Outcome measures for irritable bowel syndrome: a scoping review
Jia-Hao Mo1, Ping Zeng1, Li-Lei Zhou1
1The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, 510006, Guangdong, China.
Selecting appropriate outcome measures in Irritable Bowel Syndrome (IBS) randomized controlled trials (RCTs) is crucial for accurate efficacy evaluation. This study organizes IBS RCT outcomes to guide better selection for future research.
Area of Science:
- Gastroenterology
- Clinical Trials
- Gut-Brain Interaction Disorders
Background:
- Irritable Bowel Syndrome (IBS) is a common gut-brain disorder.
- Current randomized controlled trials (RCTs) often lack justification for outcome selection, potentially hindering efficacy evaluation.
Purpose of the Study:
- To systematically organize outcome information from IBS RCTs.
- To categorize outcomes into domains and identify measurement instruments.
- To classify measures by therapeutic mechanisms, IBS subtypes, and research aims for improved selection.
Main Methods:
- Systematic literature search of PubMed, Embase, and Cochrane Library up to May 2023.
- Combined "IBS" and "RCT" search terms with information specialist input.
- Categorized outcomes and instruments into domains, stratified by IBS subtype and intervention.
Main Results:
- Analyzed 408 studies; outcomes included global improvement (76.96%), individual symptoms (64.46%), quality of life (43.63%), and psychological status (24.26%).
- Key instruments: IBS-SSS, BSFS, IBS-QOL, HADS.
- IBS subtypes showed specific symptom focus (e.g., straining in IBS-C, urgency in IBS-D); psychological domain evaluation was limited in drug trials; long-term recurrence rates were underreported.
Conclusions:
- Appropriate outcome measure selection, guided by drug mechanisms, IBS subtypes, and research objectives, enhances efficacy evaluation.
- Further attention is needed for placebo effect and long-term outcome assessment in IBS RCTs.
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