Objective: To obtain systematic and comprehensive evidence regarding the benefits and safety of PDE5i compared to those of placebo.
Methods: All randomized controlled trials (RCTs) reporting on the effectiveness of PDE5i in FSD were identified through comprehensive searches of PubMed, the Cochrane Library and Embase, and a meta-analysis and systematic review of these studies were conducted.
Results: Fourteen studies were included for meta-analysis. Because RCTs included in our study adopted different questionnaires for the measurement of sexual function, most of the data had to be separated rather than pooling the results. Summarizing the results of each comparison, we found that the use of PDE5i resulted in a significant improvement in sexual functioning compared with placebo in most studies, except for a few sporadic negative results. However, pooled data for adverse events showed significantly higher rates of headache, flushing, and vision changes in PDE5i treatment group [risk ratio (RR) 2.59, 95%95% confidence interval (CI), 1.93–3.47, P<0.00001; RR 5.74, 95% CI, 3.60–9.14, P<0.00001; and RR 4.64, 95% CI, 2.16–9.98, P<0.0001, respectively]. However, no one reported the need of any additional therapy for these adverse events.
Conclusions: Our results indicate that PDE5i would be effective for female sexual dysfunction. Though there were significantly higher rates of adverse events, use of PDE5i was still relatively safe. More well-designed, double-blind, crossover RCTs reporting results from standardized questionnaires should be conducted to accurately solve this issue.
