scholarly journals Safety and Efficacy of Remdesivir for the Treatment of COVID-19: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 24 ◽  
pp. 237-245
Author(s):  
Mohammad Tasavon Gholamhoseini ◽  
Vahid Yazdi-Feyzabadi ◽  
Reza Goudarzi ◽  
Mohammad Hossein Mehrolhassani

Purpose: To evaluate the safety and efficacy of remdesivir in adult patients with COVID-19. Methods: PubMed, Embase, Scopus, Web of Science, Cochrane Library, ClinicalTrials.gov, and medRxiv databases were searched using a search strategy tailored to each database. The Consolidated Standards of Reporting Trials (CONSORT) and Strengthening the reporting of observational studies in epidemiology (STROBE) checklists were used for the studies' qualitative assessment. The outcomes studied were mortality, all adverse events, serious adverse events, and clinical improvement. The quantitative synthesis was conducted using fixed and random effects models in the CMA 2.2. Heterogeneity was tested using the I-squared (I2) measure. Results: In general, six studies, including five randomized controlled trials and one cohort study were found eligible. Comparison of the findings related to both groups receiving remdesivir (10-day remdesivir group) and placebo/control group showed that remdesivir treatment had no significant effect on mortality at day 14 of the treatment (RR=0.769; 95% CI :0.563-1.050; p=0.098), and all adverse events (RR= 1.078; 95% CI: 0.908-1.279; p= 0.392). However, remdesivir had a significant effect on clinical improvement at day 14 compared to placebo/control (OR= 1.447; 95% CI: 1.005-2.085; p= 0.047) and reduced serious adverse events (RR= 0.736; 95% CI: 0.611-0.887; p= 0.001). Conclusion: Remdesivir has positive effects on clinical improvement, and reduction of the risk of serious adverse events. However, it does not influence the mortality at day 14 of treatment.

Author(s):  
Bixi Gao ◽  
Nan Sun ◽  
Yanbo Yang ◽  
Yue Sun ◽  
Mingjia Chen ◽  
...  

Abstract Background Fremanezumab (TEV-48125) is a fully humanized immunoglobulin G isotype 2a selective monoclonal antibody that potently binds to calcitonin gene-related peptide (CGRP). It is one of novel therapeutic drugs for the prevention of migraine, which is one of the most common neurological diseases worldwide. Several clinical trails have been conducted to investigate the safety and efficacy of fremanezumab, but there is no systematic review of existing literature has been performed. Hence, we performed a meta-analysis to investigate the efficacy and safety of fremanezumab for prevention of migraine. Method Pubmed (MEDLINE), Embase, and Cochrane Library were searched from January 2001 to August 2019 for randomized controlled trials (RCTs). Five RCTs with 3379 patients were finally included in our study. Result We pooled 3379 patients from 5 RCTs, the primary endpoints were mean monthly migraine and headache days, baseline to week 12. We found that fremanezumab led to a significant reduction in migraine days (P < 0.0001) and headache days (P < 0.0001) during 12 weeks compared with placebo. In addition, after using fremanezumab, the risk of at least one adverse event (P=0.001) or related to the trail regimen (P=0.0005) significantly increase compared with placebo. Conclusions Fremanezumab has good efficacy for the prevention of migraine. The administration of fremanezumab can cause some mild adverse events but not serious adverse events.


2019 ◽  
Author(s):  
Weili Wang ◽  
Kuang-Huei Chen ◽  
Ying-Chieh Pan ◽  
Szu-Nian Yang ◽  
Yuan-Yu Chan

