Clinic Institute of Gynecology, Obstetrics and Neonatology, Faculty of Medicine-University of Barcelona, Hospital Clínic of Barcelona, Barcelona, Spain.
Gynecology, Obstetrics and Neonatology Service, Hospital Joan XXIII, Tarragona, Spain.
JAMA Netw Open. 2023 Feb 1;6(2):e2255697. doi: 10.1001/jamanetworkopen.2022.55697.
Survivors of breast cancer present more severe symptoms of genitourinary syndrome of menopause (GSM) than patients without history of breast cancer. Recently, new treatments, such as vaginal laser therapy, have appeared, but evidence of their efficacy remains scarce.
To assess the safety and efficacy of carbon dioxide (CO2) vs sham vaginal laser therapy after 6 months of follow-up in survivors of breast cancer with GSM receiving aromatase inhibitors.
DESIGN, SETTING, AND PARTICIPANTS: This prospective double-blind sham-controlled randomized clinical trial with two parallel study groups was performed during October 2020 to March 2022 in a tertiary referral hospital. Survivors of breast cancer using aromatase inhibitors were assessed for eligibility, and eligible patients were randomized into the 2 treatment groups. Follow-up was conducted at 6 months. Data were analyzed in July 2022.
All patients from both groups were instructed to use the first-line treatment (FLT) based on nonhormonal moisturizers and vaginal vibrator stimulation. Patients for each group were allocated to 5 monthly sessions of fractional CO2 laser therapy (CLT) or sham laser therapy (SLT).
The primary outcome was sexual function, evaluated through Female Sexual Function Index (FSFI) score. Other subjective measures of efficacy included a visual analog scale of dyspareunia, vaginal pH, a Vaginal Health Index, quality of life (assessed via Short-Form 12), and body image (assessed with the Spanish Body Image Scale). Objective measures of efficacy included vaginal maturation index, vaginal epithelial elasticity (measured in Pascals) and vaginal epithelial thickness (measured in millimeters). Measures were assessed before and after the intervention. Tolerance (measured on a Likert scale), adverse effects, and estradiol levels were recorded.
Among 211 survivors of breast cancer assessed, 84 women were deemed eligible and 72 women (mean [SD] age, 52.6 [8.3] years) were randomized to CLT (35 participants) or SLT (37 participants) and analyzed. There were no statistically significant differences between groups at baseline. At 6 months, both groups showed improvement in FSFI (mean [SD] score at baseline vs 6 months: CLT, 14.8 [8.8] points vs 20.0 [9.5] points; SLT, 15.6 [7.0] points vs 23.5 [6.5] points), but there was no significant difference between CLT and SLT groups in the improvement of sexual function evaluated through the FSFI test overall (mean [SD] difference, 5.2 [1.5] points vs 7.9 [1.2] points; P = .15) or after excluding women who were not sexually active (mean [SD] difference, 2.9 [1.4] points vs 5.5 [1.1] points; P = .15). There were also no differences between improvement of the 2 groups at 6 months of follow-up in the other assessed subjective outcomes, including dyspareunia (mean [SD] difference, -4.3 [3.4] vs -4.5 [2.3]; P = .73), Vaginal Health Index (mean [SD] difference, 3.3 [4.1] vs 5.0 [4.5]; P = .17), body image (mean [SD] difference, -3.7 [4.5] vs -2.7 [4.8]; P = .35), and quality of life (mean [SD] difference, -0.3 [3.6] vs -0.7 [3.2]; P = .39). Similarly, there were no differences in improvements in objective outcomes, including vaginal pH (mean [SD] difference, -0.6 [0.9] vs -0.8 [1.2]; P = .29), vaginal maturation index (mean [SD] difference, 10.2 [17.4] vs 14.4 [17.1]; P = .15), vaginal epithelial thickness (mean [SD] difference, 0.021 [0.014] mm vs 0.013 [0.012] mm; P = .30), vaginal epithelial elasticity (mean [SD] difference, -1373 [3197] Pascals vs -2103 [3771] Pascals; P = .64). There were significant improvements in the overall analysis regardless of group in many outcomes. The 2 interventions were well tolerated, but tolerance was significantly lower in the CLT group than the SLT group (mean [SD] Likert scale score, 3.3 [1.3] vs 4.1 [1.0]; P = .007). No differences were observed in complications or serum estradiol levels.
