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 frequency ≤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.
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.
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.
This is a preview of subscription content, access via your institution.
Buy single article
Instant access to the full article PDF.
Tax calculation will be finalised during checkout.
Fernandez-Banares F, Salas A, Forne M, Esteve M, Espinos J, Viver JM (1999) Incidence of collagenous and lymphocytic colitis: a 5-year population-based study. Am J Gastroenterol 94:418–423
Bohr J, Tysk C, Eriksson S, Jarnerot G (1995) Collagenous colitis in Orebro, Sweden, an epidemiological study 1984–1993. Gut 37:394–397
Agnarsdottir M, Gunnlaugsson O, Orvar KB, Cariglia N, Birgisson S, Bjornsson S, Thorgeirsson T, Jonasson JG (2002) Collagenous and lymphocytic colitis in Iceland. Dig Dis Sci 47:1122–1128
Tremaine WJ (2000) Collagenous colitis and lymphocytic colitis. J Clin Gastroenterol 30:245–249
Pardi DS (2004) Microscopic colitis. An update. Inflamm Bowel Dis 10:860–870
Bohr J, Olesen M, Tysk C, Järnerot G (2000) Collagenous and lymphocytic colitis: a clinical and histopathological review. Can J Gastroenterol 14:943–947
Veress B, Lofberg R, Bergman L (1995) Microscopic colitis syndrome. Gut 36:880–886
Lazenby AJ, Yardley JH, Giardiello FM, Jessurun J, Bayless TM (1989) Lymphocytic (microscopic) colitis: a comparative histopathologic study with particular reference to collagenous colitis. Hum Pathol 20:18–28
Stolte M, Ritter M, Borchard F, Koch-Scherrer G (1990) Collagenous gastroduodenitis on collagenous colitis. Endoscopy 22:186–187
Carpenter HA, Tremaine WJ, Batts KP, Czaja AJ (1992) Sequential histologic evaluations in collagenous colitis. Correlations with disease behavior and sampling strategy. Dig Dis Sci 37:1903–1909
Armes J, Gee DC, Macrae FA, Schroeder W, Bhathal PS (1992) Collagenous colitis: jejunal and colorectal pathology. J Clin Pathol 45:784–787
Bohr J, Tysk C, Yang P, Danielsson D, Jarnerot G (1996) Autoantibodies and immunoglobulins in collagenous colitis. Gut 39:73–76
Jarnerot G, Tysk C, Bohr J et al (1995) Collagenous colitis and fecal stream diversion. Gastroenterology 109:449–455
Duerr RH, Targan SR, Landers CJ et al (1991) Anti-neutrophil cytoplasmic antibodies in ulcerative colitis: comparison with other colitides/diarrheal illnesses. Gastroenterology 100:1590–1596
Beaugerie L, Pardi DS (2005) Review article: drug-induced microscopic colitis-proposal for a scoring system and review of the literature. Aliment Pharmacol Ther 22:277–284
Fine K, Ogunji F, Lee E, Lafon G, Tanzi M (1999) Randomized, double-blind placebo-controlled trial of bismuth subsalicylate for microscopic colitis (abstr.). Gastroenterology 166:A880
Baert F, Schmit A, D’Haens G, Dedeurwaerdere F, Louis E, Cabooter M, De Vos M, Fontaine F, Naegels S, Schurmans P, Stals H, Geboes K, Rutgeerts P (2002) Budesonide in collagenous colitis-a double-blind placebo-controlled trial with histological follow-up. Gastroenterology 122:20–25
Miehlke S, Heymer P, Bethke B, Bästlein E, Meier E, Bartram HP, Wilhelms G, Lehn N, Dorta G, DeLarive J, Tromm A, Bayerdörffer E, Stolte M (2002) Budesonide treatment for collagenous colitis–a randomized, double-blind, placebo-controlled, multicenter trial. Gastroenterology 123:978–984
Bonderup OK, Hansen JB, Birket-Smith L, Vestergaard V, Teglbjaerg PS, Fallingborg J (2003) Budesonide treatment of collagenous colitis: a randomised, double blind, placebo controlled trial with morphometric analysis. Gut 52:248–251
Madisch A, Heymer P, Voss C, Wigginghaus B, Bastlein E, Bayerdorffer E, Meier E, Schimming W, Bethke B, Stolte M, Miehlke S (2005) Oral budesonide therapy improves quality of life in patients with collagenous colitis. Int J Colorectal Dis 20:312–316
