The safety of green tea extract supplementation in postmenopausal women at risk for breast cancer: results of the Minnesota Green Tea Trial
Green tea is thought to provide health benefits, though adverse reactions to green tea extract (GTE) have been reported. We conducted a randomized, double-blind, placebo-controlled study of GTE on breast cancer biomarkers, including mammographic density, in which 1075 postmenopausal women were rando...
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| Veröffentlicht in: | Food and chemical toxicology 2015-09, Vol.83, p.26-35 |
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| creator | Dostal, Allison M. Samavat, Hamed Bedell, Sarah Torkelson, Carolyn Wang, Renwei Swenson, Karen Le, Chap Wu, Anna H. Ursin, Giske Yuan, Jian-Min Kurzer, Mindy S. |
| description | Green tea is thought to provide health benefits, though adverse reactions to green tea extract (GTE) have been reported. We conducted a randomized, double-blind, placebo-controlled study of GTE on breast cancer biomarkers, including mammographic density, in which 1075 postmenopausal women were randomly assigned to consume GTE containing 843 mg (-)-epigallocatechin-3-gallate (EGCG) or placebo daily for one year. There were no significant differences in % of women with adverse events (AEs, 75.6% and 72.8% of the GTE group and placebo group, respectively) or serious AEs (2.2 % and 1.5% of GTE and placebo groups, respectively). Women on GTE reported significantly higher incidence of nausea (P |
| doi_str_mv | 10.1016/j.fct.2015.05.019 |
| format | Article |
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•Green tea may have health benefits and also cause adverse symptoms in high doses.•The safety of green tea extract (GTE) was assessed in postmenopausal women.•GTE was associated with higher incidence of nausea and skin-related adverse events.•GTE was associated with higher incidence of ALT elevations compared to placebo.•Adverse events were mainly mild and transient; GTE was generally well tolerated.</description><identifier>ISSN: 0278-6915</identifier><identifier>EISSN: 1873-6351</identifier><identifier>DOI: 10.1016/j.fct.2015.05.019</identifier><identifier>PMID: 26051348</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Adverse events ; Aged ; Anticarcinogenic Agents - adverse effects ; Anticarcinogenic Agents - therapeutic use ; Antioxidants - adverse effects ; Antioxidants - chemistry ; Antioxidants - therapeutic use ; Biomarkers - blood ; Breast cancer ; Breast Density ; Breast Neoplasms - blood ; Breast Neoplasms - diagnostic imaging ; Breast Neoplasms - epidemiology ; Breast Neoplasms - prevention & control ; Camellia sinensis - chemistry ; Catechin - adverse effects ; Catechin - analogs & derivatives ; Catechin - analysis ; Catechin - therapeutic use ; Dietary Supplements - adverse effects ; Dietary Supplements - analysis ; Double-Blind Method ; EGCG ; Female ; Food Handling ; Green tea ; Hepatic Insufficiency - etiology ; Hepatic Insufficiency - physiopathology ; Hepatotoxicity ; Humans ; Mammary Glands, Human - abnormalities ; Middle Aged ; Minnesota - epidemiology ; Plant Extracts - adverse effects ; Plant Extracts - chemistry ; Plant Extracts - therapeutic use ; Plant Leaves - chemistry ; Postmenopausal ; Radiography ; Risk Factors ; Severity of Illness Index</subject><ispartof>Food and chemical toxicology, 2015-09, Vol.83, p.26-35</ispartof><rights>2015 Elsevier Ltd</rights><rights>Copyright © 2015 Elsevier Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c414t-4054524077ce92df3c2416132055b78947fd74a17046481cc1fc8f79559213dd3</citedby><cites>FETCH-LOGICAL-c414t-4054524077ce92df3c2416132055b78947fd74a17046481cc1fc8f79559213dd3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.fct.2015.05.019$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,780,784,885,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26051348$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Dostal, Allison M.