title: Budesonide in collagenous colitis: a double-blind placebo-controlled trial with histologic follow-up.
abstract: OBJECTIVE
  Collagenous colitis (CC) is a well-described entity causing chronic diarrhea and characteristic histologic findings. Several treatment options have been suggested, but no controlled data are available. We conducted a placebo-controlled trial to show the clinical and histologic effects of budesonide in CC.
  
  
  METHODS
  Twenty-eight patients were randomly assigned to receive placebo (n = 14) or budesonide 9 mg daily (n = 14) for 8 weeks. Patients were evaluated clinically, and blinded biopsy specimens were analyzed from fixed locations at weeks 0 and 8. Clinical response was defined as a decrease of at least 50% in the disease activity score (number of bowel movements in the last 7 days). At week 8, nonresponders received open-label budesonide for the next 8-week period; responders discontinued treatment and were followed up.
  
  
  RESULTS
  Three patients discontinued the study prematurely. Intention-to-treat analysis showed clinical response in 8 of 14 patients in the budesonide group compared with 3 of 14 responders for placebo (P = 0.05) after 8 weeks of blinded therapy, together with improved stool consistency. Histologically, there was no change in the mean thickness of the collagen band but a significant decrease of the lamina propria infiltrate in the budesonide group (P < 0.001).
  
  
  CONCLUSIONS
  Budesonide is efficacious in inducing short-term clinical response in CC with significant reduction of the histologic infiltrate in the lamina propria.
authors.affiliation: Imelda Hospital Bonheiden, Belgium.
authors.forename: Filip
authors.initials: F
authors.lastname: Baert
authors.forename: Alain
authors.initials: A
authors.lastname: Schmit
authors.forename: Geert
authors.initials: G
authors.lastname: D'Haens
authors.forename: Franceska
authors.initials: F
authors.lastname: Dedeurwaerdere
authors.forename: Edouard
authors.initials: E
authors.lastname: Louis
authors.forename: Marc
authors.initials: M
authors.lastname: Cabooter
authors.forename: Martine
authors.initials: M
authors.lastname: De Vos
authors.forename: Fernand
authors.initials: F
authors.lastname: Fontaine
authors.forename: Serge
authors.initials: S
authors.lastname: Naegels
authors.forename: Piet
authors.initials: P
authors.lastname: Schurmans
authors.forename: Hedwig
authors.initials: H
authors.lastname: Stals
authors.forename: Karel
authors.initials: K
authors.lastname: Geboes
authors.forename: Paul
authors.initials: P
authors.lastname: Rutgeerts
mesh_terms: D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001706:Biopsy; D019819:Budesonide / Q000008:administration & dosage* / Q000009:adverse effects; D002908:Chronic Disease; D003092:Colitis / Q000188:drug therapy* / Q000473:pathology; D003967:Diarrhea / Q000188:drug therapy / Q000473:pathology; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D000893:Anti-Inflammatory Agents; D019819:Budesonide