Polysomnography in Homeopathic Remedy Effects

描述（由申请人提供）：经典顺势疗法是一种有200年历史的补充和替代医学（CAM）体系，它声称一种能在健康人身上引起症状的物质（证明）可以在病人身上治愈类似的症状（类似物法）。在一项综合顺势疗法证据、健康心理学和心理生理学方法的设计中，这项经过修订的为期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）对成人受试者（N=60）的多导睡眠记录的影响。主要的具体目的是：1 .评估两种不同的顺势疗法与安慰剂对人类受试者标准睡眠阶段和频谱脑电图的影响；和二世。确定两种不同的顺势疗法与安慰剂对人类受试者睡眠脑电图非线性特征的影响；第二目标是：评估基线个体差异特征和主观期望对上述生理结果的影响。该研究将检查治疗效果与失眠相关的两种不同的人类人格特征之间的相互作用，以及在经典顺势疗法中报告的对每种治疗反应最强烈的人的重叠。受试者将被分为两个亚临床组（其他方面为健康人）：(i)敌意人格特质得分高的人（A型/冠心病倾向，包含在Nux Vomica的补救图片中）（n=30）和（ii）焦虑敏感性人格特质得分高的人（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（这是两种顺势疗法的常见症状），并在研究前和研究期间至少7天内用不含咖啡咖啡因的饮料代替（据报道，饮料咖啡是许多顺势疗法的临床解毒剂）。在为期四周的方案中，在每个研究周的前两个晚上，他们将在家中接受通宵多导睡眠仪睡眠记录，即第1和2天（基线1），第8和9天（安慰剂），第15和16天（基线2），以及第22和23天（补救措施[A]或补救措施[B]）。所有患者将在第8天的睡前接受单盲安慰剂治疗（在任何治疗之前给予安慰剂，以消除遗留效应和/或实验者对安慰剂反应的意向性风险，之前顺势疗法证明中报告的问题）。在第22天的就寝时间，在随机、双盲的基础上，每种性格类型的一半受试者将接受一剂Nux Vomica，另一半受试者将接受一剂crouda咖啡。所有参与者还将在四周内记录主观睡眠和症状模式。统计分析将包括层次线性模型和一般线性模型。在以往的研究中，所选择的30c剂量的药物对健康动物的睡眠脑电图都有特定而不同的影响。这项研究将有助于我们理解经典顺势疗法治疗特定临床疾病患者的神经生理和生物心理社会机制的长期目标。

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.