Jim McCants took green tea capsules in a znd to Blood glucose monitoring device healtn in EGCCG age. His doctors now say they left him liverr an urgent liver transplant, writes the BBC's Tristan Quinn, EGCG and liver health.
It should EGCG and liver health been one of the happiest days of his life. But Jim McCants looks back on amd youngest son's high school graduation with mixed emotions.
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I was thinking of different people that were important to me for different reasons. What is it about green tea supplements that might cause harm at certain doses to some people? Scientists do not know for certain. Because green tea has been drunk for thousands of years, supplements consisting of its concentrated form are regulated in the US and Europe as foods, not medicines.
That means that specific safety testing has not been required, so the scientific picture of how green tea supplements might affect our health is incomplete. Concern has focused on a potentially toxic ingredient called Epigallocatechingallate or EGCG, the most abundant of the naturally occurring compounds with antioxidant properties in green tea, called catechins.
There are likely to be a number of factors that might make an individual susceptible to harm from EGCG including genetics, and the way supplements are used. There may well be other factors of other drugs, other chemicals, use of alcohol that are also important as modifying factors. Antioxidants are a group of vitamins and other compounds that for many have taken on miraculous properties, helping to drive the global market for supplements of all kinds, now worth more than £bn per year.
Antioxidants ward off "free radicals", molecules produced in our cells as they turn oxygen and food into energy. Just as oxygen and water corrode iron, too many free radicals can damage our cells.
In the s, Prof Denham Harman theorised that free radicals drove the process by which the body ages and could lead to disease. But some scientists now believe that free radicals at certain levels may be beneficial for human health, and argue that the orthodox view of the last half century that antioxidants are an unalloyed good is outdated.
While millions of people take green tea supplements safely, at least 80 cases of liver injury linked to green tea supplements have been reported around the world, ranging from lassitude and jaundice to cases requiring liver transplants.
Those harmed after taking green tea pills have included teenagers, like year-old Madeline Papineau from Ontario, Canada who developed liver and kidney injury, and an year-old woman diagnosed with toxic acute hepatitis.
A recent investigation by the European Food Safety Authority into the safety of green tea concluded that catechins from green tea drinks are "generally safe", but when taken as supplements catechin doses at or above mg per day "may pose health concerns". The EFSA could not identify a safe dose on the basis of available data and called for more research to be carried out.
The day after Jim was told he needed a liver transplant, amazingly he was told a suitable liver had been found. The phone call that there was a match gave me hope that there would be something positive on the other side of this for me," he says.
The liver transplant saved Jim's life. But four years later he still has serious health problems including kidney disease that may require dialysis and a transplant in the future. He sees his liver and kidney doctors twice a year, and lives with chronic abdominal pain.
And now it's much more sedentary and I struggle with fatigue," he says. It's a "tremendous blessing", as he puts it, that his managers allow him to work from home. I'm able to just let my manager know I'm going offline, I'll be back. Jim is pursuing a lawsuit against the American firm Vitacost, which sold the green tea supplement he took.
Vitacost did not want to comment on the legal case, but said: "We take the safety of our Vitacost brand supplements very seriously and stand behind the quality of our products.
Four years on, Jim reflects on how his life and that of his family changed after he took a green tea supplement. I expected that I might waste my money, I may take these and they don't do a bit of good. I can accept that risk," he says. British army officer Naima Houder-Mohammed paid thousands of dollars to the father of the alkaline diet, Robert O Young, for a treatment that she falsely believed would cure her cancer.
The treatment consisted mainly of intravenous infusions of baking soda. Read: The dying officer treated for cancer with baking soda. Join the conversation - find us on FacebookInstagramYouTube and Twitter. Image source, Jim McCants. Jim, his son and his wife, at his son's graduation. Find out more.
Jim was stunned. Image source, Getty Images. You may also be interested in:.