Miehlke S, Madisch A, Bethke B, Stolte M (2005) Time to remission with budesonide in collagenous colitis. Aliment Pharmacol Ther 21:1507–1508
Miehlke S, Madisch A, Voss C, Morgner A, Heymer P, Kuhlisch E, Bethke B, Stolte M (2005) Long-term follow-up of collagenous colitis after induction of clinical remission with budesonide. Aliment Pharmacol Ther 22:1115–1119
Gupta I, Gupta V, Parihar A, Gupta S, Ludtke R, Safayhi H, Ammon HP (1998) Effects of Boswellia serrata gum resin in patients with bronchial asthma: results of a double-blind, placebo-controlled, 6-week clinical study. Eur J Med Res 3:511–514
Sander O, Herborn G, Rau R (1998) Is H15 (resin extract of Boswellia serrata, “incense”) a useful supplement to established drug therapy of chronic polyarthritis? Results of a double-blind pilot study. Z Rheumatol 57(1):11–16
Kimmatkar N, Thawani V, Hingorani L, Khiyani R (2003) Efficacy and tolerability of Boswellia serrata extract in treatment of osteoarthritis of knee–a randomized double blind placebo controlled trial. Phytomedicine 10:3–7
Gerhardt H, Seifert F, Buvari P, Vogelsang H, Repges R (2001) Therapy of active Crohn disease with Boswellia serrata extract H 15. Z Gastroenterol 39:11–17
Gupta I, Parihar A, Malhotra P, Singh GB, Ludtke R, Safayhi H, Ammon HP (1997) Effects of Boswellia serrata gum resin in patients with ulcerative colitis. Eur J Med Res 2:37–43
Gupta I, Parihar A, Malhotra P, Gupta S, Ludtke R, Safayhi H, Ammon HP (2001) Effects of gum resin of Boswellia serrata in patients with chronic colitis. Planta Med 67:391–395
Chande N, McDonald JW, Macdonald JK (2005) Interventions for treating collagenous colitis. Cochrane Database Syst Rev 19:CD003575
Madisch A, Miehlke S, Eichele E, Bethke B, Mrwa J, Wilhelms G, Debus M, Bästlein E, Kuhlisch E, Stolte M (2005) Boswellia Serrata Extract for the Treatment of collagenous colitis: a randomized, double-Blind, placebo-controlled, multicenter Trial. Gastroenterology 128:A581
Sailer ER, Schweizer S, Boden SE, Ammon HP, Safayhi H (1998) Characterization of an acetyl-11-keto-beta-boswellic acid and arachidonate-binding regulatory site of 5-lipoxygenase using photoaffinity labeling. Eur J Biochem 256:364–368
Safayhi H, Mack T, Sabieray J Anazodo MI, Subramanian LR, Ammon HP (1992) Boswellic acids: novel, specific, nonredox inhibitors of 5-lipoxygenase. J Pharmacol Exp Ther 261/3:1143–1146
Safayhi H, Sailer ER, Ammon HPT (1995) Mechanism of 5-lipoxygenase inhibition by acetyl-11-keto-ß-boswellic acid. Mol Pharmacol 47:1212–1216
Safayhi H, Sailer ER, Ammon HPT (1996) 5-lipoxygenase inhibition by acetyl-11-keto-ß-boswellic acid (AKBA) by a novel mechanism. Phytomedicine 3/1:71
Krieglstein CF, Anthoni C, Rijcken EJ, Laukotter M, Spiegel HU, Boden SE, Schweizer S, Safayhi H, Senninger N, Schurmann G (2001) Acetyl-11-keto-beta-boswellic acid, a constituent of a herbal medicine from Boswellia serrata resin, attenuates experimental ileitis. Int J Colorectal Dis 16:88–95
Syrovets T, Buchele B, Gedig E, Slupsky JR, Simmet T (2000) Acetyl-boswellic acids are novel catalytic inhibitors of human topoisomerases I and II alpha. Mol Pharmacol 58:71–81
We thank R. Beckmann for assistance in data collection. We also thank M. Stewart for critical reviewing the manuscript. We are grateful to the following colleagues for recruiting patients to the study: R. Abuagela, H.-P. Bartram, P. Dietz, M. Dornberg, D. Fuchs, E. Grüger, C Haferland, J. Keymling, E. Meier, J. Morgenthaler, P. Rohde, G. Stegemann-Özdemir, and H. Wollmann.
About this article
Cite this article
Madisch, A., Miehlke, S., Eichele, O. et al. Boswellia serrata extract for the treatment of collagenous colitis. A double-blind, randomized, placebo-controlled, multicenter trial. Int J Colorectal Dis 22, 1445–1451 (2007). https://doi.org/10.1007/s00384-007-0364-1
- Microscopic colitis
- Collagenous colitis
- Boswellia serrata extract