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Effect of Fractional Carbon Dioxide Laser vs Sham Treatment on Symptom Severity in Women With Postmenopausal Vaginal SymptomsA Randomized Clinical Trial

Educational Objective
To learn whether fractional carbon dioxide laser is superior to a sham treatment for vaginal symptoms associated with menopause.
Key Points

Question  Is fractional carbon dioxide laser an effective treatment for vaginal symptoms associated with menopause?

Findings  This sham-controlled, double-blinded, randomized clinical trial included 90 women with postmenopausal vaginal symptoms. After 12 months, treatment with fractional carbon dioxide laser compared with sham treatment resulted in a change in visual analog scale score for overall symptom severity of –17.2 vs –26.6 (range, 0-100; lower scores indicate less symptom severity) and Vulvovaginal Symptom Questionnaire score of –3.1 vs –1.6 (range 0-20; lower scores indicate less symptoms). Neither comparison was statistically significant.

Meaning  Among women with postmenopausal vaginal symptoms, treatment with fractional carbon dioxide laser vs sham treatment did not improve vaginal symptoms after 12 months.

Abstract

Importance  Postmenopausal vaginal symptoms are common and frequently detrimental to a woman’s quality of life. Fractional carbon dioxide vaginal laser is increasingly offered as a treatment, but the efficacy remains unproven.

Objective  To determine the efficacy of fractional carbon dioxide laser for treatment of vaginal symptoms associated with menopause.

Design, Setting, and Participants  A double-blind, randomized, sham-controlled trial with 12-month follow-up was undertaken at a single tertiary referral hospital in Sydney, Australia. Enrollment commenced on September 19, 2016, with final follow-up on June 30, 2020. Participants were postmenopausal women with vaginal symptoms substantive enough to seek medical treatment. Of 232 participants approached, 85 were randomized.

Interventions  Three treatments using a fractional microablative carbon dioxide laser system performed 4 to 8 weeks apart, with 43 women randomized to the laser group and 42 to the sham group.

Main Outcomes and Measures  The co–primary outcomes were symptom severity assessed using a visual analog scale (VAS; range, 0-100; 0 indicates no symptoms and 100 indicates the most severe symptoms) and the Vulvovaginal Symptom Questionnaire (VSQ; range, 0-20; 0 indicates no symptoms and 20 indicates the most severe symptoms) at 12 months. The minimal clinically important difference was specified as a 50% decrease in both VAS and VSQ severity scores. There were 5 prespecified secondary outcomes, including quality of life (range, 0-100; higher scores indicate better quality of life), the Vaginal Health Index Score (range, 5-25; higher scores indicate better health), and vaginal histology (premenopausal or postmenopausal status).

Results  Of 85 randomized participants (mean [SD] age, 57 [8] years), 78 (91.7%) completed the 12-month follow-up. From baseline to 12 months, there was no significant difference between the carbon dioxide laser group and the sham group in change in symptom severity (VAS score for overall vaginal symptoms: –17.2 vs –26.6; difference, 9.4 [95% CI, –28.6 to 47.5]; VAS score for the most severe symptom: –24.5 vs –20.4; difference –4.1 [95% CI, –32.5 to 24.3]; VSQ score: –3.1 vs –1.6; difference, –1.5 [95% CI, –5.9 to 3.0]). There were no significant differences between the laser and sham group in the mean quality of life score (6.3 vs 1.4; difference, 4.8 [95% CI, –3.9 to 13.5]) and Vaginal Health Index Score (0.9 vs 1.3; difference, –0.4 [95% CI, –4.3 to 3.6]) or in histological comparisons between laser and sham treatment groups. There were 16 adverse events in the laser group and 17 in the sham group, including vaginal pain/discomfort (44% vs 68%), spotting, discharge, and lower urinary tract symptoms. No severe adverse events were reported in either group.

Conclusions and Relevance  Among women with postmenopausal vaginal symptoms, treatment with fractional carbon dioxide laser vs sham treatment did not significantly improve vaginal symptoms after 12 months.

Trial Registration  Australian and New Zealand Clinical Trials Registry: ACTRN12616001403426

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Article Information

Corresponding Author: Jason A. Abbott, PhD, School of Women’s and Children’s Health, UNSW Sydney, Royal Hospital for Women, Level 1, Barker St, Randwick 2031, NSW, Australia (j.abbott@unsw.edu.au).

Accepted for Publication: August 16, 2021.

Author Contributions: Drs Li and Abbott had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Deans, Nesbitt-Hawes, Lyons, Segelov, Abbott.

Acquisition, analysis, or interpretation of data: Li, Maheux-Lacroix, Deans, Nesbitt-Hawes, Budden, Nguyen, Lim, Song, McCormack, Abbott.

Drafting of the manuscript: Li, Deans, Abbott.

Critical revision of the manuscript for important intellectual content: Li, Maheux-Lacroix, Nesbitt-Hawes, Budden, Nguyen, Lim, Song, McCormack, Lyons, Segelov, Abbott.

Statistical analysis: Li, Maheux-Lacroix, Abbott.

Obtained funding: Nesbitt-Hawes, Budden, Lyons, Segelov, Abbott.

Administrative, technical, or material support: Li, Maheux-Lacroix, Deans, Nesbitt-Hawes, Budden, Nguyen, Lim, Song, McCormack, Abbott.

Supervision: Deans, Budden, Lyons, Abbott.

Conflict of Interest Disclosures: Dr Li reported receiving grants from Australian Gynaecological Endoscopy and Surgery (AGES) during the conduct of the study. Dr Maheux-Lacroix reported receiving grants from Canadian Institutes of Health Research and Fonds de recherche en Sante-Quebec outside the submitted work. Dr Nesbitt-Hawes reported receiving grants from AGES during the conduct of the study. Dr Nguyen reported receiving grants from AGES during the conduct of the study. Dr Lim reported receiving grants from AGES during the conduct of the study. Dr Song reported receiving grants from AGES during the conduct of the study. Dr McCormack reported receiving grants from AGES during the conduct of the study. Dr Lyons reported receiving grants from AGES during the conduct of the study. Dr Segelov reported receiving grants from AGES during the conduct of the study. Dr Abbott reported receiving grants from AGES during the conduct of the study and personal fees for serving on an advisory board from Hologic and Vifor, personal fees for a speakers bureau from Bayer, and grants from Merck Sharp and Dohme for contracted research outside the submitted work. No other disclosures were reported.

Funding/Support: This trial was partly funded by the Australasian Gynaecological Endoscopy and Surgery (AGES) Society and the Royal Hospital for Women.

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Data Sharing Statement: See Supplement 3.

Additional Contributions: We would like to thank Kylie-Ann Mallitt, PhD (UNSW Sydney, Australia), for statistical guidance and Catherine Camaris, MD (Prince of Wales Hospital, Sydney, Australia), and the Breast Cancer Network Australia for their support. No compensation was provided for their roles.

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