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


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).
Internal Medicine, Seoul National University College of Medicine ; Internal Medicine, Healthcare Research Institute, Seoul National University Hospital Healthcare System Gangnam Center, Seoul.
Ji Won
JW
Yoon
Internal Medicine, Seoul National University College of Medicine ; Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Seon Mee
SM
Kang
General Medicine Division, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
Jason L
JL
Vassy
Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Hayley
H
Shin
Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Yun Hee
YH
Lee
Internal Medicine, Seoul National University College of Medicine ; Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Hwa Young
HY
Ahn
Internal Medicine, Seoul National University College of Medicine ; Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Sung Hee
SH
Choi
Internal Medicine, Seoul National University College of Medicine.
Kyong Soo
KS
Park
Internal Medicine, Seoul National University College of Medicine ; Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Hak Chul
HC
Jang
Internal Medicine, Seoul National University College of Medicine ; Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Soo
S
Lim
Ginsam; Oral antidiabetic therapy; Panax ginseng