Conditioned Placebo Effects & Treatment of Hypertension

描述（由申请方提供）：本研究将比较安慰剂胶囊在治疗临界高血压（BH）患者中的非条件作用和条件作用。在抗高血压药物试验中，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，大多数研究都依赖于传统的临床血压（BP）测量。然而，动态血压监测（ABPM）是评价任何降压治疗有效性的金标准，安慰剂对ABP的影响几乎可以忽略不计。然而，也有证据表明，当在活性药物之后给予安慰剂时，可能会产生更深远的影响。由共同首席研究员（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条件安慰剂效应可能具有真正的治疗效果。一项这样的研究，这将提供拟议的研究的基础，发现安慰剂后，活性药物降低家庭血压，但ABP没有进行评估。拟议的研究将扩展前一项研究，并将在社区卫生中心，在文化多样性，经济弱势人群中进行。120例未经治疗的BH患者将通过诊所、家庭和ABP记录监测其BP。在4周的电话连接家庭监测导入期（在整个研究期间持续）后，将他们随机分为3组：无药物组、活性药物组（β受体阻滞剂-利尿剂组合）或匹配安慰剂组。这将能够评价非条件安慰剂效应。在接下来的4周内，所有3组均将接受活性药物。将在每个阶段结束时测量ABPM和门诊BP。在最后阶段，每组患者将随机分配至无药物组或安慰剂组。将在2周后测量ABPM和门诊血压，但将继续测量家庭血压，直至血压恢复至140/90 mmHg。假设条件安慰剂效应将导致BP延迟恢复至治疗前水平，并且纳入无药物组将区分这与药物洗脱效应。为了促进和评估药物依从性，将使用电子容器（MEMscaps）。条件安慰剂效应的证明，产生持续降低血压可能会导致更经济的治疗，副作用更少。

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.