Hepatoprotective effect of Antrodia Cinnamomea mycelia extract in subhealth Japanese adults: a randomized, double-blind, placebo-controlled clinical study

Abstract

Antrodia cinnamomea, a unique Taiwanese fungus (mushroom), has demonstrated the hepatoprotective activities in animals with liver injury. Nevertheless, there are few studies reporting the efficacy of the fungus in subhealth subjects (alanine aminotransferase (ALT) levels between 31 and 50 U/L and aspartate aminotransferase (AST) levels ≤ 50 U/L). In this study, we assessed the ameliorating effect of a A. cinnamomea mycelia extract (ACME) on liver health in asymptomatic individuals with marginally high ALT levels. Forty-four eligible Japanese adults were enrolled in this randomized, double-blind, placebo-controlled clinical study and instructed to take an ACME capsule (250 mg of ACME powder) or a placebo capsule daily for 12 weeks. The primary outcomes (i.e. ALT and AST) were analyzed at 0, 4, 8, and 12 weeks. No treatment-related adverse effects were observed throughout this study. In efficacy analyses with the per-protocol (PP) cohort of participants, there were no significant changes in ALT and AST levels within and between groups. However, subgroup analysis showed that ACME could significantly improve the mean ALT level of regular drinkers, consuming alcoholic drinks more than twice a week, after the study in comparison with the result of the placebo group. This exploratory study indicated that the ACME might effectively improve liver health in regular drinkers.