March 23, 2018 / 3:33 PM / 4 months ago

Costly menopause vaginal treatments no better than placebo

(Reuters Health) - For women bothered by vaginal symptoms after menopause, prescription local estrogen treatments and expensive specialty lubricants may provide relief, but no more so than a dummy drug, researchers say.

Nearly half of postmenopausal women report bothersome vaginal dryness, pain and other symptoms, but there isn’t much evidence supporting the value of prescription treatments, the study authors write in JAMA Internal Medicine.

“Our work suggests that the expensive $200 prescription treatment is not better than a cheap, over-the-counter treatment, which is helpful information for many women who can’t afford the more expensive therapy - and whose insurance doesn’t cover it,” said lead author Dr. Caroline Mitchell of the Vincent Center for Reproductive Biology at Massachusetts General Hospital in Boston.

“Overall, most women in our study - no matter what treatment they were randomized to - improved, which is a positive result for women in general,” she told Reuters Health by email.

Mitchell and colleagues enrolled 300 postmenopausal women between ages 55 and 64 with moderate to severe symptoms of vulvovaginal itching, dryness, irritation and pain during intercourse in a 12-week randomized clinical trial that took place in 2017 at Kaiser Permanente Washington Health Research Institute in Seattle and the University of Minnesota in Minneapolis.

Women were randomly assigned to use one of three combinations of treatments: Vagifem vaginal estradiol tablets plus a placebo gel lacking active ingredients in specialty “feminine moisturizers;” or nonhormonal Replens vaginal moisturizer plus a placebo tablet lacking hormones or other active ingredients; or the placebo gel and placebo tablets.

Based on interviews and questionnaires, researchers scored the severity of the women’s symptoms from 1 to 3, with 3 being the most severe. They also asked women to identify their “most bothersome symptom.” For 60 percent of women, this was pain with vaginal penetration; for 21 percent, it was vulvovaginal dryness.

At the outset of the study, all the participants rated the severity of their most bothersome symptom at about 2.5.

Women were given instructions for using their assigned tablets and gels over the next 12 weeks. The researchers also collected samples to measure vaginal moisture and pH, which they repeated at the end of the study. The participants answered questionnaires about their symptoms throughout the trial.

The research team found at the end of the trial that women in all of the groups had average reductions of 1.2 to 1.4 points, or about 50 percent, in the severity of their most bothersome symptom.

“Although over half of women had a reduction in symptoms, fewer women had a complete resolution of symptoms,” Mitchell noted. “More research and better treatments are needed for these symptoms.”

For women assigned to use the Vagifem tablets, there were also slight changes in the vaginal wall and pH, but these were not associated with reduced symptoms, the researchers note.

In follow-up studies, Mitchell and colleagues are using the samples from this trial to evaluate the different factors that may affect the severity of symptoms, such as the vaginal microbiome, vaginal inflammation and vaginal estrogen receptors. The research team wants to understand the root causes of postmenopausal vaginal discomfort.

“Since all women have a decrease in estrogen after menopause, but only half get vaginal discomfort, we suspect it is more than just low estrogen,” Mitchell said.

A limitation of the trial is that it only studied a 10-microgram dose of the estradiol tablet, said Dr. Alison Huang, a women’s health and menopause researcher at the University of California, San Francisco School of Medicine who co-wrote a commentary accompanying the study.

“We’re finding that the treatments we think are more effective don’t turn out to be that way,” she said in a telephone interview. “This is sometimes disappointing but can force us to change our deeply entrenched beliefs about treatments.”

For now, women and their doctors should opt for the cheapest moisturizer available over the counter, at least until new evidence suggests otherwise, Huang said.

“If you’re a woman suffering from these symptoms, this study suggests you’re not any more likely to benefit from taking prescription tablets,” she said. “This means we can save women - and their insurers - a little bit of money.”

SOURCE: bit.ly/2G3IbtR and bit.ly/2FUOSlK JAMA Internal Medicine, online March 19, 2018.

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