Evidence map›Paper›PMID 28368909›Full record

Trial reportInflammatory bowel diseases2017

2.4 g Mesalamine (Asacol 400 mg tablet) Once Daily is as Effective as Three Times Daily in Maintenance of Remission in Ulcerative Colitis: A Randomized, Noninferiority, Multi-center Trial.

Yasuo Suzuki, Mitsuo Iida, Hiroaki Ito, Haruo Nishino, Toshihide Ohmori, Takehiro Arai, Tadashi Yokoyama, Takanori Okubo, Toshifumi Hibi

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Inflammatory bowel diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
2.1field-weighted citation impact, top 11% 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

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  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. Trial
  4. Trial
  5. Review
  6. Article
  7. Maneuvering Clinical Pathways for Ulcerative Colitis.Current gastroenterology reports · 2019
    Review
  8. Article
  9. Review
  10. Review
  11. Review
  12. Root Extract ofFrontiers in pharmacology · 2018
    Article
  13. Review
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

9 authors at 5 institutions in 1 country.

Yasuo Suzuki*Department of Internal Medicine, Toho University Sakura Medical Center, Sakura, Japan;†Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan;‡Kinshukai Infusion Clinic, Osaka, Japan;§Matsushima Clinic, Yokohama, Japan;‖Ohmori Toshihide Gastro-Intestinal Clinic, Ageo, Japan;¶Toukatsu Tsujinaka Hospital, Abiko, Japan;**Yokoyama Hospital for Gastroenterological Diseases, Nagoya, Japan. T. Yokoyama is now with theYokoyama IBD Clinic, Nagoya, Japan;††Clinical Research 2, Zeria Pharmaceutical Co., Ltd., Tokyo, Japan; and‡‡Center for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University, Tokyo, Japan.
Mitsuo Iida
Hiroaki Ito
Haruo Nishino
Toshihide Ohmori
Takehiro Arai
Tadashi Yokoyama
Takanori Okubo
Toshifumi Hibi
Kitasato University · JPKyushu Central Hospital of the Mutual Aid Association of Public School Teachers · JPTaoka Hospital · JPToho University Medical Center Sakura Hospital · JPZeria Pharmaceutical (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe noninferiority of pH-dependent release mesalamine (Asacol) once daily (QD) to 3 times daily (TID) administration was investigated.

methodsThis was a phase 3, multicenter, randomized, double-blind, parallel-group, active-control study, with dynamic and stochastic allocation using central registration. Patients with ulcerative colitis in remission (a bloody stool score of 0, and an ulcerative colitis disease activity index of ≤2), received the study drug (Asacol 2.4 g/d) for 48 weeks. The primary efficacy endpoint of the nonrecurrence rate was assessed on the full analysis set. The noninferiority margin was 10%.

resultsSix hundred and four subjects were eligible and were allocated; 603 subjects received the study drug. The full analysis set comprised 602 subjects (QD: 301, TID: 301). Nonrecurrence rates were 88.4% in the QD and 89.6% in the TID. The difference between nonrecurrence rates was -1.3% (95% confidence interval: -6.2, 3.7), confirming noninferiority. No differences in the safety profile were observed between the two treatment groups. On post hoc analysis by integrating the QD and the TID, nonrecurrence rate with a mucosal appearance score of 0 at determination of eligibility was significantly higher than the score of 1. The mean compliance rates were 97.7% in the QD and 98.1% in the TID.

conclusionsQD dosing with Asacol is as effective and safe as TID for maintenance of remission in patients with ulcerative colitis. Additionally, this study indicated that maintaining a good mucosal state is the key for longer maintenance of remission.

Indexed as

Administration, OralAdultAnti-Inflammatory Agents, Non-SteroidalColitis, UlcerativeDouble-Blind MethodDrug Administration ScheduleEquivalence Trials as TopicFemaleFollow-Up StudiesHumansMaleMesalamineMiddle AgedPatient CompliancePrognosisRemission InductionAnti-Inflammatory Agents, Non-SteroidalMesalamine

Identifiers

PMID28368909
PMCPMC5404402
OpenAlexW2597736957

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.