Systematic Review and Meta-Analysis of Linezolid and Daptomycin for Treatment of Vancomycin-Resistant Enterococcal Bloodstream Infections

ABSTRACTBloodstream infections due to vancomycin-resistant enterococci (VRE-BSI) result in substantial patient mortality and cost. Daptomycin and linezolid are commonly prescribed for VRE-BSI, but there are no clinical trials to determine optimal antibiotic selection. We conducted a systematic review for investigations that compared daptomycin and linezolid for VRE-BSI. We searched Medline from 1966 through 2012 for comparisons of linezolid and daptomycin for VRE-BSI. We included searches of EMBASE, clinicaltrials.gov, and national meetings. Data were extracted using a standardized instrument. Pooled odds ratios (OR) and 95% confidence intervals (95% CI) were calculated using a fixed-effects model. Our search yielded 4,243 publications, of which 482 contained data on VRE treatment. Most studies (452/482) did not present data on BSI or did not provide information on linezolid or daptomycin. Among the remaining 30 studies, 9 offered comparative data between the two agents. None were randomized clinical trials. There was no difference in microbiologic (n= 5 studies, 517 patients; OR, 1.0; 95% CI, 0.4 to 1.7;P= 0.95) and clinical (n= 3 studies, 357 patients; OR, 1.2; 95% CI, 0.7 to 2.0;P= 0.7) cures between the two antibiotics. There was a trend toward increased survival with linezolid compared to daptomycin treatment (n= 9 studies, 1,074 patients; OR, 1.3; 95% CI, 1.1 to 1.8;I2= 0 [whereI2is a measure of inconsistency]), but this did not reach statistical significance (P= 0.054). There are limited data to inform clinicians on optimal antibiotic selection for VRE-BSI. Available studies are limited by small sample size, lack of patient-level data, and inconsistent outcome definitions. Additional research, including randomized clinical trials, is needed before conclusions can be drawn about treatment options for VRE therapy.

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Broccoli and Helicobacter Pylori: A Systematic Review

Complementary Medicine Journal ◽

10.32598/cmja.10.1.440.1 ◽

2020 ◽

Vol 10 (1) ◽

pp. 2-11

Author(s):

Fatemeh Azizi-Soleiman ◽

◽

Maryam Zamanian ◽

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Helicobacter Pylori ◽

Sample Size ◽

Randomized Clinical Trials ◽

Small Sample Size ◽

Small Sample ◽

Animal Testing ◽

H Pylori ◽

Positive Effect

Objective: Pharmacological treatment of Helicobacter pylori (H. pylori) infection is based on the use of at least two antibiotics with a double dose of proton pump inhibitor which results in antibiotic resistance. Anti-helicobacterial activity of sulforaphane-rich broccoli has been evaluated in laboratory studies. This study aimed to systematically review the conducted randomized clinical trials that have examined the effect of broccoli on H. pylori in humans. Methods: This study is a systematic review of randomized clinical trials on the effect of broccoli on H. pylori. The search was conducted in PubMed, OVID, Web of Science, and Scopus databases using the keywords: Helicobacter pylori, broccoli sprouts, H. pylori, randomized clinical trials, and Brassica, without any time limits for studies conducted until 2019. After excluding duplicates, the titles and abstracts of remained articles were evaluated by two researchers and then the related ones were extracted. Next, their full-texts were examined to select the final articles for review. We included clinical trials and excluded those were in the laboratory or animal testing phases or their full-texts were unavailable. Results: Three studies that had met the inclusion criteria were considered for the review. Overall, neither in the articles that reviewed in the present study nor in the articles that did not enter the review process due to unavailability of their full-texts or having a very small sample size, no clear positive effect of broccoli on inhibiting H. pylori infection in humans had been reported. Conclusion: Due to the lack of optimal results from broccoli consumption for the control of H. pylori infection in humans, it is recommended that longer studies with sufficient sample size and appropriate dose of broccoli along with standard treatment be performed in the future.