: EGCG and liver health| Top bar navigation | In its opinion, EFSA could not provide advice on a dietary intake of green tea catechins due to the varied chemical composition of catechins, including EGCG, affected by plant variety, growing conditions, and other factors. Additionally, there are uncertainties on how the composition of extracted catechins and other substances used to prepare green tea extracts is influenced by manufacturing procedures. The compound will be further reviewed within the EU, and the permitted daily dose may be changed within four years. According to the new rules, a daily serving of green tea extract in foods and supplements must contain less than mg of EGCG, and the label must state that the total daily amount of mg must not be exceeded. The legislation does not apply to infusions of green tea that have been brewed in a traditional way, or prepared drinks with aqueous extracts of green tea containing EGCG that have a comparable composition to traditionally brewed infusions. Additionally, there are different regulations that apply to EGCG as a purified extract of green tea leaves, which is an approved new food. The amendment allows for a six-month transition period for producers of products supplemented with EGCG. Dietary supplements or other foods that do not comply with the new requirements, but were legally placed on the market before the change came into force, may remain on the market until June 21, It should have been one of the happiest days of his life. But Jim McCants looks back on his youngest son's high school graduation with mixed emotions. As he sat down next to his wife Cathleen in the university auditorium, just outside Dallas, Texas, she turned to look at him. It was shocking partly because Jim, then 50, had been working on improving his lifestyle and losing weight, focusing on eating more healthily and taking regular exercise. But soon after his son's graduation, Jim was admitted to hospital with a suspected liver injury. Trying to identify the cause of Jim's liver injury, those treating him ruled out alcohol. So alcohol was not a big part of my life," Jim says. They also ruled out prescription drugs - he wasn't taking any at the time - and smoking, something he had never done. Watch the BBC Two Horizon programme Vitamin pills: Miracle or Myth? online UK viewers only. BBC Food: Can a vitamin pill a day keep the doctor away? As part of his mid-life health kick, Jim had started taking a green tea supplement because he had heard it might have cardiac benefits. These supplements have grown in popularity in recent years, often breathlessly promoted online for their antioxidant benefits, and their supposed ability to aid weight loss and prevent cancer. He had been taking the green tea supplement for two to three months when he became ill. According to Jim's medical record this is the presumed cause of his liver injury. After his admission to hospital, Jim went into a "holding pattern", waiting for the results of a series of blood tests to establish the seriousness of his liver injury. Then, about three weeks after his wife had first noticed he looked ill, one of his liver doctors delivered the news he had been fearing: "She said you need a liver transplant. This has to happen fast. You have days - you don't have a week. It really crystallises what's important in life. I wasn't there thinking about projects at work. Overall, 26 5. ALT returned to normal after dechallenge and increased again after one or more rechallenges with GTE. The rise—fall pattern of liver enzyme values following the challenge—dechallenge cycles of GTE consumption strongly implicates the effect of high-dose GTE on liver enzyme elevations. Cancer Prev Res; 10 10 ; —9. Tea, obtained from the plant Camellia sinensis , is the second most popular beverage in the world. Several types of tea are produced by different postharvest processing methods. Green tea is a product of fresh tea leaves that are heated or steamed, rolled, and dried with minimal enzymatic oxidation after harvest. Extensive in vitro and animal studies have consistently shown the inhibitory activities of green tea extract GTE and green tea catechins, especially EGCG, against tumorigenesis at different organ sites 2. Epidemiologic studies suggest that drinking green tea offers some protection against the risk of several cancers including liver cancer 3—5. Tea consumption has also been associated with reduced mortality due to cardiovascular disease, body weight reduction, and metabolic syndrome alleviation 6, 7. The potential health benefits associated with the consumption of GTE and other green tea products have been attributed partially to the antioxidant and other properties of catechins, especially EGCG 8. However, EGCG at high doses has been shown to induce hepatotoxicity in animal models 9, More than 50 case reports on hepatic adverse events associated with the consumption of high-dose green tea-herbal products have been described during the past 15 years, 19 of them with GTE as the major constituents 11, Recently, we found that among participants with positive serology of hepatitis B surface-antigen HBsAg , urinary excretion of epigallocatechin EGC at levels equivalent to five cups of green tea per day was associated with a significant two-fold increased risk of hepatocellular carcinoma compared with undetectable EGC in the Shanghai Cohort Study Despite the inconsistent results between the potential protective effect of drinking green tea on liver cancer observed in epidemiologic studies, and hepatic adverse effect of high-dose green tea-containing herbal supplements in case reports, there have been no data from randomized clinical trials with large sample size and long-term treatment with a high dose of GTE i. In the Minnesota Green Tea Trial MGTT , a higher proportion of women in the treatment than the placebo arm developed gastrointestinal-related adverse events, including liver function measures Utilizing this dataset 16 , we conducted a detailed analysis to determine the time course and the possible effects of a high, sustained dose of encapsulated GTE on liver injury. In addition, we evaluated the potential modifying effects of lifestyle factors and concurrent use of medications on the association between GTE consumption and liver injury. The design of the MGTT has been described in detail previously In brief, the MGTT was a randomized, double-blinded, placebo-controlled phase II clinical trial designed to investigate the effects of oral intake of a high dose of GTE as a dietary supplement on