Parenti Michele, Degliuomini Rebecca Susanna, Cosmi Erich, Vitagliano Amerigo, Fasola Elena, Origoni Massimo, Salvatore Stefano, Buzzaccarini Giovanni
Gynaecologic and Obstetrics Clinic, Department of Women's and Children's Health, University of Padua, 35128, Padua, Italy.
Department of Obstetrics and Gynaecology, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Via Olgettina 60, 20132, Milan, Italy; Italian Association of Functional and Esthetic Gynecology (AIGEF), Milan, Italy.
Eur J Obstet Gynecol Reprod Biol. 2023 Dec;291:178-189. doi: 10.1016/j.ejogrb.2023.10.028. Epub 2023 Oct 27.
Botulinum toxin (BoNT) administration has been proposed in the gynecologic field for pelvic, vulvar and vaginal disorders. On this regard, we aimed assessing the therapeutic effectiveness and safety of BoNT usage in the treatment of vaginal, vulvar and pelvic pain disorders.
We searched for all the original articles without date restriction until 31.12.2021. We included all the original articles which administered botulinum toxin in the vulva or vagina of women suffering from vaginismus, dyspareunia, and chronic pelvic pain. Only English language studies and those performed in humans were eligible. We excluded all case reports and pilot study from the qualitative analysis, although we accurately evaluated them. 22 original studies were finally included in the systematic review.
Botulinum toxin injection was found to be effective in improving vulvar and vaginal dyspareunia, vaginismus, and chronic pelvic pain. No irreversible side effects were detected. Major side effects reported were transient urinary or fecal incontinence, constipation and rectal pain. The risk of bias assessment proved original articles to be of medium quality. No metanalysis could have been performed since lack of congruency in the definition of pathology and methods of botulinum toxin administration.
Data extraction pointed out different endpoints and different methods of analysis. Studies focus on different types of participants and use various techniques and timing. According to the best evidence available, different techniques provide evidence about positive outcomes, with the need for a standardized protocol.
肉毒杆菌毒素(BoNT)已被提议用于妇科领域治疗盆腔、外阴和阴道疾病。在这方面,我们旨在评估BoNT用于治疗阴道、外阴和盆腔疼痛性疾病的治疗效果和安全性。
我们检索了截至2021年12月31日无日期限制的所有原始文章。我们纳入了所有在患有阴道痉挛、性交困难和慢性盆腔疼痛的女性外阴或阴道中注射肉毒杆菌毒素的原始文章。仅纳入英文研究和以人为对象开展的研究。尽管我们对所有病例报告和试点研究进行了准确评估,但在定性分析中排除了这些研究。最终有22项原始研究被纳入系统评价。
发现肉毒杆菌毒素注射在改善外阴和阴道性交困难、阴道痉挛和慢性盆腔疼痛方面有效。未检测到不可逆的副作用。报告的主要副作用为短暂性尿失禁或大便失禁、便秘和直肠疼痛。偏倚风险评估显示原始文章质量中等。由于病理学定义和肉毒杆菌毒素给药方法缺乏一致性,无法进行荟萃分析。
数据提取指出了不同的终点和不同的分析方法。研究关注不同类型的参与者,并使用各种技术和时间安排。根据现有最佳证据,不同技术均提供了积极结果的证据,但需要标准化方案。