Stop Hypertension with Acupuncture Research Program (SHARP)

September 2001 - March 2005

Project Description - This pilot randomized controlled trial (RCT) (n=192) was designed to gather preliminary data regarding the efficacy of acupuncture for treating mild to moderate hypertension without the use of pharmacologic therapy. The New England Research Institute (NERI) is the organizational center for the study. Patients were stratified by antihypertensive medication history and allocated randomly to one of three acupuncture treatment groups, each delivered twice weekly for 6 weeks: 1) Standardized Acupuncture, 2) Individualized Acupuncture, or 3) Sham Acupuncture (Control group). All patients were diagnosed by non-treating acupuncturists using a TCM protocol, but only those in the Individualized group were treated accordingly. The primary endpoint was change in systolic BP, adjusted for baseline level, from baseline to 4 months post-randomization. In addition, use of conventional medical treatments was monitored in order to test whether acupuncture reduces the need to introduce or resume pharmacologic treatment. Changes in quality of life were also assessed and compared across treatment groups.

Current Status - Recruitment for this study is complete and data analysis is underway. A paper describing the design of the study has been published (see below), preliminary results have been presented at various conferences and manuscripts are currently undergoing peer-review at various journals.

Results: Mean blood pressure decreased 4.8/4.8 mm Hg from baseline; 42% of patients had blood pressures below 140/90 at 10 weeks without use of anti-hypertensives. However, the meanbaseline-adjusted decrease in systolic blood pressure at 10 weeks did not differ between subjects randomized to active (Individualized and Standardized) versus sham (Control) acupuncture (-4.78 vs. -4.45 mm Hg, p=0.89). Individualized ( Ind ) acupuncture subjects experienced the largest decrease in diastolic blood pressure (-6.12 mm Hg vs. -4.72 for Control patients), but the differences among the treatment groups were not significant (p=0.46). A trend toward greater improvement in diastolic blood pressure from 2 weeks to 10 weeks was observed in the patients randomized to Individualized treatments, suggesting that a longer series of treatments might have revealed greater treatment differences; however, the observed difference in trends were not significant (p=0.23). Stratifying the subjects by ages, race, obesity, history of antihypertensive use, or primary TCM diagnosis did not reveal any sub-groups of subjects for whom the benefits of TCM acupuncture differed significantly from sham acupuncture. Future trials will be required to evaluate potential benefits of TCM acupuncture under different treatment schedules, among different patient populations, as a complement to western or herbal treatment, or compared to alternative controls.

Publications:

1. Kalish LA, Buczynski B, Connell P, Gemmel A, Goertz C, Macklin E, Pian-Smith M, Stevens S, Thompson J, Valaskatgis P, Wayne P, Zusman, R. Stop Hypertension with the Acupuncture Research Program (SHARP): Clinical Trial Design and Screening Results. Controlled Clinical Trials 2004 Feb; 25(1):76-103.

2. Macklin EA, Buczyski B, Connell P, Pian-Smith M, Stevens S, Thompson J, Valaskatgis P, Wayne P, Zusman R. Results of the Stop Hypertension With Acupuncture Research Program (SHARP) Pilot Trial (Abstract). J Alt Compl Med ., 2004; 10(1): 214-215.

3. Macklin EA, Wayne PM, Pian-Smith M, Stevens S, Thompson J, Valaskatgis P, Zusman R. Results of the Stop Hypertension with the Acupuncture Research Program (SHARP): a randomized controlled clinical trial.  Submitted to Hypertension .

Principle Investigator: Eric Macklin, PhD (New England Research Institute)

NESA Participants:
Consultants and Investigators: Peter Valaskatgis, MAc, LicAc; Peter Wayne , PhD; Weidong Lu , MB, MPH, LicAc; Zhenzhen Zhang, LicAc

Acupuncture Providers: Kate Billings, LicAc; Sheng Zhuang Chiu, Lic Ac; Edward Chiu, LicAc; Amy Hull MEd, MAOM, LicAc; Diane Iuliano , MAc, LicAc; Joseph Kay, LicAc; Zhi-Ping Li, LicAc, MA; Richard Mandell, LicAc; Henry McCann, LicAc; Nicole Stockman LicAc; Peter Valaskatgis, MAc, LicAc; Wei ( Vivien ) Zhang, LicAc

Collaborating Institutions - New England Research Institute, Massachusetts General Hospital

Funding Agency – NIH---Grant # U01AT 000210-03

Research Faculty and Staff

Ongoing or Completed Studies:

• Seminar Series
• Faculty Publications
• NESA Institutional Review Board
• NEWTT (NESA East-West Think Tank)