CLINICAL TRIAL OF ACUPUNCTURE FOR TREATING HYPERTENSION

几项随机对照试验表明，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，部分原因是与常规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估针灸治疗轻中度高血压的临床疗效。 合格患者必须在随机化前至少4周内未使用降压药物。 经过筛选期以确定符合关键合格标准（包括BP在目标范围内）的患者后，将900例患者按抗高血压药物治疗史分层，并随机分配至三个针灸治疗组之一，每个治疗组每周一次，持续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。 除给药人员外，所有人均对治疗组分配设盲。 结局数据将对治疗给药者设盲。 主要终点将是收缩压从基线至随机化后4个月的变化（根据基线水平调整）。（将对舒张压进行平行分析。） 每个治疗组300例患者将确保检测高血压控制方面的小组差异的高统计学把握度。 所有患者将在随机化后随访12个月，经常监测血压，包括在选定的治疗访视时进行治疗前和治疗后测量，以评估短期效果。 还将对收缩压和舒张压的整个12个月轨迹进行建模，以研究治疗差异出现的速度以及任何此类影响的持续时间。 此外，将监测常规药物治疗的使用，以测试针灸是否减少了引入或恢复药物治疗的需要。 将评估生活质量的变化，并在治疗组间进行比较。

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.