Laser treatment improved dryness, burning, and dyspareunia but caused more pain
All 3 treatment groups showed statistically significant improvement in vaginal dryness at 20 weeks, but only the laser-alone arm and the laser plus estriol arms showed improvement in dyspareunia and burning. The total FSFI scores improved significantly only in the laser plus estriol arm (TABLE). No difference in the vaginal maturation index was noted between groups; however, improved numbers of parabasal cells were found in participants in the laser treatment arms.
While participants in the laser treatment arms (alone and in combination with estriol) showed significant improvement in the VAS domains of dyspareunia and burning compared with those treated with estriol alone, there was a contradictory finding of more pain in both laser arms at 20 weeks compared with the estriol-alone group, based on the FSFI. The FSFI is a validated, objective quality-of-life questionnaire, and the finding of more pain with laser treatment is a concern.
WHAT THIS EVIDENCE MEANS FOR PRACTICE
Exercise caution when interpreting these study findings. While this preliminary study showed that fractionated CO2 laser treatment had favorable outcomes for dyspareunia, dryness, and burning, the propensity for increased vaginal pain with this treatment is a concern. This study was not adequately powered to analyze multiple comparisons in postmenopausal women with GSM symptoms. There were significant baseline differences, with less bothersome burning and sexual complaints based on the FSFI and VAS, in the vaginal estriol arm. The finding of more pain in the laser treatment arms at 20 weeks compared with that in the vaginal estriol arm is of concern and warrants further investigation.
-- Cheryl B. Iglesia, MD
Exercise caution when interpreting these study findings. While this preliminary study showed that fractionated CO2 laser treatment had favorable outcomes for dyspareunia, dryness, and burning, the propensity for increased vaginal pain with this treatment is a concern. This study was not adequately powered to analyze multiple comparisons in postmenopausal women with GSM symptoms. There were significant baseline differences, with less bothersome burning and sexual complaints based on the FSFI and VAS, in the vaginal estriol arm. The finding of more pain in the laser treatment arms at 20 weeks compared with that in the vaginal estriol arm is of concern and warrants further investigation.
-- Cheryl B. Iglesia, MD
Study strengths and weaknesses
This study is one of the first of its kind to compare laser therapy alone and in combination with local estriol to vaginal estriol alone for the treatment of GSM. The trial’s strength is in its design as a double-blind, placebo-controlled block randomized trial, which adds to the prospective cohort trials that generally show favorable outcomes for fractionated laser for the treatment of GSM.
The study’s weaknesses include its small sample size, single trial site, and short-term follow-up. Findings from this trial should be considered preliminary and not generalizable. Other weaknesses are the 3 of 45 participants lost to follow-up and the significant baseline differences among the women, with lower bothersome baseline VAS scores in the estriol arm.
Furthermore, this study was not powered for multiple comparisons, and conclusions favoring laser therapy cannot be overinflated. Lasers such as CO2 target the chromophore water, and indiscriminate use in severely dry vaginal epithelium may cause more pain or scarring. Longer-term follow-up is needed.
More research also is needed to develop guidelines related to pre-laser treatment to achieve optimal vaginal pH and ideal vaginal maturation, including, for example, vaginal priming with estrogen, DHEA, or other moisturizers.
This study also suggests the use of vaginal laser therapy as a drug delivery mechanism for combination therapy. Many vaginal estrogen treatments are expensive (despite prescription drug coverage), and laser treatments are very expensive (and not covered by insurance), so research to optimize outcomes and minimize patient expense is needed.
Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.