Abstract Objectives To examine the effectiveness and safety of yoga for women with sleep problems by performing a systematic review and meta-analysis.Methods Medline/PubMed, Clincalkey, ScienceDirect, Embase, PsycINFO, and the Cochrane Library were searched throughout the month of June 2019. Randomized controlled trials comparing yoga groups with control groups in women with sleep problems were included. Two reviewers independently evaluated risk of bias by using the risk of bias tool suggested by the Cochrane Collaboration for programming and conducting systematic reviews and meta-analyses. The main outcome measure was sleep quality or the severity of insomnia, which was measured using subjective instruments, such as the Pittsburgh Sleep Quality Index (PSQI), Insomnia severity index (ISI), or objective instruments, such as polysomnography, actigraphy, and safety of the intervention. For each outcome, standardized mean difference (SMD) and 95% confidence intervals (CIs) were determined. Results Nineteen studies including 1832 participants were included in this systematic review. Meta-analyses revealed positive effects of yoga using PSQI or ISI scores in 16 randomized control trials (RCTs) compared with the control group in improving sleep quality in women, PSQI (SMD = −0.54; 95% CI = −0.89 to −0.19 ; P = 0.003). However, three RCTs revealed no effects of yoga compared with the control group in reducing the severity of insomnia in women using ISI (SMD = −0.13; 95% CI = −0.74 to 0.48; P = 0.69). Seven RCTs revealed no evidence for effects of yoga compared with the control group in improving sleep quality for women with breast cancer using PSQI (SMD = −0.15 ; 95% CI = −0.31 to 0.01; P = 0.5). Four RCTs revealed no evidence for the effects of yoga compared with the control group in improving the sleep quality for peri-or postmenopausal women using PSQI (SMD = −0.31; 95% CI = −0.95 to 0.33; P = 0.34).Yoga was not associated with serious adverse events. Discussion This systematic review and meta-analysis found that yoga intervention in some groups of women was beneficial in managing sleep problems. Despite certain disadvantages in methodology in the included studies, yoga may be recommended as a complementary therapy to women.


Author(s):  
Pinky Kotecha ◽  
Alexander Light ◽  
Enrico Checcucci ◽  
Daniele Amparore ◽  
Cristian Fiori ◽  
...  

AbstractObjectiveThe aim of this systematic review is to evaluate the data currently available regarding the repurposing of different drugs for Covid-19 treatment. Participants with suspected or diagnosed Covid-19 will be included. The interventions being considered are drugs being repurposed, and comparators will include standard of care treatment or placebo.MethodsWe searched Ovid-MEDLINE, EMBASE, Cochrane library, clinical trial registration site in the UK(NIHR), Europe (clinicaltrialsregister.eu), US (ClinicalTrials.gov) and internationally (isrctn.com), and reviewed the reference lists of articles for eligible articles published up to April 22, 2020. All studies in English that evaluated the efficacy of the listed drugs were included. Cochrane RoB 2.0 and ROBINS-I tool were used to assess study quality. This systematic review adheres to the PRISMA guidelines. The protocol is available at PROSPERO (CRD42020180915).ResultsFrom 708 identified studies or clinical trials, 16 studies and 16 case reports met our eligibility criteria. Of these, 6 were randomized controlled trials (763 patients), 7 cohort studies (321 patients) and 3 case series (191 patients). Chloroquine (CQ) had a 100% discharge rate compared to 50% with lopinavir-ritonavir at day 14, however a trial has recommended against a high dosage due to cardiotoxic events. Hydroxychloroquine (HCQ) has shown no significant improvement in negative seroconversion rate which is also seen in our meta-analysis (p=0.68). Adverse events with HCQ have a significant difference compared to the control group (p=0.001). Lopinavir-ritonavir has shown no improvement in time to clinical improvement which is seen in our meta-analyses (p=0.1). Remdesivir has shown no significant improvement in time to clinical improvement but this trial had insufficient power.DiscussionDue to the paucity in evidence, it is difficult to establish the efficacy of these drugs in the treatment of Covid-19 as currently there is no significant clinical effectiveness of the repurposed drugs. Further large clinical trials are required to achieve more reliable findings. A risk-benefit analysis is required on an individual basis to weigh out the potential improvement in clinical outcome and viral load reduction compared to the risks of the adverse events. (1-16)


BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e048416
Author(s):  
Surjit Singh ◽  
Daisy Khera ◽  
Ankita Chugh ◽  
Pushpinder Singh Khera ◽  
Vinay Kumar Chugh

