Van Patten Cheri L, Olivotto Ivo A, Chambers G Keith, Gelmon Karen A, Hislop T Gregory, Templeton Edith, Wattie Angela, Prior Jerilynn C
British Columbia Cancer Agency, Vancouver Cancer Centre, Vancouver Hospital and Health Sciences Centre, and University of British Columbia, Vancouver, British Columbia, Canada.
J Clin Oncol. 2002 Mar 15;20(6):1449-55. doi: 10.1200/JCO.2002.20.6.1449.
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.
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.
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 micromol/L) compared with placebo (0.43 +/- 0.37 micromol/L) (P =.02). Overall acceptability and compliance were high and similar in both groups.
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.
乳腺癌幸存者的血管舒缩症状，如潮热和盗汗，通常会因化疗、他莫昔芬，和/或在诊断时停止激素替代疗法而加重。本研究评估了一种含有植物雌激素的大豆饮料作为绝经后乳腺癌女性潮热治疗方法的可接受性和有效性。
对患有中度潮热且曾接受早期乳腺癌治疗的绝经后女性进行了一项随机、安慰剂对照、双盲临床试验。根据他莫昔芬的使用情况对女性进行分层，并随机分为饮用含90毫克异黄酮的大豆饮料组（n = 59）或安慰剂大米饮料组（n = 64）。女性在基线时使用每日更年期日记记录潮热的次数和严重程度，持续4周，并在饮用500毫升大豆或安慰剂饮料的同时记录12周。
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，可能由于强烈的安慰剂效应，两组的潮热都有显著减少。两组均出现轻度胃肠道副作用，但大豆组出现的频率和严重程度更高。饮用大豆的女性在6周时的平均血清染料木黄酮浓度（0.61±0.43微摩尔/升）显著高于安慰剂组（0.43±0.37微摩尔/升）（P = 0.02）。两组的总体可接受性和依从性都很高且相似。
大豆饮料在缓解乳腺癌女性潮热方面并不比安慰剂更有效。建议未来对其他化合物进行研究，以确定乳腺癌幸存者潮热的安全有效治疗方法。
