Objectives: To investigate the incidence of Korean herbal medicine(KHM; prescribed herbal medicine by doctors of traditional Korean medicine)-induced adverse effects combined used with Western medicine on liver function.
Methods: Sixty nine inpatients who took KHM and Western medicine for various conditions were enrolled for prospective observational study. All patients were given liver and renal function tests at the start of hospitalization(baseline) and at approximately 4-week intervals thereafter taking KHM and Western medicine. 69 patients had got analyzed AST(aspartic aminotransferase), ALT(alanine aminotransferase) and ALP(alkaline phosphatase), of them 63 patients had got analyzed TB(total bilirubin), DB(direct bilirubin). 66 patients had renal function tests(Blood Urea Nitrogen ; BUN, Creatinine; Crea., Uric acid). Of them 66 patients completed questionnaire. Data were analysed statistically.
Results:
1. Fifty three patients showed normal liver function test(LFT) at baseline, 50(72.5%) remained within the normal range at the second test while 3(4.3%) revealed slight increase of LFT. However no one had raised LFT regarding level of liver injury. Sixty one patients were normal LFT at the second test.
2. Sixteen of 69 patients were abnormal at baseline, 11 recovered to normal and 5 remained at abnormal. Eight of 69 patients were abnormal at the second LFT. Among them, there was no significant increase in LFT level between the first and second test.
3. The 5 most frequently used herbal medicines on patients with Abnormalized LFT were Glycyrrhiza glabra Linne, Angelica gigas, Atractylodes japonica koidzumi, Cimicifuga heraclerifolia, Bupleurum falcatum Linne but these herbal medicines were also used on other patients with normal LFT.
4. Age, gender, drinking, smoking didn''t have correlation with LFT changes.
Conclusions: The current study showed that the combined-prescription of KHM and Western medicine did not cause any Drug-Induced Liver Injury. In some cases, this combination treatment increased LFTs but those increases were slight not having statistical significance. Additional large scale and systematical nationwide studies are required.
Key Words: Drug-Induced Liver Injury(DILI), Herbal Medicine, Adverse Drug Reaction(ADR), Liver Fuction Tests(LFT)