Background: As Phyllanthus niruri has been shown to have anti-inflammatory, antioxidant and hepatoprotective properties, the current study was designed to examine its efficacy and safety in non-alcoholic steatohepatitis (NASH) treatment. Methods: Fifty-two patients with biopsy-proven possible or definite NASH from eight hospitals across Malaysia were randomized (1:1) to receive two capsules of Phyllanthus niruri (Hepar-P®; n=25) or matched placebo (n=27) three times daily for 48 weeks. The primary endpoint of efficacy was the changes in aspartate transaminase (AST) and alanine transaminase (ALT) levels, while the other biochemical, anthropometric and histological changes were used as the secondary endpoints. Safety of treatment was confirmed through adverse events (AEs) reporting, physical examination and regular monitoring of blood parameters. Results: After 48 weeks of treatment, the changes in the AST (p=0.39) and ALT (p>0.95) levels did not significantly differ between the Phyllanthus and placebo groups. There were also no significant differences in the changes of body mass index, HbA1C and lipid profile between the two groups. Furthermore, six patients in the Phyllanthus group consented to repeat biopsy at week 48, and no histological changes of clinical significance were observed. Mild or moderate AEs occurred throughout the study period in 76.9% of the patients, but were not significantly different between the two groups (p=0.42). Conclusion: Although Phyllanthus niruri was generally well tolerated with no significant safety concerns, the current study was unable to demonstrate its clinical benefits in NASH treatment.
Key words: Hepatocellular carcinoma, liver cirrhosis, Malaysia, non-alcoholic fatty liver disease, Phyllanthus.