Efficacy and safety of Korean red ginseng as adjunctive therapy in type 2 diabetes mellitus: a 12-week randomized, double-blind, placebo-controlled trial.

BACKGROUND

Korean Red Ginseng (KRG) has been investigated as adjunctive therapy for type 2 diabetes mellitus (T2DM), but randomized controlled evidence evaluating metabolic efficacy and short-term safety in patients receiving stable oral antidiabetic therapy remains limited.

METHODS

In this 12-week randomized, double-blind, placebo-controlled trial, 70 adults with well-controlled T2DM receiving stable oral antidiabetic medications were assigned to KRG (2 g/day) or placebo. Outcomes included oral glucose tolerance test (OGTT)-derived insulin, C-peptide, and glucagon responses, insulin sensitivity indices, fasting plasma glucose (FPG), HbA1c, oxidative stress markers, antioxidant capacity, lipid profiles, and renal and hepatic safety parameters. Between-group comparisons used baseline-adjusted ANCOVA with Benjamini-Hochberg false discovery rate correction; efficacy analyses included participants with post-baseline data (n = 65).

RESULTS

Compared with placebo, KRG was associated with lower 120-min OGTT insulin (adjusted mean difference -6.992, 95% CI -14.205 to -0.222; p = 0.047) and higher ISI(0-120) (5.400, 0.972 to 9.829; p = 0.018). KRG was also associated with lower oxidized low-density lipoprotein (-5.645, -10.054 to -1.238; p = 0.013), malondialdehyde (-0.571, -1.090 to -0.053; p = 0.031), total cholesterol (-12.633, -24.752 to -0.515; p = 0.041), and low-density lipoprotein cholesterol (-10.171, -18.130 to -2.211; p = 0.013). FPG, 2-h glucose, and HbA1c did not differ significantly between groups. No hypoglycemic events occurred, and renal and hepatic safety markers remained stable.

CONCLUSIONS

KRG was well tolerated and associated with favorable effects on selected indices of postprandial insulin sensitivity, lipid peroxidation markers, and lipid profile in this well-controlled T2DM population. Its short-term metabolic effects may be more apparent in post-load insulin dynamics than in conventional glycemic markers.