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Vaginal estradiol, moisturizer no better than placebo for postmenopausal symptoms
The severity of postmenopausal vulvovaginal symptoms can be improved with a vaginal estradiol or moisturizer; however, these treatments do not offer additional benefit compared with placebo, according to a study published in JAMA Internal Medicine.
“Nearly half of postmenopausal women report bothersome vulvovaginal symptoms, but few data support the efficacy of two commonly recommended treatments,” Caroline M. Mitchell, MD, from the Vincent Center for Reproductive Biology at Massachusetts General Hospital, and colleagues wrote.
Mitchell and colleagues conducted a randomized clinical trial to evaluate whether a low-dose vaginal estradiol tablet and a vaginal moisturizer improves moderate-to-severe postmenopausal vulvovaginal symptoms, including itching, pain, dryness, irritation or pain with penetration, compared with placebo.
A total of 302 women (mean age, 61 years; 88% white; 81% sexually active) were recruited and randomly assigned to receive one of three treatments for 12 weeks: Vagifem (estradiol, Novo Nordisk) 10-cg tablet once a day for 2 weeks then two times per week plus placebo gel three times per week (n = 102), vaginal moisturizer plus placebo tablet (n = 100) or placebo gel plus placebo tablet (n = 100).
Data showed that participants most frequently reported most bothersome symptoms included pain with vaginal penetration (60%) and vulvovaginal dryness (21%). There were similar mean baseline severities of the most bothersome symptom across treatments (estradiol = 2.4; moisturizer = 2.5; placebo = 2.5). Mean reductions in the severity of the most bothersome symptom were similar among patients using estradiol (1.4; 95% CI, 1.6 to 1.2), moisturizer (1.2; 95% CI, 1.4 to 1) and placebo (1.3; 95% CI, 1.5 to 1.1).
Estradiol and moisturizer did not significantly differ compared with placebo. There were similar mean total improvements in Female Sexual Function Index score between estradiol (5.4; 95% CI, 4-6.9) and placebo (4.5; 95% CI, 2.8-6.1) and moisturizer (3.1; 95% CI, 1.7-4.5) and placebo (P = .17).
“Shared decision making for treatment of postmenopausal vulvovaginal symptoms can be based on cost and patient formulation preference; vaginal estradiol tablets appear not to add benefit beyond vaginal gel or moisturizer,” Mitchell and colleagues concluded.
In a related editorial, Alison J. Huang, MD, MAS, MPhil, and Deborah Grady, MD, MPH, both from the department of medicine at the University of California, San Francisco, suggest that until new evidence surfaces, physicians and their patients who experience vulvovaginal symptoms should choose the cheapest OTC moisturizer or lubricant. – by Alaina Tedesco
Disclosure: Mitchell reports being a consultant for Symbiomix Therapeutics. Please see study for all other authors’ relevant financial disclosures. Huang reports receiving research grants from Pfizer Inc and Astellas Pharma. Grady reports being a consultant for MenoGeniX.