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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

BACKGROUND AND AIM

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.

METHODS AND 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.

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  • Authors+Show Affiliations

    ,

    Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Canada. v.vuksan@utoronto.ca

    , , , , , , , , , ,

    Source

    MeSH

    Administration, Oral
    Aged
    Blood Glucose
    Cross-Over Studies
    Diabetes Mellitus, Type 2
    Double-Blind Method
    Drug Therapy, Combination
    Drugs, Chinese Herbal
    Female
    Glycated Hemoglobin A
    Humans
    Hypoglycemic Agents
    Insulin
    Male
    Middle Aged
    Panax
    Patient Compliance
    Plant Roots
    Time Factors
    Treatment Outcome

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    16860976

    Citation

    Vuksan, Vladimir, et al. "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." Nutrition, Metabolism, and Cardiovascular Diseases : NMCD, vol. 18, no. 1, 2008, pp. 46-56.
    Vuksan V, Sung MK, Sievenpiper JL, et al. 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. Nutr Metab Cardiovasc Dis. 2008;18(1):46-56.
    Vuksan, V., Sung, M. K., Sievenpiper, J. L., Stavro, P. M., Jenkins, A. L., Di Buono, M., ... Naeem, A. (2008). 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. Nutrition, Metabolism, and Cardiovascular Diseases : NMCD, 18(1), pp. 46-56.
    Vuksan V, et al. 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. Nutr Metab Cardiovasc Dis. 2008;18(1):46-56. PubMed PMID: 16860976.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - 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. AU - Vuksan,Vladimir, AU - Sung,Mi-Kyung, AU - Sievenpiper,John L, AU - Stavro,P Mark, AU - Jenkins,Alexandra L, AU - Di Buono,Marco, AU - Lee,Kwang-Seung, AU - Leiter,Lawrence A, AU - Nam,Ki Yeul, AU - Arnason,John T, AU - Choi,Melody, AU - Naeem,Asima, Y1 - 2006/07/24/ PY - 2006/01/10/received PY - 2006/04/18/revised PY - 2006/04/19/accepted PY - 2006/7/25/pubmed PY - 2008/1/25/medline PY - 2006/7/25/entrez SP - 46 EP - 56 JF - Nutrition, metabolism, and cardiovascular diseases : NMCD JO - Nutr Metab Cardiovasc Dis VL - 18 IS - 1 N2 - BACKGROUND AND AIM: 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. METHODS AND 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. SN - 1590-3729 UR - https://www.unboundmedicine.com/medline/citation/16860976/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0939-4753(06)00109-8 DB - PRIME DP - Unbound Medicine ER -