Department of Obstetrics/Gynecology-Female Pelvic Medicine & Reconstructive Surgery, Marshfield Clinic Health System, Marshfield, WI, USA.
Advanced Urogynecology of Michigan, P.C., Dearborn, MI, USA; Department of Female Pelvic Medicine & Reconstructive Surgery, Beaumont Health, Wayne, MI, USA.
J Sex Med. 2021 Apr;18(4):761-769. doi: 10.1016/j.jsxm.2021.01.188. Epub 2021 Mar 20.
Despite some prospective case series showing effectiveness of vaginal laser to treat genitourinary syndrome of menopause (GSM), there is a paucity of placebo-controlled level one evidence.
To assess the effect of fractional carbon dioxide (CO) laser therapy to treat GSM against a sham comparator.
We conducted a parallel, randomized, double-blind, sham-controlled trial to compare menopausal women treated with fractional CO laser against sham treatment for improvement in GSM-related dyspareunia. Three treatments were given 6 weeks apart, and participants attended a 6-month visit from study start for primary (proportion improved) and secondary (vaginal health index, VHI; visual analogue scale, VAS; modified global assessment, PGI-I; Female Sexual Function Index, FSFI; Day-to-Day Impact of Vaginal Aging, DIVA; Urinary Distress Inventory short-form, UDI-6) assessments.
The primary endpoint was a 2-stage improvement in GSM-related dyspareunia from baseline to 6 months determined by a severity scale, and the proportion of subjects who achieved this were compared between groups.
Thirty participants were randomized to laser (n = 14) or sham (n = 16). In the treatment arm, 13 attended all treatments, and 1 attended at least 2 while in the sham arm, 14 attended all treatments, and 2 attended at least 2 treatments. Twelve (86%) in the treatment arm and 16 (100%) in the sham arm attended the 6-month visit. There were no differences in the proportion improved between treatments and controls (64% vs. 67%, respectively, P = 1.000). Both arms showed significant within-group improvements based on VHI and VAS, but not between groups. Similar findings were observed on sexual impact questionnaires with improvements within both groups from baseline to 6 months but not by median differences between the groups at 6 months. There were no adverse events in either of the arms.
Further well-powered research is needed to determine efficacy of fractional CO laser for the treatment of GSM, especially in light of a potential placebo effect.
STRENGTHS & LIMITATIONS: We present a sham-controlled double-blinded randomized trial using validated tools; the main limitation included an underpowered proportion of sexually active participants for the primary outcome.
This study was underpowered to draw conclusions regarding the efficacy of fractional CO laser therapy in the treatment of GSM. We did observe improvements in the sham-arm to suggest a possible placebo contribution. Further well-powered level one research is needed to demonstrate the therapeutic effect of this novel modality. Cruff J, Khandwala S, A Double-Blind Randomized Sham-Controlled Trial to Evaluate the Efficacy of Fractional Carbon Dioxide Laser Therapy on Genitourinary Syndrome of Menopause. J Sex Med 2021;18:761-769.
尽管一些前瞻性病例系列研究表明阴道激光治疗女性生殖泌尿综合征（GSM）有效，但缺乏一级安慰剂对照证据。
评估二氧化碳（CO）激光治疗 GSM 的效果，与假对照相比。
我们进行了一项平行、随机、双盲、假对照试验，比较了接受二氧化碳激光治疗的绝经后妇女与假治疗的 GSM 相关性交痛改善情况。三组治疗间隔 6 周，参与者从研究开始进行 6 个月的随访，以评估主要（改善比例）和次要（阴道健康指数、VHI；视觉模拟量表、VAS；改良总体评估、PGI-I；女性性功能指数、FSFI；阴道老化日常影响、DIVA；尿失禁影响量表短表、UDI-6）。
30 名参与者被随机分配至激光（n=14）或假（n=16）组。在治疗组中，13 名参与者接受了所有治疗，1 名参与者至少接受了 2 次治疗；而在假治疗组中，14 名参与者接受了所有治疗，2 名参与者至少接受了 2 次治疗。12 名（86%）治疗组和 16 名（100%）假治疗组参加了 6 个月的随访。治疗组和对照组的改善比例无差异（分别为 64%和 67%，P=1.000）。两组均表现出基于 VHI 和 VAS 的显著组内改善，但组间无差异。两组在性影响问卷上也有类似的发现，两组在 6 个月时均有改善，但组间中位数差异无统计学意义。两组均无不良事件。
需要进一步进行强有力的研究来确定二氧化碳激光治疗 GSM 的疗效，特别是考虑到可能存在安慰剂效应。
我们报告了一项使用验证工具的假对照双盲随机试验；主要的局限性是主要结局的性活跃参与者比例不足。
本研究对于确定二氧化碳激光治疗 GSM 的疗效的效力不足。我们确实观察到假治疗组的改善，表明可能存在安慰剂作用。需要进一步进行强有力的一级研究来证明这种新治疗方法的治疗效果。克鲁夫 J、坎德拉瓦 S、一项评估二氧化碳激光治疗女性生殖泌尿综合征疗效的双盲随机假对照试验。J 性医学 2021；18：761-769。
