Efficacy of vaginal estradiol or vaginal moisturizer vs placebo for treating postmenopausal vulvovaginal symptoms a randomized clinical trial

Caroline M. Mitchell, Susan D. Reed, Susan Diem, Joseph C. Larson, Katherine M. Newton, Kristine E. Ensrud, Andrea Z. LaCroix, Bette Caan, Katherine A. Guthrie

Research output: Contribution to journalArticle

33 Citations (Scopus)

Abstract

IMPORTANCE Nearly half of postmenopausal women report bothersome vulvovaginal symptoms, but few data support the efficacy of 2 commonly recommended treatments. OBJECTIVE 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. DESIGN, SETTING, AND PARTICIPANTS 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. INTERVENTIONS 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). MAIN OUTCOMES AND MEASURES The main outcomewas 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. RESULTS 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). CONCLUSIONS AND RELEVANCE 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.

Original languageEnglish (US)
Pages (from-to)681-690
Number of pages10
JournalJAMA internal medicine
Volume178
Issue number5
DOIs
StatePublished - May 2018

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Estradiol
Randomized Controlled Trials
Placebos
Foams and Jellies Vaginal Creams
Pain
Therapeutics
Pruritus
Tablets
Gels
Outcome Assessment (Health Care)

PubMed: MeSH publication types

  • Journal Article
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

Cite this

Efficacy of vaginal estradiol or vaginal moisturizer vs placebo for treating postmenopausal vulvovaginal symptoms a randomized clinical trial. / 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.

In: JAMA internal medicine, Vol. 178, No. 5, 05.2018, p. 681-690.

Research output: Contribution to journalArticle

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. / Efficacy of vaginal estradiol or vaginal moisturizer vs placebo for treating postmenopausal vulvovaginal symptoms a randomized clinical trial. In: JAMA internal medicine. 2018 ; Vol. 178, No. 5. pp. 681-690.
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abstract = "IMPORTANCE Nearly half of postmenopausal women report bothersome vulvovaginal symptoms, but few data support the efficacy of 2 commonly recommended treatments. OBJECTIVE 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. DESIGN, SETTING, AND PARTICIPANTS 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. INTERVENTIONS 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). MAIN OUTCOMES AND MEASURES The main outcomewas 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. RESULTS 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). CONCLUSIONS AND RELEVANCE 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.",
author = "Mitchell, {Caroline M.} and Reed, {Susan D.} and Susan Diem and Larson, {Joseph C.} and Newton, {Katherine M.} and Ensrud, {Kristine E.} and LaCroix, {Andrea Z.} and Bette Caan and Guthrie, {Katherine A.}",
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T1 - Efficacy of vaginal estradiol or vaginal moisturizer vs placebo for treating postmenopausal vulvovaginal symptoms a randomized clinical trial

AU - Mitchell, Caroline M.

AU - Reed, Susan D.

AU - Diem, Susan

AU - Larson, Joseph C.

AU - Newton, Katherine M.

AU - Ensrud, Kristine E.

AU - LaCroix, Andrea Z.

AU - Caan, Bette

AU - Guthrie, Katherine A.

PY - 2018/5

Y1 - 2018/5

N2 - IMPORTANCE Nearly half of postmenopausal women report bothersome vulvovaginal symptoms, but few data support the efficacy of 2 commonly recommended treatments. OBJECTIVE 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. DESIGN, SETTING, AND PARTICIPANTS 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. INTERVENTIONS 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). MAIN OUTCOMES AND MEASURES The main outcomewas 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. RESULTS 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). CONCLUSIONS AND RELEVANCE 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.

AB - IMPORTANCE Nearly half of postmenopausal women report bothersome vulvovaginal symptoms, but few data support the efficacy of 2 commonly recommended treatments. OBJECTIVE 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. DESIGN, SETTING, AND PARTICIPANTS 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. INTERVENTIONS 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). MAIN OUTCOMES AND MEASURES The main outcomewas 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. RESULTS 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). CONCLUSIONS AND RELEVANCE 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.

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