Evidence map›Paper›PMID 23436336›Full record

Trial reportGut2014

Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study.

Simon P L Travis, Silvio Danese, Limas Kupcinskas, Olga Alexeeva, Geert D'Haens, Peter R Gibson, Luigi Moro, Richard Jones, E David Ballard, Johan Masure and 2 more

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gut, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 95 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
95citing papers in PubMed, 13 pooled it
19.0field-weighted citation impact, top 1% 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

95 citing papers in PubMed, 13 syntheses or guidelines pooled it, 257 citations in OpenAlex.

  1. Pooled it
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  3. Saudi consensus guidance for the diagnosis and management of inflammatory bowel disease in children and adolescents.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2025
    Guideline
  4. Pooled it
  5. Ulcerative Colitis-Diagnostic and Therapeutic Algorithms.Deutsches Arzteblatt international · 2020
    Pooled it
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  12. Oral budesonide for induction of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2015
    Pooled it
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  14. Trial
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35 more citing papers are in PubMed but not listed here.

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

12 authors at 11 institutions in 10 countries.

Simon P L TravisTranslational Gastroenterology Unit, John Radcliffe Hospital, , Oxford, UK.
Silvio Danese
Limas Kupcinskas
Olga Alexeeva
Geert D'Haens
Peter R Gibson
Luigi Moro
Richard Jones
E David Ballard
Johan Masure
Matteo Rossini
William J Sandborn
Academic Medical Center · NLCosmo Pharmaceuticals (Italy) · ITCosmo Tech (France) · FRFerring Pharmaceuticals (Switzerland) · CHFondazione Humanitas per la Ricerca · ITJohn Radcliffe Hospital · GBLithuanian University of Health Sciences · LTMonash University · AUNizhny Novgorod Regional Clinical Hospital named after Semashko · RUUniversity of California, San Diego · USVerus Research (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveBudesonide MMX is a novel oral formulation of budesonide that uses Multi-Matrix System (MMX) technology to extend release to the colon. This study compared the efficacy of budesonide MMX with placebo in patients with active, mild-to-moderate ulcerative colitis (UC).

designPatients were randomised 1:1:1:1 to receive budesonide MMX 9 mg or 6 mg, or Entocort EC 9 mg (budesonide controlled ileal-release capsules; reference arm) or placebo once daily for 8 weeks. The primary endpoint was combined clinical and endoscopic remission, defined as UC Disease Activity Index score ≤1 with a score of 0 for rectal bleeding and stool frequency, no mucosal friability on colonoscopy, and a ≥1-point reduction in endoscopic index score from baseline.

results410 patients were evaluated for efficacy. Combined clinical and endoscopic remission rates with budesonide MMX 9 mg or 6 mg, Entocort EC and placebo were 17.4%, 8.3%, 12.6% and 4.5%, respectively. The difference between budesonide MMX 9 mg and placebo was significant (OR 4.49; 95% CI 1.47 to 13.72; p=0.0047). Budesonide MMX 9 mg was associated with numerically higher rates of clinical (42.2% vs 33.7%) and endoscopic improvement (42.2% vs 31.5%) versus placebo. The rate of histological healing (16.5% vs 6.7%; p=0.0361) and proportion of patients with symptom resolution (23.9% vs 11.2%; p=0.0220) were significantly higher for budesonide MMX 9 mg than placebo. Adverse event profiles were similar across groups.

conclusionBudesonide MMX 9 mg was safe and more effective than placebo at inducing combined clinical and endoscopic remission in patients with active, mild-to-moderate UC.

Indexed as

Administration, OralAdolescentAdultAgedAnti-Inflammatory AgentsBudesonideColitis, UlcerativeDelayed-Action PreparationsDouble-Blind MethodDrug Administration ScheduleFemaleHumansInduction ChemotherapyIntention to Treat AnalysisMaleMiddle AgedAnti-Inflammatory AgentsBudesonideDelayed-Action PreparationsIBDInflammatory Bowel DiseaseUlcerative Colitis

Identifiers

PMID23436336
PMCPMC3933176
OpenAlexW2098254123

What OpenQuestion holds

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LicenceCC BY-NC
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.