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Published in: International Journal of Colorectal Disease 4/2005

01-07-2005 | Original Article

Oral budesonide therapy improves quality of life in patients with collagenous colitis

Authors: Ahmed Madisch, Peter Heymer, Claudia Voss, Bernd Wigginghaus, Elke Bästlein, Ekkehard Bayerdörffer, Eberhard Meier, Wolfgang Schimming, Birgit Bethke, Manfred Stolte, Stephan Miehlke

Published in: International Journal of Colorectal Disease | Issue 4/2005

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Abstract

Introduction

Collagenous colitis is an idiopathic microscopic colitis characterised by watery diarrhoea. The impact of collagenous colitis on quality of life has not been assessed. Our aim was to assess quality of life in patients with this condition and compare the effect of treatment with budesonide capsules or placebo on this parameter.

Methods

Patients with chronic diarrhoea and histologically-proven collagenous colitis were randomised to receive either budesonide controlled-release capsules (Entocort capsules, AstraZeneca, Lund, Sweden), 9 mg/day, or placebo for 6 weeks. Quality of life was measured using the validated Gastrointestinal Quality of Life Index (GIQLI) at baseline and after 6 weeks. With the GIQLI, scores range from 0 to 144, with higher scores representing better quality of life.

Results

Complete quality of life assessment was available in 29 patients (budesonide: n=17; placebo: n=12). At baseline, quality of life was low in patients with collagenous colitis (mean 76). After 6 weeks of treatment, the mean GIQLI score increased significantly in the budesonide group (from 67 to 92, p<0.001), but remained unchanged in the placebo group (86–88). The mean score of the dimensions symptoms (p=0.001), emotional functioning (p=0.003) and physical functioning (p=0.017) increased significantly in the budesonide group compared with the placebo group. A significantly larger proportion of patients in the budesonide group experienced improved stool consistency (p<0.01) and a significant reduction in the mean stool frequency compared with those in the placebo group (p<0.01).

