Systematic review and meta-analysis of phosphodiesterase type 5 inhibitors for the treatment of female sexual dysfunction

Background: Clinical studies evaluating the effectiveness and safety of phosphodiesterase type 5 inhibitors (PDE5is) for female sexual dysfunction have reported conflicting results.

Objectives: To systematically review evidence from studies comparing PDE5is with placebo in the treatment of female sexual dysfunction.

Search strategy: Searches of PubMed, the Cochrane Library, and Embase databases were performed using the MeSH terms "females/female/women", "sexual", and "sildenafil/tadalafil/vardenafil/PDE5/PDE5i".

Selection criteria: All randomized controlled trials, available in English, published no later than January 28, 2015 comparing the effectiveness of PDE5is, or PDE5is in combination with other agents, with placebo in improving female sexual function were included.

Data collection and analysis: The inclusion criteria were met by 14 studies, which were analyzed by two reviewers.

Main results: The randomized controlled trials included in the present study adopted different questionnaires for measuring sexual function; consequently, most of the data had to be considered separately rather than pooled. Generally, the use of PDE5is resulted in significant improvements in sexual function compared with placebo, with some studies demonstrating negative results. Pooled data regarding adverse events demonstrated significantly higher rates of headache, flushing, and changes in vision in PDE5i-treated patients.

Conclusions: PDE5is could be an effective treatment modality for female sexual dysfunction. Although there were significant increases in adverse events in comparison with placebo, PDE5is were still relatively safe.