From the Department of Obstetrics & Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, University of Kansas School of Medicine.
Department of Obstetrics & Gynecology, Washington University in St. Louis.
Female Pelvic Med Reconstr Surg. 2021 Jan 1;27(1):e152-e160. doi: 10.1097/SPV.0000000000000870.
The aims of the study were to systematically review the literature and to synthesize the evidence for the effectiveness of botulinum toxin injection to the pelvic floor muscles for treating pelvic floor myofascial pain in female patients.
This systematic literature search was performed in February 2018 and updated in September 2019. Articles were screened based on predefined criteria: (1) adult population, (2) female patients, (3) treatment of pelvic pain by transvaginal botulinum toxin injection into the pelvic floor, (4) published in English or English translation available, (5) study design including randomized controlled trials, cohort studies, and case series with more than 10 participants, and (6) quantitative report of pain scores. Nine studies were included in the primary analysis, and an unpublished study was included in a sensitivity analysis. A random effects model with robust variance estimation was used to estimate the pooled mean difference in patient-reported pain scores after botulinum toxin injection.
A statistically significant reduction in patient-reported pain scores was noted at 6 weeks after botulinum toxin injection (mean difference, 20.3; 95% confidence interval, 11.7-28.9) and continued past 12 weeks (mean difference, 19.4; 95% confidence interval, 14.6-24.2). Significant improvement was noted in secondary outcomes including dyspareunia, dyschezia, and quality of life.
This systematic review and meta-analysis support the conduct of future, large-scale randomized controlled trials to determine the efficacy and optimize administration of botulinum toxin injections for treatment of pelvic floor myofascial pain and associated symptoms in women.
本研究旨在系统地回顾文献，并综合评估肉毒毒素注射盆底肌治疗女性盆底肌筋膜疼痛的有效性。
本系统文献检索于 2018 年 2 月进行，并于 2019 年 9 月进行了更新。文章根据预先设定的标准进行筛选：（1）成人人群，（2）女性患者，（3）经阴道注射肉毒毒素治疗盆底疼痛，（4）以英文发表或提供英文翻译，（5）研究设计包括随机对照试验、队列研究和超过 10 例的病例系列研究，（6）疼痛评分的定量报告。共有 9 项研究纳入主要分析，1 项未发表的研究纳入敏感性分析。采用随机效应模型和稳健方差估计来估计肉毒毒素注射后患者报告的疼痛评分的汇总平均差异。
肉毒毒素注射后 6 周时，患者报告的疼痛评分显著降低（平均差异，20.3；95%置信区间，11.7-28.9），并持续至 12 周后（平均差异，19.4；95%置信区间，14.6-24.2）。次要结局包括性交困难、排便困难和生活质量均有显著改善。
本系统评价和荟萃分析支持未来进行大规模随机对照试验，以确定肉毒毒素注射治疗女性盆底肌筋膜疼痛及相关症状的疗效，并优化其管理。
