BIOMARKERS OF HOMEOPATHY IN FIBROMYALGIA

描述（改编自申请人摘要）：临床研究人员尚未 然而，任何单一的干预措施， 针对FM的多症状性质，一种慢性衰弱性非关节炎， 风湿性疾病传统顺势疗法，一种有争议的替代疗法， 声称提供这样一种综合干预， 症状这项修订后的R21，2年探索性有效性研究将涉及 3个月平行组（N=60）、随机化、安慰剂对照、双盲 临床试验，额外3个月可选交叉，双盲 FM的个体化顺势疗法治疗试验。我们将使用自我报告 问卷调查，压痛点检查，和生理指标， 对顺势疗法药物和安慰剂的反应（即，脑电图阿尔法活动， 立位心率变异性 具体目标和假设是：1）评价 针对精神、情感和身体的个人选择的顺势疗法治疗 在双盲条件下， 安慰剂治疗组接受相同的注意力， 治疗程序，仅在分发药物的内容上有所不同 小瓶。研究人员假设，个别选择顺势疗法， 补救措施将导致精神，心理，情感和身体的改善 症状的FM比安慰剂; 2），以确定能力的急性变化 在脑电图α活动，以区分积极的安慰剂顺势疗法补救措施 在FM患者的嗅觉给药后， 对治疗有反应者和无反应者。预测是活跃的 顺势疗法药物将导致比安慰剂更大的EEG α阻断;以及 3)评估静息EEG α功率和立位HRV作为总体 随着时间的推移，FM的临床改善。FM的全球临床改善将 与静息EEG和直立HRV的平行改善相关。

DESCRIPTION (Adapted from Applicant's Abstract): Clinical researchers have not yet demonstrated therapeutic effectiveness of any single intervention that can target the polysymptomatic nature of FM, a chronic debilitating nonarticular rheumatic disorder. Classical homeopathy, a controversial alternative therapy, claims to provide such an integrative intervention to treat the totality of symptoms. This revised R21, 2-year exploratory effectiveness study will involve a 3-month parallel group (N=60), randomized, placebo-controlled, double-blind clinical trial, with an additional 3-month optional crossover, double-blind trial of individualized homeopathic treatment of FM. We will use self-report questionnaires, tender point examinations, and physiological markers of response to the homeopathic remedies and placebo (i.e., EEG alpha activity and orthostatic HRV. Specific aims and hypotheses are: 1) to evaluate the effectiveness of individually-chosen homeopathic treatment for the mental, emotional and somatic symptomatology of FM under double-blind conditions in which active and placebo-treated groups receive the same amount of attention using the same treatment procedures and differ only in the contents of the dispensed drug vials. The investigators hypothesize that individually chosen homeopathic remedies will lead to improvement in spiritual, mental, emotional, and somatic symptoms of FM than will placebo; 2) to determine the ability of acute changes in EEG alpha activity to differentiate active from placebo homeopathic remedies upon olfactory administration in FM patients and to predict subsequent responders and non-responders to treatment. The prediction is that active homeopathic remedies will lead to greater EEG alpha blocking than placebo; and 3) to assess resting EEG alpha power and orthostatic HRV as markers of global clinical improvement in FM over time. Global clinical improvement in FM will correlate with parallel improvements in resting EEG and orthostatic HRV.