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互补和替代医学（CAM）的一种200年历史的系统，该系统声称可以在健康人中引起症状的物质（证明）可以治愈病人的类似症状（类似的法律）。 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）。主要的特定目的是：I。评估两种不同的主动疗法与安慰剂对标准睡眠阶段的影响和人类受试者的光谱脑电图； ii。确定两种不同的活性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；次要目标是：iii。评估基线个体差异特征和主观期望的贡献，以改变上述生理结果。该研究将研究疗法效应与与失眠有关的两个不同人格特征的相互作用，并重叠经典顺势疗法中报道的人的相互作用，以对每种补救措施做出最强烈的反应。受试者将属于两个原本健康的人的亚临床组：（i）那些在敌意的人格特征（A/冠状动脉型；包含在Nux Vomica的补救症中）（n = 30）和（ii）在焦虑敏感性的人格特征上得分很高的人（panic-Paric-proce; coffea creedy; coffea cruda of Coffea cruda）（N = 30）（N = 30）。所有受试者还将报告饮用咖啡的失眠症（这种疗法的症状是一种疗法类型），并将在研究期间至少7天内用非咖啡咖啡因的饮料代替它（据报道，饮料咖啡是许多顺势疗法的临床反替代物）。在为期4周的协议中，在每个研究周的前两晚，他们将在家中进行全夜多聚会睡眠记录，即在第1和第2天（基线1），8和9（安慰剂），15和16（基线2），以及22和23（补救措施[A]或Remedy [B]）。所有人都将在第8天就睡前接受安慰剂（在任何补救措施之前给予安慰剂，以消除安慰剂反应上的背负效果和/或实验者意图的风险，在先前的顺势疗法证明中报告的问题）。在第22天就睡前，每种人格类型的受试者中有一半将收到一剂的Nux vomica，一半将在随机的双盲基础上获得一剂咖啡屑。所有参与者还将在4周内记录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。 30C剂量的选择的疗法在先前的研究中对健康动物的睡眠脑电图显示出了特定和不同的影响。这项研究将有助于我们了解特定临床状况患者的经典顺势疗法治疗治疗的神经生理和生物心理社会机制。