Green Tea Extract to Prevent Colorectal Adenomas, Results of a Randomized, Placebo-Controlled Clinical Trial

التفاصيل البيبلوغرافية
العنوان: Green Tea Extract to Prevent Colorectal Adenomas, Results of a Randomized, Placebo-Controlled Clinical Trial
المؤلفون: Thomas Seufferlein, Thomas J. Ettrich, Stefan Menzler, Helmut Messmann, Gerhard Kleber, Alexander Zipprich, Stefanie Frank-Gleich, Hana Algül, Klaus Metter, Frank Odemar, Theodor Heuer, Ulrich Hügle, Rüdiger Behrens, Andreas W. Berger, Catharina Scholl, Katharina L. Schneider, Lukas Perkhofer, Friederike Rohlmann, Rainer Muche, Julia C. Stingl
المصدر: American Journal of Gastroenterology. 117:884-894
بيانات النشر: Ovid Technologies (Wolters Kluwer Health), 2022.
سنة النشر: 2022
مصطلحات موضوعية: Adenoma, Double-Blind Method, Tea, Hepatology, Plant Extracts, Gastroenterology, Humans, Colorectal Neoplasms, Antioxidants
الوصف: Preclinical, epidemiological, and small clinical studies suggest that green tea extract (GTE) and its major active component epigallocatechingallate (EGCG) exhibit antineoplastic effects in the colorectum.A randomized, double-blind trial of GTE standardized to 150 mg of EGCG b.i.d. vs placebo over 3 years was conducted to prevent colorectal adenomas (n = 1,001 with colon adenomas enrolled, 40 German centers). Randomization (1:1, n = 879) was performed after a 4-week run-in with GTE for safety assessment. The primary end point was the presence of adenoma/colorectal cancer at the follow-up colonoscopy 3 years after randomization.The safety profile of GTE was favorable with no major differences in adverse events between the 2 well-balanced groups. Adenoma rate in the modified intention-to-treat set (all randomized participants [intention-to-treat population] and a follow-up colonoscopy 26-44 months after randomization; n = 632) was 55.7% in the placebo and 51.1% in the GTE groups. This 4.6% difference was not statistically significant (adjusted relative risk 0.905; P = 0.1613). The respective figures for the per-protocol population were 54.3% (151/278) in the placebo group and 48.3% (129/267) in the GTE group, indicating a slightly lower adenoma rate in the GTE group, which was not significant (adjusted relative risk 0.883; P = 0.1169).GTE was well tolerated, but there was no statistically significant difference in the adenoma rate between the GTE and the placebo groups in the whole study population.
تدمد: 1572-0241
0002-9270
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::41db16ab61924d486f759cdc185d2ace
https://doi.org/10.14309/ajg.0000000000001706
حقوق: CLOSED
رقم الأكسشن: edsair.doi.dedup.....41db16ab61924d486f759cdc185d2ace
قاعدة البيانات: OpenAIRE