Approaches to investigating natural products and botanicals used in alternative medicine

Research on complementary and alternative medicine (CAM), and in particular herbal medicine, is associated with unique challenges. Research methods designed to address these challenges provide a unifying theme for the diverse topics that form the body of this work. This thesis is organized into chapters each focused on a different aspect of natural products used in alternative medicine. The research reports include: (1) A critical evaluation of comfrey research aimed at determining its safety and efficacy. This literature review demonstrates that the comfrey ban is not supported by research reports when these reports are evaluated from a CAM perspective. (2) A clinical trial using a low molecular weight pectin (PectaSol). In this small trial with healthy individuals, PectaSol increased the urinary excretion of arsenic and cadmium (p < 0.05) and lead and mercury (p < 0.1) suggesting a possible role for low molecular weight pectin in the treatment of heavy metal poisoning. (3) The development of a stress induced luteal phase defect ovine model for testing vitex (a botanical used to treat menstrual disorders). Using identical endotoxin administration regimes as the stressor Finnish Landrace ewes were more susceptible to luteal phase defects (characterized by low ovulation and low luteal phase progesterone) than Targhee ewes. In addition, a biphasic pattern of prolactin release in response to endotoxin was observed. (4) The development of a pituitary cell culture assay to characterize the activity of vitex and other botanicals. This assay was used to determine that there was high variability between commercial vitex extracts, complete extraction as a tincture is accomplished within an hour, and that the lipophilic fraction of tinctures has greater activity than the hydrophilic fraction. In addition, of sixteen herbs screened using the bioassay two herbs demonstrated activity: Dicentra formosa displayed prolactin inhibition, while Dioscorea villosa stimulated the release of prolactin. Taken together, these diverse studies provide examples of research approaches that provide meaningful results in the field of CAM.