Evidence map›Paper›PMID 26746169›Full record

SynthesisJournal of Crohn's & colitis2016

Systematic Review and Meta-analysis: Placebo Rates in Induction and Maintenance Trials of Ulcerative Colitis.

Vipul Jairath, Guangyong Zou, Claire E Parker, John K Macdonald, Mahmoud H Mosli, Reena Khanna, Lisa M Shackelton, Margaret K Vandervoort, Turki AlAmeel, Mohammad Al Beshir and 16 more

Open access · hybridAbstract readMeta-AnalysisSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Journal of Crohn's & colitis, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 3 pooled it
5.7field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 48 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors at 10 institutions in 6 countries.

Vipul JairathTranslational Gastroenterology Unit, Nuffield Department of Medicine, University of Oxford, UK Robarts Research Institute, University of Western Ontario, London, ON, Canada Department of Medicine, University of Western Ontario, London, ON, Canada vipul.jairath@robartsinc.com.
Guangyong ZouRobarts Research Institute, University of Western Ontario, London, ON, Canada Department of Epidemiology and Biostatistics, University of Western Ontario, London, ON, Canada.
Claire E ParkerRobarts Research Institute, University of Western Ontario, London, ON, Canada Department of Medicine, University of Western Ontario, London, ON, Canada.
John K MacdonaldRobarts Research Institute, University of Western Ontario, London, ON, Canada Department of Medicine, University of Western Ontario, London, ON, Canada.
Mahmoud H MosliRobarts Research Institute, University of Western Ontario, London, ON, Canada Department of Medicine, University of Western Ontario, London, ON, Canada Department of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.
Reena KhannaRobarts Research Institute, University of Western Ontario, London, ON, Canada Department of Medicine, University of Western Ontario, London, ON, Canada.
Lisa M ShackeltonRobarts Research Institute, University of Western Ontario, London, ON, Canada.
Margaret K VandervoortRobarts Research Institute, University of Western Ontario, London, ON, Canada.
Turki AlAmeelDepartment of Medicine, King Fahad Specialist Hospital-Dammam, Dammam, Saudi Arabia.
Mohammad Al BeshirDepartment of Medicine, King Fahad Specialist Hospital-Dammam, Dammam, Saudi Arabia.
Majid AlMadiDivision of Gastroenterology, King Khalid University Hospital, King Saud University, Riyadh, Saudi Arabia.
Talal Al-TaweelHaya Al-Habeeb Gastroenterology Center, Mubarak Al-Kabeer Hospital, Jabriya, Kuwait.
Nathan S S AtkinsonTranslational Gastroenterology Unit, Nuffield Department of Medicine, University of Oxford, UK.
Sujata BiswasTranslational Gastroenterology Unit, Nuffield Department of Medicine, University of Oxford, UK.
Thomas P ChapmanTranslational Gastroenterology Unit, Nuffield Department of Medicine, University of Oxford, UK.
Parambir S DulaiRobarts Research Institute, University of Western Ontario, London, ON, Canada Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.
Mark A GlaireDivision of Medical Sciences, University of Oxford, Oxford, UK.
Daniel HoekmanDepartment of Gastroenterology, Academic Medical Center, Amsterdam, The Netherlands.
Andreas KoutsoumpasTranslational Gastroenterology Unit, Nuffield Department of Medicine, University of Oxford, UK.
Elizabeth MinasDepartment of Geratology, Oxford University Hospitals NHS Trust, Oxford, UK.
Mark A SamaanDepartment of Gastroenterology, Guy's and St Thomas' Hospital NHS Trust, London, UK.
Simon TravisTranslational Gastroenterology Unit, Nuffield Department of Medicine, University of Oxford, UK.
Geert D'HaensRobarts Research Institute, University of Western Ontario, London, ON, Canada Department of Gastroenterology, Academic Medical Center, Amsterdam, The Netherlands.
Barrett G LevesqueRobarts Research Institute, University of Western Ontario, London, ON, Canada Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.
William J SandbornRobarts Research Institute, University of Western Ontario, London, ON, Canada Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.
Brian G FeaganRobarts Research Institute, University of Western Ontario, London, ON, Canada Department of Medicine, University of Western Ontario, London, ON, Canada Department of Medicine, University of Western Ontario, London, ON, Canada.
Western University · CAUniversity of Oxford · GBKing Fahad Specialist Hospital · SAAcademic Medical Center · NLKing Abdulaziz University · SAKing Khalid University Hospital · SAMubarak Al Kabeer Hospital · KWOxford University Hospitals NHS Trust · GBSt Thomas' Hospital · GBUniversity of California, San Diego · US

Funding

Training Grant in GastroenterologyT32DK007202 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI GHOSH, PRADIPTA · 1985 to 2022
$7.7M
NIDDK NIH HHS T32 DK007202
6 · The paper itself

Abstract

BACKGROUND AND

aimsMinimisation of the placebo responses in randomised controlled trials [RCTs] is essential for efficient evaluation of new interventions. Placebo rates have been high in ulcerative colitis [UC] clinical trials, and factors influencing this are poorly understood. We quantify placebo response and remission rates in UC RCTs and identify trial design factors influencing them.

methodsMEDLINE, EMBASE, and the Cochrane Library were searched from inception through April 2014 for placebo-controlled trials in adult patients with UC of a biological agent, corticosteroid, immunosuppressant, or aminosalicylate. Data were independently doubly extracted. Quality was assessed using the Cochrane risk of bias tool.

resultsIn all, 51 trials [48 induction and 10 maintenance phases] were identified. Placebo response and remission rates were pooled according to random-effects models, and mixed-effects meta-regression models were used to evaluate effects of study-level characteristics on these rates. Pooled estimates of placebo remission and response rates for induction trials were 10% (95% confidence interval [CI] 7-13%) and 33% [95% CI 29-37%], respectively. Corresponding values for maintenance trials were 19% [95% CI 11-30%] and 22% [95% CI 17-28%]. Trials enrolling patients with more active disease confirmed by endoscopy [endoscopy subscore ≥ 2] were associated with lower placebo rates. Conversely, placebo rates increased with increasing trial duration and number of study visits.

conclusionsObjective assessment of greater disease activity at trial entry by endoscopy lowered placebo rates, whereas increasing trial duration and more interactions with healthcare providers increased placebo rates. These findings have important implications for design and conduct of clinical trials.

Indexed as

Induction ChemotherapyMaintenance ChemotherapyPlacebo EffectAnti-Inflammatory AgentsColitis, UlcerativeHumansImmunosuppressive AgentsModels, StatisticalRandomized Controlled Trials as TopicResearch DesignTreatment OutcomeAnti-Inflammatory AgentsImmunosuppressive AgentsDAIDisease Activity IndexMayo Clinic ScoreMCSrandomised controlled trialRCTUCulcerative colitis

Identifiers

PMID26746169
PMCPMC4957452
OpenAlexW2229293842

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.