Botanicals from Central America for Menopause

描述（由申请人提供）：更年期是一种普遍的女性经历，定义为在中年期间停止月经至少12个月。根据世界卫生组织的数据，到2030年，美国将有6000多万绝经后妇女，全世界将有12亿绝经后妇女。多年来，激素替代疗法（HRT）一直是更年期症状治疗的金标准。然而，根据妇女健康倡议的结果，许多妇女正在寻找更年期的替代治疗方法。虽然黑升麻、红三叶草和大豆等植物药似乎是有希望的替代疗法，但最近出现了安全性和有效性的问题。因此，研究和开发更年期的其他治疗方案是非常重要的。在中美洲国家，特别是危地马拉和哥斯达黎加，女性的更年期症状与美国女性相似。然而，这些妇女不寻求西医治疗，而是使用包括草药在内的自然方法来改善围绝经期和绝经后的生活质量。假设：中美洲传统上用于治疗更年期症状的特定植物提取物将具有与其传统用途相对应的生物活性。因此，这些提取物可以标准化用于动物或人类研究。我们的初步工作表明，在危地马拉和哥斯达黎加，至少有12种植物被传统地用于更年期。本研究的目的是收集和提取来自这两个国家的这些植物物种，并在与更年期相关的特定生物测定中测试提取物的活性。拟议工作的总体目标是根据生物测定结果开发标准化的植物提取物，用于更年期的对症治疗。标准化提取物将被用作R01申请的基础，以评估动物模型和/或人体中试研究中的生物活性。成功验证和标准化用于治疗更年期的传统植物性药物不仅对中美洲妇女而且对世界其他地区的妇女都具有重要意义。

DESCRIPTION (provided by applicant): Menopause is a universal female experience, and is defined as cessation of menstruation for at least 12 months during the midlife period. According to the World Health Organization, by the year 2030, there will be more than 60 million postmenopausal women in the United States and 1.2 billion postmenopausal women worldwide. For many years, hormone replacement therapy (HRT) has been the gold standard for the symptomatic treatment of menopause. However, in light of the results of the Women's Health Initiative, many women are searching for alternative treatments for menopause. While, botanicals such as black cohosh, red clover and soy appear to be promising alternative therapies, recently questions of safety and efficacy have arisen. Thus, it is extremely important to focus on the research and development of other treatment alternatives for menopause. In Central American countries, specifically Guatemala and Costa Rica, women have menopausal symptoms similar to their U.S. counterparts. However, these women do not seek Western medical treatment, but use natural methods including herbal medicines to improve the quality of life in the peri- and postmenopausal periods. Hypothesis: Specific botanical extracts that have been used traditionally in Central America for the treatment menopausal symptoms will have biological activities that correspond with their traditional use. Thus, these extracts can be standardized for use in animal or human studies. Our preliminary work has indicated that there are at least twelve plant species that have been used traditionally, both in Guatemala and Costa Rica, for menopause. The objective of this investigation is to collect and extract these plant species from both countries, and test the extracts for activity in specific bioassays that are relevant to menopause. The overall goal of the proposed work is to develop standardized botanical extracts, based on the bioassay results, for the symptomatic treatment of menopause. The standardized extracts would then be used as the basis of an R01 application to assess biological activity in an animal model and or pilot human study. Successful validation and standardization of traditional plant-based medicines used to treat menopause has great significance not only for the women of Central America but the rest of the world as well.