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Planta Med 2020; 86(02): 132-143
DOI: 10.1055/a-1063-1649
Biological and Pharmacological Activity
Original Papers
Georg Thieme Verlag KG Stuttgart · New York

The Effects of a Fixed Combination of Berberis aristata and Silybum marianum on Dyslipidaemia – A Meta-analysis and Systematic Review

Barbara Tóth
1   Department of Pharmacognosy, Interdisciplinary Excellence Centre, University of Szeged, Szeged, Hungary
2   Interdisciplinary Centre of Natural Products, University of Szeged, Szeged, Hungary
,
Dávid Németh
3   Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary
,
Alexandra Soós
3   Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary
,
Péter Hegyi
3   Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary
,
Gréta Pham-Dobor
4   First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary
,
Orsolya Varga
5   Department of Preventive Medicine, Faculty of Public Health, University of Debrecen, Debrecen, Hungary
,
Viktória Varga
1   Department of Pharmacognosy, Interdisciplinary Excellence Centre, University of Szeged, Szeged, Hungary
2   Interdisciplinary Centre of Natural Products, University of Szeged, Szeged, Hungary
,
Tivadar Kiss
1   Department of Pharmacognosy, Interdisciplinary Excellence Centre, University of Szeged, Szeged, Hungary
2   Interdisciplinary Centre of Natural Products, University of Szeged, Szeged, Hungary
,
Patrícia Sarlós
4   First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary
,
Bálint Erőss
3   Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary
,
Dezső Csupor
1   Department of Pharmacognosy, Interdisciplinary Excellence Centre, University of Szeged, Szeged, Hungary
2   Interdisciplinary Centre of Natural Products, University of Szeged, Szeged, Hungary
› Author AffiliationsSupported by: János Bolyai Research Scholarship from the Hungarian Academy of Sciences
Supported by: Research grant from the National Research, Development and Innovation Office 115796
Supported by: Economic Development and Innovation Operative Programme Grant GINOP 2.3.2-15-2016-00048
Supported by: Ministry of Human Capacities, Hungary 20391-3/2018/FEKUSTRAT
Supported by: Human Resources Development Operational Programme Grants EFOP-3.6.2-16-2017-0006
Further Information

Publication History

received 09 September 2019
revised 18 October 2019

accepted 15 November 2019

Publication Date:
29 November 2019 (online)

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Abstract

A fixed combination of Berberis aristata and Silybum marianum (Berberol) has been used by patients with dyslipidaemia. The aim of the present meta-analysis was to systematically evaluate the efficacy and safety of a fixed combination of B. aristata and S. marianum (Berberol) on serum lipid levels compared to placebo in a meta-analysis based on randomised, controlled trials. The meta-analysis was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement, using the PICO (patients, intervention, comparison, outcome) format, and it was registered in the International Prospective Register of Systematic Reviews. The Cochrane Central Register of Controlled Trials, PubMed, Embase, and Web of Science databases were searched for relevant studies. Placebo-controlled clinical studies involving adult patients with a condition of dyslipidaemia and receiving a fixed combination of B. aristata and S. marianum were included. Four randomised trials, including a total of 491 patients, were pooled in statistical analysis. According to the present meta-analysis, Berberol significantly lowered the low-density lipoprotein level, total cholesterol, fasting plasma glucose levels, and the Homeostatic Model Assessment index compared to placebo; however, its effects on the high-density lipoprotein level, triglyceride level, and body mass index were not statistically significant by the end of a 3-month treatment period. Berberol appeared to be safe, and it did not increase the levels of alanine transaminase, aspartate transaminase, and creatine kinase enzymes. Berberol is an effective and presumably safe complementary therapy for the treatment of dyslipidaemia; however, the evidence supporting its use is very limited. The optimum dose and duration of treatment are unclear. A comprehensive evaluation of efficacy and safety is required in further high-quality clinical studies involving larger patient populations.

Key words

silymarin - Silybum marianum - Compositae - berberine - Berberis aristata - Berberidaceae - dyslipidaemia - meta-analysis

Supporting Information

 

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