title: Multicentre randomized placebo-controlled trial of ursodeoxycholic acid with or without colchicine in symptomatic primary biliary cirrhosis.
abstract: OBJECTIVE
  To establish the efficacy of combination therapy with ursodeoxycholic acid (UDCA) and colchicine in patients with symptomatic primary biliary cirrhosis (PBC), defined by the presence of liver cirrhosis, pruritus or bilirubin exceeding 2 mg/mL.
  
  
  METHODS
  A total of 90 patients were randomly assigned to ursodeoxycholic acid 500 mg/daily plus placebo (UDCA group, n=44), or ursodeoxycholic acid at the same dosage plus colchicine, 1 mg/daily (UDCA/C group, n=46). The two groups were comparable for age, sex, stage of disease, severity of pruritus, bilirubin, and Mayo score. All patients underwent clinical, ultrasonographic, and biochemical examinations at entry and then every 6 months up to 3 years of follow-up. Patients with cirrhosis underwent endoscopy every 12 months. In a sub-group of patients without cirrhosis, who consented, liver biopsy was repeated at the end of the study.
  
  
  RESULTS
  The number of treatment failures (i.e. dead, orthotopic liver transplantation (OLT), complications of cirrhosis, doubling of bilirubin, untreatable pruritus) was 11 (25%) in the UDCA group and four (9%) in the UDCA/C group (P < 0.05). No significant differences were observed in terms of improvement of liver enzymes related to cholestasis and cytolysis and of amelioration of pruritus. The Mayo score values increased less above the baseline values at 24 and 36 month-intervals in the UDCA/C group than in the UDCA group. Histological evaluation at baseline and at the end of the study was available for 15 patients with pre-cirrhotic stage. A significant reduction in histological grading score was observed in patients from the UDCA/C group, whereas no changes in these histological scores were observed in the UDCA group.
  
  
  CONCLUSIONS
  The addition of colchicine to ursodeoxycholic acid in patients with symptomatic primary biliary cirrhosis results in a small but significant reduction of disease progress.
authors: Cattedra di Gastroenterologia, Dipartimento Biomedico di Medicina Interna e Specialistica, University of Palermo, Palermo, Italy. palmasio@unipa.it
authors: P L
authors: PL
authors: Almasio
authors: A
authors: A
authors: Floreani
authors: M
authors: M
authors: Chiaramonte
authors: G
authors: G
authors: Provenzano
authors: P
authors: P
authors: Battezzati
authors: A
authors: A
authors: Crosignani
authors: M
authors: M
authors: Podda
authors: L
authors: L
authors: Todros
authors: F
authors: F
authors: Rosina
authors: G
authors: G
authors: Saccoccio
authors: F
authors: F
authors: Manenti
authors: G
authors: G
authors: Ballardini
authors: F P
authors: FP
authors: Bianchi
authors: P J
authors: PJ
authors: Scheuer
authors: S E
authors: SE
authors: Davies
authors: A
authors: A
authors: Craxì
mesh_terms: D000328:Adult; D000368:Aged; D001706:Biopsy; D003078:Colchicine / Q000008:administration & dosage*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008099:Liver / Q000473:pathology; D008105:Liver Cirrhosis, Biliary / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D014580:Ursodeoxycholic Acid / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D014580:Ursodeoxycholic Acid; D003078:Colchicine