Controlled Clinical Trials 25 (2004) 76 – 103
www.elsevier.com/locate/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 for Complementary 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
successful conventional pharmacological treatment include side effects, out-of-pocket expenses, patient
noncompliance 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 absence of antihypertensive therapy. Following screening,
participants were randomized to one of three groups: individualized, standardized or control acupuncture.
Treatments were designed according to principles of TCM; nonspecific effects associated with the interventions
were standardized across the randomized groups. For individualized acupuncture, points were tailored to each
* Corresponding author. Current affiliation: Clinical Research Program, Children’s Hospital, Boston, 300 Longwood Ave.,
Boston, MA 02115, USA. Tel.: +1-617-355-2663; fax: +1-617-355-2312.
E-mail addresses: leslie.kalish@childrens.harvard.edu (L.A. Kalish), emacklin@neri.org (E.A. Macklin).
1 Current affiliation: Samueli Institute, Alexandria, VA, USA.
2 Reprint requests to Eric A. Macklin. Tel.: +1-617-923-7747x251; fax: +1-617-926-8246.
0197-2456/$ - see front matter D 2004 Elsevier Inc. All rights reserved.
doi:10.1016/j.cct.2003.08.006

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participant. Standardized acupuncture used a prespecified set of points. The invasive sham control acupuncture
regimen was designed to be non-active. Each participant received a ‘‘prescription’’ for individualized acupuncture
from an acupuncturist who was masked to treatment assignment, and was subsequently treated by an independent
acupuncturist. Patients and those assessing BP were masked to treatment group. Acupuncture was delivered 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 SBP from baseline to 10 weeks. DBP, BP trajectories over the 12-month follow-up and
antihypertensive medication requirements will also be examined. Initial contact was documented for 1442
prospective participants from March 2001 to April 2002; 424 provided informed consent and 192 were ultimately
randomized.
D 2004 Elsevier Inc. All rights reserved.
Keywords: Acupuncture; Blood pressure; Hypertension; Randomized clinical trial; Traditional Chinese medicine
1. Introduction
Hypertension is a condition with tremendous financial and public health impact. Although blood
pressure (BP) can be controlled in most individuals, in practice, the majority of hypertensive
individuals are unrecognized and/or inadequately treated with conventional pharmacologic therapies
[1]. Acupuncture provides an alternative treatment approach with great potential advantages, but with
little rigorous scientific evidence to support it. The Stop Hypertension with the Acupuncture Research
Program (SHARP) trial is a pilot randomized clinical trial designed to gather preliminary data
regarding the efficacy of acupuncture for treating hypertension without the use of pharmacologic
therapy. This paper describes the design of SHARP and our experience with recruitment and screening
for the trial.
1.1. Hypertension
Hypertension, defined as systolic blood pressure (SBP) of z140 mm Hg and/or diastolic blood
pressure (DBP) of z90 mm Hg [2], affects an estimated 640 million persons worldwide [3], including
approximately 50 million Americans [1,4]. The costs of inadequately controlled blood pressure can be
measured financially and medically. Its financial impact in the United States is enormous—US$47.2
billion in direct and indirect costs in 2002 [4]. Medically, the long-term consequences of untreated
hypertension are among the most common and serious causes of morbidity and mortality in the United
States, including myocardial infarction, stroke, congestive heart failure and renal failure.
Despite large-scale national efforts to identify, educate and treat individuals with hypertension, only
69% of hypertensive individuals are aware that they are hypertensive. Approximately half of all
hypertensives take prescribed medications, but blood pressure is adequately controlled in only a quarter
of the total [1,5]. Although the efficacy of lifestyle modifications and antihypertensive drugs for essential
hypertension has been well established in clinical studies [6– 8], treatment with conventional medical
treatments may be limited by side effects, out-of-pocket costs, patient noncompliance with prescribed
regimens, insufficient dosages of prescribed medications to achieve an adequate level of control, health-
care provider neglect of hypertension, and the individual’s inability to make lasting and meaningful
healthy lifestyle changes [2,9–14].

