Polysomnography in Homeopathic Remedy Effects

多导睡眠图在顺势疗法中的作用

• 批准号: 6866104
• 负责人: IRIS Roberta BELL
• 金额: $ 21.57万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-02-01 至 2008-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6866104
• 关键词: alternative medicine; angers; anxiety; behavioral /social science research tag; clinical research; clinical trials; data collection methodology /evaluation; drug screening /evaluation; electroencephalography; expectancy; human subject; human therapy evaluation; personal log /diary; personality; placebos; polysomnography; psychic activity level; sign /symptom; sleep disorders; social psychology

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.

描述（由申请人提供）：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，它声称可以在健康人（provings）中引起症状的物质可以在病人（相似律）中治愈类似症状。在一项综合顺势疗法证明、健康心理学和心理生理学方法的设计中，这项修订的3年R21探索性研究（NCCAM PAR 03-153）将评估两种不同的顺势疗法、植物源性药物（[A]：Nux Vomica 30 c或[B]：Coffea Cruda 30 c）对成年男女受试者（N=60）多导睡眠记录的影响。主要的具体目标是：一。评估两种不同的活性顺势疗法药物与安慰剂对人类受试者的标准睡眠阶段和频谱EEG的影响;以及II.确定两种不同的活性顺势疗法药物与安慰剂对人类受试者睡眠EEG的非线性特征的影响;次要目的是：III.评估基线个体差异特征和主观期望在改变上述生理结果中的贡献。该研究将检查治疗效果与两种不同的人类人格特征的相互作用，这些人格特征与失眠相关，并与经典顺势疗法中报告的对每种治疗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，其他方面健康的人：（i）在敌意人格特质上得分高的人（A型/冠心病倾向;包含在Nux Vomica的治疗图片中）（n=30）和（ii）在焦虑敏感性人格特质上得分高的人（恐慌倾向;包含在Coffea Cruda的治疗图片中）（n=30）。所有受试者还将报告因喝咖啡而失眠（两种药物类型的顺势疗法中常见的症状），并在研究前至少7天和研究期间用不含咖啡因的饮料代替（据报道，饮料咖啡是许多顺势疗法的临床解毒剂）。在为期4周的方案中，在每个研究周的前两个晚上，他们将在家中接受整夜多导睡眠记录，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（治疗[A]或治疗[B]）。所有人将在第8天就寝时接受安慰剂，单盲（在任何补救措施之前给予安慰剂，以消除遗留效应和/或实验者对安慰剂反应的故意性，先前顺势疗法证明中报告的问题）。在第22天就寝时，每种性格类型的一半受试者将接受一剂Nux Vomica，另一半将接受一剂Coffea Cruda（随机、双盲）。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。在以前的研究中，30 c剂量的所选药物对健康动物的睡眠脑电图表现出特定和不同的影响。这项研究将有助于我们的长期目标，了解神经生理和生物心理社会机制的经典顺势疗法治疗患者的特定临床条件。