Objective: To observe the clinical effect of Shugan Yiyang Capsules combined with sertraline in the treatment of premature ejaculation (PE).

Methods: We randomly assigned 192 PE patients to receive sertraline hydrochloride 50 mg qd (control group, n = 96) or sertraline hydrochloride 50 mg qd plus Shugan Yiyang Capsules at the dose of 4 capsules tid ( combination therapy group, n = 96) , both for 6 weeks. We compared the intravaginal ejaculatory latency time (IELT) and Chinese Index of Premature Ejaculation ( CIPE) scores between the two groups of patients before and after medication and at 6 weeks after drug withdrawal.

Results: Compared with the baseline, the IELT was significantly increased after 6 weeks of medication in the combination therapy group ([1.41 ± 0.53] vs [6.69 ± 3.56] min, P < 0.05) and the control group ([1.43 ± 0.48] vs [5.37 ± 2.91] min, P < 0.05), and so was the CIPE score in the former (9. 80 ± 2.06 vs 21.62 ± 4.76, P < 0.05) and the latter group ([9.41 ± 1.97] vs [20.85 ± 4.83] , P < 0.05). In comparison with the pre-medication indexes, the IELT ([3.77 ± 1.63] min) and CIPE score (16.92 ± 3.37) of the combined therapy group were remarkably improved at 6 weeks after drug withdrawal (P < 0.05), but not those of the control ([1.19 ± 1.34] min and 10.59 ± 2.38, P > 0.05).

Conclusion: Shugan Yiyang Capsules combined with sertraline have a definite and lasting effect on premature ejaculation.

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