Berberis aristata combined with Silybum marianum on lipid profile in patients not tolerating statins at high doses

Aim: To evaluate the effects of Berberis aristata combined with Silybum marianum in dyslipidemic patients intolerant to statins at high doses. Methods: 137 euglycemic, dyslipidemic subjects, with previous adverse events to statins at high doses, were enrolled. Statins were stopped for 1 month (run-in), then they were re-introduced at the half of the previously taken dose. At randomization, patients tolerating the half dose of statin, were assigned to add placebo or B. aristata/. S. marianum 588/105mg, 1 tablet during the lunch and 1 tablet during the dinner, for six months. We evaluated lipid profile and safety parameters variation at randomization, and after 3, and 6 months. Results: B. aristata/. S. marianum reduced fasting plasma glucose (-9mg/dl), insulin (-0.7μU/ml), and HOMA-index (-0.35) levels compared to baseline and also to placebo. Lipid profile did not significantly change after 6 months since the reduction of statin dosage and the introduction of B. aristata/. S. marianum, while it worsened in the placebo group both compared to placebo and with active treatment (+23.4mg/dl for total cholesterol,+19.6mg/dl for LDL-cholesterol,+23.1mg/dl for triglycerides with placebo compared to B. aristata/. S. marianum). We did not record any variations of safety parameters in nether of groups. Conclusions: B. aristata/. S. marianum can be considered as addition to statins in patients not tolerating high dose of these drugs.