title: Long-term follow-up of collagenous colitis after induction of clinical remission with budesonide.
abstract: BACKGROUND
  Budesonide (Entocort) is effective for the treatment of collagenous colitis.
  
  
  OBJECTIVE
  To assess the long-term outcome of patients after induction of clinical remission by budesonide treatment.
  
  
  METHODS
  Fifty-one patients with chronic diarrhoea and histologically proven collagenous colitis were enrolled in randomized, placebo-controlled crossover trial using budesonide 9 mg daily for 6 weeks. Patients in clinical remission after either initial or crossover budesonide treatment were followed using standardized questionnaires. Clinical relapse was defined as five or more loose stools/day for at least 4 consecutive days.
  
  
  RESULTS
  A total of 33 patients achieved clinical remission (85% per-protocol). During a median follow-up of 16 months, clinical relapse occurred in 20 patients (61%), after a median time of 2 weeks (range: 1-104, mean: 10 weeks). Patient age <60 years was identified as a significant risk factor for clinical relapse (OR = 7.4, P = 0.048). Budesonide was used for treatment of clinical relapse in 80% of patients achieving clinical response in all of them.
  
  
  CONCLUSIONS
  Budesonide is effective in the treatment of collagenous colitis. Clinical relapses may occur in a considerable number of patients, particularly in those <60 years. Treatment of clinical relapse with budesonide appears to be an effective option.
authors.affiliation: Medical Department I, Technical University Hospital, Dresden, Germany. stephan.miehlke@uniklinikum-dresden.de
authors.forename: S
authors.initials: S
authors.lastname: Miehlke
authors.forename: A
authors.initials: A
authors.lastname: Madisch
authors.forename: C
authors.initials: C
authors.lastname: Voss
authors.forename: A
authors.initials: A
authors.lastname: Morgner
authors.forename: P
authors.initials: P
authors.lastname: Heymer
authors.forename: E
authors.initials: E
authors.lastname: Kuhlisch
authors.forename: B
authors.initials: B
authors.lastname: Bethke
authors.forename: M
authors.initials: M
authors.lastname: Stolte
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D019819:Budesonide / Q000627:therapeutic use*; D046729:Colitis, Collagenous / Q000188:drug therapy*; D018592:Cross-Over Studies; D003967:Diarrhea / Q000188:drug therapy / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D019819:Budesonide