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Supplementation of Probiotics and Its Effects on Physically Active Individuals and Athletes: Systematic Review

International Journal of Sport Nutrition and Exercise Metabolism ◽

10.1123/ijsnem.2018-0227 ◽

2019 ◽

Vol 29 (5) ◽

pp. 481-492 ◽

Cited By ~ 7

Author(s):

Gabriella Berwig Möller ◽

Maria Júlia Vieira da Cunha Goulart ◽

Bruna Bellincanta Nicoletto ◽

Fernanda Donner Alves ◽

Cláudia Dornelles Schneider

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Randomized Clinical Trials ◽

Small Sample Size ◽

Gastrointestinal Symptoms ◽

Small Sample ◽

Control Group ◽

Probiotic Supplementation ◽

Physically Active ◽

Positive Effects

The aim of this study was to conduct a systematic review of the effects of probiotic supplementation on physically active individuals. The participants, interventions, comparisons, outcome and study design inclusion criteria were (a) studies involving healthy adults or older subjects of both sexes who did physical exercise (including athletes and physically active individuals), (b) interventions with probiotics, (c) inclusion of a control group, (d) outcomes not previously defined, and (e) clinical trials and randomized clinical trials, with no language or date restrictions. The search was conducted in the following scientific databases: MEDLINE, Embase, SciELO, Scopus, and Lilacs. Search terms were “Probiotics” OR “Prebiotics” OR “Microbiota” AND “Exercise” OR “Athletes.” The articles were first screened by title and abstract by two independent reviewers and disagreements resolved by a third reviewer. Data were extracted independently by the same two reviewers; results were extracted in duplicate and then compared to avoid errors. A total of 544 articles were retrieved and 24 were included. A total of 1,680 patients were included, most of them being male (n = 1,134, 67.5%), with a mean age of 30.9 ± 6.1 years. Following probiotic supplementation, positive effects have been reported for several outcomes including respiratory tract infection, immunologic markers, and gastrointestinal symptoms in both athletes and nonathletes. However, published studies have distinct protocols and measured outcomes, and some of them have small sample size and failed to prove beneficial effect on probiotic supplementation, leading to inconclusive results for standardized supplementation protocols.

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

10.1101/2020.09.30.20204693 ◽

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.

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Rapid systematic review on clinical evidence of chloroquine and hydroxychloroquine in COVID-19: critical assessment and recommendation for future clinical trials

10.1101/2020.06.01.20118901 ◽

2020 ◽

Author(s):

Yitong Wang ◽

Shuyao Liang ◽

Tingting Qiu ◽

Ru Han ◽

Monique Dabbous ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trial ◽

Clinical Trials ◽

Interim Analysis ◽

Small Sample Size ◽

Length Of Hospital Stay ◽

Small Sample ◽

China National Knowledge Infrastructure ◽

Clinical Trial Registry ◽

Treatment Benefit

AbstractPurposeThis study aims to critically assess the published studies of Chloroquine (CQ) and hydroxychloroquine (HCQ) for the treatment of COVID-19 and provide recommendations for future clinical trials for the COVID-19 pandemic.MethodA rapid systematic review was conducted by searching the PubMed, Embase, and China National Knowledge Infrastructure databases on April 13, 2020. Three clinical trial registry platforms, including ClinicalTrials.gov, the EU Clinical Trials Register, and the Chinese Clinical Trial Register were also complementarily searched.ResultsA total of 10 clinical studies were identified, including 3 randomized controlled trials (RCTs), 1 comparative nonrandomized trial, 5 single-arm trials, and 1 interim analysis. The heterogeneity among studies of the baseline disease severity and reported endpoints made a pooled analysis impossible. CQ and HCQ (with or without azithromycin) showed significant therapeutic benefit in terms of virologic clearance rate, improvement in symptoms and imaging findings, time to clinical recovery, and length of hospital stay in 1 RCT, 4 single-arm trials, and the interim analysis, whereas no treatment benefit of CQ or HCQ was observed in the remaining 4 studies. Limitations of the included studies ranged from small sample size, to insufficient information concerning baseline patient characteristics, to potential for selection bias without detailing the rationale for exclusion, and presence of confounding factors.ConclusionBased on the studies evaluated, there still lacked solid evidence supporting the efficacy and safety of HCQ and CQ as a treatment for COVID-19 with or without azithromycin. This emphasized the importance of robust RCTs investing HCQ/CQ to address the evidence uncertainties.

