![]() Issues surrounding CAM are complex indeed, even defining CAM can be difficult. These considerations are germane to discussions underway in Canada and the United States about the best ways to evaluate complementary or alternative medicine (CAM). A therapy is sufficiently scientifically plausible to merit the time and expense of definitive testing if it is either biologically or clinically plausible. Clinical data from epidemiological studies, case reports, case series and small, formal open or controlled clinical trials may confer clinical plausibility. This preliminary research may be termed “plausibility building.” When biochemical, tissue and animal data point to a mechanism of action or demonstrate the desired biological effect, they thereby confer biological plausibility. 1 Only sufficiently promising therapies merit the effort and expense of final confirmation (or refutation) with large, definitive RCTs. Before the definitive RCT, there is usually a lengthy process of information gathering to rule out toxicity, optimize the parameters of the treatment and determine the clinical importance of its apparent effect. It is not always appreciated that such high-cost, definitive RCTs come near the end, not the beginning, of the process of evaluating new therapies. There is a trend toward seriously crediting only RCTs with large numbers of participants, and this calls for a complex study design and infrastructure. ![]() It is not sufficient for the RCT to demonstrate a statistically and clinically significant effect it must also be designed, and its results analyzed, in accordance with rigorous criteria set by clinical trial authorities. ![]() Proof that a treatment is efficacious typically requires at least one definitive RCT or several convincing ones. Everyone familiar with scientific medicine understands the importance of the randomized controlled trial (RCT), because it is the gold standard for evaluating treatment efficacy. ![]()
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