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.

中文翻译：

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点阵二氧化碳激光与假治疗对绝经后阴道症状女性症状严重程度的影响：一项随机临床试验。

重要性 绝经后阴道症状很常见，并且常常对女性的生活质量有害。分数二氧化碳阴道激光越来越多地作为一种治疗方法提供，但疗效仍未得到证实。目的确定点阵二氧化碳激光治疗更年期相关阴道症状的疗效。设计、设置和参与者 在澳大利亚悉尼的一家三级转诊医院进行了一项为期 12 个月的双盲、随机、假对照试验。招募于 2016 年 9 月 19 日开始，最终随访时间为 2020 年 6 月 30 日。参与者是绝经后妇女，其阴道症状严重到足以就医。在接近的 232 名参与者中，85 名被随机分配。干预 使用分数次微烧二氧化碳激光系统进行的三种治疗相隔 4 至 8 周，其中 43 名女性随机分配到激光组，42 名女性随机分配到假手术组。主要结果和措施 共同主要结果是使用视觉模拟量表（VAS；范围，0-100；0 表示无症状，100 表示最严重的症状）和外阴阴道症状问卷（VSQ；范围，0 -20；0 表示没有症状，20 表示症状最严重）在 12 个月时。最小的临床重要差异被指定为 VAS 和 VSQ 严重程度评分均下降 50%。有 5 个预先设定的次要结果，包括生活质量（范围，0-100；分数越高表明生活质量越好）、阴道健康指数评分（范围，5-25；得分越高表明健康状况越好）和阴道组织学（绝经前或绝经后状态）。结果 在 85 名随机参与者（平均 [SD] 年龄，57 [8] 岁）中，78 名（91.7%）完成了 12 个月的随访。从基线到 12 个月，二氧化碳激光组和假手术组在症状严重程度的变化方面没有显着差异（整体阴道症状的 VAS 评分：-17.2 vs -26.6；差异，9.4 [95% CI，-28.6至 47.5]；最严重症状的 VAS 评分：-24.5 与 -20.4；差异 -4.1 [95% CI，-32.5 至 24.3]；VSQ 评分：-3.1 与 -1.6；差异，-1.5 [95% CI， -5.9 到 3.0]）。激光组和假手术组的平均生活质量评分（6.3 vs 1.4；差异，4.8 [95% CI，-3.9 至 13.5]）和阴道健康指数评分（0.9 vs 1.3；差异，- 0.4 [95% CI, -4.3 到 3.6]）或激光和假治疗组之间的组织学比较。激光组有 16 起不良事件，假手术组有 17 起，包括阴道疼痛/不适（44% vs 68%）、点滴出血、分泌物和下尿路症状。两组均未报告严重不良事件。结论和相关性 在有绝经后阴道症状的女性中，点阵二氧化碳激光治疗与假治疗相比，12 个月后没有显着改善阴道症状。试验注册澳大利亚和新西兰临床试验注册：ACTRN12616001403426。和下尿路症状。两组均未报告严重不良事件。结论和相关性 在有绝经后阴道症状的女性中，点阵二氧化碳激光治疗与假治疗相比，12 个月后没有显着改善阴道症状。试验注册澳大利亚和新西兰临床试验注册：ACTRN12616001403426。和下尿路症状。两组均未报告严重不良事件。结论和相关性 在有绝经后阴道症状的女性中，点阵二氧化碳激光治疗与假治疗相比，12 个月后没有显着改善阴道症状。试验注册澳大利亚和新西兰临床试验注册：ACTRN12616001403426。