Abstract
The purpose of this meta-analysis was to evaluate the efficacy and safety of the once-daily use of 5 mg tadalafil in the treatment of patients with premature ejaculation. The databases MEDLINE/PubMed, EMBASE, and Cochrane Library from January 1980 until December 2024 were searched to identify randomized controlled trials (RCTs) that referred to the use of tadalafil for the treatment of premature ejaculation. A systematic review and meta-analysis was conducted. Five publications involving 397 patients were included in the meta-analysis. No statistically significant difference was identified between tadalafil and placebo for intravaginal ejaculatory latency time (IELT; mean difference [MD] = 68.43; 95% confidence interval [CI] = [−12.59 to 149.45]; p = .10) and Arabic index of premature ejaculation (AIPE; MD = 11.44; 95% CI = [−11.79, 34.66]; p = .33). Tadalafil appeared to improve the score of the premature ejaculation diagnostic tool (PEDT; MD = −0.30; 95% CI = [−0.57, −0.03]; p = .03). In terms of adverse events, the tadalafil group was significantly higher than the placebo group for headache (odds ratio [OR] = 16.06, 95% CI = [3.80, 67.94], p = .0002), back pain and myalgia (OR = 21.76, 95% CI = [4.17, 113.53], p = .0003), flushing (OR = 6.05, 95% CI = [1.05, 34.92], p = .04), and dyspepsia (OR = 10.27, 95% CI = [1.90, 55.96], p < .007). Our meta-analysis indicates that the once-daily use of 5 mg tadalafil had no statistically significant effect in the treatment of premature ejaculation. Meanwhile, the tadalafil therapy showed a higher risk of complications.