scholarly journals Efficacy and safety of cyclosporine in the management of coronavirus disease 2019: A protocol for systematic review and meta-analysis

Author(s):  
Ibtihal Abdallah ◽  
Mohamed Aabdien ◽  
Mohammed Danjuma

Introduction Cyclosporine may improve the clinical course and outcomes of Coronavirus disease 2019 (COVID-19) due to its antiviral and anti-cytokine effects as shown in vitro. A few ongoing trials are exploring the benefit of adding it to the standard of care (SOC) of COVID-19 patients. Objectives The primary objective is to evaluate the severity of COVID-19, determined by oxygen saturation, intensive care unit (ICU) admission, or the World Health Organization COVID-19 clinical severity scale in patients treated with oral or intravenous cyclosporine added to SOC compared SOC alone or placebo. Secondary objectives include mortality, length of hospitalization, length of ICU stay, and laboratory measurements as well as the safety outcomes of cyclosporine. Methodology A systematic review and meta-analysis of randomized clinical trials and observational studies that compared cyclosporine to placebo or SOC in COVID-19 patients will be conducted. PubMed, EMBASE, Web of Science, Cochrane Central Register of Controlled Trials, Google Scholar, and ClinicalTrials.gov will be explored for studies that satisfy pre-specified inclusion criteria. Quality assessment of all included studies will be performed. Meta-analyses will be done utilizing random effect models to estimate the effect of cyclosporine on the severity of COVID-19. Heterogeneity will be assessed utilizing Q statistics. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be followed. Results The result of this synthesis will inform potential changes in the management of COVID-19 patients, especially regarding the role of calcineurin inhibitors. Additionally, it will serve as hypothesis generating for potential future prospective studies.

2015 ◽  
Vol 2015 ◽  
pp. 1-10 ◽  
Author(s):  
Yun-Jung Choi

Objectives. This study was conducted to review systematically adjunctive treatments for weight reduction in patients with schizophrenia and compare efficacies of clinical trials through meta-analysis, so as to provide effective clinical guideline regarding weight control for patients taking atypical antipsychotics.Methods. Candidate clinical trials were identified through searching the Cochrane Central Register of Controlled Trials, PubMed, and PsycINFO. Fourteen randomized clinical trials were included for systematic review and meta-analysis from 132 potential trials. The Comprehensive Meta-Analysis version 2 was used for meta-analysis.Results. Difference in means and significances from meta-analyses regarding weight control by adjunctive treatments showed that topiramate, aripiprazole, or sibutramine was more effective than metformin or reboxetine. Psychiatric evaluations did not show statistically significant changes between treatment groups and placebo groups except topiramate adjunctive treatments. Adverse effects regarding adjunctive therapies were tolerable and showed statistically no significances compared to control groups.Conclusion. Though having several reports related to exacerbation of psychiatric symptoms, topiramate and aripiprazole are more efficacious than other medications in regard to weight reduction and less burden of critical adverse effects as well as being beneficial for clinical improvement.


2021 ◽  
Author(s):  
TG Savian ◽  
J Oling ◽  
FZM Soares ◽  
RO Rocha

Clinical Relevance Vital bleaching impairs the bonding of adhesive systems to enamel and dentin. Thus, restoration placement should be delayed for at least two weeks after completion of bleaching procedures. SUMMARY Objective: This systematic review evaluates the influence of vital bleaching on the bond strength of adhesive systems to enamel and dentin. Methods: This review was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA). In vitro studies comparing the bond strength of bleached and unbleached enamel and dentin were searched at the electronic databases—PubMed/MEDLINE, Scopus, and Web of Science—with no limit on year or language. The studies were screened and had data extracted by two reviewers independently. Bond strength data were meta-analyzed using the inverse variance method and the random effect model (p≤0.05). Results: The electronic search provided 4941 eligible studies, and 52 were included in the systematic review and the meta-analysis. The global meta-analysis showed that bleaching impairs the bond strength of adhesive systems to enamel and dentin (p<0.001; mean difference [MD]: –0.96; confidence interval [CI]: −1.18 to −0.73), regardless of the bleaching agent (p<0.001; MD: −9.98; CI: −1.37 to −0.58) or substrate (p<0.001; MD: −0.89; CI: −1.12 to −0.66). The detrimental effect of bleaching on bond strength was not observed after two and three weeks after bleaching (p=0.1; MD: −0.39; CI: −0.84 to 0.65; and p=0.18; MD: −0.99; CI: −2.45 to 0.47, respectively). Conclusion: This systematic review and meta-analysis demonstrated that vital bleaching impairs the bonding of adhesive systems to enamel and dentin, and this adverse effect persists for two weeks.


BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e018556 ◽  
Author(s):  
Madhu Wagle ◽  
Francesco D’Antonio ◽  
Eirik Reierth ◽  
Purusotam Basnet ◽  
Tordis A Trovik ◽  
...  

ObjectivesThe primary objective of this systematic review was to evaluate the association between dental caries and preterm birth (PTB). The secondary objective was ascertaining the difference between women with dental caries who experienced PTB and those who did not with regard to decayed, missing and filled teeth (DMFT), and decayed, missing and filled surfaces (DMFS) indices.MethodsMEDLINE, Embase, CINAHL and Cochrane databases were searched initially in November 2015 and repeated in December 2016. We included observational cohort and case–control studies. Only studies reporting the risk of PTB in women affected compared with those not affected by dental caries in pregnancy were included. Random-effect meta-analyses were used to compute the summary OR of PTB among women with caries versus women without caries, and the mean difference in either DMFT or DMFS indices between women experiencing PTB and those without PTB.ResultsNine observational studies (4826 pregnancies) were included. Women affected by dental caries during pregnancy did not show a significantly higher risk of PTB (OR: 1.16, 95% CI 0.90 to 1.49, P=0.25, I2=35%). Also, the women with PTB did not show significantly higher DMFT or DMFS indices (summary mean differences: 1.56, P=0.10; I2=92% and −0.15, P=0.9, I2=89%, respectively).ConclusionDental caries does not appear to be a substantial risk factor for PTB.Trial registration numberNCT01675180; Pre-results.


2020 ◽  
Vol 21 (14) ◽  
pp. 4982 ◽  
Author(s):  
Pietro Gentile ◽  
Aris Sterodimas ◽  
Jacopo Pizzicannella ◽  
Laura Dionisi ◽  
Domenico De Fazio ◽  
...  

Stromal vascular fraction (SVF) containing adipose stem cells (ASCs) has been used for many years in regenerative plastic surgery for autologous applications, without any focus on their potential allogenic role. Allogenic SVF transplants could be based on the possibility to use decellularized extracellular matrix (ECM) as a scaffold from a donor then re-cellularized by ASCs of the recipient, in order to develop the advanced therapy medicinal products (ATMP) in fully personalized clinical approaches. A systematic review of this field has been realized in accordance with the Preferred Reporting for Items for Systematic Reviews and Meta-Analyses-Protocols (PRISMA-P) guidelines. Multistep research of the PubMed, Embase, MEDLINE, Pre-MEDLINE, PsycINFO, CINAHL, Clinicaltrials.gov, Scopus database, and Cochrane databases has been conducted to identify articles and investigations on human allogenic ASCs transplant for clinical use. Of the 341 articles identified, 313 were initially assessed for eligibility on the basis of the abstract. Of these, only 29 met all the predetermined criteria for inclusion according to the PICOS (patients, intervention, comparator, outcomes, and study design) approach, and 19 have been included in quantitative synthesis (meta-analysis). Ninety-one percent of the studies previously screened (284 papers) were focused on the in vitro results and pre-clinical experiments. The allogenic use regarded the treatment of perianal fistulas, diabetic foot ulcers, knee osteoarthritis, acute respiratory distress syndrome, refractory rheumatoid arthritis, pediatrics disease, fecal incontinence, ischemic heart disease, autoimmune encephalomyelitis, lateral epicondylitis, and soft tissue defects. The information analyzed suggested the safety and efficacy of allogenic ASCs and ECM transplants without major side effects.


