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Efficacy and safety of berberine for dyslipidaemias: A systematic review and meta-analysis of randomized clinical trials

In recent years, berberine has become widely used as an effective alternative to treat dyslipidaemias; much clinical evidence has emerged. It is important to systematically and critically evaluate the existing evidence. This study aims to evaluate the efficacy and safety of berberine in patients wit...

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Published in:Phytomedicine (Stuttgart) 2018-11, Vol.50, p.25-34
Main Authors: Ju, Jianqing, Li, Jingen, Lin, Qian, Xu, Hao
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description In recent years, berberine has become widely used as an effective alternative to treat dyslipidaemias; much clinical evidence has emerged. It is important to systematically and critically evaluate the existing evidence. This study aims to evaluate the efficacy and safety of berberine in patients with dyslipidaemias. A systematic review and meta-analysis of randomized clinical trials. Five electronic databases were searched up to Apr 15, 2018 to identify randomized controlled trials (RCTs) of berberine in treatment of dyslipidaemias. The outcomes were lipid profile parameters and adverse events. Study selection, data collection, risk of bias assessment, data analyses and interpretations were conducted according to the Cochrane handbook. Sixteen trials with total of 2147 participants were judged to be eligible and were included in the meta-analysis. The included trials were assessed to be of high clinical heterogeneity. The methodological quality of the majority of the trials was generally low in terms of random sequence generation, allocation concealment, blinding and incomplete outcome data. Thus, selection bias, performance bias, detection bias, attrition bias and confounding bias might exist. Meta-analysis showed that berberine significantly reduced levels of total cholesterol (TC) (MD = -0.47  mmol/l 95% CI [-0.64, -0.31], p 
doi_str_mv 10.1016/j.phymed.2018.09.212
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It is important to systematically and critically evaluate the existing evidence. This study aims to evaluate the efficacy and safety of berberine in patients with dyslipidaemias. A systematic review and meta-analysis of randomized clinical trials. Five electronic databases were searched up to Apr 15, 2018 to identify randomized controlled trials (RCTs) of berberine in treatment of dyslipidaemias. The outcomes were lipid profile parameters and adverse events. Study selection, data collection, risk of bias assessment, data analyses and interpretations were conducted according to the Cochrane handbook. Sixteen trials with total of 2147 participants were judged to be eligible and were included in the meta-analysis. The included trials were assessed to be of high clinical heterogeneity. The methodological quality of the majority of the trials was generally low in terms of random sequence generation, allocation concealment, blinding and incomplete outcome data. Thus, selection bias, performance bias, detection bias, attrition bias and confounding bias might exist. Meta-analysis showed that berberine significantly reduced levels of total cholesterol (TC) (MD = -0.47  mmol/l 95% CI [-0.64, -0.31], p &lt; 0.00001), low-density lipoprotein cholesterol (LDL-C) (MD =-0.38  mmol/l 95% CI [-0.53, -0.22], p &lt; 0.00001) and triglycerides (TG) (MD = -0.28  mmol/l 95% CI [-0.46, -0.10], p = 0.002). Berberine also increased the level of high-density lipoprotein cholesterol (HDL-C) when used alone (MD = 0.08  mmol/l 95% CI [0.03, 0.12], p = 0.001). No significant differences were found between groups in terms of incidence of adverse events (RR = 0.64 95% CI [0.31, 1.30], p = 0.22). No severe adverse effects were reported in either group. Berberine improves lipid profiles in dyslipidaemias with satisfactory safety. Nevertheless, these findings should be interpreted with caution because of the high clinical heterogeneity and high risk of bias in the included trials. Rigorous clinical trials should be carried out to provide more reliable evidence. 