Positive Health Online

Abstract

KALISH and others, New England Research Institutes, 9 Galen Street, Watertown, MA 02472, USA, leslie.kalish@childrens.harvard.edu, introduce the methodology of the Stop Hypertension with Acupuncture Research Programme (SHARP).

Background

Hypertension is a major public health problem. Acupuncture has been studied as an alternative therapy for controlling blood pressure, but previous studies have serious methodological limitations. This paper describes the design of the Stop Hypertension with the Acupuncture Research Programme (SHARP) trial, a pilot randomized clinical trial designed to gather preliminary data about the efficacy of traditional Chinese medicine (TCM)-based acupuncture for control of essential hypertension.

Methodology

The design of the SHARP trial combined rigorous clinical trial methodology with principles of TCM. Eligible participants had systolic blood pressures of 140-179 mm Hg and diastolic blood pressures of 90-109 mm at baseline. Participants were randomized to one of three groups: individualized, standardized or control acupuncture. For individualized acupuncture, points were tailored to each participant. Standardized acupuncture used a previously specified set of points. The invasive sham control acupuncture was designed to be non-active. Each participant received a prescription for individualized acupuncture from an acupuncturist who was blinded to treatment assignment, and was subsequently treated by a different acupuncturist. Acupuncture was administered twice a week for 6 weeks. Follow-up visits were every 2 weeks to week 10 and then at months 4, 6, 9 and 12. The primary endpoint will be change in systolic blood pressure from baseline to 10 weeks. Diastolic blood pressure, blood pressure trajectories over the 12-month follow-up period, and antihypertensive medication requirements will also be examined.

Results

Initial contact was documented for 1442 prospective participants from March 2001 to April 2002; 424 provided informed consent and 192 participants were randomized.

Conclusion

SHARP looks to be on track for interesting results.

References

Kalish LA, Buczynski B, Connell P., Gemmel A, Goertz C, Macklin EA, Pian-Smith M, Stevens S, Thompson J, Valaskatgis P, Wayne PM, Zusman RM. Stop Hypertension with the Acupuncture Research Program (SHARP): clinical trial design and screening results. Controlled Clinical Trials 25(1): 76-103, Feb 2004.