2021 ◽  
pp. 003435522110432
Author(s):  
Areum Han

Objective: Mindfulness- and acceptance-based intervention (MABI) is an emerging evidenced-based practice, but no systematic review incorporating meta-analyses for MABIs in stroke survivors has been conducted. The objective of this systematic review was to measure the effectiveness of MABIs on outcomes in people with stroke. Method: Three electronic databases, including PubMed, CINAHL, and PsycINFO, were searched to identify relevant studies published in peer-reviewed journals. The methodological quality of the included studies was assessed. Data were extracted and combined in a meta-analysis with a random-effect model to compute the size of the intervention effect. Results: A total of 11 studies met the eligibility criteria. Meta-analyses found a small-to-moderate effect of MABIs on depressive symptoms (standardized mean difference [SMD] = 0.39, 95% confidence interval [CI] = [0.12, 0.66]) and a large effect on mental fatigue (SMD = 1.22, 95% CI = [0.57, 1.87]). No statistically significant effect of MABIs on anxiety, quality of life, and mindfulness was found, but there was a trend in favor of MABIs overall. Conclusions: This meta-analysis found positive effects of MABIs on depressive symptoms and mental fatigue in stroke survivors, but future high-quality studies are needed to guarantee treatment effects of MABIs on varied outcomes in stroke survivors.


Hand ◽  
2021 ◽  
pp. 155894472110432
Author(s):  
Emily M. Graham ◽  
Jeremie D. Oliver ◽  
Russell Hendrycks ◽  
Dino Maglic ◽  
Shaun D. Mendenhall

Background The Pulvertaft weave technique (PT) is frequently used during tendon repairs and transfers. However, this technique is associated with limitations. In this systematic review and meta-analysis, quantitative and qualitative analyses were performed on in vitro, biomechanical studies that compared the PT with alternative techniques. Methods Articles included for qualitative and/or qualitative analysis were identified following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies included in the meta-analysis were analyzed either as continuous data with inverse variance and random effects or as dichotomous data using a Mantel-Haenszel analysis assuming random effects to calculate an odds ratio. Results A comprehensive electronic search yielded 8 studies meeting inclusion criteria for meta-analysis. Two studies with a total of 65 tendon coaptations demonstrated no significant difference in strength between the PT and traditional side-to-side (STS) techniques ( P = .92). Two studies with a total of 43 tendon coaptations showed that the STS with 1 weave has a higher yield strength than the PT ( P = .03). Two studies with a total of 62 tendon repairs demonstrated no significant difference in strength between the PT and the step-cut (SC) techniques ( P = .70). The final 2 studies included 46 tendon repairs and demonstrated that the wrap around (WA) technique has a higher yield strength than the PT ( P < .001). Conclusions The STS, SC, and WA techniques are preferred for improving tendon form. The STS and WA techniques have superior yield strengths than the PT, and the SC technique withstands similar stress to failure as the PT.


2021 ◽  
Vol 26 (1) ◽  
Author(s):  
Gbadebo Collins Adeyanju ◽  
Elena Engel ◽  
Laura Koch ◽  
Tabea Ranzinger ◽  
Imtiaz Bin Mohammed Shahid ◽  
...  

Abstract Background Pregnant women are at high risk for severe influenza. However, maternal influenza vaccination uptake in most World Health Organization (WHO) European Region countries remains low, despite the presence of widespread national recommendations. An influenza vaccination reduces influenza-associated morbidity and mortality in pregnancy, as well as providing newborns with protection in their first months. Potential determinants of vaccine hesitancy need to be identified to develop strategies that can increase vaccine acceptance and uptake among pregnant women. The primary objective of the systematic review is to identify the individual determinants of influenza vaccine hesitancy among pregnant women in Europe, and how to overcome the hesitancy. Methods Databases were searched for peer-reviewed qualitative and quantitative studies published between 2009 and 2019 inclusive. Databases included PubMed via MEDLINE, Cochrane Central Register for Controlled Trials, PsycINFO, SAGE Journals, Taylor and Francis and Springer nature. These covered themes including psychology, medicine, and public health. Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) approach, 11 studies were eligible and analyzed for significant determinants of influenza vaccine hesitancy among pregnant women in Europe. Results The most commonly reported factors were psychological aspects, for example concerns about safety and risks to mother and child, or general low risk perception of becoming ill from influenza. Doubts about the effectiveness of the vaccine and a lack of knowledge about this topic were further factors. There was also influence of contextual factors, such as healthcare workers not providing adequate knowledge about the influenza vaccine or the pregnant lady stating their antivaccine sentiment. Conclusion Health promotion that specifically increases knowledge among pregnant women about influenza and vaccination is important, supporting a valid risk judgment by the pregnant lady. The development of new information strategies for dialogue between healthcare providers and pregnant women should form part of this strategy.


2020 ◽  
Vol 9 (1) ◽  
Author(s):  
Steven Kwasi Korang ◽  
Sophie Juul ◽  
Emil Eik Nielsen ◽  
Joshua Feinberg ◽  
Faiza Siddiqui ◽  
...  

