Sarma et al. (2008)
2
|
Safety review |
Case reports of experimental and clinical data (n = 216) |
GTE (multi‐ingredient supplement |
Oral application |
5–120 days |
Expert Committee concluded that the safety information for green tea arising from diverse sources provides a signal for the possibility of liver damage caused by products that contain concentrated GTEs |
Liver damage possible (n = 27) |
Liver damage probable (n = 7) |
(1966–2007) |
Mazzanti et al. (2009)
5
|
Review |
Case reports (n = 34) |
GTE (n = 15) |
Oral application |
4–1460 days |
Analysis of the published case reports suggests a causal association between green tea and liver damage |
(1999–2008) |
Multicomponent preparations (n = 19) |
Mazzanti et al. (2015)
4
|
Review |
Case reports (n = 19) |
GTE (multi‐ingredient supplement) |
Oral application |
14–365 days |
Safety concern with GTE especially when green tea is associated with other ingredients |
(2008–2015) |
Oketch‐Rabah et al. (2019)
6
|
Safety review |
Experimental animal studies (n = 127) |
GTE (different compositions) |
Oral application |
>14 days |
Animal and human data indicate that repeated oral administration of bolus doses of GTE during fasting significantly increases bioavailability of catechins |
Clinical data (n = 355) |
Case reports associate hepatotoxicity with EGCG intake amounts from 140 mg to ∼1000 mg/day and substantial interindividual variability in susceptibility, possibly because of genetic factors |
Clinical trials (n = 4) |
Toxicological studies show a hepatocellular pattern of liver injury |
Published case reports (n = 51) |
Reviews and miscellaneous reports (n = 52 + 35) |
(2008–2016) |
Hoofnagle et al. (2021)
7
|
Retrospective analysis |
40 cases of green tea–associated liver injury 3% of 1414 DILIN patients |
GTE (multi‐ingredient supplement) |
Oral application |
15–448 days (median 72 days) |
The liver injury was typically hepatocellular (95%) with marked serum aminotransferase elevations and modest increases in alkaline phosphatase. Severe course in 14 patients (35%), liver transplantation in 3 (8%), and chronic injury 12 patients (3%). HLA typing indicated a high prevalence of HLA‐B*35:01, found in 72% (95% CI: 58%‐87%) of green tea cases, but only 15% (95% CI: 10%‐20%) caused by other supplements and 12% (95% CI: 10%‐14%) attributed to drugs, the latter rate being similar to population controls (95% CI: 10.5%‐11.5%), suggesting that it is idiosyncratic and immune mediated |
(2004–2018) |