April 17, 2023 – Vaginal laser “rejuvenation” does not relieve certain symptoms of menopause or improve sexual function in breast cancer survivors, new research shows, but will it be enough to stop some health care providers 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 editorial published alongside the study in JAMA Network Open.
In Gunter’s view, it’s highly unlikely that the clinical practice of laser therapy for what’s known as genitourinary syndrome of menopause will stop in the U.S. without FDA action.
That means “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,” she said. “There is simply too much money to be made.”
Many people have symptoms of GSM in menopause, and if they’re not treated, these symptoms can last for decades.
Vaginal laser therapy has emerged as a way to improve sexual function, vaginal lubrication, and moisture, while avoiding long-term use of pills and creams, Gunter explained.
The buzz surrounding vaginal laser therapy suggests it’s essentially a well-researched “spa treatment with no downside,” she said. But the “reality of laser for GSM and so-called vaginal rejuvenation is far different from the promise.”
The FDA has not cleared these laser devices, and there’s limited evidence to show they’re safe and effective.
For instance, a 2021 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, where a doctor goes through the motions of performing the treatment, but actually does not.
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, drugs given to patients who have already gone through menopause, a “uniquely important group for study, as they typically experience worse symptoms and may have safety concerns with hormonal therapies,” Gunter said.
All 72 women were told to use first-line treatment for genitourinary syndrome of menopause based on nonhormonal moisturizers and vaginal vibrator stimulation; 35 were randomly assigned 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 outcomes related to these menopause symptoms, 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.
The team also found no significant differences between real and sham laser therapy in key secondary outcomes, with both groups having significant improvements in all key areas.
Kristin Rojas, MD, a breast surgical oncologist and gynecologic surgeon based in Miami, 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 to improve symptoms of genitourinary syndrome of menopause was a “valid hypothesis,” Gunter said. But “some physicians who promote vaginal laser therapy appear to have gone from proof-of-concept studies to offering the therapy as safe and effective.”