Evaluation of soy phytoestrogens for the treatment of hot flashes in breast cancer survivors: A North Central Cancer Treatment Group trial
Evaluation of soy phytoestrogens for the treatment of hot flashes in breast cancer survivors: A North Central Cancer Treatment Group trial
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DOI：
10.1200/jco.2000.18.5.1068
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发表时间：
2000-03-01
影响因子：
45.3
通讯作者：
Novotny, PJ
中科院分区：
文献类型：
--
作者：
Quella, SK;Loprinzi, CL;Novotny, PJ
目的：潮热是一些乳腺癌幸存者的重要临床问题。对于这一突出的临床问题，需要安全、有效的治疗。虽然雌激素或孕激素替代疗法可以缓解这个问题，但在这些妇女中使用激素疗法仍然存在安全性问题。基于轶事信息，我们假设大豆来源的植物雌激素，大豆中的弱雌激素样物质，当它们与雌激素受体结合时表现出雌激素激动剂和/或拮抗剂作用，可以缓解潮热。目前的试验是为了研究这一假设，患者和方法：这一双盲临床试验涉及大量潮热的乳腺癌幸存者，随机分组后，患者经历1周基线期，没有治疗，随后是4周的片剂或安慰剂。然后，患者以双盲方式交叉至对侧组，持续最后4周。患者完成每日CT问卷调查，记录潮热频率、强度和感觉到的副作用。结果：在177名随机分组并开始使用研究物质的妇女中，155名（88%）在前5周提供了可用数据; 149提供了整个9周的可用数据，没有证据表明该产品在减少潮热方面比安慰剂更有效，在研究完成时，患者在33%的时间里更喜欢说产品，37%的时间里更喜欢安慰剂，31%的时间里都不喜欢。结论：该产品不能缓解乳腺癌幸存者的潮热。J Clin Oncol 18：1068-1074，（C）2000，美国临床肿瘤学会。
Purpose: Hot flashes represent a significant clinical problem for some breast cancer survivors. Safe, effective treatment is needed for this prominent clinical problem. Although it has been shown that estrogen or progesterone replacement therapy can alleviate this problem, there are continued safety concerns regarding the use of hormonal therapies in these women. Based on anecdotal information, we hypothesized that soy-derived phytoestrogens, weak estrogen-like substances in the soybean that demonstrate estrogen agonist and/or antagonist effects when they bind to estrogen receptors, could alleviate hot flashes. This current trial was designed to investigate this hypothesis,Patients and Methods: This double-blind clinical trial involved breast cancer survivors with substantial hot flashes, After randomization, patients underwent a I-week baseline period with no therapy, This was followed by 4 weeks of either say tablets or placebo. The patients then crossed over to the opposite arm in a double-blind manner for the last 4 weeks. patients completed ct daily questionnaire documenting hot flash frequency, intensity, and perceived side effects.Results: Of the 177 women who were randomized and started the study substance, 155 (88%) provided useable data over the first 5 weeks; 149 provided usable data over the entire 9 weeks, There was no suggestion that the say product was more effective in reducing hot flashes than the placebo, At study completion, patients preferred the say product 33% of the time, the placebo 37% of the time, and neither substance 31% of the time. No toxicity was observed.Conclusion: The say product did not alleviate hot flashes in breast cancer survivors. J Clin Oncol 18:1068-1074, (C) 2000 by American Society of Clinical Oncology.