Document Detail

Ursodeoxycholic acid in the treatment of primary biliary cirrhosis: a short-term, randomized, double-blind controlled, cross-over study with long-term follow up.
MedLine Citation:
PMID:  8100153     Owner:  NLM     Status:  MEDLINE    
In order to evaluate the efficacy of ursodeoxycholic acid (UDCA) in the treatment of Chinese patients with primary biliary cirrhosis, a short-term, randomized, double-blind controlled, cross-over study was done with long-term follow up. In the first part of the study, 12 patients were randomly chosen to receive either UDCA 600 mg/day for 3 months followed by a placebo for 3 months or a placebo for 3 months followed by UDCA for 3 months. The clinical symptoms of pruritus improved when the patients were receiving UDCA but became worse when receiving a placebo. Mean serum levels of alkaline phosphatase (ALPase), gamma-glutamyl transferase (gamma-GT), total bilirubin, cholesterol, alanine aminotransferase (ALT) and aspartate aminotransferase all decreased below the baseline values when receiving UDCA treatment and all increased above the baseline values when receiving the placebo. The difference was statistically significant. In the second part of the study, 19 patients received long-term UDCA treatment (mean 20 months). The clinical symptoms of pruritus improved in 90% of the pruritic patients. Serum levels of ALPase, gamma-GT and ALT fell significantly from the pretreatment values, 6, 12 and from the mean 20 months after UDCA treatment. Serum levels of total bilirubin fell significantly 6 and 12 months after UDCA treatment but did not reach statistical significance at the last follow up. No patient lost antimitochondrial antibody and elevated immunoglobulin levels did not improve significantly, but the Mayo clinical risk score improved significantly after long-term UDCA treatment.(ABSTRACT TRUNCATED AT 250 WORDS)
S J Hwang; C Y Chan; S D Lee; J C Wu; S H Tsay; K J Lo
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of gastroenterology and hepatology     Volume:  8     ISSN:  0815-9319     ISO Abbreviation:  J. Gastroenterol. Hepatol.     Publication Date:    1993 May-Jun
Date Detail:
Created Date:  1993-07-29     Completed Date:  1993-07-29     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8607909     Medline TA:  J Gastroenterol Hepatol     Country:  AUSTRALIA    
Other Details:
Languages:  eng     Pagination:  217-23     Citation Subset:  IM    
Department of Medicine, Veterans General Hospital-Taipei, Taiwan, Republic of China.
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MeSH Terms
Alkaline Phosphatase / blood
Bilirubin / blood
Cholesterol / blood
Double-Blind Method
Follow-Up Studies
Liver Cirrhosis, Biliary / blood,  drug therapy*
Middle Aged
Serum Albumin / analysis
Ursodeoxycholic Acid / adverse effects,  therapeutic use*
gamma-Glutamyltransferase / blood
Reg. No./Substance:
0/Serum Albumin; 128-13-2/Ursodeoxycholic Acid; 57-88-5/Cholesterol; 635-65-4/Bilirubin; EC; EC Phosphatase

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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