Document Detail

The combination of ursodeoxycholic acid and methotrexate for primary biliary cirrhosis is not better than ursodeoxycholic acid alone.
MedLine Citation:
PMID:  9252088     Owner:  NLM     Status:  MEDLINE    
BACKGROUND/AIMS: Many therapies have been tried in primary biliary cirrhosis. It has been suggested that a combination of ursodeoxycholic acid and methotrexate may offer advantages. Because the benefit and safety of this combination is uncertain, we conducted this prospective, randomized, double-blind, controlled trial. METHODS: Twenty-five patients with well-defined primary biliary cirrhosis were randomly assigned to receive either ursodeoxycholic acid (500 mg/day) plus methotrexate (10 mg/week) or ursodeoxycholic acid plus placebo for a period of 48 weeks. Clinical, biochemical and histologic evolution were assessed. RESULTS: In both groups the clinical response was similar and heterogeneous. In patients of ursodeoxycholic acid alone group, biochemical and histologic changes were comparable to those of patients of ursodeoxycholic acid plus methotrexate at 48 weeks. The addition of methotrexate was not associated with substantial adverse affects. CONCLUSIONS: The use of methotrexate in combination with ursodeoxycholic acid was not followed by an additive benefit over ursodeoxycholic acid alone, nor was substantial toxicity added. Unless larger and longer controlled trials with clinical, biochemical and histologic controls show it to be a safe and effective therapy for primary biliary cirrhosis, ursodeoxycholic acid+methotrexate should not be used as a proven and accepted treatment.
A González-Koch; J Brahm; C Antezana; G Smok; M A Cumsille
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Journal of hepatology     Volume:  27     ISSN:  0168-8278     ISO Abbreviation:  J. Hepatol.     Publication Date:  1997 Jul 
Date Detail:
Created Date:  1997-09-25     Completed Date:  1997-09-25     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8503886     Medline TA:  J Hepatol     Country:  DENMARK    
Other Details:
Languages:  eng     Pagination:  143-9     Citation Subset:  IM    
Gastroenterology Center, University of Chile Clinical Hospital, Santiago.
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MeSH Terms
Cholagogues and Choleretics / administration & dosage,  adverse effects,  therapeutic use*
Double-Blind Method
Drug Therapy, Combination
Liver / drug effects,  pathology
Liver Cirrhosis, Biliary / blood,  drug therapy*,  pathology
Methotrexate / administration & dosage,  adverse effects,  therapeutic use*
Middle Aged
Prospective Studies
Treatment Outcome
Ursodeoxycholic Acid / administration & dosage,  adverse effects,  therapeutic use*
Reg. No./Substance:
0/Cholagogues and Choleretics; 128-13-2/Ursodeoxycholic Acid; 59-05-2/Methotrexate

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