ALTERNATIVE THERAPIES FOR MENOPAUSE: A RANDOMIZED TRIAL

描述：（改编自研究者摘要）激素替代疗法 (HRT：雌激素和雌激素）仍然是治疗妇女的选择， 血管痉挛症状，长期HRT已被推荐用于预防 目的替代HRT的需求，以及HRT的可用性和使用 非处方产品，包括膳食植物雌激素补充剂， 自然疗法药物的数量急剧增长。这些产品中很少有 面临着随机试验的严格要求， 对长期结果的影响。 这项为期四年的随机对照试验的目的是评估 利用植物雌激素的三种替代方法的有效性和安全性 治疗绝经期和绝经后妇女的血管扩张症状。将处理剂 之所以选择它，是因为科学证据支持其可能的益处， 产品的可用性，并对其使用频率进行充分的质量控制 在自然疗法医学中，我们有能力使参与者对 干预五个建议的治疗组如下：1）酯化 雌激素和微粒化孕酮：9）单一草药产品，黑升麻; 3)多植物制剂; 4）组合方案，其包括 相同的多植物制剂加大豆饮食咨询;和5）安慰剂。的 主要目的是比较三种替代治疗，HRT， 安慰剂对血管痉挛症状的频率和强度的影响， Wiklund更年期症状检查表和每日更年期症状日记。的 第二个目的是比较三种替代治疗的效果，HRT， 1）阴道细胞学（阴道成熟指数）; 2)血脂（总胆固醇、HDL和LDL胆固醇、甘油三酯）; 3） 骨矿物质密度（髋关节和脊柱双能X线吸收扫描）; 4） 葡萄糖代谢（胰岛素、空腹血糖）;和5）凝血因子 （纤维蛋白原，派-1）。 假设与安慰剂相比， 在这项研究中测试将有以下效果：减少热的频率 闪光和盗汗，促进阴道成熟，减少阴道 通过成熟指数测量的萎缩，降低总胆固醇和LDL， 对HDL无影响，降低骨密度（BMD）下降速率， 对葡萄糖代谢或凝血因子没有影响。完成 具体目标调查人员建议做以下工作：1）招募和 将400名绝经期和绝经后妇女随机分为5个治疗组， 1年; 2）收集主要和次要结局的测量结果， 基线、3个月、6个月和12个月;以及3）比较 接受替代HRT和安慰剂组治疗的组。

DESCRIPTION: (Adapted from Investigator's Abstract) Hormone replacement therapy (HRT: estrogen and progestin) remains the treatment of choice for women with vasomotor symptoms, and long-term HRT has been recommended for prevention purposes. The demand for alternatives to HRT, and the availability and use of over-the-counter products including dietary phytoestrogen supplements and naturopathic medicines, has grown dramatically. Few of these products have faced the rigors of randomized trials and none have been tested to evaluate their effects on long-term outcomes. The purpose of this four-year randomized controlled trial is to evaluate the efficacy and safety of three alternative approaches utilizing phytoestrogens to treat vasomotor symptoms in peri- and postmenopausal women. The treatments were chosen because of the scientific evidence supporting a possible benefit, the availability of products with adequate quality control their frequency of use in naturopathic medicine, and our ability to blind participants to the intervention. The five proposed treatment arms are as follow: 1) esterified estrogen and micronized progesterone: 9) a single herbal product, black cohosh; 3) a multibotanical preparation; 4) a combination regimen that includes the same multibotanical preparation plus soy diet counseling; and 5) placebo. The primary aim is to compare the effects of three alternative treatments, HRT, and placebo on the frequency and intensity of vasomotor symptoms measured by The Wiklund Menopause Symptom Checklist and a daily Vasomotor Symptom Diary. The secondary aims are to compare the effects of three alternative treatments, HRT, and placebo on the following: 1) vaginal cytology (vaginal maturation index); 2) serum lipids (total cholesterol, HDL and LDL cholesterol, triglycerides); 3) bone mineral density (hip and spine dual energy x-ray absorptiometry scan); 4) glucose metabolism (insulin, fasting blood glucose); and 5) coagulation factors (fibrinogen, PAI-1). The hypotheses are that compared to placebo the three alternative treatments tested in this study will have the following effects: reduce frequency of hot flashes and night sweats, improve vaginal maturation and decrease vagina atrophy as measured by maturation index, lower total cholesterol and LDL with no effect on HDL, reduce the rate of decline in bone mineral density (BMD), and have no effect on glucose metabolism or clotting factors. To accomplish the specific aims the investigators propose to do the following: 1) recruit and randomize 400 peri- and post-menopausal women to one of five treatment arms for one year; 2) collect measurements of primary and secondary outcomes at baseline, three, six, and 12 months; and 3) compare changes in outcomes in the groups taking alternative treatments to those in the HRT and placebo groups.