Budesonide is effective in treating lymphocytic colitis
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Budesonide is effective in treating lymphocytic colitis : a randomized double-blind placebo-controlled study. / Miehlke, Stephan; Madisch, Ahmed; Karimi, Diana; Wonschik, Susann; Kuhlisch, Eberhard; Beckmann, Renate; Morgner, Andrea; Mueller, Ralph; Greinwald, Roland; Seitz, Gerhard; Baretton, Gustavo; Stolte, Manfred.
in: GASTROENTEROLOGY, Jahrgang 136, Nr. 7, 06.2009, S. 2092-100.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Budesonide is effective in treating lymphocytic colitis
T2 - a randomized double-blind placebo-controlled study
AU - Miehlke, Stephan
AU - Madisch, Ahmed
AU - Karimi, Diana
AU - Wonschik, Susann
AU - Kuhlisch, Eberhard
AU - Beckmann, Renate
AU - Morgner, Andrea
AU - Mueller, Ralph
AU - Greinwald, Roland
AU - Seitz, Gerhard
AU - Baretton, Gustavo
AU - Stolte, Manfred
PY - 2009/6
Y1 - 2009/6
N2 - 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.
AB - 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.
KW - Administration, Oral
KW - Adolescent
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Biopsy, Needle
KW - Budesonide
KW - Colitis, Lymphocytic
KW - Colonoscopy
KW - Dose-Response Relationship, Drug
KW - Double-Blind Method
KW - Drug Administration Schedule
KW - Female
KW - Follow-Up Studies
KW - Germany
KW - Glucocorticoids
KW - Humans
KW - Immunohistochemistry
KW - Male
KW - Middle Aged
KW - Probability
KW - Quality of Life
KW - Recurrence
KW - Reference Values
KW - Risk Assessment
KW - Severity of Illness Index
KW - Time Factors
KW - Treatment Outcome
KW - Young Adult
KW - Journal Article
KW - Multicenter Study
KW - Randomized Controlled Trial
U2 - 10.1053/j.gastro.2009.02.078
DO - 10.1053/j.gastro.2009.02.078
M3 - SCORING: Journal article
C2 - 19303012
VL - 136
SP - 2092
EP - 2100
JO - GASTROENTEROLOGY
JF - GASTROENTEROLOGY
SN - 0016-5085
IS - 7
ER -