Stop Hypertension with the Acupuncture Research Program (SHARP): clinical trial design and screening results

Kalish, Leslie A.; Buczynski, Beverly; Connell, Patricia; Gemmel, Allison; Goertz, Christine; Macklin, Eric A.; Pian-Smith, May C. M.; Stevens, Stephanie; Thompson, James; Valaskatgis, Peter; Wayne, Peter M.; Zusman, Randall M.

doi:10.1016/j.cct.2003.08.006

Cited by 39 publications

(34 citation statements)

References 49 publications

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“…A separate team of treating acupuncturists, masked to BP, administered the most recently prescribed treatment for IND participants or substituted STD or CNTL acupuncture for participants randomly assigned to those treatment groups. Details of the criteria used for TCM diagnoses, acupuncture point definitions, including depth and duration of needle insertion, needle stimulation, elicitation of de qi (a dull aching and irradiating sensation indicative of effective needle placement), and locations of control points are provided in Kalish et al 39 Blood chemistries, lipid profiles, complete blood cell counts, and urinalysis were performed at baseline, 10 weeks, 6 months, and 12 months. QoL data were collected using self-administered Medical Outcomes Study Short Form questionnaires 41 at baseline, 10 weeks, and 12 months.…”

Section: Trial Designmentioning

confidence: 99%

“…The complete study design has been published. 39 The trial protocol was approved by applicable institutional review boards and was monitored by an independent data and safety monitoring board. Prospective study participants were recruited from outpatient clinics, referrals from Boston-area physicians, via advertising in periodicals and on public transportation, and through mass mailings to age-eligible Boston residents.…”

Section: Trial Designmentioning

confidence: 99%

“…The Stop Hypertension with the Acupuncture Research Program (SHARP) pilot trial 39 overcomes these limitations by combining rigorous methodology, adherence to principles of TCM acupuncture, and a large sample size. We investigated whether acupuncture administered according to principles of TCM more effectively controlled hypertension than invasive sham acupuncture and whether acupuncture individualized to each participant's TCM diagnosis was more effective than acupuncture at preselected acupuncture points.…”

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Stop Hypertension With the Acupuncture Research Program (SHARP)

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Abstract-Case studies and small trials suggest that acupuncture may effectively treat hypertension, but no large randomized trials have been reported. 3 Modalities of complementary and alternative medicine, including acupuncture, are being used by patients with increasing frequency, 4 but these therapies lack demonstrated efficacy and safety for treating cardiovascular disease and hypertension. 5 Acupuncture has been used in traditional Chinese medicine (TCM) to treat symptoms related to hypertension for Ͼ2500 years. 6 Today, acupuncture is commonly used to treat hypertension in China and the West. [7][8][9] The efficacy of acupuncture is well supported for treating postoperative dental pain 10 and nausea 11,12 with few reported adverse effects. 13 Acupuncture has been found effective for treating a number of other acute 14 -16 and chronic 17,18 conditions in a growing number of randomized trials, although opinion differs on the role of placebo effects. 19,20 Mechanistic studies have demonstrated effects of acupuncture on the activity and plasma concentrations of blood pressure modulators, including: renin, aldosterone, angiotensin II, norepinephrine, serotonin, enkephalins, and ␤-endorphins. [21][22][23][24][25][26][27][28][29] The efficacy of acupuncture for treating hypertension is suggested by a large number of published case series and uncontrolled trials. 22,23,25,30 -32 Three randomized trials 33-35 reported significant reductions in BP relative to randomly assigned control groups treated for 4 to 8 weeks, whereas 3 others did not report significant effects of acupuncture relative to control subjects. 36 -38 They were all relatively small trials (nϭ10 to 68), and all but Yin et al 35 were limited

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Section: Trial Designmentioning

confidence: 99%

Section: Trial Designmentioning

confidence: 99%

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“…2,3 However, evidence of efficacy in lowering blood pressure from controlled trials, particularly in the setting of a Western society, has been scant. 4 Several features of acupuncture make it a potentially attractive therapeutic…”

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Randomized Trial of Acupuncture to Lower Blood Pressure

et al. 2007

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Background-Arterial hypertension is a prime cause of morbidity and mortality in the general population. Pharmacological treatment has limitations resulting from drug side effects, costs, and patient compliance. Thus, we investigated whether traditional Chinese medicine acupuncture is able to lower blood pressure. Methods and Results-We randomized 160 outpatients (age, 58Ϯ8 years; 78 men) with uncomplicated arterial hypertension in a single-blind fashion to a 6-week course of active acupuncture or sham acupuncture (22 sessions of 30 minutes' duration). Seventy-eight percent were receiving antihypertensive medication, which remained unchanged. Primary outcome parameters were mean 24-hour ambulatory blood pressure levels after the treatment course and 3 and 6 months later. One hundred forty patients finished the treatment course (72 with active treatment, 68 with sham treatment). There was a significant (PϽ0.001) difference in posttreatment blood pressures adjusted for baseline values between the active and sham acupuncture groups at the end of treatment. For the primary outcome, the difference between treatment groups amounted to 6.4 mm Hg (95% CI, 3.5 to 9.2) and 3.7 mm Hg (95% CI, 1.6 to 5.8) for 24-hour systolic and diastolic blood pressures, respectively. In the active acupuncture group, mean 24-hour ambulatory systolic and diastolic blood pressures decreased significantly after treatment by 5.4 mm Hg (95% CI, 3.2 to 7.6) and 3.0 mm Hg (95% CI, 1.5 to 4.6), respectively. At 3 and 6 months, mean systolic and diastolic blood pressures returned to pretreatment levels in the active treatment group. Conclusions-Acupuncture according to traditional Chinese medicine, but not sham acupuncture, after 6 weeks of treatment significantly lowered mean 24-hour ambulatory blood pressures; the effect disappeared after cessation of acupuncture treatment.

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“…Published reports have indicated that acupuncture has a benefi cial effect on blood pressure in studies of laboratory animals (Lee and Kim, 1994;Zhou et al 1993) and humans (Kalish et al 2004;Sainani, 2003;Guo and Ni, 2003;Chiu et al 1997;Smith, 1992). The aim of the present study was to assess the effect of acupuncture on blood pressure in hypertensive patients undergoing treatment in a complementary medicine clinic.…”

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The Effect of Acupuncture on Blood Pressure in Hypertensive Patients Treated in a Complementary Medicine Clinic

Weil

Friger

Press

et al. 2007

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Background: Hypertension is a major health problem with serious medical and fi nancial consequences. Experimental studies in animals and clinical studies in humans have demonstrated that acupuncture can reduce blood pressure signifi cantly in hypertensive patients. The objective was to assess the effect of acupuncture on blood pressure in hypertensive patients treated at a complementary medicine clinic.

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Stop Hypertension with the Acupuncture Research Program (SHARP): clinical trial design and screening results

Cited by 39 publications

References 49 publications

Stop Hypertension With the Acupuncture Research Program (SHARP)

Stop Hypertension With the Acupuncture Research Program (SHARP)

Randomized Trial of Acupuncture to Lower Blood Pressure

The Effect of Acupuncture on Blood Pressure in Hypertensive Patients Treated in a Complementary Medicine Clinic

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