Introduction: Clomipramine is effective in treating premature ejaculation, a common form of male sexual dysfunction that affects individual's mental health and quality of life, but its optimal dosage remains controversial. Aim: In this systematic review and meta-analysis, we aimed to evaluate the efficacy, safety, and optimal dose of clomipramine for treating premature ejaculation among men. Methods: Eligible studies of PubMed, Embase, and Web of Science were identified from the date of inception to June 21, 2020. We conducted the study according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Data of the study characteristics, intravaginal latency ejaculatory time (IELT), adverse events, success rate, and satisfaction rate of clomipramine vs placebo were extracted and analyzed. The risk ratio and mean difference were used for quantitatively analyzing binary outcomes and continuous outcomes. The standardized mean difference was applied to the outcome of satisfaction rate. The Mantel–Haenszel method was used for meta-analysis under random-effects model. To assess dose effect of clomipramine, a meta-regression analysis was performed. Main Outcome Measures: The primary outcomes were the IELT and adverse events, and the secondary outcomes were the success rate and satisfaction rate of clomipramine treatment relative to the placebo. Results: A total 14 randomized controlled trials with 710 patients were included for quantitative analysis. Clomipramine significantly increased the IELT compared with the placebo (mean difference: 1.47, 95% CI: 0.73–2.21). However, clomipramine was associated with higher risks of overall adverse events and adverse events in the nervous and respiratory systems. Significant dosage effects on the IELT (estimate: 0.0637, 95% CI: 0.0074–0.12) and a slightly increasing slope on adverse events were revealed. Conclusion: Clomipramine increased the IELT and yielded greater satisfaction than the placebo, and the higher dose results in a superior IELT without leading to higher risk of adverse events under a dosage of 50-mg clomipramine. Wu P-C, Hung C-S, Kang Y-N, et al. Tolerability and Optimal Therapeutic Dosage of Clomipramine for Premature Ejaculation: A Systematic Review and Meta-Analysis. Sex Med 2020;9:100283.
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