Evidence map›Paper›PMID 34617003›Full record

ArticleJournal of the Canadian Association of Gastroenterology2021

Declining Use of Corticosteroids for Crohn's Disease Has Implications for Study Recruitment: Results of a Pilot Randomized Controlled Trial.

M T Balart, L Russell, N Narula, G Bajaj, U Chauhan, K J Khan, A N Marwaha, E Ching, J Biro, S Halder and 9 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of the Canadian Association of Gastroenterology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 79% 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

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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

19 authors at 2 institutions in 1 country.

M T BalartFarncombe Family Digestive Health Research Institute, Hamilton, ON, Canada.
L RussellMcMaster University Medical Centre, Hamilton, ON, Canada.ORCID https://orcid.org/0000-0001-8634-0775
N NarulaMcMaster University Medical Centre, Hamilton, ON, Canada.ORCID https://orcid.org/0000-0002-1536-8436
G BajajMcMaster University Medical Centre, Hamilton, ON, Canada.
U ChauhanFarncombe Family Digestive Health Research Institute, Hamilton, ON, Canada.
K J KhanFarncombe Family Digestive Health Research Institute, Hamilton, ON, Canada.
A N MarwahaGI Health Centre, Burlington, ON, Canada.
E ChingGI Health Centre, Burlington, ON, Canada.
J BiroMcMaster University Medical Centre, Hamilton, ON, Canada.
S HalderMcMaster University Medical Centre, Hamilton, ON, Canada.
F TseFarncombe Family Digestive Health Research Institute, Hamilton, ON, Canada.
J K MarshallFarncombe Family Digestive Health Research Institute, Hamilton, ON, Canada.
S M CollinsFarncombe Family Digestive Health Research Institute, Hamilton, ON, Canada.
P MoayyediFarncombe Family Digestive Health Research Institute, Hamilton, ON, Canada.ORCID https://orcid.org/0000-0002-3616-9292
P BercikFarncombe Family Digestive Health Research Institute, Hamilton, ON, Canada.
E F VerduFarncombe Family Digestive Health Research Institute, Hamilton, ON, Canada.
G I LeontiadisFarncombe Family Digestive Health Research Institute, Hamilton, ON, Canada.ORCID https://orcid.org/0000-0001-5072-7599
D ArmstrongFarncombe Family Digestive Health Research Institute, Hamilton, ON, Canada.ORCID https://orcid.org/0000-0003-2487-1479
M I Pinto-SanchezFarncombe Family Digestive Health Research Institute, Hamilton, ON, Canada.ORCID https://orcid.org/0000-0002-9040-9824
McMaster University Medical Centre · CAPopulation Health Research Institute · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCorticosteroids (CS) have been used extensively to induce remission in Crohn's disease (CD); however, they are associated with severe side effects. We hypothesized that the administration of an exclusive enteral nutrition (EEN) formula to CS would lead to increased CD remission rates and to decreased CS-related adverse events. We proposed to undertake a pilot study comparing EEN and CS therapy to CS alone to assess decrease symptoms and inflammatory markers over 6 weeks.

aimThe overall aim was to assess study feasibility based on recruitment rates and acceptability of treatment in arms involving EEN.

methodsThe pilot study intended to recruit 100 adult patients with active CD who had been prescribed CS to induce remission as part of their care. The patients were randomized to one of three arms: (i) standard-dose CS; (ii) standard-dose CS plus EEN (Modulen 1.5 kcal); or (iii) short-course CS plus EEN.

resultsA total of 2009 CD patients attending gastroenterology clinics were screened from October 2018 to November 2019. Prednisone was prescribed to only 6.8% (27/399) of patients with active CD attending outpatient clinics. Of the remaining 372 patients with active CD, 34.8% (139/399) started or escalated immunosuppressant or biologics, 49.6% (198/399) underwent further investigation and 8.8% (35/399) were offered an alternative treatment (e.g., antibiotics, surgery or investigational agents in clinical trials). Only three patients were enrolled in the study (recruitment rate 11%; 3/27), and the study was terminated for poor recruitment.

conclusionThe apparent decline in use of CS for treatment of CD has implications for CS use as an entry criterion for clinical trials.

Indexed as

Change prescriptionInflammatory bowel diseaseNutritionPilot

Identifiers

PMID34617003
PMCPMC8489529
OpenAlexW3203331166

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.