</creatorcontrib><creatorcontrib>Samavat, Hamed</creatorcontrib><creatorcontrib>Bedell, Sarah</creatorcontrib><creatorcontrib>Torkelson, Carolyn</creatorcontrib><creatorcontrib>Wang, Renwei</creatorcontrib><creatorcontrib>Swenson, Karen</creatorcontrib><creatorcontrib>Le, Chap</creatorcontrib><creatorcontrib>Wu, Anna H.</creatorcontrib><creatorcontrib>Ursin, Giske</creatorcontrib><creatorcontrib>Yuan, Jian-Min</creatorcontrib><creatorcontrib>Kurzer, Mindy S.</creatorcontrib><title>The safety of green tea extract supplementation in postmenopausal women at risk for breast cancer: results of the Minnesota Green Tea Trial</title><title>Food and chemical toxicology</title><addtitle>Food Chem Toxicol</addtitle><description>Green tea is thought to provide health benefits, though adverse reactions to green tea extract (GTE) have been reported. We conducted a randomized, double-blind, placebo-controlled study of GTE on breast cancer biomarkers, including mammographic density, in which 1075 postmenopausal women were randomly assigned to consume GTE containing 843 mg (-)-epigallocatechin-3-gallate (EGCG) or placebo daily for one year. There were no significant differences in % of women with adverse events (AEs, 75.6% and 72.8% of the GTE group and placebo group, respectively) or serious AEs (2.2 % and 1.5% of GTE and placebo groups, respectively). Women on GTE reported significantly higher incidence of nausea (P < 0.001) and dermatologic AEs (P = 0.05) and significantly lower diarrhea incidence (P = 0.02). More women in the GTE group experienced an alanine aminotransferase (ALT) elevation compared with placebo group (n = 36, (6.7%) vs. n = 4, (0.7%); P < 0.001). There were no statistically significant differences between groups in frequencies of other AEs. Overall, AEs were mainly mild and transient, indicating that daily consumption of GTE containing 843 mg EGCG is generally well tolerated by a group of predominantly Caucasian postmenopausal women. However, 6.7% of GTE consumers experienced ALT elevations, with 1.3% experiencing ALT-related serious AEs.
•Green tea may have health benefits and also cause adverse symptoms in high doses.•The safety of green tea extract (GTE) was assessed in postmenopausal women.•GTE was associated with higher incidence of nausea and skin-related adverse events.•GTE was associated with higher incidence of ALT elevations compared to placebo.•Adverse events were mainly mild and transient; GTE was generally well tolerated.</description><subject>Adverse events</subject><subject>Aged</subject><subject>Anticarcinogenic Agents - adverse effects</subject><subject>Anticarcinogenic Agents - therapeutic use</subject><subject>Antioxidants - adverse effects</subject><subject>Antioxidants - chemistry</subject><subject>Antioxidants - therapeutic use</subject><subject>Biomarkers - blood</subject><subject>Breast cancer</subject><subject>Breast Density</subject><subject>Breast Neoplasms - blood</subject><subject>Breast Neoplasms - diagnostic imaging</subject><subject>Breast Neoplasms - epidemiology</subject><subject>Breast Neoplasms - prevention & control</subject><subject>Camellia sinensis - chemistry</subject><subject>Catechin - adverse effects</subject><subject>Catechin - analogs & derivatives</subject><subject>Catechin - analysis</subject><subject>Catechin - therapeutic use</subject><subject>Dietary Supplements - adverse effects</subject><subject>Dietary Supplements - analysis</subject><subject>Double-Blind Method</subject><subject>EGCG</subject><subject>Female</subject><subject>Food Handling</subject><subject>Green tea</subject><subject>Hepatic Insufficiency - etiology</subject><subject>Hepatic Insufficiency - physiopathology</subject><subject>Hepatotoxicity</subject><subject>Humans</subject><subject>Mammary Glands, Human - abnormalities</subject><subject>Middle Aged</subject><subject>Minnesota - epidemiology</subject><subject>Plant Extracts - adverse effects</subject><subject>Plant Extracts - chemistry</subject><subject>Plant