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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, Vol. 136, No. 7, 06.2009, p. 2092-100.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Miehlke, S, Madisch, A, Karimi, D, Wonschik, S, Kuhlisch, E, Beckmann, R, Morgner, A, Mueller, R, Greinwald, R, Seitz, G, Baretton, G & Stolte, M 2009, 'Budesonide is effective in treating lymphocytic colitis: a randomized double-blind placebo-controlled study', GASTROENTEROLOGY, vol. 136, no. 7, pp. 2092-100. https://doi.org/10.1053/j.gastro.2009.02.078

APA

Miehlke, S., Madisch, A., Karimi, D., Wonschik, S., Kuhlisch, E., Beckmann, R., Morgner, A., Mueller, R., Greinwald, R., Seitz, G., Baretton, G., & Stolte, M. (2009). Budesonide is effective in treating lymphocytic colitis: a randomized double-blind placebo-controlled study. GASTROENTEROLOGY, 136(7), 2092-100. https://doi.org/10.1053/j.gastro.2009.02.078

Vancouver

Miehlke S, Madisch A, Karimi D, Wonschik S, Kuhlisch E, Beckmann R et al. Budesonide is effective in treating lymphocytic colitis: a randomized double-blind placebo-controlled study. GASTROENTEROLOGY. 2009 Jun;136(7):2092-100. https://doi.org/10.1053/j.gastro.2009.02.078

Bibtex

@article{5f734d9d8b1d4ffa81bc72a0aaa8d4cd,
title = "Budesonide is effective in treating lymphocytic colitis: a randomized double-blind placebo-controlled study",
abstract = "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.",
keywords = "Administration, Oral, Adolescent, Adult, Aged, Aged, 80 and over, Biopsy, Needle, Budesonide, Colitis, Lymphocytic, Colonoscopy, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Follow-Up Studies, Germany, Glucocorticoids, Humans, Immunohistochemistry, Male, Middle Aged, Probability, Quality of Life, Recurrence, Reference Values, Risk Assessment, Severity of Illness Index, Time Factors, Treatment Outcome, Young Adult, Journal Article, Multicenter Study, Randomized Controlled Trial",
author = "Stephan Miehlke and Ahmed Madisch and Diana Karimi and Susann Wonschik and Eberhard Kuhlisch and Renate Beckmann and Andrea Morgner and Ralph Mueller and Roland Greinwald and Gerhard Seitz and Gustavo Baretton and Manfred Stolte",
year = "2009",
month = jun,
doi = "10.1053/j.gastro.2009.02.078",
language = "English",
volume = "136",
pages = "2092--100",
journal = "GASTROENTEROLOGY",
issn = "0016-5085",
publisher = "W.B. Saunders Ltd",
number = "7",

}

RIS

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 -