Evidence map›Paper›PMID 18325386›Full record

Trial reportGastroenterology2008

Rosiglitazone for active ulcerative colitis: a randomized placebo-controlled trial.

James D Lewis, Gary R Lichtenstein, Julius J Deren, Bruce E Sands, Stephen B Hanauer, Jeffrey A Katz, Bret Lashner, Daniel H Present, Shaokun Chuai, Jonas H Ellenberg and 3 more

2 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Gastroenterology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 119 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
119citing papers in PubMed, 5 pooled it
9.1field-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.

NCT00065065 phase2completednot on this map

A Randomized, Placebo-controlled Trial of Rosiglitazone for Treatment of Ulcerative Colitis

TypeinterventionalSponsorJames LewisRan2002 to 2008Enrolled105ConditionsUlcerative Colitis, Inflammatory Bowel DiseaseArmsRosiglitazone, Placebo
NCT04750135 phase2unknown statusnot on this mapstarted 2021, after this paper: background citation

Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis

TypeinterventionalSponsorNational Hepatology & Tropical Medicine Research InstituteRan2021 to 2021Enrolled40ConditionsUlcerative Colitis, Inflammatory Bowel DiseasesArmsmetformin 500 mg TID Oral Tablet, Placebo
3 · Its place in the literature

Who cites it

119 citing papers in PubMed, 5 syntheses or guidelines pooled it, 223 citations in OpenAlex.

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  6. Trial
  7. Randomized clinical trial: atorvastatin versus placebo in patients with acute exacerbation of mild to moderate ulcerative colitis.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2014
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59 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 6 institutions in 1 country.

James D LewisDivision of Gastroenterology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA. lewisjd@mail.med.upenn.edu
Gary R Lichtenstein
Julius J Deren
Bruce E Sands
Stephen B Hanauer
Jeffrey A Katz
Bret Lashner
Daniel H Present
Shaokun Chuai
Jonas H Ellenberg
Lisa Nessel
Gary D Wu
Rosiglitazone for Ulcerative Colitis Study Group
University of Pennsylvania · USCase Western Reserve University · USCleveland Clinic · USIcahn School of Medicine at Mount Sinai · USMassachusetts General Hospital · USUniversity of Chicago · US

Funding

Randomized Trial of Rosiglitazone for Ulcerative ColitisR01DK059961 · NIDDK · UNIVERSITY OF PENNSYLVANIA · PI LEWIS, JAMES D · 2001 to 2005
$3.2M
NIDDK NIH HHS DK059961NIDDK NIH HHS R01 DK059961
6 · The paper itself

Abstract

BACKGROUND &

aimsThiazolidinedione ligands for the gamma subtype of peroxisome proliferator-activated receptors (PPARgamma), widely used to treat type 2 diabetes mellitus, have been proposed as novel therapies for ulcerative colitis (UC).

methodsThis multicenter, randomized, double-blind, placebo-controlled clinical trial compared the efficacy of rosiglitazone (Avandia; GlaxoSmithKline, Philadelphia, PA) 4 mg orally twice daily vs placebo twice daily for 12 weeks in 105 patients with mild to moderately active UC. Disease activity was measured with the Mayo score. The primary end point was clinical response (>/=2-point reduction) at week 12. Clinical remission (Mayo score </=2), endoscopic remission, and quality of life were secondary outcomes.

resultsAfter 12 weeks of therapy, 23 patients (44%) treated with rosiglitazone and 12 patients (23%) treated with placebo achieved clinical response (P = .04). Remission was achieved in 9 patients (17%) treated with rosiglitazone and 1 patient (2%) treated with placebo (P = .01). Endoscopic remission was uncommon in either treatment arm (8% rosiglitazone vs 2% placebo; P = .34). Clinical improvement was evident as early as 4 weeks after beginning treatment (P = .049). Quality of life was improved significantly at week 8 (P = .01), but not at week 4 (P = .48) or week 12 (P = .14). Serious adverse events were rare.

conclusionsRosiglitazone was efficacious in the treatment of mild to moderately active UC.

Indexed as

Administration, OralAdultAnti-Inflammatory AgentsColitis, UlcerativeColonoscopyDouble-Blind MethodDrug Administration ScheduleFemaleGastrointestinal AgentsHumansMaleMiddle AgedPatient SelectionQuality of LifeRosiglitazoneSeverity of Illness IndexAnti-Inflammatory AgentsGastrointestinal AgentsRosiglitazoneThiazolidinediones

Identifiers

PMID18325386
PMCPMC2276587
OpenAlexW2127633278

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.