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1.2. Acupuncture
Acupuncture has been a component of the Chinese health-care system for at least 2500 years and is
widely practiced in the United States [15]. Acupuncture is based on the traditional Chinese medicine
(TCM) concept that there are channels (or ‘‘meridians’’) of energy flow (‘‘qi’’) within the body that help
maintain the health of the individual and that disease and pain result from imbalances of qi. For any
particular Western medically defined illness, there may be several different underlying patterns of
disharmony from the TCM perspective. These patterns are diagnosed by symptoms and signs and by
observing the patient’s overall affect (complexion and demeanor), tongue (color, shape, coating and
texture) and radial pulse (speed, depth, rhythm, shape, quality and strength).
Acupuncture is seen as a way to access the energy channels and to restore balance by adding energy
where it is deficient and releasing energy where it is obstructed. The practice of acupuncture
encompasses several types of related techniques. All acupuncture involves stimulation of specific
anatomic locations on the body (corporeal points) or on the ear (auricular points), most commonly by
penetration of the skin with thin, solid metallic needles. Selection of corporeal points is based on
knowledge of the ‘‘action and effects’’ of the points, as developed from ancient texts and over 2000 years
of clinical experience. Modern TCM theory holds that there are also auricular points corresponding to
particular organs, areas of the body or bodily systems. Accordingly, modern day acupuncture treatments
often include both corporeal and auricular points.
Acupuncture needles are so thin that there is usually minimal discomfort when they penetrate the skin.
The needles are advanced to varying tissue depths, depending on the location in the body, and a
characteristic ‘‘de qi’’ feeling is elicited. The patient often describes de qi as a warmth, fullness, tingling
or aching in the tissue, while the acupuncturist may sense the needle being grasped or tugged (‘‘like a
fish biting the hook’’). De qi sensations have been correlated with the stimulation of A-delta fibers,
followed by C-fibers and then by group 2 fibers [16–18]. Recent studies have quantified the mechanical
grasping of needles and related it to deformation of subcutaneous connective tissue [19]. Such
mechanically induced changes in connective tissue structure (caused by needle insertion and rotation)
have been hypothesized as mechanisms by which acupuncture can affect a wide range of local and
remote physiological processes [20]. It has been argued that in clinical trials in which there was
questionable efficacy of acupuncture, the de qi sensation was not properly elicited and thus the failures
may have been due to poor technique.
Possible mechanisms by which acupuncture reduces blood pressure in hypertensive patients include
decreases in plasma renin, aldosterone and angiotensin II activity [21–24], increased excretion of
sodium [25] and changes in plasma norepinephrine, serotonin and endorphin levels [26–28]. Enkepha-
lins and h-endorphins mediate acupuncture’s effects to attenuate bradykinin-induced experimental
hypertension in laboratory cats [29–31]. Some of these mechanisms are the same ones targeted by
successful classes of pharmacological antihypertensive agents. As an example, angiotensin converting
enzyme (ACE) inhibitors achieve their effect by inhibiting the activation of angiotensin I to its more
active form. Chiu et al. [22] found lower angiotensin I levels in hypertensive patients who received
acupuncture, compared with a control group of hypertensive patients who did not receive acupuncture.
A review of the literature reveals multiple published reports of the effectiveness of acupuncture on
blood pressure and other hemodynamic parameters in humans [21–24,28,32–45]. There is a strong
prima facie case for undertaking a more definitive study. The results of all studies to date, however, must
be treated with caution because of serious methodological limitations: small sample sizes, lack of

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randomization, inadequate or unspecified follow-up, poorly described treatment content, poorly
characterized study subjects and rudimentary statistical analyses. The need exists for a rigorously
designed and conducted randomized clinical trial in order to definitively evaluate the effectiveness of
acupuncture for the management of hypertension.
One of the challenges in reaching definitive conclusions about the efficacy of acupuncture results
from variability in acupuncture methodology, including the acupuncture points selected, duration of each
treatment session, length of treatment course, intervals between treatments and form of needle
stimulation (manual, thermal or electrical). Thus it is critically important that clinical trials involve
reproducible standardized treatment protocols.
