Browse > Article

Safety of Prescribed Korean Herbal Medicine on Liver Function : Prospective Multi-center Pilot Study  

Yun, Young-Ju (Division of Standard Research. Korea Institute of Oriental Medicine)
Park, Jae-Heon (Department of Neuropsychiatry, College of Oriental Medicine, WonkWang University)
Paeck, Eun-Kyung (Haema Traditional Korean Medical Clinic)
Park, Jae-Hyung (Haema Traditional Korean Medical Clinic)
Jeong, Seul-Ki (Myungsung Traditional Korean Medical Clinic)
Park, Hae-Mo (Department of Preventive Medicine, College of Oriental Medicine, Sangji University)
Lee, Sun-Dong (Department of Preventive Medicine, College of Oriental Medicine, Sangji University)
Shin, Byung-Cheul (Department of Oriental Rehabilitation Medicine, School of Oriental Medicine, Pusan National University)
Publication Information
Journal of Physiology & Pathology in Korean Medicine / v.23, no.3, 2009 , pp. 715-722 More about this Journal
Abstract
The aim of this study was to investigate the safety of short-term use of Korean herbal medicine (KHM; prescribed herbal medicine by doctors of traditional Korean medicine) on liver function. Three hundred eighty four outpatients who took KHM for various conditions were enrolled for multi-center, prospective observational study. Of them 237 patients completed questionnaire and were checked liver function (aspartic aminotransferase;AST, alanine aminotransferase;ALT, alkaline phosphatase;ALP, total bilirubin;t-Bil, direct bilirubin;d-Bil, gamma glutamyltranspeptidase;GGT, protein and albumin) before and after taking KHM (duration; 21.4${\pm}$10.0 days), and data were analysed statistically. Of the 213 patients showing normal liver function test (LFT) at baseline, 209 (98.1%) remained within the normal range at the second test while 3 (1.4%) revealed slight increase of LFT. Only one subject had raised LFT regarding level of liver injury without perceived symptoms. Twenty-four of 237 patients were abnormal at baseline, and 16 at the second testing. Of the patients taking KHM, only 4 changed from normal to abnormal while 12 from abnormal to normal in their LFT. There were no significant increase in LFT level between the first and second test, except in the t-Bil level, however, the change of t-Bil was small and within normal range. The current study showed that the use of KHM did not increase the frequency of abnormal LFTs, at least in the short term.
Keywords
korean herbal medicine(KHM); liver function test(LFT); drug induced liver injury(DILI); safety;
Citations & Related Records
Times Cited By KSCI : 6  (Citation Analysis)
연도 인용수 순위
1 Itoh, S., Marutani, K., Nishijima, T., Matsuo, S., Itabashi, M. Liver injuries induced by herbal medicine, syo-saiko-to(xiao-chai-hu-tang). Dig Dis Sci. 40(8):1845-1848, 1995   DOI   ScienceOn
2 Li, B., Wang, Z., Fang, J.J., Xu, C.Y., Chen, W.X. Evaluation of prognostic markers in severe drug-induced liver disease. World J Gastroenterol. 13(4):628-632, 2007   DOI
3 이용연, 송기철, 최병렬, 서상훈, 유화승, 최우진, 조정효, 이연월, 손창규, 조종관. 가미청간산을 투여한 알콜성 간질환 환자 25예에 대한 임상보고. 대한한방내과학회지 22(4): 613-619, 2001
4 김동준. 독성 간손상의 진단 및 보고체계 구축을 위한 다기관 공동연구. 독성물질국가관리사업연구보고서, 5: 402-405. 2006
5 안병민. 식물제제에 의한 간손상. 대한소화기학회, 44: 113- 125, 2004
6 이시형, 박정섭, 여현수, 최유경, 전찬용, 박종형, 김동우. 입원환자 한약투여와 약인성 간손상과의 관계. 대한한방내과학회지 27(3):572-578, 2006   과학기술학회마을
