Abstract: PD44-12
Sources of Funding: None

Introduction

Female Sexual Dysfunction (FSD) is a highly prevalent disease that has an immense impact on personal relationships and quality of life. The literature describes various treatment modalities with mixed effects across the four domains: hypoactive sexual desire disorder, arousal disorder, orgasmic disorder, and sexual pain disorder. The limited efficacy of medical treatment likely speaks to a significant psychological component of the disease. The purpose of this meta-analysis of randomized controlled trials (RCTs) was to quantify the placebo effect of various pharmacologic modalities for FSD.

Methods

Utilizing MOOSE guidelines, we conducted a systematic review of PubMed®, EMBASE®, clinicaltrials.gov, and the Cochrane Review databases. Using search terms &[Prime]female sexual dysfunction&[Prime] and &[Prime]treatment,&[Prime] in combination with &[Prime]vulvovaginal atrophy,&[Prime] &[Prime]vaginismus,&[Prime] &[Prime]vaginal atrophy,&[Prime] &[Prime]vulvodynia,&[Prime] and &[Prime]vestibulitis,&[Prime] 603 relevant articles were retrieved. Twenty-two RCT&[prime]s met initial inclusion/exclusion criteria and included a placebo arm. Of these, eight studies that utilized the primary outcome measure, the Female Sexual Function Index (FSFI), were ultimately selected for meta-analysis. The placebo effect on FSFI was compared to the respective study&[prime]s treatment effect using inverse-variance weighting in a random effects analysis model.

Results

Across the eight studies, 1,723 women with clinical pretreatment FSD received placebo. 2,236 women were in the treatment arm of the respective studies and received various pharmacologic interventions including flibanserin, bupropion, onabotulinum toxin A, intravaginal Prasterone, intranasal oxytocin, ospemifene, and bremelanotide. Women receiving placebo improved 3.62 [95% CI: (3.29-3.94)] on the FSFI (Figure 1). The treatment arm had a corresponding increase of 5.35 [95% CI: (4.13-6.57)].

Conclusions

This meta-analysis of Level 1 evidence demonstrates that 67.7% of the treatment effect for FSD is accounted for by placebo. This is consistent with the current literature. Further, this study suggests that the current treatments for FSD are, overall, minimally superior to placebo alone which reinforces the significant psychosocial element of the disease process in women.

Funding

None