1.3. Potential acceptance by patients
In 1997, 41% of adults in the United States used alternative medical therapies (including acupuncture)
[46], suggesting that these therapies are gaining acceptance with the general public. Surveys have
demonstrated that the alternative treatments are often offered because of patient request and in the hopes
of minimizing or avoiding unwanted side effects of conventional medicines [47].
2. Study organization
The SHARP trial was funded as a cooperative agreement by the National Center for Complementary
and Alternative Medicine (NCCAM), National Institutes of Health. The New England Research
Institutes (NERI) was the organizational center for the study. All clinical work was performed at the
Massachusetts General Hospital (MGH). Trial activities at the MGH were divided between a
Hypertension Center and an Acupuncture Center. Consultants from the New England School of
Acupuncture and Wake Forest University collaborated on the design, monitoring and analysis of the
trial. A data and safety monitoring board, appointed by NCCAM, provided independent monitoring of
the study. See Appendix A for a complete list of investigators.
3. Treatment groups, treatment comparisons and endpoints
Patients in SHARP were randomized to one of three acupuncture treatment groups: individualized
(Ind), standardized (Std) or control (Ctl) (see Fig. 1). The protocols for all three groups are based on
principles of TCM acupuncture, including the control regimen, which was designed to be inactive.
The control treatment involved needling of non-acupuncture points with minimal stimulation, an
‘‘invasive sham’’ acupuncture procedure [48]. To maintain blinding, patients were told in the consent
form only that the control treatment used points ‘‘not used to treat hypertension.’’ The fact that the
control points were not traditional acupuncture points was not mentioned and the terms ‘‘sham’’ and
‘‘placebo’’ were not used. This language was approved by institutional review boards from the NERI and
the MGH (Partners Health Care System).
The two primary treatment comparisons will test the overall effect of acupuncture [(Std+Ind) versus
Ctl] and specifically whether TCM-based acupuncture that has been individually tailored to the patient
has an advantage over a standardized regimen that is also based on principles of TCM [Ind versus Std].

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Fig. 1. Clinical trial schema.
Other treatment comparisons [Std versus Ctl, Ind versus Ctl] will be performed as secondary analyses.
Treatment comparisons will be made for each of several endpoints:
 Change in SBP from baseline to 10 weeks (primary endpoint);
 Change in DBP from baseline to 10 weeks;
 Characterization of the trajectories of SBP and DBP over the entire 1-year period, including treatment
group comparisons at time-points other than 10 weeks, an evaluation of how quickly any beneficial
effect may begin, and how long the effect may last;
 Percentage of patients who initiate or resume conventional antihypertensives and the duration from
randomization to initiation/resumption of conventional antihypertensives;
 Immediate effects (pre- versus post-acupuncture treatment) on SBP and DBP; and
 Acupuncture beliefs, masking assessment, adverse events and quality of life.
The choice of SBP rather than DBP for the primary endpoint is based on both medical and statistical
arguments. Medically, SBP is more closely related to long-term cardiovascular outcomes than is DBP
[49–51]. From the viewpoint of statistical efficiency, the measurement that has lower intraperson
variability (higher within-person correlation) would be preferable. We estimated intraperson correlation
of SBP and DBP measurements from the National Center for Health Statistics (NCHS) [52]. As part of
the NCHS survey, blood pressure measurements were taken three times at a single medical exam. Age-
and gender-stratified population standard deviations are reported by the NCHS for each measurement
and for the average of the three measurements. Assuming the pairwise within-person correlations are
equal within each stratum, these standard deviations can be used to estimate the correlations. Across age
groups from 45 to 74 years, within-person correlations were higher for SBP (range 0.82–0.84) than for
DBP (range 0.76 –0.80), suggesting that SBP would result in a more efficient treatment comparison.
