Evidence map›Paper›PMID 39367753›Full record

SynthesisUnited European gastroenterology journal2024

Defining mucosal healing in randomized controlled trials of inflammatory bowel disease: A systematic review and future perspective.

Tommaso Lorenzo Parigi, Virginia Solitano, Alessandro Armuzzi, Manuel Barreiro de Acosta, Jake Begun, Shomron Ben-Horin, Luc Biedermann, Jean-Frederic Colombel, Axel Dignass, Mathurin Fumery and 11 more

Abstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in United European gastroenterology journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
  8. 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

21 authors.

Tommaso Lorenzo ParigiDivision of Immunology, Transplantation and Infectious Disease, Università Vita-Salute San Raffaele, Milan, Italy.
Virginia SolitanoDivision of Immunology, Transplantation and Infectious Disease, Università Vita-Salute San Raffaele, Milan, Italy.
Alessandro ArmuzziIBD Center, IRCCS Humanitas Research Hospital, Milan, Italy.
Manuel Barreiro de AcostaGastroenterology Department, Hospital Clínico Universitario de Santiago de Compostela, Santiago, Spain.ORCID 0000-0001-5915-1477
Jake BegunFaculty of Medicine, Mater Research Institute University of Queensland, Brisbane, Queensland, Australia.
Shomron Ben-HorinSheba Medical Center, Tel Aviv, Israel.ORCID 0009-0001-1586-6056
Luc BiedermannDepartment of Gastroenterology & Hepatology, University Hospital Zurich, Zurich, Switzerland.
Jean-Frederic ColombelThe Henry Janowitz Department of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Axel DignassDepartment of Medicine and Agaplesion Markus Hospital, Goethe University, Frankfurt am Main, Germany.
Mathurin FumeryGastroenterology Department, Centre Hospitalier Universitaire d'Amiens, and PeriTox, Université de Picardie Jules Verne, Amiens, France.
Subrata GhoshUniversity College Cork, Cork, Ireland.
Taku KobayashiCenter for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.ORCID 0000-0002-2073-4234
Edouard LouisDepartment of Gastroenterology, Liège University Hospital, Liege, Belgium.
Fernando MagroHospital de Sao Joao, Porto, Portugal.ORCID 0000-0003-2634-9668
Remo PanaccioneInflammatory Bowel Disease Unit, University of Calgary, Calgary, Alberta, Canada.
Astrid RauschHospital Britanico de Buenos Aires, Buenos Aires, Argentina.
Walter ReinischDivision Gastroenterology & Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
Christian SelingerLeeds Gastroenterology Institute, Leeds Teaching Hospitals NHS Trust, Leeds, UK.ORCID 0000-0003-2022-5859
Vipul JairathDivision of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada.ORCID 0000-0002-1092-0033
Silvio DaneseDivision of Immunology, Transplantation and Infectious Disease, Università Vita-Salute San Raffaele, Milan, Italy.
Laurent Peyrin-BirouletDepartment of Gastroenterology, INFINY Institute, FHU-CURE, Nancy University Hospital, and INSERM, Nutrition-Genetics and Environmental Risk Exposure, University of Lorraine, Vandœuvre-lès-Nancy, France.ORCID 0000-0003-2536-6618

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMucosal healing (MH) is an established treatment goal in inflammatory bowel disease (IBD). However, various definitions of MH exist. We aimed to identify how MH is defined in randomized controlled trials (RCTs) in ulcerative colitis (UC) and Crohn's disease (CD).

methodsWe searched MEDLINE, EMBASE, and the Cochrane library from inception to December 2023 for phase 2 and 3 RCTs of advanced therapies in IBD.

resultsOne hundred forty-four studies were included, 72 in UC and 72 in CD, published between 1997 and 2023. In UC, 64% (46/72) RCTs reported MH as an endpoint. 12 definitions of MH were found, from endoscopic assessment alone (35/46; 76%) to the more recent combination of histology and endoscopy (10/46; 22%). 96% (44/46) of studies used the Mayo Endoscopic Subscore. In CD, reporting of MH lagged behind UC, with only 12% (9/72) of trials specifically defining MH as an endpoint, 7 as "absence of ulceration," 2 as Simplified Endoscopic Score for CD score ≤2 or 0. Histological assessment was performed in 3 RCTs of CD. Centralized reading of endoscopy was used in 48% (35/72) of RCTs of UC and 22% (16/72) of CD. Only 1 RCT included transmural healing as an endpoint.

conclusionsA standard definition of MH in IBD is lacking. Definitions have evolved particularly in UC, which now includes the addition of histological evaluation. Transmural healing holds promise as a future target in CD. We support a greater standardization of definitions as we expect endpoints to become increasingly stringent and multimodal with computers automating the assessment.

Indexed as

Colitis, UlcerativeIntestinal MucosaRandomized Controlled Trials as TopicWound HealingCrohn DiseaseEndoscopy, GastrointestinalHumansInflammatory Bowel DiseasesTreatment Outcomeclinical trialsCrohn's diseasedeep remissionendoscopyhistological healinghistologic healingIBDneutrophilspathologyulcerative colitis

Identifiers

PMID39367753
PMCPMC11578850

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.