Enhancing the Placebo Effect in Irritable Bowel Syndrome

描述（由申请人提供）：这项资助将继续我们正在进行的关于如何增强安慰剂效应的研究，并提供关于安慰剂效应的科学有效性和临床意义的关键数据。我们的模型使用肠易激综合征（IBS）来研究由不同的病人-医生环境引起的安慰剂效应。在第一阶段，260名患者将被随机分配到一个为期3周的三组随机对照试验中，比较：假针治疗（一种经过验证的假针灸安慰剂装置）在患者与医生互动的背景下，与积极的认知、情感和符号互动“增强”。3.在“有限”的语境互动中给出相同的假动作。没有治疗控制。测试的主要问题是，两个假器械臂和无治疗臂的“非特异性”效应是否以类似于“剂量依赖性”的方式单调表现，即“增强”臂>“有限”臂>等待列表的自然史。这个试验也让我们可以回答1。肠易激综合征中的安慰剂效应可以增强，即“增强”安慰剂干预是否比“有限”安慰剂干预产生更大的安慰剂效应？“有限”安慰剂干预是否比自然史组产生更大的安慰剂效应，而在无治疗对照组中是否有任何“非特异性”效应。为了维护伦理规范，第二阶段将继续相同的背景，但假针灸将无缝切换到verum针灸，以探索针灸治疗IBS的疗效。此外，第二项平行定性研究将通过同样的三个组跟踪27名额外的患者（其结果数据将被排除在更大的研究分析之外）；该研究将通过访谈来探索患者对肠易激综合症的解释和理解（人类学家称之为“意义”）与他们对安慰剂和verum治疗的反应之间的关系。

DESCRIPTION (provided by applicant): This grant continues our ongoing research on how placebo effects can be enhanced and provides crucial data on the placebo effect's scientific validity and clinical significance. Our model uses Irritable Bowel Syndrome (IBS) to study the placebo effects elicited by different patient-practitioner contexts. In phase one, 260 patients will be randomized to a 3 week three arm RCT comparing: 1. sham needle treatment (a validated sham acupuncture placebo device) given in the context of a patient-practitioner interaction 'augmented' with positive cognitive, emotional and symbolic interactions, 2. identical sham given within a 'limited' contextual interaction, 3. a no treatment control. The primary question tested is whether the 'nonspecific' effects across the two sham device arms and the no treatment arm behave monotonically in a manner analogous to 'dose dependence' i.e. is 'augmented' arm > 'limited arm' > wait-list natural history. This trial also allows us to answer whether 1. the placebo effect in IBS can be enhanced, i.e., does an 'augmented' placebo intervention elicit a greater placebo effect than a 'limited' placebo intervention and 2. whether the 'limited' placebo intervention elicits a greater placebo effect than natural history arm with any 'non-specific' effects attendant to being in a no-treatment control. To maintain ethical norms, phase two will continue the same context, but sham acupuncture will seamlessly be switched to verum acupuncture to explore acupuncture's efficacy in IBS. In addition, a second parallel qualitative study will follow 27 additional patients (whose outcome data will be excluded from the larger study's analysis) through the same three arms; the study will use interviews to explore the relationships between patients' interpretations and understandings (what anthropologists call 'meaning') of IBS, and their responses to placebo and verum treatment.