We also used data from the Pawtucket Heart Health Project [53]. In a repeated measures analysis of
blood pressure measurements obtained over the course of several months, the estimated residual intra-
person correlations for SBP and DBP were 0.74 and 0.67, respectively (H. Feldman, personal
communication). These values are lower than the values from the NCHS, since they represent correlations
between repeated measurements taken over a period of months rather than at a single sitting. However, as in
the NCHS data, SBP has the higher correlation, suggesting that it would yield a more sensitive measure of
treatment effect.

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4. Screening and eligibility
Prospective study participants were identified through a combination of efforts including direct
recruitment of patients receiving care at the Hypertension Center, brochures at the Hypertension Center
and at other health clinics within and outside of the MGH, postings throughout the MGH, mass
mailings, advertisements in newspapers and magazines, posters in the Boston subways and internet
listings. In an effort to recruit participants through medical practitioners, an e-mail posting was sent to all
physicians at the MGH and at several other major Boston-area hospitals, and presentations were made to
health practitioners at several local medical facilities. Recruitment was also greatly enhanced by reports
featuring the trial on local and national television news, in the Boston Globe and in other local
newspapers.
The screening process involved at least three visits to the Hypertension Center over a period of weeks.
For safety reasons, subjects were scheduled for blood pressure measurements during screening at
intervals no greater than 14 days. Subjects could be found ineligible, or could drop out because they
became uninterested in the study, at any time during screening. In particular, a stage 3 blood pressure
reading at any time during screening (SBPz180 and/or DBPz110) excluded potential participants from
entering the trial.
After a verbal introduction to the trial, prospective participants were asked several screening questions
in interview format, including some eligibility criteria and minimal demographic information. This level
of screening was typically done over the phone. All subsequent screening procedures took place in the
Hypertension Center after providing written consent. Procedures differed depending on whether or not
patients were on antihypertensive medications at the start of screening.
Following an initial blood pressure check, patients on antihypertensive medications were evaluated
for the potential level of risk associated with stopping their medications in order to participate in the trial.
This evaluation included a physical exam, clinical history, medication history, electrocardiogram (ECG)
and assessment of liver function, electrolytes, fasting blood sugar, renal function, fasting lipid profile,
urinalysis and a complete blood count.
Following these evaluations, patients were tapered off of antihypertensives with the goal of avoiding
the risks associated with rebound hypertension. Medications were discontinued one at a time at weekly
intervals in this order: diuretics, ACE inhibitors, angiotensin receptor blockers, calcium channel
blockers, a adrenergic receptor antagonists, direct acting vasodilators, centrally acting agents and h
adrenergic receptor blockers. Combination medications were discontinued one component at a time.
Blood pressure was measured before discontinuing each successive medication (at least weekly). All
medications except for h adrenergic receptor blockers and centrally acting agents were discontinued
abruptly. h adrenergic receptor blockers and centrally acting agents were discontinued more gradually:
1/2 full dose for 3 consecutive days, 1/4 full dose for 3 consecutive days and 1/4 full dose every other
day for two dosages. Two weeks after completion of tapering, the patient could begin the final
‘‘qualifying’’ sequence of blood pressure measurements (see below) and was required to repeat the ECG
and laboratory tests for electrolytes, renal function, blood sugar, lipids and urinalysis. The liver function
tests and complete blood count did not have to be repeated unless clinically indicated. Patients with
laboratory values that were initially out of eligibility range but within range upon repeat testing were
considered eligible.
Patients not on antihypertensive medications went through a similar screening process except they did
not have to repeat the laboratory measurements or ECG. The physical exam, medical and medication

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histories, lab measurements and ECG did not have to precede the qualifying sequence of blood pressure
measurements.
A qualifying sequence of blood pressure measurements during screening was required for all patients.
Minimum requirements consisted of three qualifying measurements satisfying SBPz140 and <180 mm
Hg and DBPz90 and <110 mm Hg, and (1) at least 4 days elapsed between the first and second
qualifiers, (2) no more than one nonqualifying blood pressure measurement between the first and second
qualifiers, (3) at least 4 days elapsed between the second and third qualifiers, (4) no nonqualifying blood
Table 1
Eligibility criteria for the SHARP trial
Inclusion criteria
1. Patients with essential hypertension meeting blood pressure criteria outlined in the text. Briefly, this entails repeatable
measurements of systolic blood pressure in the range 140 to 179 mm Hg and of diastolic blood pressure in the range 90 –
109 mm Hg in the absence of antihypertensive therapy.
