Dilution and Succussion in Homepathic Remedy Dose-Response Patterns

描述(由申请人提供)：根据PAR-03-153向NCCAM提供的这项修订的R21探索性拨款的目的是扩展PI先前的人类嗅觉心理生理学研究，并开发一种定量脑电(QEEG)生物测定，用于注册单独有效(显著)与非活性顺势疗法或安慰剂的药物。顺势疗法的创始人，塞缪尔·哈内曼医学博士，最初提出嗅探作为临床药物管理的有效途径。一致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的过程中，即使在超过阿伏加德罗数的超稀释溶液中，琥珀(剧烈摇动)也可能持久地改变溶剂的物理结构以产生秩序，即独特的信息信号。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(流畅)来优化微弱信号(顺势疗法信息)检测的模型。以前还没有研究直接检查用不同数量的琥珀酸配制的给定药物稀释对人类群体的影响。这项研究的具体目的是：i.评估在嗅觉给药期间使用急性诱发反应定量脑电(QEEG)阿尔法功率以检测在给定稀释度下制备的每个稀释步骤不同次数的顺势药物(Sulphur)的存在的可行性；ii.确定在嗅觉给药期间在定量脑电(QEEG)阿尔法功率中使用急性诱发反应的幅度以检测在两个不同的顺势系列稀释因素(用给定的每个稀释步骤的继发次数制备)下单一顺势药物的存在的可行性；iii.评估单独的多峰药物(Pulsatilla)结果的普适性。受试者将是N=108(n=54/补救)具有中等(不是很好的全球健康)的年轻成年志愿者，对硫磺或白头翁的潜在补救措施进行预先筛选，并在两个阶段的研究中进行测试(每阶段一个补救措施)。每个参与者都将接受顺势疗法体质类型问卷的预筛选，以确定两种测试药物之一的症状的高标准分数，然后是间隔一周的三次实验室会议(在每种药物类型中，6c、12c和30c的稀释顺序受试者分配是平衡的)。每个疗程将包括8个完整的区组设计，随机双盲，安慰剂对照(包括无药物稀释的溶剂和药物稀释的普通蒸馏水)嗅觉测试(使用通过气流压力传感器的时间锁定的嗅觉-脑电记录)，使用仅用搅拌、10、20或30种液体配制的给定药物稀释液。本研究填补了顺势疗法临床研究中的一个主要需求，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和药物人相互作用因素。这项研究的结果以及通过后续R01进行的后续研究可能会提高顺势疗法药物制造和用于患者护理的处方的标准化，从而提高这种全球领先的补充和替代医学形式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.