title: Silymarin use and liver disease progression in the Hepatitis C Antiviral Long-Term Treatment against Cirrhosis trial.
abstract: BACKGROUND
  Silymarin is the most commonly used herbal product for chronic liver disease; yet, whether silymarin protects against liver disease progression remains unclear.
  
  
  OBJECTIVE
  To assess the effects of silymarin use on subsequent liver disease progression in 1049 patients of the Hepatitis C Antiviral Long-Term Treatment against Cirrhosis (HALT-C) trial who had advanced fibrosis or cirrhosis and had failed prior peginterferon plus ribavirin treatment.
  
  
  METHODS
  Patients recorded their use of silymarin at baseline and were followed up for liver disease progression (two point increase in Ishak fibrosis score across baseline, year 1.5, and year 3.5 biopsies) and over 8.65 years for clinical outcomes.
  
  
  RESULTS
  At baseline, 34% of patients had used silymarin, half of whom were current users. Use of silymarin was associated (P < 0.05) with male gender; oesophageal varices; higher ALT and albumin; and lower AST/ALT ratio, among other features. Baseline users had less hepatic collagen content on study biopsies and had less histological progression (HR: 0.57, 95% CI: 0.33-1.00; P-trend for longer duration of use=0.026). No effect was seen for clinical outcomes.
  
  
  CONCLUSIONS
  Silymarin use among patients with advanced hepatitis C-related liver disease is associated with reduced progression from fibrosis to cirrhosis, but has no impact on clinical outcomes (Clinicaltrials.gov #NCT00006164).
authors.affiliation: Nutritional Epidemiology Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Rockville, MD 20852, USA. freedmanne@mail.nih.gov
authors.forename: N D
authors.initials: ND
authors.lastname: Freedman
authors.forename: T M
authors.initials: TM
authors.lastname: Curto
authors.forename: C
authors.initials: C
authors.lastname: Morishima
authors.forename: L B
authors.initials: LB
authors.lastname: Seeff
authors.forename: Z D
authors.initials: ZD
authors.lastname: Goodman
authors.forename: E C
authors.initials: EC
authors.lastname: Wright
authors.forename: R
authors.initials: R
authors.lastname: Sinha
authors.forename: J E
authors.initials: JE
authors.lastname: Everhart
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use*; D018450:Disease Progression; D005260:Female; D006526:Hepatitis C / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008103:Liver Cirrhosis / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D028321:Plant Preparations / Q000627:therapeutic use; D020011:Protective Agents / Q000627:therapeutic use; D012838:Silymarin / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D028321:Plant Preparations; D020011:Protective Agents; D012838:Silymarin