Complementary and Alternative Medicine Detoxification: Safety and Efficacy

描述（由申请人提供）：暴露于合成化学品，包括杀虫剂、溶剂和阻燃剂，与许多人类疾病的发生或加重有关，包括癌症、自身免疫性疾病、心血管疾病和不育症。国家和地区的生物监测项目越来越多地表明，美国人体内积累了数百种化学物质。慢性低水平污染物暴露导致体内化学物质积累;这种生物积累与一些人类疾病和新出现的综合征有关。目前，没有常规的临床实践指南解决减轻身体负担（解毒）的疾病治疗或预防。CAM从业者和美国公众通常使用解毒方法，目的是降低人体化学污染物的浓度。虽然一些CAM解毒干预措施的初步数据证明了替代终点的有效性，但尚未进行良好的对照研究。在这个职业转型奖的指导阶段，我将完成数据分析，提交手稿，并寻求独立的研究职位。此外，在三名职业研究人员的指导下，我将完成高级课程，临床试验培训，负责进行研究的培训，以及高级CAM解毒方法培训。在该奖项的独立阶段，我将在健康成年人中进行CAM解毒方案的第一次随机对照试验，以确定是否可以实现减少储存的化学物质，2）耐受性良好，3）改善生理功能或生活质量。本研究的短期目标是获得关于解毒的初步安全性和有效性数据。这项研究的长期目标和候选人是发展必要的合作和基础设施，以便对CAM解毒方法进行更大规模的试验，以预防和治疗环境引起的疾病。

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.