Effects of a nutraceutical combination (berberine, red yeast rice and policosanols) on lipid levels and endothelial function randomized, double-blind, placebo-controlled study

Background and aims: Some nutraceuticals are prescribed as lipid-lowering substances. However, doubts remain about their efficacy. We evaluated the effects of a nutraceutical combination (NC), consisting of 500 mg berberine, 200 mg red yeast rice and 10 mg policosanols, on cholesterol levels and endothelial function in patients with hypercholesterolemia. Methods and results: In this single centre, randomized, double-blind, placebo-controlled study, 50 hypercholesterolemic patients (26 males and 24 females, mean age 55 +/- 7 years, total cholesterol 6.55 +/- 0.75 mmol/l, BMI 28 +/- 3.5) were randomized to 6 weeks of treatment with a daily oral dose of NC (25 patients) or placebo (25 patients). In a subsequent open-label extension of 4 weeks, the whole sample received NC. The main outcome measure was decrease total cholesterol (C) levels in the NC arm. Secondary outcome measures were decreased low-density lipoprotein cholesterol (LDL-C) and triglyceride levels, and improved endothelial-dependent flow-mediated dilation (FMD) and insulin sensitivity in relation to NC. Evaluation of absolute changes from baseline showed significant reductions in NC versus placebo for C and LDL-C (C: -1.14 +/- 0.88 and -0.03 +/- 0.78 mmol/l, p < 0.001; LDL-C: -1.06 +/- 0.75 and -00.4 +/- 0.54 mmol/l, p < 0.001), and a significant improvement of FMD (3 +/- 4% and 0 3% respectively, p < 0.05). After the extension phase, triglyceride levels decreased significantly from 1.57 +/- 0.77 to 1.26 +/- 0.63 mmol/l, p < 0.05 and insulin sensitivity improved in a patient subgroup with insulin resistance at baseline (HOMA: from 3.3 +/- 0.4 to 2.5 +/- 1.3, p < 0.05). No adverse effect was reported. Conclusions: This NC reduces cholesterol levels. The reduction is associated with improved endothelial function and insulin sensitivity. (C) 2009 Elsevier B.V. All rights reserved.