Polysomnography in Homeopathic Remedy Effects

描述(申请人提供)：经典顺势疗法是一个有200年历史的补充和替代医学(CAM)系统，它声称一种可以在健康人身上引起症状的物质(证明)可以治愈病人的类似症状(相似定律)。在一项综合了顺势疗法、健康心理学和心理生理学方法的设计中，这项为期3年的R21探索性研究(NCCAM PAR 03-153)将评估两种不同的顺势疗法植物衍生疗法([A]：Nux Vomica 30c或[B]：Coffea Cruda 30c)对成年受试者的多导睡眠图睡眠记录的影响，无论男女(N=60)。主要的具体目标是：1.评估两种不同的主动顺势疗法与安慰剂对受试者标准睡眠阶段和频谱脑电的影响；以及2.确定两种不同的主动顺势疗法与安慰剂对受试者睡眠脑电非线性特征的影响；次要目标是：3.评估基线个体差异特征和主观期望在改变上述生理结果方面的贡献。这项研究将考察治疗效果与两种不同的人类人格特征之间的相互作用，这两种人格特征与失眠有关，并与经典顺势疗法中报道的对每种药物反应最强烈的人的人格特征重叠。受试者将分为两个亚临床组：(I)在敌对个性特征上得分高的人(A型/易冠脉倾向；包含在Nux Vomica的补救图片中)(n=30)和(Ii)在焦虑敏感的个性特征上得分高的(恐慌倾向；包含在Coffea Cruda的补救图片中)(n=30)。所有受试者还将报告因喝咖啡而失眠(这是两种药物类型的顺势疗法中常见的症状)，并将在研究前和研究期间至少7天内用不含咖啡的饮料取代(据报道，饮料咖啡是许多顺势疗法的临床解毒剂)。在为期4周的方案中，每个研究周的前两个晚上，他们将在家中进行通宵多导睡眠记录，即第1天和第2天(基线1)，第8天和第9天(安慰剂)，15天和16天(基线2)，第22天和23天(补救措施[A]或补救措施[B])。所有人都将在第8天的睡前接受安慰剂，单盲(在任何药物之前给予安慰剂，以消除遗留效应的风险和/或实验者有意对安慰剂反应，这是以前顺势疗法证明中报告的问题)。在第22天的就寝时间，来自每种性格类型的一半的受试者将接受一剂Nux Vomica，另一半的受试者将随机、双盲地接受一剂Coffea Cruda。所有参与者还将记录4周内的主观睡眠和症状模式。统计分析将包括分层线性模型和一般线性模型。在先前的研究中，所选的30c剂量的每种药物对健康动物的睡眠脑电都显示出特定和不同的影响。这项研究将有助于我们的长期目标，了解具有特定临床条件的患者接受经典顺势疗法治疗的神经生理学和生物心理社会机制。

DESCRIPTION (provided by applicant): Classical homeopathy is a 200-year old system of complementary and alternative medicine (CAM), which claims that a substance that can cause symptoms in a healthy person (provings) can cure similar symptoms in a sick person (Law of Similars). In a design synthesizing homeopathic provings, health psychology, and psychophysiological methodologies, this revised 3-year R21 exploratory study (NCCAM PAR 03-153) will assess the effects of two different homeopathic, plant-derived remedies ([A]: Nux Vomica 30c or [B]: Coffea Cruda 30c) on polysomnographic sleep recordings of adult human subjects of both sexes (N=60). Primary Specific Aims are: I. To evaluate the effects of two different active homeopathic remedies versus placebo on standard sleep stages and spectral EEG in human subjects; and II.To determine the effects of two different active homeopathic remedies versus placebo on nonlinear characteristics of sleep EEG in human subjects; The Secondary Aim is: III. To assess the contribution of baseline individual difference traits and subjective expectation in modifying the physiological outcomes above. The study will examine the interaction of the remedy effects with two different human personality traits associated with insomnia and overlapping those of persons reported in classical homeopathy to respond most strongly to each remedy. Subjects will fall into two subclinical groups of otherwise healthy persons: (i) those who score high on the personality trait of hostility (Type A/coronary-prone; contained within remedy picture of Nux Vomica)(n=30) and (ii) those who score high on the personality trait of anxiety sensitivity (panic-prone; contained within remedy picture of Coffea Cruda)(n=30). All subjects also will report insomnia from drinking coffee (a symptom common in homeopathy to both remedy types) and will replace it with a non-coffee caffeinated beverage for at least 7 days before and for the duration of the study (beverage coffee is reportedly a clinical antidote for many homeopathic remedies). During the 4-week protocol, on the first two nights of each study week, they will undergo at home, all-night polysomnographic sleep recordings, i.e., on days 1 and 2 (baseline 1), 8 and 9 (placebo), 15 and 16 (baseline 2), and 22 and 23 (remedy [A] OR remedy [B]). All will receive placebo at bedtime on day 8, single-blind (placebo given before any remedy to eliminate risk of carry-over effects and/or experimenter intentionality on placebo responses, problems reported in previous homeopathic provings). At bedtime on day 22, half of the subjects from each personality type will receive one dose of Nux Vomica and half will receive one dose of Coffea Cruda on a randomized, double-blind basis. All participants will also record subjective sleep and symptom patterns over the 4 weeks. Statistical analyses will include hierarchical linear models and general linear models. The chosen remedies in 30c doses each showed specific and different effects on sleep electroencephalograms of healthy animals in previous studies. This study will contribute to our long-range goal of understanding the neurophysiological and biopsychosocial mechanisms of classical homeopathic remedy treatment in patients with specific clinical conditions.