Quella S K, Loprinzi C L, Barton D L, Knost J A, Sloan J A, LaVasseur B I, Swan D, Krupp K R, Miller K D, Novotny P J
Mayo Clinic and Mayo Foundation, Rochester, USA.
J Clin Oncol. 2000 Mar;18(5):1068-74. doi: 10.1200/JCO.2000.18.5.1068.
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.
This double-blind clinical trial involved breast cancer survivors with substantial hot flashes. After randomization, patients underwent a 1-week baseline period with no therapy. This was followed by 4 weeks of either soy tablets or placebo. The patients then crossed over to the opposite arm in a double-blind manner for the last 4 weeks. Patients completed a daily questionnaire documenting hot flash frequency, intensity, and perceived side effects.
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 soy product was more effective in reducing hot flashes than the placebo. At study completion, patients preferred the soy product 33% of the time, the placebo 37% of the time, and neither substance 31% of the time. No toxicity was observed.
The soy product did not alleviate hot flashes in breast cancer survivors.
潮热是一些乳腺癌幸存者面临的重大临床问题。对于这一突出的临床问题，需要安全、有效的治疗方法。尽管已表明雌激素或孕激素替代疗法可缓解该问题，但对于这些女性使用激素疗法仍存在持续的安全担忧。基于传闻信息，我们推测大豆衍生的植物雌激素，即大豆中具有微弱雌激素样作用的物质，在与雌激素受体结合时表现出雌激素激动剂和/或拮抗剂效应，可能会缓解潮热。本次试验旨在研究这一假设。
这项双盲临床试验纳入了有严重潮热症状的乳腺癌幸存者。随机分组后，患者接受为期1周的无治疗基线期。随后是4周的大豆片或安慰剂治疗。然后患者以双盲方式交叉至另一组，进行最后4周的治疗。患者每天完成一份问卷，记录潮热频率、强度和感知到的副作用。
在177名随机分组并开始使用研究药物的女性中，155名（88%）在前5周提供了可用数据；149名在整个9周内提供了可用数据。没有迹象表明大豆产品在减轻潮热方面比安慰剂更有效。在研究结束时，患者在33%的时间里更喜欢大豆产品，37%的时间里更喜欢安慰剂，31%的时间里对两种药物都无偏好。未观察到毒性反应。
大豆产品未能缓解乳腺癌幸存者的潮热症状。
