title: Natural health products and drug disposition.
abstract: Botanicals such as herbal products (HPs) and nutraceuticals (NCs) are often regarded as low risk because of their long history of human use. Anecdotal and literature reports of adverse drug events (ADEs) and clinical studies with HPs are increasing, but many of the reports are incomplete and contradictory. These reports need to identify confounding factors and explain contradictory findings if they are to help health care professionals or patients understand what risks are involved. HPs are complex botanicals, not single-active ingredient (SAI) products. Studies can be confounded by different manufacturing processes and formulations, including cosmetics and food supplements; environment; chemotypes; misidentification or adulteration; and factors associated with the patient or user population such as use, total drug load, and genetics. Future studies need to be conducted with characterized product that includes all commercially available related products. Clinical trials should be relevant to the user population and take into account the confounding factors that may influence the interpretation of the findings.
authors.affiliation: Therapeutic Products Directorate, Health Canada, Holland Cross 3102C3, Ottawa, Ontario, Canada, K1A 1B6. brian_foster@hc-sc.gc.ca
authors.forename: Brian C
authors.initials: BC
authors.lastname: Foster
authors.forename: J Thor
authors.initials: JT
authors.lastname: Arnason
authors.forename: Colin J
authors.initials: CJ
authors.lastname: Briggs
mesh_terms: D000818:Animals; D001688:Biological Products / Q000737:chemistry / Q000592:standards / Q000627:therapeutic use; D006293:Health Promotion; D006801:Humans; D008517:Phytotherapy / Q000379:methods* / Q000592:standards; D028321:Plant Preparations / Q000737:chemistry / Q000592:standards / Q000627:therapeutic use*
chemical_list: D001688:Biological Products; D028321:Plant Preparations