Double-blinded placebo-controlled study of Phyllanthus urinaris for the treatment of chronic hepatitis B

Background: Previous studies suggested that Phyllanthus species have an anti-viral effect on hepatitis B, but methodologies have been inadequate. Aims: This study aimed to investigate the anti-viral effect of Phyllanthus urinaris . Methods: Chronic hepatitis B patients with positive hepatitis B e-antigen (HBeAg), hepatitis B virus (HBV) DNA>500 000 copies/mL and elevated alanine transaminase (ALT) were recruited. Patients were randomized into groups of 12 receiving P. urinaris 1, 2 and 3 g three times daily for 6 months or placebo (six cases). The primary endpoint was HBV DNA reduction, and secondary endpoints were HBeAg seroconversion and ALT normalization. Results: On an intention-to-treat analysis there was no difference in log(10) [HBV DNA] reduction of the Phyllanthus 1-g (0.18+/-1.42), 2-g (0.33+/-1.08) and 3-g (0.85+/-1.30) groups vs. placebo (0.28+/-0.85) (P=0.90, 0.92 and 0.38, respectively) at the end of treatment. The percentage of patients among the placebo, Phyllanthus 1-g, 2-g and 3-g groups undergoing HBeAg seroconversion (0%, 9.1%, 8.3% and 16.7%, respectively) and ALT normalization (0%, 0%, 8.3% and 33.3%) were not significantly different at the end of treatment. No delayed virological or biochemical response was documented at 24 weeks after the cessation of treatment. No serious adverse event was reported. Conclusion: P. urinaris treatment for 6 months has no demonstrable anti-viral effect in chronic hepatitis B.