1. A randomized controlled trial of 85 participants found no significant difference in vaginal symptom severity after 12 months between those who underwent fractional carbon dioxide laser treatment versus those who did not.
2. There were no significant differences between the groups with regards to patient-reported quality of life and vaginal health, or with regards to histology.
Evidence Rating Levels: 1 (Excellent)
Study Rundown: Vaginal symptoms including dryness, itchiness, burning, pain and dyspareunia are experienced by approximately half of all postmenopausal women. These symptoms are caused by a decline in the body’s natural estrogen production during menopause and can be treated with local or systemic hormone replacement therapy (HRT). However, HRT can be ineffective or contraindicated in some women and there remains an ongoing need for safe alternatives in the treatment of postmenopausal vaginal symptoms. Fractional laser treatments have shown some promise in early studies looking at pathologic changes to vaginal tissue after application, although high quality evidence about clinically-important outcomes is lacking. The present blinded, randomized controlled trial (RCT) randomized 85 symptomatic postmenopausal women in Sydney, Austrailia to receive either fractionated carbon dioxide laser treatment or a sham procedure. 78 patients in total completed the study, with 40 in the laser group and 38 in the sham group. There were no significant differences in symptom severity at 12 months. 8 participants in both the laser and sham groups reported a clinically significant improvement in their symptoms. Quality of life, vaginal and sexual health and pathology results were also not significantly different between the two groups. 16 patients in the laser group and 17 patients in the sham group reported adverse events during the trial. This trial demonstrated that fractional carbon dioxide laser treatment was not more effective than a sham procedure at addressing vaginal symptoms of menopause. Some drawbacks of this work include the relatively stringent exclusion criteria, which precluded many women with comorbid conditions from participating in the trial – this reduces the external validity of the reported findings. Additionally, the authors noted that after the first few tissue samples taken for histologic study were inadequate, they started taking larger biopsy samples which are associated with more discomfort and bleeding. This could have affected the quality of life and symptoms reported by patients in the weeks between treatment in both groups. Otherwise, the trial demonstrated strong methodology for investigating a relatively new therapy for a common problem. Further study should confirm the findings reported here to inform decisions about whether women’s health clinicians invest time and money into this equipment and offer vaginal laser services.
Click here to read the study in JAMA
Click here to read an accompanying editorial in JAMA
Relevant Reading: Vaginal and urinary symptoms of menopause
In-Depth [randomized controlled trial]: Participants were randomized on a 1:1 basis using block-randomization completed by a third party. The sham procedure was completed using the same laser equipment as the intervention group with different settings applied (i.e., 40W power in the treatment group, 0.5W power in the controls). Both groups underwent the same procedure, which included local anesthesia with lidocaine and application of the laser for 20 minutes. Data were collected at every study visit & stored remotely using the REDCAP server. Cytology and biopsy data were collected at 6 and 12 months, respectively. Blinding of clinicians was achieved by assigning separate individuals to the assessment of patient eligibility versus carrying out the procedure. Vaginal symptoms were assessed using a visual analogue scale ranging from 0 to 100 indicating symptom severity as well as a Vulvovaginal Symptom Questionnaire (VSQ) which addressed symptoms and their psychosocial impact on patients. The threshold for minimally clinically significant improvement was determined to be a 50% reduction in severity for both measures. The change in VAS score after 12 months was –17.2 points in the intervention group versus –26.6 in the sham group. The absolute difference was 9.4 points (95% confidence interval [CI], –28.7 to 47.5). There was also no significant difference in VSQ scores after 12 months (3.1 vs –1.6; difference, –1.5 [95% CI, –6.0 to 3.0]). A subgroup analysis comparing women who had naturally reached menopause versus those who had iatrogenically induced it found no differences in symptoms between laser and sham treatment either. The proportion of patients achieving clinically significant improvement in symptoms was 22% in the intervention group and 21% in the sham group (P = 0.43). The mean difference in scores for quality of life was 6.3 points in the laser group and 1.4 in the sham group at 12 months, with a difference of 4.9 points (95% CI -3.9 to 13.5). Similarly, the vaginal health index demonstrated a mean score difference of -0.4 points between the intervention and control groups (95% CI -4.3 to 3.6). Finally, vaginal biopsies were compared for histologic differences; a shift to premenopausal histology was reported in 9% of the laser patient samples after treatment, and 12.5% of the sham group – there was no significant difference between groups. The most commonly reported adverse events were vaginal pain/discomfort (44% of the laser group, 68% of the sham group), spotting (30% versus 5%) and lower urinary tract symptoms or confirmed infection (15% versus 5%).
Image: PD
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