Efficacy of Open-Label Placebo, Double-Blind Placebo, and Peppermint Oil in IBS

开放标签安慰剂、双盲安慰剂和薄荷油对 IBS 的疗效

• 批准号: 8963051
• 负责人: Ted Kaptchuk
• 金额: $ 84.37万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-01 至 2020-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8963051
• 关键词: Address; Affect; Analysis of Covariance; Blinded; Candidate Disease Gene; Clinical; Clinical Research; Control Groups; Deception; Double-Blind Method; Ethnography; Genetic; Genetic Polymorphism; Interview; Irritable Bowel Syndrome; North America; Patients; Peppermint oil; Personality Traits; Pharmaceutical Preparations; Placebo Control; Placebo Effect; Placebos; Population; Randomized; Randomized Controlled Trials; Research; Research Design; Research Personnel; Surveys; Symptoms; Testing; United States; arm; burden of illness; chronic abdominal pain; clinical practice; clinically relevant; clinically significant; cost; design; experience; follow-up; health care service utilization; innovation; insight; open label; pill; psychologic; public health relevance; response; trait

R01AT008573 Lembo, Anthony (contact PI) Project Summary/Abstract Irritable bowel syndrome (IBS) affects 7-15% of the population in North America and results in high health care utilization costs. Despite the heavy disease burden of IBS, few therapies have been proven safe and widely effective. In a previous large (N=262) randomized controlled trial (RCT), our team showed that IBS can be successfully treated with blinded placebo. Our team has also shown in a recent RCT (N=80) that open-label placebo pills can result in statistically and clinically significant improvements in IBS symptoms compared to a no treatment control group. Furthermore, we recently completed a survey of 853 patients and found that >60% would be willing to be treated for chronic abdominal pain with open-label placebo. To follow up on these studies, the current application seeks to determine whether blinding (i.e., open-label vs. double-blind) affects the efficacy of placebo compared to no treatment control. We propose a 6-week RCT with 280 IBS patients on standard treatment for IBS who will be randomly assigned to one of five arms (A) open-label placebo (n=70), (B) double-blind placebo (n=70), (C) open-label peppermint oil (n=35), (D) double-blind peppermint oil (n=35), and (E) no treatment control (n=70). Groups A, B, C, and D comprise a 2x2 factorial design, to which we have added a no treatment control (E). Given that the study primarily concerns placebo effects and peppermint oil is being used as a control, patients will be assigned to placebo vs peppermint in a 2:1 ratio. This design will allow us to examine a number of questions in the treatment of IBS that are critical to both practice and research design, including: (1) Is open-label placebo more effective than no treatment control? (2) Are open-label treatments more effective than double-blind treatments? Secondary questions include: 1) Does the difference in abdominal cramps, a symptom associated with IBS, between peppermint oil and placebo vary depending on whether treatments are delivered open-label or double-blind?; (2) Confirming our previous findings that the COMT val158met polymorphisms predict placebo response in IBS; (3) Replicating our previous finding that the psychological traits of extraversion, agreeableness, and openness are associated with placebo response in IBS. We will also perform a nested “in-depth” qualitative study (N=50) to assess patients’ experiences.

R01AT008573 Lembo，Anthony（联系PI） 项目摘要/摘要 肠易激综合征（IBS）影响北美7-15％的人口，并导致高医疗保健利用成本。尽管IBS的伯恩（IB）伯恩（Burnen）疾病，但很少有疗法被证明是安全且广泛有效的。在以前的大型（n = 262）随机对照试验（RCT）中，我们的团队表明，可以通过盲目的安慰剂成功治疗IBS。我们的团队还在最近的RCT（n = 80）中表明，与无治疗对照组相比，开放标签的安慰剂药可以在统计学和临床​​上显着改善IBS症状。此外，我们最近完成了对853例患者的调查，发现> 60％的患者愿意接受开放标签安慰剂的慢性腹痛治疗。为了跟进这些研究，当前的应用程序旨在确定与没有治疗控制相比，盲目（即开放标签与双盲）是否会影响安慰剂的效率。我们提出了一个为期6周的RCT，对280名IBS患者进行标准治疗的IBS，他们将随机分配到五个臂之一（a）开放标签安慰剂（n = 70）， （b）双盲安慰剂（n = 70），（c）开放标签的薄荷油（n = 35），（d）双盲薄荷油（n = 35）和（e）无处理控制（n = 70）。 A，B，C和D组构成了2x2阶乘设计，我们添加了未治疗控制（E）。鉴于该研究主要涉及安慰剂效应和薄荷油作为对照，因此将以2：1的比例将患者分配给安慰剂与薄荷。设计将使我们能够研究对IBS的许多问题，这些问题对实践和研究设计至关重要，包括：（1）开放标签的安慰剂比没有治疗控制更有效？ （2）开放标签治疗是否比双盲治疗更有效？次要问题包括：1）薄荷油和安慰剂之间的腹部痉挛差异，与IBS相关的症状是否会根据治疗是开放标签还是双盲？ （2）证实我们以前的发现，即COMT Val158met多态性预测IBS中的安慰剂反应； （3）复制我们以前的发现，即外向性，愉快性和开放性的心理特征与IBS中的安慰剂反应有关。我们还将进行一项嵌套的“深入”定性研究（n = 50），以评估患者的经历。