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Vaginal estradiol was no better than gel or placebo at alleviating menopause-related vulvovaginal symptoms, researchers reported.

According to the randomized clinical trial comparing low-dose vaginal estradiol tables, vaginal moisturizer, and placebo, all groups had similar average reductions in the severity score for most bothersome vulvovaginal symptoms after 12 weeks, as follows:

• Estradiol: -1.4 (95% CI -1.6 to -1.2)
• Moisturizer: -1.2 (-1.4 to -1.0)
• Placebo: -1.3 (-1.5 to -1.1)

The study, published in and led by Caroline M. Mitchell, MD, of Massachusetts General Hospital in Boston, found that the mean total score on the Female Sexual Function Index also had similar improvements when comparing estradiol to placebo (5.4, 4.0-6.9 vs 4.5, 2.8-6.1, P=0.64) and moisturizer compared with placebo (3.1, 1.7-4.5 versus 4.5, 2.8-6.1; P=0.17).

"Recommendations for treatment of [genitourinary syndrome of menopause] focus primarily on vaginal products," the researchers wrote, adding that vaginal estrogen cream can provide relief for most women with symptoms including vaginal dryness, itching, pain, and burning.

"Although clinicians often recommend vaginal moisturizers, few studies exist to support this recommendation."

The trial included 302 postmenopausal women -- 102 of whom were randomized to receive Vagifem 10-μcg estradiol tablet daily for 2 weeks and twice weekly thereafter in addition to placebo gel, 100 women who received a placebo tablet plus the over-the-counter vaginal moisturizer Replens, and 100 women who received dual placebo.

Treatment effects were determined based on questionnaires, including a composite vaginal symptom score, Female Sexual Function Index, Vaginal Maturation Index (VMI), Female Sexual Distress Score, vaginal pH, as well as treatment satisfaction and meaningful benefit. The trial's primary outcome was measured as a decrease in severity for the most bothersome symptom after 12 weeks.

Among the group, 60% reported pain with vaginal penetration at baseline, which was the most common symptom reported.

Overall treatment adherence was relatively high -- 94% of whom were tablet adherent and 90% were gel adherent -- and did not significantly differ across the treatment groups.

More women who were in the estradiol tablet treatment group had a change in pH compared with placebo, marked by a pH of over 5 at baseline down to 5 or less after 12 weeks (46% versus 12%, P<0.001). This group also saw a greater increase in VMI superficial cells compared with baseline (57% versus 11%, P<0.001).

However, more women in this group also reported a "meaningful benefit" from treatment, despite no major variances in treatment outcomes (80% versus 65% [placebo], P=0.02).

"The present study compared each of the active treatments with matching placebo tablet or placebo gel only, forgoing the opportunity to confirm or exclude a reasonable differential effect between active treatments," said the authors of an , Alison J. Huang, MD, of the University of California, San Francisco, and Deborah Grady, MD, of the San Francisco Veterans Affairs Health Care System.

They went on to suggest a different type of trial design that might have yielded more beneficial findings to everyday practice: "A rigorous side-by-side assessment of hormonal and nonhormonal vaginal treatments arguably has the potential to provide new insights in clinical care, especially when conducted by investigators without any affiliation with the treatment manufacturers."

Huang and Grady added that the findings weren't particularly surprising in regards to the over-the-counter gel, since the placebo gel used to compare the Replens moisturizer had a viscosity and pH that were similar to those of Replens and included ingredients similar to those of vaginal lubricants. However, the finding on vaginal estradiol tablets "provides intriguing new data to reevaluate the current emphasis on estrogen in treatment of postmenopausal vulvovaginal symptoms," and therefore challenges the "longstanding" focus on vaginal estrogen therapy, the commentary said.

Ultimately, the research group suggested that providers guide patients with these symptoms to treatments "based on cost and formulation preference," while Huang and Grady suggest that women choose "the cheapest moisturizer or lubricant available over the counter -- at least until new evidence arises to suggest that there is any benefit to doing otherwise."

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