Highlights
- •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.
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.
Keywords
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Article info
Publication history
Published online: November 24, 2018
Accepted:
November 22,
2018
Received in revised form:
November 15,
2018
Received:
November 9,
2018
Identification
Copyright
© 2018 Published by Elsevier B.V.
