Conditioned Placebo Effects & Treatment of Hypertension

条件安慰剂效应

• 批准号: 6585590
• 负责人: Thomas G Pickering
• 金额: $ 45.41万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 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 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6585590
• 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治疗边缘性高血压（BH）患者中的非条件和条件作用。在降压药试验中，安慰剂的使用是常规的，但安慰剂几乎总是在活性药物之前给药，而且大多数研究都依赖于传统的临床血压测量。然而，动态血压监测（ABPM）是评估任何抗高血压治疗有效性的金标准，而安慰剂对ABP的影响大多可以忽略不计。然而，也有证据表明，在服用活性药物后再服用安慰剂，可能会产生更深远的影响。联合首席研究员（Ader博士）进行的一系列动物和人类研究表明，这种习得的或经典的安慰剂效应可能具有真正的治疗效果。其中一项研究将为本研究提供基础，该研究发现，在活性药物后给予安慰剂可降低血压，但ABP未被评估。拟议的研究将扩展先前的研究，并将在社区保健中心，在文化多样化、经济上处于不利地位的人口中进行。120例未经治疗的BH患者将通过临床、家庭和ABP记录监测血压。经过4周的电话家庭监测磨合期（在整个研究过程中持续进行），他们将被随机分为3组：没有药物，有效药物（-阻滞剂-利尿剂组合），或匹配安慰剂。这将使评估无条件安慰剂效应成为可能。在接下来的4周内，所有3组都将接受有效药物治疗。在每个周期结束时测量ABPM和临床血压。在最后一段时间，每组患者将随机分为无药组和安慰剂组。ABPM和临床血压将在2周后测量，但家庭血压将继续测量，直到血压恢复到140/90 mmHg。假设条件安慰剂效应会导致BP延迟恢复到预处理水平，无药物组的纳入将其与药物洗脱的影响区分开来。为了促进和评估药物的依从性，将使用电子容器（MEMscaps）。有条件的安慰剂效应的证明可以产生持续的血压降低，这可能导致更经济的治疗和更少的副作用。