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.

There is an increasing interest in the role of traditional Chinese medicine (TCM) in rheumatoid arthritis (RA), as evidenced by recent trials comparing their efficacy against established disease-modifying antirheumatic drugs. While the TCM in these trials seem to support a favorable cost-benefit ratio, many products are marketed under the guise of TCM, potentially exposing the user to unpredicted adverse events. We present the case of a patient with RA, who developed side effects from treatment with adulterated TCM. While TCM may be of value in the treatment of rheumatic diseases, their application in routine care continues to warrant careful consideration of safety and reliability.