The Reliability of the Placebo Effect in Asthma

描述(由申请人提供)：在临床试验和实际临床实践中，安慰剂通常被引用为改善各种人类疾病的体征和症状。在此基础上，安慰剂治疗的效果作为比较Verum治疗效果的基线。尽管这是一种常见的做法，但尚不清楚在单一场合表现出安慰剂反应的受试者是否有能力对重复服用类似的安慰剂(即具有可靠的安慰剂反应)表现出反应，以及在临床试验的背景下，单一或可靠的安慰剂反应是否与正在研究的疾病的自然病史不同。此外，在确实表现出可靠的安慰剂反应的受试者中，尚不清楚这种对安慰剂的反应能力是否在各种安慰剂形式(例如，药物安慰剂与设备安慰剂)中是一致的，或者是否表现出安慰剂反应的能力优先与特定的方式有关。哮喘是一种常见的疾病，在这种疾病中，安慰剂的作用已经被很好地描述出来了，而且肺功能的变化可以在很短的时间内发生。在这方面，哮喘是研究安慰剂现象的许多方面的一个很好的模型。为了解决我们关于哮喘模型中安慰剂效应的性质的问题，我们将在志愿者的生理实验中研究吸入安慰剂和经过验证的假针刺针对肺功能的影响，并将其与自然病史发生的肺功能变化进行比较，具体目的如下： 目的1.获得稳定期哮喘患者对吸入安慰剂的可靠反应频率的数据，将其与仅由自然病史引起的哮喘患者分开。这些信息将被用来计划未来对常规和补充疗法中安慰剂反应的临床和机制研究。 目的2.获得与自然病史相关的哮喘缓解期患者对安慰剂--假针灸--的可靠反应频率的数据。这些信息将被用来计划未来对常规和补充疗法中安慰剂反应的临床和机制研究。 目的3.获得关于缓解期哮喘患者吸入安慰剂和安慰剂的持续安慰剂反应频率的初步数据。 对我们研究问题的回答将提供有关安慰剂反应不同于自然历史的特性的重要信息，并将为未来研究安慰剂现象机制的试验、解释安慰剂衍生数据以及设计传统和补充疗法的安慰剂对照临床试验的未来R01应用提供合理的基础。

DESCRIPTION (provided by applicant): Placebos are commonly cited as improving signs and symptoms of a wide variety of human diseases both within clinical trials and, by implication, in actual clinical practice. On this basis, the effects of the placebo treatment serve as the baseline against which the effects of the verum treatments are compared. Despite this common practice, it is not known if subjects who manifest a placebo response on a single occasion have the capacity to manifest a response to the repeated administration of a similar placebo (i.e. have a reliable placebo response), and if single or reliable placebo responses in the context of a clinical trial differ from the natural history of the disease under study. In addition, in subjects who do manifest a reliable placebo response, it is not known if this capacity to respond to a placebo is consistent across a variety of placebo modalities (e.g. pharmacological vs. device placebos), or if the capacity to manifest a placebo response is preferentially related to a particular modality. Asthma is a common disease, in which placebo effects have been well described, and in which changes in lung function can occur over short periods of time. In this regard, asthma is an excellent model in which to study many aspects of placebo phenomena. To address our questions regarding the nature of placebo effects in an asthma model, we will study the effects of an inhaled placebo and a validated sham acupuncture needle on lung function in a physiological experiment on volunteers and compare these to lung function changes occurring due to natural history with the following specific aims: Aim 1. To obtain data on the frequency of a reliable response to an inhaled placebo in individuals with stable asthma separate from that occurring due to natural history alone. This information will be used to plan future clinical and mechanistic investigation of the placebo response in conventional and complementary therapies. Aim 2. To obtain data on the frequency of a reliable response to device placebo - sham acupuncture - in individuals with stable asthma separate from that occurring due to natural history alone. This information will be used to plan future clinical and mechanistic investigation of the placebo response in conventional and complementary therapies. Aim 3. To obtain preliminary data on the frequency of a consistent placebo response to an inhaled placebo and a device placebo in individuals with stable asthma. The answers to our research questions will provide important information regarding the properties of placebo responses in distinction from natural history and will form a rational basis for future trials investigating the mechanisms of the placebo phenomenon, for the interpretation of placebo-derived data, and for the design of future R01 applications of placebo-controlled clinical trials of conventional and complementary therapies.