title: Effects of a nutraceutical combination containing berberine (BRB), policosanol, and red yeast rice (RYR), on lipid profile in hypercholesterolemic patients: A meta-analysis of randomised controlled trials.
abstract: OBJECTIVE
  A nutraceutical combination containing berberine, policosanol, and red yeast rice, largely marketed in Europe (Armolipid Plus(®)) (AP), has been reported to induce significant improvements in plasma lipids, insulin resistance and other components of the metabolic syndrome. However, literature study designs and results were heterogeneous and it was thus necessary to systematically review and meta-analyse all relevant randomised clinical trials (RCTs) to explore and quantify the effects of the dietary supplement AP on lipid profile. The aim of our meta-analysis was the evaluation of the effect of AP on lipid profile.
  
  
  RESULTS
  We conducted a structures search on PubMed and Google Scholar to identify eligible articles published prior to 2015. Eleven RCTs were subjected to meta-analysis by means of random effects models using the Standardised Mean Differences approach (Hedges' method) and the Mean Differences approach as a sensitivity analysis. Data from 11 randomised clinical trials, corresponding to 1970 nutraceutical combination and 1954 control patients (3924 total patients), were included after the peer evaluation and data extraction of two independent evaluators. Heterogeneity was significant in all models. A significant effect was found for all lipid parameters. The effect size (relative change from baseline (%)) was -1.3 (9.9%) for total cholesterol, -1.17 (-13.7%) for LDL-c, +0.17 (+3.7%) for HDL-c and -0.24 (-7.0%) for Triglycerides.
  
  
  CONCLUSIONS
  This meta-analysis confirms that the nutraceutical combination containing berberine, policosanol, and red yeast rice has shown to be an effective product for the improvement of the lipid profile.
authors.affiliation: Lipid Research Unit, Internal Medicine Service, General University Hospital "Gregorio Marañón", Madrid, Spain. Electronic address: arrigo.cicero@unibo.it.
authors.forename: Jesus
authors.initials: J
authors.lastname: Millán
authors.affiliation: Dyslipidemia Research Unit, Medical and Surgical Sciences Department, University of Bologna, Italy.
authors.forename: Arrigo F G
authors.initials: AF
authors.lastname: Cicero
authors.affiliation: Biostatistics and Data Management Core Facility, IDIBAPS, Hospital Clinic Barcelona, Barcelona, Spain; Biostatistics Unit, Faculty of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Francisco
authors.initials: F
authors.lastname: Torres
authors.affiliation: Lipid Research Unit, Internal Medicine Service, General University Hospital "Gregorio Marañón", Madrid, Spain.
authors.forename: Anna
authors.initials: A
authors.lastname: Anguera
mesh_terms: D001599:Berberine / Q000008:administration & dosage / Q000494:pharmacology; D001688:Biological Products / Q000008:administration & dosage / Q000494:pharmacology; D019587:Dietary Supplements; D005233:Fatty Alcohols / Q000008:administration & dosage / Q000494:pharmacology; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy*; D000960:Hypolipidemic Agents / Q000008:administration & dosage / Q000494:pharmacology; D008055:Lipids / Q000097:blood*; D016032:Randomized Controlled Trials as Topic
chemical_list: D001688:Biological Products; D005233:Fatty Alcohols; D000960:Hypolipidemic Agents; D008055:Lipids; C117343:red yeast rice; D001599:Berberine; C080710:policosanol
keywords: Berberina; Berberine; Hipercolesterolemia; Hypercholesterolemic; Nutraceutical; Nutraceuticos; Policosanol