Ospemifene for the treatment of vulvar and vaginal atrophy: A meta-analysis of randomized trials. Part I: Evaluation of efficacy

• Published in: Maturitas Vol. 121; pp. 86 - 92
• Main Authors: Di Donato, Violante, schiavi, Michele Carlo, iacobelli, Valentina, D’oria, Ottavia, Kontopantelis, Evangelos, Simoncini, Tommaso, Muzii, Ludovico, Benedetti Panici, Pierluigi
• Format: Journal Article
• Language: English
• Published: Ireland Elsevier B.V 01.03.2019
• Subjects: Atrophy - drug therapy; Dyspareunia; Female; Humans; Ospemifene; Randomized controlled trial; Randomized Controlled Trials as Topic; Selective Estrogen Receptor Modulators - therapeutic use; SERM; Tamoxifen - analogs & derivatives; Tamoxifen - therapeutic use; Treatment Outcome; Vagina - pathology; Vaginal Diseases - drug therapy; Vulva - pathology; Vulvar Diseases - drug therapy; Vulvovaginal atrophy; Dyspareunia; Ospemifene; SERM; Vulvovaginal atrophy; Randomized controlled trial
• ISSN: 0378-5122; 1873-4111
• DOI: 10.1016/j.maturitas.2018.11.016

•Ospemifene is a novel selective estrogen receptor modulator for the treatment of vulvo-vaginal atrophy and dyspareunia.•This meta-analysis reviews all the published randomized controlled trials on the efficacy of ospemifene.•This drug seems to be an effective treatment for dyspareunia and vaginal dryness. To evaluate the efficacy of ospemifene in treating dyspareunia associated with postmenopausal vulvo-vaginal atrophy (VVA). A structured search was carried out in PubMed-Medlin, Embase, Cochrane Controlled Trials Register databases through to 31 July 2018. The search included the following terms: "Ospemifene", "vulvovaginal atrophy", "dyspareunia", “SERM” and "randomized controlled trial" (RCTs). Four outcomes were selected: vaginal pH; proportions of parabasal and superficial vaginal cells; and perception of the most bothersome symptom (vaginal dryness or dyspareunia). A random-effects model was used in the meta-analysis. Study quality and bias risk were assessed with the Cochrane tool. Six RCTs comparing the efficacy of ospemifene against placebo after 12 and 52 weeks of treatment were included in the meta-analysis. At 12 weeks, changes in vaginal Ph (SMD: -0.96, 95% CI:-1.12 to –0.81; p < 0.0001), parabasal cells (SMD: -36.84 95% CI -46.95 to -26.72; p < 0.0001), superficial cells (SMD: 8.23, 95% CI 3.73–12.74, p < 0.0003), and dyspareunia (SMD= - 2.70, 95% CI - 2.88 to -2.52, p < 0.0001) indicated that ospemifene was more effective than placebo. The present meta-analysis suggests that ospemifene 60 mg is associated with significant improvement in the morphological and physiological features of the vaginal mucosa that correlate with the symptoms associated with postmenopausal VVA.