Laser, Estrogen Comparable for Genitourinary Syndrome of Menopause

By Will Boggs MD

November 01, 2019

NEW YORK (Reuters Health) - Vaginal laser therapy and vaginal estrogen therapy provide similar benefits in women with genitourinary syndrome of menopause (GSM), according to findings from the VeLVET trial.

As many as 50% of menopausal women report symptoms of GSM. Estrogen therapy is considered when first-line treatments (vaginal moisturizers, vaginal lubricants and continued sexual activity) fail, and some small, short-term studies have demonstrated benefits from vaginal laser therapy.

Dr. Marie Fidela R. Paraiso of Cleveland Clinic, in Ohio, and colleagues from six institutions compared improvement in symptoms of GSM between women who underwent CO2 fractional vaginal laser therapy and those treated with vaginal estrogen alone in an open-label noninferiority study of 69 women.

The primary outcome, visual analog scale (VAS) scores for vaginal dryness at six months, did not differ significantly between the treatment groups. And there were no significant differences between the groups for the other GSM symptoms evaluated (vaginal burning, vaginal itching and dysuria), the researchers report in Menopause, online September 30.

Changes in vaginal maturation index demonstrated a significantly higher estrogenic effect in the estrogen group than in the laser group.

Women in the estrogen group were more likely to show improvement in desire and arousal after treatment, but this difference disappeared after adjustment for age, menopausal status, previous estrogen use and sexual activity.

More women in the estrogen group (82.8%) than in the laser therapy group (71.9%) rated their improvement as "better or much better," but this difference fell short of statistical significance.

Adverse events did not differ significantly between the treatment groups.

The study was underpowered as a result of early termination of enrollment due to a U.S. Food and Drug Administration (FDA) requirement to obtain and maintain an Investigational Device Exemption (IDE).

"Laser therapy may be considered for the short-term treatment of GSM," the authors conclude. "Additional well-designed studies with adequate power and longer-term follow-up are warranted."

Dr. Antonia Pearson of the University of Sydney, Australia, who recently demonstrated the benefits of vaginal laser therapy in treating vulvovaginal atrophy in women with breast cancer, told Reuters Health by email, "Several treatment options exist for the treatment of genitourinary symptoms of menopause. Given the 2018 FDA warning about the use of vaginal laser and the lack of robust evidence for both the efficacy and safety of this treatment, women should use alternatives to laser first where safe, in accordance with current guidelines."

"At present, until further studies have been done, if vaginal laser is to be used, women should be counseled about the lack of definitive evidence for its effectiveness and long-term adverse outcomes," said Dr. Pearson, who was not involved in the study. "Hopefully, the current trials underway internationally will reassure us that this is a good option to recommend to patients."

"Genitourinary symptoms are very common and very distressing in breast-cancer survivors, which is my area of research, particularly in women on aromatase inhibitors to prevent breast-cancer recurrence," Dr. Pearson said. "Genitourinary symptoms in these women tend to occur more frequently and be more severe than postmenopausal women in general. Vaginal estrogen treatments have traditionally been discouraged in these women due to concerns of increasing breast-cancer recurrence, although they may be safe due to low systemic absorption."

The 2018 FDA warning against the use of vaginal laser therapy in this setting is available at https://bit.ly/2N1lHhV.

The study did not have commercial funding.

Dr. Paraiso did not respond to a request for comments.

SOURCE: https://bit.ly/2VR9eB3

Menopause 2019.

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