Seeing the light: the need for randomized trials of vaginal laser in postmenopausal women
In the past several years, fractional laser treatment of the vagina has been proposed as a treatment for symptoms of vulvovaginal atrophy. Laser treatment has been used for many years to treat skin discoloration and scarring in dermatology and has been shown to induce collagen production and tissue remodeling.3 Use of laser in gynecology presumes that vulvovaginal symptoms are due to the thinning of the vaginal mucosa and loss of underlying collagen that occurs with menopause. Examination of pre- and posttreatment vaginal biopsies shows a significant increase in vaginal mucosal thickness,4 and vaginal samples show an increase in Lactobacillus colonization and decrease in pH.5 Case report and case series data suggest that the treatment is well tolerated by patients, and is not associated with serious adverse events.6
In this issue of the journal, Cruz et al report the results of the first randomized trial of laser therapy with a sham intervention control for moderate or severe symptoms of vulvovaginal atrophy.7 Given the increased use of and promotion of lasers for this use, it is somewhat surprising that this is the first randomized trial in the literature. The study compared laser + placebo cream versus sham laser + estriol cream versus laser + estriol cream in postmenopausal Brazilian women. Fractional CO2 laser, at settings comparable to currently marketed devices, was delivered in two sessions 4 weeks apart. Estriol cream, which is not available commercially in the United States, was used 3 times a week for 20 weeks.
Women between 45 and 70 years of age were eligible for the trial if they were amenorrheic for ≥2 years, and reported moderate or severe dyspareunia, vulvovaginal dryness, or burning. The primary outcomes of the trial were symptom relief, as reported on a visual acuity scale (VAS) and improvement in the Vaginal Health Index (VHI), a physical examination score of severity of atrophy. Investigators also administered the Female Sexual Function Index (FSFI) questionnaire before and after treatment.
Fifteen women were enrolled in each arm, for a total of 45, with a 93% retention rate at study end. Biologic effects were similar across treatments; all three groups showed a comparable improvement in vaginal maturation index, and decrease in parabasal cells. VHI improved in all three groups compared with enrollment, but at 20 weeks, laser + placebo had a significantly lower (worse) score than sham laser + estriol, or laser + estriol. The primary symptom outcome was also comparable between treatment groups: there was a significant decrease in VAS scores for dyspareunia, dryness, and burning in each group over the course of the trial (except for burning and dryness in estriol, where starting scores were significantly lower). VAS scores at week 20 were comparable between the groups. The secondary symptom outcome of FSFI, however, demonstrated differences: FSFI scores in the sham laser + estriol and laser + estriol improved, but the total FSFI score in the laser + placebo group got slightly worse, driven in large part by a significant drop (worsening) in the score for the pain domain.