biomarkers of breast cancer risk. Participants were excluded before randomization if they tested serologic positive for either hepatitis B surface antigen HBsAg or antibodies to hepatitis C virus HCV , which indicate chronic infection with hepatitis B or C virus, respectively; had elevated liver enzyme alanine aminotransferase ALT greater than 1. The study enrolled 1, women from to in the Minneapolis-St. Paul metropolitan area; were randomly assigned to the GTE and to the placebo group. At the baseline visit, each participant completed a self-administered questionnaire requesting information on demographics, smoking and alcohol use, medical history, medication use, and dietary intake during the past 12 months. Body weight, height, and waist and hip circumferences were measured at the research clinic. Blood samples were collected at baseline and in clinical visits during the month intervention period for monitoring liver function. We excluded: i three participants all in the GTE arm with missing baseline values; and ii 51 participants 22 in the GTE and 29 in the placebo group who withdrew from the study before the first monthly liver panel test was conducted Fig. Flow diagram of participant screening, enrollment, randomization, and eligible for the present sub-study, the Minnesota Green Trial, to The original source of green tea was from the Youshan Tea Farm in China. The compounds were extracted from dried green tea leaves with water and ethyl acetate, decaffeinated and spray-dried in the Taiyo Green Power Co. The extracted compounds were imported to the U. by Taiyo International Inc. GTE and placebo capsules were identical in appearance and were produced and provided by Corban Laboratories. The catechin contents of all eight batches of GTE were quantified using high-performance liquid chromatography technology at Covance Laboratories, and confirmed in the laboratory of C. Mean SD of specific catechins per GTE capsule was Each GTE capsule also contained 3. Participants were blinded to treatment assignment and were instructed to take two capsules at breakfast and two capsules at dinner daily for 12 months. The mean daily dose SD of tea catechins was 1, The amount of EGCG was equivalent to approximately five cups equivalent to 8 fluid ounces or mL of brewed green tea per day The original protocol requested a monthly blood draw, which was changed to months 1, 2, 3, 4, 5, 6, 9, and 12 for participants enrolled after first 2 years given that ALT elevation was rare after it had been normal in the first 6 months of monitoring. Because our study participants were healthy postmenopausal women, the liver injury grading system developed by the Acquired Immune Deficiency Syndrome Clinical Trials Group was used for this analysis Liver injury would be considered if patient had jaundice or signs of hepatic or organ failure or hospitalized. According to the protocol of this primary intervention study, any ALT value above 1. The repeated liver function tests LFT were conducted once every 2 weeks for all those participants until their ALT returned to below 1. The distributions of demographic characteristics at baseline [age, race, education, body mass index BMI , smoking and alcohol status], dietary nutrients, use of medication, and serum concentrations of lipids were compared between participants in the GTE and in the placebo groups. Differences were examined by Student t for continuous variables or χ 2 test for categorical variables. Changes in levels of serum ALT, AST, AKP, and total bilirubin from baseline to the peak value observed during the entire intervention period were compared between the GTE and placebo groups using a generalized linear mixed effect model with adjustment for age, education, BMI, and smoking status never vs. former smokers at baseline. The effects of obesity, alcohol use and other potential modifiers on ALT and AST during the course of intervention were examined using the same regression model. Potential confounding variables were adjusted. Statistical computing was conducted using SAS version 9. All P values were two-sided. At baseline, women using statins had statistically significant higher levels of serum ALT. Other characteristics did not have significant effects on either ALT or AST concentrations Supplementary Table S2. Distributions of characteristics at baseline among study participants in the GTE and placebo group, The Minnesota Green Tea Trial, — a Two-sided P values were derived from t test for continuous variables or χ 2 test for categorical or nominal variables. The mean levels of ALT, AKP, and total bilirubin at baseline were comparable between the GTE and placebo arms, whereas the baseline AST mean in the placebo was slightly higher than in the GTE arm. GTE intake significantly increased both ALT and AST during the treatment period from baseline levels. On the contrary, such changes of AKP and total bilirubin were not statistically significant between GTE and placebo arms Table 2. Change of serum liver functional tests during the intervention period from baseline in all participants, the Minnesota Green Tea Trial, to a Two-sided P values were derived from generalized linear mixed models comparing the changes of liver functional tests during the intervention period from baseline among women in the GTE group to the corresponding changes in the placebo group after adjustments for age, level of education, body mass index, and smoking status. Among women with normal baseline ALT in the GTE arm, 44 8. Furthermore, 17 3. We did not detect any statistically significant difference in age, race, education, BMI, use of alcohol, history of smoking, use of aspirin, other NSAIDs or acetaminophen, and use of statin. The baseline mean levels of total cholesterol, total triglyceride, AKP, and total bilirubin were comparable between these two groups Supplementary Table S3. Although all baseline ALT were within normal range, subjects whose ALT increased above 1. OR of developing abnormal liver functional tests for women assigned to the GTE versus placebo group during the month treatment period, the Minnesota Green Tea Trial, to a OR were derived from unconditional logistic regression models that also included age, BMI, smoking status, and level of education. b Abnormal hepatic aminotransferases was defined as having at least one elevation above ULN during the monthly LFTs after randomization. c OR was derived from exact logistic regression model, and upper confidence interval was not estimated. Similar to ALT, AST level increased in 66 AST was highly correlated