Conclusion

Quality of life is seriously reduced in patients with collagenous colitis. Six-week treatment with oral budesonide controlled-release capsules significantly improves quality of life and clinical symptoms compared with placebo in these patients.
Literature
1.
go back to reference Lindstrom CG (1976) ‘Collagenous colitis’ with watery diarrhea. A new entity. Pathol Eur 11:87–89PubMed Lindstrom CG (1976) ‘Collagenous colitis’ with watery diarrhea. A new entity. Pathol Eur 11:87–89PubMed
2.
go back to reference Bohr J, Tysk C, Eriksson S et al (1996) Collagenous colitis: a retrospective study of clinical presentation and treatment in 163 patients. Gut 39:846–851PubMed Bohr J, Tysk C, Eriksson S et al (1996) Collagenous colitis: a retrospective study of clinical presentation and treatment in 163 patients. Gut 39:846–851PubMed
3.
go back to reference Jessurun J, Yardley JH, Giardiello FM et al (1987) Chronic colitis with thickening of the subepithelial collagen layer (collagenous colitis): histopathological findings in 15 patients. Hum Pathol 18:839–848PubMed Jessurun J, Yardley JH, Giardiello FM et al (1987) Chronic colitis with thickening of the subepithelial collagen layer (collagenous colitis): histopathological findings in 15 patients. Hum Pathol 18:839–848PubMed
4.
go back to reference Stolte M, Ritter M, Borchard F et al (1990) Collagenous gastroduodenitis and collagenous colitis. Endoscopy 22:186–187PubMed Stolte M, Ritter M, Borchard F et al (1990) Collagenous gastroduodenitis and collagenous colitis. Endoscopy 22:186–187PubMed
5.
go back to reference Ayata G, Ithamukkala S, Sapp H et al (2002) Prevalence and significance of inflammatory bowel disease-like morphologic features in collagenous and lymphocytic colitis. Am J Surg Pathol 26:1414–1423CrossRefPubMed Ayata G, Ithamukkala S, Sapp H et al (2002) Prevalence and significance of inflammatory bowel disease-like morphologic features in collagenous and lymphocytic colitis. Am J Surg Pathol 26:1414–1423CrossRefPubMed
6.
go back to reference Bürgel N, Bojarski C, Mankertz J et al (2002) Mechanisms of diarrhea in collagenous colitis. Gastroenterology 123:433–443CrossRefPubMed Bürgel N, Bojarski C, Mankertz J et al (2002) Mechanisms of diarrhea in collagenous colitis. Gastroenterology 123:433–443CrossRefPubMed
7.
go back to reference Fernandez-Banares F, Salas A, Forne M et al (1999) Incidence of collagenous and lymphocytic colitis: a 5-year population-based study. Am J Gastroenterol 94:418–423CrossRefPubMed Fernandez-Banares F, Salas A, Forne M et al (1999) Incidence of collagenous and lymphocytic colitis: a 5-year population-based study. Am J Gastroenterol 94:418–423CrossRefPubMed
8.
go back to reference Agnarsdottir M, Gunnlaugsson O, Orvar KB et al (2002) Collagenous and lymphocytic colitis in Iceland. Dig Dis Sci 47:1122–1128CrossRefPubMed Agnarsdottir M, Gunnlaugsson O, Orvar KB et al (2002) Collagenous and lymphocytic colitis in Iceland. Dig Dis Sci 47:1122–1128CrossRefPubMed
9.
go back to reference McKeage K, Goa KL (2002) Budesonide (Entocort EC capsules). A review of its therapeutic use in the management of active Crohn’s disease in adults. Drugs 62:2263–2282PubMed McKeage K, Goa KL (2002) Budesonide (Entocort EC capsules). A review of its therapeutic use in the management of active Crohn’s disease in adults. Drugs 62:2263–2282PubMed
10.
go back to reference Baert F, Schmit A, D’Haens G et al (2002) Budesonide in collagenous colitis—a double-blind placebo-controlled trial with histological follow-up. Gastroenterology 122:20–25PubMed Baert F, Schmit A, D’Haens G et al (2002) Budesonide in collagenous colitis—a double-blind placebo-controlled trial with histological follow-up. Gastroenterology 122:20–25PubMed
11.
go back to reference Miehlke S, Heymer P, Bethke B et al (2002) Budesonide treatment for collagenous colitis—a randomized, double-blind, placebo-controlled, multicenter trial. Gastroenterology 123:978–984CrossRefPubMed Miehlke S, Heymer P, Bethke B et al (2002) Budesonide treatment for collagenous colitis—a randomized, double-blind, placebo-controlled, multicenter trial. Gastroenterology 123:978–984CrossRefPubMed
12.
go back to reference Bonderup OK, Hansen JB, Birket-Smith L et al (2003) Budesonide treatment of collagenous colitis: a randomised, double blind, placebo controlled trial with morphometric analysis. Gut 52:248–251CrossRefPubMed Bonderup OK, Hansen JB, Birket-Smith L et al (2003) Budesonide treatment of collagenous colitis: a randomised, double blind, placebo controlled trial with morphometric analysis. Gut 52:248–251CrossRefPubMed
