![]() All participants received written and oral information regarding the natural and potential risks of the study and gave their informed consent. Thus, 84 subjects (49 women and 35 men) with type 2 diabetes were included in the study. Ninety-seven Chinese volunteers were screened, and 13 subjects were excluded from the study due to failure to meet the recruitment criteria. The subjects were recruited from diabetes outpatient department of Xinhua Hospital by advertising in the clinic. HbA1c, blood glucose and HOMA index were used to determine the efficacy of berberine. Berberine was given to both newly diagnosed diabetic patients and poorly controlled diabetic patients alone or combination with other hypoglycemic agents for three months. This pilot study was to assess the efficacy of berberine in human subjects with type 2 diabetes. Hence, if the efficacy and safety of berberine are confirmed, it can serve as a new class of anti-diabetic medication. The chemical structure of Berberine and related isoquinoline alkaloids are quite different from the commonly used other hypoglycemic agents, such as sulphonylureas, biguanides, thiazolidinediones, or acarbose. nH2O) - the most popular form of berberine, is used in this pilot study.Berberine is an Over-the-Counter (OTC) drug, which is used to treat gastrointestinal infections in China. īerberine (molecular formula C 20H 19NO 5 and molecular weight of 353.36) is the main active component of an ancient Chinese herb Coptis chinensis French, which has been used to treat diabetes for thousands of years. 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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