School of Korean Medicine, Dongguk University, Goyang-si.
Department of Acupuncture & Moxibustion, Dongguk University Bundang Oriental Hospital, Seongnam-si, Gyeonggi-do, Republic of Korea.
Medicine (Baltimore). 2021 Mar 12;100(10):e24019. doi: 10.1097/MD.0000000000024019.
BACKGROUND: Irritable bowel syndrome (IBS) is a disorder which has considerable effect to patient's quality of life and social functioning. Its main symptoms include recurrent abdominal pain and/or bloating associated with abnormal stool form or frequency. The recommendable treatment of IBS is a medication including loperamide, cimetropium, tricyclic antidepressants, and selective serotonin receptor inhibitors, but it has limited effects and several side effects dissatisfy IBS patients. As an alternative therapy, Xiaoyao-san (XYS) is gaining interest for IBS patients. XYS, a traditional Chinese medicine (TCM), has wide scope of indications and it can be prescribed for various gastrointestinal disorders in TCM syndromes but there has been no systematic review on IBS. Therefore, this review aims on systematically validating the curative effect of XYS on IBS. METHODS: Electronic databases, manual search, and contact to author e-mail will be used for searching randomized controlled trials about the use of XYS for IBS. We will select studies by the predefined criteria and collect the data on study participants, interventions, control groups, outcome measurement, adverse events, and risk of bias. Primary outcome will be the efficacy rate, and secondary outcomes will be the IBS-centered indices (abdominal pain score, abdominal distension score, diarrhea or constipation score, bowel symptom severity scale), index about quality of life, and adverse events. Review Manager software and Cochrane Collaboration "risk of bias" tools will be used for meta-analysis and assessment of risk of bias. RESULTS: This review will identify the clinical evidence of XYS's effectiveness and safety for IBS according to formal evaluation aspects. CONCLUSION: This review will further support the evidence-based usage of XYS for IBS treatment. ETHICS AND DISSEMINATION: No ethical approval is required since there is no personal information collection and patient recruitment. TRIAL REGISTRATION NUMBER: Research Registry; reviewregistry986.
背景:肠易激综合征(IBS)是一种对患者生活质量和社会功能有重大影响的疾病。其主要症状包括反复发作的腹痛和/或腹胀,伴有异常的粪便形态或频率。IBS 的推荐治疗方法是药物治疗,包括洛哌丁胺、西咪替丁、三环类抗抑郁药和选择性 5-羟色胺受体抑制剂,但疗效有限,且有几种副作用令 IBS 患者不满意。作为替代疗法,逍遥散(XYS)正受到 IBS 患者的关注。XYS 是一种中药(TCM),适应证广泛,可用于治疗 TCM 综合征中的各种胃肠道疾病,但尚未有关于 IBS 的系统评价。因此,本综述旨在系统评估 XYS 治疗 IBS 的疗效。
方法:将使用电子数据库、手动搜索和联系作者电子邮件来搜索关于 XYS 治疗 IBS 的随机对照试验。我们将根据预设标准选择研究,并收集研究参与者、干预措施、对照组、结局测量、不良事件和偏倚风险的数据。主要结局将是疗效率,次要结局将是 IBS 为中心的指标(腹痛评分、腹胀评分、腹泻或便秘评分、肠症状严重程度量表)、生活质量指标和不良事件。Review Manager 软件和 Cochrane 协作“偏倚风险”工具将用于荟萃分析和偏倚风险评估。
结果:本综述将根据正式评估方面确定 XYS 治疗 IBS 的有效性和安全性的临床证据。
结论:本综述将进一步支持基于证据的 XYS 治疗 IBS 的应用。
伦理和传播:由于不收集个人信息和招募患者,因此不需要伦理批准。
注册号:Research Registry;reviewregistry986。
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