Dapoxetine for the treatment of premature ejaculation: a meta-analysis of randomized controlled trials with trial sequential analysis

BACKGROUND: The safety and efficacy of dapoxetine for the treatment of premature ejaculation (PE) is still controversial. Thus, we decided to conduct a meta-analysis using trial sequential analysis (TSA) to determine the sufficiency of conclusions. OBJECTIVE: Evaluate the efficacy and safety of dapoxetine in the treatment of patients with PE and assess the reliability of the findings. DESIGN: Meta-analysis of randomized controlled trials (RCTs). METHODS: Electronic databases including PUBMED, EMBASE, Cochrane Library, CNKI and Wanfang data were reviewed up to July 2017. RCTs evaluating the efficacy of dapoxetine in patients with PE and reporting intravaginal ejaculatory latency time (IELT), patient global impression of change (PGIC) and/or adverse events (AEs) were included. MAIN OUTCOME MEASURES: Mean differences between trials in efficacy for IELT, and risk ratios for PGIC and treatment-emergent AEs. SAMPLE: 8 RCTs. RESULTS: For IELT and PGIC, significant effects were found for all doses of dapoxetine versus placebo, and similar results were obtained in subgroups of the 30-mg dose versus 60-mg dose. There were also statistically different dose-related effects on AEs. Trial sequential analysis showed that the result of our meta-analysis was confirmed and further trials are unnecessary. CONCLUSIONS: The evidence suggests that dapoxetine may be a safe and effective drug for patients with PE. REGISTRATION: Not registered, no published protocol.