Evidence map›Paper›PMID 26577683›Full record

Trial reportJournal of Crohn's & colitis2016

Twice-daily Budesonide 2-mg Foam Induces Complete Mucosal Healing in Patients with Distal Ulcerative Colitis.

Makoto Naganuma, Nobuo Aoyama, Yasuo Suzuki, Haruo Nishino, Kiyonori Kobayashi, Fumihito Hirai, Kenji Watanabe, Toshifumi Hibi

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

Trial report in Journal of Crohn's & colitis, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 3 pooled it
4.9field-weighted citation impact, top 4% 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

22 citing papers in PubMed, 3 syntheses or guidelines pooled it, 50 citations in OpenAlex.

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  15. Budesonide Foam for Ulcerative Colitis Patients Experiencing Inadequate Response to Biological Therapy.Medical science monitor : international medical journal of experimental and clinical research · 2019
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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

8 authors at 8 institutions in 1 country.

Makoto NaganumaCenter for Diagnostic and Therapeutic Endoscopy, School of Medicine, Keio University, Tokyo, Japan maknaganuma@gmail.com.
Nobuo AoyamaGastrointestinal Endoscopy and Inflammatory Bowel Disease Center, Aoyama Medical Clinic, Hyogo, Japan.
Yasuo SuzukiDepartment of Internal Medicine, Sakura Medical Center, Toho University, Chiba, Japan.
Haruo NishinoColo-Proctology Center, Matsushima Clinic, Kanagawa, Japan.
Kiyonori KobayashiDepartment of Research and Development Center for New Medical Frontiers, School of Medicine, Kitasato University, Kanagawa, Japan.
Fumihito HiraiDepartment of Gastroenterology, Fukuoka University Chikushi Hospital, Fukuoka, Japan.
Kenji WatanabeDepartment of Gastroenterology, Osaka City General Hospital, Osaka, Japan.
Toshifumi HibiCenter for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University, Tokyo, Japan.
Fukuoka University · JPKeio University · JPKitasato Institute Hospital · JPKitasato University · JPMatsushiro Seismological Observatory · JPOsaka City General Hospital · JPShiga Medical Center for Adults · JPToho University Medical Center Sakura Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsMucosal healing is an important therapeutic goal for ulcerative colitis. Once-daily administration of budesonide 2-mg foam is widely used for inducing clinical remission. No study has assessed the usefulness of twice-daily budesonide 2mg foam on mucosal healing in ulcerative colitis patients. We explored the efficacy for mucosal healing of once- or twice-daily budesonide foam in distal ulcerative colitis patients.

methodsThis study was a multicentre, randomised, double-blind, placebo-controlled trial. In all, 165 patients with active, mild to moderate distal ulcerative colitis were randomised to three groups: once- or twice-daily budesonide 2mg/25ml foam, or placebo foam, for 6 weeks. Complete mucosal healing [endoscopic subscore = 0] and the safety profile were assessed at Week 6. Prespecified and post hoc analyses were used.

resultsThe percentages of complete mucosal healing in the twice-daily budesonide foam group were 46.4% compared with 23.6% in the once-daily group [p = 0.0097], or 5.6% in the placebo group [p < 0.0001]. The percentages of clinical remission and the percentages of endoscopic subscore ≤ 1 in the twice-daily budesonide foam group were 48.2% and 76.8%, compared with 50.9% and 69.1% in the once-daily group [no difference], or 20.4% and 46.3% in the placebo group [p = 0.0029 and p = 0.0007], respectively. In the subgroup of patients with previous use of a 5-aminosalicylic acid suppository or enema, there was a greater percentage of complete mucosal healing in the twice-daily budesonide foam group [32.0%] compared with that in the once-daily [8.7%, p = 0.0774] or placebo groups [4.8%, p = 0.0763], though there was no significant difference. No serious adverse event occurred.

conclusionsA significantly greater percentage of patients receiving twice-daily administration of budesonide foam compared with once-daily administration/placebo achieved complete mucosal healing. This is the first study to evaluate the endoscopic efficacy of twice-daily administration of 6-week budesonide foam treatment for ulcerative colitis.

Indexed as

Administration, RectalAdolescentAdultAgedAnti-Inflammatory AgentsBudesonideColitis, UlcerativeColonColonoscopyDouble-Blind MethodDrug Administration ScheduleFemaleFollow-Up StudiesHumansInduction ChemotherapyIntestinal MucosaAnti-Inflammatory AgentsBudesonidebudesonide foammucosal healingUlcerative colitis

Identifiers

PMID26577683
PMCPMC4955911
OpenAlexW2254842468

What OpenQuestion holds

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LicenceCC BY
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.