Conditioned Placebo Effects & Treatment of Hypertension

条件安慰剂效应

• 批准号: 6947844
• 负责人: Thomas G Pickering
• 金额: $ 44.91万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-27 至 2007-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6947844
• 关键词: antihypertensive agents; behavioral /social science research tag; behavioral medicine; beta antiadrenergic agent; cardiovascular disorder therapy; clinical research; clinical trials; diuretics; drug screening /evaluation; human subject; human therapy evaluation; hypertension; low socioeconomic status; patient care management; patient oriented research; placebos; telecommunications

DESCRIPTION (provided by applicant): This study will compare the unconditioned and conditioned effects of placebo capsules in the treatment of patients with borderline hypertension (BH). The use of placebos is routine in trials of antihypertensive medication, but the placebo is nearly always given before the active drug, and most studies have relied on traditional clinic measurement of blood pressure (BP). However, ambulatory BP monitoring (ABPM) is the gold standard for evaluating the effectiveness of any antihypertensive treatment, and placebo effects on ABP have mostly been negligible. However, there is also evidence that when a placebo is given after the active drug, there may be a more profound effect. A long series of both animal and human studies by the co-principal investigator (Dr. Ader) have shown that such learned or classically conditioned placebo effects may have genuinely therapeutic effects. One such study, which will provide the basis for the proposed study, found that placebo given after the active drug lowered home BP, but ABP was not evaluated. The proposed study will extend the previous one, and will be performed in Community Health Centers, in a culturally diverse, economically disadvantaged population. 120 patients with untreated BH will have their BPs monitored by clinic, home, and ABP recording. After a 4-week run-in period of telephone-linked home monitoring (continued throughout the study) they will be randomized to 3 groups: no drug, active drug (a beta blocker-diuretic combination), or matching placebo. This will enable evaluation of the unconditioned placebo effect. For the next 4 weeks all 3 groups will receive active drug. ABPM and clinic BP will be measured at the end of each period. For the final period patients in each group will be randomized to no drug or placebo. ABPM and clinic BP will be measured after 2 weeks, but home BP will continue until BP returns to 140/90 mmHg. It is hypothesized that the conditioned placebo effect will result in a delayed return of BP to pretreatment levels, and the inclusion of the No Drug group will distinguish this from the effects of drug washout. To promote and assess compliance with the medications, electronic containers (MEMscaps) will be used. The demonstration of a conditioned placebo effect that produces a sustained reduction of BP could result in more economical treatment with fewer side effects.

描述（由申请人提供）：本研究将比较安慰剂胶囊在边缘高血压（BH）患者治疗中的无条件和条件影响。安慰剂的使用是在降压药物试验中常规的，但是安慰剂几乎总是在活性药物之前给予，并且大多数研究都依赖于传统的血压诊所测量（BP）。然而，门诊BP监测（ABPM）是评估任何降压治疗有效性的黄金标准，而安慰剂对ABP的影响大多是可以忽略的。但是，也有证据表明，当活性药物后给予安慰剂时，可能会产生更深远的作用。联合主管研究者（Ader博士）的一系列动物和人类研究表明，这种学识渊博或经典的安慰剂作用可能具有真正的治疗作用。一项这样的研究将为拟议的研究提供基础，发现活跃药物后给予的安慰剂降低了家庭BP，但未评估ABP。拟议的研究将扩大前一项研究，并将在社区卫生中心进行，以文化多样化，经济不利的人群进行。 120例未经治疗的BH患者将通过诊所，家庭和ABP记录监测其BPS。经过4周的电话连接家庭监测（在整个研究中持续）后，它们将被随机分为3组：无药物，活性药物（β受体阻滞剂 - 二尿组合）或匹配的安慰剂。这将使无条件的安慰剂效应评估。在接下来的4周内，所有3组将接受活性药物。 ABPM和诊所BP将在每个时期结束时测量。对于最后一段时间，每个组的患者将被随机分为无药物或安慰剂。 ABPM和Clinic BP将在2周后测量，但家庭BP将持续到BP恢复至140/90 mmHg。假设条件的安慰剂效应将导致BP延迟返回到预处理水平，而NO药物组的纳入将与药物冲洗的影响区分开来。为了促进和评估对药物的依从性，将使用电子容器（MEMSCAP）。调节的安慰剂效应的证明会导致BP持续减少，可能会导致更经济的治疗，而副作用较少。