The primary outcome was change from baseline to end-point in the Clinical Global Impression Scale, a clinician-rated scale based on review of patient symptoms that was adapted to evaluate sexual function. Secondary outcomes were changes in 3 other sexual function scales, the Hamilton Rating Scale for Depression, and measured hormone levels.
Investigators followed the women for 8 weeks, measuring outcomes at 2, 4, and 8 weeks.
Sildenafil is better than placebo
Using an intention-to-treat analysis with the last measurement (2, 4, or 8 weeks) as the end-point, both the treatment and placebo groups experienced improvement in sexual function. The sildenafil group improved more than the placebo group. On the Clinical Global Impression Scale (1 to 7, with higher scores indicating worse sexual function), sildenafil users went from a mean of 4.8 to 2.8, while placebo users went from a mean of 4.7 to 3.6. The difference in mean change from baseline was 0.8 (95% confidence interval [CI] 0.6-1.0; P=.001). Using a more conservative analysis in which participants who did not return for the 8-week follow-up visit were assumed to have returned to baseline, the difference in mean change from baseline was smaller (0.6, 95% CI, 0.3-0.8; P=0.03) but still statistically significant.
Orgasmic function shows significant improvement
The sexual function scales used as secondary outcomes provided more detail about which types of sexual dysfunction benefited from sildenafil. On all 3 scales, orgasmic function significantly favored sildenafil over placebo. In the domains of desire, arousal, and pain disorders, small to moderate improvements were seen in both groups, with no statistically significant differences. One potential confounder—a difference in the course of participants’ underlying depression— was ruled out because depression scale results remained unchanged from baseline to endpoint in both groups.
Baseline levels of cortisone, estradiol, follicle-stimulating hormone, leuteinizing hormone, progesterone, prolactin, sex hormone-binding globulin, testosterone, thyroid-stimulating hormone, and thyroxine, were normal, with no differences between the sildenafil and placebo groups.
WHAT’S NEW: Women have an evidence-based option
Like their male counterparts, we can now offer women whose depression is effectively treated by SRI antidepressants—and who are motivated to stay sexually active despite medication-associated side effects—an effective pharmacotherapeutic treatment.
