Traditional Chinese medicine causing hepatotoxicity in patients with chronic hepatitis B infection: a 1-year prospective study.

BACKGROUND: Safety of traditional Chinese medicine in patients with chronic hepatitis B is unknown. AIM: To study the clinical outcome of traditional Chinese medicine-induced hepatotoxicity in chronic hepatitis B patients. PATIENTS AND METHODS: All chronic hepatitis B patients in 2004 with liver dysfunction requiring hospitalization were screened prospectively for traditional Chinese medicine intake. The hepatotoxicity of individual traditional Chinese medicine elements was determined by extensive search of both English and Chinese publications.
RESULTS: Of 45 chronic hepatitis B patients, the liver dysfunction in seven (15.6%) was attributable to traditional Chinese medicine. All had liver dysfunction pattern resembling those of acute exacerbation of chronic hepatitis B. Three patients had adverse outcomes (two deaths, one liver transplantation). One patient had accelerated course of cirrhosis now awaiting liver transplantation. The identified hepatotoxic components were Polygonum multiflorum Thunb, Cassia obtusifolia L, Melia toosendan Sieb., Rheum palmatum L., Scolopendra subspinipes mutilans L, Alisma orientale Juzepe, Glycyrrhiza uralensis Fisch. and Mentha haplocalyx Briq. One traditional Chinese medicine formula was adulterated with a highly hepatotoxic agent, N-nitrosofenfluramine.
CONCLUSIONS: Traditional Chinese medicine-related hepatotoxicity resulted in high mortality in chronic hepatitis B patients. Prospective randomized-controlled trials with the same stringent criteria as western medicine clinical trials are required for Chinese medicines, to document their efficacies and safety before they can be advocated for the treatment of patients.