United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts

Oketch-Rabah, Hellen A.; Roe, Amy L.; Rider, Cynthia; Bonkovsky, Herbert L.; Giancaspro, Gabriel I.; Navarro, Victor J.; Paine, Mary F.; Betz, Joseph M.; Marles, Robin J.; Casper, Steven; Gurley, Bill J.; Jordan, Scott A.; He, Kongwang; Kapoor, Mahendra P.; Rao, Theertham P.; Sherker, Averell H.; Fontana, Robert J.; Rossi, Simona; Vuppalanchi, Raj; Seeff, Leonard B.; Stolz, Andrew; Ahmad, Jawad; Koh, Christopher; Serrano, José; Dog, Tieraona Low; Ko, Richard

doi:10.1016/j.toxrep.2020.02.008

Cited by 114 publications

(91 citation statements)

References 158 publications

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“…With 11,609 the largest HILI case number was published in 2019 ( Figure 3 ) as a consequence of the ongoing worldwide use of RUCAM for assessing causality in suspected HILI cases ( Table 4 ). In particular, contributing countries were in alphabetical order Australia [ 29 ], Brazil [ 183 ], China [ 48 , 196 , 197 , 198 , 199 , 200 , 201 ], Germany [ 213 , 214 , 215 ], India [ 217 ], Italy [ 222 ], Korea [ 103 ], Spain [ 115 , 117 , 240 , 241 , 242 ], Switzerland [ 244 ], and the US [ 245 , 246 , 247 , 248 , 249 , 250 , 251 , 252 , 253 , 254 ]. Most of the 11,619 HILI cases published in 2019 were from China [ 48 , 196 ] and Korea [ 103 ], with 6971 cases published by Shen et al [ 48 ], 2019 cases reported by Byeon et al [ 103 ], and 1552 cases provided by Chow et al [ 196 ].…”

Section: Worldwide Publications Of Hili Cases Assessed For Causalimentioning

confidence: 99%

“…Most of the 11,619 HILI cases published in 2019 were from China [ 48 , 196 ] and Korea [ 103 ], with 6971 cases published by Shen et al [ 48 ], 2019 cases reported by Byeon et al [ 103 ], and 1552 cases provided by Chow et al [ 196 ]. However, until mid 2020 only 57 HILI cases were published ( Table 4 ) [ 202 , 203 , 253 , 254 ], suggesting for the whole year 2020 at best 100 cases ( Figure 3 ).…”

Section: Worldwide Publications Of Hili Cases Assessed For Causalimentioning

confidence: 99%

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Worldwide Use of RUCAM for Causality Assessment in 81,856 Idiosyncratic DILI and 14,029 HILI Cases Published 1993–Mid 2020: A Comprehensive Analysis

Teschke

Danan²

2020

Medicines

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Background: A large number of idiosyncratic drug induced liver injury (iDILI) and herb induced liver injury(HILI) cases of variable quality has been published but some are a matter of concern if the cases were not evaluated for causality using a robust causality assessment method (CAM) such as RUCAM (Roussel Uclaf Causality Assessment Method) as diagnostiinjuryc algorithm. The purpose of this analysis was to evaluate the worldwide use of RUCAM in iDILI and HILI cases. Methods: The PubMed database (1993–30 June 2020) was searched for articles by using the following key terms: Roussel Uclaf Causality Assessment Method; RUCAM; Idiosyncratic drug induced liver injury; iDILI; Herb induced liver injury; HILI. Results: Considering reports published worldwide since 1993, our analysis showed the use of RUCAM for causality assessment in 95,885 cases of liver injury including 81,856 cases of idiosyncratic DILI and 14,029 cases of HILI. Among the top countries providing RUCAM based DILI cases were, in decreasing order, China, the US, Germany, Korea, and Italy, with China, Korea, Germany, India, and the US as the top countries for HILI. Conclusion: Since 1993 RUCAM is certainly the most widely used method to assess causality in IDILI and HILI. This should encourage practitioner, experts, and regulatory agencies to use it in order to reinforce their diagnosis and to take sound decisions.

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Section: Worldwide Publications Of Hili Cases Assessed For Causalimentioning

confidence: 99%

Section: Worldwide Publications Of Hili Cases Assessed For Causalimentioning

confidence: 99%

Worldwide Use of RUCAM for Causality Assessment in 81,856 Idiosyncratic DILI and 14,029 HILI Cases Published 1993–Mid 2020: A Comprehensive Analysis

Teschke

Danan²

2020

Medicines

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“…Indeed, although EGCG in a dose range level equal to 800-1600 mg seems to be well tolerated [18,19], adverse hepatotoxic effects, probably due to a GT catechins abuse, pose health concerns [20]. The European Food Safety Authority (EFSA), reviewing the conclusions of several studies aimed at evaluating the effects of EGCG on the liver, concluded that if the green tea beverage intake is generally safe, some precautions must be taken toward supplements, because many of them bring doses of catechins that can cause liver health problems [21,22]. In reality, the great variability of the preparation methods and the composition of the supplements means that the amount of catechins in these products can differ considerably between one product and another.…”

Section: Introductionmentioning

confidence: 99%

Coumaroyl Flavonol Glycosides and More in Marketed Green Teas: An Intrinsic Value beyond Much-Lauded Catechins

et al. 2020

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Marketed green teas (GTs) can highly vary in their chemical composition, due to different origins, processing methods, and a lack of standardization of GT-based products. Consequently, biological activities become difficult to correlate to the presence/content of certain constituents. Herein, ultra-high-performance liquid chromatography (UHPLC) combined with high-resolution tandem mass spectrometry (HR MS/MS) was successfully applied to six commercial GT products, extracted by ethanol sonication, to disclose their polyphenol profile beyond the well-known catechins. The relative abundance of each class of metabolites was correlated to antiradical and antilipoperoxidant data through hierarchical clustering analysis, since it reasonably affects the beneficial properties of the product that reaches the consumer. The thiobarbituric acid reactive substances (TBARS) assay demonstrated that GT extracts effectively counteracted the UV-induced lipoperoxidation of hemp oil, which is highly rich in Polyunsaturated Fatty Acids (PUFAs), and therefore highly unstable. The Relative Antioxidant Capacity Index (RACI) comprehensively emphasized that gunpower and blend in filter GTs appeared to be the less active matrices, and except for a GT-based supplement, the Sencha GT, which was particularly rich in flavonol glycosides, was the most active, followed by Bancha GT.

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“…97,98 Key issues around liver injury by GTE are obviously settled now, as the United States Pharmacopeia and DILIN members finally made it and confirmed that GTE are potentially hepatotoxic by using the updated RUCAM and thereby breaking boundaries to good medicine based on evidence and a diagnostic algorithm in line with artificial intelligence proposals. 99 Networks and regulatory databases: Generally problematic are reports presented as network data when case presentations and causality assessments are poor. 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.…”

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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United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts

Cited by 114 publications

References 158 publications

Worldwide Use of RUCAM for Causality Assessment in 81,856 Idiosyncratic DILI and 14,029 HILI Cases Published 1993–Mid 2020: A Comprehensive Analysis

Worldwide Use of RUCAM for Causality Assessment in 81,856 Idiosyncratic DILI and 14,029 HILI Cases Published 1993–Mid 2020: A Comprehensive Analysis

Coumaroyl Flavonol Glycosides and More in Marketed Green Teas: An Intrinsic Value beyond Much-Lauded Catechins

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

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