ObjectivesEvaluation of remdesivir, an RNA polymerase inhibitor, for effectiveness in adults with COVID-19.Data sourcesElectronic search for eligible articles of PubMed, Cochrane Central and clinicaltrials.gov was performed on 20 September 2020.Participants and study eligibility criteriaOnly randomised controlled trials (RCTs) evaluating efficacy of remdesivir in COVID-19 were included for meta-analysis.InterventionsRemdesivir was compared with standard of care.Primary and secondary outcomesPrimary outcome was mortality and secondary outcomes were time to clinical improvement and safety outcomes like serious adverse events, respiratory failure.Study appraisal and synthesis methodsData synthesis was done with Cochrane review manager 5 (RevMan) V.5.3. Cochrane risk of bias V.2.0 tool was used for methodological quality assessment. The GRADE pro GDT was applied for overall quality of evidence.Results52 RCTs were screened and 4 studies were included in analysis, with total of 7324 patients. No mortality benefit was observed with remdesivir versus control group (OR=0.92 (95% CI 0.79 to 1.07), p=0.30, moderate quality evidence). Significantly higher rates of clinical improvement (OR=1.52 (95% CI 1.24 to 1.87), p<0.0001, low quality) and faster time to clinical improvement (HR=1.28 (95% CI 1.12 to 1.46), p=0.0002, very low quality) was observed with remdesivir versus control group. Significant decrease was found in the risk of serious adverse events (RR=0.75 (95% CI 0.62 to 0.90), p=0.0003, low quality); however, no difference was found in the risk of respiratory failure (RR=0.85 (95% CI 0.41 to 1.77), p=0.67, very low quality evidence) with remdesivir.ConclusionsAs per the evidence from current review, remdesivir has shown no mortality benefit (moderate quality evidence) in the treatment of COVID-19. From a cost–benefit perspective, it is our personal opinion that it should not be recommended for use, especially in low and lower middle income countries.Trial registration numberPROSPERO registration number: CRD42020189517.


2020 ◽  
Author(s):  
Weili Wang ◽  
Kuang-Huei Chen ◽  
Ying-Chieh Pan ◽  
Szu-Nian Yang ◽  
Yuan-Yu Chan

Abstract Background: To examine the effectiveness and safety of yoga of women with sleep problems by performing a systematic review and meta-analysis. Methods: Medline/PubMed, ClinicalKey, ScienceDirect, Embase, PsycINFO, and the Cochrane Library were searched throughout the month of June, 2019. Randomized controlled trials comparing yoga groups with control groups in women with sleep problems were included. Two reviewers independently evaluated risk of bias by using the risk of bias tool suggested by the Cochrane Collaboration for programming and conducting systematic reviews and meta-analyses. The main outcome measure was sleep quality or the severity of insomnia, which was measured using subjective instruments, such as the Pittsburgh Sleep QualityIndex (PSQI),Insomnia Severity Index (ISI), or objective instruments such as polysomnography, actigraphy, and safety of the intervention. For each outcome, a standardized mean difference (SMD) and confidence intervals (CIs) of 95% were determined. Results: Nineteen studies in this systematic review included 1832 participants. The meta-analysis of the combined data conducted according to Comprehensive Meta-Analysis showed a significant improvement in sleep (SMD =−0.327, 95% CI=−0.506 to −0.148,P<0.001).Meta-analyses revealed positive effects of yoga using PSQI scores in 16 randomized control trials (RCTs), compared with the control group in improving sleep quality among women usingPSQI (SMD = −0.54; 95% CI = −0.89 to −0.19; P = 0.003). However, three RCTs revealed no effects of yoga compared to the control groupin reducing insomnia among women using ISI (SMD = −0.13; 95% CI = −0.74 to 0.48; P = 0.69).Yoga was not associated with any serious adverse events. Discussion: This systematic review and meta-analysis demonstrated that yoga intervention in women can be beneficial whencompared to non-active control conditions in term of managing sleep problems.The moderator analyses suggest that participants in the non-breast cancer subgroup and participants in the non-peri/postmenopausal subgroup were associated with greater benefits, with a direct correlation of total class time with quality of sleep among other related benefits.


