title: Korean red ginseng (Panax ginseng) improves glucose and insulin regulation in well-controlled, type 2 diabetes: results of a randomized, double-blind, placebo-controlled study of efficacy and safety.
abstract: OBJECTIVE
  To address the paucity of randomized clinical studies assessing ginseng on long-term outcomes in type 2 diabetes, we assessed the clinical antidiabetic efficacy and safety of 12 weeks of supplementation with a Korean red ginseng (KRG) preparation, dose, and mode of administration, selected from an acute, clinical, screening model.
  
  
  RESULTS
  Nineteen participants with well-controlled type 2 diabetes (sex: 11 M:8 F, age: 64+/-2 years, BMI: 28.9+/-1.4 kg/m(2), HbA(1c): 6.5%) completed the study. Using a double-blind, randomized, crossover design, each participant received the selected KRG preparation (rootlets) and placebo at the selected dose (2 g/meal=6 g/day) and mode of administration (preprandial oral agent [-40 min]) for 12 weeks as an adjunct to their usual anti-diabetic therapy (diet and/or medications). Outcomes included measures of efficacy (HbA1c and fasting- and 75-g oral glucose tolerance test [OGTT]-plasma glucose [PG], plasma insulin [PI], and insulin sensitivity index [ISI] indices); safety (liver, kidney, haemostatic, and blood-pressure function); and compliance (returned capsules, diet-records, and body-weight). There was no change in the primary endpoint, HbA(1c). The participants, however, remained well-controlled (HbA1c=6.5%) throughout. The selected KRG treatment also decreased 75 g-OGTT-PG indices by 8-11% and fasting-PI and 75 g-OGTT-PI indices by 33-38% and increased fasting-ISI (homeostasis model assessment [HOMA]) and 75 g-OGTT-ISI by 33%, compared with placebo (P<0.05). Safety and compliance outcomes remained unchanged.
  
  
  CONCLUSIONS
  Although clinical efficacy, as assessed by HbA1c, was not demonstrated, 12 weeks of supplementation with the selected KRG treatment maintained good glycemic control and improved PG and PI regulation safely beyond usual therapy in people with well-controlled type 2 diabetes. Further investigation with similarly selected KRG treatments may yield clinical efficacy.
authors.affiliation: Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Canada. v.vuksan@utoronto.ca
authors.forename: Vladimir
authors.initials: V
authors.lastname: Vuksan
authors.forename: Mi-Kyung
authors.initials: MK
authors.lastname: Sung
authors.forename: John L
authors.initials: JL
authors.lastname: Sievenpiper
authors.forename: P Mark
authors.initials: PM
authors.lastname: Stavro
authors.forename: Alexandra L
authors.initials: AL
authors.lastname: Jenkins
authors.forename: Marco
authors.initials: M
authors.lastname: Di Buono
authors.forename: Kwang-Seung
authors.initials: KS
authors.lastname: Lee
authors.forename: Lawrence A
authors.initials: LA
authors.lastname: Leiter
authors.forename: Ki Yeul
authors.initials: KY
authors.lastname: Nam
authors.forename: John T
authors.initials: JT
authors.lastname: Arnason
authors.forename: Melody
authors.initials: M
authors.lastname: Choi
authors.forename: Asima
authors.initials: A
authors.lastname: Naeem
mesh_terms: D000284:Administration, Oral; D000368:Aged; D001786:Blood Glucose / Q000187:drug effects*; D018592:Cross-Over Studies; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007328:Insulin / Q000097:blood*; D008297:Male; D008875:Middle Aged; D005894:Panax; D010349:Patient Compliance; D018517:Plant Roots; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D004365:Drugs, Chinese Herbal; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; C517652:hemoglobin A1c protein, human