Effect of soy phytoestrogens on hot flashes in postmenopausal women with breast cancer: A randomized, controlled clinical trial
Effect of soy phytoestrogens on hot flashes in postmenopausal women with breast cancer: A randomized, controlled clinical trial
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DOI：
10.1200/jco.20.6.1449
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发表时间：
2002-03-15
影响因子：
45.3
通讯作者：
Prior, JC
中科院分区：
文献类型：
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作者：
Van Patten, CL;Olivotto, IA;Prior, JC
目的：乳腺癌幸存者的血管症状，如潮热和盗汗，通常会因化疗和他莫昔芬和/或诊断时停止激素替代治疗而恶化。本研究评估了可接受性和有效性的大豆饮料含有植物雌激素作为治疗潮热绝经后妇女乳腺cancer.Methods：一个随机的，安慰剂对照，双盲临床试验进行了中度潮热绝经后妇女谁是以前治疗早期乳腺癌。妇女被分层使用他莫昔芬和随机大豆饮料（n = 59）含有90毫克的咖啡酮或安慰剂大米饮料（n = 64）。妇女每天记录潮热的数量和严重程度，每天记录绝经日记，在基线时持续4周，在摄入500 ml时持续12周。结果：大豆组和安慰剂组在潮热次数或潮热评分方面没有显著差异。然而，可能是因为强烈的安慰剂效应，两组都有显着减少潮热。两组均出现轻度胃肠道副作用，但大豆组发生的频率和严重程度更高。与安慰剂组（0.43 +/- 0.37 mumol/l）相比，食用大豆的女性在第6周的平均血清染料木黄酮浓度显著更高（0.61 +/- 0.43 mumol/l）。（P =.02）。整体的可接受性和依从性都很高，在两个group.Conclusion相似：大豆饮料并没有缓解潮热的女性乳腺癌任何超过安慰剂。建议对其他化合物进行进一步研究，以确定乳腺癌幸存者潮热的安全有效疗法。
Purpose : Vasomotor symptoms, such as hot flashes and night sweats, in breast cancer survivors are often worsened by chemotherapy and tamoxifen, and/or the discontinuation of hormone replacement therapy at diagnosis. This study evaluated the acceptability and effectiveness of a soy beverage containing phytoestrogens as a treatment for hot flashes in postmenopausal women with breast cancer.Methods: A randomized, placebo-controlled, double-blind clinical trial was conducted in postmenopausal women with moderate hot flashes who were previously treated for early-stage breast cancer. Women were stratified for tamoxifen use and randomized to a soy beverage (n = 59) containing 90 mg of isoflavones or to a placebo rice beverage (n = 64). Women recorded the number and severity of hot flashes daily with a daily menopause diary for 4 weeks at baseline and for 12 weeks while consuming 500 ml. of a soy or placebo beverage.Results: There were no significant differences between the soy and placebo groups in the number of hot flashes or hot flash scores. However, presumably because of a strong placebo effect, both groups had significant reductions in hot flashes. Mild gastrointestinal side effects were experienced by both groups but occurred with greater frequency and severity with soy. The mean serum genistein concentration at 6 weeks was significantly higher in women who consumed soy (0.61 +/- 0.43 mumol/L) compared with placebo (0.43 +/- 0.37 mumol/l.) (P =.02). Overall acceptability and compliance were high and similar in both groups.Conclusion: The soy beverage did not alleviate hot flashes in women with breast cancer any more than did a placebo. Future research into other compounds is recommended to identify safe and effective therapies for hot flashes in breast cancer survivors.