2018 ◽  
Vol 7 (1) ◽  
pp. 124-133 ◽  
Author(s):  
Zahra Ghorbani ◽  
Mojgan Mirghafourvand

Objectives: An increase in life expectancy results in the aging population growth. This study was designed to evaluate the efficacy and adverse events of ginseng that could be used as a herbal medicine in women with sexual dysfunction. Materials and Methods: The authors of this study searched Cochrane Library, MEDLINE, Web of Science, Embase, Scopus, ProQuest, Google Scholar, and Persian databases without a time limitation until May 2018 and examined all the randomized clinical trials (RCTs) that compared the effect of different types of ginseng on sexual function of menopausal women as compared to the placebo controls. The Cochrane risk of bias tool was used to assess the methodological quality of the included studies. The heterogeneity was determined using the I2 index. In addition, standardized mean difference (SMD) was used instead of mean differences (MD) and a random effect was reported instead of fixed effect in meta-analysis. Results: The eligibility criteria were found in five RCTs. All the included studies were placebo-controlled. Two trials had a parallel design while three studies used a crossover design. Although four trials indicated that ginseng significantly improved sexual function, they didn’t report any treatment effect compared to the placebo group. Based on the results of meta-analysis obtained from five studies including 531 women, there was no statistically significant effect of ginseng on female sexual dysfunction (FSD) compared to the placebo control group (SMD: 0.26; 95% CI: -0.26 to 0.76). Nonetheless, there was a considerable heterogeneity among the studies (I2 = 81%; P < 0.0001). Moreover, all the included studies assessed adverse events, but in three of the RCTs, there was no significant difference between the placebo and ginseng groups. Conclusions: The evidence regarding ginseng as a therapeutic agent for sexual dysfunction is unjustifiable. Rigorous studies seem warranted in this respect.


2021 ◽  
Author(s):  
Junwu Wang ◽  
Pengzhi Shi ◽  
Dong Chen ◽  
Shuguang Wang ◽  
Pingchuan Wang ◽  
...  

Mesenchymal stem cells (MSCs) therapy is considered one of the most promising treatments in the context of the coronavirus disease 2019 (COVID-19) pandemic. However, the safety and effectiveness of MSCs in the treatment of COVID-19-associated pneumonia patients need to be systematically reviewed and analyzed. Two independent researchers searched for the relevant studies published between October 2019 and April 2021 in PubMed, Embase, Cochrane Library, WAN FANG, and CNKI databases. A total of 22 studies involving 371 patients were included in the present study. MSCs were administered in 247 participants, and MSCs were allogeneic from umbilical cord, adipose tissue, menstrual blood, placenta, Wharton's jelly, or unreported sources. Combined results found that MSCs group significantly reduced the incidence of adverse events (OR = 0.43, 95%CI. = 0.22~0.84, P = 0.01) and mortality (OR = 0.17, 95%CI. = 0.06~0.49, P < 0.01), and the difference compared with control group was statistically significant. No MSCs treat-related serious adverse events were reported. The lung function and radiographic outcomes, and biomarker levels of inflammation and immunity all showed improvement trends. Therefore, MSCs therapy is an effective and safe method in the treatment of COVID-19-associated pneumonia and shows advantages in less adverse events and mortality. However, a standard and effective MSCs treatment program needs to be developed.


2020 ◽  
Author(s):  
Weili Wang ◽  
Kuang-Huei Chen ◽  
Ying-Chieh Pan ◽  
Szu-Nian Yang ◽  
Yuan-Yu Chan

Abstract Objectives: To examine the effectiveness and safety of yoga of women with sleep problems by performing a systematic review and meta-analysis. Methods: Medline/PubMed, ClinicalKey, ScienceDirect, Embase, PsycINFO, and the Cochrane Library were searched throughout the month of June, 2019. Randomized controlled trials comparing yoga groups with control groups in women with sleep problems were included. Two reviewers independently evaluated risk of bias by using the risk of bias tool suggested by the Cochrane Collaboration for programming and conducting systematic reviews and meta-analyses. The main outcome measure was sleep quality or the severity of insomnia, which was measured using subjective instruments, such as the Pittsburgh Sleep QualityIndex (PSQI),Insomnia Severity Index (ISI), or objective instruments such as polysomnography, actigraphy, and safety of the intervention. For each outcome, a standardized mean difference (SMD) and confidence intervals (CIs) of 95% were determined. Results: Nineteen studies in this systematic review included 1832 participants. The meta-analysis of the combined data conducted according to Comprehensive Meta-Analysis showed a significant improvement in sleep (SMD =−0.327, 95% CI=−0.506 to −0.148,P<0.001).Meta-analyses revealed positive effects of yoga using PSQI scores in 16 randomized control trials (RCTs), compared with the control group in improving sleep quality among women usingPSQI (SMD = −0.54; 95% CI = −0.89 to −0.19; P = 0.003). However, three RCTs revealed no effects of yoga compared to the control groupin reducing insomnia amongwomen using ISI (SMD = −0.13; 95% CI = −0.74 to 0.48; P = 0.69).Yoga was not associated with any serious adverse events. Discussion: This systematic review and meta-analysis demonstrated that yoga intervention in women can be beneficial whencompared to non-active control conditions in term of managing sleep problems.The moderator analyses suggest that participants in the non-breast cancer subgroup and participants in the non-peri/postmenopausal subgroup were associated with greater benefits, with a direct correlation of total class time with quality of sleep among other related benefits.


