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.
| Macklin, Eric A; Wayne, Peter M; Kalish, Leslie A et al. (2006) Stop Hypertension with the Acupuncture Research Program (SHARP): results of a randomized, controlled clinical trial. Hypertension 48:838-45 |
| Kalish, Leslie A; Buczynski, Beverly; Connell, Patricia et al. (2004) Stop Hypertension with the Acupuncture Research Program (SHARP): clinical trial design and screening results. Control Clin Trials 25:76-103 |