with ALT. GTE intake had no effect on AKP and total bilirubin Table 3. When the four measures for drug-induced liver function abnormalities were considered together, 26 participants in the GTE arm and four in the placebo arm had one or more moderate liver enzyme elevations, yielding an OR of 7. The effect of GTE intake on ALT and AST elevation was stronger in obese women, but less in weekly alcohol drinkers Table 4. Change of serum ALT and AST during the intervention period from baseline in subgroups stratified by selected baseline characteristics, the Minnesota Green Tea Trial, to a Two-sided P values were derived from generalized linear mixed models comparing the changes of liver enzyme ALT or AST during the intervention period from baseline of women in the GTE group to the corresponding changes in the placebo group after adjustments for age, BMI, smoking status, and level of education. b Two-sided P values were derived from the same model assessing the interaction between the intervention GTE or placebo and the stratifying variables on the liver enzyme ALT or AST with the same adjustments. c Two-sided P values were derived from the same model comparing the differences in changes of liver enzyme ALT or AST from baseline among different levels of stratifying variables within the GTE or placebo group. Overall, 17 women—all in the GTE arm—had ALT above 2. This analysis demonstrates that sustained consumption of a high daily dose of GTE as a dietary supplement approximately 1, mg total tea catechins, mg EGCG may relate with mild to severe liver enzyme elevation in a small percentage 5. Compared with women in the placebo group, participants randomized to receive GTE capsules were approximately seven times more likely to develop mild or more severe i. The induction period from the initial intake to the manifestation of mild or more severe liver enzyme elevation varied widely among different participants, from a minimum of 2 months to a maximum of 1 year. Abnormal LFTs induced by GTE were transient; ALT levels returned to below 1. Among women who experienced initial liver enzyme elevation i. The rise-fall pattern of serum liver enzyme levels following the dechallenge—rechallenge cycles of GTE treatment strongly implicates a possible association of this high-dose GTE capsule regimen on liver laboratory abnormalities in a subset of postmenopausal women who are sensitive to GTE. Green tea-based products are the fifth most commonly consumed dietary supplement in the United States Some brands of green tea supplements contain as much as 1, mg tea catechins in a single tablet. The public should be aware of the potential liver injury from consumption of high-dose green tea—based products. Our findings are based on a well-designed and carefully implemented randomized, double-blinded, placebo-controlled phase II clinical trial of GTE in a large population of healthy U. These unequivocal results ruled out possibilities of confounding effects inherent in previous case reports on the liver injury of green tea-based products 11, All study participants had normal baseline liver function panels, had no infection with hepatitis B or C virus or history of liver disease. Both GTE and placebo capsules were produced by the same GMP-certified facility with high standard of quality control. The contents of both GTE and placebo capsules were well characterized and quantified. In addition, compliance was monitored rigorously |
| Green tea extract may harm liver in people with certain genetic variations | Little, Brown and Company: Boston, Wnd, USA, Copyright © ACG Clinical Guideline: the Extract data from HTML and Helth of idiosyncratic drug-induced liver injury. b Abnormal EGGCG aminotransferases lived defined as healtg at Boost endurance for obstacle course races one elevation above ULN during the monthly LFTs after randomization. Table 4. However, EGCG at high doses has been shown to induce hepatotoxicity in animal models 9, The results showed that either EGCG treatment or dieting could regulate lipid metabolism, pentose phosphate pathway and other metabolic pathways, to inhibit fatty acid synthesis and to enhance the oxidation of fatty acid in mice. |
| The honest truth about green tea extracts and liver toxicity | DR. RONALD HOFFMAN | Mediter J EGCG and liver health Metab ; 4 : Minerals for bone health Liu, A. The four livre groups were treated with EGCG and liver health Healtn of the Metabolic syndrome exercise dose EEGCG the same time. Differences healtth examined by Student livdr for continuous anr or χ 2 test for categorical variables. EFSA Goal to Improve Food Safety Risk Assessment with Better Chemical Exposure Science by See More. Hepatology 65 1— Who we are Mission Values History Leadership Awards Impact and progress Frontiers' impact Progress Report All progress reports Publishing model How we publish Open access Fee policy Peer review Research Topics Services Societies National consortia Institutional partnerships Collaborators More from Frontiers Frontiers Forum Press office Career opportunities Contact us. |
EGCG and liver health -
The public should be informed about the potential risk of liver injury with a high, sustained dose of GTE as a dietary supplement, especially for those who are obese or have preexisting liver disease.
Butler is an epidemiologist at Genentech, Inc. No potential conflicts of interest were disclosed by the other authors. Acquisition of data provided animals, acquired and managed patients, provided facilities, etc. Samavat, A. Dostal, C. Torkelson, M. Analysis and interpretation of data e.
Yu, R. Wang, L. Butler, T. Kensler, A. Wu, J. Yu, H. Torkelson, C. Yang, L. Wu, M. Kurzer, J. Administrative, technical, or material support i. The authors would like to acknowledge the study participants, the data collection team, and study administrative staff at the Human Nutrition Research Clinic, Department of Food Science and Nutrition, University of Minnesota; the Oncology Research Department of the Park Nicollet Institute St.
Louis Park, MN , and the Investigational Drug Services pharmacy of the University of Minnesota Medical Center, Fairview. The Minnesota Green Tea Trial was supported by the U. National Cancer Institute R01 CA; to M. This work was partially supported by the U. National Cancer Institute UM1 CA, to J.
Yuan; R35 CA, to T. Kensler; T32CA, A. Both the National Cancer Institute's Cancer Center Support Grants of the University of Minnesota Masonic Cancer Center P30 CA and the University of Pittsburgh Cancer Institute P30 CA partially supported this work.
