SEATTLE— A clinical trial compared two treatments for postmenopausal vaginal discomfort, dryness, itching, and pain during sexual intercourse, which around half of women experience after menopause. At 12 weeks, symptoms had improved with either treatment—low-dose vaginal estrogen or a vaginal moisturizer—as well as with placebo gel. Better understanding of the causes of postmenopausal symptoms could lead to more effective treatment options, which are needed for this common, bothersome problem, the research team concludes in their JAMA Internal Medicine report: “Efficacy of Vaginal Estradiol or Vaginal Moisturizer vs. Placebo for Treating Postmenopausal Vulvovaginal Symptoms: A Randomized Clinical Trial.”
“This study once again shows the importance of placebo-controlled trials to increase our understanding of the relative benefits of commonly used products,” says Katherine Newton, PhD, a senior investigator (emeritus) at Kaiser Permanente Washington Health Research Institute (KPWHRI). Dr. Newton led Kaiser Permanente Washington’s involvement in the study, which was conducted at Kaiser Permanente Washington and the University of Minnesota.
“The fact that all three treatments were able to reduce symptoms is great news for women,” says Caroline Mitchell, MD, MPH, of the Massachusetts General Hospital (MGH) Department of Obstetrics and Gynecology, and first author of the report. “It means that regular use of any of these treatments is likely to have benefit, whether the cost is $20 or $200.” Dr. Mitchell is also an assistant professor of obstetrics, gynecology and reproductive biology at Harvard Medical School.
The study, part of the Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) trials, enrolled more than 300 women, most age 55 to 64, who reported moderate to severe symptoms of vaginal itching, dryness, irritation, and pain with sexual activity. At the end of the study period all three groups—on vaginal estradiol tablets, a vaginal moisturizer, or the gel used as a placebo—had similar decreases in the severity of their most bothersome symptom.
“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,” says co-author Susan Reed, MD, MPH, a professor of obstetrics and gynecology at the University of Washington and an affiliate investigator at KPWHRI. “More couples are remaining sexually intimate despite aging, and better therapies for vaginal discomfort need to be developed.”
The senior author of the report is Katherine Guthrie, PhD, of the Fred Hutchinson Cancer Research Center. Additional co-authors are Andrea LaCroix, PhD, of the University of California at San Diego and KPWHRI; Susan Diem, MD, MPH, and Kristine Ensrud, MD, MPH, of the University of Minnesota; Joseph Larson, MS, of the Fred Hutchinson Cancer Research Center; and Bette Caan, DrPH, of Kaiser Permanente of Northern California.
National Institute on Aging grant 5RO1 AG048209 funded the study.
A Randomized Clinical Trial