title: The efficacy and safety of ospemifene in treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy: a systematic review and meta-analysis.
abstract: BACKGROUND
  Ospemifene, a novel selective estrogen receptor modulator, has been developed for the treatment of vulvovaginal atrophy and dyspareunia in postmenopausal women.
  
  
  OBJECTIVE
  We carried out a systematic review and meta-analysis to assess the efficacy and safety of the drug for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy.
  
  
  METHODS
  A literature review was performed to identify all published randomized double-blind, placebo-controlled trials of ospemifene for the treatment of vulvovaginal atrophy and dyspareunia. The search included the following databases: MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. The reference lists of the retrieved studies were also investigated. A systematic review and meta-analysis was conducted.
  
  
  METHODS
  Six publications involving a total of 1,772 patients were used in the analysis, including three randomized controlled trials (RCTs) that were short-term (12 weeks) comparisons of ospemifene with placebo and three RCTs that were long-term (1 year) comparisons of ospemifene with placebo.
  
  
  RESULTS
  For the comparison of short-term ospemifene with placebo, parabasal cells (the standardized mean difference [SMD] = -37.5, 95% confidence interval [CI] = -41.83 to -33.17, P < 0.00001), superficial cells (SMD = 9.24, 95% CI = 7.70 to 10.79, P < 0.00001), vaginal PH (SMD = -0.89, 95% CI = -0.98 to -0.80, P = 0.00001), and dyspareunia (SMD = -0.37, 95% CI = -0.43 to -0.30, P = 0.00001) indicated that ospemifene was more effective than the placebo. For the comparison of long-term ospemifene with placebo, endometrial thickness (SMD = 0.90, 95% CI = 0.58 to 1.23, P = 0.00001), treatment emergent adverse event, discontinuations due to adverse event, and serious adverse event indicated that ospemifene was generally safe.
  
  
  CONCLUSIONS
  This meta-analysis indicates that ospemifene to be an effective and safe treatment for dyspareunia associated with postmenopausal vulvar and vaginal atrophy.
authors.affiliation: Department of Urology, Beijing Tian-Tan Hospital, Capital Medical University, Beijing, China.
authors.forename: Yuanshan
authors.initials: Y
authors.lastname: Cui
authors.forename: Huantao
authors.initials: H
authors.lastname: Zong
authors.forename: Huilei
authors.initials: H
authors.lastname: Yan
authors.forename: Nan
authors.initials: N
authors.lastname: Li
authors.forename: Yong
authors.initials: Y
authors.lastname: Zhang
mesh_terms: D001284:Atrophy / Q000473:pathology; D004311:Double-Blind Method; D004414:Dyspareunia / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D005260:Female; D006801:Humans; D017698:Postmenopause; D020845:Selective Estrogen Receptor Modulators / Q000009:adverse effects / Q000627:therapeutic use*; D013629:Tamoxifen / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome; D014621:Vagina / Q000473:pathology*; D014844:Vulva / Q000473:pathology*
chemical_list: D020845:Selective Estrogen Receptor Modulators; D013629:Tamoxifen; C119141:Ospemifene
keywords: Dyspareunia; Meta-Analysis; Ospemifene; Randomized Controlled Trial; Sexual Pain; Vulvovaginal Atrophy