Clinical—Alimentary TractBudesonide Is Effective in Treating Lymphocytic Colitis: A Randomized Double-Blind Placebo-Controlled Study
Section snippets
Materials and Methods
This study was designed as a randomized, double-blind, placebo-controlled, multicenter clinical study. It was performed in various centers throughout Germany which submitted their biopsy specimen to one of the study pathologists. The study was approved by the independent ethics committee of the Dresden University Hospital. All study participants were given a detailed description of the study, and their written informed consent was obtained. The study was conducted in accordance with good
Study Population
A total of 42 patients with lymphocytic colitis were randomly assigned in 31 German study centers between June 2002 and March 2006. Patients in both groups had well-matched demographic and baseline characteristics (Table 1). The majority of patients (67%) were women; the median age was 61 years in both treatment groups. The median stool frequency was approximately 5 per day, and virtually all patients had watery or loose stools. Previous use of antidiarrheal medications (mostly loperamide) was
Discussion
This was the first randomized, placebo-controlled trial investigating the efficacy of oral budesonide in lymphocytic colitis. We showed that budesonide induces effective clinical and histologic remission in patients with lymphocytic colitis. After 6 weeks of treatment with budesonide 9 mg/d, the clinical remission rates were 86% compared with 48% with placebo (P = .010). In addition, treatment with budesonide was safe, and the rate of AEs was low.
In lymphocytic colitis no established treatment
Acknowledgments
All authors contributed to interpretation of the study findings and in the writing of the manuscript. Medical writing support was provided by Christoph Müller–Löbnitz, Forchheim (Germany) and Margaret Bray, Ashford (United Kingdom), with funding from Dr Falk Pharma GmbH.
The statistical analysis of the entire data sets pertaining to efficacy (specifically primary and major secondary efficacy end points) and safety was independently conducted by a biostatistician (E.K.) who is not employed by the
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Conflicts of interest The authors disclose the following: S.M. has received honoraria from Dr Falk Pharma GmbH for oral presentations and consultancies and research grant support from Dr Falk Pharma GmbH. A. Madisch has received honoraria from Dr Falk Pharma GmbH for oral presentations and research grant support from Dr Falk Pharma GmbH. A. Morgner has received honoraria from Dr Falk Pharma GmbH for oral presentations. M.S. has received honoraria from Dr Falk Pharma GmbH for oral presentations and research grant support from Dr Falk Pharma GmbH. R.M. and R.G. are employees of Dr Falk Pharma GmbH. The remaining authors disclose no conflicts.
Funding The study was supported by Dr Falk Pharma GmbH, Freiburg, Germany.