Boswellia serrata extract for the treatment of collagenous colitis a double-blind randomized, placebo-controlled, multicenter trial.
Background & Aims: To investigate the effect of Boswellia serrata extract (BSE) on symptoms, quality of life and histology in patients with collagenous colitis.
Methods: Patients with chronic diarrhoea and histologically proven collagenous colitis were randomized to receive either oral BSE 400 mg three times daily for 6 weeks or placebo. Complete colonoscopy and histology were performed before and after treatment. Clinical symptoms and quality of life were assessed by standardized questionnaires and SF-36. The primary endpoint was the percentage of patients with clinical remission after 6 weeks (stool frequency [less then or equal to] 3 soft/solid stools per day on average during the last week). Patients of the placebo group with persistent diarrhea received open-label cross-over BSE therapy for a further 6 weeks.
Results: Thirty-one patients were randomized, 26 patients were available for per-protocol-analysis. After 6 weeks the proportion of patients in clinical remission was higher in the BSE group than in the placebo group (per protocol 63.6%; 95%CI: 30.8-89.1 versus 26.7%, 95%CI: 7.7-55.1; p = 0.04; intention-to-treat 43.8% versus 26.7%, p = 0.25). Compared to placebo, BSE treatment had no effect on histology and quality of life. Five patients discontinued BSE treatment prematurely. Discontinuation was due to: adverse events (n = 1), unwillingness to continue (n = 3), or loss to follow-up for unknown reasons (n = 1). Seven patients received cross-over BSE therapy, five of whom achieved complete remission.
Conclusions: Our study suggests that BSE might be clinically effective in patients with collagenous colitis. Larger trials are clearly necessary to establish the clinical efficacy of Boswellia serrata extract.
A. Madisch (a), S. Miehlke (a), O. Eichele (b), J. Mrwa (a), B. Bethke (c), E. Kuhlisch (d), E. Bastlein (e), G. Wilhelms (e), A. Morgner (a), B. Wigginghaus (e), M. Stolte (c)
(a)Medical Department I, Technical University Hospital, Dresden, Germany
(b) Koblenz, Technical University Hospital, Dresden, Germany
(c) Institute for Pathology, Klinikum Bayreuth, Bayreuth, Germany
(d) Institute of Medical Informatics and Biometry, Technical University Hospital, Dresden, Germany
(e) Cologne, Goslar, Osnabruck, Germany
E-mail address: Ahmed.Madisch@uniklinikum-dresden.de
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|Author:||Madisch, A.; Miehlke, S.; Eichele, O.; Mrwa, J.; Bethke, B.; Kuhlisch, E.; Bastlein, E.; Wilhelms, G|
|Publication:||Phytomedicine: International Journal of Phytotherapy & Phytopharmacology|
|Date:||Jun 1, 2008|
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