OBJECTIVE:To investigate the effects of Ningmitai capsule combined with sertraline on patients with premature ejaculation (PE) and an increased anterior-posterior diameter (APD) of the seminal vesicles (SVs).METHODS:Sixty men with acquired PE were enrolled and randomly divided into two groups.The combined group was treated with Ningmitai capsule and sertraline,while the control group was treated with sertraline alone.Main outcomes were measured using the premature ejaculation diagnostic tool (PEDT),APD of SVs,and Clinical Global Impression of Change questionnaire and compared before and after 3 months of treatment.RESULTS:Comparing after treatment with before treatment outcomes within each group,the PEDT score was significantly reduced in the combined group (12.1 ± 2.5 vs 8.6 ± 3.2,P ＜ 0.001,respectively) and control group (12.9 ± 2.6 vs 10.3 ± 1.6,P ＜ 0.001,respectively).Furthermore,the PEDT score after treatment was significantly lower in the combined compared with control group (8.6 ± 3.2 vs 10.3 ± 1.6,P =0.01 1,respectively).The APD of SVs in the combined group was significantly decreased after treatment [(10.8 ± 2.4) vs (12.9 ± 2.2) mm,P =0.001],while the APD of SVs in the control group was equivalent before and after treatment.The treatment response rate was not significantly higher in the combined compared with control group.CONCLUSION:These results indicated that the effect of Ningmitai capsule combined with sertraline was better than that of sertraline alone for the treatment of PE patients exhibiting an increased APD of SVs.The therapeutic effect found for the combined treatment may be due to antibacterial and anti-inflammatory activity reported for Ningmitai capsule,and may suggest that seminal vesiculitis is a potential pathophysiological factor in acquired PE.