Efficacy and safety of ginsam, a vinegar extract from Panax ginseng, in type 2 diabetic patients: Results of a double‐blind, placebo‐controlled study

Abstract Aims/Introduction: The efficacy, dose–response relationship and safety of ginsam, a vinegar extract from Panax ginseng , were evaluated in an 8‐week, double‐blind, randomized, placebo‐controlled study in drug‐naïve patients with type 2 diabetes. Materials and Methods: A total of 72 diabetic patients were randomized to receive 1500, 2000 or 3000 mg of ginsam, or placebo daily for 8 weeks ( n = 18 in each group). The primary end‐point was the changes from the baseline HbA 1c level. The secondary end‐points were the changes of fasting and postprandial 2‐h glucose concentration, and the proportion of patients achieving a reduction in HbA 1c >0.5%. Results: In the intention‐to‐treat analysis, ginsam treatment reduced HbA 1c level significantly: −0.56 ± 0.25% in the 1500 mg group, −0.31 ± 0.12% in the 2000 mg group, and −0.29 ± 0.11% in the 3000 mg group (all P < 0.05), with a significant difference between the 1500 mg ginsam and the placebo group (−0.02 ± 0.12%, P = 0.021). The changes in fasting glucose concentration followed the same pattern: −21.40, −14.27 and −6.76 mg/dL for 1500, 2000, and 3000 mg, respectively, vs −2.25 mg/dL for the placebo. The percentage of patients whose HbA 1c level decreased by >0.5% differed significantly between the placebo group (11.1%) and the 1500 mg (27.8%) and 2000 mg (27.8%) groups. No severe adverse events were observed in any group. Conclusions: An 8‐week treatment with ginsam, a vinegar extract from P. ginseng , moderately improved HbA 1c level and was well tolerated in type 2 diabetic patients with inadequate glycemic control. This trial was registered with ClinicalTrial.Gov (no. NCT01008163). (J Diabetes Invest, doi: 10.1111/j.2040‐1124.2011.00185.x, 2011)