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 HbA1c 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 HbA1c >0.5%.

Results: In the intention-to-treat analysis, ginsam treatment reduced HbA1c 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 HbA1c 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 HbA1c 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).

Keywords: Ginsam; Oral antidiabetic therapy; Panax ginseng.

Figure 1

Flow chart of enrolment of the study subjects.

Figure 2

Changes of HbA_1c level, and fasting and postload glucose concentration and percentage of patients whose HbA_1c decreased by >0.5% during 8 weeks of treatment with ginsam.

Figure 3

Correlations between the changes of HbA_1c and the changes of tumor necrosis factor‐α (TNF‐α) or interleukin‐6 (IL‐6) levels. The changes of HbA_1c were positively and significantly correlated with changes of TNF‐α and IL‐6.