Vaginal Estradiol, Moisturizer No Better Than Placebo for Postmenopausal Vulvovaginal Symptoms
- In a randomized, double-blind trial, neither a vaginal estradiol tablet nor a vaginal moisturizer provided additional benefit over placebo tablet and gel in reducing vulvovaginal symptoms in postmenopausal women
- Most subjects, including those on dual placebo, reported at least 50% decrease in symptom severity
- The lack of efficacy of active treatment over dual placebo was similar regardless of what women identified as their most bothersome symptom at baseline
- The choice of treatment for postmenopausal vulvovaginal symptoms should be based on patient preference regarding cost and formulation
Vaginal estrogen tablets and vaginal moisturizers are commonly recommended to postmenopausal women for relief of vulvovaginal symptoms such as dryness, itching, pain or burning. However, few data are available on their efficacy.
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Now a randomized, double-blind, two-center study has shown that neither a prescription vaginal estradiol tablet nor an over-the-counter vaginal moisturizing gel was more efficacious than dual placebo when used for 12 weeks. The results were published in JAMA Internal Medicine.
Caroline M. Mitchell, MD, director of the Vulvovaginal Disorders Program and an investigator in the Vincent Center for Reproductive Biology at Massachusetts General Hospital, and colleagues conducted the study between April 2016 and April 2017.
They recruited 302 postmenopausal women using direct mailings and Facebook ads. Participants had to report at least one moderate to severe symptom of vulvovaginal itching, pain, irritation or dryness at least weekly within the past 30 days or pain with penetration at least once monthly. Most subjects were 55 to 64 years old (78%), white (88%) and sexually active (81%) with a male or female partner (68%) and/or with self-stimulation (45%).
At the time of enrollment, subjects selected their most bothersome symptom (MBS) and rated its severity from zero (none) to three (severe). The most commonly reported MBS was pain with vaginal penetration (60%), followed by vulvovaginal dryness (21%). The average severity of the MBS was similar between treatment groups at the start of the study.
As part of the study, the women were randomly assigned 1:1:1 to Vagifem 10-mcg tablet + placebo vaginal gel, placebo vaginal tablet + Replens vaginal moisturizer, or placebo tablet + placebo gel.
Little Difference in Outcomes Among Groups
The primary outcome, reduction in severity 12 weeks later, did not differ among treatment groups:
- Estradiol: −1.4 (95% CI, −1.6 to −1.2); =.25 vs placebo
- Moisturizer: −1.2 (95% CI, −1.4 to −1.0); =.31 vs placebo
- Placebo: −1.3 (95% CI, −1.5 to −1.1)
The researchers point out that fewer than half of participants had a decrease of two or more points (49% estradiol, 35% moisturizer, 45% placebo), which would represent a shift from moderate or severe to mild or no symptoms.
The lack of benefit of active treatment over dual placebo was similar whether women chose pain with vaginal penetration, vaginal dryness or another symptom as their MBS.
Most subjects did report at least a 50% decrease in symptom severity. Adherence and adverse events did not vary significantly across treatment groups.
The researchers conclude that most women will achieve more than 50% reduction in symptom severity with regular, consistent use of a nonprescription vaginal lubricating gel. Vaginal estradiol does not seem to offer additional relief.
Not all gel formulations may have the same effects, the authors note, and some women may prefer non-gel products. Treatment choice should be based on individual patient preferences regarding cost and formulation.
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