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Review

Impact of Berberine or Berberine Combination Products on Lipoprotein, Triglyceride and Biological Safety Marker Concentrations in Patients with Hyperlipidemia: A Systematic Review and Meta-Analysis

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References

  • Adorni MP, Zimetti F, Lupo MG, Ruscica M, Ferri N. 2020. Naturally occurring PCSK9 inhibitors. Nutrients. 12(5):1440. doi:10.3390/nu12051440.
  • Affuso F, Mercurio V, Ruvolo A, Pirozzi C, Micillo F, Carlomagno G, Grieco F, Fazio S. 2012. A nutraceutical combination improves insulin sensitivity in patients with metabolic syndrome. World J Cardiol. 4(3):77–83. doi:10.4330/wjc.v4.i3.77.
  • Affuso F, Ruvolo A, Micillo F, Saccà L, Fazio S. 2010. Effects of a nutraceutical combination (berberine, red yeast rice and policosanols) on lipid levels and endothelial function randomized, double-blind, placebo-controlled study. Nutr Metab Cardiovasc Dis. 20(9):656–661. doi:10.1016/j.numecd.2009.05.017.
  • Afsharinasab M, Mohammad-Sadeghipour M, Reza Hajizadeh M, Khoshdel A, Mirzaiey V, Mahmoodi M. 2020. The effect of hydroalcoholic Berberis integerrima fruits extract on the lipid profile, antioxidant parameters and liver and kidney function tests in patients with nonalcoholic fatty liver disease. Saudi J Biol Sci. 27(8):2031–2037. doi:10.1016/j.sjbs.2020.04.037.
  • Cannon CP, Blazing MA, Giugliano RP, McCagg A, White JA, Theroux P, Darius H, Lewis BS, Ophuis TO, Jukema JW, et al. 2015. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med. 372(25):2387–2397. doi:10.1056/NEJMoa1410489.
  • Chan M, Qin Z, Man S-C, Lam M, Lai WH, Ng RMK, Lee CK, Wong TL, Lee EHM, Wong HK, et al. 2022. Adjunctive berberine reduces antipsychotic-associated weight gain and metabolic syndrome in patients with schizophrenia: a randomized controlled trial [published correction appears in Psychiatry Clin Neurosci. 2022 Oct;76(10):536]. Psychiatry Clin Neurosci. 76(3):77–85. doi:10.1111/pcn.13323.
  • Cianci A, Cicero AF, Colacurci N, Matarazzo MG, De Leo V. 2012. Activity of isoflavones and berberine on vasomotor symptoms and lipid profile in menopausal women. Gynecol Endocrinol. 28(9):699–702. doi:10.3109/09513590.2011.652250.
  • Cicero AFG, Fogacci F, Bove M, Giovannini M, Veronesi M, Borghi C. 2019. Short-term effects of dry extracts of artichokeand berberis in hypercholesterolemic patients without cardiovascular disease. Am J Cardiol. 123(4):588–591. doi:10.1016/j.amjcard.2018.11.018.
  • Cicero AFG, Fogacci F, Bove M, Ventura F, Giovannini M, Borghi C. 2018. Optimizing lipid pattern by adding a combined nutraceutical or pravastatin to fenofibrate treatment in hypertriglyceridemic subjects: single site, randomized, open-label, post-market clinical investigation. High Blood Press Cardiovasc Prev. 25(4):355–359. doi:10.1007/s40292-018-0277-9.
  • Cicero AFG, Fogacci F, Morbini M, Colletti A, Bove M, Veronesi M, Giovannini M, Borghi C. 2017. Nutraceutical effects on glucose and lipid metabolism in patients with impaired fasting glucose: a pilot, double-blind, placebo-controlled, randomized clinical trial on a combined product. High Blood Press Cardiovasc Prev. 24(3):283–288. doi:10.1007/s40292-017-0206-3.
  • Cicero AFG, Fogacci F, Stoian AP, Vrablik M, Al Rasadi K, Banach M, Toth PP, Rizzo M. 2021. Nutraceuticals in the management of dyslipidemia: which, when, and for whom? Could nutraceuticals help low-risk individuals with non-optimal lipid levels? Curr Atheroscler Rep. 23(10):57. doi:10.1007/s11883-021-00955-y.
