A systematic review and meta-analysis of the safety of Hydroxychloroquine in a randomized controlled trial and observational studies

2021 ◽  
Vol 16 ◽  
Author(s):  
Mahanjit Konwar ◽  
Miteshkumar Maurya ◽  
Urmila M. Thatte ◽  
Nithya J. Gogtay ◽  
Debdipta Bose
Keyword(s):  
Systematic Review ◽  
Active Treatment ◽  
Observational Studies ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Random Effect ◽  
Safety Data ◽  
Total Sample ◽  
Randomized Controlled ◽  
Newcastle Ottawa Scale

Introduction: Hydroxychloroquine (HCQ) has recently become the focus of attention in the current COVID-19 pandemic. With an increase in the off-label use of HCQ, concern for the safety of HCQ has been raised. We, therefore, performed this systematic review to analyze the safety data of HCQ against placebo and active treatment in various disease conditions. Methods: We searched PubMed, Embase, and Cochrane for Randomized Controlled trials (RCTs) and Observational studies (OSs) that evaluated HCQ for the treatment of any disease other than COVID19 in adult patients up to May 2020. We assessed the quality of the included studies using Risk of Bias 2 (for RCTs) and Newcastle–Ottawa Scale (for OSs). Data were analyzed with random-effect meta-analysis. Sensitivity and subgroup analyses were performed to identify heterogeneity. Results: A total of 6641 studies were screened, and 49 studies (40 RCTs and 9 OSs) with a total sample size of 35044 patients were included. The use of HCQ was associated with higher risks of TDAEs as compared to placebo/no active treatment [RR 1.47, 95%CI 1.03-2.08]. When HCQ was compared with active treatments, the risks of AEs [RR 0.74, 95% CI 0.63-0.86] and TDAEs were less in the HCQ arm [RR 0.57, 95% CI 0.39-0.81]. The outcomes did not differ in the sensitivity analysis. Conclusion: The results suggest that the use of HCQ was associated with a lower risk of AEs and TDAEs as compared to active treatment, whereas posing higher risk of TDAEs as compared to placebo.

Changing evidence over time: updated meta-analysis regarding anti-TNF efficacy in childhood chronic uveitis

Rheumatology ◽  
2020 ◽  
Author(s):  
Ilaria Maccora ◽  
Eleonora Fusco ◽  
Edoardo Marrani ◽  
Athimalaipet V Ramanan ◽  
Gabriele Simonini
Keyword(s):  
Observational Studies ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Pooled Analysis ◽  
Primary Outcome Measure ◽  
Systemic Steroid ◽  
Biologic Treatment ◽  
Chronic Uveitis ◽  
Randomized Controlled

Abstract Objective To summarize evidence regarding efficacy of anti-TNFα in childhood chronic uveitis, refractory to common DMARDs. Methods An updated systematic search was conducted between November 2012 and January 2020. Studies investigating the efficacy of anti-TNFα therapy, in children of ages <16 years, as the first biologic treatment for childhood chronic uveitis, refractory to topical and/or systemic steroid and at least one DMARD were eligible for inclusion. The primary outcome measure was the improvement of intraocular inflammation according to Standardization of Uveitis Nomenclature Working Group criteria. A combined estimate of the proportion of children responding to etanercept (ETA), infliximab (INF), and adalimumab (ADA) was determined. Results We identified 1677 articles of which 37 articles were eligible. Three were randomized controlled trials, one on ETA and two on ADA, and were excluded from pooled analysis. From the observational studies, a total of 487 children were identified: 226 received ADA, 213 INF and 48 ETA. The proportion of responding children was 86% (95% CI: 76%, 95%) for ADA, 68% (95% CI: 50%, 85%) for INF and 36% (95% CI: 9%, 67%) for ETA. Pooled analysis showed clear differences (χ2 = 32.2, P < 0.0001): ADA and INF were both significantly superior to ETA (χ2 = 26.8, P < 0.0001, and χ2 = 7.41, P < 0.006, respectively), ADA significantly superior to INF (χ2 = 13.4, P < 0.0002). Conclusion This meta-analysis, consistent with recent randomized controlled trial data, suggests the efficacy of ADA and INF in childhood chronic uveitis treatment. However, ADA results were superior to those of INF in this clinical setting.

