Evidence map›Paper›PMID 31111881›Full record

SynthesisJournal of Crohn's & colitis2019

Adverse Events and Nocebo Effects in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Christopher Ma, Nicola R Panaccione, Tran M Nguyen, Leonardo Guizzetti, Claire E Parker, Isra M Hussein, Niels Vande Casteele, Reena Khanna, Parambir S Dulai, Siddharth Singh and 2 more

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

Synthesis in Journal of Crohn's & colitis, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 4 pooled it
2.0field-weighted citation impact, top 14% 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

13 citing papers in PubMed, 4 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Review
  6. Article
  7. Review
  8. Risk factors associated with nocebo effects: A review of reviews.Brain, behavior, & immunity - health · 2024
    Review
  9. Article
  10. Review
  11. Article
  12. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 2 countries.

Christopher MaDivision of Gastroenterology & Hepatology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
Nicola R PanaccioneFaculty of Health Science, Western University, London, Ontario, Canada.
Tran M NguyenDepartment of Medicine, University of Toronto, Toronto, Ontario, Canada.
Leonardo GuizzettiRobarts Clinical Trials, Inc., London, Ontario, Canada.
Claire E ParkerRobarts Clinical Trials, Inc., London, Ontario, Canada.
Isra M HusseinDepartment of Medicine, University of Toronto, Toronto, Ontario, Canada.
Niels Vande CasteeleRobarts Clinical Trials, Inc., London, Ontario, Canada.
Reena KhannaDivision of Gastroenterology, Western University, London, Ontario, Canada.
Parambir S DulaiDivision of Gastroenterology, University of California San Diego, La Jolla, California, USA.
Siddharth SinghDivision of Gastroenterology, University of California San Diego, La Jolla, California, USA.
Brian G FeaganRobarts Clinical Trials, Inc., London, Ontario, Canada.
Vipul JairathRobarts Clinical Trials, Inc., London, Ontario, Canada.
Western University · CAUniversity of California San Diego · USRobarts Clinical Trials · CAUniversity of Toronto · CAUniversity of Calgary · CA

Funding

Comparative Risks and Benefits of Pharmacological Therapies for Older Patients with Inflammatory Bowel DiseasesK23DK117058 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI SINGH, SIDDHARTH · 2018 to 2022
$971k
NIDDK NIH HHS K23 DK117058
6 · The paper itself

Abstract

BACKGROUND AND

aimsNocebo effects, adverse outcomes occurring in patients receiving inert therapy, contribute to adverse event [AE] reporting in randomized controlled trials [RCTs]. High placebo AE rates may result in inaccurate estimation of treatment-related AEs. We estimate the pooled rate of AEs in patients randomized to placebo compared to active therapy in inflammatory bowel disease [IBD] RCTs.

methodsMEDLINE, EMBASE and CENTRAL were searched to March 1, 2017 for RCTs of conventional medical therapies for Crohn's disease [CD] or ulcerative colitis [UC]. Rates of AEs, serious AEs [SAEs], AE-related trial withdrawal, infections and worsening IBD were pooled using a random-effects model.

resultsWe included 124 CD [n = 26 042] and 71 UC RCTs [n = 16 798]. The pooled placebo AE rate was 70.6% (95% confidence interval [CI]: 65.3%, 75.4%) and 54.5% [47.8%, 61.1%] in CD and UC RCTs, respectively. There was no significant risk difference [RD] in AE, SAE or AE-related withdrawal rates between CD patients receiving placebo or active drug. A 1.6% [95% CI: 0.1%, 3.1%] increase in AE rates was observed among UC patients randomized to active therapy. Patients receiving active therapy had a higher risk of infection (RD 1.0% [95% CI: 0.4%, 1.7%] for CD, 2.9% [95% CI: 1.4%, 4.4%] for UC) although a lower risk of worsening CD (RD -3.2% [95% CI: -4.8%, -1.5%]) or UC (RD -3.7% [95% CI: -5.7%, -1.8%]).

conclusionsAEs are commonly reported by patients randomized to either placebo or active treatment in IBD RCTs. Clinically relevant differences in AE, SAE and AE-related withdrawal were not observed.

Indexed as

Nocebo EffectColitis, UlcerativeCrohn DiseaseGastrointestinal AgentsHumansInflammatory Bowel DiseasesRandomized Controlled Trials as TopicGastrointestinal AgentsAdverse eventinflammatory bowel diseasenocebo

Identifiers

PMID31111881
PMCPMC6751339
OpenAlexW2946370977

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.