Complementary Alternative Cardiovascular Medicine

Chapter 1 / CAM and CVD 5
The criteria for classification of a CAM therapy as safe are the absence
of documented significant adverse events associated with the CAM
therapy and the absence of an obvious theoretical model for significant
adverse events. In our judgment, these criteria are not suitable for some
cardiovascular CAM therapies, because in a CVD prevention and treatment
program, such therapies are likely to be used for an extended time
period (sometimes decades) and be used with prescribed medications
that change over time. The recent unexpected adverse events associated
with HRT indicate that large studies lasting 3 yr or longer are often
necessary to document safety. Because such studies are not presently
available for most CAM therapies described in this book (e.g., herbal,
vitamin, and nutraceutical supplements), physicians should consider
advising patients that in the absence of strong data supporting safety, we
are basing our recommendations on the studies to date that have not
demonstrated significant adverse events. However, the lack of large
studies of appropriate duration leaves the issue of safety uncertain.
A TEMPLATE FOR ASSESSING INFORMATION ON CAM
A thorough evaluation of the rapidly expanding medical literature
regarding CAM and CVD requires an assessment of the quality of the
source and the publication (print or Web), the type of study (research
design), the significance and limitations of the findings (statistics and
possible sources of bias), and relevance of the findings to patient. Groups
of investigators with quality research experience or an academic background
are often sources of high-quality studies. Respected peer-reviewed
journals represent the greatest likelihood that a critical, unbiased evaluation
of the study, the data, and the presentation has preceded publication.
Studies performed by individuals with something to gain from the outcome
(i.e., manufacturers of the product being studied) require careful
scrutiny by a peer-reviewed journal or the reader before integrating such
findings in best evidence-based analysis. Abstracts, even those that are
presented at highly respected national meetings, have only been superficially
critiqued concerning study methods, and a clinician’s assessment
of the findings presented should await peer-reviewed publication. This is
particularly difficult in the current information environment where the
findings of positive studies are often presented to the public (patients) via
television, radio, or print media within days, even hours, of presentation.
The patient may not easily accept the appropriate wait-and-see attitude.
The research study design (often referred to as the type of study) plays
a major role in determining the importance of the findings to evidencebased
medical decision making. The least valuable contributors to evi-