PMID- 30284992 OWN - NLM STAT- MEDLINE DCOM- 20190125 LR - 20221207 IS - 0975-4466 (Electronic) IS - 0256-4947 (Print) IS - 0256-4947 (Linking) VI - 38 IP - 5 DP - 2018 Sep-Oct TI - Dapoxetine for the treatment of premature ejaculation: a meta-analysis of randomized controlled trials with trial sequential analysis. PG - 366-375 LID - 10.5144/0256-4947.2018.366 [doi] AB - 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. CONFLICT OF INTEREST: No relationship with manufacturer of drug. FAU - Li, Jing AU - Li J AD - Dr. Jing Li, Department of Urology,, Xinxiang Central Hospital,, Xinxiang 453000, China, T: +8613462286403, hnxx.lijing029@163.com, ORCID: http:// orcid.org/0000-0003-3030-354X. FAU - Liu, Dezhi AU - Liu D FAU - Wu, Jinfeng AU - Wu J FAU - Fan, Xiaoyong AU - Fan X FAU - Dong, Qianqian AU - Dong Q LA - eng PT - Journal Article PT - Meta-Analysis PT - Review PL - Saudi Arabia TA - Ann Saudi Med JT - Annals of Saudi medicine JID - 8507355 RN - 0 (Benzylamines) RN - 0 (Naphthalenes) RN - 0 (Serotonin Uptake Inhibitors) RN - GB2433A4M3 (dapoxetine) SB - IM MH - Benzylamines/adverse effects/*therapeutic use MH - Ejaculation/drug effects MH - Humans MH - Male MH - Naphthalenes/adverse effects/*therapeutic use MH - Premature Ejaculation/*drug therapy MH - Randomized Controlled Trials as Topic MH - Selective Serotonin Reuptake Inhibitors/adverse effects/*therapeutic use MH - Time Factors PMC - PMC6180218 COIS- CONFLICT OF INTEREST: No relationship with manufacturer of drug. EDAT- 2018/10/05 06:00 MHDA- 2019/01/27 06:00 PMCR- 2018/09/01 CRDT- 2018/10/05 06:00 PHST- 2018/10/05 06:00 [entrez] PHST- 2018/10/05 06:00 [pubmed] PHST- 2019/01/27 06:00 [medline] PHST- 2018/09/01 00:00 [pmc-release] AID - asm-5-366 [pii] AID - 10.5144/0256-4947.2018.366 [doi] PST - ppublish SO - Ann Saudi Med. 2018 Sep-Oct;38(5):366-375. doi: 10.5144/0256-4947.2018.366.