Safety studies on epigallocatechin gallate (EGCG) preparations. Part 2: Dermal, acute and short-term toxicity studies

Isbrucker, Richard; Edwards, John S.; Wolz, E.; Davidovich, A.; Bausch, Jochen

doi:10.1016/j.fct.2005.11.003

Cited by 278 publications

(273 citation statements)

References 23 publications

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“…Data are shown as the mean±SD of seven to ten samples. Bars with different letters show significant differences (P<0.05) the other hand, several recent studies have also noted that excess intake of green tea supplements induced hepatotoxicity in both rodents and humans (Lambert et al 2010;Mazzanti et al 2009;Isbrucker et al 2006). In addition, the present study showed for the first time that high-dose GTPs caused nephrotoxicity in mice as observed by increased serum creatinine level (Fig.…”

Section: Discussionsupporting

confidence: 56%

High-dose green tea polyphenols induce nephrotoxicity in dextran sulfate sodium-induced colitis mice by down-regulation of antioxidant enzymes and heat-shock protein expressions

Inoue

Akiyama

Maeda‐Yamamoto

et al. 2011

Cell Stress and Chaperones

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Previously, we reported that oral feeding of 1% green tea polyphenols (GTPs) aggravated the dextran sulfate sodium (DSS)-induced colitis in mice. In the present study, we assessed the toxicity of 1% GTPs in several organs from normal and DSS-exposed mice. Sixty-two male ICR mice were initially divided into four groups. Nontreated group (group 1, n=15) was given standard diet and water, GTPs (group 2, n=15) received 1% GTPs in diet and water, DSS (group 3, n=15) received diet and 5% DSS in water, and GTPs + DSS group (group 4, n=17) received 1% GTPs in diet and 5% DSS in water. We found that group 4 significantly increased (P<0.05) kidney weight, the levels of serum creatinine and thiobarbituric acid-reactive substances in both kidney and liver, as compared with those in group 3. The mRNA expression levels of antioxidant enzymes and heat-shock proteins (HSPs) in group 4 were lower than those of group 3. For instance, heme oxygenase-1 (HO-1), HSP27, and 90 mRNA in the kidney of group 4 were dramatically down-regulated as compared with those of group 3. Furthermore, 1% GTPs diet decreased the expression of HO-1, NAD(P)H:quinone oxidoreductase 1 (NQO1) and HSP90 in kidney and liver of non-treated mice. Taken together, our results indicate that high-dose GTPs diet disrupts kidney functions through the reduction of antioxidant enzymes and heat-shock protein expressions in not only colitis but also non-treated ICR mice.

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Section: Discussionsupporting

confidence: 56%

High-dose green tea polyphenols induce nephrotoxicity in dextran sulfate sodium-induced colitis mice by down-regulation of antioxidant enzymes and heat-shock protein expressions

Inoue

Akiyama

Maeda‐Yamamoto

et al. 2011

Cell Stress and Chaperones

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“…Oral administration (po) of Teavigo (a green tea polyphenol preparation containing 90% EGCG) or Polyphenon E for 13 or nine weeks, respectively, to Beagle dogs resulted in dose-dependent toxicity and death (19). Vomiting and diarrhea were observed throughout both studies.…”

Section: Hepatic and Gastrointestinal Toxicities Of Green Tea Polyphementioning

confidence: 96%

“…In the dog, where bioavailability is much higher, hepatotoxicity, nephrotoxicity, and intestinal toxicity were observed. Toxicity was greater in fasted, than in prefed, dogs (19). The AUC plasma (area under the curve) in the prefed dogs was 19.8 µg h/mL as compared to 205 µg h/mL in fasted dogs following administration of 300 mg/kg, po.…”

Section: Hepatic and Gastrointestinal Toxicities Of Green Tea Polyphementioning

confidence: 97%

“…Although it is likely that the catechins are responsible for the toxicity in the dogs, a role for caffeine cannot be rule out since although Teavigo is caffeine-free, Polyphenon E contains 0.7% caffeine. Oral administration of 2000 mg/kg and intragastric administration (ig) Teavigo to rats resulted in lethality in 80% of animals treated (19). Histological analysis revealed hemorrhagic lesions in the stomach and intestine.…”