scholarly journals Diet quality during preconception or pregnancy and gestational weight gain: protocol for a systematic review and meta-analysis

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e033130
Author(s):  
Yamei Yu ◽  
Isabelle Hardy ◽  
Wenguang Sun ◽  
Dean A Fergusson ◽  
William Fraser ◽  
...  
Keyword(s):  
Systematic Review ◽  
Weight Gain ◽  
Gestational Weight Gain ◽  
Diet Quality ◽  
Meta Analysis ◽  
Random Effect ◽  
Primary Data ◽  
Gestational Weight ◽  
Newcastle Ottawa Scale ◽  
Scientific Meetings

IntroductionInappropriate gestational weight gain (GWG), including inadequate and excessive GWG, has become pandemic across nations and continents. This review aims to synthesise the evidence on the correlation between diet quality and GWG. If this association is confirmed, improving diet quality could become an intervention target in the efforts to reduce inappropriate GWG.Methods and analysisWe will conduct a systematic review of all prospective cohort studies on diet quality in preconception or pregnancy and GWG. Our secondary outcomes include gestational diabetes, pre-eclampsia and birth weight. A comprehensive search of all published articles in MEDLINE ALL (Ovid), Embase (Ovid), Food Science and Technology Abstracts (Ovid) and CINAHL (EBSCOHost), from database creation to 20 April 2019, will be conducted. Studies will be screened for eligibility by title, abstract and full text in duplicate by two independent reviewers. Study quality and risk of bias will be assessed using the adapted Newcastle–Ottawa Scale. Results will be reported following the meta-analysis of observational studies in epidemiology guidelines. If sufficient data are available, a meta-analysis will be conducted to synthesise the effect size reported as OR with 95% CI using both fixed-effect and random-effect models. I2 statistics and visual inspection of the forest plots will be used to assess heterogeneity and identify the potential sources of heterogeneity. Publication bias will be assessed by visual inspections of funnel plots and Egger’s test.Ethics and disseminationFormal ethical approval is not required as no primary data will be collected. We aim to publish the results of this study in a peer-reviewed journal and present them at conferences and scientific meetings to promote knowledge transfer.PROSPERO registration numberCRD42019128732

scholarly journals Anaphylactic and nonanaphylactic reactions to SARS-CoV-2 vaccines: a systematic review and meta-analysis

2021 ◽  
Vol 17 (1) ◽  
Author(s):  
Saad Alhumaid ◽  
Abbas Al Mutair ◽  
Zainab Al Alawi ◽  
Ali A. Rabaan ◽  
Raghavendra Tirupathi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Case Series ◽  
Incidence Rates ◽  
Effect Sizes ◽  
Cross Sectional ◽  
Randomized Controlled ◽  
Pooled Prevalence ◽  
History Of