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


2019 ◽  
Vol 8 (1) ◽  
Author(s):  
James D. Millard ◽  
Elizabeth A. Mackay ◽  
Laura J. Bonnett ◽  
Geraint R. Davies

Abstract Background Pyrazinamide (PZA) is a key component of current and future regimens for tuberculosis (TB). Inclusion of PZA at higher doses and for longer durations may improve efficacy outcomes but must be balanced against the potential for worse safety outcomes. Methods We will search for randomised and quasi-randomised clinical trials in adult participants with and without the inclusion of PZA in TB treatment regimens in the Cochrane infectious diseases group’s trials register, Cochrane central register of controlled trials (CENTRAL), MEDLINE, EMBASE, LILACS, the metaRegister of Controlled Trials (mRCT) and the World Health Organization (WHO) international clinical trials registry platform. One author will screen abstracts and remove ineligible studies (10% of which will be double-screened by a second author). Two authors will review full texts for inclusion. Safety and efficacy data will be extracted to pre-piloted forms by one author (10% of which will be double-extracted by a second author). The Cochrane risk of bias tool will be used to assess study quality. The study has three objectives: the association of (1) inclusion, (2) dose and (3) duration of PZA with efficacy and safety outcomes. Risk ratios as relative measures of effect for direct comparisons within trials (all objectives) and proportions as absolute measures of effect for indirect comparisons across trials (for objectives 2 and 3) will be calculated. If there is insufficient data for direct comparisons within trials for objective 1, indirect comparisons between trials will be performed. Measures of effect will be pooled, with corresponding 95% confidence intervals and p values. Meta-analysis will be performed using the generalised inverse variance method for fixed effects models (FEM) or the DerSimonian-Laird method for random effects models (REM). For indirect comparisons, meta-regression for absolute measures against dose and duration data will be performed. Heterogeneity will be quantified through the I2-statistic for direct comparisons and the τ2 statistic for indirect comparisons using meta-regression. Discussion The current use of PZA for TB is based on over 60 years of clinical trial data, but this has never been synthesised to guide rationale use in future regimens and clinical trials. Systematic review registration: International Prospective Register of Systematic Reviews (PROSPERO) CRD42019138735


2020 ◽  
pp. 106002802096445
Author(s):  
Enrica Di Martino ◽  
Alessio Provenzani ◽  
Patrizio Vitulo ◽  
Piera Polidori

Background: The comparative efficacy of pirfenidone, nintedanib, and pamrevlumab in slowing the rate of forced vital capacity (FVC) decline and mortality in patients with idiopathic pulmonary fibrosis (IPF) is unknown. Objective: To perform a systematic review and meta-analysis (MA) of these drugs for IPF. Methods: We searched CENTRAL, PubMed, EMBASE, ClincalTrials.gov, and the World Health Organization’s registry databases up to March 2020. Phase II/III randomized controlled trials in adults with IPF were eligible. The random-effect model was implemented calculating the effect size and respective 95% CI as Cohen’s d for change from baseline FVC (in percentage predicted and liters) and odds ratio (OR) for 10% reduction in FVC and all-cause mortality (ACM). Results: Six studies were included in the MA. For change from baseline in percentage predicted FVC, the MA indicated that the 3 drugs were more effective than placebo (pirfenidone: d=3.30%, 95% CI=2.15-4.45; nintedanib: d=3.15%, 95% CI=2.35-3.95; pamrevlumab: d=4.30%, 95% CI=0.45-8.15). These results are superimposable to those relating to change from baseline FVC in liters (pirfenidone: d=0.09L, 95% CI=0.04-0.14; nintedanib: d=0.13L, 95% CI=0.10-0.16; pamrevlumab: d=0.20L, 95% CI=0.05-0.35). Each drug had a positive effect on 10% reduction in FVC (pirfenidone: OR=0.57, 95% CI=0.45-0.74; nintedanib: OR=0.66, 95% CI=0.51-0.85; pamrevlumab: OR=0.24, 95% CI=0.08-0.73), but only pirfenidone showed an effect on ACM (OR=0.50; 95% CI=0.31-0.83). Conclusion and Relevance: This MA provided encouraging results on pamrevlumab efficacy in slowing the decline in FVC compared with pirfenidone and nintedanib. Actually, in phase 3, it could become a potential IPF treatment.


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