Gastro Unit, Medical Division, Copenhagen University Hospital Hvidovre, Hvidovre 2650, Denmark.
Copenhagen IBD Center, Copenhagen University Hospital Hvidovre, Hvidovre 2650, Denmark.
World J Gastroenterol. 2023 May 28;29(20):3185-3202. doi: 10.3748/wjg.v29.i20.3185.
BACKGROUND: Irritable bowel syndrome (IBS) is the most prevalent gastrointestinal disorder in developed countries and reduces patients' quality of life, hinders their ability to work, and increases health care costs. A growing number of trials have demonstrated an aberrant gut microbiota composition in IBS, also known as 'gut dysbiosis'. Fecal microbiota transplantation (FMT) has been suggested as a treatment for IBS. AIM: To assess the efficacy and safety of FMT for the treatment of IBS. METHODS: We searched Cochrane Central, MEDLINE, EMBASE and Web of Science up to 24 October 2022 for randomised controlled trials (RCTs) investigating the effectiveness of FMT compared to placebo (including autologous FMT) in treating IBS. The primary outcome was the number of patients with improvements of symptoms measured using a validated, global IBS symptoms score. Secondary outcomes were changes in quality-of-life scores, non-serious and serious adverse events. Risk ratios (RR) and corresponding 95%CI were calculated for dichotomous outcomes, as were the mean differences (MD) and 95%CI for continuous outcomes. The Cochrane risk of bias tool was used to assess the quality of the trials. GRADE criteria were used to assess the overall quality of the evidence. RESULTS: Eight RCTs (484 participants) were included in the review. FMT resulted in no significant benefit in IBS symptoms three months after treatment compared to placebo (RR 1.19, 95%CI: 0.68-2.10). Adverse events were reported in 97 participants in the FMT group and in 45 participants in the placebo group (RR 1.17, 95%CI: 0.63-2.15). One serious adverse event occurred in the FMT group and two in the placebo group (RR 0.42, 95%CI: 0.07-2.60). Endoscopic FMT delivery resulted in a significant improvement in symptoms, while capsules did not. FMT did not improve the quality of life of IBS patients but, instead, appeared to reduce it, albeit non significantly (MD -6.30, 95%CI: -13.39-0.79). The overall quality of the evidence was low due to moderate-high inconsistency, the small number of patients in the studies, and imprecision. CONCLUSION: We found insufficient evidence to support or refute the use of FMT for IBS. Larger trials are needed.
背景:肠易激综合征(IBS)是发达国家最常见的胃肠道疾病,降低了患者的生活质量,阻碍了他们的工作能力,并增加了医疗保健成本。越来越多的试验表明 IBS 存在肠道微生物群落组成异常,也称为“肠道菌群失调”。粪便微生物群移植(FMT)已被提议作为 IBS 的一种治疗方法。
目的:评估 FMT 治疗 IBS 的疗效和安全性。
方法:我们检索了 Cochrane 中央、MEDLINE、EMBASE 和 Web of Science,截至 2022 年 10 月 24 日,以寻找比较 FMT 与安慰剂(包括自体 FMT)治疗 IBS 的疗效的随机对照试验(RCT)。主要结局是使用经过验证的全球 IBS 症状评分衡量的症状改善的患者人数。次要结局是生活质量评分的变化、非严重和严重不良事件。二分类结局采用风险比(RR)和相应的 95%置信区间(CI)表示,连续性结局采用均数差(MD)和 95%CI 表示。使用 Cochrane 偏倚风险工具评估试验质量。使用 GRADE 标准评估证据的总体质量。
结果:综述纳入了 8 项 RCT(484 名参与者)。与安慰剂相比,FMT 在治疗后三个月对 IBS 症状没有显著益处(RR 1.19,95%CI:0.68-2.10)。FMT 组有 97 名参与者和安慰剂组有 45 名参与者报告了不良事件(RR 1.17,95%CI:0.63-2.15)。FMT 组发生 1 例严重不良事件,安慰剂组发生 2 例(RR 0.42,95%CI:0.07-2.60)。内镜 FMT 给药可显著改善症状,而胶囊则不能。FMT 并未改善 IBS 患者的生活质量,反而似乎降低了生活质量,尽管没有统计学意义(MD-6.30,95%CI:-13.39-0.79)。由于中等高度的不一致性、研究中患者数量少以及不精确性,证据的总体质量较低。
结论:我们发现没有足够的证据支持或反驳 FMT 治疗 IBS 的使用。需要更大规模的试验。
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