2. Written informed consent.
Exclusion criteria
1. Secondary hypertension: e.g., renovascular disease, Cushing’s disease, hyperaldosteronism.
2. Uncontrolled diabetes mellitus: fasting blood glucose >180 mg/dl.
3. Other medical conditions that would preclude safe participation: e.g., endocrine disorders, thyroid disease, renal failure,
anemia, hemorrhagic diathesis.
4. Anticipating major surgery during the next 12 months.
5. Unwilling to complete all study visits: anticipated absence of >7 days during the first 4 weeks of acupuncture treatment;
anticipated absence of >14 days during the remainder of acupuncture unless the patient agrees to be scheduled for all 12
acupuncture treatments before their anticipated absence; only able to schedule acupuncture on consecutive days each week.
6. Prior recent acupuncture: within the past 6 months.
7. Unable or unwilling to taper off of all antihypertensive medications.
8. Currently taking or probable need for treatment with the following medications during the next 12 months (chronic is
defined as >7 days continuous use): chronic bronchodilators, including inhalation therapy (bronchodilators on an as-needed
basis were permitted); chronic sympathomimetic drugs (including weight reduction medications; sympathomimetic nasal
sprays and oral decongestants were permitted); chronic aspirin therapy (except once-daily cardiovascular prophylaxis);
nonsteroidal inflammatory drugs, including ibuprofen, naproxen, indomethacin; anticonvulsant medications; chronic
dicyclomine hydrochloride; venlafaxine; immunosuppressive drugs or cytotoxic drugs within 12 months of enrollment; oral
contraceptives containing estrogen (except postmenopausal hormone replacement); chronic oral corticosteroids (except
topical, intraarticular, or inhaled corticosteroids or oral corticosteroids in short courses); anabolic steroids; bile acid-binding
resins; chronic antipsychotic, tricyclic or tetracyclic antidepressant medications or lithium; monoamine oxidase inhibitors;
bupropion hydrochloride; warfarin; ticlopidine; clopidogrel.
9. Age: <18 years.
10. Pregnancy: pregnant within the past 4 months; currently pregnant; women of childbearing potential who were not using one
of the following forms of birth control: abstinence, barrier methods or intrauterine device.
11. Hemoglobin, platelet count or white blood count: clinically significant abnormalities.
12. Serum potassium: outside the normal range.
13. Alanine aminotransferase (SGPT): >1.5Âupper limit of normal.
14. Aspartate aminotransferase (SGOT): >1.5Âupper limit of normal.
15. Serum bilirubin: >1.3Â upper limit of normal.
16. Blood urea nitrogen or creatinine: clinically significant abnormalities.
17. Protein on urine dipstick: z2+.

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pressure measurements between the second and third qualifiers, and (5) no more than 31 days elapsed
from the first to the third qualifier.
Additional assessments during screening included self-administered questionnaires to collect infor-
mation on demographics, lifestyle, quality of life and acupuncture beliefs (described below). These
questionnaires were completed after consent was obtained.
Eligibility criteria for the randomized trial are listed in Table 1.
5. Randomization and stratification
Randomization took place at the time of the first acupuncture treatment via direct internet access
to the NERI’s randomization software, with a back-up system using sealed envelopes. As explained
below, auricular acupuncture alternated between ears at consecutive treatment visits. To ensure that
the three treatment groups were balanced with respect to which ear was treated first, the starting
ear was chosen randomly at the time of randomization to acupuncture treatment group. Simulta-
neous randomization to the three acupuncture treatment groups and two starting ears was
implemented by considering the six combinations as if they were six different treatment groups.
A permuted block allocation scheme (block size 6) was used, stratified by history of antihyper-
tensive medication history, with two strata: use versus no use of antihypertensives during the prior
6 months.
