title: American Ginseng Extract (Panax quinquefolius L.) Is Safe in Long-Term Use in Type 2 Diabetic Patients.
abstract: Aim. The objective of the present study was to test the safety of supplementation with the American ginseng (AG) interventional material as an adjunct to conventional therapy (diet and/or medications) in type 2 diabetes, using a double-blind, randomized, placebo-controlled, parallel design. Methods. Each participant received either AG (10% ginsenosides) or placebo capsules (500 mg/meal = 3 g/day) for a period of 12 weeks. Outcomes included measures of safety including kidney function (urates and creatinine), liver function (AST and ALT), and haemostatic function (PV and INR). Results. Seventy-four participants with well-controlled type 2 diabetes (sex: 28 M and 46 F, age: 63 ± 9.5, BMI: 32 ± 5, and HbA1c: 7 ± 1.3), randomized to either intervention (n = 35) or control (n = 39) group, completed the study. There was no change in any of the measures of safety between treatments from baseline. The number or severity of adverse events did not differ between the AG intervention and placebo. Conclusion. Following 12 weeks of supplementation with AG, safety was not compromised in a high cardiovascular disease (CVD) risk population of patients with type 2 diabetes. This demonstrated that safety is noteworthy, as reviews have continuously warned of possible adverse effects of ginseng consumption.
authors.affiliation: Centre for Applied Pharmacy, Faculty of Pharmacy and Biochemistry, University of Zagreb, 10 000 Zagreb, Croatia.
authors.forename: Iva
authors.initials: I
authors.lastname: Mucalo
authors.affiliation: Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital, Li Ka Shing Knowledge Institute, Toronto, ON, Canada M5C 2T2.
authors.forename: Elena
authors.initials: E
authors.lastname: Jovanovski
authors.affiliation: Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital, Li Ka Shing Knowledge Institute, Toronto, ON, Canada M5C 2T2 ; Departments of Nutritional Sciences and Medicine, Faculty of Medicine, University of Toronto, Toronto, ON, Canada M5S 3E2.
authors.forename: Vladimir
authors.initials: V
authors.lastname: Vuksan
authors.affiliation: Department of Endocrinology, Diabetes and Metabolic Disease, Dubrava University Hospital, University of Zagreb, 10 000 Zagreb, Croatia.
authors.forename: Velimir
authors.initials: V
authors.lastname: Božikov
authors.affiliation: Clinical Department of Laboratory Diagnostics, Dubrava University Hospital, University of Zagreb, 10 000 Zagreb, Croatia.
authors.forename: Zeljko
authors.initials: Z
authors.lastname: Romić
authors.affiliation: Department of Endocrinology, Diabetes and Metabolic Disease, Dubrava University Hospital, University of Zagreb, 10 000 Zagreb, Croatia.
authors.forename: Dario
authors.initials: D
authors.lastname: Rahelić