Complementary Alternative Cardiovascular Medicine

176 Alternative Cardiovascular Medicine
2. Observational studies and randomized studies, which demonstrate an
effect at a 1% and 5% significance level, respectively.
3. Consensus reports.
Clinical Trials Evaluating the Clinical Effect
of Acupuncture in Cardiovascular Disease
The effects of acupuncture and acupressure are described side-byside
with other treatments, which stimulate the nerves of the skin. These
related treatment methods involve electrical stimulation of the nerves,
either through the skin (TENS) or through an electrode implanted in the
spinal cord (SCS). Even though these are different kinds of treatments,
they employ the same basic mechanism—stimulating sensory nerves of
the skin.
ANGINA PECTORIS
Level A Randomized Clinical Trials. For nearly two decades, a
Swedish research group has carried out well-conducted studies on the
effects of TENS and SCS. In an early study, 21 patients with severe
angina pectoris were randomly allocated to 10 wk of TENS or no treatment
(control) after a 3-wk run-in period. Compared to the control group,
the TENS group experienced increased exercise tolerance and decreased
ST depression and recovery time (all p < 0.001) (19,20). TENS was prescribed
3 times 1 h daily, plus during angina attacks. To elucidate the
underlying mechanism, the group conducted a series of invasive studies
(19–22), in which the effect of pacing with and without TENS was
compared, using intracoronary measurements of hemodynamics. Although
the treatments were not allocated randomly, they are mentioned
in this chapter, because the results underline the clinical findings and
randomization was used, for example, when the effect of naloxone was
compared to the effect of a saline injection (22). Naloxone produced no
significant difference when compared to a saline injection. The main
results of the studies were a decrease in lactate production and in afterload
during pacing with TENS.
Other Level A Clinical Trials. To eliminate the potential bias from
patient and acupuncturist expectancy, a triple-design was used for a study
of 49 patients with stable exercise-induced angina pectoris: three individual
tests on the same patients were performed by three separate
research teams, each of which was unaware of the outcome of the other
tests (11,23–25). The patients were initially given a psychosocial test,
which included the patients’ treatment outcome expectations for angina
pectoris.
Second, the patients were randomized to genuine or sham acupuncture
for their angina pectoris, using clinical data, exercise tolerance, and