Fractional Carbon Dioxide Laser not superior to Sham Treatment for Postmenopausal Vaginal Symptoms: JAMA

Fractional laser treatments are used as a nonhormonal alternative for postmenopausal vaginal symptoms.

A double-blind, randomized, sham-controlled trial with 12-month follow-up was undertaken by Fiona G. Li et al at a single tertiary referral hospital in Sydney, Australia. Enrollment commenced on September 19, 2016, with final follow-up on June 30, 2020. Participants were postmenopausal women with vaginal symptoms substantive enough to seek medical treatment. Of 232 participants approached, 85 were randomized.

Three treatments using a fractional microablative carbon dioxide laser system performed 4 to 8 weeks apart, with 43 women randomized to the laser group and 42 to the sham group.

The co–primary outcomes were symptom severity assessed using a visual analog scale (VAS; range, 0-100; 0 indicates no symptoms and 100 indicates the most severe symptoms) and the Vulvovaginal Symptom Questionnaire (VSQ; range, 0-20; 0 indicates no symptoms and 20 indicates the most severe symptoms) at 12 months. The minimal clinically important difference was specified as a 50% decrease in both VAS and VSQ severity scores. There were 5 prespecified secondary outcomes, including quality of life (range, 0-100; higher scores indicate better quality of life), the Vaginal Health Index Score (range, 5-25; higher scores indicate better health), and vaginal histology (premenopausal or postmenopausal status).

Of 85 randomized participants (mean [SD] age, 57 [8] years), 78 (91.7%) completed the 12-month follow-up. From baseline to 12 months, there was no significant difference between the carbon dioxide laser group and the sham group in change in symptom severity (VAS score for overall vaginal symptoms: –17.2 vs –26.6; difference, 9.4; VAS score for the most severe symptom: –24.5 vs –20.4; difference –4.1; VSQ score: –3.1 vs –1.6; difference, –1.5).

There were no significant differences between the laser and sham group in the mean quality of life score (6.3 vs 1.4; difference, 4.8) and Vaginal Health Index Score (0.9 vs 1.3; difference, –0.4) or in histological comparisons between laser and sham treatment groups.

There were 16 adverse events in the laser group and 17 in the sham group, including vaginal pain/discomfort (44% vs 68%), spotting, discharge, and lower urinary tract symptoms. No severe adverse events were reported in either group.

In this randomized clinical trial involving women with postmenopausal vaginal symptoms, treatment with fractional carbon dioxide laser vs sham treatment did not result in improvement in symptom severity, quality of life, or vaginal histology. The demand for effective alternatives to hormonal treatments for vaginal menopausal symptoms, particularly when hormonal treatments are contraindicated (eg, hormone-sensitive breast cancer), has contributed to a rapid dissemination and uptake of commercially available fractional carbon dioxide laser, despite no data from sham-controlled trials to date.

Introduction of devices and treatments in women's health prior to evidence of efficacy and safety have had consequential effects on both individual health and health care policy, with synthetic mesh procedures for vaginal prolapse being a notable example. The physical, psychosocial, and economic effects of vaginal symptoms of menopause are substantive, although not life-threatening. Clinical outcomes and cost-effectiveness of treatments, whether devices or drugs, should be evaluated rigorously prior to integration into routine treatment.

The annual cost of laser treatment to the individual for management of vaginal menopausal symptoms was reported to be $2733,24 and because there is no demonstratable difference vs sham treatment, it cannot be considered to be cost-effective.

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

Source: JAMA. 2021;326(14):1381-1389. doi:10.1001/jama.2021.14892