Abstract
Background and aims
Whether herbal and dietary supplements (HDS) are safer than Western conventional drugs is controversial. The aim of this study was to explore the characteristics and risk factors for HDS-induced liver injury (HILI) in Taiwan.
Methods
This is a 9-year multi-center prospective study conducted in Taiwan from 2011 to 2019. Patients with HILI were compared to those with conventional drug-induced liver injury (CILI).
Results
A total of 1,297 patients were enrolled, of whom 285 (22.0%) had HILI and 1,012 (78.0%) had CILI. Compared to the CILI group, the HILI group had higher initial serum alanine aminotransferase, alkaline phosphatase (ALP), peak ALP and bilirubin levels, and higher rates of jaundice, ascites, encephalopathy, coagulopathy, sepsis and acute liver failure. In addition, the HILI group had a higher mortality rate than the CILI group (12.6 vs. 8.0%, p = 0.016). Hepatitis B carrier status, elevated baseline liver biochemical tests and the use of crude herbs (without processing) were associated with an increased risk of HILI-related mortality (adjusted hazard ratios [95% confidence intervals]: 2.90 [1.43–5.99], 2.40 [1.01–5.68] and 2.94 [1.45–5.97], respectively).
Conclusions
HDS are popular and incriminated in more than one-fifth of drug-induced liver injuries in Taiwan. The patients with HILI were more severe than those with CILI in terms of liver biochemical tests, complications and mortality. Hepatitis B carriers, those with elevated baseline liver tests and crude herb users may have a higher risk of HILI-related mortality. The prudent use of HDS is suggested in these high-risk subjects.
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Data availability
The data that support the findings of this study are available from the corresponding author upon reasonable request.
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Acknowledgements
The authors thanks Yi-Chen Yeh, MD, and Fen-Yau Li, MD, Department of Pathology and Laboratory Medicine, Taipei Veterans General Hospital, for their reading and interpretation of the liver pathology.
Funding
The study was supported by the Grants from Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare, Taiwan (DOH100-99TFDA-P-092 and DOH101-FDA-41103), and Taipei Veterans General Hospital, Taiwan (V110C-022).
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YSH: study concept and design, data collection and interpretation, statistical analysis, and drafting manuscript. TTC: study concept and design, data collection and interpretation, and manuscript editing for important intellectual contents. CYP: data collection and interpretation, and manuscript editing for important intellectual contents. GHL: data collection and interpretation, and manuscript editing for important intellectual contents. CWH: data collection and interpretation, and manuscript editing for important intellectual contents. CTH: data collection and interpretation, and manuscript editing for important intellectual contents. YHH: manuscript review for important intellectual contents. All authors were responsible for reading and approving the final manuscript.
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Yi-Shin Huang, Ting-Tsung Chang, Cheng-Yuan Peng, Gin-Ho Lo, Chao-Wei Hsu, Chi-Tan Hu, and Yi-Hsiang Huang declare that they have no conflict of interest.
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The present study is not an animal research.
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Our research complies with the guidelines for human studies and has been conducted ethically in accordance with the World Medical Association Declaration of Helsinki. This study was approved by the Institutional Review Board of each participating hospital for all the data collection and analysis.
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Huang, YS., Chang, TT., Peng, CY. et al. Herbal and dietary supplement-induced liver injury in Taiwan: comparison with conventional drug-induced liver injury. Hepatol Int 15, 1456–1465 (2021). https://doi.org/10.1007/s12072-021-10241-3
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DOI: https://doi.org/10.1007/s12072-021-10241-3