Effect of Fractional Carbon Dioxide vs Sham Laser on Sexual Function in Survivors of Breast Cancer Receiving Aromatase Inhibitors for Genitourinary Syndrome of Menopause

Abstract

ImportanceSurvivors of breast cancer present more severe symptoms of genitourinary syndrome of menopause (GSM) than patients without history of breast cancer. Recently, new treatments, such as vaginal laser therapy, have appeared, but evidence of their efficacy remains scarce.ObjectiveTo assess the safety and efficacy of carbon dioxide (CO2) vs sham vaginal laser therapy after 6 months of follow-up in survivors of breast cancer with GSM receiving aromatase inhibitors.Design, Setting, and ParticipantsThis prospective double-blind sham-controlled randomized clinical trial with two parallel study groups was performed during October 2020 to March 2022 in a tertiary referral hospital. Survivors of breast cancer using aromatase inhibitors were assessed for eligibility, and eligible patients were randomized into the 2 treatment groups. Follow-up was conducted at 6 months. Data were analyzed in July 2022.InterventionsAll patients from both groups were instructed to use the first-line treatment (FLT) based on nonhormonal moisturizers and vaginal vibrator stimulation. Patients for each group were allocated to 5 monthly sessions of fractional CO2 laser therapy (CLT) or sham laser therapy (SLT).Main Outcomes and MeasuresThe primary outcome was sexual function, evaluated through Female Sexual Function Index (FSFI) score. Other subjective measures of efficacy included a visual analog scale of dyspareunia, vaginal pH, a Vaginal Health Index, quality of life (assessed via Short-Form 12), and body image (assessed with the Spanish Body Image Scale). Objective measures of efficacy included vaginal maturation index, vaginal epithelial elasticity (measured in Pascals) and vaginal epithelial thickness (measured in millimeters). Measures were assessed before and after the intervention. Tolerance (measured on a Likert scale), adverse effects, and estradiol levels were recorded.ResultsAmong 211 survivors of breast cancer assessed, 84 women were deemed eligible and 72 women (mean [SD] age, 52.6 [8.3] years) were randomized to CLT (35 participants) or SLT (37 participants) and analyzed. There were no statistically significant differences between groups at baseline. At 6 months, both groups showed improvement in FSFI (mean [SD] score at baseline vs 6 months: CLT, 14.8 [8.8] points vs 20.0 [9.5] points; SLT, 15.6 [7.0] points vs 23.5 [6.5] points), but there was no significant difference between CLT and SLT groups in the improvement of sexual function evaluated through the FSFI test overall (mean [SD] difference, 5.2 [1.5] points vs 7.9 [1.2] points; P = .15) or after excluding women who were not sexually active (mean [SD] difference, 2.9 [1.4] points vs 5.5 [1.1] points; P = .15). There were also no differences between improvement of the 2 groups at 6 months of follow-up in the other assessed subjective outcomes, including dyspareunia (mean [SD] difference, −4.3 [3.4] vs −4.5 [2.3]; P = .73), Vaginal Health Index (mean [SD] difference, 3.3 [4.1] vs 5.0 [4.5]; P = .17), body image (mean [SD] difference, −3.7 [4.5] vs −2.7 [4.8]; P = .35), and quality of life (mean [SD] difference, −0.3 [3.6] vs −0.7 [3.2]; P = .39). Similarly, there were no differences in improvements in objective outcomes, including vaginal pH (mean [SD] difference, −0.6 [0.9] vs −0.8 [1.2]; P = .29), vaginal maturation index (mean [SD] difference, 10.2 [17.4] vs 14.4 [17.1]; P = .15), vaginal epithelial thickness (mean [SD] difference, 0.021 [0.014] mm vs 0.013 [0.012] mm; P = .30), vaginal epithelial elasticity (mean [SD] difference, −1373 [3197] Pascals vs −2103 [3771] Pascals; P = .64). There were significant improvements in the overall analysis regardless of group in many outcomes. The 2 interventions were well tolerated, but tolerance was significantly lower in the CLT group than the SLT group (mean [SD] Likert scale score, 3.3 [1.3] vs 4.1 [1.0]; P = .007). No differences were observed in complications or serum estradiol levels.Conclusions and RelevanceIn this randomized clinical trial, vaginal laser treatment was found to be safe after 6 months of follow-up, but no statistically significant differences in efficacy were observed between CLT and SLT.Trial RegistrationClinicalTrials.gov identifier: NCT04619485

Genitourinary Syndrome of Menopause and the False Promise of Vaginal Laser Therapy

“…However, there were no improvements in subjective or objective outcomes, including symptoms or histological changes on vaginal biopsy, in the laser group compared with the sham procedure. 7 The laser was safe, with only minor adverse events reported.…”

“…5 While it would be an important finding if the device were as effective as vaginal estrogen, given the low quality of the data, we cannot currently reach that conclusion.In 2021, a double-blind, sham-controlled randomized clinical trial with 12 months of follow-up by Li et al 6 was published in JAMA, finding no difference between fractional carbon dioxide vaginal laser therapy and sham laser therapy for GSM. 6 While the laser appeared safe, it did not improve symptoms or quality of life, and there were no changes in vaginal histology vs the sham procedure.The study by Li et al 6 should have been enough to pause laser therapy outside of clinical trials.Unfortunately, it was not.In this study by Mension et al, 7 we have another prospective, double-blind, sham-controlled randomized clinical trial of laser therapy for GSM, this time for patients with breast cancer using…”

“…In this study by Mension et al, 7 we have another prospective, double-blind, sham-controlled randomized clinical trial of laser therapy for GSM, this time for patients with breast cancer using…”

“…aromatase inhibitors. 7 This is uniquely important group for study, as they typically experience worse symptoms and may have safety concerns with hormonal therapies. However, there were no improvements in subjective or objective outcomes, including symptoms or histological changes on vaginal biopsy, in the laser group compared with the sham procedure.…”

Error in Key Points, Main Text, and Funding/Support

“…In the Original Investigation titled “Effect of Fractional Carbon Dioxide vs Sham Laser on Sexual Function in Survivors of Breast Cancer Receiving Aromatase Inhibitors for Genitourinary Syndrome of Menopause: The LIGHT Randomized Clinical Trial,” published February 10, 2023, the Key Points said weekly instead of monthly; the main text gave the wrong manufacturer for Cerviron; and the Funding/Support section did not accurately describe the funding. This article has been corrected …”