Evidence map›Paper›PMID 29935082›Full record

ArticleJournal of gastroenterology and hepatology2019

Effect of a concomitant elemental diet with maintenance anti-tumor necrosis factor-α antibody therapy in patients with Crohn's disease: A multicenter, prospective cohort study.

Fumihito Hirai, Tetsuya Ishida, Fuminao Takeshima, Shojiro Yamamoto, Ichiro Yoshikawa, Shinya Ashizuka, Haruhiko Inatsu, Keiichi Mitsuyama, Suketo Sou, Ryuichi Iwakiri and 6 more

Open access · hybridAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of gastroenterology and hepatology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 5 pooled it
1.3field-weighted citation impact, top 18% 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

12 citing papers in PubMed, 5 syntheses or guidelines pooled it, 20 citations in OpenAlex.

  1. Pooled it
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  6. Article
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  10. British Dietetic Association consensus guidelines on the nutritional assessment and dietary management of patients with inflammatory bowel disease.Journal of human nutrition and dietetics : the official journal of the British Dietetic Association · 2023
    Article
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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

16 authors at 12 institutions in 1 country.

Fumihito HiraiDepartment of Gastroenterology, Fukuoka University Chikushi Hospital, Fukuoka, Japan.ORCID http://orcid.org/0000-0002-5493-5675
Tetsuya IshidaDepartment of Gastroenterology, Oita Red Cross Hospital, Oita, Japan.
Fuminao TakeshimaDepartment of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Shojiro YamamotoDepartment of Gastroenterology and Hematology, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
Ichiro YoshikawaThe Third Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Fukuoka, Japan.
Shinya AshizukaDepartment of Internal Medicine, Circulatory and Body Fluid Regulation, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
Haruhiko InatsuDepartment of Internal Medicine, Circulatory and Body Fluid Regulation, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
Keiichi MitsuyamaDivision of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Fukuoka, Japan.
Suketo SouDepartment of Endoscopy, Tobata Kyoritsu Hospital, Fukuoka, Japan.
Ryuichi IwakiriDepartment of Internal Medicine and Gastrointestinal Endoscopy, Saga University School of Medicine, Saga, Japan.
Ryoichi NozakiColoproctology Center Takano Hospital, Kumamoto, Japan.
Hidehisa OhiDepartment of Gastroenterology, Izuro Imamura hospital, Kagoshima, Japan.
Motohiro EsakiDepartment of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Mitsuo IidaKyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan.
Toshiyuki MatsuiDepartment of Gastroenterology, Fukuoka University Chikushi Hospital, Fukuoka, Japan.
Additional Power of Elemental Diet on Maintenance Biologics Therapy in Crohn's Disease (ADORE) Study Group
University of Miyazaki · JPFukuoka University · JPHiroshima Kyoritsu Hospital · JPImamura Hospital · JPKurume University · JPKyushu Central Hospital of the Mutual Aid Association of Public School Teachers · JPKyushu University · JPNagasaki University · JPOita Red Cross Hospital · JPSaga University · JPTakano Hospital · JPUniversity of Occupational and Environmental Health Japan · JP

Funding

EA Pharma Co., Ltd.
6 · The paper itself

Abstract

BACKGROUND AND

aimThe aim of this study was to clarify the additional effect of a concomitant elemental diet (ED) for patients with Crohn's disease on maintenance anti-tumor necrosis factor-α antibody (anti-TNF).

methodsCrohn's disease patients who received anti-TNF induction therapy were enrolled. Patients who achieved clinical response (defined as delta Crohn's disease activity index [CDAI] > 70 and CDAI < 200) at 10-14 weeks after the start of infliximab or adalimumab were included. Eligible patients took a tolerability test of ED (900 kcal/day) for 3 days. Then, patients who preferred concomitant ED and whose ED tolerance was confirmed were allocated to the ED group and given Elental 900 kcal/day or more. Other patients were allocated to the non-ED group. The primary endpoint was the cumulative remission rate at 2 years after baseline. Clinical relapse was defined as CDAI > 200 and/or need for additional treatment. Adherence to the ED was confirmed at each visit.

resultsSeventy-two patients were included. Thirty-seven were allocated to the ED group, and 35 were allocated to the non-ED group. The cumulative remission rate at 2 years was not significantly different between the two groups (60.9% vs 56.7%, P = 0.98). Adherence to the ED in the ED group was relatively low, and only 11 patients were maintained on an ED of 900 kcal/day.

conclusionsThe addition of ED for Crohn's disease patients who responded to initial anti-TNF induction therapy was not found to improve outcomes. The efficacy of concomitant ED in other clinical settings, such as loss of response, needs to be clarified in the future (UMIN000009789).

Indexed as

Food, FormulatedAdalimumabAdultCrohn DiseaseFemaleFollow-Up StudiesGastrointestinal AgentsHumansInduction ChemotherapyInfliximabMaleMiddle AgedPatient ComplianceProspective StudiesRecurrenceRisk FactorsAdalimumabGastrointestinal AgentsInfliximabTumor Necrosis Factor-alphaadherenceCrohn's diseaseelemental dietTNF-α inhibitor

Identifiers

PMID29935082
PMCPMC7379489
OpenAlexW2810192293

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.