Complementary Alternative Cardiovascular Medicine

Chapter 1 / CAM and CVD 7
disease case-control study where subjects who were identified as using
antioxidant vitamins also consumed known (and unknown)
cardioprotective dietary substances to a greater extent than the control
group. Selecting a control group that was matched for smoking, serum
cholesterol, and blood pressure would miss these and other important
variables.
Another important bias occurs when factors that are not appropriately
considered in the interpretation of the findings could distort the outcome
of observational research design studies. This is the basis for the reliance
on large, randomized, controlled, and blinded clinical trials of appropriate
duration. This is the gold standard of research design. The random
assignment to the experimental or control group should eliminate selection
bias, and the blinding of the patient and the team that is collecting
the data about which patients are receiving the product or treatment vs
placebo should eliminate patient and observer bias. The size and duration
of the trial should allow for the determination of a statistically significant
difference in outcome (based on reasonable clinical projections)
in the experimental vs the control group. Such studies are essential to
arrive at an evidenced-based decision regarding the safety and efficacy
of any treatment options, including CAM.
Large clinical trails of sufficient duration to prove or disprove efficacy
and determine the type and frequency of adverse events are expensive,
both financially and in investigator effort. However, there is no
substitute for the findings of such a study, and, as clinicians, although we
counsel in the present based on best available evidence, we must lobby
strongly for the funding of appropriate clinical trials of CAM therapies in
the near future.
A scoring system for published CAM articles is essential for assessing
the relative values of such studies to the clinician. The US Agency for
Heath Care Policy Research (AHCPR) has produced valuable evidencebased
clinical guidelines for cardiovascular care during the last decade.
For each such guideline, the expert committee has presented the criteria
to score published studies regarding their value. These guidelines are
useful to the clinician who must assimilate data from studies on CAM
and CVD to determine his or her own counseling guidelines.
The editor’s recommendations to the authors of this text are based on
the Strength-of-Evidence Ratings section in the US Department of Health
and Human Services AHCPR Clinical Practice Guideline number 17:
Cardiac Rehabilitation (12). We consider this a practical scoring system
for clinicians and suggest that when combined with the criteria proposed
by Weiger and colleagues (with an awareness of the issue of safety as it
applies to CAM treatment of CVDs), it will provide the clinician with a