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Phytomedicine. 2015 Feb 15;22(2):231-7. doi: 10.1016/j.phymed.2014.11.018. Epub 2014 Dec 18.

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.

Author information

1
Department of Internal Medicine and Therapeutics, University of Pavia, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy ; Center for the Study of Endocrine-Metabolic Pathophysiology and Clinical Research, University of Pavia, Pavia, Italy . Electronic address: giuseppe.derosa@unipv.it.
2
Department of Internal Medicine and Therapeutics, University of Pavia, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.
3
Department of Internal Medicine and Therapeutics, University of Pavia, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy ; PhD School in Experimental Medicine, University of Pavia, Pavia, Italy.

Abstract

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, and were 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.

KEYWORDS:

Berberis aristata and Silybum marianum; Dyslipidemia; Lipid profile; Myalgia; Statins

PMID:
25765827
DOI:
10.1016/j.phymed.2014.11.018
[Indexed for MEDLINE]

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