OBJECTIVE: To evaluate the efficacy and safety of tramadol hydrochloride with behavioral modification in delaying ejaculation in patients with premature ejaculation. METHODS:Seventy-two potent men with premature ejaculation were equally and randomly assigned to a treatment group and control group, the former received 50 mg tramadol hydrochloride with behavioral modification approximately 2 hours before planned sexual activity, while the latter underwent behavioral therapy only, both treated for 8 weeks. Intravaginal ejaculatory latency time (IELT), intercourse satisfaction of the partners, total therapeutic effectiveness, adverse reactions, and hepatic and renal function of the patients were recorded and compared before and after the treatment. RESULTS: Both the treatment and the control groups showed significant differences from pretreatment in the mean IELT and intercourse satisfaction domain values (P < 0.01). The total rate of effectiveness was 72.2% in the treatment group and 47.2% in the control. The former exhibited even more significant improvement than the latter in the mean IELT, intercourse satisfaction domain values and total rate of effectiveness (P < 0.05). Adverse reactions occurred in 10 cases (27.8%), and no statistically significant differences were found in hepatic and renal function before and after treatment (P > 0.05). CONCLUSION:Tramadol hydrochloride with behavioral modification showed positive effects in prolonging IELT and improving partners' intercourse satisfaction. Yet more multicenter and double-blind studies are required to evaluate its efficacy and safety as a routine therapy for premature ejaculation.
RCT Entities:
OBJECTIVE: To evaluate the efficacy and safety of tramadol hydrochloride with behavioral modification in delaying ejaculation in patients with premature ejaculation. METHODS: Seventy-two potent men with premature ejaculation were equally and randomly assigned to a treatment group and control group, the former received 50 mg tramadol hydrochloride with behavioral modification approximately 2 hours before planned sexual activity, while the latter underwent behavioral therapy only, both treated for 8 weeks. Intravaginal ejaculatory latency time (IELT), intercourse satisfaction of the partners, total therapeutic effectiveness, adverse reactions, and hepatic and renal function of the patients were recorded and compared before and after the treatment. RESULTS: Both the treatment and the control groups showed significant differences from pretreatment in the mean IELT and intercourse satisfaction domain values (P < 0.01). The total rate of effectiveness was 72.2% in the treatment group and 47.2% in the control. The former exhibited even more significant improvement than the latter in the mean IELT, intercourse satisfaction domain values and total rate of effectiveness (P < 0.05). Adverse reactions occurred in 10 cases (27.8%), and no statistically significant differences were found in hepatic and renal function before and after treatment (P > 0.05). CONCLUSION:Tramadol hydrochloride with behavioral modification showed positive effects in prolonging IELT and improving partners' intercourse satisfaction. Yet more multicenter and double-blind studies are required to evaluate its efficacy and safety as a routine therapy for premature ejaculation.