Dilution and Succussion in Homepathic Remedy Dose-Response Patterns

顺势疗法剂量反应模式中的稀释和震荡

• 批准号: 7144840
• 负责人: IRIS Roberta BELL
• 金额: $ 22.65万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7144840
• 关键词: alternative medicine; clinical research; solvents; sulfur; water

DESCRIPTION (provided by applicant): The purpose of this revised R21 exploratory grant to NCCAM in response to PAR-03-153 is to extend the PI's previous human olfactory psychophysiology research and develop a quantitative electroencephalographic (qEEG) bioassay for registration of individually active (salient) versus inactive homeopathic remedies or placebo. Homeopathy's founder, Samuel Hahnemann MD, originally proposed olfactory sniffing as a valid route for clinical remedy administration. Convergent basic science evidence suggests that succussion (vigorous shaking) in the preparation of homeopathic remedies from animal, mineral, and plant sources, may persistently modify the physical structure of solvent to generate order, i.e., a unique informational signal, even in ultra-diluted solutions beyond Avogadro's number. Torres and Ruiz (1996) proposed that stochastic resonance in sensory systems is a model for optimizing detection of a weak signal (homeopathic remedy information) by addition of noise (succussions). No previous research has directly examined the effects in human populations of a given remedy dilution prepared with different numbers of succussions. Specific aims for the study are: I. To evaluate the feasibility of using acute evoked responses in quantitative electroencephalography (qEEG) alpha power during olfactory administration to detect the presence of a single homeopathic remedy (Sulphur) at different numbers of succussions per dilution step, prepared at a given dilution; II. To determine the feasibility of using the magnitude of acute evoked responses in quantitative electroencephalography (qEEG) alpha power during olfactory administration to detect the presence of a single homeopathic remedy at two different homeopathic serial dilution factors (prepared with a given number of succussions per dilution step); III. To evaluate the generalizability of findings for a separate polycrest remedy (Pulsatilla). Subjects will be N=108 (n=54/remedy) young adult volunteers with moderate (not excellent global health) prescreened for potential remedy salience of either Sulphur or Pulsatilla and tested in a two-phase study (one remedy per phase). Each participant will undergo pre-screening with the Homeopathic Constitutional Type Questionnaire for high criterion scores for symptoms of one of the two test remedies, followed by three laboratory sessions spaced one week apart (dilution sequence subject allocation balanced within each remedy type for 6c, 12c, and 30c potencies). Each session will involve eight presentations within a complete block design of randomized double-blind, placebo- controlled (both succussed remedy-free solvent and succussed plain distilled water) olfactory sniff tests (using time-locked sniff-EEG recordings via an airflow pressure transducer), using a given remedy dilution prepared with stirring only, 10, 20, or 30 succussions. The present study fills a major need in homeopathic clinical research to explore and understand remedy-related and remedy-person interactive factors that could contribute to well-known problems in replicability. Findings from this and follow- up studies via subsequent R01s could improve standardization of homeopathic remedy manufacturing and prescribing used in patient care and thereby advance the quality of clinical treatments and research for this leading form of complementary and alternative medicine worldwide.

描述（由申请人提供）：针对 PAR-03-153 向 NCCAM 提供的修订版 R21 探索性资助的目的是扩展 PI 之前的人类嗅觉心理生理学研究，并开发一种定量脑电图 (qEEG) 生物测定法，用于注册个体活性 (显着）与非活性顺势疗法或安慰剂相比。顺势疗法的创始人塞缪尔·哈尼曼医学博士最初提出嗅觉作为临床治疗给药的有效途径。一致的基础科学证据表明，在制备来自动物、矿物和植物的顺势疗法药物时，震荡（剧烈摇动）可能会持续改变溶剂的物理结构以产生秩序，即独特的信息信号，即使在超稀释的情况下也是如此。超出阿伏加德罗数的解。 Torres 和 Ruiz (1996) 提出，感觉系统中的随机共振是通过添加噪声（震荡）来优化微弱信号（顺势疗法信息）检测的模型。之前没有任何研究直接检验过通过不同次数的震荡制备的给定药物稀释液对人群的影响。该研究的具体目标是： I. 评估在嗅觉给药期间使用定量脑电图 (qEEG) α 功率中的急性诱发反应来检测每个稀释步骤不同次数的震荡时单一顺势疗法药物（硫）的存在的可行性，以给定的稀释度制备；二.确定在嗅觉给药期间使用定量脑电图 (qEEG) α 功率中的急性诱发反应幅度来检测两种不同顺势疗法系列稀释因子（每个稀释步骤以给定数量的震荡进行制备）下单一顺势疗法药物的存在的可行性）；三．评估单独的多冠疗法（白头翁）的研究结果的普遍性。受试者将是 N=108（n=54/药物）的年轻成年志愿者，他们的健康状况中等（全球健康状况不佳），针对硫磺或白头翁的潜在药物显着性进行预筛选，并在两阶段研究中进行测试（每阶段一种药物）。每位参与者将接受顺势疗法体质类型问卷的预筛选，以获得两种测试疗法之一的症状高标准分数，然后进行三场实验室会议，间隔一周（稀释序列受试者分配在每种疗法类型中平衡，为 6c、12c）和 30c 效力）。每个会议将涉及随机双盲、安慰剂对照（均是无补救溶剂和纯蒸馏水）嗅觉嗅探测试（通过气流压力传感器使用时间锁定嗅探脑电图记录）的完整区块设计中的八次演示），使用仅搅拌制备的给定药物稀释液，振荡 10、20 或 30 次。本研究满足了顺势疗法临床研究的主要需求，以探索和理解可能导致众所周知的可复制性问题的与治疗相关的和治疗者交互的因素。这项研究的结果以及通过后续 R01 进行的后续研究可以提高顺势疗法药物生产和患者护理处方的标准化，从而提高全球这种领先的补充和替代医学形式的临床治疗和研究的质量。