Department of Clinical Sciences, Division of Obstetrics and Gynecology, Karolinska Institutet Danderyd Hospital, Stockholm, and the Center for Clinical Research, Uppsala University, County Council of Västmanland Central Hospital, and the School of Health, Care and Social Welfare, Mälardalen University, Västerås, Sweden.
Obstet Gynecol. 2020 Sep;136(3):524-532. doi: 10.1097/AOG.0000000000004008.
To evaluate pain reduction after two injections of 50 units botulinum toxin A compared with placebo for provoked vestibulodynia.
We conducted a double-blinded, placebo-controlled randomized trial of 50 units botulinum toxin A or placebo injected in the bulbocavernosus muscles twice, 3 months apart, in women with provoked vestibulodynia. Primary outcome was self-reported dyspareunia or pain at tampon use on a visual analog scale (VAS, 0-100). Secondary outcomes were pain at weekly tampon insertion (VAS score), reduction of pelvic floor hypertonicity (measured with a vaginal manometer), adverse events, and sexual function and distress. A sample size of 38 participants for each group was calculated to achieve a statistical power of 80% based on an effect size of 20 VAS units (0-100) (mean score range 56-76±31 SD).
Between May 2016 and June 2018, 124 women with provoked vestibulodynia were assessed, and 88 were randomized to botulinum toxin A (BTA group, n=44) or placebo (placebo group, n=44). Primary outcome showed a lower but statistically nonsignificant pain rating by 7 VAS units (95% CI -15.0 to 0.4) in the BTA group compared with the placebo group. Secondary results showed a significant decrease in pain at weekly tampon insertion by 11 VAS units (95% CI -16.6 to 6.0) with botulinum toxin A injection. The vaginal manometer measured lower maximum contraction strength by 7 mm Hg (95% CI -12.7 to -2.4) and lower 10-second endurance strength by 4 mm Hg (95% CI -7.72 to -1.16) in the BTA group compared with the placebo group. No changes were observed for sexual function and distress, but there was a significant increase in women attempting vaginal intercourse in the BTA group (0.27, 95% CI 0.06-0.48). No severe adverse events were reported.
Twice-repeated injections of 50 units of botulinum toxin A in women with provoked vestibulodynia did not reduce dyspareunia or pain at tampon use, but secondary outcomes suggested positive effects of the treatment.
ClinicalTrials.gov, NCT02773641.
评估与安慰剂相比，50 单位肉毒杆菌毒素 A 两次注射治疗诱发性阴道痉挛的疼痛缓解效果。
我们进行了一项双盲、安慰剂对照随机试验，将 50 单位肉毒杆菌毒素 A 或安慰剂注射到阴道球海绵体肌中，每 3 个月一次，共两次，入组患有诱发性阴道痉挛的女性。主要结局是使用视觉模拟量表（VAS，0-100）报告性交痛或使用卫生棉条时的疼痛。次要结局是每周插入卫生棉条时的疼痛（VAS 评分）、盆底肌肉紧张度降低（阴道测压计测量）、不良事件以及性功能和困扰。根据 20 个 VAS 单位（0-100）（平均评分范围 56-76±31 标准差）的效应大小，计算每组 38 名参与者的样本量，以实现 80%的统计学效力。
2016 年 5 月至 2018 年 6 月，对 124 名患有诱发性阴道痉挛的女性进行了评估，其中 88 名被随机分配至肉毒杆菌毒素 A 组（BTA 组，n=44）或安慰剂组（n=44）。主要结局显示，BTA 组的疼痛评分比安慰剂组低 7 个 VAS 单位（95%CI-15.0 至 0.4），但差异无统计学意义。次要结果显示，BTA 注射组每周插入卫生棉条时的疼痛显著降低 11 个 VAS 单位（95%CI-16.6 至 6.0）。阴道测压计测量到 BTA 组最大收缩强度降低 7mmHg（95%CI-12.7 至-2.4），10 秒耐力强度降低 4mmHg（95%CI-7.72 至-1.16）。性功能和困扰无变化，但 BTA 组尝试阴道性交的女性明显增加（0.27，95%CI 0.06-0.48）。未报告严重不良事件。
对患有诱发性阴道痉挛的女性进行两次 50 单位肉毒杆菌毒素 A 注射并未减轻性交痛或使用卫生棉条时的疼痛，但次要结局提示该治疗有积极效果。
ClinicalTrials.gov，NCT02773641。
