Pockaj Barbara A, Loprinzi Charles L, Sloan Jeff A, Novotny Paul J, Barton Debra L, Hagenmaier Andrea, Zhang Huayan, Lambert George H, Reeser Kristine A, Wisbey Joyce A
Department of Surgery, Mayo Clinic, Scottsdale, Arizona 85259, USA.
Cancer Invest. 2004;22(4):515-21. doi: 10.1081/cnv-200026394.
Hot flashes cause significant morbidity in postmenopausal women, including women with breast cancer. We undertook a pilot study to estimate the effectiveness of black cohosh to reduce hot flashes.
Women who reported significant hot flashes (> or = 14 per week) were enrolled. Black cohosh was given in the form of the commercial product Remifemin. The first week was a no-treatment baseline period, and therapy was given for the subsequent 4 weeks. Hot flash data were collected by daily questionnaires during baseline and treatment weeks. Adverse effects were recorded.
Twenty-one women completed the study. Their mean age was 56 years (range, 38-80). Thirteen patients had a history of breast cancer. Six patients were taking tamoxifen or raloxifene. Patients reported an average of 8.3 hot flashes per day during the baseline week. The reduction in mean daily hot flash frequency was 50% (95% CI, 34%-65%), while weekly hot flash scores were reduced 56% (95% CI, 40%-71%) at completion of the study. Overall, patients reported less trouble with sleeping, less fatigue, and less abnormal sweating. No patients stopped therapy because of adverse effects.
Black cohosh appeared to reduce hot flashes and had a low toxicity. The efficacy found in this trial seems to be more than would be expected by a placebo effect (20%-30% hot flash reduction in previous trials). These results suggest that further evaluation of this black cohosh preparation with a phase III randomized trial is indicated.
潮热会给绝经后女性（包括乳腺癌女性患者）带来严重不适。我们开展了一项初步研究，以评估黑升麻减轻潮热的效果。
招募报告有严重潮热（每周≥14次）的女性。黑升麻采用商业产品黑升麻异丙醇萃取物（Remifemin）的形式给药。第一周为无治疗基线期，随后进行4周治疗。在基线期和治疗周期间，通过每日问卷收集潮热数据，并记录不良反应。
21名女性完成了研究。她们的平均年龄为56岁（范围38 - 80岁）。13名患者有乳腺癌病史。6名患者正在服用他莫昔芬或雷洛昔芬。患者在基线周期间平均每天有8.3次潮热。在研究结束时，平均每日潮热频率降低了50%（95%置信区间，34% - 65%），而每周潮热评分降低了56%（95%置信区间，40% - 71%）。总体而言，患者报告睡眠问题、疲劳和异常出汗情况有所减轻。没有患者因不良反应而停止治疗。
黑升麻似乎能减轻潮热且毒性较低。本试验中发现的疗效似乎超过了安慰剂效应（先前试验中潮热减少20% - 30%）的预期。这些结果表明，需要通过III期随机试验对这种黑升麻制剂进行进一步评估。
