaxis

Objective--To determine if hydroxychloroquine (HCQ) reduces the incidence of new illness, hospitalization or death among outpatients at risk for or infected with SARS-CoV-2 (COVID-19). Design--Systematic review and meta-analysis of randomized clinical trials. Data sources--Search of MEDLINE, EMBASE, PubMed, medRxiv, PROSPERO, and the Cochrane Central Register of Controlled Trials. Also review of reference lists from recent meta-analyses. Study selection--Randomized clinical trials in which participants were treated with HCQ or placebo/standard-of-care for pre-exposure prophylaxis, post-exposure prophylaxis, or outpatient therapy for COVID-19. Methods--Two investigators independently extracted data on trial design and outcomes. Medication side effects and adverse reactions were also assessed. The primary outcome was COVID-19 hospitalization or death. When unavailable, new COVID-19 infection was used. We calculated random effects meta-analysis according to the method of DerSimonian and Laird. Heterogeneity between the studies was evaluated by calculation of Cochran Q and I2 parameters. An Egger funnel plot was drawn to investigate publication bias. We also calculated the fixed effects meta-analysis summary of the five studies. All calculations were done in Excel, and results were considered to be statistically significant at a two-sided threshold of P=.05. Results--Five randomized controlled clinical trials enrolling 5,577 patients were included. HCQ was associated with a 24% reduction in COVID-19 infection, hospitalization or death, P=.025 (RR, 0.76 [95% CI, 0.59 to 0.97]). No serious adverse cardiac events were reported. The most common side effects were gastrointestinal. Conclusion--Hydroxychloroquine use in outpatients reduces the incidence of the composite outcome of COVID-19 infection, hospitalization, and death. Serious adverse events were not reported and cardiac arrhythmia was rare. Systematic review registration--This review was not registered.

scholarly journals Efficacy of remdesivir versus placebo for the treatment of COVID-19: A protocol for systematic review and meta-analysis of randomized controlled trials

2020 ◽  
Author(s):  
Desye Gebrie ◽  
Desalegn Getnet ◽  
Tsegahun Manyazewal
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Antiviral Drug ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Significant Heterogeneity ◽  
List Type ◽  
Randomized Controlled

AbstractBackgroundIn spite of the global containment on prevention efforts, the spread of coronavirus disease 2019 (COVID-19) is continuing to rise, with 1.1 million confirmed cases and 60,124 deaths recorded worldwide since 04 April 2020. The outbreak has a significant threat to international health and economy. At present, there is no approved vaccine or treatment for the disease, while efforts are underway. Remdesivir, a nucleotide-analogue antiviral drug developed for Ebola, is determined to prevent and stop infections with COVID-19, while results are yet controversial. Here, we aim to conduct a systematic review and meta-analysis of randomized controlled trials to compare the effectiveness of remdesivir and placebo in patients with COVID-19.Method and analysisWe will search MEDLINE-PubMed, Embase, Cochrane Library, ClinicalTrials.gov, and Google scholar databases without restriction in year of publication. We will include randomized controlled trials that assessed the effectiveness of remdesivir versus placebo for patients confirmed with COVID-19. We will follow the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA 2015) guidelines for the design and reporting of the results. The primary endpoint will be time to clinical recovery. The secondary endpoints will be all cause mortality, discharged date, frequency of respiratory progression, and treatment-emergent adverse events. Two independent authors will perform study selection, data extraction, and methodology quality assessment. RevMan 5.3 software will be used for statistical analysis. Random/fixed effect model will be carried out to calculate mean differences for continuous outcomes and risk ratio for dichotomous outcomes between remdesivir and placebo.Ethics and disseminationThis study does not require ethical approval, because no participant’s data will be involved in this systematic review and meta-analysis. The findings of this study will be published in reputable and peer-reviewed journal.RegistrationThis review protocol is submitted in PROSPERO database for registration and we will include the registration number in the revised version of the manuscript.Strengths and limitations of this study➣This systematic review and meta-analysis will be derived from only randomized controlled trials which will increase the quality of evidences.➣This systematic review and meta-analysis will be derived from only randomized controlled trials which will reduce between study heterogeneity.➣Subgroup and sensitivity analysis will be carried out to identify possible reasons that may cause significant heterogeneity between studies.➣The use of Cochrane risk of bias tool to assess risk of bias for each included studies to extract and synthesize evidence based conclusions.➣One of the limitation of this study might be the restriction of trials published in English language.

scholarly journals Impact of social distancing measures for preventing coronavirus disease 2019 [COVID-19]: A systematic review and meta-analysis protocol

