Incidence of Herb-induced Liver Injury Caused by Kampo Formulae Containing Scutellariae Radix

Abstract

Objective: Herb-induced liver injury due to Kampo formulae is a clinically relevant adverse effect, which may be associated with formulae containing Scutellariae Radix. We explored this incident relationship further by surveying outpatients treated with a Kampo formula containing Scutellariae Radix (KFCSR) at our clinic.

Methods: We included patients who had been treated with a novel KFSCR formulation between November 2014 and October 2015. The participants underwent liver injury-related blood tests (examining the aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transpeptidase, and total bilirubin levels, as well as the percentage of eosinophils in the white blood cell count) before and after treatment to evaluate its efficacy.

Results: In total, 43 of the 363 patients treated during the study period received KFCSRs and 37 underwent blood tests before and after treatment. Liver injury occurred in four patients (10.8%) and all patients recovered quickly after cessation of the formula.

Conclusions: We found that 10.8% of patients treated with KFCSR developed liver injury, which was higher than that reported previously. We believe that herb-induced liver injury should be seriously considered as a risk factor for KFCSRs. Further investigation is warranted to verify these results.