13.
go back to reference Eypasch E, Wood-Dauphinee S, Williams JI et al (1993) The gastrointestinal quality of life index. A clinical index for measuring patient status in gastroenterologic surgery. Chirurg 64:264–274PubMed Eypasch E, Wood-Dauphinee S, Williams JI et al (1993) The gastrointestinal quality of life index. A clinical index for measuring patient status in gastroenterologic surgery. Chirurg 64:264–274PubMed
14.
go back to reference Eypasch E, Williams JI, Wood-Dauphinee S et al (1995) Gastrointestinal quality of life index: development, validation and application of a new instrument. Br J Surg 82:216–222PubMed Eypasch E, Williams JI, Wood-Dauphinee S et al (1995) Gastrointestinal quality of life index: development, validation and application of a new instrument. Br J Surg 82:216–222PubMed
15.
go back to reference Irvine EJ, Feagan B, Rochon J et al (1994) Quality of life: a valid and reliable measure of therapeutic efficacy in the treatment of inflammatory bowel disease. Canadian Crohn’s Relapse Prevention Trial Study Group. Gastroenterology 106:287–296PubMed Irvine EJ, Feagan B, Rochon J et al (1994) Quality of life: a valid and reliable measure of therapeutic efficacy in the treatment of inflammatory bowel disease. Canadian Crohn’s Relapse Prevention Trial Study Group. Gastroenterology 106:287–296PubMed
16.
go back to reference Irvine EJ, Greenberg GR, Feagan BG et al (2000) Quality of life rapidly improves with budesonide therapy for active Crohn’s disease. Inflamm Bowel Dis 6:181–187PubMed Irvine EJ, Greenberg GR, Feagan BG et al (2000) Quality of life rapidly improves with budesonide therapy for active Crohn’s disease. Inflamm Bowel Dis 6:181–187PubMed
17.
go back to reference Sailer M, Bussen D, Debus ES et al (1998) Quality of life in patients with benign anorectal disorders. Br J Surg 85:1716–1719CrossRefPubMed Sailer M, Bussen D, Debus ES et al (1998) Quality of life in patients with benign anorectal disorders. Br J Surg 85:1716–1719CrossRefPubMed
18.
go back to reference Barrat C, Capelluto E, Catheline J-M et al (2001) Quality of life 2 years after laparoscopic total fundoplication: a prospective study. Surg Laparosc Endosc Percutan Tech 11:347–350PubMed Barrat C, Capelluto E, Catheline J-M et al (2001) Quality of life 2 years after laparoscopic total fundoplication: a prospective study. Surg Laparosc Endosc Percutan Tech 11:347–350PubMed
19.
go back to reference Miehlke S, Madisch A, Bästlein E et al (2003) Time to clinical remission in patients with collagenous colitis treated with budesonide capsules—results from a randomized, double-blind, placebo-controlled trial. Gut 52:A214 Miehlke S, Madisch A, Bästlein E et al (2003) Time to clinical remission in patients with collagenous colitis treated with budesonide capsules—results from a randomized, double-blind, placebo-controlled trial. Gut 52:A214
20.
go back to reference Fine K, Ogunji F, Lee E et al (1999) Randomized, double-blind placebo-controlled trial of bismuth subsalicylate for microscopic colitis. Gastroenterology 116:A880 Fine K, Ogunji F, Lee E et al (1999) Randomized, double-blind placebo-controlled trial of bismuth subsalicylate for microscopic colitis. Gastroenterology 116:A880
21.
go back to reference Munck LK, Kjeldsen J, Philipsen E et al (2003) Incomplete remission with short-term prednisolone treatment in collagenous colitis: a randomized study. Scand J Gastroenterol 38:606–610CrossRefPubMed Munck LK, Kjeldsen J, Philipsen E et al (2003) Incomplete remission with short-term prednisolone treatment in collagenous colitis: a randomized study. Scand J Gastroenterol 38:606–610CrossRefPubMed
22.
go back to reference Chande N, McDonald JW, MacDonald JK (2003) Interventions for treating collagenous colitis. Cochrane Database Syst Rev CD003575 Chande N, McDonald JW, MacDonald JK (2003) Interventions for treating collagenous colitis. Cochrane Database Syst Rev CD003575
Metadata
Title
Oral budesonide therapy improves quality of life in patients with collagenous colitis
Authors
Ahmed Madisch
Peter Heymer
Claudia Voss
Bernd Wigginghaus
Elke Bästlein
Ekkehard Bayerdörffer
Eberhard Meier
Wolfgang Schimming
Birgit Bethke
Manfred Stolte
Stephan Miehlke
Publication date
01-07-2005
Publisher
Springer-Verlag
Published in
International Journal of Colorectal Disease / Issue 4/2005
Print ISSN: 0179-1958
Electronic ISSN: 1432-1262
DOI
https://doi.org/10.1007/s00384-004-0660-y

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