  • D’Addato S, Scandiani L, Mombelli G, Focanti F, Pelacchi F, Salvatori E, Di Loreto G, Comandini A, Maffioli P, Derosa G, et al. 2017. Effect of a food supplement containing berberine, ­monacolin K, hydroxytyrosol and coenzyme Q10 on lipid levels: a randomized, double-blind, placebo controlled study. Drug Des Devel Ther. 11:1585–1592. Published 2017 May 23. doi:10.2147/DDDT.S128623.
  • Dahlberg CJ, Ou JJ, Babish JG, Lamb JJ, Eliason S, Brabazon H, Gao W, Kaadige MR, Tripp ML. 2017. A 13-week low glycemic load diet and lifestyle modification program combining low glycemic load protein shakes and targeted nutraceuticals improved weight loss and cardio-metabolic risk factors. Can J Physiol Pharmacol. 95(12):1414–1425. doi:10.1139/cjpp-2016-0704.
  • Deedwania P, Murphy SA, Scheen A, Badariene J, Pineda AL, Honarpour N, Keech AC, Sever PS, Pedersen TR, Sabatine MS, et al. 2021. Efficacy and safety of PCSK9 inhibition with evolocumab in reducing cardiovascular events in patients with metabolic syndrome receiving statin therapy: secondary analysis from the FOURIER randomized clinical trial. JAMA Cardiol. 6(2):139–147. doi:10.1001/jamacardio.2020.3151.
  • Derosa G, Bonaventura A, Bianchi L, Romano D, D’Angelo A, Fogari E, Maffioli P. 2013a. Effects of Berberis aristata/Silybum marianum association on metabolic parameters and adipocytokines in overweight dyslipidemic patients. J Biol Regul Homeost Agents. 27(3):717–728.
  • Derosa G, Bonaventura A, Bianchi L, Romano D, D’Angelo A, Fogari E, Maffioli P. 2013b. Berberis aristata/Silybum marianum fixed combination on lipid profile and insulin secretion in dyslipidemic patients. Expert Opin Biol Ther. 13(11):1495–1506. doi:10.1517/14712598.2013.832751.
  • Derosa G, D’Angelo A, Bonaventura A, Bianchi L, Romano D, Maffioli P. 2013c. Effects of berberine on lipid profile in subjects with low cardiovascular risk. Expert Opin Biol Ther. 13(4):475–482. doi:10.1517/14712598.2013.776037.
  • Derosa G, D’Angelo A, Maffioli P. 2016. The role of a fixed Berberis aristata/Silybum marianum combination in the treatment of type 1 diabetes mellitus. Clin Nutr. 35(5):1091–1095. doi:10.1016/j.clnu.2015.08.004.
  • Derosa G, D’Angelo A, Romano D, Maffioli P. 2017. Effects of a combination of Berberis aristata, Silybum marianum and monacolin on lipid profile in subjects at low cardiovascular risk; a double-blind, randomized, placebo-controlled trial. Int J Mol Sci. 18(2):343. Published 2017 Feb 7. doi:10.3390/ijms18020343.
  • Derosa G, D’Angelo A, Vanelli A, Maffioli P. 2020. An evaluation of a nutraceutical with berberine, curcumin, inositol, banaba and chromium picolinate in patients with fasting dysglycemia. Diabetes Metab Syndr Obes. 13:653–661. Published 2020 Mar 3. doi:10.2147/DMSO.S232791.
  • Derosa G, Romano D, D’Angelo A, Maffioli P. 2015a. Berberis aristata combined with Silybum marianum on lipid profile in patients not tolerating statins at high doses. Atherosclerosis. 239(1):87–92. doi:10.1016/j.atherosclerosis.2014.12.043.
  • Derosa G, Romano D, D’Angelo A, Maffioli P. 2015b. 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. Phytomedicine. 22(2):231–237. doi:10.1016/j.phymed.2014.11.018.
  • Dong B, Li H, Singh AB, Cao A, Liu J. 2015. Inhibition of PCSK9 transcription by berberine involves down-regulation of hepatic HNF1α protein expression through the ubiquitin-proteasome degradation pathway. J Biol Chem. 290(7):4047–4058. doi:10.1074/jbc.M114.597229.
  • Emamat H, Zahedmehr A, Asadian S, Nasrollahzadeh J. 2022. The effect of barberry (Berberis integerrima) on lipid profile and systemic inflammation in subjects with cardiovascular risk factors: a randomized controlled trial. BMC Complement Med Ther. 22(1):59. Published 2022 Mar 7. doi:10.1186/s12906-022-03539-8.
