CLINICAL TRIAL OF ACUPUNCTURE FOR TREATING HYPERTENSION

针灸治疗高血压的临床试验

• 批准号: 6452239
• 负责人: Leslie Kalish
• 金额: $ 0.14万
• 依托单位: NEW ENGLAND RESEARCH INSTITUTES, INC.
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-06-01 至 2004-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6452239
• 关键词: acupuncture /acupressure; cardiovascular disorder diagnosis; cardiovascular disorder therapy; clinical research; clinical trials; cooperative study; data collection methodology /evaluation; human subject; human therapy evaluation; hypertension; longitudinal human study; outcomes research; quality of life; statistics /biometry

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.

一些随机对照试验表明，降低血压（BP）可以转化为降低的心血管发病率和死亡率。 然而，许多高血压患者的治疗不足，部分原因是与常规医疗疗法相关的成本和副​​作用。 许多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。 这项随机对照临床试验将评估针灸治疗轻度至中度高血压的临床有效性。 合格的患者必须在随机分组前至少4周内不含降压药。 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. 治疗组的分配将对除了管理治疗的所有人视而不见。 结果数据将对接受治疗的人视而不见。 主要终点将是收缩BP的变化，根据基线的基线至2个月后，对基线水平进行了调整。 （将对舒张压BP进行并行分析。）每个治疗组300名患者将确保检测高血压控制小组差异的高统计能力。 随机分组后，所有患者将进行12个月，并经常监测BP，包括在选定治疗就诊时进行治疗前和治疗后测量，以评估短期影响。 还将对整个12个月的收缩压和舒张压BP进行建模，以研究出现的治疗差异的速度以及任何此类效果的持续时间。 此外，将监测使用常规医疗治疗，以测试针灸是否减少了引入或恢复药理治疗的需求。 将在治疗组之间评估和比较生活质量的变化。