Cited by 550Gastrointestinal motility and disordersStatistical Methods in Clinical TrialsEthics in Clinical Research

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Design of Treatment Trials for Functional Gastrointestinal Disorders

Irvine, E. Jan, Tack, Jan, Crowell, Michael D., Gwee, Kok Ann, Ke, Meiyun, Schmulson, Max J., Whitehead, William E., Spiegel, Brennan·2016·Gastroenterology

DOI 10.1053/j.gastro.2016.02.010

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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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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: Tack, Jan
Crowell, Michael D.
Gwee, Kok Ann
Schmulson, Max J.
Whitehead, William E.
Spiegel, Brennan
Venue: Gastroenterology
Publisher: Elsevier BV
Published: 2016-05
Volume: 150
Issue: 6
Pages: 1469-1480.e1
ISSN: 0016-5085 (ISSN-L)
DOI: 10.1053/j.gastro.2016.02.010
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
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
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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