Titre du document / Document title

Budesonide or prednisone in combination with ursodeoxycholic acid in primary sclerosing cholangitis : A randomized double-blind pilot study

Auteur(s) / Author(s)

Belgian-Dutch PSC Study Group, BELGIQUE
VAN HOOGSTRATEN H. J. F. ; VLEGGAAR F. P. ; BOLAND G. J. ; VAN STEENBERGEN W. ; GRIFFIOEN P. ; HOP W. C. J. ; VAN HATTUM J. ; VAN BERGE HENEGOUWEN G. P. ; SCHALM S. W. ; VAN BUUREN H. R. ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

Department of Hepatogastroenterology, University Hospital Rotterdam, Rotterdam, PAYS-BAS
Department of Hepatogastroenterology, University Hospital Utrecht, Utrecht, PAYS-BAS
Department of Hepatogastroenterology, University Hospital Leuven, Leuven, BELGIQUE
Department of Clinical Chemistry, University Hospital Rotterdam, Rotterdam, PAYS-BAS
Department of Epidemiology and Biostatistics, University Hospital Rotterdam, Rotterdam, PAYS-BAS

Résumé / Abstract

OBJECTIVE: PSC has characteristics of an (auto)immune-mediated disease; however, few studies have evaluated corticosteroid therapy for this disorder. METHODS: We performed an 8-wk double-blind randomized pilot study to assess the effects of additional treatment with 9 mg budesonide (n = 6) versus 3 mg budesonide (n = 6) versus 10 mg prednisone (n = 6) in patients who had been treated with UDCA (mean dose, 12 mg/kg/day) for at least 5 months without achieving biochemical remission. Pruritus and fatigue were evaluated using visual analog scales. Serum liver biochemistry was measured every 4 wk. At entry and at the end of the trial, adrenocorticotrophic hormone (ACTH) and dehydroepiandrosterone (DHEA) were measured to assess effects on the pituitary-adrenal axis. Duodenal bile was collected for assessment of biliary corticosteroid activity. RESULTS: Pruritus decreased significantly more in the prednisone group compared to both the 3-mg and the 9-mg budesonide groups (p < 0.05). Alkaline phosphatase (mean: -23.4%; p = 0.03) and IgG (mean: -16.2%; p = 0.04) decreased in the prednisone group, whereas bilirubin, γ-glutamyl transferase, aspartate aminotransferase, and alanine aminotransferase did not change significantly. No significant clinical or liver biochemical changes were observed in the 3-mg and 9-mg budesonide groups. Significantly larger drops in serum ACTH were found in the 10-mg prednisone group (-40.7%; p = 0.04) and 9-mg budesonide group (-36.6%; p = 0.02) compared to the 3-mg budesonide group (+19.0%). No significant differences in percentage change in baseline values for DHEA between the three treatment arms were found. Mononuclear cell proliferation assays did not demonstrate corticosteroid activity in bile. Autoimmune hepatitis was observed in one case (9 mg budesonide) when corticosteroids were tapered off. CONCLUSION: The results of this pilot study suggest only minor beneficial short-term effects of prednisone but not budesonide on symptoms and serum liver tests in UDCA-treated PSC patients.

Revue / Journal Title

The American journal of gastroenterology   ISSN 0002-9270 

Source / Source

2000, vol. 95, n^o8, pp. 2015-2022 (39 ref.)

Langue / Language

Anglais

Editeur / Publisher

Blackwell Publishing, Oxford, ROYAUME-UNI  (1954) (Revue)

Mots-clés anglais / English Keywords

Sclerosing cholangitis ; Primitive ; Chemotherapy ; Budesonide ; Prednisolone ; Drug combination ; Ursodeoxycholic acid ; Clinical trial ; Randomization ; Double blind study ; Human ; Corticosteroid ; Digestive diseases ; Biliary tract disease ; Immunopathology ;

Mots-clés français / French Keywords

Angiocholite sténosante ; Primitif ; Chimiothérapie ; Budésonide ; Prednisolone ; Association médicamenteuse ; Acide ursodéoxycholique ; Essai clinique ; Randomisation ; Etude double insu ; Homme ; Corticostéroïde ; Appareil digestif pathologie ; Voie biliaire pathologie ; Immunopathologie ;

Mots-clés espagnols / Spanish Keywords

Angiocolitis estenosante ; Primitivo ; Quimioterapia ; Budesónida ; Prednisolona ; Asociación medicamentosa ; Acido ursodeoxicólico ; Ensayo clínico ; Aleatorización ; Estudio doble ciego ; Hombre ; Corticoesteroide ; Aparato digestivo patología ; Vía biliar patología ; Inmunopatología ;

Localisation / Location

INIST-CNRS, Cote INIST : 11062, 35400009102089.0280