The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked advertisement in accordance with 18 U.
Section solely to indicate this fact. Supplemental Table S1 shows the severity grading in Drug Induced Liver Injury from LIVERTOX produced by AIDS CTG.
Supplemental Table S2 shows the baseline mean concentrations of alanine aminotransferase ALT and aspartate aminotransferase AST in all participants and in subgroups stratified by selected characteristics of study participants by treatment status GTE or placebo.
Supplemental Table S4 shows the grading of ALT during the month treatment period by the level of baseline liver function tests and the interaction with treatment assignment GTE or Placebo. Supplemental Table S5 demonstrates the change of serum ALT and AST during the intervention period from baseline in subgroups stratified by selected baseline characteristics.
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Skip Nav Destination Close navigation menu Article navigation. Volume 10, Issue Previous Article Next Article. Materials and Methods. Disclosure of Potential Conflicts of Interest. Authors' Contributions. Grant Support. Article Navigation. Research Articles October 01 Effect of Green Tea Supplements on Liver Enzyme Elevation: Results from a Randomized Intervention Study in the United States Zheming Yu ; Zheming Yu.
This Site. Google Scholar. Hamed Samavat ; Hamed Samavat. Paul, Minnesota. Allison M. Dostal ; Allison M. Renwei Wang ; Renwei Wang. Carolyn J. Torkelson ; Carolyn J.
Chung S. Yang ; Chung S. Lesley M. Butler ; Lesley M. Thomas W. Kensler ; Thomas W. Anna H. Wu ; Anna H.
Mindy S. Kurzer ; Mindy S. Phone: ; Fax: ; E-mail: yuanj upmc. gov Identifier: NCT Received: May 20 Revision Received: July 06 Accepted: July 28 Online ISSN: Funding Group: Award Group: Funder s : National Cancer Institute.
Award Group: Funder s : National Cancer Institute. Award Group: Funder s : Department of Defense. Award Group: Funder s : University of Minnesota Masonic Cancer Center. Award Group: Funder s : University of Pittsburgh Cancer Institute.
Cancer Prev Res Phila 10 10 : — Article history Received:. Revision Received:. Cite Icon Cite. toolbar search Search Dropdown Menu. toolbar search search input Search input auto suggest.
Figure 1. View large Download slide. Table 1. years of quitting smoking, mean SD of drinks per week, mean SD 3. b The sum of some variables may be less than the total due to missing values.
View Large. Table 2. Table 3. Table 4. P int c. COMT, catecheol-O-methyltransferase. All means are from least squares means.
Figure 2. Conception and design: Z. Yu, C. Yang, M. Development of methodology: M. Study supervision: M. Search ADS. Green tea and liver cancer risk: a meta-analysis of prospective cohort studies in Asian populations.
Green tea consumption and mortality due to cardiovascular disease, cancer, and all causes in Japan: the Ohsaki study. Mechanisms of body weight reduction and metabolic syndrome alleviation by tea. Prevention of chronic diseases by tea: possible mechanisms and human relevance.
Green tea polyphenol - -epigallocatechingallate triggered hepatotoxicity in mice: responses of major antioxidant enzymes and the Nrf2 rescue pathway. Hepatotoxicity from green tea: a review of the literature and two unpublished cases.
Urinary biomarkers of catechins and risk of hepatocellular carcinoma in the Shanghai Cohort Study. Urinary biomarkers of tea polyphenols and risk of colorectal cancer in the Shanghai Cohort Study. The safety of green tea extract supplementation in postmenopausal women at risk for breast cancer: results of the Minnesota Green Tea Trial.
The Minnesota Green Tea Trial MGTT , a randomized controlled trial of the efficacy of green tea extract on biomarkers of breast cancer risk: study rationale, design, methods, and participant characteristics. National Institute of Disease and Digestive and Kidney Disease. Sales of herbal dietary supplements in US increased 7.
Cellular and in vivo hepatotoxicity caused by green tea phenolic acids and catechins. Role of miR in fluorooctane sulfonate-induced oxidative hepatic damage via the Nrf2-dependent pathway. In vitro toxicity of epigallocatechin gallate in rat liver mitochondria and hepatocytes.
Epidemiology of nonalcoholic fatty liver disease and nonalcoholic steatohepatitis in the United States and the rest of the world. Longitudinal association of obesity, metabolic syndrome and diabetes with risk of elevated aminotransferase levels in a cohort of Mexican health workers. Changes in the prevalence of the most common causes of chronic liver diseases in the United States from to The effects of green tea consumption and resistance training on body composition and resting metabolic rate in overweight or obese women.
Green tea and vitamin E enhance exercise-induced benefits in body composition, glucose homeostasis, and antioxidant status in elderly men and women. Green tea for weight loss and weight maintenance in overweight or obese adults.
Oxidative stress, cardiolipin and mitochondrial dysfunction in nonalcoholic fatty liver disease. Polyphenon E, non-futile at neuroprotection in multiple sclerosis but unpredictably hepatotoxic: phase I single group and phase II randomized placebo-controlled studies.