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A Systematic Review of the Potential Use of Neurofeedback in Patients With Schizophrenia

Schizophrenia Bulletin Open ◽

10.1093/schizbullopen/sgaa005 ◽

2020 ◽

Vol 1 (1) ◽

Author(s):

Veronica Gandara ◽

Jaime A Pineda ◽

I-Wei Shu ◽

Fiza Singh

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Negative Symptoms ◽

Randomized Clinical Trials ◽

Neurodevelopmental Disorder ◽

Self Regulation ◽

Small Sample ◽

Lessons Learned ◽

Cognitive Symptoms ◽

Everyday Functioning

Abstract Schizophrenia (SCZ) is a neurodevelopmental disorder characterized by positive symptoms (hallucinations and delusions), negative symptoms (anhedonia, social withdrawal) and marked cognitive deficits (memory, executive function, and attention). Current mainstays of treatment, including medications and psychotherapy, do not adequately address cognitive symptoms, which are essential for everyday functioning. However, recent advances in computational neurobiology have rekindled interest in neurofeedback (NF), a form of self-regulation or neuromodulation, in potentially alleviating cognitive symptoms in patients with SCZ. Therefore, we conducted a systematic review of the literature for NF studies in SCZ to identify lessons learned and to identify steps to move the field forward. Our findings reveal that NF studies to date consist mostly of case studies and small sample, single-group studies. Despite few randomized clinical trials, the results suggest that NF is feasible and that it leads to measurable changes in brain function. These findings indicate early proof-of-concept data that needs to be followed up by larger, randomized clinical trials, testing the efficacy of NF compared to well thought out placebos. We hope that such an undertaking by the field will lead to innovative solutions that address refractory symptoms and improve everyday functioning in patients with SCZ.

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Use of systematic reviews to justify the conduct of urology clinical trials

10.21203/rs.3.rs-33014/v1 ◽

2020 ◽

Author(s):

Samuel Shepard ◽

Audrey Wise ◽

Bradley S. Johnson ◽

Matt Vassar

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Systematic Reviews ◽

Randomized Clinical Trials ◽

Data Extraction ◽

Statistical Significance ◽

Extraction Process ◽

Current Data ◽

Research Waste ◽

Pubmed Search

Abstract Background Given the increased amount of research being funded in the field of urology, reducing the amount of research waste is vital. Systematic reviews are an essential tool in aiding in reducing waste in research; they are a comprehensive summary of the current data on a clinical question. The aim of this study is to evaluate the use of systematic reviews as justification in conducting randomized clinical trials (RCT) in high impact urology journals. Methods On December 13, 2019, one of us (BJ) conducted a PubMed search for randomized controlled trials published in the top four urology journals according to their Google Scholar h5-index. Using a masked data extraction process each RCT was searched for systematic reviews. Then each review was evaluated for if it was justification for conducting the trial based on the context the systematic review was used.Results Of the 566 articles retrieved 281 were included. Overall 60.5% (170/281) trials cited a systematic review. We found only 47.6% (134/281) studies cited a systematic review as “verbatim” justification for conducting the trial. Regression analysis yielded a finding of statistical significance in showing a correlation of studies over medical devices were more likely to cite a systematic review than other study topics ( adjusted odds ratio 2.01, 95% CI, 1.08 - 3.73) A total of 409 different systematic review citations were recorded in the 281 trials.Conclusion Less than half of clinical trials cited a systematic review as justification for conducting the trial. If clinical trials were required to support their studies with systematic reviews we believe this would greatly reduce the amount of research waste within clinical research.

