Complementary Alternative Cardiovascular Medicine

Chapter 11 / Acupuncture and CVD 175
ACUPUNCTURIST BIAS
When compared with surgery and pharmacological treatment, the
risk of inducing bias is far greater in acupuncture treatment because of
the extensive and prolonged contact between patient and doctor: 10–12
consultations of 45 min, for a 3-wk period, in patients with angina pectoris.
Accordingly, it is important to address the possible bias from the
“Rosenthal Effect” induced by the acupuncturist. This effect is present
in a range of experimental settings, for example, reaction time, animal
learning, human learning, and ability testing (12). Furthermore, the size
of this effect is substantial, with 95% confidence limits ranging from
0.62–1.22 standard deviations (13). The importance of this in cardiovascular
disease (CVD) is underlined by observations of the lethal, healing,
and conditioning power of words (14), as well as the following examples
of the physiological effects of human touch, a distinctive feature of
acupuncture. Rats receiving a high-cholesterol diet and a one-to-one
relationship with the investigator, including touch three times daily,
showed a 60% reduction in diet-induced arteriosclerosis when compared
with an untouched control group (15). When touched daily, premature
infants in incubators increased their weight faster than infants in
the same condition who were not touched (16). In patients with unconscious
arrhythmias, manual pulse taking had a normalizing effect on the
heart rhythm (17,18). In conclusion, acupuncture trials require an adjustment
concerning the Rosenthal effect.
COMMENTS CONCERNING THE “GRADING” OF CLINICAL AND SCIENTIFIC
STUDIES ACCORDING TO EVIDENCE LEVEL
The Agency for Health Care Policy and Research (AHCPR) of the US
Public Health Service has suggested that studies be “graded” according
to the following criteria:
1. Well-designed, well-conducted, controlled trials
2. Observational studies and small clinical studies
3. Expert opinion/panel consensus
As indicated in the previous section, this “grading” requires an adjustment
in acupuncture trials. Accordingly, for the present evidence analysis,
the “grading” has been adjusted as follows:
1. Well-designed, well-conducted, controlled trials that demonstrate an
effect of acupuncture at a 1% significance level. Alternatively, welldesigned,
well-conducted trials that have eliminated patient and acupuncturist
bias and demonstrate an effect of acupuncture at a 5%
significance level.