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Women who underwent vaginal laser therapy for postmenopausal vaginal symptoms saw no improvement in symptom severity, quality of life, or their overall vaginal health, according to results of a randomized trial.

There was no significant difference between fractional microablative carbon dioxide laser treatment and sham therapy in change in vaginal symptom severity from baseline to 1 year (visual analog scale [VAS] score for overall symptoms -17.2 vs -26.6; difference 9.4, 95% CI -28.6 to 47.5), reported Fiona Li, MD, of the University of New South Wales in Sydney, and colleagues.

Importantly, the laser therapy did not improve patients' most serious vaginal symptom (VAS score -24.5 vs -20.4; difference -4.1, 95% CI -32.5 to 24.3), the researchers wrote in .

Between the two treatment groups, there was no significant difference in the number of patients who reported more than a 50% reduction in severity of their most serious vaginal symptom at 1 year (22% vs 21%, P=0.43), which did not meet the minimal clinically important difference.

Researchers also found no significant differences in quality-of-life scores (6.3 vs 1.4; difference 4.8, 95% CI -3.9 to 13.5) and Vaginal Health Index scores (0.9 vs 1.3; difference -0.4, 95% CI -4.3 to 3.6) between the two groups.

"Among women with postmenopausal vaginal symptoms, treatment with fractional carbon dioxide laser vs sham treatment did not significantly improve vaginal symptoms after 12 months," Li and colleagues concluded.

They noted that the demand for effective alternatives to hormonal therapies to treat vaginal issues after menopause "has contributed to a rapid dissemination and uptake of commercially available fractional carbon dioxide laser, despite no data from sham-controlled trials to date," calling for a rigorous evaluation of clinical outcomes and cost-effectiveness of new treatments.

Vaginal laser treatment aims to destroy tissues in a small surface area of the vagina to induce reparative changes. These changes could theoretically include a rebuilding of the inner vaginal lining, more collagen production, and improved circulation.

However, in 2018, the FDA issued a warning about devices marketed for use in "vaginal rejuvenation" procedures, citing serious risks and a lack of adequate evidence on their efficacy. Three randomized controlled trials (RCTs) have been published since then, showing no real improvement with the laser or energy-based treatments -- but this study is the first to use a sham-controlled design.

"The study by Li et al in this issue of JAMA represents the largest and longest-term RCT to evaluate the effectiveness of vaginal laser therapy to manage [genitourinary syndrome of menopause]," wrote Marisa Adelman, MD, and Ingrid Nygaard, MD, MS, of the University of Utah School of Medicine in Salt Lake City, in an .

"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," Adelman and Nygaard added, citing vaginal mesh products that were widely adopted for pelvic organ prolapse. The editorialists called for a limit on fractional carbon dioxide laser therapy to research settings until higher-quality evidence is gathered.

Li and colleagues conducted a double-blind, randomized trial to evaluate the efficacy of fractional laser therapy for postmenopausal vaginal symptoms. Trial participants were included if they did not have their menstrual period within the last year and endured a vaginal symptom severe enough to seek treatment, including dyspareunia, burning, itching, or severe dryness. All patients were required to discontinue vaginal estrogen for 6 months prior to the start of the trial.

Women were randomized to either the laser treatment or a sham group. They underwent three treatments total, which were spaced out 1 to 2 months from each other. One year after treatment, clinicians evaluated changes in symptom severity, measured by a VAS (which ranged from a score of 0 to 100) and the Vulvovaginal Symptom Questionnaire (range from 0 to 20), with higher scores indicating worse symptoms. They also measured quality of life and vaginal health via the Vaginal Health Index and histological samples taken at baseline and 6 months after treatment.

The study included 85 patients (mean age 57) who were treated at a university teaching hospital in Sydney from September 2016 to June 2019. No patients discontinued treatment after randomization, and 78 completed the 12-month follow-up.

Overall, 16 patients in the laser group and 17 in the sham treatment group experienced an adverse event, which included self-resolving vaginal pain or discomfort (44% vs 68%), spotting (30% vs 5%), lower urinary tract symptoms or confirmed infection (15% vs 5%), and vaginal discharge (11% vs 11%). No serious adverse events were reported in either group.

Li and colleagues recognized that this study may be limited by a change in laboratory-based assessment during the study, as they switched from cytological vaginal samples to full biopsies. This provided fewer, but more reliable, samples for blinded histological assessment and identification of pre- or postmenopausal vaginal cells.

Additionally, the study was not powered to detect any significant differences in symptom severity after breast cancer treatment or natural menopause, and could not detect uncommon, but clinically relevant, adverse events.

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