title: Boswellia serrata extract for the treatment of collagenous colitis. A double-blind, randomized, placebo-controlled, multicenter trial.
abstract: OBJECTIVE
  The objective of this study was 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 diarrhea 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<or=3 soft /solid stools per day on average during the last week). Patients of the placebo group with persistent diarrhea received open-label 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 vs 26.7%, 95%CI, 7.7-55.1; p=0.04; intention-to-treat 43.8% vs 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 open-label 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 BSE.
authors.affiliation: Medical Department I, Technical University Hospital, Fetscherstrasse 74, 01307, Dresden, Germany. ahmed.madisch@uniklinikum-dresden.de
authors.forename: Ahmed
authors.initials: A
authors.lastname: Madisch
authors.forename: Stephan
authors.initials: S
authors.lastname: Miehlke
authors.forename: Otto
authors.initials: O
authors.lastname: Eichele
authors.forename: Jenny
authors.initials: J
authors.lastname: Mrwa
authors.forename: Birgit
authors.initials: B
authors.lastname: Bethke
authors.forename: Eberhard
authors.initials: E
authors.lastname: Kuhlisch
authors.forename: Elke
authors.initials: E
authors.lastname: Bästlein
authors.forename: Georg
authors.initials: G
authors.lastname: Wilhelms
authors.forename: Andrea
authors.initials: A
authors.lastname: Morgner
authors.forename: Bernd
authors.initials: B
authors.lastname: Wigginghaus
authors.forename: Manfred
authors.initials: M
authors.lastname: Stolte
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D029743:Boswellia; D002908:Chronic Disease; D046729:Colitis, Collagenous / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D003106:Colon / Q000187:drug effects* / Q000473:pathology; D003967:Diarrhea / Q000188:drug therapy / Q000209:etiology* / Q000473:pathology; D004311:Double-Blind Method; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D010936:Plant Extracts / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D005765:Gastrointestinal Agents; D010936:Plant Extracts