In this randomized clinical trial, vaginal laser treatment was found to be safe after 6 months of follow-up, but no statistically significant differences in efficacy were observed between CLT and SLT.
ClinicalTrials.gov identifier: NCT04619485.
与没有乳腺癌病史的患者相比，乳腺癌幸存者出现更严重的绝经后女性生殖泌尿系统综合征（GSM）症状。最近，出现了一些新的治疗方法，如阴道激光治疗，但它们的疗效证据仍然很少。
评估二氧化碳（CO2）与假阴道激光治疗在接受芳香酶抑制剂治疗的 GSM 乳腺癌幸存者 6 个月随访后的安全性和有效性。
设计、设置和参与者：这是一项前瞻性、双盲、假对照、随机临床试验，有两个平行的研究组，于 2020 年 10 月至 2022 年 3 月在一家三级转诊医院进行。对使用芳香酶抑制剂的乳腺癌幸存者进行了资格评估，符合条件的患者被随机分配到 2 个治疗组。随访时间为 6 个月。数据于 2022 年 7 月进行分析。
所有患者都被指示使用基于非激素保湿剂和阴道振动器刺激的一线治疗（FLT）。每个组的患者都被分配到 5 次每月的分数二氧化碳激光治疗（CLT）或假激光治疗（SLT）。
主要结局是性功能，通过女性性功能指数（FSFI）评分来评估。其他主观疗效测量包括性交疼痛的视觉模拟评分、阴道 pH 值、阴道健康指数、生活质量（通过简短 12 项评估）和身体形象（用西班牙语身体形象量表评估）。客观疗效测量包括阴道成熟指数、阴道上皮弹性（以帕斯卡为单位）和阴道上皮厚度（以毫米为单位）。在干预前后进行测量。记录耐受性（用李克特量表测量）、不良反应和雌二醇水平。
在 211 名评估的乳腺癌幸存者中，有 84 名女性被认为符合条件，有 72 名女性（平均[标准差]年龄，52.6[8.3]岁）被随机分配到 CLT（35 名参与者）或 SLT（37 名参与者）并进行分析。两组在基线时没有统计学上的差异。在 6 个月时，两组的 FSFI 评分都有所改善（基线时的平均[标准差]得分与 6 个月时的得分：CLT，14.8[8.8]分与 20.0[9.5]分；SLT，15.6[7.0]分与 23.5[6.5]分），但 CLT 和 SLT 组在 FSFI 测试整体评估的性功能改善方面没有统计学上的差异（平均[标准差]差异，5.2[1.5]分与 7.9[1.2]分；P=0.15），或排除无性生活的女性后（平均[标准差]差异，2.9[1.4]分与 5.5[1.1]分；P=0.15）。在 6 个月的随访中，两组在其他评估的主观结局方面也没有差异，包括性交疼痛（平均[标准差]差异，-4.3[3.4]分与-4.5[2.3]分；P=0.73）、阴道健康指数（平均[标准差]差异，3.3[4.1]分与 5.0[4.5]分；P=0.17）、身体形象（平均[标准差]差异，-3.7[4.5]分与-2.7[4.8]分；P=0.35）和生活质量（平均[标准差]差异，-0.3[3.6]分与-0.7[3.2]分；P=0.39）。同样，在客观结局的改善方面也没有差异，包括阴道 pH 值（平均[标准差]差异，-0.6[0.9]分与-0.8[1.2]分；P=0.29）、阴道成熟指数（平均[标准差]差异，10.2[17.4]分与 14.4[17.1]分；P=0.15）、阴道上皮厚度（平均[标准差]差异，0.021[0.014]毫米与 0.013[0.012]毫米；P=0.30）和阴道上皮弹性（平均[标准差]差异，-1373[3197]帕斯卡与-2103[3771]帕斯卡；P=0.64）。无论组如何，许多结局都有显著的整体改善。两种干预措施都耐受良好，但 CLT 组的耐受性明显低于 SLT 组（平均[标准差]李克特量表评分，3.3[1.3]分与 4.1[1.0]分；P=0.007）。未观察到并发症或血清雌二醇水平的差异。
在这项随机临床试验中，阴道激光治疗在 6 个月的随访后被发现是安全的，但在 CLT 和 SLT 之间没有观察到统计学上显著的疗效差异。
ClinicalTrials.gov 标识符：NCT04619485。
Zotero 插件