PD44-12 FEMALE SEXUAL DYSFUNCTION TREATMENT: A META-ANALYSIS OF THE PLACEBO EFFECT ACROSS RANDOMIZED CONTROLLED TRIALS

Abstract

You have accessJournal of UrologySexual Function/Dysfunction: Female1 Apr 2017PD44-12 FEMALE SEXUAL DYSFUNCTION TREATMENT: A META-ANALYSIS OF THE PLACEBO EFFECT ACROSS RANDOMIZED CONTROLLED TRIALS James M. Weinberger, Justin Houman, Ashley Caron, Avi S. Baskin, A. Lenore Ackerman, Karyn S. Eilber, and Jennifer T. Anger James M. WeinbergerJames M. Weinberger More articles by this author , Justin HoumanJustin Houman More articles by this author , Ashley CaronAshley Caron More articles by this author , Avi S. BaskinAvi S. Baskin More articles by this author , A. Lenore AckermanA. Lenore Ackerman More articles by this author , Karyn S. EilberKaryn S. Eilber More articles by this author , and Jennifer T. AngerJennifer T. Anger More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.2069AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES 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 ″female sexual dysfunction″ and ″treatment,″ in combination with ″vulvovaginal atrophy,″ ″vaginismus,″ ″vaginal atrophy,″ ″vulvodynia,″ and ″vestibulitis,″ 603 relevant articles were retrieved. Twenty-two RCT′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′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. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e884 Advertisement Copyright & Permissions© 2017MetricsAuthor Information James M. Weinberger More articles by this author Justin Houman More articles by this author Ashley Caron More articles by this author Avi S. Baskin More articles by this author A. Lenore Ackerman More articles by this author Karyn S. Eilber More articles by this author Jennifer T. Anger More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...