Evidence map›Paper›PMID 15972298›Full record

Trial reportGut2006

Randomised controlled trial of azathioprine and 5-aminosalicylic acid for treatment of steroid dependent ulcerative colitis.

S Ardizzone, G Maconi, A Russo, V Imbesi, E Colombo, G Bianchi Porro

Registry-linked trialOpen access · bronzeAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Gut, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00542152 (A Randomized, Multicenter Open Label Study Comparing Cyclosporine With Infliximab in Steroid-refractory Severe Attacks of Ulcerative Colitis), which is not on this map. Cited by 139 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
139citing papers in PubMed, 14 pooled it
16.1field-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.

NCT00542152 phase4completednot on this mapstarted 2007, after this paper: background citation

A Randomized, Multicenter Open Label Study Comparing Cyclosporine With Infliximab in Steroid-refractory Severe Attacks of Ulcerative Colitis

TypeinterventionalSponsorGroupe d'Etude Therapeutique des Affections Inflammatoires DigestivesRan2007 to 2010Enrolled115ConditionsUlcerative Colitis, Steroid RefractoryArmsCYCLOSPORINE VS INFLIXIMAB
3 · Its place in the literature

Who cites it

139 citing papers in PubMed, 14 syntheses or guidelines pooled it, 508 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2020
    Pooled it
  4. Guideline
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2016
    Pooled it
  9. Pooled it
  10. Methotrexate for induction of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2014
    Pooled it
  11. Guideline
  12. Indian Society of Gastroenterology consensus on ulcerative colitis.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2012
    Guideline
  13. Pooled it
  14. Pooled it
  15. Trial
  16. Trial
  17. Trial
  18. Clinical features and current treatment approach to ulcerative proctitis.Translational gastroenterology and hepatology · 2025
    Review
  19. Article
  20. Review

79 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

S ArdizzoneCattedra di Gastroenterologia, Azienda Ospedaliera "L Sacco", Polo Universitario, Via G.B. Grassi 74, 20157 Milano, Italy. samari1@tin.it
G Maconi
A Russo
V Imbesi
E Colombo
G Bianchi Porro
Luigi Sacco Hospital · ITOspedale San Paolo · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsThere are limited evidence based data concerning the use of azathioprine in ulcerative colitis. We aimed to compare the efficacy of azathioprine and oral 5-aminosalicylic acid in inducing remission of steroid dependent ulcerative colitis.

methodsSeventy two patients with steroid dependent ulcerative colitis were admitted to this investigator-blind study. Steroid dependence was defined as a requirement for steroid therapy > or =10 mg/day during the preceding six months, with at least two attempts to discontinue the medication. The disease had to be clinically and endoscopically active at study entry, and all patients were taking systemic prednisolone (40 mg/day). Patients were randomised to receive azathioprine 2 mg/kg/day or oral 5-aminosalicylic acid 3.2 g/day, for a six month follow up period. The outcome of the treatment was defined as (1) success, indicating induction of clinical and endoscopic remission and steroid discontinuation, or (2) failure, indicating the absence of clinical and endoscopic remission and therefore the need for at least one further cycle of systemic steroids to control symptoms, apart from the initial one, or colectomy.

resultsSignificantly more patients in the azathioprine than in the 5-aminosalicylic acid group had clinical and endoscopic remission, and discontinued steroid therapy, both in the intention to treat (azathioprine v 5-aminosalicylic acid: 19/36 patients (53%) v 7/36 (21%); odds ratio (OR) 4.78 (95% confidence interval (CI) 1.57-14.5)) and per protocol (azathioprine v 5-aminosalicylic acid: 19/33 patients (58%) v 7/34 (21%); OR 5.26 (95% CI 1.59-18.1)) analysis.

conclusionsAzathioprine is significantly more effective than 5-aminosalicylic acid in inducing clinical and endoscopic remission and avoiding steroid requirement in the treatment of steroid dependent ulcerative colitis.

Indexed as

AdolescentAdultAgedAnti-Inflammatory Agents, Non-SteroidalAzathioprineColitis, UlcerativeDrug Therapy, CombinationFemaleGastrointestinal AgentsGlucocorticoidsHumansImmunosuppressive AgentsMaleMesalamineMiddle AgedPrednisoloneAnti-Inflammatory Agents, Non-SteroidalAzathioprineGastrointestinal AgentsGlucocorticoidsImmunosuppressive AgentsMesalaminePrednisolone

Identifiers

PMID15972298
PMCPMC1856376
OpenAlexW2115000032

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.