Treatment of non-alcoholic steatohepatitis with Phyllanthus urinaria: A randomized trial

Authors

  • Vincent Wai-Sun Wong,

    1. Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China
    2. Department of Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China
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  • Grace Lai-Hung Wong,

    1. Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China
    2. Department of Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China
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  • Anthony Wing-Hung Chan,

    1. Department of Anatomical and Cellular Pathology, The Chinese University of Hong Kong, Hong Kong, China
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  • Winnie Chiu-Wing Chu,

    1. Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China
    2. Department of Imaging and Interventional Radiology, The Chinese University of Hong Kong, Hong Kong, China
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  • Paul Cheung-Lung Choi,

    1. Department of Anatomical and Cellular Pathology, The Chinese University of Hong Kong, Hong Kong, China
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  • Angel Mei-Ling Chim,

    1. Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China
    2. Department of Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China
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  • Karen Kar-Lum Yiu,

    1. Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China
    2. Department of Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China
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  • Jun Yu,

    1. Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China
    2. Department of Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China
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  • Francis Ka-Leung Chan,

    1. Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China
    2. Department of Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China
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  • Henry Lik-Yuen Chan

    Corresponding author
    1. Department of Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China
    • Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China
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  • Clinical trial registration: ClinicalTrials.gov (NCT01210989).

Correspondence

Dr Henry Chan, 9/F, Department of Medicine and Therapeutics, Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin, Hong Kong. E-mail: hlychan@cuhk.edu.hk

Abstract

Background and Aims

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.

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