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A clinical trial comparing two common treatments for postmenopausal vaginal discomfort to placebo treatment found that both low-dose vaginal estrogen and a vaginal moisturizer produced symptom improvements similar to those associated with placebo after 12 weeks of treatment.
The authors note that better understanding of the causes of postmenopausal symptoms could lead to more effective treatment options for this bothersome problem.
The results were published online in JAMA Internal Medicine.
“The fact that all three treatments—vaginal estradiol tablets, a vaginal moisturizer and the lubricating gel we used as a placebo—were able to reduce symptoms is great news for women, since it means that regular use of any of these treatments is likely to have benefit, whether the cost is $20 or $200,” said corresponding author Caroline Mitchell, HMS assistant professor of obstetrics, gynecology and reproductive biology at Massachusetts General Hospital.
“The significant impact of vaginal discomfort on the lives of women is reflected by how quickly we were able to enroll more than 300 participants in less than a year. Women are desperate for some kind of intervention for these symptoms,” Mitchell said.
The authors, from seven research centers across the country, note that symptoms such as vaginal dryness, itching and pain during sexual intercourse affect around half of postmenopausal women and can have negative quality-of-life effects similar to those of chronic conditions like arthritis or irritable bowel syndrome.
But more than half of affected women use no medical treatments. Available nonprescription products, such as vaginal lubricants and moisturizers, can be messy; and prescription hormonal treatments in the form of creams, vaginal tablets and oral pills can be expensive and may raise concerns about safety.
The current trial was designed to assess the effectiveness of the two most commonly recommended treatments—low-dose estrogen vaginal tablets and a nonhormonal vaginal moisturizer.
The study enrolled 302 women, most between the ages of 55 and 64, who reported moderate to severe symptoms of vaginal itching, dryness, irritation or pain with sexual activity.
Participants were randomly divided into three groups, one receiving a low-dose vaginal estrogen tablet and a placebo vaginal gel, one receiving a placebo vaginal tablet and a nonprescription vaginal moisturizer and one receiving both placebo tablets and placebo gel.
Participants were instructed to administer the vaginal tablet once a day for 2 weeks and then twice a week for the remaining 10 weeks of the study period. The moisturizing gels were to be applied every three days throughout the study period. Neither participants nor study staff knew to which group individual participants were assigned.
At the end of the study period all three groups had similar decreases in the severity of their most bothersome symptom. A similar proportion of women in each group had at least a 50 percent decrease in overall symptom severity.
Improvement in sexual function and overall treatment satisfaction were also similar across all three groups. There was a significantly higher positive response to the question, “Did you have a meaningful benefit from the treatment?” among those receiving the vaginal estrogen tablet than among those receiving placebos.
Mitchell notes that, while most studies of treatments for vaginal discomfort show a significant placebo effect, the size of the response to placebo treatments in this trial was surprising.
“It’s hard to say whether the properties of the placebo gel itself, which is an excellent lubricant, are responsible, but our results suggest that regular use of any one of these products may be helpful,” she said.
“During the 12 weeks of the trial, more than 90 percent of women used the medication regularly, but prior studies suggest that many women do not continue use of this type of treatment beyond six months. A remaining question is whether women find the benefits of the treatment worthwhile enough to continue regular use,” Mitchell said.
Co-author Susan Reed, of the University of Washington, added, “It was notable that the overwhelming majority of women in our study were bothered by pain with sexual activity and earnestly wanted to help find a treatment for the many women bothered by this problem. More couples are remaining sexually intimate despite aging, and better therapies for vaginal discomfort need to be developed.”
The study was funded by the National Institute on Aging (5RO1AG048209).
Adapted from a Mass General news release.