  • Gentile M, Calcaterra I, Strazzullo A, Pagano C, Pacioni D, Speranza E, Rubba P, Marotta G. 2015. Effects of Armolipid Plus on small dense LDL particles in a sample of patients affected by familial combined hyperlipidemia. Clin Lipidol. 10(6):475–480. doi:10.2217/clp.15.37.
  • Ghafarzadegan R, Javaheri J, Asgari M, Golitaleb M, Maraki F, Ghafarzadegan R, Zarei M. 2021. The effect of combined herbal capsule on glycemic indices and lipid profile in patients with type 2 diabetes mellitus: a randomized controlled clinical trial. Jundishapur J Nat Pharm Prod. 16(4):e109488. doi:10.5812/jjnpp.109488.
  • Gobalakrishnan S, Asirvatham SS, Janarthanam V. 2016. Effect of silybin on lipid profile in hypercholesterolaemic rats. J Clin Diagn Res. 10(4):FF01–FF05. doi:10.7860/JCDR/2016/16393.7566.
  • Gonnelli S, Caffarelli C, Stolakis K, Cuda C, Giordano N, Nuti R. 2015. Efficacy and tolerability of a nutraceutical combination (red yeast rice, policosanols, and berberine) in patients with low-moderate risk hypercholesterolemia: A double-blind, placebo-controlled study. Curr Ther Res Clin Exp. 77:1–6. Published 2014 Nov 15. doi:10.1016/j.curtheres.2014.07.003.
  • Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, et al. 2019. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines. Circulation. 139(25):e1082–e1143. doi:10.1161/CIR.0000000000000625.
  • Higgins JP, Thompson SG. 2002. Quantifying heterogeneity in a meta-analysis. Stat Med. 21(11):1539–1558. doi:10.1002/sim.1186.
  • Huang Y-H, Chen S-T, Liu F-H, Hsieh S-H, Lin C-H, Liou M-J, Wang C-C, Huang C-H, Liu G-H, Lin J-R, et al. 2019. The efficacy and safety of concentrated herbal extract granules, YH1, as an add-on medication in poorly controlled type 2 diabetes: A randomized, double-blind, placebo-controlled pilot trial. PLoS One. 14(8):e0221199. Published 2019 Aug 15. doi:10.1371/journal.pone.0221199.
  • Iloon Kashkooli R, Najafi SS, Sharif F, Hamedi A, Hoseini Asl MK, Najafi Kalyani M, Birjandi M. 2015. The effect of berberis vulgaris extract on transaminase activities in non-alcoholic fatty liver disease. Hepat Mon. 15(2):e25067. Published 2015 Feb 5. doi:10.5812/hepatmon.25067.
  • Izzo R, de Simone G, Giudice R, Chinali M, Trimarco V, De Luca N, Trimarco B. 2010. Effects of nutraceuticals on prevalence of metabolic syndrome and on calculated Framingham Risk Score in individuals with dyslipidemia. J Hypertens. 28(7):1482–1487. doi:10.1097/HJH.0b013e3283395208.
  • Knapp G, Hartung J. 2003. Improved tests for a random effects meta-regression with a single covariate. Stat Med. 22(17):2693–2710. doi:10.1002/sim.1482.
  • Li M, Liu Y, Qiu Y, Zhang J, Zhang Y, Zhao Y, Jia Q, Li J. 2021. The effect of berberine adjunctive treatment on glycolipid metabolism in patients with schizophrenia: A randomized, double-blind, placebo-controlled clinical trial. Psychiatry Res. 300:113899. doi:10.1016/j.psychres.2021.113899.
  • Li Y, Jiang L, Jia Z, Xin W, Yang S, Yang Q, Wang L. 2014. A meta-analysis of red yeast rice: An effective and relatively safe alternative approach for dyslipidemia. PLoS One. 9(6):e98611. doi:10.1371/journal.pone.0098611.
  • Marazzi G, Cacciotti L, Pelliccia F, Iaia L, Volterrani M, Caminiti G, Sposato B, Massaro R, Grieco F, Rosano G, et al. 2011. Long-term effects of nutraceuticals (berberine, red yeast rice, policosanol) in elderly hypercholesterolemic patients. Adv Ther. 28(12):1105–1113. doi:10.1007/s12325-011-0082-5.
