Safety of Korean Herbal Medicine Used with Western Medicine on Liver Function
: Prospective Observational Study

Bae, Su-hyun; Park, Sang-eun; Kang, Chang-wan; Hong, Sang-hoon

The Journal of Internal Korean Medicine > Volume 34(2); 2013 > Article

Original Article

The Journal of Internal Korean Medicine 2013;34(2): 192-203.

한방병원 입원환자의 한⋅양방 약물 병용에 따른 간 기능 안전성 평가 : 전향적 관찰연구

배수현¹, 박상은², 강창완³, 홍상훈¹

¹동의대학교 부속 동의의료원 한방내과
²동의대학교 부속 울산한방병원 한방내과
³동의대학교 데이터정보학과

Safety of Korean Herbal Medicine Used with Western Medicine on Liver Function : Prospective Observational Study

Su-hyun Bae¹, Sang-eun Park², Chang-wan Kang³, Sang-hoon Hong¹

¹Dept. of Oriental Internal Medicine, College of Oriental Medicine, Dong-Eui University, Dong-Eui Medial Center
²Dept. of Oriental Internal Medicine, College of Oriental Medicine, Dong-Eui University, Ul-san Hospital
³Dept. of Data Information Science, College of Natural Science, Dong-Eui University

Correspondence

Sang-hoon Hong ,Tel: 051-850-8810, Fax: 051-867-5162, Email: shhong@deu.ac.kr

Published online: June 30, 2013.

ABSTRACT

Objectives:
To investigate the incidence of drug-induced liver injury (DILI) by combined-prescription of Korean herbal medicine (KHM; prescribed herbal medicine by doctors of traditional Korean medicine) and Western medicine on liver function.

Methods :
Sixty-nine in-patients who took KHM and Western medicine for various conditions were enrolled for prospective observational study. All subjects were given liver and renal function tests at the start of hospitalization to establish a baseline. After taking KHM and Western medicine, tests were done at approximately 4-week intervals afterwards.

Results:
Fifty-three subjects showed normal liver function test (LFT) at baseline, 50 subjects (72.5%) remained within the normal range at the second test, while 3 subjects (4.3%) tests revealed slight increase of LFT. However not a single patient had a high enough raised LFT to indicate liver injury. Sixteen of 69 subjects had abnormal baseline, 11 subjects recovered to normal levels and 5 subjects remained at abnormal level. Among all subjects, there was no statistically significant increase in LFT level between the first and second tests.

Conclusions:
This study shows that the combined-prescription of KHM and Western medicine did not cause any DILI. In some cases, combined treatment increased LFT levels but those increases were not high enough to have statistical significance. Additional large scale and systematical studies are required for more conclusive proof and results.

Key words: drug-induced liver injury, herbal medicine, adverse drug reaction, liver function tests