METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
方法:我们搜索了所有原始文章,没有日期限制,直到31.12.2021。我们包括了所有在患有阴道痉挛的女性的外阴或阴道中施用肉毒杆菌毒素的原始文章,性交困难,和慢性盆腔疼痛.只有英语语言研究和在人类中进行的研究才有资格。我们从定性分析中排除了所有病例报告和试点研究,尽管我们准确地评估了它们。22项原始研究最终纳入系统评价。
结果:发现肉毒毒素注射可有效改善外阴和阴道性交困难,阴道痉挛,和慢性盆腔疼痛.没有检测到不可逆的副作用。报告的主要副作用是短暂性尿失禁或大便失禁,便秘和直肠疼痛。偏差评估的风险证明原始文章质量中等。由于在肉毒杆菌毒素的病理学定义和给药方法方面缺乏一致性,因此无法进行元分析。
结论:数据提取指出了不同的终点和不同的分析方法。研究侧重于不同类型的参与者,并使用各种技术和时机。根据现有的最好证据,不同的技术提供了积极结果的证据,需要一个标准化的协议。