CLINICAL TRIAL OF ACUPUNCTURE FOR TREATING HYPERTENSION

一些随机对照试验表明，降低血压（BP）可以降低心血管疾病的发病率和死亡率。然而，许多高血压患者没有得到充分的治疗，部分原因是与传统医学疗法相关的费用和副作用。可以控制高血压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灸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4周不服用降压药。经过一段时间的筛选，以确定符合关键资格标准的患者，包括血压在目标范围内，900例患者将根据降压用药史分层，随机分配到三个针灸治疗组之一，每个治疗组每周进行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。治疗组的分配将对除实施治疗者外的所有人保密。结果数据将对那些进行治疗的人保密。主要终点将是收缩压的变化，根据基线水平调整，从基线到随机化后4个月。（平行分析舒张压。）每个治疗组300例患者将确保检测高血压控制的小组差异具有较高的统计效力。随机分组后，所有患者将随访12个月，经常监测血压，包括在选定的治疗就诊时测量治疗前后的血压，以评估短期效果。整个12个月的收缩压和舒张压轨迹也将被建模，以研究治疗差异可能出现的速度，以及任何此类效果的持续时间。此外，将监测传统医学治疗的使用情况，以测试针灸是否减少了引入或恢复药物治疗的需要。将评估和比较各治疗组的生活质量变化。

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.