Drug-induced liver injury associated with Complementary and Alternative Medicine: a review of adverse event reports in an Asian community from 2009 to 2014

BMC Complementary and Alternative Medicine

Research Article

Sui Yung Chan¹  Desmond Chun Hwee Teo¹  Han Hui Cheong²  Siew Har Tan³  Adena Theen Lim³  Patricia Suet Leng Ng³  Dorothy Su Lin Toh³ 

[1] Department of Pharmacy, Faculty of Science, National University of Singapore, Block S4A Level 3, 18 Science Drive 4, S117543, Singapore, Republic of Singapore;Department of Pharmacy, Faculty of Science, National University of Singapore, Block S4A Level 3, 18 Science Drive 4, S117543, Singapore, Republic of Singapore;Department of Pharmacy, KK Women’s and Children’s Hospital, 100 Bukit Timah Road, 229899, Singapore, Singapore;Vigilance and Compliance Branch, Health Sciences Authority Singapore, 11 Biopolis Way, #11-03, Helios, 138667, Singapore, Singapore;

关键词: Hepatotoxicity;    Complementary and Alternative Medicine;    Adverse event;    Traditional Chinese Medicine;   

DOI  :  10.1186/s12906-016-1168-z

 received in 2015-10-06, accepted in 2016-06-14,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundThe use of Complementary and Alternative Medicine (CAM) has been increasing over the years. A recent review of adverse event reports (AERs) associated with CAM in Singapore found a notable number of AERs submitted. The objectives of this study are to analyse hepatotoxicity cases associated with CAM in Singapore based on spontaneous adverse event reporting to the Health Sciences Authority (HSA), and to highlight safety signals for specific herbal ingredients.MethodsAERs associated with CAM and hepatotoxicity submitted to the Vigilance and Compliance Branch (VCB) of the HSA from 2009 to 2014 were compiled. The following information was extracted and analysed: Demographic information; time to onset; hospitalisation status; outcome; type of hepatotoxicity; ingredients of CAM, and the total daily doses (TDD); concurrent western medicines and health supplements; and reporter details.ResultsFifty-seven reports were eligible for analysis. Thirty-five (61.4 %) cases involved Traditional Chinese Medicine (TCM). The Roussel Uclaf Causality Assessment Method was applied in 29 (82.9 %) of these cases, and the median score was 4 (range: 1–8). Chai Hu (Radix bupleuri) was suspected in 11 (31.4 %) cases. TDDs of most ingredients were within recommended doses of the Chinese Pharmacopoeia.ConclusionsDrug-induced liver injury is still poorly understood and more objective assessments are warranted. Reporting of adverse events should be strongly advocated to facilitate future analyses and the understanding of risk-benefit profiles of CAM.

【 授权许可】

CC BY   
© The Author(s). 2016

【 图 表 】

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