Abstract Background Currently there is no systematic review and meta-analysis of the global incidence rates of anaphylactic and nonanaphylactic reactions to SARS-CoV-2 vaccines in the general adult population. Objectives To estimate the incidence rates of anaphylactic and nonanaphylactic reactions after COVID-19 vaccines and describe the demographic and clinical characteristics, triggers, presenting signs and symptoms, treatment and clinical course of confirmed cases. Design A systematic review and meta-analysis. Preferred Reporting Items for Systematic Reviews and Meta-Analyses [PRISMA] statement was followed. Methods Electronic databases (Proquest, Medline, Embase, Pubmed, CINAHL, Wiley online library, and Nature) were searched from 1 December 2020 to 31 May 2021 in the English language using the following keywords alone or in combination: anaphylaxis, non-anaphylaxis, anaphylactic reaction, nonanaphylactic reaction, anaphylactic/anaphylactoid shock, hypersensitivity, allergy reaction, allergic reaction, immunology reaction, immunologic reaction, angioedema, loss of consciousness, generalized erythema, urticaria, urticarial rash, cyanosis, grunting, stridor, tachypnoea, wheezing, tachycardia, abdominal pain, diarrhea, nausea, vomiting and tryptase. We included studies in adults of all ages in all healthcare settings. Effect sizes of prevalence were pooled with 95% confidence intervals (CIs). To minimize heterogeneity, we performed sub-group analyses. Results Of the 1,734 papers that were identified, 26 articles were included in the systematic review (8 case report, 5 cohort, 4 case series, 2 randomized controlled trial and 1 randomized cross-sectional studies) and 14 articles (1 cohort, 2 case series, 1 randomized controlled trial and 1 randomized cross-sectional studies) were included in meta-analysis. Studies involving 26,337,421 vaccine recipients [Pfizer-BioNTech (n = 14,505,399) and Moderna (n = 11,831,488)] were analyzed. The overall pooled prevalence estimate of anaphylaxis to both vaccines was 5.0 (95% CI 2.9 to 7.2, I2 = 81%, p =  < 0.0001), while the overall pooled prevalence estimate of nonanaphylactic reactions to both vaccines was 53.9 (95% CI 0.0 to 116.1, I2 = 99%, p =  < 0.0001). Vaccination with Pfizer-BioNTech resulted in higher anaphylactic reactions compared to Moderna (8.0, 95% CI 0.0 to 11.3, I2 = 85% versus 2.8, 95% CI 0.0 to 5.7, I2 = 59%). However, lower incidence of nonanaphylactic reactions was associated with Pfizer-BioNTech compared to Moderna (43.9, 95% CI 0.0 to 131.9, I2 = 99% versus 63.8, 95% CI 0.0 to 151.8, I2 = 98%). The funnel plots for possible publication bias for the pooled effect sizes to determine the incidence of anaphylaxis and nonanaphylactic reactions associated with mRNA COVID-19 immunization based on mRNA vaccine type appeared asymmetrical on visual inspection, and Egger’s tests confirmed asymmetry by producing p values < 0.05. Across the included studies, the most commonly identified risk factors for anaphylactic and nonanaphylactic reactions to SARS-CoV-2 vaccines were female sex and personal history of atopy. The key triggers to anaphylactic and nonanaphylactic reactions identified in these studies included foods, medications, stinging insects or jellyfish, contrast media, cosmetics and detergents, household products, and latex. Previous history of anaphylaxis; and comorbidities such as asthma, allergic rhinitis, atopic and contact eczema/dermatitis and psoriasis and cholinergic urticaria were also found to be important. Conclusion The prevalence of COVID-19 mRNA vaccine-associated anaphylaxis is very low; and nonanaphylactic reactions occur at higher rate, however, cutaneous reactions are largely self-limited. Both anaphylactic and nonanaphylactic reactions should not discourage vaccination.

scholarly journals A Systematic Review and Meta-Analysis of Randomized Controlled Trials Comparing the Safety of Dapagliflozin in Type 1 Diabetes Patients

2020 ◽  
Author(s):  
Sumanta Saha ◽  
Sujata Saha
Keyword(s):  
Systematic Review ◽  
Type 1 Diabetes ◽  
Side Effects ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Random Effect ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Randomized Controlled

