A randomized controlled trial has demonstrated that vaginal laser "rejuvenation" does not relieve symptoms of genitourinary syndrome of menopause (GSM) or improve sexual function in breast cancer survivors.
But will it be enough to stop some practitioners from promoting the false promise of laser therapy and cashing in on it?
Probably not, "because history tells us that facts do not always get in the way of ego and profit," wrote Jen Gunter, MD, with Kaiser Permanente Northern California, in an invited commentary published alongside the JAMA Network Open study.
In Gunter's view, it's highly unlikely that the clinical practice of laser therapy for GSM will halt in the United States without Food and Drug Administration (FDA) intervention.
Therefore, "many practitioners here and around the world will likely continue to use the offensive 'vaginal rejuvenation' language to coax patients into paying thousands of dollars to treat GSM for what the most robust current evidence tells us is an ineffective procedure," Gunter said. "There is simply too much money to be made."
Many individuals experience symptoms of GSM in menopause, and these symptoms can persist for decades, if left untreated.
Vaginal laser therapy has emerged as an option for improving sexual function as well as vaginal lubrication and moisture, and avoiding long-term use of pills and creams, Gunter explained.
The hype surrounding vaginal laser therapy suggests it's essentially a well-researched "spa treatment with no downside," Gunter said. However, the "reality of laser for GSM and so-called vaginal rejuvenation is far different from the promise."
These laser devices have not been cleared by the FDA and there's limited evidence to support their safety or efficacy.
For instance, a 2021 double-blind, sham-controlled randomized controlled trial of postmenopausal women with vaginal symptoms found that fractional carbon dioxide vaginal laser therapy does not improve symptoms or quality of life, or lead to changes in vaginal histology, vs sham vaginal laser therapy.
The study "should have been enough to pause laser therapy outside of clinical trials. Unfortunately, it was not," Gunter said.
The new study provides similar findings — this time in breast cancer survivors with GSM receiving aromatase inhibitors, a "uniquely important group for study, as they typically experience worse symptoms and may have safety concerns with hormonal therapies," Gunter noted.
All 72 women were instructed to use first-line treatment for GSM based on nonhormonal moisturizers and vaginal vibrator stimulation; 35 were randomly allocated to five monthly sessions of fractional carbon dioxide vaginal laser therapy and 37 to sham laser therapy.
At the 6-month follow-up, all women showed significant improvement in subjective and objective outcomes related to GSM, regardless of whether they received real or sham laser therapy, according to the authors, led by Eduard Mension, MD, with Hospital Clinic of Barcelona, Spain.
Mension and colleagues found no significant between-group differences in Female Sexual Function Index (FSFI) scores at 6 months in all women (P = .15) or in the subgroup of sexually active women (P = .15).
The team also found no significant differences between real and sham laser therapy in key secondary outcomes, with both groups experiencing significant improvements in dyspareunia, Vaginal Health Index, Body Image Scale, vaginal pH, vaginal maturation index, and vaginal elasticity.
Although vaginal laser therapy appeared to be safe, with only mild adverse events, it was not as well tolerated as sham laser therapy.
Kristin Rojas, MD, breast surgical oncologist and gynecologic surgeon based in Miami, Florida, was not surprised by the new data, tweeting: "I'll say it again people: these cash-based 'rejuvenation' therapies are no better than placebo."
The idea that laser therapy might stimulate blood flow and collagen and consequently improve symptoms of GSM was a "valid hypothesis," Gunter said. However, "some physicians who promote vaginal laser therapy appear to have gone from proof-of-concept studies to offering the therapy as safe and effective."
The study was funded by Instituto de Salud Carlos III and the European Union. Mension and Gunter report no relevant financial relationships.
JAMA Netw Open. Published online February 10, 2023. Full text. Editorial.
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Cite this: False Promise of Vaginal Laser Therapy in Breast Cancer Survivors - Medscape - Apr 13, 2023.
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