MedicalResearch.com Interview with:
Caroline Mitchell, MD, MPH
Vincent Center for Reproductive Biology
Assistant Professor, Obstetrics, Gynecology & Reproductive Biology
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: In this study we compared two commonly recommended treatments for menopausal vaginal discomfort – low dose vaginal estradiol tablets and a vaginal moisturizer – to placebo, and found no difference in reduction of symptom severity; all three groups improved over 12 weeks of treatment. This is great news for women, as it means that using any treatment regularly is likely to have benefit, whether it costs $20 or $200.
Symptoms of vaginal dryness, irritation and pain with sex, which occur in over half of postmenopausal women, cause a significant decrease in quality of life and negatively impact intimate relationships. The significant impact of these symptoms is reflected in the fact that we enrolled all 302 participants in under a year, a faster enrollment than any of the four prior trials conducted by the MsFlash research network that evaluated treatments for hot flashes. Women were desperate for some kind of intervention for these symptoms.
MedicalResearch.com: What should readers take away from your report?
Response: First, the positive outcome of the trial is that most women had an improvement in their symptoms and had improved sexual function at the end of 12 weeks. Women should seek treatment for vaginal pain and dryness after menopause, as these symptoms can be treated with a variety of interventions.
Second, our results suggest that when used regularly, simple vaginal gels as well as vaginal moisturizers and vaginal estrogen may all work to reduce symptoms, and that patients do not necessarily need to pay a lot of money for expensive treatments.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: We still don’t understand what causes postmenopausal vaginal discomfort in some women, but not others. All women have decreased levels of estrogen after menopause, but not all women have symptoms of vaginal discomfort. Understanding the underlying causes would help provide more targeted and possibly more effective therapies. As part of the clinical trial we collected biologic samples which are currently being analyzed to try and define potential etiologies of postmenopausal vaginal discomfort.
MedicalResearch.com: Is there anything else you would like to add?
Response: 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 should be developed.
Disclosures: None of the authors have direct conflicts of interest or financial disclosures relevant to this manuscript. By way of full disclosure, Dr. Mitchell is a consultant for Symbiomix Therapeutics. Dr. Reed receives grant support from Bayer Pharmaceuticals. Dr. LaCroix served on a scientific advisory board for Sermonix, Inc. All other authors have nothing to report.
Mitchell CM, Reed SD, Diem S, Larson JC, Newton KM, Ensrud KE, LaCroix AZ, Caan B, Guthrie KA. Efficacy of Vaginal Estradiol or Vaginal Moisturizer vs Placebo for Treating Postmenopausal Vulvovaginal SymptomsA Randomized Clinical Trial. JAMA Intern Med. Published online March 19, 2018. doi:10.1001/jamainternmed.2018.0116
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