Evidence map›Paper›PMID 15549326›Full record

Trial reportInternational journal of colorectal disease2005

Oral budesonide therapy improves quality of life in patients with collagenous colitis.

Ahmed Madisch, Peter Heymer, Claudia Voss, Bernd Wigginghaus, Elke Bästlein, Ekkehard Bayerdörffer, Eberhard Meier, Wolfgang Schimming, Birgit Bethke, Manfred Stolte and 1 more

Abstract readClinical TrialRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in International journal of colorectal disease, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 2 pooled it
2.2field-weighted citation impact, top 13% 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

23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 81 citations in OpenAlex.

  1. Pooled it
  2. Interventions for treating collagenous colitis.The Cochrane database of systematic reviews · 2017
    Pooled it
  3. Trial
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Diagnosis and Management of Microscopic Colitis.The American journal of gastroenterology · 2017
    Review
  10. Optimal management of collagenous colitis: a review.Clinical and experimental gastroenterology · 2016
    Review
  11. Article
  12. Microscopic colitis: Common cause of unexplained nonbloody diarrhea.World journal of gastrointestinal pathophysiology · 2014
    Review
  13. Diagnosis and management of microscopic colitis: current perspectives.Clinical and experimental gastroenterology · 2014
    Review
  14. Article
  15. Microscopic colitis.World journal of gastroenterology · 2012
    Review
  16. Review of the microscopic colitides.Current gastroenterology reports · 2011
    Review
  17. Review
  18. Therapeutic benefits of budesonide in gastroenterology.Therapeutic advances in chronic disease · 2010
    Article
  19. Diagnosis and management of microscopic colitis.World journal of gastroenterology · 2008
    Review
  20. Microscopic colitis: an approach to treatment.Canadian journal of gastroenterology = Journal canadien de gastroenterologie · 2008
    Review
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

11 authors at 4 institutions in 1 country.

Ahmed MadischMedical Department I, Technical University Hospital, Fetscherstrasse 74, 01307 Dresden, Germany.
Peter Heymer
Claudia Voss
Bernd Wigginghaus
Elke Bästlein
Ekkehard Bayerdörffer
Eberhard Meier
Wolfgang Schimming
Birgit Bethke
Manfred Stolte
Stephan Miehlke
TU Dresden · DEBayreuth Medical Center · DEKlinikum St. Marien Amberg · DEStädtisches Klinikum Dresden · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCollagenous colitis is an idiopathic microscopic colitis characterised by watery diarrhoea. The impact of collagenous colitis on quality of life has not been assessed. Our aim was to assess quality of life in patients with this condition and compare the effect of treatment with budesonide capsules or placebo on this parameter.

methodsPatients with chronic diarrhoea and histologically-proven collagenous colitis were randomised to receive either budesonide controlled-release capsules (Entocort capsules, AstraZeneca, Lund, Sweden), 9 mg/day, or placebo for 6 weeks. Quality of life was measured using the validated Gastrointestinal Quality of Life Index (GIQLI) at baseline and after 6 weeks. With the GIQLI, scores range from 0 to 144, with higher scores representing better quality of life.

resultsComplete quality of life assessment was available in 29 patients (budesonide: n=17; placebo: n=12). At baseline, quality of life was low in patients with collagenous colitis (mean 76). After 6 weeks of treatment, the mean GIQLI score increased significantly in the budesonide group (from 67 to 92, p<0.001), but remained unchanged in the placebo group (86-88). The mean score of the dimensions symptoms (p=0.001), emotional functioning (p=0.003) and physical functioning (p=0.017) increased significantly in the budesonide group compared with the placebo group. A significantly larger proportion of patients in the budesonide group experienced improved stool consistency (p<0.01) and a significant reduction in the mean stool frequency compared with those in the placebo group (p<0.01).

conclusionQuality of life is seriously reduced in patients with collagenous colitis. Six-week treatment with oral budesonide controlled-release capsules significantly improves quality of life and clinical symptoms compared with placebo in these patients.

Indexed as

Quality of LifeAdministration, OralAnti-Inflammatory AgentsBudesonideColitis, CollagenousDouble-Blind MethodFemaleHumansMaleMiddle AgedPlacebosTreatment OutcomeAnti-Inflammatory AgentsBudesonidePlacebos

Identifiers

PMID15549326
OpenAlexW1989212758

What OpenQuestion holds

Textmetadata
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.