文档介绍：Controlled Clinical Trials 25 (2004) 76–103
ate/conclintrial
Design paper
Stop Hypertension with the Acupuncture Research Program
(SHARP): clinical trial design and screening results
Leslie A. Kalisha,*, Beverly Buczynskib, Patricia Connella,
Allison Gemmela, Christine Goertzc,1, Eric A. Macklina,2,
May Pian-Smithd, Stephanie Stevensa,e, James Thompsond,
Peter Valaskatgisf, Peter M. Waynef, Randall M. Zusmanb
a New England Research Institutes, 9 Galen Street, Watertown, MA 02472, USA
b Division of Hypertension and Vascular Medicine, Cardiac Unit, Medical Services, Massachusetts General Hospital,
Department of Medicine, Harvard Medical School, Boston, MA, USA
c National Center plementary and Alternative Medicine, National Institutes of Health, Bethesda, MD, USA
d Department of Anesthesia and Critical Care, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA
e Marblehead Holistic Health Consultants, Marblehead, MA, USA
f New England School of Acupuncture, Watertown, MA, USA
Received 14 January 2003; accepted 8 August 2003
Abstract
Hypertension is a major public health problem with serious medical and financial consequences. Barriers to
essful conventional pharmacological treatment include side effects, out-of-pocket expenses, patient
pliance and insufficient dosages. Acupuncture has been studied as an alternative therapy for controlling
blood pressure (BP) but previous studies have serious methodological limitations. This paper describes the
design of the Stop Hypertension with the Acupuncture Research Program (SHARP) trial, a pilot randomized
clinical trial designed to gather preliminary data regarding the efficacy of traditional Chinese medicine (TCM)-
based acupuncture for control of essential hypertension. The design of the SHARP trial balanced rigorous
clinical trial methodology with principles of TCM. Eligible participants had systolic BP (SBP) 140–179 mm Hg
and diastolic BP (DBP) 90–109 mm Hg in the