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Shanghai Clinical Center for Endocrine and Metabolic Diseases and Division of Endocrine and Metabolic Diseases (Y.Z., X.L., N.Z., L.H., J.H., G.N.), E-Institutes, Shanghai Universities, Rui-Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, Peoples Republic of China; Department of Endocrinology (D.Z., M.W.), Chang-Hai Hospital, the Second Military Medical University, Shanghai 200433, Peoples Republic of China; Department of Endocrinology (W.L., P.W.), Ren-Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200127, Peoples Republic of China; and Department of Endocrinology (J.Y., G.R.), Min-Hang Hospital, Shanghai 201100, Peoples Republic of China
Address all correspondence and requests for reprints to: Guang Ning, M.D., Ph.D., Shanghai Clinical Center for Endocrine and Metabolic Diseases, Shanghai Institute of Endocrinology and Metabolism, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 RuiJin 2nd Road, Shanghai 200025, Peoples Republic of China. E-mail: guangning{at}medmail.com.cn.
Context: Berberine, a natural plant alkaloid, is usually used as an antibiotic drug. The potential glucose-lowering effect of berberine was noted when it was used for diarrhea in diabetic patients. In vitro and in vivo studies have then showed its effects on hyperglycemia and dyslipidemia.
Objective: The objective of the study was to evaluate the efficacy and safety of berberine in the treatment of type 2 diabetic patients with dyslipidemia.
Design: One hundred sixteen patients with type 2 diabetes and dyslipidemia were randomly allocated to receive berberine (1.0 g daily) and the placebo for 3 months. The primary outcomes were changes in plasma glucose and serum lipid concentrations. Glucose disposal rate (GDR) was measured using a hyperinsulinemic euglycemic clamp to assess insulin sensitivity.
Results: In the berberine group, fasting and postload plasma glucose decreased from 7.0 ± 0.8 to 5.6 ± 0.9 and from 12.0 ± 2.7 to 8.9 ± 2.8 mM/liter, HbA1c from 7.5 ± 1.0% to 6.6 ± 0.7%, triglyceride from 2.51 ± 2.04 to 1.61 ± 1.10 mM/liter, total cholesterol from 5.31 ± 0.98 to 4.35 ± 0.96 mM/liter, and low-density lipoprotein-cholesterol from 3.23 ± 0.81 to 2.55 ± 0.77 mM/liter, with all parameters differing from placebo significantly (P < 0.0001, P < 0.0001, P < 0.0001, P = 0.001, P < 0.0001, and P <0.0001, respectively). The glucose disposal rate was increased after berberine treatment (P = 0.037), although no significant change was found between berberine and placebo groups (P = 0.063). Mild to moderate constipation was observed in five participants in the berberine group.
Conclusions: Berberine is effective and safe in the treatment of type 2 diabetes and dyslipidemia.
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