Evidence map›Paper›PMID 38655866›Full record

Trial reportInflammatory bowel diseases2025

Efficacy of Dose Escalation of Oral 5-Aminosalicylic Acid for Ulcerative Colitis With a Mayo Endoscopic Subscore of 1: An Open Label Randomized Controlled Trial.

Tomohiro Fukuda, Yasuhiro Aoki, Hiroki Kiyohara, Ayumi Yokoyama, Atsushi Nakazawa, Yusuke Yoshimatsu, Shinya Sugimoto, Kosaku Nanki, Yohei Mikami, Kayoko Fukuhara and 10 more

Open access · hybridAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Inflammatory bowel diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.7field-weighted citation impact, top 16% 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

4 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. Selective Drug-Free Active Surveillance in Ulcerative Colitis: Biomarker-Guided, Patient-Centered Approach.JGH open : an open access journal of gastroenterology and hepatology · 2026
    Review
  3. Review
  4. 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

20 authors at 5 institutions in 1 country.

Tomohiro FukudaDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.ORCID 0000-0002-6539-5002
Yasuhiro AokiDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Hiroki KiyoharaDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.ORCID 0000-0001-6315-3782
Ayumi YokoyamaDepartment of Gastroenterology, Tokyo Saiseikai Central Hospital, Tokyo, Japan.
Atsushi NakazawaDepartment of Gastroenterology, Tokyo Saiseikai Central Hospital, Tokyo, Japan.
Yusuke YoshimatsuDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Shinya SugimotoDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.ORCID 0000-0002-1560-1605
Kosaku NankiDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Yohei MikamiDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Kayoko FukuharaCenter for Preventive Medicine, Keio University School of Medicine, Tokyo, Japan.
Shinta MizunoDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Tomohisa SujinoCenter for Diagnostic and Therapeutic Endoscopy, Keio University School of Medicine, Tokyo, Japan.
Makoto MutaguchiCenter for Diagnostic and Therapeutic Endoscopy, Keio University School of Medicine, Tokyo, Japan.
Kaoru TakabayashiCenter for Diagnostic and Therapeutic Endoscopy, Keio University School of Medicine, Tokyo, Japan.
Yuichi MorohoshiDepartment of Gastroenterology, Yokohama Municipal Citizen's Hospital, Kanagawa, Japan.
Yasuo HosodaDepartment of Gastroenterology, National Hospital Organization Saitama Hospital, Saitama, Japan.
Haruhiko OgataCenter for Diagnostic and Therapeutic Endoscopy, Keio University School of Medicine, Tokyo, Japan.
Yasushi IwaoCenter for Preventive Medicine, Keio University School of Medicine, Tokyo, Japan.
Makoto NaganumaDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Takanori KanaiDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Keio University · JPSaiseikai Central Hospital · JPKansai Medical University · JPSaitama Municipal Hospital · JPYokohama Municipal Citizen's Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEndoscopic healing is generally defined as Mayo endoscopic subscore (MES) ≤1 in ulcerative colitis (UC). However, patients with an MES of 1 are at higher relapse risk than those with an MES of 0. This study evaluated the therapeutic efficacy of proactive dose escalation of oral 5-aminosalicylic acid (5-ASA) in UC patients with an MES of 1.

methodsAn open-label, randomized controlled trial was conducted in 5 hospitals between 2018 and 2022. Ulcerative colitis patients in clinical remission under oral 5-ASA therapy and diagnosed as having an MES of 1 were enrolled. Patients receiving maintenance therapy other than 5-ASA and immunomodulator were excluded. Patients were randomly assigned in a 1:1 ratio to receive either a dose-escalated (intervention) or constant dose (control) of 5-ASA. Concomitant immunomodulator was used as the stratification factor in the randomization. The primary end point was relapse within 1 year. The subgroup analysis was stratified for the use of immunomodulators.

resultsThe full analysis set included 79 patients (39 intervention and 40 control). Immunomodulators were used in 20 (25.3%) patients. Relapse was less in the intervention group (15.4%) than the control group (37.5%; P = .026). In the subgroup with concomitant immunomodulators, relapse was also less in the intervention group (10.0%) than the control group (70.0%; P = .020). In patients without immunomodulators, the difference was not significant between 2 groups (intervention, 17.2%; control, 26.7%; P = .53).

conclusionsDose escalation of 5-ASA reduced relapse within 1 year in UC patients in clinical remission with an MES of 1.

Indexed as

Anti-Inflammatory Agents, Non-SteroidalColitis, UlcerativeMesalamineAdministration, OralAdultColonoscopyDose-Response Relationship, DrugFemaleHumansMaleMiddle AgedRecurrenceRemission InductionSeverity of Illness IndexTreatment OutcomeAnti-Inflammatory Agents, Non-SteroidalMesalaminecolonoscopyinflammationinflammatory bowel diseaselarge intestineulcerative colitis

Identifiers

PMID38655866
PMCPMC11879217
OpenAlexW4395095619

What OpenQuestion holds

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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.