Division of Urogynecology, Department of Obstetrics and Gynecology, Mount Auburn Hospital, Cambridge, MA; Department of Obstetrics and Gynecology, and Beth Israel Deaconess Medical Center, Boston, MA; Department of Obstetrics, Gynecology, and Reproductive Biology, Harvard Medical School, Boston, MA.
Division of Urogynecology, Department of Obstetrics and Gynecology, Mount Auburn Hospital, Cambridge, MA; Department of Obstetrics and Gynecology, and Beth Israel Deaconess Medical Center, Boston, MA; Department of Obstetrics, Gynecology, and Reproductive Biology, Harvard Medical School, Boston, MA.
Am J Obstet Gynecol. 2019 Nov;221(5):517.e1-517.e9. doi: 10.1016/j.ajog.2019.06.044. Epub 2019 Jun 27.
Pelvic pain is estimated to effect 15% of women, and onabotulinumtoxin A is used to treat a variety of pain disorders. However, the data on the use of onabotulinumtoxin A for the treatment of women with myofascial pelvic pain are limited.
The objective of the study was to compare the effect of onabotulinumtoxin A vs placebo injections to the pelvic floor muscles in women with myofascial pelvic pain.
This was a double-blind, randomized, placebo-controlled trial in women with myofascial pelvic pain. Women ≥18 years were eligible if they reported pain ≥6 on a 10 point visual analog scale ≥50% of the time and had pain on palpation ≥6 on the visual analog scale in ≥1 of 6 pelvic floor muscle groups. Participants were randomly allocated to a pelvic floor injection of 200 units of onabotulinumtoxin A or 20 mL of saline. All participants started 8 weeks of physical therapy 4 weeks after the injection. Participants completed validated questionnaires at baseline, 2, 4, and 12 weeks after injection. At each visit, a urogynecologist who was blinded to treatment arm performed a clinical examination with palpation of the left and right sides of 6 pelvic floor muscle groups. The primary outcome was change in participant-reported pain on palpation of the most painful pelvic floor muscle at 2 weeks. Analyses were intention to treat.
We consented 60 women. One participant was lost to follow-up after she was consented; therefore, we randomized 59 women. The groups had similar demographic and clinical characteristics. With regard to the primary outcome, there was no significant difference between the intervention and placebo groups in the change in participant-reported pain on palpation of the most painful pelvic floor muscle at 2 weeks. There were no significant differences in participant-reported pain on palpation for any muscle group at 4 or 12 weeks. At 4 and 12 weeks, participants in the intervention group reported greater declines in overall pelvic pain on the visual analog scale compared with the placebo group, although these differences were not statistically significant (both P = .16). Using the Patient Global Impression of Improvement index, participants in the intervention group were more likely to report their symptoms were improved at 4 and 12 weeks compared with the placebo group, although this difference was significant only at 4 weeks (P = .03 and P = .10, respectively). At 2 weeks, the placebo group had a significant improvement in the Pelvic Floor Distress Inventory score compared with the intervention group (P = .01); however, this difference did not persist at 4 (P = .19) or 12 weeks (P = .11). At 2 weeks, the most common adverse event was constipation in the intervention and placebo groups, with 10.1% reporting de novo constipation. This was followed by urinary incontinence in the intervention group (22%) and urinary tract infection (9%) in the placebo group.
Pelvic floor onabotulinumtoxin A injections for myofascial pelvic pain were not more effective than saline injections at decreasing muscle pain on palpation. Despite this, participants who received onabotulinumtoxin A were more likely than those who received saline to report improvement, albeit not statistically significant, in their overall pelvic floor pain at 4 and 12 weeks.
据估计，15%的女性会受到盆腔疼痛的影响，而肉毒杆菌毒素 A 则用于治疗各种疼痛疾病。然而，关于肉毒杆菌毒素 A 治疗肌筋膜性盆腔疼痛女性的数据有限。
本研究旨在比较肉毒杆菌毒素 A 与安慰剂注射治疗肌筋膜性盆腔疼痛女性的疗效。
这是一项肌筋膜性盆腔疼痛女性的双盲、随机、安慰剂对照试验。18 岁及以上的女性，如果她们的疼痛程度在 10 分制视觉模拟量表上≥6 分，且≥50%的时间有疼痛，并且在 6 个骨盆底肌肉群中的≥1 个有≥6 分的触诊压痛，那么就有资格参加。参与者被随机分配到骨盆底注射 200 单位肉毒杆菌毒素 A 或 20 毫升生理盐水。所有参与者在注射后 4 周开始接受 8 周的物理治疗。参与者在基线、注射后 2、4 和 12 周时完成了经过验证的问卷。每次就诊时，一位对治疗臂不知情的泌尿科医生对 6 个骨盆底肌肉群的左侧和右侧进行触诊检查。主要结局是在 2 周时，根据患者报告的最痛骨盆底肌肉触诊压痛的变化。分析采用意向治疗。
我们同意了 60 名女性。1 名参与者在同意后失访，因此我们随机分配了 59 名女性。两组的人口统计学和临床特征相似。关于主要结局，在 2 周时，干预组和安慰剂组在最痛骨盆底肌肉触诊压痛方面的患者报告疼痛变化无显著差异。在 4 周和 12 周时，任何肌肉群的触诊压痛均无显著差异。在 4 周和 12 周时，与安慰剂组相比，干预组的患者报告在视觉模拟量表上的整体骨盆疼痛有更大的下降，尽管这些差异没有统计学意义（均 P =.16）。使用患者整体印象改善指数，与安慰剂组相比，干预组在 4 周和 12 周时更有可能报告症状改善，尽管这一差异仅在 4 周时具有统计学意义（P=.03 和 P=.10）。在 2 周时，与干预组相比，安慰剂组的骨盆底窘迫量表评分有显著改善（P=.01）；然而，这一差异在 4 周（P=.19）或 12 周（P=.11）时并未持续。在 2 周时，最常见的不良事件是干预组和安慰剂组的便秘，分别有 10.1%和 10.1%的患者报告新出现的便秘。其次是干预组的尿失禁（22%）和安慰剂组的尿路感染（9%）。
对于肌筋膜性盆腔疼痛，与安慰剂相比，骨盆底肉毒杆菌毒素 A 注射并不能更有效地减轻触诊时的肌肉疼痛。尽管如此，与接受生理盐水注射的患者相比，接受肉毒杆菌毒素 A 注射的患者更有可能报告他们的整体骨盆底疼痛在 4 周和 12 周时有改善，尽管这并不具有统计学意义。
