Barton D L, Loprinzi C L, Quella S K, Sloan J A, Veeder M H, Egner J R, Fidler P, Stella P J, Swan D K, Vaught N L, Novotny P
Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA.
J Clin Oncol. 1998 Feb;16(2):495-500. doi: 10.1200/JCO.1998.16.2.495.
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.
We developed and conducted a placebo-controlled, randomized, 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.
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 < or = .05). At the study end, patients did not prefer vitamin E over the placebo (32% v 29%, respectively).
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.
潮热是一些乳腺癌幸存者面临的重大临床问题。尽管雌激素或孕激素制剂可缓解许多患者的这些症状，但对于此类女性使用激素制剂仍存在担忧。因此，人们认为需要为乳腺癌幸存者提供非激素治疗潮热的方法。基于维生素E有帮助的传闻证据，我们设计了一项试验来研究此事。
我们开展并实施了一项安慰剂对照、随机交叉试验，在1周的基线期后，患者每天服用4周的800国际单位维生素E，然后服用4周外观相同的安慰剂，或反之。在基线周以及随后的两个4周治疗期，使用日记来测量潜在毒性和潮热情况。
接受毒性评估的120名患者未显示出任何毒性。完成第一个治疗期的105名患者在两个研究组中潮热频率的降低相似（分别为25%和22%；P = 0.90）。然而，交叉分析显示，维生素E与潮热的最小程度降低相关（每天比安慰剂少一次潮热）（P≤0.05）。在研究结束时，患者对维生素E的偏好并不高于安慰剂（分别为32%和29%）。
尽管该试验能够显示与安慰剂相比，维生素E在统计学上显著降低了潮热，但这种降低的临床幅度很小。
