Evidence map›Paper›PMID 11413109›Full record

Trial reportGut2001

Interleukin 10 (Tenovil) in the prevention of postoperative recurrence of Crohn's disease.

J F Colombel, P Rutgeerts, H Malchow, M Jacyna, O H Nielsen, J Rask-Madsen, S Van Deventer, A Ferguson, P Desreumaux, A Forbes and 3 more

Open access · bronzeAbstract readClinical TrialMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Gut, 2001. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 81 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
81citing papers in PubMed, 6 pooled it
8.7field-weighted citation impact, top 2% 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

81 citing papers in PubMed, 6 syntheses or guidelines pooled it, 239 citations in OpenAlex.

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  16. Engineering cytokine therapeutics.Nature reviews bioengineering · 2023
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21 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

13 authors at 1 institution in 1 country.

J F ColombelGastroenterology Unit, Hopital Claude Huriez, Lille, France. jfcolombel@chru-lille.fr
P Rutgeerts
H Malchow
M Jacyna
O H Nielsen
J Rask-Madsen
S Van Deventer
A Ferguson
P Desreumaux
A Forbes
K Geboes
L Melani
M Cohard
KU Leuven · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsNew lesions of Crohn's disease occur early after ileal or ileocolonic resection and ileocolonic anastomosis. We performed a double blind controlled trial to evaluate the safety and tolerance of recombinant human interleukin 10 (IL-10; Tenovil) in subjects operated on for Crohn's disease. We also assessed the effect of Tenovil in preventing endoscopic recurrence 12 weeks after surgery.

methodsPatients with Crohn's disease who underwent curative ileal or ileocolonic resection and primary anastomosis were randomised within two weeks after surgery to receive subcutaneous Tenovil 4 microg/kg once daily (QD) (n=22) or 8 microg/kg twice weekly (TIW) (n=21), or placebo (QD or TIW) (n=22). An ileocolonoscopy was performed after 12 weeks of treatment.

resultsCompliance was excellent. The most frequently observed adverse events were mild and moderate in severity and equally distributed across treatment groups. Thirty seven patients in the pooled Tenovil group and 21 patients in the pooled placebo group were evaluable by endoscopy. At 12 weeks, 11 of 21 patients (52%) in the placebo group had recurrent lesions compared with 17 of 37 patients (46%) in the Tenovil group (ns). The incidence of severe endoscopic recurrence was similar in both groups (9%).

conclusionTenovil treatment for 12 consecutive weeks in patients with Crohn's disease after intestinal resection was safe and well tolerated. No evidence of prevention of endoscopic recurrence of Crohn's disease by Tenovil was observed.

Indexed as

AdultChemotherapy, AdjuvantColonoscopyCrohn DiseaseDouble-Blind MethodElectrophoresis, Agar GelFemaleHematocritHemoglobinsHumansInterleukin-1Interleukin-10Intestinal MucosaMalePatient ComplianceReverse Transcriptase Polymerase Chain ReactionHemoglobinsInterleukin-1Interleukin-10Tumor Necrosis Factor-alpha

Identifiers

PMID11413109
PMCPMC1728363
OpenAlexW2118688515

What OpenQuestion holds

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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.