一项随机、双盲、安慰剂对照、交叉试验，以评估EstroSense对绝经前女性2-羟雌酮:16α-羟雌酮比值的影响。

A randomized, double-blind, placebo-controlled, cross-over trial to evaluate the effect of EstroSense on 2-hydroxyestrone:16α-hydroxyestrone ratio in premenopausal women.

作者信息

Green Tim, See Janet, Schauch Marita, Reil Julie, Glover Melissa, Brix Jennifer, Gerry Adella, Li Kathy, Newman Mark, Gahler Roland J, Wood Simon

机构信息

Adjunct Professor, Food, Nutrition and Health, University of British Columbia, Vancouver, BC, Canada.

PGX Centre, Coquitlam, BC, Canada.

出版信息

J Complement Integr Med. 2022 Oct 6;20(1):199-206. doi: 10.1515/jcim-2022-0301. eCollection 2023 Mar 1.

DOI:10.1515/jcim-2022-0301

PMID:36201753

Abstract

OBJECTIVES

Some estrogen metabolites are associated with increased breast cancer risk, while others are protective. Research efforts have focused on modifiable factors, including bioactive compounds found in food or supplements, promoting estrogen profiles with anti-cancer properties. EstroSense is a nutraceutical product with bioactive compounds, including Indole-3-carbinol and green-tea catechins, which may favourably affect estrogen profiles. This study was conducted to determine if EstroSense use, compared to placebo, promotes a higher urinary 2-hydroxyestrone:16α-hydroxyestrone ratio (2-OHE:16α-OHE), a biomarker associated with a lowered risk of breast cancer.

METHODS

A total of 148 premenopausal women were recruited from British Columbia, Canada to participate in a randomized, double-blind, cross-over, multicentre, placebo-controlled study in which women were randomized to a treatment sequence that consisted of either EstroSense, followed by placebo or vice-versa. The women were instructed to consume three capsules per day of EstroSense or the placebo for three menstrual cycles (∼12 weeks). The primary outcome was the measurement of 2-OHE1:16α-OHE1 in casual samples at baseline and after each treatment phase.

RESULTS

After 12 weeks of intervention, the mean (95% CI) urinary 2-OHE:16α-OHE was 4.55 (2.69, 6.42) (p<0.001) higher following EstroSense than placebo adjusted for baseline values.

CONCLUSIONS

EstroSense use led to markedly higher urinary 2-OHE1:16α-OHE1 than the placebo, a biomarker associated with a lower risk of breast cancer.

REGISTRATION

http://clinicaltrials.gov (NCT02385916).

摘要

目的

一些雌激素代谢产物与乳腺癌风险增加有关，而另一些则具有保护作用。研究工作集中在可改变的因素上，包括食物或补充剂中发现的生物活性化合物，以促进具有抗癌特性的雌激素谱。EstroSense是一种含有生物活性化合物的营养保健品，包括吲哚 - 3 - 甲醇和绿茶儿茶素，可能对雌激素谱产生有利影响。本研究旨在确定与安慰剂相比，使用EstroSense是否能提高尿中2 - 羟基雌酮：16α - 羟基雌酮比值（2 - OHE：16α - OHE），这是一种与降低乳腺癌风险相关的生物标志物。

方法

从加拿大不列颠哥伦比亚省招募了148名绝经前女性，参与一项随机、双盲、交叉、多中心、安慰剂对照研究，女性被随机分配到一个治疗序列，该序列包括先服用EstroSense，然后服用安慰剂，或者反之。这些女性被指示每天服用三粒EstroSense胶囊或安慰剂，持续三个月经周期（约12周）。主要结局是在基线和每个治疗阶段后，测量随机样本中的2 - OHE1：16α - OHE1。