OBJECTIVETo compare the efficacy and safety of sildenafil plus sertraline with those of sertraline alone in the treatment of premature ejaculation (PE).

METHODSSeventy-two patients with PE but without any obvious organic cause were enrolled in this study. They were randomly divided into Groups A and B of equal number. Group A received 50 mg sertraline daily 4 to 6 hours before planned sexual activity for 12 weeks, and Group B were given 50 mg sertraline daily plus 50 mg sildenafil as needed, 1 hour before planned sexual activity, for 12 weeks. Before and after the treatment, the mean intravaginal ejaculation latency time, the intercourse satisfaction, the mean number of coituses per week and the drug-related side effects were evaluated.

RESULTSThe mean intravaginal ejaculatory latency time was (0.59 +/- 0.12), (3.9 +/- 0.15) minutes (P < 0.001) at baseline and post-treatment in Group A, and (0.56 +/- 0.11), (5.6 +/- 0.12) minutes (P < 0.001) in Group B, improved in both of the 2 groups, but more significantly in Group B (P < 0.05). Before and after the treatment, the mean intercourse satisfaction domain values of the IIEF were (8.9 +/- 1.2), (10.8 +/- 1.1) (P < 0.05) and (8.8 +/- 1.1), (13.8 +/- 1.3) (P < 0.001) in Groups A and B, respectively, significantly greater in Group B than in Group A (P < 0.05) after the treatment; the mean numbers of coituses per week in Groups A and B were (0.9 +/- 0.2), (1.9 +/- 0.3) (P < 0.05) and (1.0 +/- 0.2), (2.7 +/- 0.2) (P <0.001) respectively, significantly larger in Group B (P<0.05) after the treatment. As for the side effects, there was a higher rate of headaches (P < 0.01) and flushing episodes (P < 0.001) in Group B than in Group A.

CONCLUSIONSertraline combined with sildenafil can produce significantly better results than sertraline alone in patients with premature ejaculation. However, the combined treatment is associated with a slight increase in the drug-related side effects.