Extracts - therapeutic use</subject><subject>Plant Leaves - chemistry</subject><subject>Postmenopausal</subject><subject>Radiography</subject><subject>Risk Factors</subject><subject>Severity of Illness Index</subject><issn>0278-6915</issn><issn>1873-6351</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kdFuFCEUhonR2LX6AN4YLr2ZlcPAMKOJSdO0tUmNN-s1YZlDyzo7jMBU-w59iD6LTybrto3emJyEAP_5fjg_Ia-BLYFB826zdDYvOQO5ZKWge0IW0Kq6amoJT8mCcdVWTQfygLxIacMYU6Ca5-SAN0xCLdoFuV1dIU3GYb6hwdHLiDjSjIbizxyNzTTN0zTgFsdssg8j9SOdQsrlIExmTmagP0LZUJNp9OkbdSHSdUSTMrVmtBjf04hpHnLa8XNx--zHEVPIhp79cVuh-XW3it4ML8kzZ4aEr-7XQ_L19GR1_Km6-HJ2fnx0UVkBIleCSSG5YEpZ7HjvassFNFBzJuVatZ1QrlfCgGKiES1YC862TnVSdhzqvq8Pycc9d5rXW-xt-Vw0g56i35p4o4Px-t-b0V_py3CthRSsaWQBvL0HxPB9xpT11ieLw2BGDHPSxbqDDhTwIoW91MaQUkT3aANM71LUG11S1LsUNSsFXel58_f7HjseYiuCD3sBlilde4w6WY9l2r2PWGB98P_B_wZGDrBm</recordid><startdate>20150901</startdate><enddate>20150901</enddate><creator>Dostal, Allison M.</creator><creator>Samavat, Hamed</creator><creator>Bedell, Sarah</creator><creator>Torkelson, Carolyn</creator><creator>Wang, Renwei</creator><creator>Swenson, Karen</creator><creator>Le, Chap</creator><creator>Wu, Anna H.</creator><creator>Ursin, Giske</creator><creator>Yuan, Jian-Min</creator><creator>Kurzer, Mindy S.</creator><general>Elsevier Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7U7</scope><scope>C1K</scope><scope>5PM</scope></search><sort><creationdate>20150901</creationdate><title>The safety of green tea extract supplementation in postmenopausal women at risk for breast cancer: results of the Minnesota Green Tea Trial</title><author>Dostal, Allison M. ; Samavat, Hamed ; Bedell, Sarah ; Torkelson, Carolyn ; Wang, Renwei ; Swenson, Karen ; Le, Chap ; Wu, Anna H. ; Ursin, Giske ; Yuan, Jian-Min ; Kurzer, Mindy S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c414t-4054524077ce92df3c2416132055b78947fd74a17046481cc1fc8f79559213dd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adverse events</topic><topic>Aged</topic><topic>Anticarcinogenic Agents - adverse effects</topic><topic>Anticarcinogenic Agents - therapeutic use</topic><topic>Antioxidants - adverse effects</topic><topic>Antioxidants - chemistry</topic><topic>Antioxidants - therapeutic use</topic><topic>Biomarkers - blood</topic><topic>Breast cancer</topic><topic>Breast Density</topic><topic>Breast Neoplasms - blood</topic><topic>Breast Neoplasms - diagnostic imaging</topic><topic>Breast Neoplasms - epidemiology</topic><topic>Breast Neoplasms - prevention & control</topic><topic>Camellia sinensis - chemistry</topic><topic>Catechin - adverse effects</topic><topic>Catechin - analogs & derivatives</topic><topic>Catechin - analysis</topic><topic>Catechin - therapeutic use</topic><topic>Dietary Supplements - adverse effects</topic><topic>Dietary Supplements - analysis</topic><topic>Double-Blind Method</topic><topic>EGCG</topic><topic>Female</topic><topic>Food Handling</topic><topic>Green tea</topic><topic>Hepatic Insufficiency - etiology</topic><topic>Hepatic Insufficiency - physiopathology</topic><topic>Hepatotoxicity</topic><topic>Humans</topic><topic>Mammary Glands, Human - abnormalities</topic><topic>Middle Aged</topic><topic>Minnesota - epidemiology</topic><topic>Plant Extracts - adverse effects</topic><topic>Plant Extracts - chemistry</topic><topic>Plant Extracts - therapeutic use</topic><topic>Plant Leaves - chemistry</topic><topic>Postmenopausal</topic><topic>Radiography</topic><topic>Risk Factors</topic><topic>Severity of Illness Index</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Dostal, Allison M.</creatorcontrib><creatorcontrib>Samavat, Hamed</creatorcontrib><creatorcontrib>Bedell, Sarah</creatorcontrib><creatorcontrib>Torkelson, Carolyn</creatorcontrib><creatorcontrib>Wang, Renwei</creatorcontrib><creatorcontrib>Swenson, Karen</creatorcontrib><creatorcontrib>Le, Chap</creatorcontrib><creatorcontrib>Wu, Anna H.</creatorcontrib><creatorcontrib>Ursin, Giske</creatorcontrib><creatorcontrib>Yuan, Jian-Min</creatorcontrib><creatorcontrib>Kurzer, Mindy S.