TY - JOUR
T1 - Effects of vaginal estradiol tablets and moisturizer on menopause-specific quality of life and mood in healthy postmenopausal women with vaginal symptoms
T2 - A randomized clinical trial
AU - Diem, Susan J.
AU - Guthrie, Katherine A.
AU - Mitchell, Caroline M.
AU - Reed, Susan D.
AU - Larson, Joseph C.
AU - Ensrud, Kristine E.
AU - Lacroix, Andrea Z.
N1 - Publisher Copyright:
©2018 The North American Menopause Society.
PY - 2018
Y1 - 2018
N2 - Objective: Compare the effects of a vaginal estradiol tablet and a vaginal moisturizer, each to placebo, on menopause-related quality of life and mood in postmenopausal women with moderate-severe vulvovaginal symptoms. Methods: A total of 302 postmenopausal women enrolled in a 12-week, double-blind, placebo-controlled randomized trial were assigned to vaginal 10 mg estradiol tablet plus placebo gel (n1/4102), vaginal moisturizer plus placebo tablet (n1/4100), or dual placebo (n1/4100). We measured change from randomization to 12 weeks in total score of the Menopause-Specific Quality of Life (MENQOL) questionnaire. We also evaluated the four MENQOL domains, depressive symptoms as measured by the Patient Health Questionnaire 8, and anxiety symptoms as measured by the Generalized Anxiety Disorder (GAD-7) questionnaire. Results: Treatment with vaginal estradiol resulted in significantly greater improvement in total MENQOL scores compared to dual placebo (mean difference between arms 0.3 at 12 weeks (95% confidence interval [CI] 0.5, 0.0; P1/40.01). A statistically significant group mean difference favoring vaginal estradiol was observed for the MENQOL sexual function domain (0.4 at 12 weeks; 95% CI 1.0, 0.1; P1/40.005), but not for any of the other domains. Treatment with vaginal moisturizer did not provide greater improvement compared to placebo in total MENQOL scores (mean difference 0.2 at 12 weeks; 95% CI 0.1, 0.4; P1/40.38) or in any of the MENQOL domains. Neither treatment group showed improvement compared with placebo in the Patient Health Questionnaire 8 or Generalized Anxiety Disorder Questionnaire . Conclusions: Treatment with low-dose vaginal estradiol, but not vaginal moisturizer, modestly improved menopause-related quality of life and sexual function domain scores in postmenopausal women with moderate- severe vulvovaginal symptoms.
AB - Objective: Compare the effects of a vaginal estradiol tablet and a vaginal moisturizer, each to placebo, on menopause-related quality of life and mood in postmenopausal women with moderate-severe vulvovaginal symptoms. Methods: A total of 302 postmenopausal women enrolled in a 12-week, double-blind, placebo-controlled randomized trial were assigned to vaginal 10 mg estradiol tablet plus placebo gel (n1/4102), vaginal moisturizer plus placebo tablet (n1/4100), or dual placebo (n1/4100). We measured change from randomization to 12 weeks in total score of the Menopause-Specific Quality of Life (MENQOL) questionnaire. We also evaluated the four MENQOL domains, depressive symptoms as measured by the Patient Health Questionnaire 8, and anxiety symptoms as measured by the Generalized Anxiety Disorder (GAD-7) questionnaire. Results: Treatment with vaginal estradiol resulted in significantly greater improvement in total MENQOL scores compared to dual placebo (mean difference between arms 0.3 at 12 weeks (95% confidence interval [CI] 0.5, 0.0; P1/40.01). A statistically significant group mean difference favoring vaginal estradiol was observed for the MENQOL sexual function domain (0.4 at 12 weeks; 95% CI 1.0, 0.1; P1/40.005), but not for any of the other domains. Treatment with vaginal moisturizer did not provide greater improvement compared to placebo in total MENQOL scores (mean difference 0.2 at 12 weeks; 95% CI 0.1, 0.4; P1/40.38) or in any of the MENQOL domains. Neither treatment group showed improvement compared with placebo in the Patient Health Questionnaire 8 or Generalized Anxiety Disorder Questionnaire . Conclusions: Treatment with low-dose vaginal estradiol, but not vaginal moisturizer, modestly improved menopause-related quality of life and sexual function domain scores in postmenopausal women with moderate- severe vulvovaginal symptoms.
KW - Anxiety
KW - Clinical trials network
KW - Depressive symptoms
KW - Postmenopausal vulvovaginal symptoms
KW - Quality of life
KW - Vaginal estrogen
KW - Vaginal moisturizer
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U2 - 10.1097/GME.0000000000001131
DO - 10.1097/GME.0000000000001131
M3 - Article
C2 - 29738424
AN - SCOPUS:85060231479
SN - 1072-3714
VL - 25
SP - 1086
EP - 1093
JO - Menopause
JF - Menopause
IS - 10
ER -