Polysomnography in Homeopathic Remedy Effects

多导睡眠图在顺势疗法中的作用

• 批准号: 7011269
• 负责人: IRIS Roberta BELL
• 金额: $ 22.09万
• 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/7011269
• 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）：经典顺势疗法是一种已有 200 年历史的补充和替代医学 (CAM) 体系，它声称一种可以引起健康人症状的物质（证明）可以治愈病人的类似症状（相似法则）。在综合顺势疗法证明、健康心理学和心理生理学方法的设计中，这项修订后的 3 年 R21 探索性研究 (NCCAM PAR 03-153) 将评估两种不同的顺势疗法、植物源性疗法的效果 ([A]：Nux Vomica 30c或 [B]：Coffea Cruda 30c) 对成年男女受试者的多导睡眠图睡眠记录（N=60）。主要具体目标是： I. 评估两种不同的积极顺势疗法与安慰剂相比对人类受试者标准睡眠阶段和频谱脑电图的影响； II. 确定两种不同的主动顺势疗法与安慰剂相比对人类受试者睡眠脑电图非线性特征的影响；次要目标是： III．评估基线个体差异特征和主观期望对改变上述生理结果的贡献。该研究将研究治疗效果与与失眠相关的两种不同人类性格特征之间的相互作用，以及经典顺势疗法中报道的对每种治疗反应最强烈的人的重叠特征。受试者将分为两个亚临床组，其他方面均健康：(i) 在敌意人格特质上得分较高的人（A 型/易患冠状动脉疾病；包含在马钱子的治疗图片中）(n=30) 和 (ii)那些在焦虑敏感性人格特征上得分较高的人（容易惊慌；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（两种治疗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，咖啡饮料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，他们将在家进行整夜多导睡眠图睡眠记录，即第 1 天和第 2 天（基线 1）、第 8 天和第 9 天（安慰剂）、第 15 天16（基线 2）、22 和 23（补救措施 [A] 或补救措施 [B]）。所有人都将在第 8 天睡前接受安慰剂，单盲（在采取任何补救措施之前给予安慰剂，以消除残留效应和/或实验者对安慰剂反应的意向性风险，这是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，一半将接受一剂 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。在之前的研究中，所选择的 30c 剂量的药物对健康动物的睡眠脑电图显示出特定且不同的影响。这项研究将有助于我们的长期目标，即了解具有特定临床状况的患者的经典顺势疗法的神经生理学和生物心理社会机制。