2020 ◽  
Author(s):  
Krishna Regmi ◽  
Cho Mar Lwin
Keyword(s):  
Public Health ◽  
Systematic Review ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
World Health ◽  
Controlled Trials ◽  
List Type ◽  
Social Distancing ◽  
Randomised Controlled ◽  
The Impact

AbstractIntroductionSocial distancing measures (SDMs) protect public health from the outbreak of coronavirus disease 2019 (COVID-19). However, the impact of SDMs has been inconsistent and unclear. This study aims to assess the effects of SDMs (e.g. isolation, quarantine) for reducing the transmission of COVID-19.Methods and analysisWe will conduct a systematic review meta-analysis research of both randomised controlled trials and non-randomised controlled trials. We will search MEDLINE, EMBASE, Allied & Complementary Medicine, COVID-19 Research and WHO database on COVID-19 for primary studies assessing the effects of SDMs (e.g. isolation, quarantine) for reducing the transmission of COVID-19, and will be reported in accordance with PRISMA statement. The PRISMA-P checklist will be used while preparing this protocol. We will use Joanna Briggs Institute guidelines (JBI Critical Appraisal Checklists) to assess the methodological qualities and synthesised performing thematic analysis. Two reviewers will independently screen the papers and extracted data. If sufficient data are available, the random-effects model for meta-analysis will be performed to measure the effect size of SDMs or the strengths of relationships. To assess the heterogeneity of effects, I2 together with the observed effects (Q-value, with degrees of freedom) will be used to provide the true effects in the analysis.Ethics and disseminationEthics approval and consent will not be required for this systematic review of the literature as it does not involve human participation. We will be able to disseminate the study findings using the following strategies: we will be publishing at least one paper in peer-reviewed journals, and an abstract will be presented at suitable national/international conferences or workshops. We will also share important information with public health authorities as well as with the World Health Organization. In addition, we may post the submitted manuscript under review to bioRxiv, medRxiv, or other relevant pre-print servers.Strengths and limitations of this studyTo our knowledge, this study will be the first systematic review to examine the impact of social distancing measures to reduce transmission of COVID-19.This study will offer highest level of evidence for informed decisions, drawing a broader framework.This protocol reduces the possibility of duplication, provides transparency to the methods and procedures that will be used, minimise potential biases and allows peer-review.This research is not externally funded, and therefore time and resource will be constrained.If included studies will be variable in sample size, quality and population, which may open to bias, and the heterogeneity of data will preclude a meaningful meta-analysis to measure the impact of specific SDMs

Acupuncture for Recurrent Headaches: A Systematic Review of Randomized Controlled Trials

Cephalalgia ◽  
1999 ◽  
Vol 19 (9) ◽  
pp. 779-786 ◽  
Author(s):  
D Melchart ◽  
K Linde ◽  
P Fischer ◽  
A White ◽  
G Allais ◽  
...  
Keyword(s):  
Systematic Review ◽  
Rate Ratio ◽  
Large Scale ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Real Life ◽  
Outcome Data ◽  
Responder Rate ◽  
Control Group ◽  
Controlled Trials

Objective: To assess whether there is evidence that acupuncture is effective in the treatment of recurrent headaches. Design: Systematic review. Study selection: Randomized or quasi-randomized clinical trials comparing acupuncture with any type of control intervention for the treatment of recurrent headaches. Data sources: Electronic databases (Medline, Embase, Cochrane Field for Complementary Medicine, Cochrane Controlled Trials Register), personal communications and bibliographies. Data collection and analysis: Information on patients, interventions, methods, and results were extracted by at least two independent reviewers using a pretested form. A pooled estimate of the responder rate ratio (responder rate in treatment group/responder rate in control group) was calculated as a crude indicator of trial results as meta-analysis of more specific outcome data was impossible due to heterogeneity and insufficient reporting. Results: Twenty-two trials, including a total of 1042 patients (median 36, range 10-150), met the inclusion criteria. Fifteen trials were in migraine patients, six in tension-headache patients, and in one trial patients with various headaches were included. The majority of the 14 trials comparing true and sham acupuncture showed at least a trend in favor of true acupuncture. The pooled responder rate ratio was 1.53 (95% confidence interval 1.11 to 2.11). The eight trials comparing acupuncture and other treatment forms had contradictory results. Conclusions: Overall, the existing evidence suggests that acupuncture has a role in the treatment of recurrent headaches. However, the quality and amount of evidence is not fully convincing. There is urgent need for well-planned, large-scale studies to assess effectiveness and efficiency of acupuncture under real life conditions.

