Budesonide or Prednisone in Combination With Ursodeoxycholic Acid in Primary Sclerosing Cholangitis: A Randomized Double-Blind Pilot Study

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.
August 2000
American Journal of Gastroenterology;Aug2000, Vol. 95 Issue 8, p2015
Academic Journal
OBJECTIVE: PSC has characteristics of an (auto)immunemediated 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.


Related Articles

  • A meta-analysis of ursodeoxycholic acid therapy versus combination therapy with corticosteroids for PBC-AIH-overlap syndrome: evidence from 97 monotherapy and 117 combinations. Huawei Zhang; Sainan Li; Jing Yang; Yuanyuan Zheng; Jianrong Wang; Wenxia Lu; Yuqing Zhou; Qin Yin; Rong Zhu; Chuanyong Guo // Gastroenterology Review / Przeglad Gastroenterologiczny;2015, Vol. 10 Issue 3, p148 

    In this study, a meta-analysis of randomised controlled trials that compared ursodeoxycholic acid (UDCA) monotherapy with therapies combining UDCA and corticosteroids was performed. We found that combination therapy with UDCA and corticosteroids was more effective than UDCA monotherapy for...

  • Research progress in medical treatment of primary biliary cirrhosis. WANG Qian; YAO Dinghang // Journal of Clinical Hepatology / Linchuang Gandanbing Zazhi;2014, Vol. 30 Issue 5, p462 

    Primary biliary cirrhosis (PBC) is an autoimmune disease. Ursodeoxycholic acid (UDCA) is the only safe and effective drug for the treatment of PBC, as proved by randomized controlled clinical trials, so it is advocated as first - line therapy. Alternative therapies are urgently needed for...

  • Treating Pemphigus Vulgaris with Prednisone and Mycophenolate Mofetil: A Multicenter, Randomized, Placebo-Controlled Trial. Beissert, Stefan; Mimouni, Daniel; Kanwar, Amrinder J.; Solomons, Neil; Kalia, Veena; Anhalt, Grant J. // Journal of Investigative Dermatology;Aug2010, Vol. 130 Issue 8, p2041 

    Non-blinded trials of pemphigus vulgaris suggest that mycophenolate mofetil (MMF) may be beneficial. In a prospective, multicenter trial, outpatients with mild or moderate pemphigus vulgaris were randomized to MMF (2 or 3 g day–1) plus oral corticosteroids or placebo plus oral...

  • Disseminated cutaneous and visceral Kaposi's sarcoma in a patient with rheumatoid arthritis receiving corticosteroids and tacrolimus. Taniguchi, Takashi; Asano, Yoshihide; Kawaguchi, Makiko; Kogure, Asako; Mitsui, Hiroshi; Sugaya, Makoto; Sato, Shinichi // Modern Rheumatology;Jun2011, Vol. 21 Issue 3, p309 

    Kaposi's sarcoma (KS) is a vascular lesion of low-grade malignant potential caused by the complex interactions between geographic, genetic, environmental, and immunological factors. We recently experienced a rare case of KS associated with rheumatoid arthritis in a patient receiving...

  • Children and adolescents with SLE: not just little adults. Morgan, TA; Watson, L; McCann, LJ; Beresford, MW // Lupus;Oct2013, Vol. 22 Issue 12, p1309 

    Juvenile-onset systemic lupus erythematosus (JSLE) represents 15–20% of all SLE cases. Whilst features of this chronic complex multisystem autoimmune disorder are highly variable, children and adolescents generally present with a more severe illness than adults and accrue greater disease...

  • Comparison of Treatment Strategies in Early Rheumatoid Arthritis. Goekoop-Ruiterman, Yvonne P. M.; de Vries-Bouwstra, Jeska K.; Allaart, Cornelia F.; van Zeben, Derkjen; Kerstens, Pit J. S. M.; Hazes, J. Mieke W.; Zwinderman, Aelko H.; Peeters, André J.; de Jonge-Bok, Johanna M.; Mallée, Constant; de Beus, Wim M.; de Sonnaville, Peter B. J.; Ewals, Jacques A. P. M.; Breedveld, Ferdinand C.; Dijkmans, Ben A. C. // Annals of Internal Medicine;3/20/2007, Vol. 146 Issue 6, p406 

    Background: In patients with early rheumatoid arthritis, initial combination therapies provide earlier clinical improvement and less progression of joint damage after 1 year compared with initial monotherapies (as demonstrated in the BeSt study). Objective: To evaluate whether the initial...

  • Systemic Corticosteroids for Acute Exacerbations of Chronic Obstructive Pulmonary Disease. Irwin, Richard S.; Madison, J. Mark // New England Journal of Medicine;6/26/2003, Vol. 348 Issue 26, p2679 

    Reports that clinical trials have provided clinicians with high-quality evidence that patients with an acute exacerbation of chronic obstructive pulmonary disease can benefit from multiple therapies including systemic corticosteroids. Improvements in the duration of hospitalization, lung...

  • Corticosteroids/methoxsalen/prednisone.  // Reactions Weekly;12/17/2011, Issue 1382, p17 

    The article describes the case of a boy with pre-B-cell acute lymphoblastic leukaemia who developed various toxicities during treatment with prednisone, corticosteroids and extracorporeal photochemotherapy (ECP) with methoxsalen for graft-versus-host disease (GVHD).

  • Bell's palsy: Corticosteroids and/or antivirals? Elliott, William T. // Clinical Cardiology Alert;Nov2009 Pharmacology Watch, p2 

    The article reports on a meta-analysis of 18 trials for the treatment of Bell's palsy with corticosteroids and antivirals. According to the meta-analysis, the combination of corticosteroids and antivirals has better results compared with treatment with steroids. The study recommended up to 80...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics