CLINICAL TRIAL OF ACUPUNCTURE FOR TREATING HYPERTENSION

一些随机对照试验已经证明，降低血压(BP)可以转化为降低心血管发病率和死亡率。然而，许多高血压患者没有得到充分的治疗，部分原因是与传统药物治疗相关的成本和副作用。可以提供高血压控制的替代治疗策略将受到许多人的欢迎。本随机对照临床试验将评价针刺治疗轻中度高血压的临床疗效。符合条件的患者必须在随机分组前至少四周内不服用降压药。经过一段时间的筛选，以确定满足关键资格标准的患者，包括血压在目标范围内的患者，900名患者将根据抗高血压药物史进行分层，并随机分配到三个针灸治疗组中的一个，每组每周进行一次，为期12周：1)标准化针灸，2)中医(个体化)针灸，或3)安慰剂(假针灸)对照组。除了那些接受治疗的人外，治疗组的分配对所有人都是盲目的。结果数据将对那些接受治疗的人视而不见。主要终点是根据基线水平调整后的收缩压变化，从基线到随机化后4个月。(将对舒张压进行平行分析。)每个治疗组300名患者将确保在高血压控制中检测小组差异的高统计能力。所有患者将在随机分组后接受为期12个月的跟踪，并经常监测血压，包括在选定的治疗访问中进行治疗前和治疗后的测量，以评估短期效果。还将模拟整个12个月的收缩压和舒张压的轨迹，以调查治疗差异可能出现的速度以及任何此类影响的持续时间。此外，还将监测常规医疗治疗的使用情况，以测试针灸是否减少了引入或恢复药物治疗的需要。生活质量的变化将在不同的治疗组之间进行评估和比较。

Several randomized controlled trials have demonstrated that lowering blood pressure (BP) can translate into reduced cardiovascular morbidity and mortality. Yet many hypertensive individuals are inadequately treated, in part because of the costs and side effects associated with conventional medical therapies. Alternative treatment strategies which can provide hypertension control would be welcomed by many. This randomized controlled clinical trial will evaluate the clinical effectiveness of acupuncture for treating mild to moderate hypertension. Eligible patients must be free of antihypertensive medication for at least 4 weeks prior to randomization. After a screening period to identify patients who satisfy key eligibility criteria, including having BP in the target range, 900 patients will be stratified by antihypertensive medication history and allocated randomly to one of three acupuncture treatment groups, each delivered weekly for 12 weeks: 1)Standardized Acupuncture, 2)Traditional Chinese Medicine (Individualized) Acupuncture, or 3)a placebo (Sham Acupuncture) Control group. The treatment group assignment will be blinded to everyone except those administering the treatment. Outcome data will be blinded to those administering the treatment. The primary endpoint will be change in systolic BP, adjusted for baseline level, from baseline to 4 months post-randomization. (Parallel analyses will be performed for diastolic BP.) 300 patients per treatment group will assure high statistical power for detecting small group differences in hypertension control. All patients will be followed for 12 months following randomization, with BP monitored frequently, including pre and post treatment measurements at selected treatment visits to assess short-term effects. The entire 12-month trajectories of systolic and diastolic BP will also be modeled in order to investigate how quickly treatment differences may appear, and the duration of any such effect. In addition, use of conventional medical treatments will be monitored in order to test whether acupuncture reduces the need to introduce or resume pharmacologic treatment. Changes in quality of life will be assessed and compared across treatment groups.