Background and Purpose: The dapagliflozin’s safety profile in insulin-treated adult type-1 diabetes mellites (T1DM) patients remains poorly explored. Therefore, this systematic review and meta-analysis compared the risk of all-cause side effects, study discontinuation of participants due to side effects, urinary tract infection (UTI), diabetic ketoacidosis, and hypoglycemia between dapagliflozin 10 mg and dapagliflozin 5 mg, dapagliflozin 10 mg and placebo, and dapagliflozin 5 mg and placebo.Materials and Methods: Parallel-arm randomized controlled trials juxtaposing the above outcomes between the afore-mentioned interventions were eligible for inclusion in this study and were searched in PubMed, Embase, and Scopus. Utilizing the Cochrane tool, the risk of bias was assessed in the recruited trials. Finally, by random-effect meta-analysis, each outcome was compared among the above interventions, and the risk ratio was estimated.Results: Four trials of varying length (1-52 weeks) sourcing data from almost 1760 participants from about 32 nations were reviewed. Overall, the trials had a low or unclear risk of bias, and only one was at a high risk of bias.  Compared to the placebo, the risk of side effects was higher in those treated with dapagliflozin 5 mg (RR=1.10; 95% CI=1.02-1.18; p=0.014; I2=0%). UTI risk was less with the 10mg dapagliflozin than its lower dose (RR=0.50; 95% CI=0.32-0.79; p-value=0.003; I2=0%). All the remaining comparisons were statistically not significantly different between the juxtaposed intervention pairs.Conclusion: In contrast to placebo, dapagliflozin 5mg increased the risk of overall adversities in insulin-treated type-1 diabetes, and dapagliflozin 10 mg had a reduced risk of UTI than its 5mg preparation.

scholarly journals The Effect of Probiotics or Synbiotics on the Hypertensive Disorders of Pregnant Women with Gestational Diabetes: A Systematic Review and Meta-analysis

2021 ◽  
Author(s):  
Rouhina Movaghar ◽  
Azizeh Farshbaf-Khalili ◽  
khadijeh Hajizade ◽  
Mehdi Ebrahimpour MirzaRezaei ◽  
Mahnaz Shahnazi
Keyword(s):  
Systematic Review ◽  
Blood Pressure ◽  
Gestational Diabetes ◽  
Pregnancy Outcomes ◽  
Meta Analysis ◽  
Total Sample ◽  
Randomized Controlled ◽  
Hypertensive Disorders ◽  
Inflammatory Drugs ◽  
Synbiotic Supplementation

AbstractIntroduction:Antioxidants and anti-inflammatory drugs have been suggested to treat preeclampsia. This systematic review and meta-analysis was conducted to investigate the efficacy of probiotic or synbiotic supplementation on hypertensive disorders in women with gestational diabetes mellitus (GDM).Methods:The databases including Cochrane, Embase, Ovid, ProQuest, Scopus, Web of Science, and PubMed were systematically searched for collecting the randomized controlled trials (RCTs) investigating the efficacy of probiotic or synbiotic supplementation versus placebo on hypertensive disorders and pregnancy outcomes in GDM until July 2020.Results:Five RCTs with a total sample size of 402 women were included in the meta-analysis. There was no significant decline in systolic blood pressure (standardized mean difference [SMD] = -3.41, 95% confidence interval [CI] = -8.32 to 1.50, P = 0.17), diastolic blood pressure (SMD = -5.11, 95% CI = -14.20 to -3.98, P = 0.27), preeclampsia (odds ratio [OR] = 1.56, 95% CI = 0.61 to 3.98, P = 0.35), cesarean section (OR = 0.52, 95% CI = 0.18 to 1.50, P = 0.23), and macrosomia (OR = 0.81, 95% CI = 0.41 to 1.57, P = 0.53). No significant increase was observed in terms of 5-minute Apgar (SMD = 0.16, 95% CI = -0.06 to 0.39, P = 0.15, I2= 0%), birth weight (SMD = -0.18, 95% CI = -0.43 to 0.06, P = 0.13, I2= 0%), and gestational age (SMD = 0.13, 95% CI = -0.11 to 0.37, P = 0.28, I2= 0%).Conclusion:Probiotic or synbiotic supplements are not associated with significant effects on pregnancy outcomes in GDM. However, due to the limited number of studies in this regard and heterogeneity between studies, future high-quality RCTs are recommended.

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