Compared to other products from GRAS plants, berberine is a single purified compound, and has glucose-lowering effect in vitro and in vivo. However, the drawback of using GRAS plants is the difficulty in control their quality as most of these botanical products are mixtures of multiple compounds. Certain botanical products from generally regarded as safe (GRAS) plants have been widely used in diabetes care because of their anti-oxidation, anti-inflammation, anti-obesity and anti-hyperglycemia properties. Thus, new oral medications are needed for long-term control of blood glucose in patients with type 2 diabetes. All of the existing oral hypoglycemic agents have subsequent failure after long term administration. Type 2 diabetes is a worldwide health threat and treatment of this disease is limited by availability of effective medications. In conclusion, this pilot study indicates that berberine is a potent oral hypoglycemic agent with beneficial effects on lipid metabolism. Functional liver or kidney damages were not observed for all patients. During the trial, 20 (34.5%) patients suffered from transient gastrointestinal adverse effects. Total cholesterol and low-density lipoprotein cholesterol (LDL-C) were decreased significantly as well. Fasting plasma insulin and HOMA-IR were reduced by 28.1% and 44.7% ( P<0.001), respectively. Berberine acted by lowering FBG and PBG from one week to the end of the trial. In study B, 48 adults with poorly controlled type 2 diabetes were treated supplemented with berberine in a 3-month trial. Significant decreases in hemoglobin A1c (HbA 1c from 9.5% ± 0.5% to 7.5% ± 0.4%, P<0.01), fasting blood glucose (FBG from 10.6 ± 0.9 mmol/L to 6.9 ± 0.5 mmol/L, P<0.01), postprandial blood glucose (PBG from 19.8 ± 1.7 to 11.1 ± 0.9 mmol/L, P<0.01) and plasma triglycerides (from 1.13 ± 0.13 mmol/L to 0.89 ± 0.03 mmol/L, P<0.05) were observed in the berberine group. The hypoglycemic effect of berberine was similar to that of metformin. In study A, 36 adults with newly diagnosed type 2 diabetes were randomly assigned to treatment with berberine or metformin (0.5 g t.i.d.) in a 3-month trial. This pilot study was to determine the efficacy and safety of berberine in the treatment of type 2 diabetic patients. Berberine has been shown to regulate glucose and lipid metabolism in vitro and in vivo.
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