Conditioned Placebo Effects & Treatment of Hypertension

描述(申请人提供)：这项研究将比较安慰剂胶囊在治疗临界高血压(BH)患者中的无条件和有条件的效果。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服用活性药物之前给予，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的影响几乎可以忽略不计。然而，也有证据表明，当安慰剂在活性药物之后给予时，可能会有更深远的影响。联合首席研究员(阿德博士)进行的一系列动物和人体研究表明，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。其中一项研究将为拟议的研究提供基础，该研究发现，在活性药物之后给予安慰剂可以降低家庭血压，但没有对ABP进行评估。这项拟议的研究将扩展先前的研究，并将在社区卫生中心进行，对象是文化多元化、经济上处于不利地位的人群。120名未经治疗的BH患者将通过诊所、家庭和ABP记录来监测他们的血压。在为期4周的电话家庭监测(在整个研究过程中继续)的磨合期之后，他们将被随机分成3组：不用药、活性药物(一种β受体阻滞剂-利尿剂组合)或匹配的安慰剂。这将使评估无条件的安慰剂效果成为可能。在接下来的4周内，所有3组都将接受活性药物治疗。在每个周期结束时测量ABPM和临床血压。在最后阶段，每组患者将被随机分成不服用药物或安慰剂的组。两周后将测量ABPM和临床血压，但家庭血压将持续测量，直到血压恢复到140/90毫米汞柱。据推测，条件性安慰剂效应将导致BP延迟恢复到治疗前水平，纳入非药物组将区别于药物洗脱的影响。为了促进和评估药物的依从性，将使用电子容器(MEMscape)。证明一种可持续降低血压的条件性安慰剂效应，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.