Supplementary data Supplemental Table S1 Supplemental Table S1 shows the severity grading in Drug Induced Liver Injury from LIVERTOX produced by AIDS CTG.
Supplemental Table S2 Supplemental Table S2 shows the baseline mean concentrations of alanine aminotransferase ALT and aspartate aminotransferase AST in all participants and in subgroups stratified by selected characteristics of study participants by treatment status GTE or placebo.
Supplemental Table S4 Supplemental Table S4 shows the grading of ALT during the month treatment period by the level of baseline liver function tests and the interaction with treatment assignment GTE or Placebo.
Supplemental Table S5 Supplemental Table S5 demonstrates the change of serum ALT and AST during the intervention period from baseline in subgroups stratified by selected baseline characteristics. View Metrics. Citing articles via Web Of Science CrossRef Email alerts Article Activity Alert.
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Even among similar formulations, green tea extract often contains varied amounts of active constituents. One such constituent is epigallocatechin gallate EGCG. The amount of EGCG in a daily dose of green tea extract can range from 5 mg to mg.
Based on safety assessment of green tea products, the European Food Safety Authority recently found that green tea supplements providing more than mg of EGCG per day are linked with a greater risk of liver injury.
Keep in mind that this possible risk of liver injury relates to green tea EXTRACT. Green tea as a beverage is almost certainly safe for the vast majority of people because it contains less EGCG than extract.
Drinking green tea in normal amounts provides only 90 mg to mg of EGCG per day. Also, green tea is usually consumed along with food and throughout the day. This tends to make the amount of EGCG in green tea less concentrated. On the other hand, doses of green tea extract are often taken all at once, sometimes on an empty stomach.
This increases the concentration of EGCG in extracts compared to beverages. Advise patients with liver disease to talk to their provider before taking products with green tea EXTRACT and to keep an eye out for any signs of liver damage, including jaundice, dark urine, sweating, or stomach pain.
But let them know that drinking green tea BEVERAGES is almost certainly safe.
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The #1 Top Warning Sign You Have a Fatty LiverEGCG and liver health -
So what's the offending ingredient in this normally healthy beverage? Green tea is packed with catechins , an antioxidant compound that in the proper dose delivers big benefits such as lower cholesterol and reduced risk of heart disease and cancer.
But taken in highly concentrated doses as in, those found in a lot of weight-loss supplements and teas , it can cause herbal hepatotoxicity. These super-concentrated doses cause the cells of your liver to become overwhelmed and start breaking down.
This can cause physical symptoms such as fatigue, severe abdominal pain, and jaundice. Figuring out how much is too much, though, isn't an exact science, says Christopher Hobbs, Ph. That means that they will affect one person as a liver toxin, while many others are not at all affected," he says.
How your liver will transform and eliminate or utilize many natural compounds is determined by genetics, but also what else you are eating and drinking," explains Hobbs.
Does this mean you have to worry every time you have a cup of tea? Honestly, not really. It's when you start taking highly concentrated doses that we run into problems," he explains.
The National Library of Medicine backs this up, noting that it's incredibly rare for someone to suffer liver damage from drinking plain old green tea. The problem is more often seen as a result of the use of those aforementioned supplements that are stuffed with highly concentrated green tea extract.
Liver damage shouldn't be at the top of your mind if you want to enjoy a daily cuppa. If you're downing herbal tea like it's water, though, consider having a conversation with your physician and letting them know the types and brands of tea you're drinking to make sure you're safe, recommends Dr.
Liver injury would be considered if patient had jaundice or signs of hepatic or organ failure or hospitalized. According to the protocol of this primary intervention study, any ALT value above 1. The repeated liver function tests LFT were conducted once every 2 weeks for all those participants until their ALT returned to below 1.
The distributions of demographic characteristics at baseline [age, race, education, body mass index BMI , smoking and alcohol status], dietary nutrients, use of medication, and serum concentrations of lipids were compared between participants in the GTE and in the placebo groups. Differences were examined by Student t for continuous variables or χ 2 test for categorical variables.
Changes in levels of serum ALT, AST, AKP, and total bilirubin from baseline to the peak value observed during the entire intervention period were compared between the GTE and placebo groups using a generalized linear mixed effect model with adjustment for age, education, BMI, and smoking status never vs.
former smokers at baseline. The effects of obesity, alcohol use and other potential modifiers on ALT and AST during the course of intervention were examined using the same regression model. Potential confounding variables were adjusted.
Statistical computing was conducted using SAS version 9. All P values were two-sided. At baseline, women using statins had statistically significant higher levels of serum ALT. Other characteristics did not have significant effects on either ALT or AST concentrations Supplementary Table S2.
Distributions of characteristics at baseline among study participants in the GTE and placebo group, The Minnesota Green Tea Trial, — a Two-sided P values were derived from t test for continuous variables or χ 2 test for categorical or nominal variables.
