Dilution and Succussion in Homepathic Remedy Dose-Response Patterns

描述（由申请人提供）：针对PAR-03-153，NCCAM获得了修订后的R21探索性资助，其目的是扩展PI先前的人类嗅觉心理生理学研究，并开发定量脑电图（qEEG）生物测定法，用于注册个体活性（突出）与非活性顺势疗法药物或安慰剂。顺势疗法的创始人，塞缪尔哈内曼医学博士，最初提出嗅觉嗅探作为一个有效的途径，临床治疗管理。汇聚的基础科学证据表明，在从动物、矿物和植物来源制备顺势疗法药物时，振荡（剧烈摇动）可能会持续改变溶剂的物理结构以产生秩序，即，一个独特的信息信号，即使在超稀释的解决方案超过阿伏伽德罗的数字。托雷斯和鲁伊斯（1996）提出，感觉系统中的随机共振是通过添加噪声（震动）来优化弱信号（顺势疗法信息）检测的模型。以前没有研究直接检查了用不同数量的冲击制备的给定药物稀释液在人群中的影响。研究的具体目标是：一。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单个顺势疗法药物（硫磺）的存在的可行性，该药物在给定稀释度下制备，每个稀释步骤的不同振荡次数; II.为了确定在嗅觉施用期间使用定量脑电图（qEEG）α功率中的急性诱发反应的幅度来检测在两个不同的顺势疗法连续稀释因子（每个稀释步骤用给定数量的振荡制备）下单一顺势疗法药物的存在的可行性; III.评价一种单独的多冠药物（白头翁）结果的普遍性。受试者将是N=108（n=54/药物）年轻成人志愿者，他们具有中度（非极好的总体健康状况），预先筛选硫磺或白头翁的潜在药物显著性，并在两阶段研究中进行测试（每个阶段一种药物）。每名受试者将接受顺势疗法体质类型问卷的预筛选，以获得两种试验药物之一的症状的高标准评分，然后进行三次实验室检查，间隔一周（稀释序列受试者分配在每种药物类型内平衡，用于6c、12 c和30 c效价）。每次会议将涉及随机双盲、安慰剂对照（无酒精溶剂和普通蒸馏水均为振荡）嗅觉嗅闻试验（通过气流压力传感器使用时间锁定的嗅闻-EEG记录）的完整区组设计中的8次演示，使用仅搅拌制备的给定药物稀释液，10、20或30次振荡。本研究填补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患者相关的和患者-人相互作用的因素。通过随后的R 01进行的这项研究和后续研究的结果可以提高顺势疗法药物生产和用于患者护理的处方的标准化，从而提高全球这种领先形式的补充和替代医学的临床治疗和研究质量。

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.