Acupuncture in the Treatment of Hypertension
Hypertension is a condition with significant
public health and financial consequences. Approximately 50 million
Americans have hypertension. Only 69% of hypertensive individuals
are aware that they are hypertensive; approximately half take prescribed
medications, but blood pressure is adequately controlled in only
a quarter of those patients. [1], [2] The
use of pharmaceutical antihypertensive agents is often associated
with side effects, contributing to low compliance with recommended
treatment regimens. Consequently, there is a growing interest in
complementary and alternative medicine (CAM) to treat hypertension
and related cardiovascular diseases. For example, the National
Center for Complementary and Alternative Medicine (NCCAM) is funding
research at both University of Michigan's Integative
Medicine Cardioprotection Research Lab and the Maharishi University
of Management's Institute
for Natural Medicine and Prevention in Iowa. [3]
Acupuncture has been used to treat hypertension in clinical practice with
very few reported adverse effects. However, to date the effectiveness of
this treatment has not been explored adequately in published studies. A systematic
literature review conducted by Y.E. Ren evaluating the benefits of acupuncture
for treating hypertension in humans summarized 13 trials. Of these, only
three were controlled and only one was single blinded and randomized. [4] The
one randomized controlled trial (RCT) included in this review was of very
poor quality. [5] Its
design included ten subjects randomized to receive either active or sham
acupuncture. Active treatments consisted of electro-acupuncture stimulation
to four pre-determined acupuncture points. Sham treatments consisted of electro-acupuncture
stimulation to so-called "non-acupuncture" locations. Treatments
lasted only five minutes. Nevertheless, the results from this small study
suggested significantly greater post-stimulation reductions in diastolic
blood pressure in the active versus sham group. [5]
In another trial conducted in China not included in Ren's review, 216 patients
with a diagnosis of primary hypertension were randomized into three active
treatment groups: ear acupuncture (N=72); corporal acupuncture (N=72); and
a combination of ear and corporal acupuncture (N=72). [6] Each
group received a 20-minute treatment once a day for 10 days. A significant
effective response was defined as either the diastolic pressure returning
to the normal range, and the reduction was >10 mmHg, or the diastolic pressure
reduction was greater then 20 mmHg even if the reduction did not return to
the normal range. All three groups showed a statistically significant reduction
of blood pressure. In the combination ear and corporal acupuncture group,
a significant effective response was observed in 43 out of 72 patients with
a total response rate of 86.1%. The total response rates for ear acupuncture
and corporal acupuncture performed alone, however, were 53.8% and 55.4% respectively.
There was no sham or non-acupuncture control administered in this trial.
Numerous other non-controlled case series have also been conducted to evaluate
the efficacy of acupuncture in managing blood pressure. Overall, these less
rigorous trials suggest acupuncture may be helpful. For example, in one study,
34 patients with stage I and II primary hypertension received 20 minute acupuncture
treatments, once a day for 30 days. [7] The
diastolic and systolic pressures were measured before and after the course
of treatment. The mean of systolic pressure was reduced from 177 mmHg to
159 mmHg and the mean of diastolic pressure was reduced from 99 mmHg to 92
mmHg. Meanwhile, significant changes in blood viscosity parameters of patients
were observed before and after the treatment. Other case studies are summarized
in Ren’s review. [4]
Mechanistic animal studies conducted in China
suggest that acupuncture could affect blood pressure regulation
by influencing blood pressure regulating hormones. One study suggests
that acupuncture reduces the renin, angiotensin II, and aldosterone
levels in two-kidney, one-clip (2K1C) hypertensive rats. [8] Another
study on spontaneous hypertensive rats found that the concentration
of serum nitric oxide (NO) was significantly higher in electroacupuncture-treated
group than that in the control group. [9]
While the results of some RCT and case series suggest some benefits of acupuncture
for managing hypertension, the results must be treated with caution because
of serious methodological limitations: (a) sample sizes have been small and
generally inadequate; (b) randomization and the use of controls is rare and
poorly characterized; (c) interventions often do not reflect traditional
clinical practice; (d)the period of follow-up has generally been inadequate
or unspecified; (e) the content of treatment is often poorly described; (f)
the subjects of the studies are not well characterized; and (g) statistical
analyses of the data obtained are often rudimentary.
To address these limitations, the NIH has recently funded a rigorously designed
RCT: "Stop
Hypertension with the Acupuncture Research Program (SHARP)." SHARP
has enrolled 190 subjects with mild to moderate hypertension, and randomly
allocated them to one of three treatments: individualized, standardized,
or sham acupuncture. Unique to this study is the application of dual diagnosis
(click for information
about the study's design). Patients are diagnosed not only with respect
to the severity of their hypertension, but also with respect to Traditional
Chinese Medicine (TCM) patterns. According to TCM theory,
subjects with identical blood pressure profiles may be diagnosed in at least
five different ways (e.g. Liver Fire Rising, Kidney Yin Deficiency). This
design will allow researchers to test two hypothesis: 1) that active treatments
(individualized + standardized) are more effective than sham treatments;
and 2) that individualized treatments tailored to specific TCM diagnoses
are more effective than standardized treatments. Details of this acupuncture
RCT are summarized in a paper characterizing the design and rationale of
this study. [10]
