Budesonide is effective in treating lymphocytic colitis: a randomized double-blind placebo-controlled study

Gastroenterology. 2009 Jun;136(7):2092-100. doi: 10.1053/j.gastro.2009.02.078. Epub 2009 Mar 17.


Background & aims: 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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Biopsy, Needle
  • Budesonide / administration & dosage*
  • Budesonide / adverse effects
  • Colitis, Lymphocytic / drug therapy*
  • Colitis, Lymphocytic / pathology*
  • Colonoscopy / methods
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Germany
  • Glucocorticoids / administration & dosage*
  • Glucocorticoids / adverse effects
  • Humans
  • Immunohistochemistry
  • Male
  • Middle Aged
  • Probability
  • Quality of Life*
  • Recurrence
  • Reference Values
  • Risk Assessment
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome
  • Young Adult


  • Glucocorticoids
  • Budesonide