The effects of repeat fractional CO₂ laser for postmenopausal vaginal symptoms following unblinding from a double-blind RCT.

IF 3.2 4区医学 Q1 OBSTETRICS & GYNECOLOGY

Climacteric Pub Date : 2025-06-26 DOI:10.1080/13697137.2025.2517131

Fiona G Li, Blake L Knapman, Erin Nesbitt-Hawes, Rebecca Deans, Jason Abbott

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引用次数: 0

Abstract

Objective: This study aimed to explore the effects of blinding on patient-reported outcomes.

Method: Findings from this prospective open-label extension study were compared to a previous double-blind sham-controlled randomized trial. Women with any postmenopausal vaginal symptom previously receiving either active or sham vaginal fractional CO₂ laser were recruited from the index randomized controlled trial (RCT), and underwent an active laser protocol. Symptom severity was assessed by co-primary outcomes of a visual analog scale (VAS) for overall and most bothersome symptom and the Vulvovaginal Symptom Questionnaire (VSQ) to 12 months.

Results: Of the 25 participants, there was a significant improvement in the co-primary outcomes at 6 months from baseline (mean difference: overall vaginal symptoms VAS, 22.0 [95% confidence interval (CI) -32.2, -11.8]; most bothersome symptom VAS, -22.1 [95% CI -36.7, -7.5]; VSQ, -2.2 [95% CI -3.8, -0.6]). At 12 months, there was significant improvement in most bothersome symptom VAS (-17.8 [95% CI -35.3, -0.3]) and VSQ (-2.3 [95% CI -3.9, -0.8]) scores. There was no significant difference in the post-treatment improvement of the co-primary outcomes at 6 and 12 months following open-label laser treatment, when compared to index RCT outcomes following active laser and sham laser treatment, respectively.

Conclusion: Blinding in randomized trials is essential for correctly interpreting clinical outcomes using lasers for genitourinary symptoms of menopause.

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重复分数CO2激光对双盲随机对照试验解盲后绝经后阴道症状的影响

目的：本研究旨在探讨盲法对患者报告结果的影响。方法：这项前瞻性开放标签扩展研究的结果与之前的双盲假对照随机试验进行比较。从随机对照试验（RCT）中招募有任何绝经后阴道症状的妇女，她们之前接受过主动或假阴道部分CO2激光治疗，并接受了主动激光治疗方案。通过视觉模拟量表（VAS）和外阴阴道症状问卷（VSQ）对12个月的总体和最恼人症状的共同主要结局进行症状严重程度评估。结果：在25名参与者中，6个月时共同主要结局较基线有显著改善(平均差值：VAS总体阴道症状22.0[95%可信区间(CI) -32.2, -11.8]；最恼人症状VAS， -22.1 [95% CI -36.7, -7.5]；Vsq, -2.2 [95% ci -3.8, -0.6])。在12个月时，大多数令人烦恼的症状VAS （-17.8 [95% CI -35.3, -0.3]）和VSQ （-2.3 [95% CI -3.9, -0.8]）评分均有显著改善。在开放标签激光治疗后6个月和12个月，与主动激光治疗和假激光治疗后的指数RCT结果相比，治疗后共同主要结局的改善无显著差异。结论：随机试验中的盲法对于正确解释激光治疗绝经期泌尿生殖系统症状的临床结果至关重要。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Climacteric 医学-妇产科学

CiteScore

1.70

自引率

7.10%

发文量

审稿时长

1 months

期刊介绍： Climacteric is the official journal of the International Menopause Society (IMS). As an international peer-reviewed journal it publishes original research and reviews of all aspects of aging in women. Climacteric was founded by the IMS in 1998 and today has become a leading journal in the publication of peer-reviewed papers on the menopause, climacteric and mid-life health. Topics covered include endocrine changes, symptoms attributed to the menopause and their treatment, hormone replacement and alternative therapies, lifestyles, and the counselling and education of peri- and postmenopausal women. Climacteric, published bimonthly, also features regular invited reviews, editorials and commentaries on recent developments. The editorial review board of Climacteric includes leading scientific and clinical experts in the field of midlife medicine and research and is headed by its Editor-in-Chief, Professor Rod Baber of Australia. He and his team of Associate Editors act independently to set a clear editorial policy, co-ordinate peer review, and ensure a rapid response to submitted papers.