Effect of an aqueous extract ofTerminalia chebulaon endothelial dysfunction, systemic inflammation, and lipid profile in type 2 diabetes mellitus: A randomized double-blind, placebo-controlled clinical study

摘要

Endothelial dysfunction is a crucial complication in type 2 diabetic patients, related to cardiovascular risk.Terminalia chebula(TC), a traditional ayurvedic herb, is known for its antioxidant and antihyperlipidemic activity. A prospective, randomized, double-blind, placebo-controlled clinical study was undertaken to evaluate the effects of an aqueous extract ofT. chebula250 and 500 mg versus placebo on endothelial dysfunction and biomarkers of oxidative stress in type 2 diabetic patients. A total of 60 eligible patients were randomized to receive eitherT. chebula250 mg,T. chebula500 mg, or placebo twice daily for 12 weeks. The subjects were assessed based on the endothelial function, the levels of nitric oxide, malondialdehyde, glutathione, high sensitivity C-reactive protein, glycosylated hemoglobin, and lipid profile at baseline and after 12 weeks of treatment. Treatment withT. chebula250 mg andT. chebula500 mg for 12 weeks significantly improved the endothelial function (reflection index) compared to placebo (absolute changes: -T. chebula250: -2.55 +/- 1.82% vs.T. chebula500: -5.21 +/- 2.41% vs. placebo: 1.40 +/- 2.11%). Other cardiovascular risk indicators were also significantly ameliorated in the treatment groups compared to placebo. In conclusion,T. chebula(especially, 500 mg BID dose) significantly minimized the cardiovascular risk factors in patients with type 2 diabetes compared to placebo.