Ursodeoxycholic acid for primary biliary cirrhosis: final results of a 12-year, prospective, randomized, controlled trial. 2002

George V Papatheodoridis, and Emilia S Hadziyannis, and Melanie Deutsch, and Stephanos J Hadziyannis
Academic Department of Medicine, Hippokration General Hospital, Athens, Greece.

OBJECTIVE The aim of this study was to evaluate whether ursodeoxycholic acid (UDCA) has any effect on the development of liver decompensation and on survival of patients with primary biliary cirrhosis (PBC). METHODS A total of 86 patients with compensated PBC were randomly assigned to receive UDCA (n = 43) or to remain untreated (controls, n = 43). There was no significant difference in the baseline characteristics between the two groups. Mean follow-up was 7.3 +/- 3.0 yr in the UDCA and 8.1 +/- 3.1 yr in the control group. Fourteen control patients were crossed-over to UDCA therapy after a median of 3.5 yr (range 2-8 yr), at their own request. RESULTS Liver decompensation developed in 41 patients (22 in the UDCA and 19 in the control group) and liver death or transplantation in 33 (19 in the UDCA and 14 in the control group) patients. There was no significant difference in the probability of development of liver decompensation, liver death, or transplantation (by log-rank test) between UDCA-treated and control patients, whether by an intention-to-treat or by treatment-as-received analysis. CONCLUSIONS UDCA was not found to have any demonstrable effect on the long-term outcome of PBC and did not improve the survival of PBC patients.

UI MeSH Term Description Entries
D008105 Liver Cirrhosis, Biliary FIBROSIS of the hepatic parenchyma due to obstruction of BILE flow (CHOLESTASIS) in the intrahepatic or extrahepatic bile ducts (BILE DUCTS, INTRAHEPATIC; BILE DUCTS, EXTRAHEPATIC). Primary biliary cholangitis involves the destruction of small intra-hepatic bile ducts and decreased bile secretion. Secondary biliary cholangitis is produced by prolonged obstruction of large intrahepatic or extrahepatic bile ducts from a variety of causes. Biliary Cirrhosis,Biliary Cirrhosis, Primary,Biliary Cirrhosis, Secondary,Cholangitis, Chronic Nonsuppurative Destructive,Liver Cirrhosis, Obstructive,Primary Biliary Cholangitis,Biliary Cirrhosis, Primary, 1,Primary Biliary Cirrhosis,Secondary Biliary Cholangitis,Secondary Biliary Cirrhosis,Biliary Cholangitides, Primary,Biliary Cholangitis, Primary,Biliary Cholangitis, Secondary,Cholangitides, Primary Biliary,Cholangitis, Primary Biliary,Cholangitis, Secondary Biliary,Cirrhosis, Biliary,Cirrhosis, Secondary Biliary,Liver Cirrhoses, Biliary,Obstructive Liver Cirrhosis,Primary Biliary Cholangitides,Secondary Biliary Cholangitides
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D011446 Prospective Studies Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group. Prospective Study,Studies, Prospective,Study, Prospective
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D014580 Ursodeoxycholic Acid An epimer of chenodeoxycholic acid. It is a mammalian bile acid found first in the bear and is apparently either a precursor or a product of chenodeoxycholate. Its administration changes the composition of bile and may dissolve gallstones. It is used as a cholagogue and choleretic. Deoxyursocholic Acid,3 alpha,7 beta-Dihydroxy-5 beta-cholan-24-oic Acid,Cholit-Ursan,Cholofalk,Delursan,Destolit,Sodium Ursodeoxycholate,Urdox,Ursacholic Acid,Urso,Urso Heumann,Ursobilane,Ursochol,Ursodiol,Ursofalk,Ursogal,Ursolite,Ursolvan,3 alpha,7 beta Dihydroxy 5 beta cholan 24 oic Acid,Acid, Deoxyursocholic,Acid, Ursacholic,Acid, Ursodeoxycholic,Ursodeoxycholate, Sodium
D016009 Chi-Square Distribution A distribution in which a variable is distributed like the sum of the squares of any given independent random variable, each of which has a normal distribution with mean of zero and variance of one. The chi-square test is a statistical test based on comparison of a test statistic to a chi-square distribution. The oldest of these tests are used to detect whether two or more population distributions differ from one another. Chi-Square Test,Chi Square Distribution,Chi Square Test,Chi-Square Distributions,Chi-Square Tests,Distribution, Chi-Square,Distributions, Chi-Square,Test, Chi-Square,Tests, Chi-Square
D016016 Proportional Hazards Models Statistical models used in survival analysis that assert that the effect of the study factors on the hazard rate in the study population is multiplicative and does not change over time. Cox Model,Cox Proportional Hazards Model,Hazard Model,Hazards Model,Hazards Models,Models, Proportional Hazards,Proportional Hazard Model,Proportional Hazards Model,Cox Models,Cox Proportional Hazards Models,Hazard Models,Proportional Hazard Models,Hazard Model, Proportional,Hazard Models, Proportional,Hazards Model, Proportional,Hazards Models, Proportional,Model, Cox,Model, Hazard,Model, Hazards,Model, Proportional Hazard,Model, Proportional Hazards,Models, Cox,Models, Hazard,Models, Hazards,Models, Proportional Hazard
D016019 Survival Analysis A class of statistical procedures for estimating the survival function (function of time, starting with a population 100% well at a given time and providing the percentage of the population still well at later times). The survival analysis is then used for making inferences about the effects of treatments, prognostic factors, exposures, and other covariates on the function. Analysis, Survival,Analyses, Survival,Survival Analyses

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