A randomized controlled trial showed that vaginal laser “rejuvenation” did not relieve symptoms of genitourinary menopause (GSM) or improve sexual function in breast cancer survivors.
But will it be enough to stop some practitioners from pushing the false promise of laser therapy and cashing in on it?
Probably not, “because history tells us that facts don’t always get in the way of ego and profit,” Jen Gunter, MD, with Kaiser Permanente Northern California, wrote in a guest commentary published alongside the JAMA Network Open study.
In Gunter’s view, it is highly unlikely that the clinical practice of laser therapy for GSM will cease in the United States without intervention from the Food and Drug Administration (FDA).
Therefore, “many practitioners here and around the world will likely continue to use the offensive language of ‘vaginal resuscitation’ to convince patients to pay thousands of dollars to treat GSM for what the strongest current evidence tells us is it’s an inefficient process,” Gunter said. . “There’s just too much money to go around.”
Many people experience GSM symptoms at 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, as well as avoiding the long-term use of pills and creams, Gunter explained.
The hype surrounding laser vaginal therapy suggests it’s essentially a well-researched “spa treatment without the downside,” Gunter said. However, “the reality of the laser for GSM and the so-called vaginal rejuvenation is very different from the promise.”
These laser devices are not FDA approved and there is limited evidence to support their safety or effectiveness.
For example, a 2021 double blind, sham controlled randomized controlled trial of postmenopausal women with vaginal symptoms found that fractionated carbon dioxide vaginal laser treatment did not improve symptoms or quality of life or lead to changes in vaginal histology, compared with sham vaginal laser treatment.
The study “should have been enough to stop laser therapy out of clinical trials. Unfortunately, it wasn’t,” Gunter said.
The new study provides similar findings — this time in breast cancer survivors with GSM taking aromatase inhibitors, a “uniquely important group to study as they typically have worse symptoms and may have safety concerns with hormone therapies,” he noted Gunter.
All 72 women were instructed to use first-line treatment for GSM based on nonhormonal moisturizers and vaginal stimulation with vibrators. 35 were randomly assigned to five monthly sessions of fractional carbon dioxide vaginal therapy and 37 to sham laser therapy.
At the 6-month follow-up, all women showed significant improvement in subjective and objective GSM-related outcomes, regardless of whether they received real or sham laser treatment, according to the authors, led by Eduard Mension, MD, with the Hospital Clinic of Barcelona, Spain.
Mension and colleagues found no significant between-group differences in Female Sexual Functioning Index (FSFI) scores at 6 months in all women (Pi = .15) or in the subgroup of sexually active women (Pi = .15).
The team also found no significant differences between real and sham laser treatment in key secondary outcomes, with both groups showing significant improvements in dyspareunia, vaginal health index, body image scale, vaginal pH, vaginal maturation index, and in vaginal elasticity.
Although vaginal laser therapy appeared to be safe, with only mild side effects, it was not as well tolerated as sham laser therapy.
Kristin Rojas, MD, a breast surgical oncologist and gynecologist based in Miami, Florida, wasn’t surprised by the new data. tweeting: “I’ll say it again folks: these cash-based ‘revival’ treatments are no better than placebo.”
The idea that laser therapy might stimulate blood flow and collagen and consequently improve GSM symptoms was a “valid hypothesis,” Gunter said. However, “some doctors promoting vaginal laser therapy seem to have moved from proof-of-concept studies to offering the treatment as safe and effective.”
The study was funded by the Instituto de Salud Carlos III and European Union. Mension and Gunter report no relevant financial relationships.
JAMA Network Open. Published online February 10, 2023. Full text. Editorial.
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