Systematic review of the incidence of herbal drug-induced liver injury in Korea.

ETHNOPHARMACOLOGICAL RELEVANCE: Herbal drugs have been generally believed to be safe, based on the natural sources and long clinical experience. With the increasing use of herbal medicine worldwide, the potential toxicity of herbal drugs, especially drug-induced liver injury (DILI), frequently becomes a medical issue. This study was aimed to estimate the incidence of DILI following herbal drug consumption in Korea

METHODS AND MATERIALS: A literature search for herbal DILI in eight databases, including PubMed, Medline, the Cochrane Library, EMBASE, and four Korean electronic databases.

RESULTS: Six studies (three prospective and three retrospective) met the necessary criteria for assessment of the risk of DILI following herbal medicine exposure. The total number of participants in the six studies was 1699 (756 males and 943 females), and the incidence of herbal DILI varied from 0 to 1.92 among them. Total incidence of herbal DILI was 0.71% (12 patients with herbal DILI), and it was significantly higher in male (1.32%) than female (0.21%) respectively (p<0.01). All of the patients that experienced DILI concomitantly ingested herbal medicine and conventional drugs.

CONCLUSIONS: This result showed the comprehensive data indicating the incident risk of hepatotoxicity in patients using herbal drugs in Korea, and presented the possibility of increased risk for the DILI by concurrent administration of herbal and conventional medicines.