Jesus Millán1, Arrigo F G Cicero2, Francisco Torres3, Anna Anguera4. 1. Lipid Research Unit, Internal Medicine Service, General University Hospital "Gregorio Marañón", Madrid, Spain. Electronic address: arrigo.cicero@unibo.it. 2. Dyslipidemia Research Unit, Medical and Surgical Sciences Department, University of Bologna, Italy. 3. Biostatistics and Data Management Core Facility, IDIBAPS, Hospital Clinic Barcelona, Barcelona, Spain; Biostatistics Unit, Faculty of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain. 4. Lipid Research Unit, Internal Medicine Service, General University Hospital "Gregorio Marañón", Madrid, Spain.
Abstract
BACKGROUND AND AIM: 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. METHODS AND 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. CONCLUSION: 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.
BACKGROUND AND AIM: A nutraceutical combination containing berberine, policosanol, and red yeastrice, 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. METHODS AND 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. CONCLUSION: This meta-analysis confirms that the nutraceutical combination containing berberine, policosanol, and red yeastrice has shown to be an effective product for the improvement of the lipid profile.
Authors: Roberta Esposito; Regina Sorrentino; Giuseppe Giugliano; Marisa Avvedimento; Roberta Paolillo; Ciro Santoro; Maria Scalamogna; Mafalda Esposito; Federica Ilardi; Francesco Rozza; Giovanni Esposito; Maurizio Galderisi; Valentina Trimarco Journal: Immun Ageing Date: 2018-11-22 Impact factor: 6.400