Efficacy and safety of dapoxetine in the treatment of premature ejaculation
Abstract
OBJECTIVE: To evaluate the clinical effect and safety of dapoxetine in the treatment of premature ejaculation (PE).
METHODS: We randomly assigned 116 PE patients to receive dapoxetine on demand at 30 mg qd (dapoxetine group, n = 60, aged 23-49 years) or oral tamsulosin at 20 mg qd (control group, n = 56, aged 24-46 years). After 4 weeks of medication, we compared the clinical global impression of change (CGIC) , PE profile (PEP) scores, intravaginal ejaculation latency time (IELT) , and adverse reactions between the two groups of patients.
RESULTS: Compared with the baseline, the IELT was remarkably prolonged after treatment both in the dapoxetine group ([0.86 ± 0.17] vs [4.32 ± 2.23] min, P 0. 05). The post-treatment rate of CGIC in the dapoxetine group had no statistically significant difference from that in the control (85.00% vs 82.14%, P > 0.05). In comparison with pre-treatment, the patients of both the dapoxetine and control groups showed dramatically improved scores after medication in perceived control over ejaculation (0.85 ± 0.23 vs 2.13 ± 0.97 and 0.88 ± 0.21 vs 2.06 ± 0.34, both P 0.05). The incidence of adverse reactions was significantly lower in the dapoxetine than in the control group (3.33% vs 30.36%, P < 0.05).
CONCLUSION: Dapoxetine is effective for the treatment of PE, with its advantages of prolonging the intravaginal ejaculation latency time, improving the quality of sexual life, and low incidence of adverse reactions.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 116 participants or records.
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