Effect of Fractional Carbon Dioxide Laser vs Sham Treatment on Symptom Severity in Women With Postmenopausal Vaginal Symptoms

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 PARTICIPANTSA 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 MEASURESThe 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). RESULTSOf 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.

The essential menopause curriculum for healthcare professionals: A European Menopause and Andropause Society (EMAS) position statement

“…Laser therapy (ablative and non-ablative) for vulvovaginal atrophy or genitourinary syndrome of menopause is a new approach, but large, long-term studies are required to explore its efficacy and safety before definite conclusions can be drawn [44,45].…”

The evidence behind the use of LASER for genitourinary syndrome of menopause, vulvovaginal atrophy, urinary incontinence and lichen sclerosus: A state‐of‐the‐art review

“…A total of 114 papers were included according to the eligibility criteria listed above. Of these, 111 studies investigated GSM, VVA, UI, and LS symptoms as primary indication (Tables 3–6); 15 RCT, 23–37 87 cohort studies, 38–124 eight case reports, 125–132 one case‐control study, 133 including a total of 9000 women, not accounting for overlap between the studies. Additionally, three cross‐sectional studies focused solely on the characteristics of AEs 134–136 .…”

“…Of the included studies, 81 studies investigated CO 2 ‐LASER from different manufacturers 23–31,33,35,36,38–58,66–93,95–104,122–125,128–131,133,136 . Twenty‐eight studies investigated Er:YAG LASER from different manufacturers 32,34,59–65,94,107–121,127,132,135 .…”

Efficacy of interventions to manage sexual dysfunction in women with cancer: a systematic review

“…Only one small RCT has been conducted with fractional CO 2 therapy in breast and gynecologic cancer survivors, and it appeared to change vaginal symptoms, including improvement of sexual function 51 . Larger RCTs in cancer patients are needed to confirm these beneficial results, particularly since this is a minimally invasive procedure ideally performed by an experienced gynecologist, 84 and recent double-blind RCTs have not found benefit in healthy postmenopausal women 85,86 . It should be noted that currently, the utilization of laser has not been fully approved by FDA to treat any gynecologic problems.…”

“…51 Larger RCTs in cancer patients are needed to confirm these beneficial results, particularly since this is a minimally invasive procedure ideally performed by an experienced gynecologist, 84 and recent double-blind RCTs have not found benefit in healthy postmenopausal women. 85,86 It should be noted that currently, the utilization of laser has not been fully approved by FDA to treat any gynecologic problems.…”