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Abstract：
OBJECTIVE: Multiple randomized controlled trials (RCTs) have investigated the efficacy of fecal microbiota transplantation (FMT) for irritable bowel syndrome (IBS), but have yielded inconsistent results. We updated the short-term and long-term efficacy of FMT in treating IBS, and performed a first-of-its-kind exploration of the relationship between gut microbiota and emotions.
METHODS: We conducted a comprehensive search of PubMed, Embase, Web of Science, and the Cochrane Library using various search strategies to identify all eligible studies. The inclusion criteria for data extraction were randomized controlled trials (RCTs) that investigated the efficacy of fecal microbiota transplantation (FMT) compared to placebo in adult patients (≥ 18 years old) with irritable bowel syndrome (IBS). A meta-analysis was then performed to assess the summary relative risk (RR) and corresponding 95% confidence intervals (CIs).
RESULTS: Out of 3,065 potentially relevant records, a total of 10 randomized controlled trials (RCTs) involving 573 subjects met the eligibility criteria for inclusion in the meta-analysis. The meta-analyses revealed no significant differences in short-term (12 weeks) (RR 0.20, 95% CI -0.04 to 0.44), long-term (52 weeks) global improvement (RR 1.38, 95% CI 0.87 to 2.21), besides short-term (12 weeks) (SMD - 48.16, 95% CI -102.13 to 5.81, I2 = 90%) and long-term (24 weeks) (SMD 2.16, 95% CI -60.52 to 64.83, I2 = 68%) IBS-SSS. There was statistically significant difference in short-term improvement of IBS-QoL (SMD 10.11, 95% CI 0.71 to 19.51, I2 = 82%), although there was a high risk of bias. In terms of long-term improvement (24 weeks and 54 weeks), there were no significant differences between the FMT and placebo groups (SMD 7.56, 95% CI 1.60 to 13.52, I2 = 0%; SMD 6.62, 95% CI -0.85 to 14.08, I2 = 0%). Sensitivity analysis indicated that there were visible significant effects observed when the criteria were based on Rome IV criteria (RR 16.48, 95% CI 7.22 to 37.62) and Gastroscopy (RR 3.25, 95%CI 2.37 to 4.47), Colonoscopy (RR 1.42, 95% CI 0.98 to 2.05). when using mixed stool FMT based on data from two RCTs, no significant difference was observed (RR 0.94, 95% CI 0.66 to -1.34). The remission of depression exhibited no significant difference between the FMT and placebo groups at the 12-week mark (SMD - 0.26, 95% CI -3.09 to 2.58), and at 24 weeks (SMD - 2.26, 95% CI -12.96 to 8.45). Furthermore, major adverse events associated with FMT were transient and self-limiting.
CONCLUSIONS: Based on the available randomized controlled trials (RCTs), the current evidence does not support the efficacy of FMT in improving global IBS symptoms in the long term. The differential results observed in subgroup analyses raise questions about the accurate identification of suitable populations for FMT. Further investigation is needed to better understand the reasons behind these inconsistent findings and to determine the true potential of FMT as a treatment for IBS.
METHODS: We conducted a comprehensive search of PubMed, Embase, Web of Science, and the Cochrane Library using various search strategies to identify all eligible studies. The inclusion criteria for data extraction were randomized controlled trials (RCTs) that investigated the efficacy of fecal microbiota transplantation (FMT) compared to placebo in adult patients (≥ 18 years old) with irritable bowel syndrome (IBS). A meta-analysis was then performed to assess the summary relative risk (RR) and corresponding 95% confidence intervals (CIs).
RESULTS: Out of 3,065 potentially relevant records, a total of 10 randomized controlled trials (RCTs) involving 573 subjects met the eligibility criteria for inclusion in the meta-analysis. The meta-analyses revealed no significant differences in short-term (12 weeks) (RR 0.20, 95% CI -0.04 to 0.44), long-term (52 weeks) global improvement (RR 1.38, 95% CI 0.87 to 2.21), besides short-term (12 weeks) (SMD - 48.16, 95% CI -102.13 to 5.81, I2 = 90%) and long-term (24 weeks) (SMD 2.16, 95% CI -60.52 to 64.83, I2 = 68%) IBS-SSS. There was statistically significant difference in short-term improvement of IBS-QoL (SMD 10.11, 95% CI 0.71 to 19.51, I2 = 82%), although there was a high risk of bias. In terms of long-term improvement (24 weeks and 54 weeks), there were no significant differences between the FMT and placebo groups (SMD 7.56, 95% CI 1.60 to 13.52, I2 = 0%; SMD 6.62, 95% CI -0.85 to 14.08, I2 = 0%). Sensitivity analysis indicated that there were visible significant effects observed when the criteria were based on Rome IV criteria (RR 16.48, 95% CI 7.22 to 37.62) and Gastroscopy (RR 3.25, 95%CI 2.37 to 4.47), Colonoscopy (RR 1.42, 95% CI 0.98 to 2.05). when using mixed stool FMT based on data from two RCTs, no significant difference was observed (RR 0.94, 95% CI 0.66 to -1.34). The remission of depression exhibited no significant difference between the FMT and placebo groups at the 12-week mark (SMD - 0.26, 95% CI -3.09 to 2.58), and at 24 weeks (SMD - 2.26, 95% CI -12.96 to 8.45). Furthermore, major adverse events associated with FMT were transient and self-limiting.
