scholarly journals Efficacy and safety of hydroxychloroquine as pre-and post-exposure prophylaxis and treatment of COVID-19. Systematic review and meta-analysis of blinded, placebo-controlled, randomized clinical trials

2021 ◽  
Author(s):  
Paulo Ricardo Martins-Filho ◽  
Lis Campos Ferreira ◽  
Luana Heimfarth ◽  
Adriano Antunes de Souza Araujo ◽  
Lucindo Jose Quintans-Junior
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Hospitalized Patients ◽  
Post Exposure Prophylaxis ◽  
Potential Candidate ◽  
Efficacy And Safety ◽  
Post Exposure ◽  
Exposure Prophylaxis

BACKGROUND Hydroxychloroquine (HCQ) is an anti-malarial and immunomodulatory drug considered a potential candidate for drug repurposing in COVID-19 due to their in vitro antiviral activity against SARS-CoV-2. Despite the potential antiviral effects and anti-inflammatory profile, the results based on clinical studies are contradictory and the quality of the decision-making process from meta-analyses summarizing the available evidence selecting studies with different designs and unblinded trials is limited. The aim of this study was to synthesize the best evidence on the efficacy and safety of HCQ as pre-and post-exposure prophylaxis and treatment of non-hospitalized and hospitalized patients with COVID-19. METHODS Searches for studies were performed in PubMed, Web of Science, Embase, Lilacs, the website ClinicalTrials.gov and the preprint server medRxiv from January 1, 2020 to May 17, 2021. The following elements were used to define eligibility criteria: (1) Population, individuals at high-risk of exposure to SARS-CoV-2 (pre-exposure), individuals who had close contact with a positive or probable case of COVID-19 (post-exposure), non-hospitalized patients with COVID-19 and hospitalized patients with COVID-19; (2) Intervention, HCQ; (3) Comparison, placebo; (4) Outcomes: incidence of SARS-CoV-2 infection, need for hospitalization, length of hospital stay, need for invasive mechanical ventilation (MV), death, and adverse events; and (5) Study type, blinded, placebo-controlled, randomized clinical trials (RCTs). Risk of bias was judged according to the Cochrane guidelines for RCTs. Treatment effects were reported as relative risk (RR) for dichotomous variables and mean difference (MD) for continuous variables with 95% confidence intervals (CI). We used either a fixed or random-effects model to pool the results of individual studies depending on the presence of heterogeneity. The GRADE system was used to evaluate the strength of evidence between use of HCQ and the outcomes of interest. RESULTS Fourteen blinded, placebo-controlled RCTs were included in the meta-analysis. Four trials used HCQ as a prophylactic medication pre-exposure to COVID-19, two as a prophylactic medication post-exposure to COVID-19, three as treatment for non-hospitalized patients, and five as treatment for hospitalized patients with COVID-19. We found no decreased risk of SARS-CoV-2 infection among individuals receiving HCQ as pre-exposure (RR = 0.90; 95% CI 0.46 to 1.77) or post-exposure (RR = 0.96; 95% CI 0.72 to 1.29) prophylaxis to prevent COVID-19. There is no decreased risk of hospitalization for outpatients with SARS-CoV-2 infection (RR = 0.64; 95% CI 0.33 to 1.23) and no decreased risk of MV (RR = 0.81; 95% CI 0.49 to 1.34) and death (RR = 1.05; 95% CI 0.62 to 1.78) among hospitalized patients with COVID-19 receiving HCQ. The certainty of the results on the lack of clinical benefit for HCQ was rated as moderate. Moreover, our results demonstrated an increased risk for any adverse events and gastrointestinal symptoms among those using HCQ. CONCLUSION Available evidence based on the results of blinded, placebo-controlled RCTs showed no clinical benefits of HCQ as pre-and post-exposure prophylaxis and treatment of non-hospitalized and hospitalized patients with COVID-19.

scholarly journals Network meta‐analysis of post‐exposure prophylaxis randomized clinical trials

HIV Medicine ◽  
2020 ◽  
Author(s):  
I Fernández ◽  
E. Lazzari ◽  
A. Inciarte ◽  
V. Diaz‐Brito ◽  
A. Milinkovic ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Post Exposure Prophylaxis ◽  
Post Exposure ◽  
Exposure Prophylaxis

scholarly journals The Efficacy and Safety of Acellular Matrix Therapy for Diabetic Foot Ulcers: A Meta-Analysis of Randomized Clinical Trials

2020 ◽  
Vol 2020 ◽  
pp. 1-12 ◽  
Author(s):  
Wentao Huang ◽  
Yongsong Chen ◽  
Nasui Wang ◽  
Guoshu Yin ◽  
Chiju Wei ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Healing Rate ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Complete Healing ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Efficacy And Safety ◽  
Acellular Matrix

Background. Acellular matrix (AM) therapy has shown promise in the treatment of diabetic foot ulcers (DFUs) in several studies. The clinical effects of AM therapy were not well established. Therefore, we conducted a meta-analysis of randomized clinical trials (RCTs) to examine the efficacy and safety of AM therapy for patients with DFUs. Methods. A literature search of 5 databases was performed to identify RCTs comparing AM therapy to standard therapy (ST) in patients with DFUs. The primary outcome was the complete healing rate and the secondary outcomes mainly included time to complete healing and adverse events. Results. Nine RCTs involving 897 patients were included. Compared with ST group, patients allocated to AM group had a higher complete healing rate both at 12 weeks (risk ratio RR=1.73, 95% confidence interval (CI): 1.31 to 2.30) and 16 weeks (RR=1.56, 95% CI: 1.28 to 1.91), a shorter time to complete healing (mean difference MD=−2.41; 95% CI: -3.49 to -1.32), and fewer adverse events (RR=0.64, 95% CI: 0.44 to 0.93). Conclusion. The present study suggests that AM therapy as an adjuvant treatment could further promote the healing of full-thickness, noninfected, and nonischemia DFUs. AM therapy also has a safety profile. More large well-designed randomized clinical trials with long follow-up duration are needed to further explore the efficacy and safety of AM therapy for DFUs.

