Clinical Review

2020 Update on Menopause

OBG Manag. 2020 June;32(6):30-35, 42 | DOI: 10.12788/obgm.0001

References

Portman DJ, Gass ML. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women’s Sexual Health and The North American Menopause Society. Maturitas. 2014;79:349-354.
Kaunitz AM, Manson JE. Management of menopausal symptoms. Obstet Gynecol. 2015;126:859-876.
Shifren JL. Genitourinary syndrome of menopause. Clin Obstet Gynecol. 2018;61:508-516.
Manson JE, Kaunitz AM. Menopause management—getting clinical care back on track. N Engl J Med. 2016;374:803-806.
Kingsberg SA, Krychman M, Graham S, et al. The women’s EMPOWER survey: identifying women’s perceptions on vulvar and vaginal atrophy and its treatment. J Sex Med. 2017;14:413-424.
The NAMS 2017 Hormone Therapy Position Statement Advisory Panel. The 2017 Hormone therapy position statement of The North American Menopause Society. Menopause. 2017;24:728-753.
American College of Obstetricians and Gynecologists. ACOG practice bulletin No. 141: Management of menopausal symptoms. Obstet Gynecol. 2014;123:202-216.
US Food and Drug Administration website. FDA warns against the use of energy-based devices to perform vaginal ‘rejuvenation’ or vaginal cosmetic procedures: FDA safety communication. https://www.fda.gov/medical-devices/safety-communications/fda-warns-against-use-energy-based-devices-perform-vaginal-rejuvenation-or-vaginal-cosmetic. Updated November 20, 2018. Accessed May 21, 2020.
US Food and Drug Administration website. Letters to industry. https://www.fda.gov/medical-devices/industry-medical-devices/letters-industry. July 24, 2018. Accessed May 21, 2020

Nurses’ Health Study report provides reassurance on long-term safety of vaginal estrogen

Bhupathiraju SN, Grodstein F, Stampfer MJ, et al. Vaginal estrogen use and chronic disease risk in the Nurses’ Health Study. Menopause. 2018;26:603-610

Bhupathiraju and colleagues published a report from the long-running Nurses’ Health prospective cohort study on the health outcomes associated with the use of vaginal estrogen.

Recap of the study

Starting in 1982, participants in the Nurses’Health Study were asked to report their use of vaginal estrogen via a validated questionnaire. For the years 1982 to 2012, investigators analyzed data from 896 and 52,901 women who had and had not used vaginal estrogen, respectively. The mean duration of vaginal estrogen use was 36 months.

In an analysis adjusted for numerous factors, the investigators observed no statistically significant differences in risk for cardiovascular outcomes (myocardial infarction, stroke, deep vein thrombosis, and pulmonary embolism) or invasive cancers (colorectal, endometrial, ovarian, or breast).

Findings uphold safety of vaginal estrogen

This landmark study provides reassurance that 3 years of use of vaginal estrogen does not increase the risk of cardiovascular events or invasive breast cancer, findings that hopefully will allow clinicians and women to feel comfortable regarding the safety of vaginal estrogen. A study of vaginal estrogen from the Women’s Health Initiative provided similar reassurance. Recent research supports guidance from The North American Menopause Society and the American College of Obstetricians and Gynecologists that vaginal estrogen can be used indefinitely, if indicated, and that use of concomitant progestin is not recommended in women who use vaginal estrogen and have an intact uterus.^6,7

I agree with the authors, who point out that since treatment of GSM may need to be continued long term (even indefinitely), it would be helpful to have data that assessed the safety of longer-duration use of vaginal estrogen.

WHAT THIS EVIDENCE MEANS FOR PRACTICE

Results from Bhupathiraju and colleagues’ analysis of data from the Nurses’ Health Study on the 3-year safety of vaginal estrogen use encourage clinicians to recommend and women to use this safe and effective treatment for GSM.

How CO2 fractionated vaginal laser therapy compares with vaginal estrogen for relief of GSM symptoms

Paraiso MF, Ferrando CA, Sokol ER, et al. A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause: the VeLVET trial. Menopause. 2020;27:50-56.

Up to 50% to 60% of postmenopausal women experience GSM symptoms. However, many fewer receive treatment, either because they do not understand that the symptoms are related to menopause or they are not aware that safe and effective treatment is available. Sadly, many women are not asked about their symptoms or are embarrassed to tell providers.

GSM affects relationships and quality of life. Vaginal lubricants or moisturizers may provide relief. US Food and Drug Administration (FDA)–approved therapies include low-dose vaginal estrogen, available as a vaginal tablet, cream, suppository, and ring; intravaginal dehydroepiandrosterone (DHEA); and oral ospemifene, a selective estrogen replacement modulator. If women have an estrogen-sensitive breast or uterine cancer, an oncologist should be involved in decisions about vaginal hormonal therapy.

Energy-based devices such as vaginal lasers appear to induce wound healing; stimulate collagen and elastin fiber formation through increased storage of glycogen; and activate fibroblasts, which leads to increased extracellular matrix and restoration of vaginal pH.

These lasers are FDA approved for use in gynecology but not specifically for the treatment of GSM. In July 2016, the FDA issued a safety alert that energy-based devices, while approved for use in gynecology, have not been approved or adequately tested for menopausal vaginal conditions, and safety concerns include reports of vaginal burns.⁸ Lacking are publications of adequately powered randomized, sham-con-trolled trials to determine if laser therapy works better for women with GSM than placebos, moisturizers, or vaginal hormone therapies.

Recently, investigators conducted a multicenter, randomized, single-blinded trial of vaginal laser therapy and estrogen cream for treatment of GSM.

Continue to: Details of the study...