6. Acupuncture treatment
We wanted any effect of the TCM diagnostic procedure itself to be constant across the treatment
groups. At the first treatment session, all patients were evaluated by a ‘‘diagnosing acupuncturist’’ who
determined a TCM diagnosis and ‘‘prescribed’’ an individualized set of corporeal needling points and
method of stimulation for each point. The diagnosing acupuncturists were masked to the patients’
treatment group. The diagnosis and prescription were recorded on a data form and forwarded to the
‘‘treating acupuncturist,’’ who then followed the prescription only if the patient was in the
individualized treatment group. Thus, two mutually exclusive sets of acupuncturists were used in
the trial.
Diagnosing and treating acupuncturists were required to have a minimum of 3 years and 1 year
postgraduate experience, respectively. In practice, participating diagnosing acupuncturists had 13 –22
years experience, and all had received acupuncture training at colleges in the Peoples’ Republic of
China. Participating treating acupuncturists had 2–18 years experience. All study acupuncturists were
licensed to practice in Massachusetts.
Training and certification for acupuncturists consisted of studying detailed training manuals and
videotapes and attending an 8-h hands-on training session with a competency/certification exam.
Continued adherence to specific protocol requirements was assured with periodic quality assurance
assessments.
The diagnosing acupuncturist had access to the patient’s blood pressure values and could use these
data in making the prescription. The patient saw a diagnosing acupuncturist before the first treatment and
for re-assessment of the TCM diagnosis and treatment prescription at the first treatment visit following

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each scheduled blood pressure assessment, except not earlier than the fifth treatment. Re-assessment was
allowed to mimic actual practice, where needling points might be modified in view of changing
symptoms and blood pressure data.
Hypertension Center staff and diagnosing acupuncturists were masked to treatment assignment,
treating acupuncturists and other Acupuncture Center staff were masked to blood pressure measure-
ments, and patients were masked both to treatment and blood pressure values.
Measures taken to maintain masking in the Acupuncture Center included utilization of separate paper
file folders (of different colors) for diagnosing and treating acupuncturists and kept in separate locked file
cabinets. A copy of the diagnosis and prescription was kept in the diagnosing acupuncturist paper file so
that the diagnosing acupuncturist would not see subsequent notes made by the treating acupuncturist.
Blood pressure values from the Hypertension Center staff were kept in envelopes and stored in the
diagnosing acupuncturist paper file so that the treating acupuncturist had no access to these data.
Likewise, treatment assignment was stored only in the treating acupuncturist paper file. Participating
acupuncturists were allowed to function only in one role during the study. Periodic quality assurance
checks confirmed the maintenance of proper masking. Breaches of masking were reported on a
standardized data collection form.
6.1. Development of acupuncture treatment protocols
All aspects of the acupuncture treatment protocols, including choice of TCM diagnostic categories
and their criteria (signs and symptoms), active and sham acupuncture point choices, needling techniques
and treatment schedules, were developed via consensus by the research team in consultation with a
group of senior TCM acupuncturists and colleagues and in combination with reviews of the scientific
literature and standard TCM textbooks.
6.2. Scheduling of acupuncture
The ideal treatment frequency and duration was twice a week for 6 weeks (total of 12 treatments),
with 3 or 4 elapsed days between consecutive treatment sessions (e.g., every Monday and Thursday).
The treatment period could extend to 8 weeks in order to complete as many of the sessions as possible if
the ideal schedule could not be adhered to.
Patients who anticipated during screening only to be able to adhere to a schedule with consecutive
day treatments each week (e.g., every Monday and Tuesday), and those who anticipated an absence of
and >7 days during the first 4 weeks of acupuncture, were not eligible to enter the randomized study.
Patients who anticipated an absence of and >14 days after the first 4 weeks until treatment was
completed were also not eligible unless they agreed to complete the 12 treatments before their
extended absence.
If a patient had to miss a week or more of acupuncture, it was considered preferable to give three
treatment sessions in the weeks preceding and following the absence rather than to extend the total
length of the treatment period. However, treatments on consecutive days or more than three treatment
sessions in a week were prohibited.
