, the US Food and Drug Administration (FDA) approved flibanserin as a treatment for hypoactive sexual desire disorder (HSDD) in premenopausal women, despite concern about suboptimal risk-benefit trade-offs. OBJECTIVE To conduct a systematic review and meta-analysis of randomized clinical trials assessing efficacy and safety of flibanserin for the treatment of HSDD in women. DATA SOURCES Medical databases (among others, Embase, Medline, Psycinfo) and trial registries were searched from inception to June 17, 2015. Reference lists of retrieved studies were searched for additional publications. STUDY SELECTION Randomized clinical trials assessing treatment effects of flibanserin in premenopausal and postmenopausal women were eligible. No age, language, or date restrictions were applied. Abstract and full-text selection was done by 2 independent reviewers. DATA EXTRACTION AND SYNTHESIS Data were extracted by one reviewer and checked by a second reviewer. Results were pooled using 2 approaches depending on the blinding risk of bias. MAIN OUTCOMES AND MEASURES Primary efficacy outcomes included number of satisfying sexual events (SSEs), eDiary sexual desire, and Female Sexual Function Index (FSFI) desire. Safety outcomes included, among others, 4 common adverse events (AEs): dizziness, somnolence, nausea, and fatigue. RESULTS Five published and 3 unpublished studies including 5914 women were included. Pooled mean differences for SSE change from baseline were 0.49 (95% CI, 0.32-0.67) between 100-mg flibanserin and placebo, 1.63 (95% CI, 0.45-2.82) for eDiary desire, and 0.27 (95% CI, 0.17-0.38) for FSFI desire. The risk ratio for study discontinuation due to AEs was 2.19 (95% CI, 1.50-3.20). The risk ratio for dizziness was 4.00 (95% CI, 2.56-6.27) in flibanserin vs placebo, 3.97 (95% CI, 3.01-5.24) for somnolence, 2.35 (95% CI, 1.85-2.98) for nausea, and 1.64 (95% CI, 1.27-2.13) for fatigue. Women's mean global impression of improvement scores indicated minimal improvement to no change. CONCLUSIONS AND RELEVANCE Treatment with flibanserin, on average, resulted in one-half additional SSE per month while statistically and clinically significantly increasing the risk of dizziness, somnolence, nausea, and fatigue. Overall, the quality of the evidence was graded as very low. Before flibanserin can be recommended in guidelines and clinical practice, future studies should include women from diverse populations, particularly women with comorbidities, medication use, and surgical menopause.

Introduction Internet-based sex therapy for men with erectile dysfunction has been advocated as an easily accessible and cost-effective treatment. Aim To test whether Internet-based sex therapy is superior to waiting list. Methods Internet-based therapy was administered to heterosexual men with erectile dysfunction or premature ejaculation, without face-to-face contact, in a waiting-list controlled design, with pre-, post-, and follow-up measurements at 3 and 6 months posttreatment. Treatment was based on the sensate-focus model of Masters and Johnson, and supplemented with cognitive restructuring techniques. Main Outcome Measures Self-reported improvement of sexual functioning, erectile functioning (men with ED), premature ejaculation (men with PE), sexual desire, overall sexual satisfaction, and sexual self-confidence. Results Ninety-eight men participated (58 ED, 40 PE). Sexual functioning was much or somewhat improved in 40 participants (48%). In participants with ED, a near significant effect of treatment was found (P = 0.065), with higher levels of sexual desire (P < 0.05) and sexual self-confidence (P = 0.05) in treated men, in addition to improved erectile functioning (P = 0.01) and overall sexual satisfaction (P < 0.001) in both groups. In participants with PE, treatment was not superior to waiting list. In participants with ED, erectile functioning (P < 0.05) and overall sexual satisfaction (P = 0.002) improved significantly. In participants with PE, latency to ejaculation (P < 0.001), sexual desire (P < 0.05), and overall sexual satisfaction (P < 0.05) improved significantly from baseline to posttreatment, with no further changes at both follow-ups. Sexual self-confidence in men with PE remained unchanged during treatment until follow-up at 3 months posttreatment, and then was found to be improved at 6-months follow-up (P < 0.05). Conclusion Internet-based sex therapy for male erectile dysfunction was efficacious for male erectile disorder. For men with premature ejaculation, however, treatment was not superior to waiting list.

Results are described of a pilot study of the efficacy of sex therapy through the Internet for thirty-nine men with erectile dysfunction or rapid ejaculation. Treatment consisted of sex therapy (Masters & Johnson, 1970), had a duration of three months, and was conducted entirely through e-mail. Forty-six percent of the participants dropped out. Fourteen (67%) participants reported an improvement of their sexual functioning. Seven (47%) participants reported the improvement had sustained one month after termination, eight (53%) participants reported no further change. We conclude that sex therapy through the Internet may yield positive results and that further controlled studies are warranted.