Purpose: To compare the safety and efficacy of dapoxetine and acupuncture for the treatment of premature ejaculation (PE) with other treatment methods. Methods: One hundred twenty patients with PE in an outpatient urology clinic were randomized to receive dapoxetine 30 mg and 60 mg, acupuncture or sham acupuncture. The intravaginal ejaculatory latency time (IELT), the PE diagnostic tool (PEDT) score, and adverse events were compared. Results: There were no differences between the groups in terms of age, body mass index, baseline IELT and PEDT scores (p > 0.05). After 4 weeks, IELT was significantly longer compared to baseline values in all groups (p < 0.001 for all comparisons). Comparisons between the groups showed that changes in IELT and PEDT observed after 4 weeks with dapoxetine 60 mg was significantly higher than those achieved in all other groups (p < 0.001 for all comparisons), changes observed with dapoxetine 30 mg was significantly higher than those achieved with acupuncture and sham acupuncture groups (p < 0.001 for both comparisons) and changes observed with acupuncture was significantly higher than those observed with sham acupuncture (p < 0.001). Conclusion: Our results confirm previous reports on the efficacy and safety of dapoxetine. Although less effective than dapoxetine, acupuncture had a significant ejaculation-delaying effect.

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