Complementary Alternative Cardiovascular Medicine

4 Alternative Cardiovascular Medicine
tion for the product or therapy. The National Institutes of Health (NIH)
and foundations with a focus on CAM are initiating such studies, but
these studies are occurring at a limited pace.
WHAT THE PHYSICIAN MUST KNOW
REGARDING CAM AND CVD
Effective physician counseling of patients regarding the CAM use for
the prevention and treatment of CVD requires, at a minimum, that physicians
be familiar with the available evidence regarding the more common
alternative therapies and be able to classify them, with respect to
their safety and efficacy. In their recent review of ethical considerations
of CAM therapies in conventional medical settings, Adams and colleagues
(9) note that a physician must be able to classify that a CAM
therapy has evidence that (1) supports safety and efficacy, (2) supports
safety but is inconclusive concerning efficacy, (3) supports efficacy but is
inconclusive concerning safety, or (4) indicates serious risk or inefficacy.
Weiger and colleagues (10) recently proposed criteria for using existing
data to provide evidence-based advice on CAM therapies to patients
with cancer. These criteria and guidelines are not disease specific and
can, in part, be used as a template for developing a guideline format that
is appropriate for counseling patients who are on CAM for CVD. Thus,
CAM therapies would be classified by, the described evidence criteria,
into four physician-response categories:
1. Recommend—The best evidence supports both efficacy and safety.
This classification requires more than three adequate quality random
clinical trials of 50 or more subjects, with 75% of trials supporting
efficacy and evidence supporting efficacy coming from more then one
clinical research team.
2. Accept; May Consider Recommending—The best evidence supports
both efficacy and safety. This requires more than one randomized clinical
trial to evaluate efficacy, with more than 50% of trials supporting
efficacy and evidence fails to meet criteria for the Recommend classification.
3. Accept—The best evidence on efficacy is inclusive, but evidence supports
safety. The evidence on efficacy is inconclusive or is inadequate
to support efficacy. The data fail to meet criteria for Recommend classification
but does not meet criteria for Discourage/Reject classification.
4. Discourage/Reject—The best evidence indicates either inefficacy or
serious risk. The criteria for this classification include more than two
adequate clinical trials of 50 or more subjects in which 67% of trials
suggest that the therapy is effective or there is evidence or a reasonable
theoretical potential that this treatment is not safe.