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 500mg berberine, 200mg red yeast rice and 10mg 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+/-0.75mmol/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+/-0.78mmol/l, p<0.001; LDL-C: -1.06+/-0.75 and -00.4+/-0.54mmol/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+/-0.63mmol/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.