Boswellia serrata extract for the treatment of collagenous colitis. A double-blind, randomized, placebo-controlled, multicenter trial
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Boswellia serrata extract for the treatment of collagenous colitis. A double-blind, randomized, placebo-controlled, multicenter trial. / Madisch, Ahmed; Miehlke, Stephan; Eichele, Otto; Mrwa, Jenny; Bethke, Birgit; Kuhlisch, Eberhard; Bästlein, Elke; Wilhelms, Georg; Morgner, Andrea; Wigginghaus, Bernd; Stolte, Manfred.
in: INT J COLORECTAL DIS, Jahrgang 22, Nr. 12, 12.2007, S. 1445-51.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Boswellia serrata extract for the treatment of collagenous colitis. A double-blind, randomized, placebo-controlled, multicenter trial
AU - Madisch, Ahmed
AU - Miehlke, Stephan
AU - Eichele, Otto
AU - Mrwa, Jenny
AU - Bethke, Birgit
AU - Kuhlisch, Eberhard
AU - Bästlein, Elke
AU - Wilhelms, Georg
AU - Morgner, Andrea
AU - Wigginghaus, Bernd
AU - Stolte, Manfred
PY - 2007/12
Y1 - 2007/12
N2 - BACKGROUND AND AIMS: 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.MATERIALS AND 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 frequencyRESULTS: 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.
AB - BACKGROUND AND AIMS: 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.MATERIALS AND 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 frequencyRESULTS: 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.
KW - Administration, Oral
KW - Aged
KW - Anti-Inflammatory Agents
KW - Boswellia
KW - Chronic Disease
KW - Colitis, Collagenous
KW - Colon
KW - Diarrhea
KW - Double-Blind Method
KW - Female
KW - Gastrointestinal Agents
KW - Germany
KW - Humans
KW - Male
KW - Middle Aged
KW - Patient Compliance
KW - Plant Extracts
KW - Quality of Life
KW - Surveys and Questionnaires
KW - Time Factors
KW - Treatment Outcome
KW - Journal Article
KW - Multicenter Study
KW - Randomized Controlled Trial
U2 - 10.1007/s00384-007-0364-1
DO - 10.1007/s00384-007-0364-1
M3 - SCORING: Journal article
C2 - 17764013
VL - 22
SP - 1445
EP - 1451
JO - INT J COLORECTAL DIS
JF - INT J COLORECTAL DIS
SN - 0179-1958
IS - 12
ER -