Evidence map›Paper›PMID 12912859›Full record

Trial reportGut2003

Interferon beta-1a in ulcerative colitis: a placebo controlled, randomised, dose escalating study.

S Nikolaus, P Rutgeerts, R Fedorak, A H Steinhart, G E Wild, D Theuer, J Möhrle, S Schreiber

Erratum issuedOpen access · bronzeAbstract readClinical TrialRandomized Controlled Trial
In one paragraph

Trial report in Gut, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 43 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 4 pooled it
4.2field-weighted citation impact, top 6% 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

43 citing papers in PubMed, 4 syntheses or guidelines pooled it, 105 citations in OpenAlex.

  1. Pooled it
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  3. Type I interferons for induction of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2015
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4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

8 authors at 7 institutions in 4 countries.

S NikolausChristian-Albrechts University, Kiel, Germany.
P Rutgeerts
R Fedorak
A H Steinhart
G E Wild
D Theuer
J Möhrle
S Schreiber
Kiel University · DEHeidelberg University · DEMcGill University · CAMerck Serono (Switzerland) · CHMount Sinai Hospital · CAUniversitair Ziekenhuis Leuven · BEUniversity of Alberta · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundand aims: Administration of interferon (IFN)-beta may represent a rational approach to the treatment of ulcerative colitis through its immunomodulatory and anti-inflammatory effects. The present study was performed to evaluate the efficacy and tolerability of IFN-beta-1a.

methodsPatients (n=18) with moderately active ulcerative colitis were randomised to receive IFN-beta-1a or placebo. IFN-beta-1a was started at a dose of 22 micro g three times a week subcutaneously, and the dose was increased at two week intervals to 44 micro g and then to 88 micro g if no response was observed. The maximum duration of treatment was eight weeks. End points were clinical treatment response, defined as a decrease of at least 3 points from baseline in the ulcerative colitis scoring system (UCSS) symptoms score and induction of endoscopically confirmed remission.

resultsBaseline characteristics and disease severity were similar in both groups. Data from 17 patients are included in this report (10 patients in the IFN-beta-1a group and seven patients in the placebo group). Clinical response was achieved in five patients (50%) in the IFN-beta-1a group and in one (14%) in the placebo group (P=0.14). Remission was achieved in three patients in the IFN-beta-1a group and in none in the placebo group (p=0.02). Most adverse reactions associated with IFN-beta-1a were influenza-like symptoms or injection site reactions, and were mild or moderate in severity.

conclusionsIFN-beta-1a may represent a promising novel treatment approach in ulcerative colitis.

Indexed as

Adjuvants, ImmunologicAdultAgedColitis, UlcerativeDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansInterferon-betaInterferon beta-1aMaleMiddle AgedAdjuvants, ImmunologicInterferon-betaInterferon beta-1a

Identifiers

PMID12912859
PMCPMC1773804
OpenAlexW2131297439

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.