Four randomized, placebo-controlled clinical trials were included. A total of 3,414 patients participated in these trials.
On the primary outcome measures, patients on flibanserin showed a statistically significantly greater improvement than those on placebo as follows:
1. “Satisfying sexual events”: standardized mean difference 0.59, which indicates a moderately large effect.
2. Sexual desire score: standardized mean difference 1.91, which indicates a large effect.
3. Female Sexual Function Index (FSFI) desire domain score: standardized mean difference 0.32, indicating a small effect.
Flibanserin was also more efficacious than placebo on the following key secondary efficacy endpoints: Female Sexual Function Index (FSFI) total score, Female Sexual Distress Scale-Revised (FSDS-R) total score, FSDS-R Item 13 score, Patient's Global Impression of Improvement score, and Patient Benefit Evaluation.
The authors state that the safety assessments “indicated that flibanserin was well tolerated.” However, adverse events were looked at only in the aggregate: proportion of women experiencing an adverse event (odds ratio 1.5), a nervous system event (odds ratio 2.6), or fatigue (odds ratio 1.7). So, stating that flibanserin was “well tolerated” does not appear to be supported by the data provided.