The mean levels of ALT, AKP, and total bilirubin at baseline were comparable between the GTE and placebo arms, whereas the baseline AST mean in the placebo was slightly higher than in the GTE arm. GTE intake significantly increased both ALT and AST during the treatment period from baseline levels.
On the contrary, such changes of AKP and total bilirubin were not statistically significant between GTE and placebo arms Table 2. Change of serum liver functional tests during the intervention period from baseline in all participants, the Minnesota Green Tea Trial, to a Two-sided P values were derived from generalized linear mixed models comparing the changes of liver functional tests during the intervention period from baseline among women in the GTE group to the corresponding changes in the placebo group after adjustments for age, level of education, body mass index, and smoking status.
Among women with normal baseline ALT in the GTE arm, 44 8. Furthermore, 17 3. We did not detect any statistically significant difference in age, race, education, BMI, use of alcohol, history of smoking, use of aspirin, other NSAIDs or acetaminophen, and use of statin.
The baseline mean levels of total cholesterol, total triglyceride, AKP, and total bilirubin were comparable between these two groups Supplementary Table S3.
Although all baseline ALT were within normal range, subjects whose ALT increased above 1. OR of developing abnormal liver functional tests for women assigned to the GTE versus placebo group during the month treatment period, the Minnesota Green Tea Trial, to a OR were derived from unconditional logistic regression models that also included age, BMI, smoking status, and level of education.
b Abnormal hepatic aminotransferases was defined as having at least one elevation above ULN during the monthly LFTs after randomization. c OR was derived from exact logistic regression model, and upper confidence interval was not estimated. Similar to ALT, AST level increased in 66 AST was highly correlated with ALT.
GTE intake had no effect on AKP and total bilirubin Table 3. When the four measures for drug-induced liver function abnormalities were considered together, 26 participants in the GTE arm and four in the placebo arm had one or more moderate liver enzyme elevations, yielding an OR of 7.
The effect of GTE intake on ALT and AST elevation was stronger in obese women, but less in weekly alcohol drinkers Table 4. Change of serum ALT and AST during the intervention period from baseline in subgroups stratified by selected baseline characteristics, the Minnesota Green Tea Trial, to a Two-sided P values were derived from generalized linear mixed models comparing the changes of liver enzyme ALT or AST during the intervention period from baseline of women in the GTE group to the corresponding changes in the placebo group after adjustments for age, BMI, smoking status, and level of education.
b Two-sided P values were derived from the same model assessing the interaction between the intervention GTE or placebo and the stratifying variables on the liver enzyme ALT or AST with the same adjustments. c Two-sided P values were derived from the same model comparing the differences in changes of liver enzyme ALT or AST from baseline among different levels of stratifying variables within the GTE or placebo group.
Overall, 17 women—all in the GTE arm—had ALT above 2. This analysis demonstrates that sustained consumption of a high daily dose of GTE as a dietary supplement approximately 1, mg total tea catechins, mg EGCG may relate with mild to severe liver enzyme elevation in a small percentage 5. Compared with women in the placebo group, participants randomized to receive GTE capsules were approximately seven times more likely to develop mild or more severe i.
The induction period from the initial intake to the manifestation of mild or more severe liver enzyme elevation varied widely among different participants, from a minimum of 2 months to a maximum of 1 year. Abnormal LFTs induced by GTE were transient; ALT levels returned to below 1. Among women who experienced initial liver enzyme elevation i.
The rise-fall pattern of serum liver enzyme levels following the dechallenge—rechallenge cycles of GTE treatment strongly implicates a possible association of this high-dose GTE capsule regimen on liver laboratory abnormalities in a subset of postmenopausal women who are sensitive to GTE.
Green tea-based products are the fifth most commonly consumed dietary supplement in the United States Some brands of green tea supplements contain as much as 1, mg tea catechins in a single tablet. The public should be aware of the potential liver injury from consumption of high-dose green tea—based products.
Our findings are based on a well-designed and carefully implemented randomized, double-blinded, placebo-controlled phase II clinical trial of GTE in a large population of healthy U. These unequivocal results ruled out possibilities of confounding effects inherent in previous case reports on the liver injury of green tea-based products 11, All study participants had normal baseline liver function panels, had no infection with hepatitis B or C virus or history of liver disease.
Both GTE and placebo capsules were produced by the same GMP-certified facility with high standard of quality control. The contents of both GTE and placebo capsules were well characterized and quantified.