2021 ◽  
Vol 2021 ◽  
pp. 1-20
Author(s):  
Huan Chen ◽  
Jiaming Lei ◽  
Sicheng Liang ◽  
Gang Luo ◽  
Mingming Deng ◽  
...  

Background and Aims. Portal vein thrombosis is a serious adverse event that occurs during liver cirrhosis. We performed a meta-analysis to evaluate the safety and efficacy of anticoagulant therapy and prophylactic anticoagulant therapy in cirrhosis patients with (/without) portal vein thrombosis. Methods. Eligible comparative studies were identified by searching the following electronic databases: PubMed, Embase, Cochrane Library, Web of Science, and CNKI. A meta-analysis was performed to calculate odds ratios and 95% confidence intervals using fixed-effects models. Recanalization and thrombus progression were defined as the primary outcomes. Secondary outcomes included adverse events and death mortality. Results. A total of 3479 patients were included in this analysis. Compared with the control group, the recanalization rate in the anticoagulant therapy group was increased P < 0.00001 in patients with cirrhosis and portal vein thrombosis without increasing adverse events. Multiple use of enoxaparin in small doses is safer than single large doses P = 0.004 . Direct oral anticoagulants are more effective P < 0.00001 and safer than traditional anticoagulants. Prophylactic anticoagulant therapy can effectively prevent portal vein thrombosis formation P < 0.00001 . Conclusions. Anticoagulation therapy can treat or prevent portal vein thrombosis in patients with liver cirrhosis and is a relatively safe treatment.


2021 ◽  
Author(s):  
Shuang Cai ◽  
Anhang Zhang ◽  
Bokai Cheng ◽  
Qiligeer Bao ◽  
Shuxia Wang

Abstract Background: Rheumatoid arthritis (RA) is a chronic inflammatory joint disease, which can cause cartilage and bone damage as well as disability. The effects of denosumab in patients with RA have been analyzed in several clinical studies. These results provide strong evidence to suggest that denosumab significantly inhibited the progression of bone erosion, increased BMD in patients with RA. We undertook a meta-analysis to summarize the efficacy and safety of denosumab in the treatment on structural damage caused by rheumatoid arthritis.Methods: We searched PubMed, Embase, Medline, The Cochrane Library, and collected randomized controlled trials of denosumab in patients with rheumatoid arthritis from the database was established until January 19, 2021.Literature was screened according to inclusion and exclusion criteria, and RevMan 5.3 software was used for Meta-analysis after quality assessment.Results: Five eligible studies were included in the primary meta-analysis. Denosumab significantly inhibited the increase of the modified Sharp erosion score(MD=-0.62, 95%CI=-0.91~-0.33,P<0.0001)、modified total Sharp score(MD=-0.78, 95%CI=1.23~-0.33,P=0.0007)compared to placebo groups at 12 months. In addition, denosumab also significantly increased lumbar spine BMD (3.73, 95% CI 2.00, 5.46, P<0.0001) compared to placebo or bisphosphonates. There was no evidence of an effect of denosumab on joint space narrowing. Adverse events, serious adverse events were similar between denosumab and placebo arms.Conclusion: Results suggest that denosumab inhibits the progression of structural damage caused by rheumatoid arthritis, with no increase in the rates of adverse events as compared with control group. Preliminary research suggests that denosumab is reasonable and promising options for preventing and treating structural destruction in rheumatoid arthritis.Trial registration: We registered our study with PROSPERO (registration number CRD42021239783); no other meta-analysis focusing on denosumab use for structural damage caused by rheumatoid arthritis were found in the PROSPERO database.


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