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Systematic Review of the Registered Clinical Trials of Coronavirus Disease 2019 (COVID-19)

10.1101/2020.03.01.20029611 ◽

2020 ◽

Cited By ~ 9

Author(s):

Rui-fang Zhu ◽

Yu-lu Gao ◽

Sue-Ho Robert ◽

Jin-ping Gao ◽

Shi-gui Yang ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Sample Size ◽

Western Medicine ◽

Observational Studies ◽

Small Sample Size ◽

Small Sample

AbstractBackgroundSince the outbreak of coronavirus disease 2019 (COVID-19), many researchers in China have immediately carried out clinical research scheme of the COVID-19. But, there is still a lack of systematic review of registered clinical trials. Therefore, we conducted a systematic review of the clinical trials of COVID-19 to summarize the characteristics of the COVID-19 registered clinical trials.MethodsThis study is based on the recommendations of the PRISMA in the Cochrane handbook. The databases from the Chinese Clinical Registration Center and the ClinicalTrials.gov were searched to collect the registered clinical trials of COVID-19. The retrieval inception date is February 9, 2020. Two researchers independently selected the literature based on inclusion and exclusion criteria, extracted data and evaluated the risk of bias.ResultsA total of 75 registered clinical trials (63 interventional studies and 12 observational studies) of COVID-19 were obtained. A majority of clinical trials were sponsored by Chinese hospitals. Only 11 trials have begun to recruit patients, and none of the registered clinical trials had been completed; 34 trials were early clinical exploratory trials or in a pre-experiment stage, 15 trials belonged to phrase III and 4 trials were phrase IV. The methods of intervention included traditional Chinese medicine involving 26 trials, Western medicine involving 30 trials, and integrated traditional Chinese medicine and Western medicine involving 19 trials. The subjects were mainly non-critical adult patients (≥ 18 years old). The median sample size of the trials was 100 (IQR: 60 - 200), and the median execute time of the trials was 179 d (IQR: 94 - 366 d). The main outcomes were clinical observation and examinations. Overall, both the methodology quality of interventional trials and observational studies were low.ConclusionsDisorderly and intensive clinical trials of COVID-19 using traditional Chinese medicine and western medicine are ongoing or will being carried out in China. However, based on the low methodology quality and small sample size and long studies execute time, we will not be able to obtain reliable, high-quality clinical evidence about COVID-19 treatment in the near future. Improving the quality of study design, prioritizing promising drugs, and using different designs and statistical methods are worth advocating and recommending for the clinical trials of COVID-19 in China.

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L-arginine effect on inflammatory mediators: A systematic review of randomized controlled clinical trials

International Journal for Vitamin and Nutrition Research ◽

10.1024/0300-9831/a000619 ◽

2019 ◽

pp. 1-9 ◽

Cited By ~ 1

Author(s):

Seyed Reza Mirhafez ◽

Mitra Hariri

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Inflammatory Mediators ◽

Randomized Clinical Trials ◽

Randomized Controlled Clinical Trials ◽

Patients With Cancer ◽

Reactive Protein ◽

Randomized Controlled ◽

Human Adults ◽

Factor Α

Abstract. L-arginine is an important factor in several physiological and biochemical processes. Recently, scientists studied L-arginine effect on inflammatory mediators such as C-reactive protein (CRP), tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6). We conducted a systematic review on randomized controlled trials assessing L-arginine effect on inflammatory mediators. We searched data bases including Google scholar, ISI web of science, SCOPUS, and PubMed/Medline up to April 2019. Randomized clinical trials assessing the effect of L-arginine on inflammatory mediators in human adults were included. Our search retrieved eleven articles with 387 participants. Five articles were on patients with cancer and 6 articles were on adults without cancer. L-arginine was applied in enteral form in 5 articles and in oral form in 6 articles. Eight articles were on both genders, two articles were on women, and one article was on men. L-arginine could not reduce inflammatory mediators among patients with and without cancer except one article which indicated that taking L-arginine for 6 months decreased IL-6 among cardiopathic nondiabetic patients. Our results indicated that L-arginine might not be able to reduce selected inflammatory mediators, but for making a firm decision more studies are needed to be conducted with longer intervention duration, separately on male and female and with different doses of L-arginine.

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