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

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.