Gastroenterology

Gastroenterology

Volume 136, Issue 7, June 2009, Pages 2092-2100
Gastroenterology

Clinical—Alimentary Tract
Budesonide Is Effective in Treating Lymphocytic Colitis: A Randomized Double-Blind Placebo-Controlled Study

https://doi.org/10.1053/j.gastro.2009.02.078Get rights and content

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.

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

References (32)

  • G.F. Bonner et al.

    Short- and long-term follow-up of treatment for lymphocytic and collagenous colitis

    Inflamm Bowel Dis

    (2000)
  • D.S. Pardi et al.

    The epidemiology of microscopic colitis: a population based study in Olmsted County, Minnesota

    Gut

    (2007)
  • M. Agnarsdottir et al.

    Collagenous and lymphocytic colitis in Iceland

    Dig Dis Sci

    (2002)
  • N. Chande et al.

    Interventions for treating lymphocytic colitis

    Cochrane Database Syst Rev

    (2007)
  • K. Fine et al.

    Randomized, double-blind, placebo-controlled trial of bismuth subsalicylate for microscopic colitis [abstract]

    Gastroenterology

    (1999)
  • G.C. Wall et al.

    Pharmacotherapy for microscopic colitis

    Pharmacotherapy

    (2007)
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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.

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