title: Budesonide is effective in treating lymphocytic colitis: a randomized double-blind placebo-controlled study.
abstract: OBJECTIVE
  Budesonide is effective in treating collagenous colitis, but no treatment is established for lymphocytic colitis. We performed a randomized, double-blind, placebo-controlled study to evaluate the effects of budesonide in patients with lymphocytic colitis.
  
  
  METHODS
  Forty-two patients (median age, 61 years) with lymphocytic colitis and chronic diarrhea were randomly assigned to groups that were given oral doses of budesonide (9 mg/d) or placebo for 6 weeks. Nonresponders at week 6 were given open-label budesonide (9 mg/d) for 6 additional weeks. A complete colonoscopy and histologic and quality-of-life analyses were performed at baseline and at week 6. The primary end point was clinical remission at 6 weeks, with last observation carried forward (LOCF). All patients who left the study in clinical remission were followed for relapse.
  
  
  RESULTS
  At week 6, 86% of patients given budesonide were in clinical remission (with LOCF) compared with 48% of patients given placebo (P = .010). Furthermore, open-label budesonide therapy induced clinical remission in 7 of 8 patients given placebo. Histologic remission was observed in 73% of patients given budesonide compared with 31% given placebo (P = .030). Only 1 patient discontinued budesonide therapy prematurely. During a mean follow-up period of 14 months, 15 patients (44.1%) experienced a clinical relapse (after a mean of 2 months); 8 of the relapsing patients were retreated with and responded again to budesonide.
  
  
  CONCLUSIONS
  Budesonide effectively induces clinical remission in patients with lymphocytic colitis and significantly improves histology results after 6 weeks. Clinical relapses occur but can be treated again with budesonide.
authors.affiliation: Medical Department I, Technical University Hospital, Dresden, Germany. stephan.miehlke@uniklinikum-dresden.de
authors.forename: Stephan
authors.initials: S
authors.lastname: Miehlke
authors.forename: Ahmed
authors.initials: A
authors.lastname: Madisch
authors.forename: Diana
authors.initials: D
authors.lastname: Karimi
authors.forename: Susann
authors.initials: S
authors.lastname: Wonschik
authors.forename: Eberhard
authors.initials: E
authors.lastname: Kuhlisch
authors.forename: Renate
authors.initials: R
authors.lastname: Beckmann
authors.forename: Andrea
authors.initials: A
authors.lastname: Morgner
authors.forename: Ralph
authors.initials: R
authors.lastname: Mueller
authors.forename: Roland
authors.initials: R
authors.lastname: Greinwald
authors.forename: Gerhard
authors.initials: G
authors.lastname: Seitz
authors.forename: Gustavo
authors.initials: G
authors.lastname: Baretton
authors.forename: Manfred
authors.initials: M
authors.lastname: Stolte
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001707:Biopsy, Needle; D019819:Budesonide / Q000008:administration & dosage* / Q000009:adverse effects; D046730:Colitis, Lymphocytic / Q000188:drug therapy* / Q000473:pathology*; D003113:Colonoscopy / Q000379:methods; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007150:Immunohistochemistry; D008297:Male; D008875:Middle Aged; D011336:Probability; D011788:Quality of Life; D012008:Recurrence; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005938:Glucocorticoids; D019819:Budesonide