Prescribed vaginal estradiol tablets with placebo gel and over-the-counter vaginal moisturizer used with placebo tablets do not reduce vulvovaginal symptoms better than dual placebos for postmenopausal women, according to a study published in JAMA Internal Medicine.
Caroline M. Mitchell, MD, of Vincent Obstetrics and Gynecology at Massachusetts General Hospital and the Department of Obstetrics at Harvard Medical School in Boston, and associates conducted a 12-week multicenter randomized clinical trial to understand the efficacy of low-dose vaginal estradiol tablets and vaginal moisturizers for moderate-to-severe vulvovaginal symptoms in postmenopausal women.
In the study, 302 women with an average age of 61 years were either administered vaginal 10-µg estradiol tablets (daily for 2 weeks, followed by twice weekly) and a placebo gel to use 3 times a week (n=102), placebo tablets to use with a vaginal moisturizer (n=100), or dual placebo (n=100). The 3 cohorts were compared; the main outcomes studied were decreases in symptom severity (scaled 0-3) of the most bothersome symptom from baseline to 12 weeks.
Secondary measures were combined vaginal symptom score, Female Sexual Function Index (FSFI) scores, which ranged from 2 to 36, modified Female Sexual Distress Score-Revised item 1, Vaginal Maturation Index, vaginal pH, and satisfaction of treatment and meaningful benefit. Reported symptoms included vulvovaginal itching, pain, dryness, irritation, or painful penetration.
The majority of women were white (88%), college educated (66%), and sexually active (81%); 97% provided primary analysis information. Painful penetration (60%) and vulvovaginal dryness (21%) were the 2 most frequent symptoms reported.
At baseline, the investigators reported similar primary outcomes between the three cohorts. The most bothersome symptom scores at baseline for the estradiol, moisturizer, and placebo groups were 2.4, 2.5, and 2.5, respectively; all groups had similar symptom reduction trends by 12 weeks (-1.4, -1.2, and -1.3, respectively) with no reported statistically significant differences.
“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,” the authors concluded.
Mitchell CM, Reed SD, Diem S, et al. Efficacy of vaginal estradiol or vaginal moisturizer vs placebo for treating postmenopausal vulvovaginal symptoms: a randomized clinical trial. JAMA Intern Med. 2018;178(5):681-690.