Boswellia serrata extract for the treatment of collagenous colitis. A double-blind, randomized, placebo-controlled, multicenter trial.
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.
Madisch
Ahmed
A
Medical Department I, Technical University Hospital, Fetscherstrasse 74, 01307, Dresden, Germany. ahmed.madisch@uniklinikum-dresden.de
Miehlke
Stephan
S
Eichele
Otto
O
Mrwa
Jenny
J
Bethke
Birgit
B
Kuhlisch
Eberhard
E
Bästlein
Elke
E
Wilhelms
Georg
G
Morgner
Andrea
A
Wigginghaus
Bernd
B
Stolte
Manfred
M
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
D000893:Anti-Inflammatory Agents; D005765:Gastrointestinal Agents; D010936:Plant Extracts