Objective: To critically evaluate the trials that have assessed the efficacy and safety of ivermectin COVID-19 and to validate the rationality of using this drug in the management of COVID-19 either as a prophylactic or therapeutic agent. Methods: The authors conducted a systematic search through various databases, i.e., Cochrane library, PubMed, clincialtrials.gov, and preprint servers, for publications from 2020 to May 2021. The keywords used for the search were: “COVID-19 and ivermectin” (with filter set for “trials”). All the trials assessing efficacy in prophylaxis and treatment of COVID-19 were included for analysis. The primary outcome was the proportion of patients showing disease progression. Secondary outcomes were mean duration of hospitalization and resolution of symptoms, the proportion of patients testing positive on day 5-7, the mortality rate in severe cases, incidence of serious adverse events, and contacts of COVID-19 positive patients who turned RT-PCR positive after prophylaxis treatment. Results: A total of 17 clinical trials were included for the evaluation. Ivermectin proved to be a beneficial add-on therapy, as it reduced the risk of disease progression (OR 0.47, 95% CI 0.30-0.74, P=0.001), led to early resolution of symptoms (MD -1.16, 95% CI -1.52--0.81, P<0.001), and had less duration of hospitalization (MD -2.21, 95% CI -3.23--1.19, P<0.001). In addition, ivermectin was better in providing effective prophylaxis (OR 0.13, 95% CI 0.05-0.30, P<0.001). The incidence of serious adverse events was low. Conclusions: As an adjunct to standard care, ivermectin has shown its efficacy and safety in treating and prophylaxis in COVID-19 disease. These results should be interpreted cautiously as these trials had significant shortcomings.
Background: In recent times, the US-FDA approved istradefylline and opicapone as an adjunct to levodopa/carbidopa for managing the "off" episodes in Parkinson’s disease. Purpose: Current meta-analysis was performed to determine the safety and efficacy of these drugs in the management of “off” episodes and to recognize which among them would provide therapeutic benefits clinically. Methods: A thorough literature search was performed through the Cochrane Library, PubMed, and clinicaltrials.gov for a period from January 2003 to October 2020, with the following keywords: Istradefylline, KW-6002, opicapone, BIA 9-1067, and Parkinson’s disease. Those randomized, double-blind placebo/active comparator-controlled trials that analyzed the efficacy and safety of istradefylline and opicapone and that were published in the English language were included. In this analysis, the outcomes focused on the least square mean change in “off” time and Unified Parkinson’s Disability Rating Scale (UPDRS) III score from baseline to the end of the study, and the incidence of treatment-emergent adverse events (TEAEs) and dyskinesia. Results: Both drugs have shown significant reduction in “off” time duration (mean difference [MD] = –0.70; 95% CI [–1.11, –0.30]; P < 0.001 for istradefylline and MD = –0.85; 95% CI [–1.09, –0.61]; P < .001 for opicapone). Istradefylline showed significant improvement in UPDRS III (MD = –1.56; 95% CI [–2.71, –0.40]; P < .008), but the same was not observed with opicapone (MD = –0.63; 95% CI [–1.42, –0.15]; P < .12). The incidence of TEAEs and dyskinesia reportedly were higher in the intervention group rather than with the placebo, (risk ratio RR =1.11, 95% CI [1.02,1.20] for istradefylline and RR =1.12, 95% CI [1.00,1.25] for opicapone, and for dyskinesia particularly, the incidence was higher with opicapone as compared to istradefylline (RR = 3.47, 95% CI [2.17, 5.57], and RR = 1.77, 95% CI [1.29, 2.44], respectively). Conclusions: Both drugs were comparable in efficacy; however, istradefylline seemed to be better in reducing the UPDRS III score. Although the incidence of TEAEs and dyskinesia were higher with both the drugs, the incidence of dyskinesia was more in the opicapone group.
Background: Leprosy is a communicable disease caused by bacteria Mycobacterium Leprae. Despite all attempts, it has not been eradicated in several underdeveloped nations since the start of the antibiotic age. It's a social issue as well as a stigmatised disease. Due to these restrictions, randomised controlled trials in leprosy confront numerous obstacles, which are reflected in the quality of study reporting. Objectives: The objective of this study is to use the Consolidated Standard for Reporting Trials (CONSORT) 2010 checklist to assess the quality of leprosy trial reporting. Methods: We assess the quality of reporting of randomised control trials on leprosy conducted after 2010 in the PubMed database, using the CONSORT checklist 2010. Second, we compare the quality of RCT reporting before and after the release of the CONSORT guidelines in 2010. Results: A total of 19 full-text eligible articles were examined and included in the final list of articles, which were then evaluated further. 4 out of 19 trials had a compliance percentage of more than 75%. 6 out of 19 trials had compliance percentage of 50% to 75%. 9 trials had a compliance percentage of below 50%. Highest compliance was 86.48% and the lowest compliance was 32.43%. When compared with trials before 2010, we could see an improvement in some criteria showing a statistically significant rise in comparison with trials conducted before 2010. Conclusion: Leprosy is still a concern in developing countries, which have failed to eradicate the disease despite their best efforts and resources. The compliance of leprosy related RCTs has improved since the introduction of the CONSORT guidelines, but the quality of reporting still remains on the lower side.
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