The efficacy and real-world effectiveness of a diet low in fermentable oligo-, di-, monosaccharides and polyols in irritable bowel syndrome: A systematic review and meta-analysis.

BACKGROUND & AIMS: A diet low in fermentable oligo-, di-, monosaccharides, and polyols (LFD) has been shown to effectively reduce irritable bowel syndrome (IBS) symptoms. Effects resulting from real-world studies may differ from those seen in efficacy studies because of the diversity of patients in real-world settings. This systematic review and meta-analysis aimed to compare the effect of the LFD on reducing IBS symptoms and improving the quality of life (QoL) in efficacy trials and real-world studies. METHODS: Major databases, trial registries, dissertations, and journals were systematically searched for studies on the LFD in adults with IBS. Meta-analysis was conducted using a random effects model with standardized mean differences (SMD) and 95% confidence intervals (CI). Outcomes of interest were all patient-reported: stool consistency, stool frequency, abdominal pain, overall symptoms, adequate symptom relief, IBS-specific QoL and adherence to the LFD. RESULTS: Eleven efficacy and 19 real-world studies were reviewed. The meta-analysis results for abdominal pain (SMD 0.35, 95% CI 0.16 to 0.54) and QoL (SMD 0.23, 95% CI -0.05 to 0.50) showed the LFD was beneficial in efficacy studies with no statistically significant results for stool frequency (SMD 0.71, 95% CI 0.34 to 1.07). Real-world studies found improvements in abdominal pain and QoL. Due to heterogeneity, no meta-analysis was done for stool consistency and overall symptoms. In these outcomes, results were mostly supportive of the LFD, but they were not always statistically significant. CONCLUSIONS: The results of this systematic review and meta-analysis suggest the LFD improves outcomes compared to a control diet (efficacy studies) or baseline data (real-world studies). Because of diverse study designs and heterogeneity of results, a clear superiority of the LFD over control diets could not be concluded. There are no indications of an efficacy-effectiveness gap for the LFD in adults with IBS.

The Efficacy of a Diet Low in Fermentable Oligo-, Di-, Monosaccharides, and Polyols in Irritable Bowel Syndrome Compared to Its "Real-world" Effectiveness: Protocol for a Systematic Review.

BACKGROUND: Irritable bowel syndrome (IBS) is associated with various gastrointestinal and nongastrointestinal symptoms and reduced quality of life. A diet low in fermentable oligo-, di-, monosaccharides, and polyols (FODMAPs) is one therapeutic option for IBS. Although the efficacy of the low FODMAP diet has been reported in several systematic reviews, the efficacy-effectiveness gap of the low FODMAP diet has not yet been assessed. OBJECTIVE: This systematic review aims to compare the efficacy of the low FODMAP diet from efficacy randomized controlled trials (RCTs) with the effectiveness of studies conducted in "real-world" settings. METHODS: RCTs, prospective and retrospective cohort studies, and retrospective audits assessing the low FODMAP diet in adults with IBS will be searched in 4 databases: Embase, MEDLINE, CENTRAL, and CINAHL. Two independent reviewers will perform study selection, data extraction, and risk of bias assessment and assess selected quality aspects from the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) protocol. Outcomes assessed are stool frequency, stool consistency, abdominal pain, overall symptom scores, adequate symptom relief, IBS-specific quality of life, and diet adherence. Data will be summarized with forest plots without summary statistics, tables, and narrative descriptions. RESULTS: The search, title and abstract screening, and full-text screening were completed in March 2021, and an updated search was done in May 2022. As of May 2023, data analysis is almost finished, and manuscript writing is in progress. Submission of the manuscript is expected by July 2023. CONCLUSIONS: The findings of this systematic review will compare the efficacy of the low FODMAP diet for IBS found in RCTs to the diet's real-world effectiveness. TRIAL REGISTRATION: PROSPERO CRD42021278952; https://tinyurl.com/32jk43ev. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41399.