A Network-Based Pharmacology Study of the Herb-Induced Liver Injury Potential of Traditional Hepatoprotective Chinese Herbal Medicines

Hong, Ming; Li, Sha; Tan, Hor Yue; Cheung, Fanny M.; Wang, Ning; Huang, Jihan; Feng, Yibin

doi:10.3390/molecules22040632

Cited by 61 publications

(48 citation statements)

References 49 publications

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“…For instance, it is not generally known among the Chinese population that natural medicines, such as the single herbs Heshouwu or Leigongteng, or the composite agents Xiao-Chai-Hu-Tang, have been associated with DILI, although laboratory studies have also shown that these treatments cause immune activation, metabolic disorders, apoptosis, and damage to liver cells. [35][36][37][38][39] We believe that such analyses of Chinese herbal medicines are essential and urgent to determine whether these and other toxic ingredients are present.…”

Section: Discussionmentioning

confidence: 99%

Incidence and Etiology of Drug-Induced Liver Injury in Mainland China

et al. 2019

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CLINICAL LIVER BACKGROUND & AIMS: We performed a nationwide, retrospective study to determine the incidence and causes of druginduced liver injury (DILI) in mainland China. METHODS: We collected data on a total of 25,927 confirmed DILI cases, hospitalized from 2012 through 2014 at 308 medical centers in mainland China. We collected demographic, medical history, treatment, laboratory, disease severity, and mortality data from all patients. Investigators at each site were asked to complete causality assessments for each case whose diagnosis at discharge was DILI (n ¼ 29,478) according to the Roussel Uclaf Causality Assessment Method. RESULTS: Most cases of DILI presented with hepatocellular injury (51.39%; 95% confidence interval [CI] 50.76-52.03), followed by mixed injury (28.30%; 95% CI 27.73-28.87) and cholestatic injury (20.31%; 95% CI 19.80-20.82). The leading single classes of implicated drugs were traditional Chinese medicines or herbal and dietary supplements (26.81%) and antituberculosis medications (21.99%). Chronic DILI occurred in 13.00% of the cases and, although 44.40% of the hepatocellular DILI cases fulfilled Hy's Law criteria, only 280 cases (1.08%) progressed to hepatic failure, 2 cases underwent liver transplantation (0.01%), and 102 patients died (0.39%). Among deaths, DILI was judged to have a primary role in 72 (70.59%), a contributory role in 21 (20.59%), and no role in 9 (8.82%). Assuming the proportion of DILI in the entire hospitalized population of China was represented by that observed in the 66 centers where DILI capture was complete, we estimated the annual incidence in the general population to be 23.80 per 100,000 persons (95% CI 20.86-26.74). Only hospitalized patients were included in this analysis, so the true incidence is likely to be higher. CONCLUSIONS: In a retrospective study to determine the incidence and causes of DILI in mainland China, the annual incidence in the general population was estimated to be 23.80 per 100,000 persons; higher than that reported from Western countries. Traditional Chinese medicines, herbal and dietary supplements, and antituberculosis drugs were the leading causes of DILI in mainland China.

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Section: Discussionmentioning

confidence: 99%

Incidence and Etiology of Drug-Induced Liver Injury in Mainland China

et al. 2019

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“…Herbal medicines and other botanicals are often used as complementary and alternative medicines which are believed safe, also has no strict safety and effective standards, should be paid great attention (Moreira et al, 2014;Lee et al, 2015;Alamgir, 2017;Cho et al, 2017;Cecilia and Orish, 2018;Jing and Teschke, 2018;Teschke et al, 2018). Herb-induced liver injury (HILI) refers to liver damage caused by TCMs, natural medicines and related preparations, resulting in adverse reactions such as dermatitis, nausea, vomiting, diarrhea, thrombocytopenia, coagulopathy, mental state changes, hepatotoxicity, nephrotoxicity, and electrolyte imbalance (Dag et al, 2014;Divya et al, 2016;Ming et al, 2017;Awortwe et al, 2018). However, the degree of HILI varies among different countries and regions (Zhou et al, 2013;Navarro et al, 2014).…”

