Preliminary study about the possible glycemic clinical advantage in using a fixed combination of Berberis aristata and Silybum marianum standardized extracts versus only Berberis aristata in patients with type 2 diabetes

Clinical Pharmacology: Advances and Applications

Volumn 5, Issue , 2013, Pages 167-174

  Di Pierro, Francesco ^a   Putignano, Pietro ^b   Villanova, Nicola ^c   Montesi, Luca ^c   Moscatiello, Simona ^c   Marchesini, Giulio ^c  

^a Velleja Research   (Italy)

^b SAN GERARDO HOSPITAL   (Italy)

^c UNIVERSITY OF BOLOGNA   (Italy)

Author keywords

Berberol ; Cholesterol; Glycosylated hemoglobin; P glycoprotein; Triglycerides

Indexed keywords

BERBERINE; BERBEROL; CHOLESTEROL; GLUCOSE; GLYCOSYLATED HEMOGLOBIN; LIVER ENZYME; LOW DENSITY LIPOPROTEIN; SILYMARIN; TRIACYLGLYCEROL; UNCLASSIFIED DRUG;

ABDOMINAL DISCOMFORT; ADULT; AGED; ANTIDIABETIC ACTIVITY; ARTICLE; CALORIC INTAKE; CHOLESTEROL BLOOD LEVEL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; ENZYME BLOOD LEVEL; FEMALE; GLYCEMIC CONTROL; HEMOGLOBIN BLOOD LEVEL; HUMAN; HUMAN CELL; LIPOPROTEIN BLOOD LEVEL; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; NON INSULIN DEPENDENT DIABETES MELLITUS; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; TRIACYLGLYCEROL BLOOD LEVEL;

EID: 84887887852     PISSN: None     EISSN: 11791438     Source Type: Journal    
DOI: 10.2147/CPAA.S54308     Document Type: Article

References (40)

