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激素治疗单独使用与激素治疗联合电疗用于深部子宫内膜异位症盆腔疼痛控制的比较:随机临床试验

Hormonal treatment isolated versus hormonal treatment associated with electrotherapy for pelvic pain control in deep endometriosis: Randomized clinical trial.

作者信息

Mira Ticiana A A, Yela Daniela A, Podgaec Sérgio, Baracat Edmund C, Benetti-Pinto Cristina L

机构信息

School of Medical Sciences, Department of Obstetrics and Gynecology, University of Campinas, Alexander Fleming, 101, Cidade Universitária, Campinas, SP, 13083-881, Brazil.

Medical School, Department of Obstetrics and Gynecology, University of São Paulo, Av. Dr. Enéas Carvalho de Aguiar, 255 - Cerqueira César, São Paulo, SP, 05403-000, Brazil.

出版信息

Eur J Obstet Gynecol Reprod Biol. 2020 Dec;255:134-141. doi: 10.1016/j.ejogrb.2020.10.018. Epub 2020 Oct 15.

Abstract

OBJECTIVE

The aim of the study was to evaluate the clinical effectiveness of complementary treatment using self-applied electrotherapy treatment for pain control over the standard hormonal treatment alone for deep infiltrative endometriosis (DIE).

STUDY DESIGN

Multicentre randomized clinical trial. We included a hundred-one participants with DIE in electrotherapy (n = 53) (hormonal treatment + electrotherapy) or control group (n = 48) (only hormonal treatment) by 8 weeks of follow-up. The primary measurement was chronic pelvic pain (CPP) using a visual analogue scale (VAS) and deep dyspareunia. The secondary outcomes were the quality of life by endometriosis health profile (EHP-30) and sexual function by female sexual function index (FSFI).

RESULTS

CPP relief was observed only in the electrotherapy group (pre:7.11 ± 2.40, post:4.55 ± 3.08, p < 0.001). In terms of deep dyspareunia, improvements were observed for both groups (electrotherapy pre:2.02 ± 0.54-1.36 ± 0.96, p < 0.001; control pre:1.95 ± 0.86-1.68 ± 0.82, p = 0.006). Considering the secondary outcomes, a higher total score post-treatment for the EHP-30 was noted in both groups. Regarding sexual function, there was a statistically significant improvement in the FSFI score for the electrotherapy group (p < 0.001), with an increase in the scores for lubrication and pain domains (p = 0.013 and p < 0.001).

CONCLUSIONS

Electrotherapy treatment using transcutaneous electrical nerve stimulation proved to be a good complementary option for pain control, showing benefits in the reduction of CPP and deep dyspareunia and improving patient's quality of life and sexual function.

摘要

目的

本研究旨在评估自我应用电疗法辅助治疗对深部浸润性子宫内膜异位症(DIE)疼痛控制的临床效果,与单纯标准激素治疗进行对比。

研究设计

多中心随机临床试验。我们纳入了101名患有DIE的参与者,将其分为电疗组(n = 53)(激素治疗 + 电疗)或对照组(n = 48)(仅接受激素治疗),随访8周。主要测量指标为使用视觉模拟量表(VAS)评估的慢性盆腔疼痛(CPP)和深部性交痛。次要结局指标为通过子宫内膜异位症健康量表(EHP - 30)评估的生活质量以及通过女性性功能指数(FSFI)评估的性功能。

结果

仅在电疗组观察到CPP缓解(治疗前:7.11±2.40,治疗后:4.55±3.08,p < 0.001)。在深部性交痛方面,两组均有改善(电疗组治疗前:2.02±0.54 - 治疗后:1.36±0.96,p < 0.001;对照组治疗前:1.95±0.86 - 治疗后:1.68±0.82,p = 0.006)。考虑次要结局指标,两组治疗后EHP - 30的总分均较高。关于性功能,电疗组FSFI评分有统计学显著改善(p < 0.001),润滑和疼痛领域的评分增加(p = 0.013和p < 0.001)。

结论

经皮电刺激神经疗法的电疗治疗被证明是一种良好的疼痛控制辅助选择,在减轻CPP和深部性交痛以及改善患者生活质量和性功能方面显示出益处。

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