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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

IMPORTANCE: Survivors 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. OBJECTIVE: To assess...

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Autores principales: Mension, Eduard, Alonso, Inmaculada, Anglès-Acedo, Sònia, Ros, Cristina, Otero, Jorge, Villarino, Álvaro, Farré, Ramon, Saco, Adela, Vega, Naiara, Castrejón, Natalia, Ordi, Jaume, Rakislova, Natalia, Tortajada, Marta, Matas, Isabel, Gómez, Sílvia, Ribera, Laura, Castelo-Branco, Camil
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9918877/
https://www.ncbi.nlm.nih.gov/pubmed/36763359
http://dx.doi.org/10.1001/jamanetworkopen.2022.55697
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author Mension, Eduard
Alonso, Inmaculada
Anglès-Acedo, Sònia
Ros, Cristina
Otero, Jorge
Villarino, Álvaro
Farré, Ramon
Saco, Adela
Vega, Naiara
Castrejón, Natalia
Ordi, Jaume
Rakislova, Natalia
Tortajada, Marta
Matas, Isabel
Gómez, Sílvia
Ribera, Laura
Castelo-Branco, Camil
author_facet Mension, Eduard
Alonso, Inmaculada
Anglès-Acedo, Sònia
Ros, Cristina
Otero, Jorge
Villarino, Álvaro
Farré, Ramon
Saco, Adela
Vega, Naiara
Castrejón, Natalia
Ordi, Jaume
Rakislova, Natalia
Tortajada, Marta
Matas, Isabel
Gómez, Sílvia
Ribera, Laura
Castelo-Branco, Camil
author_sort Mension, Eduard
collection PubMed
description IMPORTANCE: Survivors 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. OBJECTIVE: To assess the safety and efficacy of carbon dioxide (CO(2)) vs sham vaginal laser therapy after 6 months of follow-up in survivors of breast cancer with GSM receiving aromatase inhibitors. DESIGN, SETTING, AND PARTICIPANTS: This 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. INTERVENTIONS: All 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 CO(2) laser therapy (CLT) or sham laser therapy (SLT). MAIN OUTCOMES AND MEASURES: The 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. RESULTS: Among 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 RELEVANCE: In 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 REGISTRATION: ClinicalTrials.gov identifier: NCT04619485
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spelling pubmed-99188772023-02-12 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 Mension, Eduard Alonso, Inmaculada Anglès-Acedo, Sònia Ros, Cristina Otero, Jorge Villarino, Álvaro Farré, Ramon Saco, Adela Vega, Naiara Castrejón, Natalia Ordi, Jaume Rakislova, Natalia Tortajada, Marta Matas, Isabel Gómez, Sílvia Ribera, Laura Castelo-Branco, Camil JAMA Netw Open Original Investigation IMPORTANCE: Survivors 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. OBJECTIVE: To assess the safety and efficacy of carbon dioxide (CO(2)) vs sham vaginal laser therapy after 6 months of follow-up in survivors of breast cancer with GSM receiving aromatase inhibitors. DESIGN, SETTING, AND PARTICIPANTS: This 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. INTERVENTIONS: All 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 CO(2) laser therapy (CLT) or sham laser therapy (SLT). MAIN OUTCOMES AND MEASURES: The 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. RESULTS: Among 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 RELEVANCE: In 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 REGISTRATION: ClinicalTrials.gov identifier: NCT04619485 American Medical Association 2023-02-10 /pmc/articles/PMC9918877/ /pubmed/36763359 http://dx.doi.org/10.1001/jamanetworkopen.2022.55697 Text en Copyright 2023 Mension E et al. JAMA Network Open. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the CC-BY License.
spellingShingle Original Investigation
Mension, Eduard
Alonso, Inmaculada
Anglès-Acedo, Sònia
Ros, Cristina
Otero, Jorge
Villarino, Álvaro
Farré, Ramon
Saco, Adela
Vega, Naiara
Castrejón, Natalia
Ordi, Jaume
Rakislova, Natalia
Tortajada, Marta
Matas, Isabel
Gómez, Sílvia
Ribera, Laura
Castelo-Branco, Camil
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Original Investigation
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9918877/
https://www.ncbi.nlm.nih.gov/pubmed/36763359
http://dx.doi.org/10.1001/jamanetworkopen.2022.55697
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