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All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c362t-4979579efeaa4ccba35fb6c39e9c6c140a9ac5e69c8ef5cb47c00280fbce2553</citedby><cites>FETCH-LOGICAL-c362t-4979579efeaa4ccba35fb6c39e9c6c140a9ac5e69c8ef5cb47c00280fbce2553</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30466986$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ju, Jianqing</creatorcontrib><creatorcontrib>Li, Jingen</creatorcontrib><creatorcontrib>Lin, Qian</creatorcontrib><creatorcontrib>Xu, Hao</creatorcontrib><title>Efficacy and safety of berberine for dyslipidaemias: A systematic review and meta-analysis of randomized clinical trials</title><title>Phytomedicine (Stuttgart)</title><addtitle>Phytomedicine</addtitle><description>In recent years, berberine has become widely used as an effective alternative to treat dyslipidaemias; much clinical evidence has emerged. It is important to systematically and critically evaluate the existing evidence. This study aims to evaluate the efficacy and safety of berberine in patients with dyslipidaemias. A systematic review and meta-analysis of randomized clinical trials. Five electronic databases were searched up to Apr 15, 2018 to identify randomized controlled trials (RCTs) of berberine in treatment of dyslipidaemias. The outcomes were lipid profile parameters and adverse events. Study selection, data collection, risk of bias assessment, data analyses and interpretations were conducted according to the Cochrane handbook. Sixteen trials with total of 2147 participants were judged to be eligible and were included in the meta-analysis. The included trials were assessed to be of high clinical heterogeneity. The methodological quality of the majority of the trials was generally low in terms of random sequence generation, allocation concealment, blinding and incomplete outcome data. Thus, selection bias, performance bias, detection bias, attrition bias and confounding bias might exist. Meta-analysis showed that berberine significantly reduced levels of total cholesterol (TC) (MD = -0.47  mmol/l 95% CI [-0.64, -0.31], p &lt; 0.00001), low-density lipoprotein cholesterol (LDL-C) (MD =-0.38  mmol/l 95% CI [-0.53, -0.22], p &lt; 0.00001) and triglycerides (TG) (MD = -0.28  mmol/l 95% CI [-0.46, -0.10], p = 0.002). Berberine also increased the level of high-density lipoprotein cholesterol (HDL-C) when used alone (MD = 0.08  mmol/l 95% CI [0.03, 0.12], p = 0.001). No significant differences were found between groups in terms of incidence of adverse events (RR = 0.64 95% CI [0.31, 1.30], p = 0.22). No severe adverse effects were reported in either group. Berberine improves lipid profiles in dyslipidaemias with satisfactory safety. Nevertheless, these findings should be interpreted with caution because of the high clinical heterogeneity and high risk of bias in the included trials. Rigorous clinical trials should be carried out to provide more reliable evidence. [Display omitted]</description><subject>Berberine</subject><subject>Berberine - pharmacology</subject><subject>CAD</subject><subject>carotid atherosclerosis</subject><subject>CAS</subject><subject>Cholesterol, HDL - blood</subject><subject>Cholesterol, LDL - blood</subject><subject>coronary artery disease ITT, intention-to-treat</subject><subject>Dyslipidaemias</subject><subject>Dyslipidemias - drug therapy</subject><subject>HDL-C</subject><subject>high-density lipoprotein cholesterol</subject><subject>Humans</subject><subject>IGT</subject><subject>impaired glucose tolerance</subject><subject>intention-to-treat</subject><subject>ITT</subject><subject>LDL-C</subject><subject>Lipid profile</subject><subject>lipid-lowering drugs</subject><subject>Lipids - blood</subject><subject>LLDs</subject><subject>low-density lipoprotein cholesterol</subject><subject>Meta-analysis</subject><subject>Randomized controlled trial</subject><subject>randomized controlled trials</subject><subject>Randomized Controlled Trials as Topic</subject><subject>RCTs</subject><subject>Systematic review</subject><subject>T2DM</subject><subject>total cholesterol</subject><subject>triglycerides</subject><subject>Triglycerides - blood</subject><subject>type 2 diabetes mellitus</subject><issn>0944-7113</issn><issn>1618-095X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><recordid>eNp9kE9r3DAQxUVpaTZpv0EIOuZidyTLstVDISxpUwj0kkNvQh6PqBb_2UreJs6nr7abXAsDA6P35o1-jF0KKAUI_WlX7n-tI_WlBNGWYEop5Bu2EVq0BZj651u2AaNU0QhRnbHzlHYAQpkG3rOzCpTWptUb9nTrfUCHK3dTz5PztKx89ryjmCtMxP0ceb-mIexD72gMLn3mNzytaaHRLQF5pD-BHv_5R1pc4SY3rCmk45qYp_MYnqnnOIQpJw18icEN6QN753Ojjy_9gj18vX3Y3hX3P759397cF1hpuRT5YFM3hjw5pxA7V9W-01gZMqhRKHDGYU3aYEu-xk41CCBb8B2SrOvqgl2f1u7j_PtAabFjSEjD4CaaD8lKUTWqkQJ0lqqTFOOcUiRv9zGMLq5WgD0itzt7Qm6PyC2Y7JbZdvWScOiOb6-mV8ZZ8OUkoPzNjCrahIEmpD5EwsX2c_h_wl_-3Jdi</recordid><startdate>20181115</startdate><enddate>20181115</enddate><creator>Ju, Jianqing</creator><creator>Li, Jingen</creator><creator>Lin, Qian</creator><creator>Xu, Hao</creator><general>Elsevier GmbH</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20181115</creationdate><title>Efficacy and safety of berberine for dyslipidaemias: A systematic review and meta-analysis of randomized clinical trials</title><author>Ju, Jianqing ; Li, Jingen ; Lin, Qian ; Xu, Hao</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c362t-4979579efeaa4ccba35fb6c39e9c6c140a9ac5e69c8ef5cb47c00280fbce2553</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Berberine</topic><topic>Berberine - pharmacology</topic><topic>CAD</topic><topic>carotid atherosclerosis</topic><topic>CAS</topic><topic>Cholesterol, HDL - blood</topic><topic>Cholesterol, LDL - blood</topic><topic>coronary artery disease ITT, intention-to-treat</topic><topic>Dyslipidaemias</topic><topic>Dyslipidemias - drug therapy</topic><topic>HDL-C</topic><topic>high-density lipoprotein cholesterol</topic><topic>Humans</topic><topic>IGT</topic><topic>impaired glucose tolerance</topic><topic>intention-to-treat</topic><topic>ITT</topic><topic>LDL-C</topic><topic>Lipid profile</topic><topic>lipid-lowering drugs</topic><topic>Lipids - blood</topic><topic>LLDs</topic><topic>low-density lipoprotein cholesterol</topic><topic>Meta-analysis</topic><topic>Randomized controlled trial</topic><topic>randomized controlled trials</topic><topic>Randomized Controlled Trials as Topic</topic><topic>RCTs</topic><topic>Systematic review</topic><topic>T2DM</topic><topic>total cholesterol</topic><topic>triglycerides</topic><topic>Triglycerides - blood</topic><topic>type 2 diabetes mellitus</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ju, Jianqing</creatorcontrib><creatorcontrib>Li, Jingen</creatorcontrib><creatorcontrib>Lin, Qian</creatorcontrib><creatorcontrib>Xu, Hao</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Phytomedicine (Stuttgart)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ju, Jianqing</au><au>Li, Jingen</au><au>Lin, Qian</au><au>Xu, Hao</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of berberine for dyslipidaemias: A systematic review and meta-analysis of randomized clinical trials</atitle><jtitle>Phytomedicine (Stuttgart)</jtitle><addtitle>Phytomedicine</addtitle><date>2018-11-15</date><risdate>2018</risdate><volume>50</volume><spage>25</spage><epage>34</epage><pages>25-34</pages><issn>0944-7113</issn><eissn>1618-095X</eissn><abstract>In recent years, berberine has become widely used as an effective alternative to treat dyslipidaemias; much clinical evidence has emerged. It is important to systematically and critically evaluate the existing evidence. This study aims to evaluate the efficacy and safety of berberine in patients with dyslipidaemias. A systematic review and meta-analysis of randomized clinical trials. Five electronic databases were searched up to Apr 15, 2018 to identify randomized controlled trials (RCTs) of berberine in treatment of dyslipidaemias. The outcomes were lipid profile parameters and adverse events. Study selection, data collection, risk of bias assessment, data analyses and interpretations were conducted according to the Cochrane handbook. Sixteen trials with total of 2147 participants were judged to be eligible and were included in the meta-analysis. The included trials were assessed to be of high clinical heterogeneity. The methodological quality of the majority of the trials was generally low in terms of random sequence generation, allocation concealment, blinding and incomplete outcome data. Thus, selection bias, performance bias, detection bias, attrition bias and confounding bias might exist. Meta-analysis showed that berberine significantly reduced levels of total cholesterol (TC) (MD = -0.47  mmol/l 95% CI [-0.64, -0.31], p &lt; 0.00001), low-density lipoprotein cholesterol (LDL-C) (MD =-0.38  mmol/l 95% CI [-0.53, -0.22], p &lt; 0.00001) and triglycerides (TG) (MD = -0.28  mmol/l 95% CI [-0.46, -0.10], p = 0.002). Berberine also increased the level of high-density lipoprotein cholesterol (HDL-C) when used alone (MD = 0.08  mmol/l 95% CI [0.03, 0.12], p = 0.001). No significant differences were found between groups in terms of incidence of adverse events (RR = 0.64 95% CI [0.31, 1.30], p = 0.22). No severe adverse effects were reported in either group. Berberine improves lipid profiles in dyslipidaemias with satisfactory safety. Nevertheless, these findings should be interpreted with caution because of the high clinical heterogeneity and high risk of bias in the included trials. Rigorous clinical trials should be carried out to provide more reliable evidence. [Display omitted]</abstract><cop>Germany</cop><pub>Elsevier GmbH</pub><pmid>30466986</pmid><doi>10.1016/j.phymed.2018.09.212</doi><tpages>10</tpages></addata></record>
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subjects Berberine
Berberine - pharmacology
CAD
carotid atherosclerosis
CAS
Cholesterol, HDL - blood
Cholesterol, LDL - blood
coronary artery disease ITT, intention-to-treat
Dyslipidaemias
Dyslipidemias - drug therapy
HDL-C
high-density lipoprotein cholesterol
Humans
IGT
impaired glucose tolerance
intention-to-treat
ITT
LDL-C
Lipid profile
lipid-lowering drugs
Lipids - blood
LLDs
low-density lipoprotein cholesterol
Meta-analysis
Randomized controlled trial
randomized controlled trials
Randomized Controlled Trials as Topic
RCTs
Systematic review
T2DM
total cholesterol
triglycerides
Triglycerides - blood
type 2 diabetes mellitus
title Efficacy and safety of berberine for dyslipidaemias: A systematic review and meta-analysis of randomized clinical trials
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