A randomized, double-blind, placebo-controlled phase II trial to examine the effect of Polyphenon E on endogenous hormone levels

Unrestricted In this randomized, double-blind, placebo-controlled phase II trial to examine the effect of Polyphenon E [containing the most important polyphenol, epidgallocatechin gallate (EGCG) in green tea] on endogenous hormone profiles, 111 participants were recruited and randomized into three different experimental arms: 400 mg EGCG daily, 800 mg EGCG daily or placebo for a period of 60 days. Four steroid hormones: androstenedione (Andr), testosterone (T), estrone (E1) and estradiol (E2), and two protein hormones: adiponectin (Adip) and insulin-like growth factor 1 (IGF1), plus two hormone binding proteins: IGF binding protein 3 (IGFbp3) and sex hormone binding globulin (SHBG) levels were measured at baseline, at end of month-1 and at end of month-2. This study failed to provide confirmatory evidence of lower serum E1 and E2 values due to green tea consumption. The E1 and E2 values declined in the group treated with EGCG but similar declines were also seen in the placebo group. The only treatment effect suggesting a protective effect against breast cancer was a decline in IGFbp3.本项旨在探究茶多酚E（Polyphenon E）[其含有绿茶中核心多酚成分表没食子儿茶素没食子酸酯（epigallocatechin gallate, EGCG）] 对机体内源性激素谱影响的随机双盲安慰剂对照II期临床试验，共招募111名受试者并将其随机分配至3个试验组：每日口服400mg EGCG组、每日口服800mg EGCG组与安慰剂组，干预周期为60天。本研究分别于基线、第1月末及第2月末，对4种类固醇激素（雄烯二酮（androstenedione, Andr）、睾酮（testosterone, T）、雌酮（estrone, E1）及雌二醇（estradiol, E2））、2种蛋白质激素（脂联素（adiponectin, Adip）及胰岛素样生长因子1（insulin-like growth factor 1, IGF1）），以及2种激素结合蛋白（胰岛素样生长因子结合蛋白3（IGF binding protein 3, IGFbp3）及性激素结合球蛋白（sex hormone binding globulin, SHBG））的水平进行了检测。本研究未获得绿茶摄入可降低血清雌酮与雌二醇水平的验证性证据。EGCG干预组的雌酮与雌二醇水平虽出现下降，但安慰剂组亦观察到类似降幅。唯一提示具有乳腺癌预防潜力的治疗效应，为胰岛素样生长因子结合蛋白3水平的下降。