Table_1_Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome: A Meta-Analysis of Randomized Controlled Trials.docx

Background:Gut microbiota has been identified as an imbalance in patients with irritable bowel syndrome (IBS). Fecal microbiota transplantation (FMT) is a novel method to restore microbiota and treat IBS patients.
ObjectiveTo conduct a meta-analysis and estimate the efficacy and safety of FMT for the treatment of IBS patients with subgroup analyses to explore the most effective way of FMT for IBS.
MethodsAll eligible studies were searched from PubMed, Embase, Web of Science, and the Cochrane Library through multiple search strategies. Data were extracted from studies comprising the following criteria: double-blind, randomized controlled trials (RCTs) that compared the efficacy of FMT with placebo for adult patients (≥18 years old) with IBS. A meta-analysis was performed to evaluate the summary relative risk (RR) and 95% confidence intervals (CIs).
ResultsA total of seven RCTs comprising 489 subjects were eligible for this meta-analysis. Pooled data showed no significant improvement of global IBS symptoms in patients with FMT compared with placebo (RR = 1.34; 95% CI 0.75–2.41, p = 0.32). A significant heterogeneity was observed among the studies (I2 = 83%, p < 0.00001). There was no significant evidence of funnel plot asymmetry (Egger's test, p = 0.719; Begg's test, p = 1.000), indicating no existence of publication bias. Subgroup analyses revealed that FMT operated by invasive routes, including gastroscope, colonoscope, and nasojejunal tube, significantly improved global IBS symptoms (RR = 1.96; 95% CI 1.23–3.11, p = 0.004) with heterogeneity (I2 = 57%, p = 0.06) and an NNT of 3 (95% CI 2–14). However, FMT delivered via oral capsules showed a negative impact on patients with IBS (RR = 0.56; 95% CI 0.33–0.96, p = 0.03) with a low heterogeneity (I2 = 39%, p = 0.2) and an NNH of 3 (95% CI 2–37).
ConclusionThe current evidence from RCTs with all routes of FMT does not show significant global improvement in patients with IBS. However, FMT operated by invasive routes significantly improved global IBS symptoms.

研究背景：肠道菌群失调已被证实存在于肠易激综合征（irritable bowel syndrome, IBS）患者体内。粪便菌群移植（fecal microbiota transplantation, FMT）作为一种新兴疗法，可通过重建肠道菌群实现肠易激综合征患者的治疗。
研究目的：开展一项荟萃分析，评估粪便菌群移植治疗肠易激综合征患者的疗效与安全性，并通过亚组分析探索治疗肠易激综合征的最优粪便菌群移植方案。
研究方法：通过多种检索策略，在PubMed、Embase、Web of Science及Cochrane图书馆中检索符合纳入标准的相关研究。纳入研究需满足以下标准：针对18岁及以上肠易激综合征成年患者，对比粪便菌群移植与安慰剂疗效的双盲随机对照试验（randomized controlled trials, RCTs）。本研究通过荟萃分析计算合并相对危险度（relative risk, RR）及95%置信区间（confidence intervals, CIs）。
研究结果：本荟萃分析共纳入7项随机对照试验，涉及489名受试者。合并数据显示，与安慰剂组相比，粪便菌群移植治疗并未显著改善肠易激综合征患者的整体症状（RR=1.34；95%CI 0.75~2.41，p=0.32）。各研究间存在显著异质性（I²=83%，p<0.00001）。漏斗图分析未显示明显不对称（Egger检验：p=0.719；Begg检验：p=1.000），提示不存在发表偏倚。亚组分析结果表明，通过侵入性途径（包括胃镜、结肠镜及鼻空肠管）实施的粪便菌群移植，可显著改善肠易激综合征患者的整体症状（RR=1.96；95%CI 1.23~3.11，p=0.004），该亚组异质性较低（I²=57%，p=0.06），需治疗人数（NNT）为3（95%CI 2~14）。而经口服胶囊递送的粪便菌群移植则对肠易激综合征患者产生了不良影响（RR=0.56；95%CI 0.33~0.96，p=0.03），该亚组异质性较低（I²=39%，p=0.2），需伤害人数（NNH）为3（95%CI 2~37）。
研究结论：现有针对所有给药途径粪便菌群移植的随机对照试验证据显示，其并未显著改善肠易激综合征患者的整体症状。但通过侵入性途径实施的粪便菌群移植，可显著改善肠易激综合征患者的整体症状。