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- Title
Efficacy of Vaginal Estradiol or Vaginal Moisturizer vs Placebo for Treating Postmenopausal Vulvovaginal Symptoms: A Randomized Clinical Trial.
- Authors
Mitchell, Caroline M.; Reed, Susan D.; Diem, Susan; Larson, Joseph C.; Newton, Katherine M.; Ensrud, Kristine E.; LaCroix, Andrea Z.; Caan, Bette; Guthrie, Katherine A.
- Abstract
<bold>Importance: </bold>Nearly half of postmenopausal women report bothersome vulvovaginal symptoms, but few data support the efficacy of 2 commonly recommended treatments.<bold>Objective: </bold>To compare the efficacy of a low-dose vaginal estradiol tablet and a vaginal moisturizer, each vs placebo, for treatment of moderate-to-severe postmenopausal vulvovaginal symptoms.<bold>Design, Setting, and Participants: </bold>This 12-week multicenter randomized clinical trial enrolled postmenopausal women with moderate to severe symptoms of vulvovaginal itching, pain, dryness, irritation, or pain with penetration.<bold>Interventions: </bold>Vaginal 10-μg estradiol tablet (daily for 2 weeks, then twice weekly) plus placebo gel (3 times a week) (n = 102) vs placebo tablet plus vaginal moisturizer (n = 100) vs dual placebo (n = 100).<bold>Main Outcomes and Measures: </bold>The main outcome was decrease in severity (0-3) of most bothersome symptom (MBS) between enrollment and 12 weeks. Additional measures included a composite vaginal symptom score, Female Sexual Function Index (FSFI) score (2-36), modified Female Sexual Distress Score-Revised item 1, treatment satisfaction and meaningful benefit, Vaginal Maturation Index, and vaginal pH.<bold>Results: </bold>The 302 women had a mean (SD) age of 61 (4) years and were primarily white (267 [88%]), college educated (200 [66%]), and sexually active (245 [81%]). Most women (294 [97%]) provided data for the primary analysis. The most commonly reported MBS was pain with vaginal penetration (182 [60%]), followed by vulvovaginal dryness (63 [21%]). Mean baseline MBS severity was similar between treatment groups: estradiol, 2.4 (95% CI, 2.3 to 2.6); moisturizer, 2.5 (95% CI, 2.3 to 2.6); placebo, 2.5 (95% CI, 2.4 to 2.6). All treatment groups had similar mean reductions in MBS severity over 12 weeks: estradiol, -1.4 (95% CI, -1.6 to -1.2); moisturizer, -1.2 (95% CI, -1.4 to -1.0); and placebo, -1.3 (95% CI, -1.5 to -1.1). No significant differences were seen between estradiol (P = .25) or moisturizer (P = .31) compared with placebo. Mean total FSFI improvement was similar between estradiol (5.4; 95% CI, 4.0 to 6.9) and placebo (4.5; 95% CI, 2.8 to 6.1) (P = .64), and between moisturizer (3.1; 95% CI, 1.7 to 4.5) and placebo (P = .17).<bold>Conclusions and Relevance: </bold>Our results suggest that neither prescribed vaginal estradiol tablet nor over-the-counter vaginal moisturizer provides additional benefit over placebo vaginal tablet and gel in reducing postmenopausal vulvovaginal symptoms.<bold>Trial Registration: </bold>clinicaltrials.gov Identifier: NCT02516202.
- Subjects
COMPARATIVE studies; ESTRADIOL; ESTROGEN; PHARMACEUTICAL gels; RESEARCH methodology; MEDICAL cooperation; QUESTIONNAIRES; RESEARCH; RESEARCH funding; VAGINAL diseases; VAGINAL medication; VULVA; EVALUATION research; RANDOMIZED controlled trials; TREATMENT effectiveness; POSTMENOPAUSE; DRUG administration; DRUG dosage
- Publication
JAMA Internal Medicine, 2018, Vol 178, Issue 5, p681
- ISSN
2168-6106
- Publication type
journal article
- DOI
10.1001/jamainternmed.2018.0116