Abstract | BACKGROUND & AIMS: 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.
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Authors | Stephan Miehlke, Ahmed Madisch, Diana Karimi, Susann Wonschik, Eberhard Kuhlisch, Renate Beckmann, Andrea Morgner, Ralph Mueller, Roland Greinwald, Gerhard Seitz, Gustavo Baretton, Manfred Stolte |
Journal | Gastroenterology
(Gastroenterology)
Vol. 136
Issue 7
Pg. 2092-100
(Jun 2009)
ISSN: 1528-0012 [Electronic] United States |
PMID | 19303012
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Glucocorticoids
- Budesonide
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Topics |
- Administration, Oral
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Biopsy, Needle
- Budesonide
(administration & dosage, adverse effects)
- Colitis, Lymphocytic
(drug therapy, pathology)
- Colonoscopy
(methods)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Administration Schedule
- Female
- Follow-Up Studies
- Germany
- Glucocorticoids
(administration & dosage, 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
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