Berberis aristata/Silybum marianum fixed combination (Berberol®) effects on lipid profile in dyslipidemic patients intolerant to statins at high dosages: A randomized, placebo-controlled, clinical trial

Aimto evaluate the efficacy of Berberis aristata/Silybum marianum (Berberol®) in a sample of dyslipidemic patients intolerant to statins at high dosages in a randomized, double blind, placebo-controlled clinical trial.Methodswe enrolled 175 euglycemic, dyslipidemic subjects, intolerant to statins at high dosages. During the run-in period, statins were stopped for 1 month, then they were re-introduced at the half of the previously taken dose. After that, patients were randomized to placebo or Berberol®, 1 tablet during the lunch and 1 tablet during the dinner, for 6 months. Anthropometric, metabolic and inflammatory parameters were assessed at randomization, at 3 and 6 months.Resultsfasting plasma glucose, insulin, and HOMA-index levels were reduced by Berberol®, but not by placebo; moreover they were lower than the ones recorded with placebo. Total cholesterol, LDL-C, triglycerides, and myeloperoxidase did not change after 6 months since the reduction of statin dosage and the introduction of Berberol®, while they increased in the placebo group, and were higher compared to the ones obtained with active treatment. No patients had serious adverse events in both groups.Conclusionsour study displays the rationale of the combination of Berberol® and a reduced dosage of statin for the treatment of hyperlipidemia in patients intolerant to statins at high dosage.