Evidence map›Paper›PMID 20878425›Full record

Trial reportJournal of gastroenterology2011

Clinical trial: Effects of an oral preparation of mesalazine at 4 g/day on moderately active ulcerative colitis. A phase III parallel-dosing study.

Nobuo Hiwatashi, Yasuo Suzuki, Keiichi Mitsuyama, Akihiro Munakata, Toshifumi Hibi

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of gastroenterology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 6 pooled it
–field-weighted citation impact
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

17 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
  2. Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2020
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Guideline
  6. Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2016
    Pooled it
  7. Efficacy of long-term 4.0 g/day mesalazine (Pentasa) for maintenance therapy in ulcerative colitis.Medical science monitor : international medical journal of experimental and clinical research · 2014
    Trial
  8. Review
  9. Review
  10. Article
  11. Review
  12. Review
  13. Remission of ulcerative colitis flare-up induced by nivolumab.International journal of colorectal disease · 2020
    Article
  14. Review
  15. Review
  16. Article
  17. Article
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

5 authors.

Nobuo HiwatashiDepartment of Gastroenterology, Iwaki Kyoritsu General Hospital, 16 Kusehara, Mimayamachi, Uchigo, Iwaki, 973-8555, Japan. incho@iwaki-kyoritsu.iwaki.fukushima.jp
Yasuo Suzuki
Keiichi Mitsuyama
Akihiro Munakata
Toshifumi Hibi

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsOral mesalazine formulations are effective in the treatment of active ulcerative colitis (UC). It is not clear what induction dose of mesalazine is optimal for treating patients with active UC. We aimed to evaluate the efficacy and safety of 4 versus 2.25 g/day for selected patients with active UC.

methodsA multicenter, randomized, double-blind, parallel-group clinical study in 39 Japanese medical institutions. A total of 123 patients with moderately active UC received 4 g/day (two divided doses) versus 2.25 g/day (three divided doses) for 8 weeks. Primary endpoint was the ulcerative colitis-disease activity index (UC-DAI) score before and after 8 weeks of treatment. The improvement of each individual UC-DAI variable, remission, and efficacy rates were secondary endpoints. Safety was determined by laboratory data, vital signs, subjective symptoms, and objective findings.

resultsPatients receiving 4 g/day achieved a change in UC-DAI score significantly superior to those receiving 2.25 g/day [-3.0 (95% confidence intervals (CI) -3.8 to -2.3) vs. -0.8 (95% CI -1.8 to 0.1), respectively]. There were significant differences in all UC-DAI variables between the groups. Remission rates were 22.0% (4 g/day) and 15.3% (2.25 g/day). The efficacy rate was significantly better with 4 versus 2.25 g/day [76.3 vs. 45.8%, respectively (95% CI 13.8-47.2); P = 0.001]. No difference was seen in adverse events or adverse drug reactions.

conclusionsA dose of 4 g/day was significantly superior to 2.25 g/day in terms of UC-DAI score for patients with moderately active UC. Safety profiles were similar for both doses.

Indexed as

AdolescentAdultAnti-Inflammatory Agents, Non-SteroidalColitis, UlcerativeDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleHumansMaleMesalamineMiddle AgedSeverity of Illness IndexTabletsTreatment OutcomeYoung AdultAnti-Inflammatory Agents, Non-SteroidalMesalamineTablets

Identifiers

PMID20878425

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.