Patients who were acutely ill on a scheduled acupuncture day were rescheduled. If there was a
question about whether to cancel, the diagnosing acupuncturist was consulted. In the event of a
cancellation, an adverse event report was filed to document the illness.

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6.3. TCM diagnosis
Prior to the trial, five TCM diagnostic categories or patterns were identified that we thought would
characterize the vast majority of patients with primary hypertension:
 Flare up of liver fire
 Liver yang rising with kidney yin deficiency
 Obstruction of phlegm and dampness
 Yin and yang deficiency
 Qi and blood deficiency leading to liver yang rising
See Table 2 for signs and symptoms consistent with these TCM diagnostic categories. The
diagnostician assigned a primary TCM diagnosis (and a secondary diagnosis, if appropriate). Not all
signs and symptoms needed to be present for a particular diagnosis to be assigned.
The TCM diagnostician could modify the diagnosis and the recommended corporeal acupuncture
points approximately every 2 weeks in view of changing symptoms and blood pressure data. Only the
diagnostician was permitted to review the patient’s blood pressure data. Blood pressure was not
measured by the Acupuncture Center except in the event that the patient had an adverse event and the
clinical management of the patient necessitated the immediate assessment of the patient’s blood pressure.
6.4. Individualized acupuncture prescription - corporeal points
In order to avoid confounding by such issues as number of needling points and duration of treatment
sessions, some restrictions were placed on the individualized acupuncture to try to match these features
with the standardized and control groups.
The diagnosing acupuncturist could prescribe 8–12 corporeal acupuncture points, based upon the
patient’s primary and secondary TCM diagnoses. Most points chosen were selected from the ‘‘pool’’ of
acupuncture points for the primary diagnostic category in Table 3. See also Fig. 2. The angle of insertion
and depth of insertion for each point are specified in Table 4. Terminology and abbreviations for
corporeal acupuncture points follow Cheng [54].
All corporeal points not on the midline were prescribed bilaterally with each prescribed bilateral point
counting as two points. For example, a prescription of 11 points might consist of 5 bilateral points and 1
point on the midline. The only exception was if the patient had a condition precluding needling on one
side (e.g., a cast, amputated limb or other condition such as a hematoma, localized skin irritation,
inflammation or infection). In these circumstances, bilateral points could be prescribed in a unilateral
fashion rather than prohibited.
Diagnosing acupuncturists could select one or two acupuncture points from outside of the primary
diagnostic category pool. If the patient had both a primary and secondary diagnosis, up to two needle
locations could be chosen from the secondary diagnostic category pool. There was also the option of
selecting one or two needle locations from outside of any of the pools. However, the total number of
points could not exceed 12 with all but two coming from the primary pool. For patients with primary and
secondary TCM diagnoses other than the 5 anticipated TCM diagnoses, 8–12 corporeal points could be
selected from any of the 5 TCM diagnostic categories (Table 3). At most, 2 points could be from outside
the pools but the total number of corporeal needles could not exceed 12.

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Document Outline

• Stop Hypertension with the Acupuncture Research Program (SHARP): clinical trial design and screening results
  • Introduction
    • Hypertension
    • Acupuncture
    • Potential acceptance by patients
  • Study organization
  • Treatment groups, treatment comparisons and endpoints
  • Screening and eligibility
  • Randomization and stratification
  • Acupuncture treatment
    • Development of acupuncture treatment protocols
    • Scheduling of acupuncture
    • TCM diagnosis
    • Individualized acupuncture prescription - corporeal points
    • Individualized acupuncture prescription-auricular (ear) points
    • Acupuncture needling
      • Individualized acupuncture
      • Standardized acupuncture
      • Control acupuncture
  • Blood pressure measurement
  • Antihypertensive medications
  • Adverse events
  • Acupuncture beliefs
  • Assessment of masking
  • Functional health status
  • Schedule of measurement
  • Statistical considerations
  • Screening experience
  • Discussion
  • Acknowledgements
  • Study organization
  • References

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