Integrative medicine refers to ongoing efforts to combine the best of conventional and evidence-based complementary therapies while emphasizing the primacy of the patient-provider relationship and the importance of patient participation in health promotion, disease prevention, and medical management. “It (integrative medicine) views patients as whole people with minds and spirits as well as bodies and includes these dimensions into diagnosis and treatment” (8). In the January 2001 British Medical Journal edition devoted entirely to integrated medicine, the Journal’s editor, Richard Smith, wrote: “It mightn’t be too pretentious (although it might) to say that such a growth (of integrative medicine) might restore the soul to medicine—the soul being that part of us that is the most important but the least easy to delineate” (9). A variety of articles and editorials have wrestled with the challenges of properly labeling and describing this field of inquiry (8;10-16).
The Dietary Supplement Health and Education Act (DSHEA) defines dietary supplements as products (other than tobacco) intended to supplement the diet that bear or contain one or more of the following dietary ingredients: a vitamin, mineral, amino acid, herb or other botanical; or a dietary substance for use to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any ingredient described above; and intended for ingestion in the form of a capsule, powder, soft gel, or gelcap, and not represented as a conventional food or as a sole item of a meal or the diet. The DSHEA legislation stipulates that botanicals and other dietary supplements are not “drugs” and, as such, are not held to the same regulatory requirements as drugs (i.e., prerequisite evidence of both safety and efficacy). Manufacturers of dietary supplements are not allowed to make “disease claims” but are permitted to make “structure/function” claims. This has resulted in a range of interpretations and has complicated both clinical decision making and efforts to perform scientific research involving botanicals (17;18).