AYURVEDIC HERBALS: EFFECTS ON LIPIDS & ATHEROSCLEROSIS

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Dr. Philippe Szapary plans a career as a clinician investigator at the University of Pennsylvania School of Medicine, focusing his research on the critical evaluation of complementary and alternative medicine (CAM). His training will include formal course work towards a Master's of Science in Clinical Epidemiology with a specific focus on patient-oriented research (POR). To supplement his formal research training, he also plans to take courses in pharmacognosy and ethnobotany at the University of the Sciences in Philadelphia (USP). Using his formal training in POR and botanical pharmacology, Dr. Szapary plans to establish himself as an independent investigator focusing on new and existing cardiovascular CAM therapies. Environment: The University of Pennsylvania and nearby USP are uniquely suited to provide complementary training and resources for this award. At Penn, the Center for Clinical Epidemiology and Biostatistics will provide the formal POR research training. The Cardiovascular Risk Intervention Program and the Division of General Internal Medicine will provide study subjects. The General Clinical Research Center will provide ancillary support including nurses, a dietitian, a biostatistical programmer and laboratory services. At USP, the Department of Pharmacognosy will provide technical support in the analysis of study drugs. Research: In the last 10 years, patients have markedly increased their use of dietary supplements to treat and prevent chronic medical conditions like atherosclerotic cardiovascular disease. This widespread use continues despite little scientific evidence of benefit from randomized controlled trials (RCTs). Current estimates suggest that 30 percent of Americans are hypercholesterolemic. Serum cholesterol remains one of the strongest predictors of risk for coronary artery disease, the leading cause of death in Americans. Herbal therapies have multiple mechanisms of action making them attractive in the prevention of a multifactorial disease process like atherosclerosis. Two Ayurvedic herbals, gugulipid and curcuminoids, appear to have hypolipidemic, antioxidant and anti- inflammatory effects in humans. In this protocol, Dr. Szapary will primarily study the hypolipidemic effects of standardized extracts of curcuminoids and gugulipid in two RCTs. These trials will assess the safety and efficacy of these two agents when used alone and in combination, as done in Ayurvedic medicine, over a 3 to 6 month period. In addition, Dr. Szapary will examine their effects on state of the art biomarkers of oxidant stress and vascular micro-inflammation, both of which are important processes in the pathogenesis of atherosclerosis. These studies will help define the role of these herbal therapies in the prevention of atherosclerosis, and serve as a model for the critical evaluation of dietary supplements in cardiovascular disease.