7 안병민. 급성 독성 간염: 원인 산정법 적용의 실제에 대하여. 대한간학회지 12(1):1-4, 2006
8 Li, J., Li, S., Du, N., Dong, Y., Xiao, X., Yang, Y., Li, L. Effects of applying integrated therapy with traditional Chinese medicine and western medicine on liver and kidney functions in patients with SARS(Report 6). Clinical trials on treatment using a combination of traditional Chinese medicine and western medicine. WHO report. pp 98-110, 2004
9 Al-Khafaji, M. Monitoring of liver enzymes in patients on Chinese Medicine. J Chinese Med. 62: 6-10, 2000
10 Wai, C.T., Tan, B.H., Chan, C.L., Sutedja, D.S., Lee, Y.M., Khor, C., Lim, S.G. Drug-induced liver injury at an Asian center: a prospective study. Liver Int. 27(4):465-474, 2007   DOI   ScienceOn
11 Danan, G., Benichou, C. Causality assessment of adverse reactions to drugs - Ⅰ. A novel method based on the conclusions of international consensus meetings; applications to drug induced liver injuries. J Clin Epidemiol. 46: 1323-1330, 1993   DOI   ScienceOn
12 천우정, 윤병구, 김남일, 이구, 양창헌, 이창우, 서정일. 경주지역에서 식물제제에 의한 급성 간손상 환자의 임상적 고찰. 대한내과학회지 63(2):141-150, 2002
13 김영석, 노진환, 문상관, 조기호, 배형섭, 이경섭. 한약의 장기 투여가 간손상에 미치는 영향. 경희의학, 15(1):71-77, 1999
14 Kim, H.C., Nam, C.H., Jee, S.H., Han, K.H., Oh, D.K., Suh, I. Normal serum aminotransferase concenrtration and risk of mortality from liver disease: prospective cohort study. BMJ. 328(7446):981-986, 2004
15 MacPherson, H., Liu, B. The safety of Chinese herbal medicine: A pilot Study for a national survey. J Altern Complement Med. 11(4):617-626, 2005   DOI   ScienceOn
16 이종태. 한국인의 한약재 복용실태 조사 연구. 식품의약품안전청 연구결과보고서, 2006
17 김강모, 김윤준, 이광혁, 백도명. 연속적으로 시행한 공장 근로자 건강검진에서 무증상 간기능검사 이상자의 임상적 특성. 대한간학회지 11(2):133-156, 2005
18 Melchart, D., Linde, K., Hager, S., Kaesmayr, J., Shaw, D., Bauer, R., Weidenhammer, W., Monitoring of liver enzymes in patients treated with traditional Chinese drugs. Complement Ther Med. 7: 208-216, 1999   DOI   ScienceOn
19 김병운. 만성간염 3,136례에 대한 임상분석과 생간건비탕의 치료효과. 대한한의학회지 14(1):216-223, 1993
20 Benichou, C. Criteria of drug-induced liver disorders -Report of an International Consensus Meeting. J Hepatol. 11: 272-276, 1990   DOI   ScienceOn
21 이상욱, 박성욱, 이형철, 고창남, 윤성우, 한지영. 뇌졸중환자에서 한약과 양약의 병용투여가 간장 및 신장에 미치는 영향. 대한한방내과학회지 24(1):68-74, 2003   과학기술학회마을
22 Pittler, M.H., Ernst, E. Systematic Review : hepatotoxic events associated with herbal medicinal products. Aliment Pharmacol Ther. 18: 451-471, 2003   DOI   ScienceOn
23 Nadir, A., Agrawai, S., King, P.D., Marshall, J.B. Acute hepatitis associated with the use of a Chinese herbal product, ma-huang. Am J Gastrenterol 91(7):1436-1438, 1996
24 Mantani, N., Kogure, T., Sakai, S., Goto, H., Shibahara, N., Kita, T., Shimada, Y., Terasawa, K. Incidence and clinical features of liver injury related to Kampo (Japanese herbal) medicine in 2,496 cases between 1979 and 1999: Problems of the lymphocyte transformation test as a diagnostic method. Phytomedicine. 9: 280-287, 2002   DOI   ScienceOn
25 안병민, 이동수, 백종태, 장성희, 장이선. 식물제제에 의한 간손상의 빈도. 독성물질국가관리사업연구보고서, 1: 569-578, 2002
26 Meier, Y., Cavallaro, M., Roos, M., Pauli-Magnus, C., Folkers, G., Meier, P.J., Fattinger, K. Incidence of drug-induced liver injury in medical inpatients. Eur J Clin Pharmacol. 61(2):135-143, 2005   DOI   ScienceOn