The Effect of Black Cohosh Extract on the Human Breast

黑升麻提取物对人体乳房的影响

• 批准号: 6760090
• 负责人: EDWARD R SAUTER
• 金额: $ 18.13万
• 依托单位: UNIVERSITY OF MISSOURI-COLUMBIA
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-06-15 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6760090
• 关键词: alternative medicine; biomarker; blood chemistry; cell differentiation; clinical research; dietary supplements; endocrine disorder; enzyme linked immunosorbent assay; estrogens; follicle stimulating hormone; glycosides; hormone therapy; human subject; human therapy evaluation; longitudinal human study; mammary gland; medicinal plants; plant extracts; postmenopause; prostate specific antigen; radioimmunoassay; receptor binding; root; sign /symptom; statistics /biometry; women' s health

DESCRIPTION (provided by applicant): Over 40 million women in the US have reached menopause, and 40% will experience symptoms significant enough to seek medical attention. Hormone replacement therapy, prescribed to ameliorate menopausal symptoms, has been associated with an increased risk of developing breast cancer. Many women use herbal preparations for menopausal complaints, believing them to be safe. Black cohosh extract (BCE) is the largest selling herbal dietary supplement in the United States used to alleviate menopausal symptoms. The mechanism of action by which BCE acts to treat menopausal symptoms of estrogen deficiency is not clear, with some data supporting a central nervous system effect, while other studies demonstrate a proestrogenic effect. The primary aim of this study is to determine if BCE administered to symptomatic postmenopausal women results in estrogenic stimulation of the breast as measured by changes in nipple aspirate fluid (NAF) levels of estradiol, pS2, follicle stimulating hormone (FSH), leutenizing hormone (LH) and prostate-specific antigen (PSA), as well as NAF cytology. Secondary aims are to 1) evaluate if BCE saponins, the proposed active constituents in BCE, are detectable in the NAF of women receiving BCE, 2) determine if BCE leads to a reduction in clinical symptoms of menopause, and 3) determine if the biomarker effects persist after stopping BCE. As the American population ages there are an increasing number of menopausal women. Interest in herbal therapies is rapidly growing among these women, including breast cancer survivors, to treat the disruptive symptoms associated with menopause. BCE binds to the estrogen receptor and in some studies stimulates breast cells. It is therefore important to demonstrate that BCE does not increase the risk of estrogen-related cancers. We have chosen biomarkers proven to be estrogen responsive proteins which are readily measured in both NAF and blood. Although prior studies failed to correlate clinical response to BCE with changes in serum levels of LH, FSH, or estradiol, it is critical to measure these markers in the breast itself, not diluted by the contribution from other organs. The findings should allow us to design a high quality R01 submission involving a larger, randomized study of longer duration which should provide some answers on the potential role of BCE in breast cancer.

描述（由申请人提供）：在美国，超过4000万妇女已经达到了更年期，40％的妇女将出现足够重要的症状以寻求医疗护理。 根据改善更年期症状的规定，激素替代疗法与患乳腺癌的风险增加有关。 许多妇女使用草药制剂来进行更年期的抱怨，认为她们是安全的。 黑色同胞提取物（BCE）是美国用于减轻更年期症状的最大销售草药饮食补充剂。 BCE采取行动治疗绝经症状的作用机理尚不清楚，其中一些数据支持中枢神经系统效应，而其他研究则表现出了源源性效应。 The primary aim of this study is to determine if BCE administered to symptomatic postmenopausal women results in estrogenic stimulation of the breast as measured by changes in nipple aspirate fluid (NAF) levels of estradiol, pS2, follicle stimulating hormone (FSH), leutenizing hormone (LH) and prostate-specific antigen (PSA), as well as NAF cytology. 次要目的是1）评估BCE Saponin是否在接受BCE的NAF中可检测到BCE中提出的活性成分，2）确定BCE是否会导致更年期临床症状的降低，并且3）3）确定生物标志物在停止BCE后是否会持续存在。 随着美国人口的年龄，更年期妇女数量越来越多。 这些女性（包括乳腺癌幸存者）对草药疗法的兴趣正在迅速增长，以治疗与更年期相关的破坏性症状。 BCE与雌激素受体结合，在某些研究中刺激了乳腺细胞。 因此，重要的是要证明BCE不会增加与雌激素相关的癌症的风险。 我们选择了被证明是雌激素反应蛋白的生物标志物，在NAF和血液中都很容易测量。 尽管先前的研究未能将与BCE的临床反应与LH，FSH或雌二醇的血清水平变化相关联，但测量乳房本身中的这些标记物至关重要，而不是因其他器官的贡献而稀释。 这些发现应该使我们能够设计高质量的R01提交，涉及更大的持续时间的更大，随机研究，这应该为BCE在乳腺癌中的潜在作用提供一些答案。

项目成果

Black cohosh does not exert an estrogenic effect on the breast.

黑升麻不会对乳房产生雌激素作用。

• DOI: 10.1080/01635580701506968
• 发表时间: 2007
• 期刊: Nutrition and cancer
• 作者: Ruhlen,RachelL;Haubner,Jenny;Tracy,JohnK;Zhu,Weizhu;Ehya,Hormoz;Lamberson,WilliamR;Rottinghaus,GeorgeE;Sauter,EdwardR
• 通讯作者: Sauter,EdwardR