Fractional CO2 laser no more effective than sham for improving postmenopausal vaginal symptoms

Reference

Li FG, Maheux-Lacroix S, Deans R, et al. Effect of fractional carbon dioxide laser vs sham treatment on symptom severity in women with postmenopausal vaginal symptoms. A randomized clinical trial. JAMA 2021;326(14):1381-1389.

Synopsis

Early observational studies report a 75% to 100% reduction in postmenopausal vaginal symptoms after fractional carbon dioxide (CO2) laser treatment. These investigators identified 85 women who were 18 years or older; amenorrheic for at least 12 months; and experiencing 1 or more vaginal symptoms, including dyspareunia, burning, itching, or severe dryness. After discontinuing the use of vaginal estrogen for at least 6 months, eligible women randomly received (concealed allocation assignment) 3 treatments, 1 month apart per standard recommendations and standard settings, of either fractional CO2 laser treatment or sham treatment with a similar device set at minimal energy setting with no tissue effect. Visual and auditory effects from the laser were similar between the groups. The individuals who assessed symptoms using previously validated symptom scoring tools remained masked to treatment group assignment. Complete follow-up occurred for 88.4% of participants in the laser group and 95.2% of those in the sham group at 12 months. Using intention-to-treat analysis, no significant group differences occurred between baseline and 12 months in changes in symptom scores, including the most severe symptoms, or quality of life, including sexual activity rates and quality scores. Similarly, no significant group differences occurred in the percentage of participants reporting a 50% or greater reduction in severe symptoms scores.