Systematic Review and Meta-analysis of Flibanserin's Effects and Adverse Events in Women with Hypoactive Sexual Desire Disorder.

OBJECTIVE: The efficacy and safety of flibanserin in the treatment of Hypoactive Sexual Desire Disorder (HSDD) is controversial. We reviewed existing evidence on the efficacy and safety of flibanserin in treating HSDD, and performed a meta-analysis of reported effects.

METHOD: Literature search was performed in PubMed, Scopus, and Cochrane library to find all trials on the efficacy of flibanserin in HSDD. Meta-analysis was performed using fixed- and random-effects models. Egger's test and "trim and fill" methods were used for the assessment of publication bias and imputation of potentially missing studies, respectively.

RESULTS: Among 105 studies that were initially found, only ten related documents (six published and four nonpublished studies) were included in the final analysis, comprising 8345 subjects (6113 and 2232 subjects in the flibanserin and placebo groups, respectively). Incomplete outcome data bias was probable in the included studies. Most studies had an acceptable validity and quality. There was no significant difference between flibanserin and placebo groups in most of the HSDD-assessed indices. Our results showed that although SSE, DSDS, FSFID and FSFI are significantly improved with flibanserin, this change did not reach statistical significance compared with placebo. For FSDSR-item 13 score and FSDSR total score, no significant difference was observed between flibanserin and placebo. The most common side effect of flibanserin was somnolence. The most common causes of heterogeneity were black ethnicity, duration of therapy, age of participants and duration of marital relationship.

CONCLUSION: the efficacy of flibanserin in women with HSDD was not found to be significantly different compared with placebo. Additional trials are required to clarify the efficacy of flibanserin for the treatment of HSDD.