A meta-analysis of the placebo rates of remission and response in clinical trials of active crohn’s disease

Su, Chinyu; Lichtenstein, Gary R.; Krok, Karen; Brensinger, Colleen M.; Lewis, James D.

doi:10.1053/j.gastro.2004.01.024

Cited by 212Inflammatory Bowel DiseaseStatistical Methods in Clinical TrialsPain Management and Placebo Effect

A meta-analysis of the placebo rates of remission and response in clinical trials of active crohn’s disease

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Su, Chinyu, Lichtenstein, Gary R., Krok, Karen, Brensinger, Colleen M., Lewis, James D.·2004·Gastroenterology

DOI 10.1053/j.gastro.2004.01.024

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Abstract

Background & aims Placebo-controlled, randomized clinical trials (PC-RCTs) are commonly used to assess therapies for Crohn's disease (CD). Knowledge of the placebo rates of remission and response and understanding of design factors that influence these rates is important for designing future clinical trials evaluating pharmacotherapy of CD. The aims of this study were to estimate rates of remission and response in patients with active CD receiving placebo and to identify factors influencing these rates.Methods We performed a systematic review and meta-analysis of PC-RCTs evaluating therapies for active CD identified from MEDLINE from 1966 to 2001.Results The pooled estimates of the placebo rates of remission and response were 18% (95% confidence interval, 14%-24%; range, 0%-50%) and 19% (95% confidence interval, 13%-28%; range, 0%-46%), respectively, both with significant heterogeneity among studies (P < 0.01 for remission, P < 0.03 for response). In multivariate models, study duration, number of study visits, and entry Crohn's Disease Activity Index score were important predictors of the placebo remission rate, with study duration the most important. However, no single factor could account for all of the heterogeneity. Factors that influence the placebo response rates were similar to those affecting the placebo remission rates. The absolute benefit of active treatment beyond placebo was generally larger when outcome was measured by response than remission.Conclusions Placebo remission and response rates in PC-RCTs for active CD are variable. Study duration, number of study visits, and disease severity at entry have a large influence on placebo remission rates.

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Authors: Su, C., Lichtenstein, G. R., Krok, K., Brensinger, C. M., & Lewis, J. D.
Affiliations: Penn Presbyterian Medical Center (US)
University of Pennsylvania (US)
Corresponding author: Su, Chinyu
ORCID: Su, Chinyu
Lichtenstein, Gary R.
Krok, Karen
Lewis, James D.
Venue: Gastroenterology
Publisher: Elsevier BV
Published: 2004-05
Volume: 126
Issue: 5
Pages: 1257-1269
ISSN: 0016-5085 (ISSN-L)
DOI: 10.1053/j.gastro.2004.01.024
OpenAlex: W2120419234
Semantic Scholar: 058b10cc701c4404bb8fe354da502b7f1d46d12b
Cited by: 212
References: 36
Citations by year: 2026: 3 · 2025: 6 · 2024: 1 · 2023: 3 · 2022: 4 · 2021: 5 · 2020: 4 · 2019: 3 · 2018: 5 · 2017: 8 · 2016: 10 · 2015: 9 · 2014: 16 · 2013: 7 · 2012: 11
FWCI: 1.93
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Gastroenterology (publishedVersion)
PubMed (publishedVersion)
Funders: National Institutes of Health (5k08dk002589-05)
National Institute of Diabetes and Digestive and Kidney Diseases (K08 DK 02589)
Topics: Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Inflammatory Bowel Disease
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Life Sciences › Neuroscience › Cognitive Neuroscience › Pain Management and Placebo Effect
Keywords: Crohn's disease, placebo response, placebo response rate, clinical trial design, study duration, CDAI, disease severity
MeSH terms: Crohn Disease, Humans, Placebos, Remission Induction, Controlled Clinical Trials as Topic

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A meta-analysis of the placebo rates of remission and response in clinical trials of active crohn’s disease

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