Section: Introductionmentioning

confidence: 99%

Polygonum multiflorum-Induced Liver Injury: Clinical Characteristics, Risk Factors, Material Basis, Action Mechanism and Current Challenges

et al. 2019

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Polygonum multiflorum Thunb. (PM), called Heshouwu in China, is a popular Chinese medicine in clinical practice. Several clinical studies have been conducted to evaluate the traditional therapeutic claims and to study the potential therapeutic activity of PM in dyslipidemia and neurodegenerative diseases, highlighting available clinical evidence. In recent years, reports on clinical adverse reactions of Raw Radix P. multiflorum (RPM) and P. multiflorum Praeparata (PMP) have been on the increase, especially with respect to liver injury. Most liver injury cases had been assessed for causality using RUCAM (Roussel Uclaf Causality Assessment Method) in this paper. However, the components of PM responsible for the reported hepatotoxic effects have not yet been identified. Moreover, many of the reports are contradictory, while studies on the mechanism involved in PM-induced liver damage are not comprehensive. This study was aimed at reviewing the status of research on liver injury due to PM, including clinical characteristics, risk factors, material basis research and mechanism of action, with a view to understanding PM-induced hepatotoxicity, and taking reasonable and effective measures to prevent it. In short, quality control is still one of the major safety problems in TCM drug safety concerns. The model of safety monitoring and risk management of PM drugs is not yet developed. Indeed, the characteristics and risk factors associated with PM require both proper understanding and control of the risk by strengthening standardization of clinical applications, basic science research, quality control in manufacturing, active monitoring methodology and enhancement of international communication and cooperation. Measures should also be encouraged and implemented to promote healthy development of the TCM industry.

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“…67,96,100 For instance, a network-based pharmacology study of the HILI potential of traditional hepatoprotective Chinese herbal medicines discusses aspects of liver injury without considering issues of causality assessment like the use of the updated RUCAM. 100 Clearly, shortcomings of methodological requirements invalidate studies like this one. Unexpectedly, not a single case of HILI was found in a retrospective study of adverse events due to complementary health products in Singapore from 2010 to 2016; adverse events were reported to the Health Sciences Authority, and analyzed were overall 147,215 adverse event reports suspected to be associated with pharmaceutical products and complementary health products, which included Chinese traditional medicines.…”

Section: Herbal Product Qualitymentioning

confidence: 99%

Herb-induced Liver Injury in Asia and Current Role of RUCAM for Causality Assessment in 11,160 Published Cases

Teschke¹,

Zhu²,

Jing³

2020

Journal of Clinical and Translational Hepatology

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Herb-induced liver injuries (HILI) by traditional herbal medicines are particular challenges in Asian countries, with issues over the best approach to establish causality. The aim of the current analysis was to provide an overview on how causality was assessed in HILI cases from Asian countries and whether the Roussel Uclaf Causality Assessment Method (RUCAM) was the preferred diagnostic algorithm, as shown before in worldwide evaluated cases of drug-induced liver injury (DILI). Using the PubMed database, publications in English language were preferred to allow for reevaluation by peers. Overall 11,160 HILI cases have assessed causality using RUCAM and were published by first authors working in Asian countries. With 21 evaluable reports, most publications came from mainland China, with Hong Kong and Taiwan, followed by Korea (n=15), Singapore (n=2), and Japan (n=1), while other Asian countries were not contributory. Most publications provided case and RUCAM data of good quality. For better presentation of future cases, however, the following recommendations are given: (1) preference of prospective study design with use of the updated RUCAM version; (2) clear separation of HILI cohorts from those of other herbal products or DILI; (3) case series for epidemiology studies should contain many essential data, possibly also as supplementary material; (4) otherwise, preference of single case reports providing individual case data and RUCAM-based causality gradings, and applying liver test threshold values; and (5) publication in English language journals. In conclusion, China and Korea are top in presenting RUCAM-based HILI cases, other Asian countries are encouraged to follow.

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A Network-Based Pharmacology Study of the Herb-Induced Liver Injury Potential of Traditional Hepatoprotective Chinese Herbal Medicines

Cited by 61 publications

References 49 publications

Incidence and Etiology of Drug-Induced Liver Injury in Mainland China

Incidence and Etiology of Drug-Induced Liver Injury in Mainland China

Polygonum multiflorum-Induced Liver Injury: Clinical Characteristics, Risk Factors, Material Basis, Action Mechanism and Current Challenges

Herb-induced Liver Injury in Asia and Current Role of RUCAM for Causality Assessment in 11,160 Published Cases

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