NEW YORK (Reuters Health) - Fractional carbon dioxide laser for treatment of vaginal symptoms associated with menopause - unapproved in the U.S. but often advertised as safe and effective "vaginal rejuvenation" - doesn't work, according to a new clinical trial.
The demand for effective non-hormonal remedies for vaginal menopausal symptoms has led to "rapid dissemination and uptake of commercially available fractional carbon dioxide laser, despite no data from sham-controlled trials to date," Dr. Jason Abbott and colleagues of UNSW Sydney, in Australia, note in JAMA.
They did a double-blind, randomized, sham-laser-controlled study involving 85 postmenopausal women seeking medical treatment for vaginal symptoms.
Forty-three women underwent three treatments fractional microablative carbon dioxide laser treatments performed four to eight weeks apart at standard power and 42 underwent sham-laser treatment performed at minimal energy settings with no tissue effect.
At 12 months, there was no significant difference between groups in change in symptom severity, assessed using a visual analog scale and the vulvovaginal symptom questionnaire. There were also no between-group differences in quality-of-life scores or histological comparisons.
There were 16 adverse events in the laser group and 17 in the sham group, including vaginal pain/discomfort (44% vs. 68%), spotting, discharge, and lower-urinary-tract symptoms. No severe adverse events were reported in either group.
The U.S. Food and Drug Administration (FDA) has not approved any energy-based devices to treat postmenopausal vaginal symptoms and, in 2018, warned that these therapies may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain.
"We are deeply concerned women are being harmed," then-FDA commissioner Dr. Scott Gottlieb said at the time.
In a JAMA editorial, Dr. Marisa Adelman and Dr. Ingrid Nygaard of the Department of Obstetrics and Gynecology, The University of Utah School of Medicine, in Salt Lake City, notes that the trajectory of "highly optimistic short-term uncontrolled studies leading to widespread clinical use of vaginal laser therapy, followed by burgeoning reports of adverse events and FDA warnings, brings an unfortunate sense of déjà vu in women's health."
"After a rush to market vaginal mesh products for the management of pelvic organ prolapse prior to the completion of rigorous randomized trials, these products are no longer marketed in the U.S.," they point out.
Based on the current study results, "use of vaginal laser technology for the management of genitourinary symptoms should be limited to a research setting until high-quality evidence supports both effectiveness and safety. The findings also highlight the importance of conducting additional rigorous studies to determine evidence-based therapies for women with genitourinary syndrome of menopause (GSM)," Dr. Adelman and Dr. Nygaard conclude.
SOURCE: https://bit.ly/3p9QVYT and https://bit.ly/3ACtc5v JAMA, online October 12, 2021.
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