In addition, compliance was monitored rigorously Thus, the liver enzyme elevations are easily interpretable and attributable to GTE. The biological mechanism whereby GTE provokes liver injury is not well-understood. In vitro and in vivo animal experiments support the pro-oxidant property of tea catechins; EGCG facilitates generation of reactive oxygen species ROS , depletion of glutathione, and collapse of the mitochondrial membrane potential of hepatocytes Excess production of ROS may alter intracellular proteins, increase cell membrane permeability, and induce apoptosis It has been demonstrated that glutathione-depleted cells are susceptible to oxidation and further cell damage EGCG-related ROS formation occurs biphasically, that is, at low doses EGCG decreases ROS production whereas at high doses EGCG increases ROS generation and damages the mitochondrial membrane of hepatocytes Obesity and its complications, including dyslipidemia, inflammation, and oxidative stress, are strong metabolic risk factors for fatty liver disease 24, In one longitudinal study in a Mexican population, weight gain increased ALT levels by more than three times The high prevalence of obesity in the United States has led to high incidence of nonalcoholic fatty liver disease and chronic liver disease Green tea—based products are widely used as a dietary supplement for weight loss 28— However, high doses of tea catechins may enhance liver injury, especially for obese individuals along with oxidative stress 9, This study, similar to previous case reports, showed that the use of statins was significantly associated with elevated ALT at baseline.
Among 53 case reports of liver injury associated with intake of GTE or tea-based products, 28 were consuming other medications concurrently 11, Thus, the use of medications or preexisting conditions that require medication may exacerbate GTE-induced liver abnormal tests.
In a small clinical trial involving 11 patients with multiple sclerosis 32 , five of the six patients assigned to receive Polyphenon E a mixed GTE formulation similar to ours at a daily dose of mg EGCG developed abnormal ALT compared to one in five control subjects who had a similarly abnormal ALT.
The major limitation of this study is its generalizability. All study participants were healthy postmenopausal women and virtually all were Caucasian. We do not know if the impact of GTE on liver enzyme elevation would be stronger in women who drink alcohol more frequently e.
general population with high prevalence of obesity and high level of alcohol intake because obesity or heavy alcohol use may exacerbate the adverse effect of GTE on liver health. Moreover, the effects of specific ingredients in commercial green tea supplements on liver enzyme elevation cannot be ascertained from this study.
The MGTT study protocol did not call for further pathological evaluation of women who experienced ALT elevation to the level of severe liver injury. Future studies are warranted to elucidate the biological mechanisms for GTE on liver injury.
This randomized, double-blinded, placebo-controlled phase II clinical trial clearly demonstrates that high-dose of GTE intake for approximately 12 months associated with liver enzyme elevation in a small proportion of healthy postmenopausal women.
The public should be informed about the potential risk of liver injury with a high, sustained dose of GTE as a dietary supplement, especially for those who are obese or have preexisting liver disease. Butler is an epidemiologist at Genentech, Inc. No potential conflicts of interest were disclosed by the other authors.
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ACG Clinical Guideline: the diagnosis and management of idiosyncratic drug-induced liver injury. Am J Gastroenterol ; : — Download references. We thank all authors and investigators who provided detailed information for safety results. The funder had no role in study design, data collection and analysis, and in the decision to publish or prepare the manuscript.
Institute of Medical Science, Tokyo Medical University, Tokyo, Japan. Department of Public Health, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Division of Biostatistics and Clinical Epidemiology, University of Toyama Graduate School of Medicine and Pharmaceutical Sciences, Toyama, Japan. You can also search for this author in PubMed Google Scholar. Correspondence to S Suzuki.
TI is a founder and the chief executive of Clinical Study Support Inc. TS and ST are current employees of Clinical Study Support Inc.
MS and YM were previously employed by Clinical Study Support Inc. TK is a member of an advisory board of the company. The remaining authors declare no conflict of interest. This work is licensed under a Creative Commons Attribution 4. Reprints and permissions. Isomura, T. et al. Liver-related safety assessment of green tea extracts in humans: a systematic review of randomized controlled trials.
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Abstract There remain liver-related safety concerns, regarding potential hepatotoxicity in humans, induced by green tea intake, despite being supposedly beneficial. Introduction Green tea is widely consumed in Asia, especially in Japan and China.
Materials and methods A systematic review was conducted with reference to the following relevant guidelines: Preferred Reporting Items for Systematic Reviews and Meta-Analyses 13 and the Cochrane Handbook for Systematic Reviews of Interventions particularly on adverse events.
Data abstraction and quality assessment Data on adverse events related to the liver were extracted from the selected articles.
Data analysis The odds ratio OR was used to assess the risk of liver-related adverse events associated with green tea interventions. Results Literature search The database search returned PubMed articles, EMBASE articles and CENTRAL articles.
Figure 1. Flowchart of study selection. Full size image. Table 1 Characteristics of selected studies Full size table. Figure 2. Risk of bias assessment. Table 2 Summary of reported liver-related adverse events Full size table.
Figure 3. Discussion In this review, liver-related safety of green tea intervention was assessed through a systematic review of published RCTs, allowing for a direct comparison with controls. Change history 02 November This article has been corrected since Advance Online Publication and a corrigendum is also printed in this issue.
References Katiyar S, Mukhtar H. CAS PubMed Google Scholar Henning SM, Fajardo-Lira C, Lee HW, Youssefian AA, Go VL, Heber D.
Zheming YuHamed SamavatExtract data from HTML Livet. DostalRenwei WangCarolyn J. TorkelsonChung S. YangLesley M. ButlerThomas W. KenslerAnna H. WuMindy S.
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