Prospective evaluation of vitamin E for hot flashes in breast cancer survivors
Prospective evaluation of vitamin E for hot flashes in breast cancer survivors
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DOI：
10.1200/jco.1998.16.2.495
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发表时间：
1998-02-01
影响因子：
45.3
通讯作者：
Novotny, P
中科院分区：
文献类型：
--
作者：
Barton, DL;Loprinzi, CL;Novotny, P
目的：潮热是一些乳腺癌幸存者的一个重要临床问题。虽然雌激素或孕激素制剂可以缓解许多患者的这些症状，但在这些妇女中使用激素制剂仍然令人担忧。因此，对于乳腺癌幸存者的潮热，人们认为需要非激素治疗。基于轶事证据，维生素E是有帮助的，我们设计了一个试验来调查这个问题。方法：我们开发并进行了一个安慰剂对照，随机，交叉试验，在1周的基线期后，患者接受4周的维生素E 800 IU每天，然后4周的一个相同的安慰剂，反之亦然。日记被用来衡量潜在的毒性和潮热在基线一周和随后的两个4周的治疗periods.Results：120例患者评价毒性未能显示任何。完成第一个治疗期的105例患者显示两个研究组的潮热频率降低相似（25% vs 22%; P = 0.90）。然而，交叉分析显示，维生素E与潮热的最小减少有关（每天比安慰剂少一次潮热）（P小于或等于0.05）。在研究结束时，患者不喜欢维生素8安慰剂（32%对29%，分别）。结论：虽然这项试验能够显示一个统计学显着减少潮热与维生素E相比，安慰剂，这种减少的临床幅度是边际。(C)1998年，美国临床肿瘤学会。
Purpose: Hot flashes represent a substantial clinical problem for some breast cancer survivors. Although estrogen or progesterone preparations can alleviate these symptoms in many patients, concern remains regarding the use of hormonal preparations in such women. Thus, there is a perceived need for nonhormonal treatments for hot flashes for breast cancer survivors. Based on anecdotal evidence that vitamin E was helpful, we designed a trial to investigate this matter.Methods: We developed and conducted a placebo-controlled, randomised, crossover trial where, after a 1 week baseline period, patients received 4 weeks of vitamin E 800 IU daily, then 4 weeks of an identical-appearing placebo, or vice versa. Diaries were used to measure potential toxicities and hot flashes during the baseline week and the two subsequent 4-week treatment periods.Results: The 120 patients evaluated for toxicity failed to show any. The 105 patients who finished the first treatment period showed a similar reduction in hot flash frequencies (25% v 22%; P = .90) for the two study arms. A crossover analysis, however, showed that vitamin E was associated with a minimal decrease in hot flashes (one less hot flash per day than was seen with a placebo) (P less than or equal to .05). At the study end, patients did not prefer vitamin 8 over the placebo (32% v 29%, respectively).Conclusion: Although this trial was able to show a statistically significant hot flash reduction with vitamin E compared to a placebo, the clinical magnitude of this reduction was marginal. (C) 1998 by American Society of Clinical Oncology.