CONCLUSIONS: Based on the available randomized controlled trials (RCTs), the current evidence does not support the efficacy of FMT in improving global IBS symptoms in the long term. The differential results observed in subgroup analyses raise questions about the accurate identification of suitable populations for FMT. Further investigation is needed to better understand the reasons behind these inconsistent findings and to determine the true potential of FMT as a treatment for IBS.
摘要：
目的：多项随机对照试验（RCT）研究了粪便菌群移植（FMT）对肠易激综合征（IBS）的疗效，但产生了不一致的结果。我们更新了FMT治疗IBS的短期和长期疗效，并对肠道微生物群和情绪之间的关系进行了首次探索。
方法：我们对PubMed进行了全面搜索，Embase,WebofScience,和Cochrane图书馆使用各种搜索策略来识别所有符合条件的研究。数据提取的纳入标准是随机对照试验（RCT），该试验研究了粪便微生物群移植（FMT）与安慰剂相比在肠易激综合征（IBS）成年患者（≥18岁）中的疗效。然后进行荟萃分析以评估汇总相对风险（RR）和相应的95％置信区间（CI）。
结果：在3,065个潜在相关记录中，共有10项随机对照试验(RCT),涉及573名受试者,符合纳入荟萃分析的资格标准.荟萃分析显示短期（12周）没有显着差异（RR0.20，95％CI-0.04至0.44），长期（52周）全球改善（RR1.38，95%CI0.87至2.21），除了短期（12周）（SMD-48.16，95％CI-102.13至5.81，I2=90％）和长期（24周）（SMD2.16，95％CI-60.52至64.83，I2=68％）IBS-SSS。IBS-QoL短期改善有统计学差异(SMD10.11,95%CI0.71~19.51,I2=82%),尽管存在较高的偏倚风险。在长期改善方面（24周和54周），FMT组和安慰剂组之间无显著差异(SMD7.56,95%CI1.60~13.52,I2=0%;SMD6.62,95%CI-0.85~14.08,I2=0%).敏感性分析表明，当标准基于罗马IV标准（RR16.48，95％CI7.22至37.62）和胃镜检查（RR3.25，95CI2.37至4.47）时，观察到明显的影响。结肠镜检查（RR1.42，95%CI0.98至2.05）。当根据来自两个RCT的数据使用混合粪便FMT时，未观察到显著差异(RR0.94,95%CI0.66至-1.34).在12周时，FMT和安慰剂组之间的抑郁缓解没有显着差异（SMD-0.26，95％CI-3.09至2.58），并在24周时（SMD-2.26，95%CI-12.96至8.45）。此外，与FMT相关的主要不良事件为短暂性和自限性.
结论：基于现有的随机对照试验（RCT），目前的证据不支持FMT在长期改善整体IBS症状方面的疗效.在亚组分析中观察到的差异结果引发了有关准确识别FMT合适种群的问题。需要进一步的调查，以更好地了解这些不一致的发现背后的原因，并确定FMT作为IBS治疗的真正潜力。
方法：我们对PubMed进行了全面搜索，Embase,WebofScience,和Cochrane图书馆使用各种搜索策略来识别所有符合条件的研究。数据提取的纳入标准是随机对照试验（RCT），该试验研究了粪便微生物群移植（FMT）与安慰剂相比在肠易激综合征（IBS）成年患者（≥18岁）中的疗效。然后进行荟萃分析以评估汇总相对风险（RR）和相应的95％置信区间（CI）。
结果：在3,065个潜在相关记录中，共有10项随机对照试验(RCT),涉及573名受试者,符合纳入荟萃分析的资格标准.荟萃分析显示短期（12周）没有显着差异（RR0.20，95％CI-0.04至0.44），长期（52周）全球改善（RR1.38，95%CI0.87至2.21），除了短期（12周）（SMD-48.16，95％CI-102.13至5.81，I2=90％）和长期（24周）（SMD2.16，95％CI-60.52至64.83，I2=68％）IBS-SSS。IBS-QoL短期改善有统计学差异(SMD10.11,95%CI0.71~19.51,I2=82%),尽管存在较高的偏倚风险。在长期改善方面（24周和54周），FMT组和安慰剂组之间无显著差异(SMD7.56,95%CI1.60~13.52,I2=0%;SMD6.62,95%CI-0.85~14.08,I2=0%).敏感性分析表明，当标准基于罗马IV标准（RR16.48，95％CI7.22至37.62）和胃镜检查（RR3.25，95CI2.37至4.47）时，观察到明显的影响。结肠镜检查（RR1.42，95%CI0.98至2.05）。当根据来自两个RCT的数据使用混合粪便FMT时，未观察到显著差异(RR0.94,95%CI0.66至-1.34).在12周时，FMT和安慰剂组之间的抑郁缓解没有显着差异（SMD-0.26，95％CI-3.09至2.58），并在24周时（SMD-2.26，95%CI-12.96至8.45）。此外，与FMT相关的主要不良事件为短暂性和自限性.
结论：基于现有的随机对照试验（RCT），目前的证据不支持FMT在长期改善整体IBS症状方面的疗效.在亚组分析中观察到的差异结果引发了有关准确识别FMT合适种群的问题。需要进一步的调查，以更好地了解这些不一致的发现背后的原因，并确定FMT作为IBS治疗的真正潜力。