scholarly journals Routine Prophylactic Endoscopic Clipping Is Not Efficacious in the Prevention of Delayed Post-Polypectomy Bleeding: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2018 ◽  
Vol 2 (3) ◽  
pp. 105-117 ◽  
Author(s):  
Nauzer Forbes ◽  
Levi Frehlich ◽  
Matthew T James ◽  
Robert J Hilsden ◽  
Gilaad G Kaplan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Fixed Effects ◽  
Randomized Trials ◽  
Meta Analysis ◽  
Risk Groups ◽  
Controlled Trials ◽  
Fixed Effects Model ◽  
Randomized Controlled ◽  
Subgroup Analyses

Abstract Background and Aims Colorectal cancer (CRC) can be prevented through colonoscopic polypectomy, but this exposes patients to risks, including delayed post-polypectomy bleeding (DPPB). Endoscopists increasingly use clips prophylactically with the aim of preventing DPPB. However, clips are costly, and data to support their efficacy in this context are inconsistent. We performed a systematic review and meta-analysis of randomized controlled trials to assess the efficacy of prophylactic clipping for preventing DPPB. Methods We searched electronic databases and other relevant sources for randomized controlled trials assessing the efficacy of prophylactic clipping versus no clipping for the prevention of DPPB. Pooled relative risks were determined using a fixed-effects model. Subgroup analyses were also performed. Results A total of 2305 citations were initially screened. Seven randomized controlled trials satisfied all criteria for inclusion. The quality of included studies was generally low to moderate. A total of 2851 patients underwent 5405 polypectomies. Delayed post-polypectomy bleeding occurred at an overall pooled rate of 2.5%. No overall benefit of clipping for preventing DPPB was observed, with a pooled relative risk of 0.86 (95% confidence interval [CI], 0.55 to 1.36). No significant patient or polyp factors predicting DPPB were found through subgroup analyses. No publication bias was identified. Conclusions Randomized trials to date do not demonstrate a protective effect of prophylactic clipping for the prevention of DPPB, and therefore, the practice of routine prophylactic clipping appears unjustified. Additional high quality randomized trials are required to identify higher-risk groups that may benefit from prophylactic clipping.

Interventions to Reduce Alcohol Harms in Low and Middle Income Countries: a Systematic Review and Meta Analysis

2018 ◽  
Author(s):  
Joao Ricardo Nickenig Vissoci
Keyword(s):  
Systematic Review ◽  
Alcohol Use ◽  
Randomized Controlled Trials ◽  
Brain Stimulation ◽  
Meta Analysis ◽  
World Health ◽  
Controlled Trials ◽  
Middle Income ◽  
Brief Motivational Intervention ◽  
Randomized Controlled

BackgroundHarmful alcohol use leads to a large burden of disease and disability which disportionately impacts LMICs. The World Health Organization and the Lancet have issued calls for this burden to be addressed, but issues remain, primarily due to gaps in information. While a variety of interventions have been shown to be effective at reducing alcohol use in HICs, their efficacy in LMICs have yet to be assessed. This systematic review describes the current published literature on alcohol interventions in LMICs and conducts a meta analysis of clinical trials evaluating interventions to reduce alcohol use and harms in LMICs.MethodsIn accordance with PRISMA guidelines we searched the electronic databases Pubmed, EMBASE, Scopus,Web of Science, Cochrane, and Psych Info. Articles were eligible if they evaluated an intervention targeting alcohol-related harm in LMICs. After a reference and citation analysis, we conducted a quality assessment per PRISMA protocol. A meta-analysis was performed on the 39 randomized controlled trials that evaluated an alcohol-related outcome.ResultsOf the 3,801 articles from the literature search, 87 articles from 25 LMICs fit the eligibility and inclusion criteria. Of these studies, 39 randomized controlled trials were included in the meta-analysis. Nine of these studies focused specifically on medication, while the others focused on brief motivational intervention, brain stimulation, AUDIT-based brief interventions, WHO ASSIST-based interventions, group based education, basic screening and interventions, brief psychological or counseling, dyadic relapse prevention, group counseling, CBT, motivational + PTSD based interview, and health promotion/awareness. Conclusion Issues in determining feasible options specific to LMICs arise from unstandardized interventions, unequal geographic distribution of intervention implementation, and uncertain effectiveness over time. Current research shows that brain stimulation, psychotherapy, and brief motivational interviews have the potential to be effective in LMIC settings, but further feasibility testing and efforts to standardize results are necessary to accurately assess their effectiveness.

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