The DOI matches its Crossref record; 147 of the 151 references it cites were found in a registry or an index.
Design of Treatment Trials for Functional Gastrointestinal Disorders
Abstract
This article summarizes recent progress and regulatory guidance on design of trials to assess the efficacy of new therapies for functional gastrointestinal disorders (FGIDs). The double-masked, placebo-controlled, parallel-group design remains the accepted standard for evaluating treatment efficacy. A control group is essential, and a detailed description of the randomization process and concealed allocation method must be included in the study report. The control will most often be placebo, but for therapeutic procedures and for behavioral treatment trials, respectively, a sham procedure and control intervention with similar expectation of benefit, but lacking the treatment principle, are recommended. Investigators should be aware of, and attempt to minimize, expectancy effects (placebo, nocebo, precebo). The primary analysis should be based on the proportion of patients in each treatment arm who satisfy a treatment responder definition or a prespecified clinically meaningful change in a patient-reported outcome measure. Data analysis should use the intention-to-treat principle. Reporting of results should follow the Consolidated Standards for Reporting Trials guidelines and include secondary outcome measures to support or explain the primary outcome and an analysis of harms data. Trials should be registered in a public location before initiation and results should be published regardless of outcome.
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“which is recommended by guidelines for the design of treatment trials in IBS. 38”
From Efficacy of Probiotics in Irritable Bowel Syndrome: Systematic Review and Meta-analysis (2023) · cites this paper as [38]
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Prebiotic effects: metabolic and health benefits
Roberfroid, M. B., Gibson, G. R., Hoyles, L., McCartney, A. L., Rastall, R. A., Rowland, I. R., Wolvers, D. A. W., Watzl, B., Szajewska, H., Stahl, B., et al. (2010) · British Journal Of Nutrition · doi:10.1017/s0007114510003363 · Cited by 2,170
Rome IV—Functional GI Disorders: Disorders of Gut-Brain Interaction
Drossman, D. A., & Hasler, W. L. (2016) · Gastroenterology · doi:10.1053/j.gastro.2016.03.035 · Cited by 1,928
Fukase, K., Kato, M., Kikuchi, S., Inoue, K., Uemura, N., Okamoto, S., Terao, S., Amagai, K., Hayashi, S., & Asaka, M. (2008) · The Lancet · doi:10.1016/s0140-6736(08)61159-9 · Cited by 1,242
Pimentel, M., Chow, E. J., & Lin, H. C. (2003) · The American Journal of Gastroenterology · doi:10.1111/j.1572-0241.2003.07234.x · Cited by 670
Ludvik, B., Giorgino, F., Jódar, E., Frias, J. P., Fernández Landó, L., Brown, K., Bray, R., & Rodríguez, Á. (2021) · The Lancet · doi:10.1016/s0140-6736(21)01443-4 · Cited by 639
Metadata
- Authors
- Irvine, E. J., Tack, J., Crowell, M. D., Gwee, K. A., Ke, M., Schmulson, M. J., Whitehead, W. E., & Spiegel, B.
- Affiliations
- St. Michael's Hospital (CA)
- Universitair Ziekenhuis Leuven (BE)
- Mayo Clinic (US)
- National University of Singapore (SG)
- Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
- Hospital General de México (MX)
- University of North Carolina at Chapel Hill (US)
- Cedars-Sinai Medical Center (US)
- Corresponding author
- Tack, Jan
- ORCID
- Venue
- Gastroenterology
- Publisher
- Elsevier BV
- Published
- 2016-05
- Volume
- 150
- Issue
- 6
- Pages
- 1469-1480.e1
- ISSN
- 0016-5085 (ISSN-L)
- OpenAlex
- W2065994042
- Cited by
- 550
- References
- 151
- Citations by year
- 2026: 7 · 2025: 7 · 2024: 17 · 2023: 12 · 2022: 19 · 2021: 25 · 2020: 22 · 2019: 22 · 2018: 31 · 2017: 22 · 2016: 20
- FWCI
- 5.29
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Gastroenterology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Keywords
- functional gastrointestinal disorders, clinical trial design, sham procedure, expectancy effects, nocebo, patient-reported outcome measures, intention-to-treat analysis, CONSORT guidelines, clinical trial registration, regulatory guidelines
- MeSH terms
- Gastrointestinal Diseases, Research Design
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