1. Ginter E, Simko V. Type 2 diabetes mellitus, pandemic in 21st century. Adv Exp Med Biol. 2012;771:42-50.
2. Ho J, Leung AK, Rabi D. Hypoglycemic agents in the management of type 2 diabetes mellitus. Recent Pat Endocr Metab Immune Drug Discov. 2011;5(1):66-73.
3. El-Kaissi S, Sherbeeni S. Pharmacological management of type 2 diabetes mellitus: an update. Curr Diabetes Rev. 2011;7(6):392-405.
4. Hoffmann IS, Roa M, Torrico F, Cubeddu LX. Ondansetron and metformin-induced gastrointestinal side effects. Am J Ther. 2003;10(6):447-451.
5. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007;356(24):2457-2471.
6. Tang LQ, Wei W, Chen LM, Liu S. Effects of berberine on diabetes induced by alloxan and a high-fat/high-cholesterol diet in rats. J Ethnopharmacol. 2006;108(1):109-115.
7. Zhang Y, Li X, Zou D, et al. Treatment of type 2 diabetes and dyslipidemia with the natural plant alkaloid berberine. J Clin Endocrinol Metab. 2008;93(7):2559-2565.
8. Yin J, Xing H, Ye J. Efficacy of berberine in patients with type 2 diabetes mellitus. Metabolism. 2008;57(5):712-717.
9. Zhang H, Wei J, Xue R, et al. Berberine lowers blood glucose in type 2 diabetes mellitus patients through increasing insulin receptor expression. Metabolism. 2010;59(2):285-292.
10. Dong H, Zhao Y, Zhao L, Lu F. The effects of berberine on blood lipids: a systemic review and meta-analysis of randomized controlled trials. Planta Med. 2013;79(6):437-446.
11. Dong H, Wang N, Zhao L, Lu F. Berberine in the treatment of type 2 diabetes mellitus: a systemic review and meta-analysis. Evid Based Complement Alternat Med. 2012;2012:591-654.
12. Derosa G, Maffioli P, Cicero AF. Berberine on metabolic and cardiovascular risk factors: an analysis from preclinical evidences to clinical trials. Expert Opin Biol Ther. 2012;12(8):1113-1124.
13. Zhang Q, Xiao X, Feng K, Wang T, Li W, Yuan T, Sun X, Sun Q, Xiang H, Wang H. Berberine Moderates Glucose and Lipid Metabolism through Multipathway Mechanism. Evid Based Complement Alternat Med. 2011;2011.
14. Yin J, Zhang H, Ye J. Traditional chinese medicine in treatment of metabolic syndrome. Endocr Metab Immune Disord Drug Targets. 2008;8(2):99-111.
15. Kong W, Wei J, Abidi P, et al. Berberine is a novel cholesterol-lowering drug working through a unique mechanism distinct from statins. Nat Med. 2004;10(12):1344-1351.
16. Hu Y, Davies GE. Berberine inhibits adipogenesis in high-fat diet-induced obesity mice. Fitoterapia. 2010;81(5):358-366.
17. Singh IP, Mahajan S. Berberine and its derivatives: a patent review (2009 - 2012). Expert Opin Ther Pat. 2013;23(2):215-231.
18. Chen W, Miao YQ, Fan DJ, et al. Bioavailability study of berberine and the enhancing effects of TPGS on intestinal absorption in rats. AAPS PharmSciTech. 2011;12(2):705-711.
19. Pan GY, Wang GJ, Liu XD, Fawcett JP, Xie YY. The involvement of P-glycoprotein in berberine absorption. Pharmacol Toxicol. 2002;91(4): 193-197.
20. Tsai PL, Tsai TH: Hepatobiliary excretion of berberine. Drug Metab Dispos. 2004;32(4):405-412.
21. Chae HW, Kim IW, Jin HE, Kim DD, Chung SJ, Shim CK. Effect of ion-pair formation with bile salts on the in vitro cellular transport of berberine. Arch Pharm Res. 2008;31(1):103-110.
22. Shan YQ, Ren G, Wang YX, et al. Berberine analogue IMB-Y53 improves glucose-lowering efficacy by averting cellular efflux especially P-glycoprotein efflux. Metabolism. 2013;62(3):446-456.
23. Zhou S, Lim LY, Chowbay B. Herbal modulation of P-glycoprotein. Drug Metab Rev. 2004;36(1):57-104.
24. World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. J Postgrad Med. 2002;48(3):206-208.
25. Atchley AE, Kitzman DW, Whellan DJ, et al. HF-ACTION Investigators. Myocardial perfusion, function, and dyssynchrony in patients with heart failure: baseline results from the single-photon emission computed tomography imaging ancillary study of the Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing (HF-ACTION) Trial. Am Heart J. 2009;158(4 Suppl):S53-S63.
26. NCEP. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation 2002;106(25):3143-4216.
27. Winer BJ. Statistical Principles in Experimental Design. 2nd edition, McGraw-Hill, New York, NY, USA, 1971.
28. Di Pierro F, Villanova N, Agostini F, Marzocchi R, Soverini V, Marchesini G. Pilot study on the additive effects of berberine and oral type 2 diabetes agents for patients with suboptimal glycemic control. Diabetes Metab Syndr Obes. 2012;5:213-217.
29. Orio F, Muscogiuri G, Palomba S, et al. Berberine improves reproductive features in obese Caucasian women with polycystic ovary syndrome independently of changes of insulin sensitivity. European J Clin Nutr. 2013;8(5):e200-e204.
30. Hu Y, Ehli EA, Kittelsrud J, et al. Lipid-lowering effect of berberine in human subjects and rats. Phytomedicine. 2012;19(10):861-867.
31. Affuso F, Ruvolo A, Micillo F, Saccà L, Fazio S. Effects of a nutraceutical combination (berberine, red yeast rice and policosanols) on lipid levels and endothelial function randomized, double-blind, placebo-controlled study. Nutr Metab Cardiovasc Dis. 2010;20(9):656-661.
32. Klimek M, Wang S, Ogunkanmi A. Safety and efficacy of red yeast rice (Monascus purpureus) as an alternative therapy for hyperlipidemia. P T. 2009;34(6):313-327.
33. Gordon RY, Cooperman T, Obermeyer W, Becker DJ. Marked variability of monacolin levels in commercial red yeast rice products: buyer beware! Arch Intern Med. 2010;170(19):1722-1727.
34. Lin YL, Wang TH, Lee MH, Su NW. Biologically active components and nutraceuticals in the Monascus-fermented rice: a review. Appl Microbiol Biotechnol. 2008;77(5):965-973.
35. Kong WJ, Wei J, Zuo ZY, et al. Combination of simvastatin with berberine improves the lipid-lowering efficacy. Metabolism. 2008;57(8):1029-1037.
36. Cameron J, Ranheim T, Kulseth MA, Leren TP, Berge KE. Berberine decreases PCSK9 expression in HepG2 cells. Atherosclerosis. 2008;201(2):266-273.
37. Kidd PM. Bioavailability and activity of phytosome complexes from botanical polyphenols: the silymarin, curcumin, green tea, and grape seed extracts. Altern Med Rev. 2009;14(3):226-246.
38. Kidd P, Head K. A review of the bioavailability and clinical efficacy of milk thistle phytosome: a silybin-phosphatidylcholine complex (Siliphos). Altern Med Rev. 2005;10(3):193-203.
39. Di Pierro F, Villanova N. L'associazione berberina e silimarina nel trattamento dell'ipercolesterolemia, del diabete e della sindrome metabolica. [The association between berberine and silymarin in hypercholesterolemia, diabetes and metabolic syndrome treatment]. Integr Nutr. 2009;12(3):19-24. Italian.
40. Derosa G, Bonaventura A, Bianchi L, et al. Berberis aristata/Silybum marianum fixed combination on lipid profile and insulin secretion in dyslipidemic patients. Expert Opin Biol Ther. Epub August 24, 2013.