Evidence map›Paper›PMID 38683433›Full record

ArticleDigestive diseases and sciences2024

Budesonide Induces Favourable Histologic and Symptomatic Recovery in Patients with Non-responsive and Refractory Coeliac Disease When Given in an Open Capsule Format.

Daniel Saitta, Lee M Henneken, Pragalathan Apputhurai, Swee Lin Chen Yi Mei, Jason A Tye-Din

Erratum issuedAbstract read
In one paragraph

Article in Digestive diseases and sciences, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing 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

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

  1. Guideline
  2. CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2026
    Review
  3. Review
  4. Article
  5. Article
  6. Diagnosis and management of celiac disease.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2025
    Review
  7. Review
  8. Review
  9. Refractory Celiac Disease: What the Gastroenterologist Should Know.International journal of molecular sciences · 2024
    Review
  10. Evolution in coeliac disease diagnosis and management.JGH open : an open access journal of gastroenterology and hepatology · 2024
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

Daniel SaittaDepartment of Gastroenterology, Western Hospital, Footscray, VIC, Australia.
Lee M HennekenDepartment of Gastroenterology, The Royal Melbourne Hospital, Parkville, VIC, Australia.
Pragalathan ApputhuraiDepartment of Health Sciences and Biostatistics, Swinburne University of Technology, Melbourne, Australia.
Swee Lin Chen Yi MeiDepartment of Gastroenterology, Box Hill Hospital, Box Hill, Victoria, Australia.
Jason A Tye-DinDepartment of Gastroenterology, The Royal Melbourne Hospital, Parkville, VIC, Australia. tyedin@wehi.edu.au.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionNon-responsive coeliac disease (NRCD), where symptoms and enteropathy persist despite a prolonged gluten-free diet (GFD), is common. Refractory coeliac disease (RCD), characterised by malabsorption and extensive enteropathy, is rare but serious. In both, treatment options are limited. Topical budesonide may help and an open capsule format promoting proximal small intestinal delivery may be advantageous.

aimTo describe the effect of budesonide and its presentation on mucosal healing, symptoms, and tolerability in NRCD and RCD.

methodsA retrospective cohort study of NRCD and RCD patients who received budesonide for enteropathy despite a strict GFD for over 12 months. Primary outcome was improvement in histology. Symptoms and adverse treatment effects were recorded.

results50 patients with NRCD (n = 14; 86% F), RCD type 1 (n = 30; 60% F), and RCD type 2 (n = 6 based on aberrant duodenal T cells; 33% F) were identified. Common RCD symptoms were diarrhoea (68%), fatigue (40%), and weight loss (34%). 16 received closed capsule budesonide (CCB) 9 mg OD and 35 open capsule budesonide (OCB) 3 mg 3 times a day. Complete and partial mucosal healing was significantly higher after OCB compared to CCB (p < 0.001, Mann-Whitney U test). Symptom improvement was also significantly higher after OCB compared to CCB (p = 0.002, Mann-Whitney U test). Side effects were mild and self-limiting and were reported in 25% of both cohorts.

conclusionOCB was well tolerated and associated with improvements in enteropathy (83%) and symptoms (90%) in NRCD and RCD. Our findings support OCB as the preferred 1st-line therapy for NRCD and RCD type 1.

Indexed as

BudesonideCeliac DiseaseAdultAgedCapsulesDiet, Gluten-FreeFemaleHumansIntestinal MucosaMaleMiddle AgedRetrospective StudiesTreatment OutcomeYoung AdultBudesonideCapsulesBudesonideCoeliac diseaseGluten-free dietNon-responsive coeliac diseaseRefractory coeliac disease

Identifiers

PMID38683433
PMCPMC11258102

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Registered trials

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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.