ALTERNATIVE THERAPIES FOR MENOPAUSE: A RANDOMIZED TRIAL

描述：(改编自《研究人员摘要》)激素替代疗法 (HRT：雌激素和孕激素)仍然是患有以下疾病的女性的首选治疗方法 血管舒缩症状，长期HRT已被推荐用于预防 目的。对HRT替代品的需求，以及HRT的可用性和使用 非处方药产品，包括膳食植物雌激素补充剂和 自然疗法药物的数量急剧增长。这些产品中很少有 面临着严格的随机试验，没有一项经过测试来评估 它们对长期结果的影响。 这项为期四年的随机对照试验的目的是评价 利用植物雌激素的三种替代治疗方法的有效性和安全性 治疗围绝经期和绝经后妇女的血管舒缩症状。这些治疗是 被选中是因为科学证据支持一种可能的益处， 具有足够质量的产品的可用性及其使用频率控制 在自然疗法医学中，以及我们使参与者对 干预。建议的五个处理臂如下：1)酯化 雌激素和微粉化黄体酮：9)单一草药产品，黑升麻； 3)多植物制剂；4)包括 同样的多种植物制剂加上大豆饮食咨询；以及5)安慰剂。这个 主要目的是比较三种替代治疗方法的效果，HRT和 安慰剂对血管运动症状频率和强度的影响 维克伦德更年期症状清单和每日血管运动症状日记。这个 次要目标是比较三种替代治疗的效果，HRT， 安慰剂：1)阴道细胞学(阴道成熟指数)； 2)血脂(总胆固醇、高密度脂蛋白、低密度脂蛋白、甘油三酯)； 骨密度(髋部和脊柱双能X线骨密度仪扫描)； 葡萄糖代谢(胰岛素、空腹血糖)；5)凝血因子 (纤维蛋白原，PAI-1)。 假设是，与安慰剂相比，这三种替代治疗 在本研究中测试将有以下效果：降低热激频率 潮热和盗汗，促进阴道成熟和减少阴道 以成熟指数衡量萎缩，降低总胆固醇和低密度脂蛋白 对高密度脂蛋白没有影响，降低骨密度(BMD)的下降率，以及 对葡萄糖代谢或凝血因子没有影响。要完成以下任务 调查人员建议做以下具体目标：1)招募和 将400名围绝经期和绝经后妇女随机分配到五个治疗组中 一年；2)收集主要和次要结果的衡量标准 基线、3个月、6个月和12个月；以及3)比较 HRT组和安慰剂组接受替代治疗的组。

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.