Section: Hepatic and Gastrointestinal Toxicities Of Green Tea Polyphementioning

confidence: 99%

“…Laboratory studies in rodents and dogs have supported the potential toxic effects of high doses of green tea-derived preparations (16,19). Oral administration (po) of Teavigo (a green tea polyphenol preparation containing 90% EGCG) or Polyphenon E for 13 or nine weeks, respectively, to Beagle dogs resulted in dose-dependent toxicity and death (19).…”

Section: Hepatic and Gastrointestinal Toxicities Of Green Tea Polyphementioning

confidence: 99%

See 2 more Smart Citations

Possible Controversy over Dietary Polyphenols: Benefits vs Risks

Lambert

Sang

Yang

2007

Chem. Res. Toxicol.

221

143

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Efficacy of Epigallocatechin-3-Gallate in Preventing Dermatitis in Patients With Breast Cancer Receiving Postoperative Radiotherapy

et al. 2022

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IMPORTANCE Safe and effective prophylactic therapies for radiation-induced dermatitis (RID) remain an unmet need.OBJECTIVE To determine if epigallocatechin-3-gallate (EGCG) solution reduces the incidence of RID in patients undergoing radiotherapy after breast cancer surgery. DESIGN, SETTING, AND PARTICIPANTSThis phase 2 double-blind, placebo-controlled randomized clinical trial enrolled 180 patients with breast cancer receiving postoperative radiotherapy at Shandong Cancer Hospital and Institute in Shandong, China, between November 2014 and June 2019. Data analysis was performed from September 2019 to January 2020.INTERVENTIONS Participants were randomly assigned (2:1) to receive either EGCG solution (660 μmol/L) or placebo (0.9% NaCl saline) sprayed to the whole radiation field from day 1 of the radiation until 2 weeks after radiation completion. MAIN OUTCOMES AND MEASURESThe primary end point was incidence of grade 2 or worse RID, defined by the Radiation Therapy Oncology Group scale. The secondary end points included RID index (RIDI), symptom index, changes in the skin temperature measured by infrared thermal images, and safety.RESULTS A total of 180 eligible patients were enrolled, of whom 165 (EGCG, n = 111; placebo, n = 54) were evaluable for efficacy (median [range] age, 46 [26-67] years). The occurrence of grade 2 or worse RID was significantly lower (50.5%; 95% CI, 41.2%-59.8%) in the EGCG group than in the placebo group (72.2%; 95% CI, 60.3%-84.1%) (P = .008). The mean RIDI in the EGCG group was significantly lower than that in the placebo group. Furthermore, symptom indexes were significantly lower in patients receiving EGCG. Four patients (3.6%) had adverse events related to the EGCG treatment, including grade 1 pricking skin sensation (3 [2.7%]) and pruritus (1 [0.9%]). CONCLUSIONS AND RELEVANCEIn this randomized clinical trial, prophylactic use of EGCG solution significantly reduced the incidence and severity of RID in patients receiving adjuvant radiotherapy for breast cancer. It has the potential to become a new choice of skin care for patients receiving radiotherapy.

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Safety studies on epigallocatechin gallate (EGCG) preparations. Part 2: Dermal, acute and short-term toxicity studies

Cited by 278 publications

References 23 publications

High-dose green tea polyphenols induce nephrotoxicity in dextran sulfate sodium-induced colitis mice by down-regulation of antioxidant enzymes and heat-shock protein expressions

High-dose green tea polyphenols induce nephrotoxicity in dextran sulfate sodium-induced colitis mice by down-regulation of antioxidant enzymes and heat-shock protein expressions

Possible Controversy over Dietary Polyphenols: Benefits vs Risks

Efficacy of Epigallocatechin-3-Gallate in Preventing Dermatitis in Patients With Breast Cancer Receiving Postoperative Radiotherapy

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