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Declining estrogen levels underlie genitourinary syndrome of menopause (GSM, previously termed vulvovaginal atrophy), a common progressive condition that, if untreated, can impair sexual function and quality of life. Based on randomized placebo-controlled trials and clinical experience, current guidelines (NEJM JW Womens Health Feb 2014 and Obstet Gynecol 2014; 123:202) recommend low-dose vaginal estrogen for women with symptomatic GSM that has not responded to over-the-counter vaginal lubricants (used with sexual activity) and moisturizers (used regularly). To reevaluate this approach, NIH-funded investigators randomized 302 women (mean age, 61; 88% white; 85% partnered) with moderate-to-severe symptoms suggestive of GSM to 10-µg estradiol tablets (Vagifem) plus placebo vaginal gel (hydroxyethylcellulose), placebo vaginal tablets plus vaginal moisturizer gel (Replens), or placebo tablets plus placebo gel. Tablets were used daily for 2 weeks, then twice weekly. Gels were used every 3 days for the duration of the 12-week trial. Participants reported the severity of their most bothersome symptom (MBS).
The most common MBS was pain with vaginal penetration (60%), followed by vaginal dryness (21%). All treatments were associated with modest and similar reductions in MBS. Likewise, improvement in sexual function was similar between estradiol and placebo and between moisturizer and placebo.
Mitchell CM et al. Efficacy of vaginal estradiol or vaginal moisturizer vs placebo for treating postmenopausal vulvovaginal symptoms: A randomized clinical trial. JAMA Intern Med 2018 Mar 19; [e-pub]. (https://doi.org/10.1001/jamainternmed.2018.0116)
Huang AJ and Grady D.Rethinking the approach to managing postmenopausal vulvovaginal symptoms. JAMA Intern Med 2018 Mar 19; [e-pub]. (https://doi.org/10.1001/jamainternmed.2018.0094)
Comment
As the authors and editorialists note, the robust response to placebo gel distinguishes this short-term trial from others (which used placebo creams and tablets, but not gels). Based on these findings, I plan to be more proactive in recommending lubricants and moisturizers. Long-term clinical trials assessing treatment of women with GSM have not been performed. Nonetheless, given our understanding of this common condition's pathophysiology (combined with clinical experience), my sense is that, over time, women with symptomatic GSM will be best served if treatment options include vaginal estrogen.