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.
Phytomedicine. 2015 Feb 15 ;22(2):231-7. Epub 2014 Dec 18. PMID: 25765827
AIM: to 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.
METHODS: we 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.
RESULTS: fasting 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, andwere higher compared to the ones obtained with active treatment. No patients had serious adverse events in both groups.
CONCLUSIONS: our 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.