Abstract:Objective To investigate the clinical effect of paroxetine and Tiaogan Yishen Decoction used alone or in combination in the treatment of premature ejaculation. Methods A total of 96 patients with premature ejaculation were randomly divided into paroxetine group, Tiaogan Yishen Decoction group, and paroxetine+Tiaogan Yishen Decoction group, with 32 patients in each group. The patients in the paroxetine group were given oral administration of paroxetine (20 mg) once every night, those in the Tiaogan Yishen Decoction group were given oral administration of the traditional Chinese medicine Tiaogan Yishen Decoction 1 dose per day (divided into two portions and taken in the morning and evening), and those in the paroxetine+Tiaogan Yishen Decoction group were given oral administration of paroxetine and Tiaogan Yishen Decoction. The course of treatment was 8 weeks for all groups, and the three groups were compared in terms of intravaginal ejaculatory latency time (IELT), Chinese Index of Sexual Function for Premature Ejaculation (CIPE), and adverse events before and after treatment and at week 10 after drug withdrawal. Results After treatment and at week 10 after drug withdrawal, all three groups had significant increases in IELT and the total score and the scores of each item of CIPE (P<0.05). Compared with the paroxetine group and the Tiaogan Yishen Decoction group, the paroxetine+Tiaogan Yishen Decoction group had a significant increase in IELT after treatment and at week 10 after drug withdrawal (P<0.05). At week 10 after drug withdrawal, the Tiaogan Yishen Decoction group had a significantly longer IELT than the paroxetine group (P<0.05), while there were no significant differences in the total score and the scores of each item of CIPE between the two groups (P>0.05). There was no significant difference in the incidence rate of adverse events between the three groups (P>0.05). Conclusion Tiaogan Yishen Decoction combined with paroxetine has good short- and long-term effects and few adverse effects in the treatment of premature ejaculation. The traditional Chinese medicine Tiaogan Yishen Decoction also has a certain application value in clinical practice because of its good safety and long-term effect.