ⓒ The Korean Society of Ginseng 264 http://ginsengres.org pISSN: 1226-8453 eISSN: 2093-4947 Review J. Ginseng Res. Vol. 34, No. 4, 264-273 (2010) DOI:10.5142/jgr.2010.34.4.264 E-mail: v.vuksan@utoronto.ca Tel: +1-416-864-5525, Fax: +1-416-864-5538 * Corresponding author INTRODUCTION Cardiovascular disease (CVD) is the leading cause of mortality in industrialized nations. Likewise, diabetes, a major risk factor in CVD, is escalating to pandemic proportions. From 1995 to 2025 the prevalence of adult diabetes was predicted to increase by 27% in developed countries and 48% in developing countries [1]. Despite numerous preventative strategies and the grow- ing armamentarium of medications available, the preva- lence of impaired glucose tolerance, diabetes and its associated vascular complications continue to grow. Al- though oral anti-hyperglycemic agents have been shown to reduce microvascular complications, they have failed to deliver the anticipated macrovascular benefts in peo- ple with diabetes [2-6]. A meta-analysis showed that the insulin senitizer, rosiglitazone, although effective at im- proving glycemic control, as assed by HbA1c, increased the risk of cardiovascular mortality by 40% in type 2 diabetes, a group already predisposed to increased pre- mature cardiovascular death [5]. Three landmark clinical trials also recently demonstrated that intensive glyce- mic control by oral agents or insulin was of no beneft [3,6] or even increased all cause mortality by 22% and cardiovascular mortality by 35% in people with poorly controlled type 2 diabetes [2]. These data indicate a clear and present need for more effective treatment strategies. Evidence is emerging to support ginseng as a new ap- proach to treat diabetes and its vascular complications. Prior to 2000, there was only a small group of flawed and poorly reported studies in humans to support the antidiabetic efficacy of ginseng [7]. The limited data prompted us to conduct a series of human trials to ad- dress systematically whether the glycemic lowering Current Clinical Evidence for Korean Red Ginseng in Management of Diabetes and Vascular Disease: A Toronto’s Ginseng Clinical Testing Program Vladimir Vuksan 1,2* , John Sievenpipper 1,2 , Elena Jovanovski 1,2 , and Alexandra L. Jenkins 1,2 1 Clinical Nutrition Risk Factor Modifcation Center, St. Michael’s Hospital, Toronto, ON, Canada 2 Departments of Nutritional Sciences and Medicine, Faculty of Medicine, University of Toronto, Toronto, ON, Canada While ginseng is reported to have a wide array of applications, there is growing evidence for its indications in diabetes and vascular disease. A clear connection, however, has not been established between ginseng’s composition, dose and its targeted effcacy in humans. We therefore developed and initiated the Korean Red Ginseng Clinical Testing Program for diabetes and vascular function which is an effcacy and safety-based clinical screening model for ginseng. The most effcacious sources, ginsenoside profles, doses, and modes of administration were examined in sequential, acute, followed by long term, random- acute, followed by long term, random- , followed by long term, random- ized-controlled trials to investigate the effcacy and safety profles. This review discusses the current state of the clinical re- This review discusses the current state of the clinical re- discusses the current state of the clinical re- search of Korean red ginseng program conducted in Toronto, paving the way for the use of clinically selected ginseng and its ginsenoside fractions in the management of diabetes and vascular diseases. Keywords: Korean red ginseng, Ginsenoside extract, Randomized controlled trial, Glycemic control, Vascular disease This is an Open Access article distributed under the terms of the Cre- ative Commons Attribution Non-Commercial License (http://creativecom- mons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. Received 30 Nov. 2010, Revised 14 Dec. 2010, Accepted 16 Dec. 2010