Dilution and Succussion in Homepathic Remedy Dose-Response Patterns

描述（由申请人提供）：为响应PAR-03-153，此次向NCCAM提供修订后的R21探索性拨款的目的是扩展PI之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，用于单独活性（显著）与非活性顺势疗法药物或安慰剂的注册。顺势疗法的创始人Samuel Hahnemann医学博士最初提出嗅觉嗅闻作为临床药物管理的有效途径。越来越多的基础科学证据表明，在从动物、矿物和植物中提取顺势疗法药物的制备过程中，震荡（剧烈摇晃）可能会持续地改变溶剂的物理结构，从而产生秩序，即一种独特的信息信号，即使在超稀释溶液中也会超过阿伏伽德罗数。Torres和Ruiz（1996）提出感觉系统中的随机共振是一种通过添加噪声（脉动）来优化检测弱信号（顺势疗法信息）的模型。以前没有研究直接检验过用不同数量的冲剂配制的特定药物稀释剂对人群的影响。该研究的具体目的是：1 .评估在嗅觉给药期间使用定量脑电图(qEEG) α功率的急性诱发反应来检测在给定稀释度下制备的每个稀释步骤中不同次数的单一顺势疗法药物（硫）的存在的可行性；2。确定在嗅觉给药期间使用定量脑电图(qEEG) α功率的急性诱发反应强度来检测单一顺势疗法药物在两个不同顺势疗法系列稀释因子（每个稀释步骤用给定数量的稀释剂制备）下存在的可行性；3。评估一种单独的多冠药物（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，他们的总体健康状况中等（不是非常好），预先筛选了硫或白头草的潜在药物显著性，并在两期研究中进行测试（每期一种药物）。每个参与者都将接受顺势疗法体质类型问卷的预筛选，以确定两种测试补救措施之一的症状的高分，然后是间隔一周的三次实验室会议（稀释顺序，受试者分配在每种补救措施类型中平衡为6c， 12c和30c效力）。每次会议将包括8个报告，在一个完整的随机双盲、安慰剂对照（包括不含溶液的溶剂和纯蒸馏水）嗅觉嗅觉测试（通过气流压力传感器使用时间锁定的嗅觉-脑电图记录）的设计中，使用给定的药物稀释剂，只搅拌，10次，20次或30次。本研究填补了顺势疗法临床研究的主要需求，即探索和了解可能导致众所周知的可复制性问题的药物相关因素和药物-人互动因素。本研究和后续r01研究的发现可以提高顺势疗法药物生产和处方在患者护理中的标准化，从而提高世界范围内这一领先形式的补充和替代医学的临床治疗和研究的质量。

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.