BIOMARKERS OF HOMEOPATHY IN FIBROMYALGIA

描述(改编自申请者摘要)：临床研究人员尚未 但证明了任何一种干预措施的治疗效果 针对FM的多症状性质，一种慢性衰弱的非关节 风湿性疾病。经典的顺势疗法，一种有争议的替代疗法， 声称提供了这样一种综合干预措施来治疗全部 症状。这项修订后的R21，为期2年的探索性有效性研究将涉及 3个月平行试验组(N=60)，随机、安慰剂对照、双盲 临床试验，额外3个月可选交叉，双盲 FM个体化顺势疗法治疗的尝试。我们将使用自我报告 调查问卷、投标点检查和生理指标 对顺势疗法药物和安慰剂的反应(即脑电阿尔法活动和 立位心率变异性。 具体的目标和假设是：1)评估 精神、情感和躯体疾病的个体化顺势疗法 双盲条件下FM的症状学研究 接受安慰剂治疗的小组使用相同的 治疗程序，唯一不同的是配发的药物的含量 瓶子。研究人员假设，个人选择的顺势疗法 补救措施将导致精神、精神、情感和躯体的改善 将FM症状定为安慰剂；2)判断急性变化能力 在脑电α活性中区分活性和安慰剂顺势疗法的药物 对FM患者进行嗅觉注射并预测随后 治疗应答者和无应答者。预测是积极的 与安慰剂相比，顺势疗法将导致更大的脑电阿尔法阻断； 3)评估静息脑电α功率和立位心率变异性作为 随着时间的推移，FM的临床改善。FM的全球临床改进将会 与静息脑电和立位心率变异性的平行改善相关。

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.