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• W3201615314 abstract "The COVID-19 outbreak has caused an unprecedented global health and financial crisis. As of August 2020, more than 20 million people worldwide have been infected; however, specific treatments remain investigational. Hydroxychloroquine, a classic drug derived from chloroquine for rheumatological diseases, has shown activity against the novel coronavirus in vitro and been authorised in some national regulatory agencies to treat patients with COVID-19.1, 2 However, some studies reported no effect on the intubation rate or mortality.3 We therefore performed a meta-analysis to evaluate the effects of hydroxychloroquine on overall mortality in patients with COVID-19. Furthermore, we employed trial sequential analysis (TSA) to verify whether the results of the meta-analysis were conclusive. Comprehensive literature searches using PubMed, Google Scholar, MedRxiv and the preprints literature were undertaken for studies published up to February 2021, using the keywords “COVID-19”, “hydroxychloroquine” and “mortality” with related MeSH terms. Two reviewers (PHC and HJJ) independently screened the titles and abstracts and extracted the data. Any discrepancy was solved by group discussion. A random-effects DerSimonian–Laird model was used to estimate the odds ratio (OR) with 95% confidence interval (CI). Heterogeneity across the studies was detected by I2 > 50% and Cochran Q-test P < .1. Subgroup analyses were performed toward the study designs, the therapeutic regimens and the COVID-19 severities to detect clinical and statistical heterogeneity. All statistical analyses were performed using the “metafor” and “meta” packages of R software (version 3.6.1., R Foundation for Statistical Computing, Vienna, Austria) We constructed TSA boundaries according to the O'Brien-Fleming alpha-spending function with two-sided α = 5% and 1 – β = 80% power. We assumed a relative risk reduction by calculating from the mean of the event proportions for both the intervention and control arms. Random-effect TSA was performed using TSA software (version 0.9.5.10 Beta; Copenhagen Trial Unit, Copenhagen, Denmark). A total of 26 studies (n = 30 167, Table 1) were selected in meta-analysis. The use of hydroxychloroquine with or without azithromycin did not reduce the mortality rates as compared with standard care (random-effects OR, 1.01; 95% CI, 0.81-1.25; I2 = 82%; Cochran P-value < .01). TSA revealed an intervention event proportion of 16%, a control event proportion of 19% and a diversity of 88%. The cumulative Z-curve did not cross the conventional boundary, and the required information size of 14 064 has been reached, demonstrating no difference in overall mortality in patients who received hydroxychloroquine with or without azithromycin compared with standard of care (TSA-adjusted OR, 1.01; 95% CI, 0.79-1.28; I2 = 77%; Cochran Q P-value < .05, Figure 1). TSA results confirmed that our meta-analysis was robust and authentic. The subgroup analyses yielded similar results that no difference exists in overall mortality in the different study designs (randomised control trials and non-randomised control trials), the different therapeutic regimens (hydroxychloroquine with and without azithromycin) and the different COVID-19 severities (all severity hospitalised, mild-to-moderate hospitalised, moderate-to-severe hospitalised and non-hospitalised patients). Chen et al PMID: 32391667 Skipper et al PMID: 32673060 Cavalcanti et al PMID: 32 706 953 RECOVERY Collaborative Group PMID: 33031652 Abd-Elsalam et al PMID: 32828135 Mitjà et al PMID: 32674126 Tang et al PMID: 32409561 WHO Solidarity Trial Consortium PMID: 33264556 Gautret et al PMID: 32205204 Rosenberg et al PMID: 32392282 Mahevas et al PMID: 32554525 Geleris et al PMID: 32379955 Yu et al PMID: 32418114 Lagier et al PMID: 32593867 Magagnoli et al PMC7274588 Paccoud et al PMID: 32556143 Arshad et al PMID: 32623082 Huang et al PMC7313782 Grimaldi et al PMID: 33025225 Ip et al PMID: 32790733 Mallat et al PMID: 33350752 Shailendra Singh (preprint) As the COVID-19 pandemic has reached critical new levels, there is an urgent need for effective treatments of the disease. A previous meta-analysis evaluating the effects of hydroxychloroquine in the treatment of COVID-19 was characterised by insufficient and often conflicting evidence.4 However, with numerous studies emerging since its publication, the previous meta-analysis, which included limited studies, does not reflect the current understanding of the literature. Thus, we performed an updated meta-analysis that showed no evidence of benefit for hydroxychloroquine in reducing mortality.4 Even if the meta-analysis alone concluded that the intervention has no effect, it still could have insufficient statistical power to investigate the true effects.5 TSA is a realistic and reliable tool to test whether the meta-analysis is adequately powered or reports spurious results because of systematic bias or random errors. The advantages of TSA include re-estimating the sample size needed or stopping further trials when the benefits of intervention are not existent.6 We performed TSA in the present meta-analysis and demonstrated that it might be futile to conduct future trials. Regarding the opportunity costs, further hydroxychloroquine trials aiming for reducing mortality should not be a top priority in the war against the COVID-19 pandemic. In conclusion, our meta-analysis with TSA suggests that the use of hydroxychloroquine in patients with COVID-19 has no benefit in reducing overall mortality. The authors thank Enago (www.enago.tw) for the support on the English language review. The authors declared no conflict of interest. PHC and CHL were involved in conceptualisation; PHC and HJJ in methodology and writing—original draft preparation; PHC in formal analysis; HJJ and LJOY in investigation; and LJOY and CHL in writing—review and editing. The data that support the findings of this study are available from the corresponding author upon reasonable request." @default.
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• W3201615314 date "2021-09-16" @default.
• W3201615314 modified "2023-09-25" @default.
• W3201615314 title "Does hydroxychloroquine reduce mortality in patients with COVID‐19? A meta‐analysis with trial sequential analysis" @default.
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• W3201615314 doi "https://doi.org/10.1111/ijcp.14448" @default.
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