Applicability of Two Clinical Scales for Causality Assessment in Acute Liver Injury Caused by Herbal Medicines or Health Tonics

Lee, Seung Hwan; Kim, Dae Hyun; Seo, Tae Jin; Cho, Seok; Jung, Phil Jin; Park, Chang Hwan; Lee, Wan Sik; Joo, Young Eun; Kim, Hyun Soo; Choi, Sung Kyu; Ryu, Jong Sun; Kim, Sei Jong

Abstract

There are no specific diagnostic markers for drug-induced liver injury. It is frequently diagnosed by subjective judgement of clinicians and the causal relationship is difficult to demonstrate. While causality assessment methods were developed, the availability in liver injury caused by herbal medicines has not been investigated. We applied RUCAM and M&V scale to 121 paitents of liver injury and compared the scores. 68 patients had liver injury by herbal medicines without other liver disease. The score of RUCAM and M&V scale was 7.3+/-1.5 and 10.0+/-3.7, repectively. All the patients were included in 'definte', 'probable', and 'possible' grade by RUCAM scale, while only 63.2% were in 'probable' and 'possible' grade by M&V scale. The concordance rate of two scales was 6.8%. 53 patients had another possible cause of liver injury. The score of RUCAM and M&V scale was 4.7+/-2.1 and 4.9+/-3.6, respectively. With RUCAM scale, 79.2% were 'probable', and 'possible' grade, while only 9.4% were 'possible' grade by M&V scale. The concordance rate of two scales was 5.7% and kappa concordance index in both groups was so low. RUCAM and M&V scale showed low concordance rate in predicting the possibility of drug-induced liver injury by herbal medicines. RUCAM scale showed higher sensitivity in causality assessment than M&V scale, but the discriminating power between drug-induced liver injury by herbal medicines and other liver injury was poor. Therefore, it is necessary to develop a new general method that can be used in patients with liver injury by herbal medicines.