title: Oral budesonide therapy improves quality of life in patients with collagenous colitis.
abstract: BACKGROUND
  Collagenous 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.
  
  
  METHODS
  Patients 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.
  
  
  RESULTS
  Complete 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).
  
  
  CONCLUSIONS
  Quality 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.
authors.affiliation: Medical Department I, Technical University Hospital, Fetscherstrasse 74, 01307 Dresden, Germany.
authors.forename: Ahmed
authors.initials: A
authors.lastname: Madisch
authors.forename: Peter
authors.initials: P
authors.lastname: Heymer
authors.forename: Claudia
authors.initials: C
authors.lastname: Voss
authors.forename: Bernd
authors.initials: B
authors.lastname: Wigginghaus
authors.forename: Elke
authors.initials: E
authors.lastname: Bästlein
authors.forename: Ekkehard
authors.initials: E
authors.lastname: Bayerdörffer
authors.forename: Eberhard
authors.initials: E
authors.lastname: Meier
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Schimming
authors.forename: Birgit
authors.initials: B
authors.lastname: Bethke
authors.forename: Manfred
authors.initials: M
authors.lastname: Stolte
authors.forename: Stephan
authors.initials: S
authors.lastname: Miehlke
mesh_terms: D000284:Administration, Oral; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D019819:Budesonide / Q000008:administration & dosage / Q000627:therapeutic use*; D046729:Colitis, Collagenous / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D010919:Placebos; D019819:Budesonide