Skip to main content

Advertisement

Log in

Boswellia serrata extract for the treatment of collagenous colitis. A double-blind, randomized, placebo-controlled, multicenter trial

International Journal of Colorectal Disease Aims and scope Submit manuscript

Abstract

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.

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3

References

  1. 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

    Article  CAS  PubMed  Google Scholar 

  2. Bohr J, Tysk C, Eriksson S, Jarnerot G (1995) Collagenous colitis in Orebro, Sweden, an epidemiological study 1984–1993. Gut 37:394–397

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  3. 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

    Article  PubMed  Google Scholar 

  4. Tremaine WJ (2000) Collagenous colitis and lymphocytic colitis. J Clin Gastroenterol 30:245–249

    Article  CAS  PubMed  Google Scholar 

  5. Pardi DS (2004) Microscopic colitis. An update. Inflamm Bowel Dis 10:860–870

    Article  PubMed  Google Scholar 

  6. Bohr J, Olesen M, Tysk C, Järnerot G (2000) Collagenous and lymphocytic colitis: a clinical and histopathological review. Can J Gastroenterol 14:943–947

    Article  CAS  PubMed  Google Scholar 

  7. Veress B, Lofberg R, Bergman L (1995) Microscopic colitis syndrome. Gut 36:880–886

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  8. 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

    Article  CAS  PubMed  Google Scholar 

  9. Stolte M, Ritter M, Borchard F, Koch-Scherrer G (1990) Collagenous gastroduodenitis on collagenous colitis. Endoscopy 22:186–187

    Article  CAS  PubMed  Google Scholar 

  10. 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

    Article  CAS  PubMed  Google Scholar 

  11. Armes J, Gee DC, Macrae FA, Schroeder W, Bhathal PS (1992) Collagenous colitis: jejunal and colorectal pathology. J Clin Pathol 45:784–787

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  12. Bohr J, Tysk C, Yang P, Danielsson D, Jarnerot G (1996) Autoantibodies and immunoglobulins in collagenous colitis. Gut 39:73–76

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  13. Jarnerot G, Tysk C, Bohr J et al (1995) Collagenous colitis and fecal stream diversion. Gastroenterology 109:449–455

    Article  CAS  PubMed  Google Scholar 

  14. 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

    Article  CAS  PubMed  Google Scholar 

  15. 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

    Article  CAS  PubMed  Google Scholar 

  16. 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

    Google Scholar 

  17. 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

    Article  CAS  PubMed  Google Scholar 

  18. 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

    Article  CAS  PubMed  Google Scholar 

  19. 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

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  20. 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

    Article  PubMed  Google Scholar 

  21. Miehlke S, Madisch A, Bethke B, Stolte M (2005) Time to remission with budesonide in collagenous colitis. Aliment Pharmacol Ther 21:1507–1508

    Article  CAS  PubMed  Google Scholar 

  22. 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

    Article  CAS  PubMed  Google Scholar 

  23. 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

    CAS  PubMed  Google Scholar 

  24. 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

    Article  CAS  PubMed  Google Scholar 

  25. 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

    Article  CAS  PubMed  Google Scholar 

  26. 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

    Article  CAS  PubMed  Google Scholar 

  27. 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

    CAS  PubMed  Google Scholar 

  28. 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

    Article  CAS  PubMed  Google Scholar 

  29. Chande N, McDonald JW, Macdonald JK (2005) Interventions for treating collagenous colitis. Cochrane Database Syst Rev 19:CD003575

    Google Scholar 

  30. 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

    Google Scholar 

  31. 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

    Article  CAS  PubMed  Google Scholar 

  32. 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

    Google Scholar 

  33. Safayhi H, Sailer ER, Ammon HPT (1995) Mechanism of 5-lipoxygenase inhibition by acetyl-11-keto-ß-boswellic acid. Mol Pharmacol 47:1212–1216

    CAS  PubMed  Google Scholar 

  34. 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

    Article  Google Scholar 

  35. 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

    Article  CAS  PubMed  Google Scholar 

  36. 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

    CAS  PubMed  Google Scholar 

Download references

Acknowledgement

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.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Ahmed Madisch.

Rights and permissions

Reprints and permissions

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

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00384-007-0364-1

Keywords

Navigation