Evidence map›Paper›PMID 16484504›Full record

Trial reportGut2006

A randomised dose finding study of oral tacrolimus (FK506) therapy in refractory ulcerative colitis.

H Ogata, T Matsui, M Nakamura, M Iida, M Takazoe, Y Suzuki, T Hibi

Erratum issuedOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
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. An erratum has been issued. Cited by 149 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
149citing papers in PubMed, 10 pooled it
14.4field-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

149 citing papers in PubMed, 10 syntheses or guidelines pooled it, 458 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Guideline
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Trial
  12. Trial
  13. Trial
  14. Review
  15. Article
  16. Review
  17. Article
  18. Review
  19. Article
  20. Article

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

4 · The record

Corrections and comments

  • Commented on by
  • Erratum issued
    Dosage error in published abstract; MEDLINE/PubMed abstract corrected; Dosage error in article text
5 · Who and what money

Authors and funding

7 authors at 7 institutions in 1 country.

H OgataDepartment of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Tokyo, 160-8582, Japan.
T Matsui
M Nakamura
M Iida
M Takazoe
Y Suzuki
T Hibi
Chiba University Hospital · JPFukuoka University · JPJikei University Kashiwa hospital · JPKeio University · JPKeio University Hospital · JPKyushu University · JPTokyo Yamate Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsImmunosuppressive therapy with intravenous ciclosporin is an alternative treatment option to total colectomy for patients with ulcerative colitis (UC), while the benefits of oral administration of tacrolimus are not well defined and are based on reports of several uncontrolled studies.

methodsPatients with refractory active UC were randomly assigned to a high trough concentration (10-15 ng/ml) group (HT group) (n = 21), low trough concentration (5-10 ng/ml) group (LT group) (n = 22), or placebo group (n = 20). Patients received an initial oral dose of 0.025 [DOSAGE ERROR CORRECTED] mg/kg tacrolimus or placebo twice daily. Efficacy was evaluated in 60 patients based on a disease activity index (DAI) score. Fifty eight patients had additional treatment with tacrolimus and were evaluated for efficacy in a 10 week open label extension.

resultsAn improvement in DAI score (>or=4 points, all categories improved) was observed for 68.4% of cases in the HT group compared with 10.0% in the placebo group (p<0.001). In the HT group, 20.0% of patients had clinical remission and 78.9% had mucosal healing. In the open label extension, 55.2% of all patients had an improved DAI score at week 10. Mean dose of prednisolone was reduced from 19.7 mg/day at study entry to 7.8 mg/day at week 10. The incidence of side effects in the HT group was significantly higher than that of the placebo group (p = 0.043). The most common event was mild finger tremor.

conclusionsOur findings demonstrate dose dependent efficacy and safety of oral tacrolimus for remission-induction therapy of refractory UC. The optimal target range appears to be 10-15 ng/ml in terms of efficacy with two week therapy.

Indexed as

Administration, OralAdultColitis, UlcerativeDose-Response Relationship, DrugDouble-Blind MethodDrug MonitoringFemaleHumansImmunosuppressive AgentsMaleMiddle AgedSeverity of Illness IndexTacrolimusTreatment OutcomeImmunosuppressive AgentsTacrolimus

Identifiers

PMID16484504
PMCPMC1860021
OpenAlexW2102804688

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.