Clinical Question

In women with postmenopausal vaginal symptoms, is local estrogen treatment better than vaginal lubricant or placebo?

Bottom Line

It is time to rethink the idea that vaginal atrophy caused by diminished estrogen is the cause of vaginal symptoms associated with menopause. Vaginal estradiol is no more effective than a non-prescription vaginal lubricant or placebo lubricant in the treatment of women with painful intercourse, vaginal dryness, or other symptoms usually associated with menopause. (Level of Evidence = 1b)

Synopsis

This study evaluated the effect of a vaginal estradiol, 10 mcg, a nonprescription vaginal lubricant, and matching placebo tablet and lubricant in 302 postmenopausal women with moderate to severe symptoms of vulvovaginal itching, pain, dryness, irritation, or pain with penetration. Estradiol was used daily for two weeks, then twice weekly; vaginal moisturizer was used every three days for 12 weeks. Results were analyzed using a modified intention-to-treat analysis, including women who returned for evaluation at one month and three months after beginning treatment, regardless of their continued use of treatment. At the beginning of the study, women were asked to identify their most bothersome symptom, which was pain with vaginal penetration (60%) or vaginal dryness (21%) for most women; the main outcome measured was the effect of treatment on this outcome. Treatment with estradiol, lubricant, or placebo produced similar results, decreasing the average score (on a scale of 0 to 3) from 2.4 (moderate severity) at the beginning of treatment to 1.0 (mild). One-half of the women in each group, including the placebo group, had a clinically significant drop in scores with treatment. Sexual function, as measured by the Female Sexual Function Index, improved in all groups, with nearly one-half of the women in all groups improving from being frequently or always distressed about their sex life to rarely or never distressed about their sex life.

Study design: Randomized controlled trial (double-blinded)

Funding source: Government

Allocation: Concealed

Setting: Outpatient (any)

Reference:MitchellCMReedSDDiemSet alEfficacy of vaginal estradiol or vaginal moisturizer vs placebo for treating postmenopausal vulvovaginal symptoms: a randomized clinical trial. JAMA Intern Med2018;178(5):681–690.