675 FUNDOPLICATION VERSUS ORAL PROTON PUMP INHIBITORS FOR GASTROESOPHAGEAL REFLUX DISEASE: A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CLINICAL TRIALS

2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
Luca Schiliró Tristão ◽  
Francisco Tustumi ◽  
Guilherme Tavares ◽  
Letícia Nogueira Datrino ◽  
Maria Carolina Andrade Serafim ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Gastroesophageal Reflux Disease ◽  
Gastroesophageal Reflux ◽  
Adverse Events ◽  
Proton Pump ◽  
Reflux Disease ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Oral Intake

Abstract   Gastroesophageal reflux disease (GERD) is a widely studied and highly prevalent condition. However, few is reported about the exact efficacy and safety of fundoplication (FPT) compared to oral intake proton-pump inhibitors (PPI). This systematic review and meta-analysis of randomized clinical trials (RCT) aims to compare PPI and FPT in relation to the efficacy, as well as the adverse events associated with these therapies. Methods This systematic review was guided by PRISMA statement. Search carried out in June 2020 was conducted on Medline, Cochrane, EMBASE and LILACS. The inclusion criteria were (I) patients with GERD; (II) Randomized clinical trials, comparing oral intake PPI with FPT; (III) relevant outcomes for this review. The exclusion criteria were (I) reviews, case reports, editorials and letters (II) transoral or endoscopic FPT (III) studies with no full text. No restrictions were set for language or period. Certainty of evidence and risk of bias were assessed with GRADE Pro and with Review Manager Version 5.4 bias assessment tool. Results Ten RCT were included. Meta-analysis showed that heartburn (RD = −0.19; 95% CI = −0.29, −0.09) was less frequently reported by patients that underwent FPT. Furthermore, patients undergoing surgery had greater pressure on the lower esophageal sphincter than those who used PPI (MD = 7.81; 95% CI 4.79, 10.83). There was no significant difference between groups in the percentage of time with pH less than 4 in 24 hours, sustained remission and Gastrointestinal Symptom Rating Scale. Finally, FPT did not increase significantly the risk for adverse events such as postoperative dysphagia and impaired belching. Conclusion FPT is a more effective therapy than PPI treatment for GERD, without significantly increasing the risk for adverse events. However, before indicating a possible surgical approach, it is extremely important to correctly assess and select the patients who would benefit from FPT, such as those with severe erosive esophagitis, severe respiratory symptoms, low adherence to continuous drug treatment and patients with non-acid reflux, to ensure better results.

scholarly journals Post-exposure prophylaxis vaccination rate and risk factors of human rabies in mainland China: a meta-analysis

2018 ◽  
Vol 147 ◽  
Author(s):  
D. L. Wang ◽  
X. F. Zhang ◽  
H. Jin ◽  
X. Q. Cheng ◽  
C. X. Duan ◽  
...  
Keyword(s):  
Risk Factors ◽  
Rural Areas ◽  
Meta Analysis ◽  
Mainland China ◽  
Vaccination Rate ◽  
Human Rabies ◽  
Post Exposure Prophylaxis ◽  
Eastern Region ◽  
Post Exposure ◽  
Exposure Prophylaxis

AbstractRabies is one of the major public health problems in China, and the mortality rate of rabies remains the highest among all notifiable infectious diseases. A meta-analysis was conducted to investigate the post-exposure prophylaxis (PEP) vaccination rate and risk factors for human rabies in mainland China. The PubMed, Web of Science, Chinese National Knowledge Infrastructure, Chinese Science and Technology Periodical and Wanfang databases were searched for articles on rabies vaccination status (published between 2007 and 2017). In total, 10 174 human rabies cases from 136 studies were included in this meta-analysis. Approximately 97.2% (95% confidence interval (CI) 95.1–98.7%) of rabies cases occurred in rural areas and 72.6% (95% CI 70.0–75.1%) occurred in farmers. Overall, the vaccination rate in the reported human rabies cases was 15.4% (95% CI 13.7–17.4%). However, among vaccinated individuals, 85.5% (95% CI 79.8%–83.4%) did not complete the vaccination regimen. In a subgroup analysis, the PEP vaccination rate in the eastern region (18.8%, 95% CI 15.9–22.1%) was higher than that in the western region (13.3%, 95% CI 11.1–15.8%) and this rate decreased after 2007. Approximately 68.9% (95% CI 63.6–73.8%) of rabies cases experienced category-III exposures, but their PEP vaccination rate was 27.0% (95% CI 14.4–44.9%) and only 6.1% (95% CI 4.4–8.4%) received rabies immunoglobulin. Together, these results suggested that the PEP vaccination rate among human rabies cases was low in mainland China. Therefore, standardised treatment and vaccination programs of dog bites need to be further strengthened, particularly in rural areas.

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