Results of a randomized clinical trial (RCT) suggest that over-the-counter moisturizer may be just as effective as vaginal estrogen tablets for treatment of vulvovaginal symptoms (VVS) in postmenopausal women. Published in JAMA Internal Medicine, the findings are from a study supported by the National Institutes of Health/National Institute on Aging that focused on moderate-to-severe VVS and a 10-µg dosage of vaginal estrogen.
For the research, 302 sexually active women with a median age of 61 were randomized to vaginal estradiol in tablet form daily for 2 weeks then twice weekly plus placebo gel 3 times a week, a placebo tablet plus vaginal moisturizer (Replens), or dual placebos on the same schedule. The primary outcome was severity of most bothersome symptom (MBS), defined by each woman at trial enrollment as vulvovaginal itching, pain, dryness, irritation, or pain with penetration. The women rated MBS on a scale of 0 (none) to 3 (severe).
During the 12-week study, the participants were contacted by telephone 3 times for assessment of adherence to the protocol and adverse events. At weeks 4 and 12, follow-up visits were conducted, at which the women completed questionnaires and vaginal samples were taken and assessed on wet mount and for pH and vaginal maturation index (baseline and week 12). Rates of adherence—94% for tablets and 90% for gel—were determined by counting remaining pills and weighing gel tubes.
Pain with penetration was the MBS most commonly reported by the participants (60%), followed by vulvovaginal dryness (21%). Mean baseline MBS severity was similar between all three treatment groups (2.4 estradiol, 2.5 moisturizer, 2.5 placebo). At the end of the trial, MBS severity reductions also were similar (-1.4, 95% CI, -1.6 to -1.2 estradiol; -1.2, 95% CI -1.4 to -1.0 moisturizer; -1.3, 95% CI -1.5 to -1.1 placebo). No significant differences were seen between estradiol (P = .25) or moisturizer (P = .31) compared with placebo. Response to estradiol was not modified by either age or years since menopause, although greater improvement in MBS was seen with placebo than with moisturizer in women aged < 60.
The authors said their results “suggest that most women can achieve greater than 50% reduction in symptom severity with regular, consistent use of a vaginal gel with lubricant properties and do not see added symptom improvement with vaginal estradiol.” Their study, they believe, is the first RCT of efficacy of nonhormonal and hormonal vaginal therapies for postmenopausal VVS and the only one with a dual-placebo arm. Generalizability of the results is limited in that the population was relatively homogenous. However, because all postmenopausal women with moderate to severe VVS were included and not just those with high vaginal pH n ad/or 5% less superficial cells, the authors believe the population is more representative of women who present in primary care settings.