Trial reportGut2003
Budesonide treatment of collagenous colitis: a randomised, double blind, placebo controlled trial with morphometric analysis.
Trial report in Gut, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 3 of them syntheses that pooled 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.
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.
Who cites it
53 citing papers in PubMed, 3 syntheses or guidelines pooled it, 230 citations in OpenAlex.
- Heterogeneity in Histological Evaluation of Microscopic Colitis in Randomized Clinical Trials: An Umbrella Review.Inflammatory bowel diseases · 2026Pooled it
- Interventions for treating collagenous colitis.The Cochrane database of systematic reviews · 2017Pooled it
- Interventions for treating lymphocytic colitis.The Cochrane database of systematic reviews · 2017Pooled it
- Trial
- Boswellia serrata extract for the treatment of collagenous colitis. A double-blind, randomized, placebo-controlled, multicenter trial.International journal of colorectal disease · 2007Trial
- Oral budesonide therapy improves quality of life in patients with collagenous colitis.International journal of colorectal disease · 2005Trial
- Plasma FABP2, IL-10, and LPS in Microscopic Colitis: An Exploratory Study of Their Biomarker Potential.Medicina (Kaunas, Lithuania) · 2026Article
- Detection of collagen band-associated regions in H&E-stained colonic biopsies of collagenous colitis patients using superpixel-based feature extraction and neural network classification.Diagnostic pathology · 2026Article
- Single-cell transcriptomic characterization of microscopic colitis.Nature communications · 2025Article
- Follow-Up of Microscopic Colitis Patients and Diarrhea Controls at 1 Year.Gastro hep advances · 2024Article
- Upadacitinib as a Novel Treatment in Therapy Refractory Collagenous Colitis.Inflammatory bowel diseases · 2023Article
- Efficacy and safety of medical therapies in microscopic colitis: a systematic review and network meta-analysis.Therapeutic advances in gastroenterology · 2023Article
- Spontaneous colonic perforation with collagenous colitis in an elderly patient.Clinical journal of gastroenterology · 2022Article
- Proctocolectomy and ileal pouch-anal anastomosis for the treatment of collagenous colitis.Clinical journal of gastroenterology · 2022Article
- A Tale of Two Colitides.Cureus · 2022Article
- Incidence of collagenous colitis in NHS Lothian: a population-based study.Frontline gastroenterology · 2022Article
- Microscopic colitis.Nature reviews. Disease primers · 2021Review
- European guidelines on microscopic colitis: United European Gastroenterology and European Microscopic Colitis Group statements and recommendations.United European gastroenterology journal · 2021Article
- Single-centre experience with anti-tumour necrosis factor treatment in budesonide-refractory microscopic colitis patients.United European gastroenterology journal · 2019Article
- UEG Week 2019 Poster Presentations.United European gastroenterology journal · 2019Article
Corrections and comments
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Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCollagenous colitis is characterised by diarrhoea, lymphocytic inflammation, and a thickened subepithelial collagen layer in the colorectal mucosa. No standard treatment of the disease is established.
aimsTo investigate the clinical and histological effect of oral budesonide (Entocort, AstraZeneca) in the treatment of collagenous colitis. PATIENTS: Twenty patients with collagenous colitis (collagen layer >10 micro m) and diarrhoea (>4 stools/day and/or stool weight >200 g/day).
methodsA randomised, double blind, placebo controlled trial of budesonide treatment. Patients were randomised to placebo or budesonide for eight weeks. Stool frequency and stool weight were registered before and after treatment. Sigmoidoscopy was performed before and after treatment, and biopsies at fixed locations were obtained for morphometric analysis.
resultsTen patients were randomised to budesonide and 10 to placebo. All 10 patients receiving budesonide had a clinical response compared with two in the placebo group (p<0.001). In the budesonide group, stool weight was reduced from 574 g/day to 200 g/day and stool frequency was reduced from 6.2/day to 1.9/day (p<0.01). The histological inflammation grade in the sigmoid mucosa and the thickness of the collagen layer were significantly reduced. A correlation between the grade of inflammation as well as collagen layer thickness and stool weight was found. No side effects were reported. Eight of 10 patients had relapse of symptoms within eight weeks after stopping treatment.
conclusionsBudesonide is a highly effective and well tolerated treatment of collagenous colitis. There is a high risk of relapse after stopping eight weeks of treatment.
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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.