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

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

  • Stephan Miehlke

      Affiliations

    • Medical Department I, Technical University Hospital, Dresden, Germany
    • Corresponding Author InformationReprint requests Address requests for reprints to: Prof Dr S. Miehlke, Medical Department I, Technical University Hospital, Fetscherstr. 74, 01307 Dresden, Germany. fax: (49) 351 458 5859
    • ,
  • Ahmed Madisch

      Affiliations

    • Medical Department I, Technical University Hospital, Dresden, Germany
    • ,
  • Diana Karimi

      Affiliations

    • Institute for Pathology, Klinikum Bayreuth, Germany
    • ,
  • Susann Wonschik

      Affiliations

    • Medical Department I, Technical University Hospital, Dresden, Germany
    • ,
  • Eberhard Kuhlisch

      Affiliations

    • Institute for Medical Biometry and Statistics, University Hospital Dresden, Dresden, Germany
    • ,
  • Renate Beckmann

      Affiliations

    • Medical Department I, Technical University Hospital, Dresden, Germany
    • ,
  • Andrea Morgner

      Affiliations

    • Medical Department I, Technical University Hospital, Dresden, Germany
    • ,
  • Ralph Mueller

      Affiliations

    • Dr. Falk Pharma GmbH, Freiburg, Germany
    • ,
  • Roland Greinwald

      Affiliations

    • Dr. Falk Pharma GmbH, Freiburg, Germany
    • ,
  • Gerhard Seitz

      Affiliations

    • Institute for Pathology, Klinikum Bamberg, Germany
    • ,
  • Gustavo Baretton

      Affiliations

    • Institute for Pathology, Technical University Hospital Dresden, Germany
    • ,
  • Manfred Stolte

      Affiliations

    • Institute for Pathology, Klinikum Bayreuth, Germany

Received 28 July 2008 ,Accepted 27 February 2009.

  • Image Result

    Proportion of patients in clinical remission at 3 and 6 weeks LOCF. ITT indicates intention-to-treat population; PP, per protocol population. *P = .015, **P = .006, ***P = .010.

    Proportion of patients in clinical remission at 3 and 6 weeks LOCF. ITT indicates intention-to-treat population; PP, per protocol population. *P = .015, **P = .006, ***P = .010.

  • Image Result

    Proportion of patients with histologic remission, response, and nonresponse at 6 weeks, *P = .030, **P = .029.

    Proportion of patients with histologic remission, response, and nonresponse at 6 weeks, *P = .030, **P = .029.

  • Image Result

    Mean number of IEL/100 epithelial cells at baseline and at 6 weeks. *P < .001 compared with baseline, **P = .013 compared with placebo, +P = .001 compared with baseline.

    Mean number of IEL/100 epithelial cells at baseline and at 6 weeks. *P < .001 compared with baseline, **P = .013 compared with placebo, +P = .001 compared with baseline.

 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.

PII: S0016-5085(09)00365-5

doi: 10.1053/j.gastro.2009.02.078

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

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