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Food and chemical toxicology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Dostal, Allison M.</au><au>Samavat, Hamed</au><au>Bedell, Sarah</au><au>Torkelson, Carolyn</au><au>Wang, Renwei</au><au>Swenson, Karen</au><au>Le, Chap</au><au>Wu, Anna H.</au><au>Ursin, Giske</au><au>Yuan, Jian-Min</au><au>Kurzer, Mindy S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The safety of green tea extract supplementation in postmenopausal women at risk for breast cancer: results of the Minnesota Green Tea Trial</atitle><jtitle>Food and chemical toxicology</jtitle><addtitle>Food Chem Toxicol</addtitle><date>2015-09-01</date><risdate>2015</risdate><volume>83</volume><spage>26</spage><epage>35</epage><pages>26-35</pages><issn>0278-6915</issn><eissn>1873-6351</eissn><abstract>Green tea is thought to provide health benefits, though adverse reactions to green tea extract (GTE) have been reported. We conducted a randomized, double-blind, placebo-controlled study of GTE on breast cancer biomarkers, including mammographic density, in which 1075 postmenopausal women were randomly assigned to consume GTE containing 843 mg (-)-epigallocatechin-3-gallate (EGCG) or placebo daily for one year. There were no significant differences in % of women with adverse events (AEs, 75.6% and 72.8% of the GTE group and placebo group, respectively) or serious AEs (2.2 % and 1.5% of GTE and placebo groups, respectively). Women on GTE reported significantly higher incidence of nausea (P < 0.001) and dermatologic AEs (P = 0.05) and significantly lower diarrhea incidence (P = 0.02). More women in the GTE group experienced an alanine aminotransferase (ALT) elevation compared with placebo group (n = 36, (6.7%) vs. n = 4, (0.7%); P < 0.001). There were no statistically significant differences between groups in frequencies of other AEs. Overall, AEs were mainly mild and transient, indicating that daily consumption of GTE containing 843 mg EGCG is generally well tolerated by a group of predominantly Caucasian postmenopausal women. However, 6.7% of GTE consumers experienced ALT elevations, with 1.3% experiencing ALT-related serious AEs.
•Green tea may have health benefits and also cause adverse symptoms in high doses.•The safety of green tea extract (GTE) was assessed in postmenopausal women.•GTE was associated with higher incidence of nausea and skin-related adverse events.•GTE was associated with higher incidence of ALT elevations compared to placebo.•Adverse events were mainly mild and transient; GTE was generally well tolerated.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>26051348</pmid><doi>10.1016/j.fct.2015.05.019</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adverse events Aged Anticarcinogenic Agents - adverse effects Anticarcinogenic Agents - therapeutic use Antioxidants - adverse effects Antioxidants - chemistry Antioxidants - therapeutic use Biomarkers - blood Breast cancer Breast Density Breast Neoplasms - blood Breast Neoplasms - diagnostic imaging Breast Neoplasms - epidemiology Breast Neoplasms - prevention & control Camellia sinensis - chemistry Catechin - adverse effects Catechin - analogs & derivatives Catechin - analysis Catechin - therapeutic use Dietary Supplements - adverse effects Dietary Supplements - analysis Double-Blind Method EGCG Female Food Handling Green tea Hepatic Insufficiency - etiology Hepatic Insufficiency - physiopathology Hepatotoxicity Humans Mammary Glands, Human - abnormalities Middle Aged Minnesota - epidemiology Plant Extracts - adverse effects Plant Extracts - chemistry Plant Extracts - therapeutic use Plant Leaves - chemistry Postmenopausal Radiography Risk Factors Severity of Illness Index |
| title | The safety of green tea extract supplementation in postmenopausal women at risk for breast cancer: results of the Minnesota Green Tea Trial |
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