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

Abstract

OBJECTIVE:

To evaluate the efficacy of ospemifene in treating dyspareunia associated with postmenopausal vulvo-vaginal atrophy (VVA).

METHODS:

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.

RESULTS:

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.

CONCLUSION:

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.

• Authors: Violante Di Donato, Michele Carlo Schiavi, Valentina Iacobelli, Ottavia D'oria, Evangelos Kontopantelis, Tommaso Simoncini, Ludovico Muzii, Pierluigi Benedetti Panici
• Journal: Maturitas (Maturitas) Vol. 121 Pg. 86-92 (Mar 2019) ISSN: 1873-4111 [Electronic] Ireland
• PMID: 30509753 (Publication Type: Journal Article, Meta-Analysis, Review)
• Copyright: Copyright © 2018. Published by Elsevier B.V.

Chemical References

• Selective Estrogen Receptor Modulators
• Tamoxifen
• Ospemifene

Topics

• Atrophy (drug therapy)
• Female
• Humans
• Randomized Controlled Trials as Topic
• Selective Estrogen Receptor Modulators (therapeutic use)
• Tamoxifen (analogs & derivatives, therapeutic use)
• Treatment Outcome
• Vagina (pathology)
• Vaginal Diseases (drug therapy)
• Vulva (pathology)
• Vulvar Diseases (drug therapy)