title: Treatment of non-alcoholic steatohepatitis with Phyllanthus urinaria: a randomized trial.
abstract: OBJECTIVE
  Non-alcoholic steatohepatitis (NASH) is a common liver disease that may progress to cirrhosis and hepatocellular carcinoma. There is currently no approved pharmacological treatment for NASH. Phyllanthus urinaria is a commonly used hepatoprotective herb that ameliorates NASH in animal studies. We aimed to test the hypothesis that Phyllanthus was superior to placebo in improving histological non-alcoholic fatty liver disease (NAFLD) activity score.
  
  
  METHODS
  This was a placebo-controlled parallel-group double-blind randomized controlled trial. Patients with histology-proven NASH were randomized to receive Phyllanthus or placebo for 24 weeks. The primary endpoint was change in NAFLD activity score from baseline to week 24. Secondary endpoints included changes in individual histological parameters, liver biochemistry and metabolic profile.
  
  
  RESULTS
  We enrolled 60 patients (40 received Phyllanthus and 20 received placebo). The change in NAFLD activity score was -0.8 ± 1.4 in the Phyllanthus group and -0.3 ± 1.3 in the placebo group (P = 0.24). The change in steatosis, lobular inflammation, ballooning and fibrosis was also similar between the two groups. Within the Phyllanthus group, although there was reduction in hepatic steatosis (-0.2 ± 0.7; P = 0.039) and ballooning grades (-0.4 ± 0.5; P < 0.001), the change was small and of limited clinical significance. Furthermore, there was no significant difference in the changes in alanine aminotransferase, aspartate aminotransferase, fasting glucose and lipid profile between the two groups.
  
  
  CONCLUSIONS
  Phyllanthus is not superior to placebo in improving NAFLD activity score in NASH patients.
authors.affiliation: Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China.
authors.forename: Vincent Wai-Sun
authors.initials: VW
authors.lastname: Wong
authors.forename: Grace Lai-Hung
authors.initials: GL
authors.lastname: Wong
authors.forename: Anthony Wing-Hung
authors.initials: AW
authors.lastname: Chan
authors.forename: Winnie Chiu-Wing
authors.initials: WC
authors.lastname: Chu
authors.forename: Paul Cheung-Lung
authors.initials: PC
authors.lastname: Choi
authors.forename: Angel Mei-Ling
authors.initials: AM
authors.lastname: Chim
authors.forename: Karen Kar-Lum
authors.initials: KK
authors.lastname: Yiu
authors.forename: Jun
authors.initials: J
authors.lastname: Yu
authors.forename: Francis Ka-Leung
authors.initials: FK
authors.lastname: Chan
authors.forename: Henry Lik-Yuen
authors.initials: HL
authors.lastname: Chan
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D004311:Double-Blind Method; D005234:Fatty Liver / Q000097:blood / Q000188:drug therapy* / Q000473:pathology*; D005260:Female; D005951:Glucose Tolerance Test; D006801:Humans; D008297:Male; D008875:Middle Aged; D065626:Non-alcoholic Fatty Liver Disease; D029803:Phyllanthus; D008517:Phytotherapy; D028321:Plant Preparations / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric
chemical_list: D008078:Cholesterol, LDL; D028321:Plant Preparations; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase