Complementary and Alternative Medicine Detoxification: Safety and Efficacy

描述(由申请人提供)：接触合成化学品，包括杀虫剂、溶剂和阻燃剂，与许多人类疾病的开始或恶化有关，包括癌症、自身免疫性疾病、心血管疾病和不孕不育。国家和地区的生物监测项目越来越多地表明，美国人在体内积累了数百种化学物质。长期接触低水平污染物会导致体内的化学积聚；这种生物积聚与许多人类疾病和新出现的综合症有关。目前，没有常规的临床实践指南针对疾病治疗或预防而减轻身体负担(解毒)。CAM从业者和美国公众通常使用排毒方法，目的是降低人体化学污染物的浓度。虽然一些CAM戒毒干预的初步数据显示了替代终点的有效性，但还没有进行良好的对照研究。在这个职业过渡奖的指导阶段，我将完成数据分析，提交手稿，并寻求一个独立的研究职位。此外，在三位职业研究人员的指导下，我将完成高级课程工作、临床试验培训、负责研究行为的培训，以及高级CAM戒毒方法培训。在该奖项的独立阶段，我将在健康成年人中进行第一次随机对照试验，以确定是否可以减少储存的化学品1)，2)耐受性良好，3)改善生理功能或生活质量。这项研究的短期目标是获得初步的戒毒安全性和有效性数据。这项研究和候选研究的长期目标是发展必要的合作和基础设施，以开展关于预防和治疗环境可归因性疾病的CAM解毒方法的更大规模试验。

DESCRIPTION (provided by applicant): Exposure to synthetic chemicals, including pesticides, solvents, and flame retardants, is associated with the initiation or exacerbation of a number of human diseases, including cancer, autoimmune diseases, cardiovascular disease, and infertility. National and regional biomonitoring programs increasingly demonstrate that Americans are accumulating hundreds of chemicals in their bodies. Chronic low-level pollutant exposure leads to chemical buildup in the body; this bioaccumulation has been associated with a number of human diseases and emerging syndromes. Currently no conventional clinical practice guidelines address body burden reduction (detoxification) for disease treatment or prevention. CAM practitioners and the American public commonly utilize detoxification methods with the intention of reducing concentrations of chemical pollutants from the human body. While preliminary data for some CAM detoxification interventions demonstrates efficacy in surrogate endpoints, well-controlled studies have not been conducted. In the mentored phase of this career transition award I will complete data analysis, submit manuscripts, and seek an independent research position. In addition, under the direction of three career researchers, I will complete advanced coursework, clinical trial training, training in the responsible conduct of research, and advanced CAM detoxification methods training. During the independent phase of the award I will conduct the first randomized, controlled trial of a CAM detoxification protocol in healthy adults to determine if reduction of stored chemicals 1) can be achieved, 2) is well tolerated, and 3) results in improvement of physiologic function or quality of life. The short-term goal of this research is to obtain preliminary safety and efficacy data on detoxification. The long-term goal of this research, and the candidate, is to develop the collaborations and infrastructure necessary to conduct larger trials on CAM detoxification approaches to the prevention and treatment of environmentally-attributable diseases.