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

YUEN, M.‐F., TAM, S., FUNG, J., WONG, D. K.‐H., WONG, B. C.‐Y., LAI, C.‐L.·2006·Alimentary Pharmacology & Therapeutics

Abstract

Summary: 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.

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  • Starting as early as 2006 with an analysis from Hong Kong, an overall 21 reports of HILI cases were published which had been assessed for causality using RUCAM with results presented by groups with first authors having their working place in mainland China, Hong Kong, or Taiwan.

    “Starting as early as 2006 with an analysis from Hong Kong,18 an overall 21 reports of HILI cases were published which had been assessed for causality using RUCAM with results presented by groups with first authors having their working place in mainland China, Hong Kong, or Taiwan.18–38”
  • In other cases, RUCAM-based causality gradings were erroneously classified as definitive.

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  • On top among the Asian countries is currently China, best explained by the large population and heavy use of herbal traditional Chinese medicines, with increasing numbers of publications and cases until 2019.

    “On top among the Asian countries is currently China, best explained by the large population and heavy use of herbal traditional Chinese medicines (TCMs), with increasing numbers of publications and cases until 2019.18–38”
  • There is now increasing awareness of the benefits provided by RUCAM among various countries, including China, Korea, and Singapore, as evidenced by reports initially published in 2004 from Korea and in 2006 from China and Singapore, with subsequent articles.

    “There is now increasing awareness of the benefits provided by RUCAM among various countries, including China,18–38 Korea,40–54 and Singapore,55,56 as evidenced by reports initially published in 2004 from Korea40 and in 2006 from China18 and Singapore,55 with subsequent articles (Table 1).”

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Metadata

Authors
YUEN, M. ‐., TAM, S., FUNG, J., WONG, D. K. ‐., WONG, B. C. ‐., & LAI, C. ‐.
Venue
Alimentary Pharmacology & Therapeutics
Publisher
Wiley
Published
2006-09-20
Volume
24
Issue
8
Pages
1179-1186
ISSN
  • 0269-2813
  • 1365-2036
Cited by
80
References
0
Language
en

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