Clinical Pharmacology, Faculty of Medicine, School of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece; Department of Gastroenterology, Hepatology and Transplant Medicine, Medical Faculty, University of Duisburg-Essen, Essen, Germany.
Clinical Pharmacology, Faculty of Medicine, School of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Clin Nutr. 2023 May;42(5):800-809. doi: 10.1016/j.clnu.2023.03.019. Epub 2023 Mar 31.
BACKGROUND: Irritable Bowel Syndrome (IBS) is a functional gastrointestinal disorder which affects a great number of patients globally. Clinical trials and meta-analyses have evaluated different therapies for IBS. Some of them have shown that probiotics play a significant role in the management of IBS-patients. Nevertheless, results are controversial, and the efficacy of the administration of probiotics remains to be confirmed, especially in regard to which type of probiotic-strains are beneficial. AIM: The aim of the present meta-analysis is to assess the efficacy and safety of the administration of probiotics to IBS-patients with a diagnosis based on Rome IV criteria, which is performed for the first time. METHODS: Electronic databases (Pubmed, Scopus and Cochrane) were searched until 26.01.2023 for randomized controlled trials (RCTs) studying the administration of probiotics in adult IBS-patients, who were categorized according to the Rome IV criteria. The risk of bias was assessed using the Cochrane Risk of Bias tool (ROB) 2.0. Weighted and standardized mean difference with the 95% confidence intervals were used for the synthesis of the results. Primary outcomes were the decrease of IBS-Symptom Severity Score (IBS-SSS) and decrease of abdominal pain. The secondary outcomes were the improvement in quality of life (QoL) and the decrease of bloating. Lastly, the adverse effects of probiotics were evaluated. The protocol of the study has been registered at protocols.io (DOI dx.doi.org/10.17504/protocols.io.14egn218yg5d/v1). RESULTS: Six double-blind (N = 970) placebo-control RCTs fulfilled the inclusion criteria and overall, nine different strains of probiotics were examined. No significant reduction in IBS-SSS (WMD -43.2, 95% CI -87.5 to 1.0, I = 82.9%) was demonstrated, whereas a significant decrease regarding abdominal pain (SMD -0.94, 95% CI -1.53 to -0.35, I = 92,2) was shown. Furthermore, no correlation between improvement of QoL and the use of probiotics (SMD -0.64, 95% CI -1.27 to 0.00, I = 93,9%) was shown. However, probiotics were associated with a significant reduction in bloating (SMD -0.28, 95% CI -0.47 to -0.09, I = 36,0%). A qualitative synthesis was conducted about adverse events and showed that the use of probiotics' is safe without severe adverse events. CONCLUSIONS: The administration of probiotics to IBS-patients demonstrated a positive effect on pain and bloating, but due to significant heterogeneity and confounding factors, that were not examined in the included studies, a definitive statement cannot be made. Moreover, probiotics did not lead to an improvement in other parameters. There is a need for larger RCTs in IBS-patients diagnosed according to Rome IV (not III) criteria and especially it is essential to be conducted RCTs which examine the administration of specific strains and have similar methodological characteristics.
背景：肠易激综合征（IBS）是一种影响全球大量患者的功能性胃肠道疾病。临床试验和荟萃分析已经评估了不同的治疗方法。其中一些研究表明，益生菌在 IBS 患者的治疗中发挥着重要作用。然而，结果存在争议，益生菌的疗效仍有待证实，特别是在哪些益生菌菌株有益方面。
目的：本荟萃分析旨在评估基于 Rome IV 标准诊断的 IBS 患者使用益生菌的疗效和安全性，这是首次进行的评估。
方法：直到 2023 年 1 月 26 日，我们在电子数据库（PubMed、Scopus 和 Cochrane）中搜索了研究益生菌在符合 Rome IV 标准的成年 IBS 患者中的应用的随机对照试验（RCT）。使用 Cochrane 偏倚风险工具（ROB）2.0 评估偏倚风险。使用加权和标准化均数差值及其 95%置信区间对结果进行综合。主要结局是 IBS 症状严重程度评分（IBS-SSS）的降低和腹痛的减轻。次要结局是生活质量（QoL）的改善和腹胀的减轻。最后，评估了益生菌的不良反应。该研究的方案已在 protocols.io（DOI dx.doi.org/10.17504/protocols.io.14egn218yg5d/v1）上注册。
结果：符合纳入标准的 6 项双盲（N=970）安慰剂对照 RCT 进行了荟萃分析，共检查了 9 种不同的益生菌菌株。未显示 IBS-SSS 显著降低（WMD-43.2，95%CI-87.5 至 1.0，I=82.9%），但显示腹痛显著减轻（SMD-0.94，95%CI-1.53 至-0.35，I=92.2%）。此外，未显示益生菌的使用与 QoL 的改善之间存在相关性（SMD-0.64，95%CI-1.27 至 0.00，I=93.9%）。然而，益生菌与腹胀的显著减轻相关（SMD-0.28，95%CI-0.47 至-0.09，I=36.0%）。对不良反应进行了定性综合分析，表明益生菌的使用是安全的，没有严重的不良反应。
结论：在 IBS 患者中使用益生菌对疼痛和腹胀有积极影响，但由于纳入研究中未检查到显著的异质性和混杂因素，因此无法做出明确的结论。此外，益生菌并没有导致其他参数的改善。需要在符合 Rome IV（而非 Rome III）标准诊断的 IBS 患者中进行更大规模的 RCT，特别是必须进行使用特定菌株且具有相似方法学特征的 RCT。
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