  • Marazzi G, Campolongo G, Pelliccia F, Quattrino S, Vitale C, Cacciotti L, Massaro R, Volterrani M, Rosano G. 2017. Comparison of low-dose statin versus low-dose statin + armolipid plus in high-intensity statin-intolerant patients with a previous coronary event and percutaneous coronary intervention (ADHERENCE trial). Am J Cardiol. 120(6):893–897. doi:10.1016/j.amjcard.2017.06.015.
  • Marazzi G, Pelliccia F, Campolongo G, Quattrino S, Cacciotti L, Volterrani M, Gaudio C, Rosano G. 2015. Usefulness of nutraceuticals (armolipid plus) versus ezetimibe and combination in statin-intolerant patients with dyslipidemia with coronary heart disease. Am J Cardiol. 116(12):1798–1801. doi:10.1016/j.amjcard.2015.09.023.
  • Mazza A, Nicoletti M, Lenti S, Torin G, Rigatelli G, Pellizzato M, Fratter A. 2021. Effectiveness and safety of novel nutraceutical formulation added to ezetimibe in statin-intolerant hypercholesterolemic subjects with moderate-to-high cardiovascular risk. J Med Food. 24(1):59–66. doi:10.1089/jmf.2020.0019.
  • Mazza A, Schiavon L, Rigatelli G, Torin G, Lenti S. 2019. The effects of a new generation of nutraceutical compounds on lipid profile and glycaemia in subjects with pre-hypertension. High Blood Press Cardiovasc Prev. 26(4):345–350. doi:10.1007/s40292-019-00332-6.
  • Mishra N, Verma R, Jadaun P. 2022. Study on the effect of berberine, myoinositol, and metformin in women with polycystic ovary syndrome: A prospective randomised study. Cureus. 14(1):e21781. Published 2022 Jan 31. doi:10.7759/cureus.21781.
  • Nejati L, Movahedi A, Salari G, Moeineddin R, Nejati P. 2022. The effect of berberine on lipid profile, liver enzymes, and fasting blood glucose in patients with non-alcoholic fatty liver disease (NAFLD): a randomized controlled trial. Med J Islam Repub Iran. 36:39. Published 2022 Apr 20. doi:10.47176/mjiri.36.39.
  • Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, Shamseer L, Tetzlaff JM, Akl EA, Brennan SE, et al. 2021. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 372:n71. doi:10.1136/bmj.n71.
  • Pirro M, Lupattelli G, Del Giorno R, Schillaci G, Berisha S, Mannarino MR, Bagaglia F, Melis F, Mannarino E. 2013. Nutraceutical combination (red yeast rice, berberine and policosanols) improves aortic stiffness in low-moderate risk hypercholesterolemic patients. PharmaNutrition. 1(2):73–77. doi:10.1016/j.phanu.2013.02.003.
  • Pirro M, Mannarino MR, Ministrini S, Fallarino F, Lupattelli G, Bianconi V, Bagaglia F, Mannarino E. 2016. Effects of a nutraceutical combination on lipids, inflammation and endothelial integrity in patients with subclinical inflammation: a randomized clinical trial. Sci Rep. 6:23587. Published 2016 Mar 23. doi:10.1038/srep23587.
  • Ray KK, Kallend D, Leiter LA, Raal FJ, Koenig W, Jaros MJ, Schwartz GG, Landmesser U, Garcia Conde L, Wright RS, et al. 2022. Effect of inclisiran on lipids in primary prevention: the ORION-11 trial. Eur Heart J. 43(48):5047–5057. doi:10.1093/eurheartj/ehac615.
  • Ruscica M, Gomaraschi M, Mombelli G, Macchi C, Bosisio R, Pazzucconi F, Pavanello C, Calabresi L, Arnoldi A, Sirtori CR, et al. 2014. Nutraceutical approach to moderate cardiometabolic risk: results of a randomized, double-blind and crossover study with Armolipid Plus. J Clin Lipidol. 8(1):61–68. doi:10.1016/j.jacl.2013.11.003.
  • Sharma R, Sharma B, Jindal M, Gupta A, Kunwar R, Lata S, Yadav A. 2017. Evaluation of hypolipidemic effect of stem part of Berberis aristata in Type 2 diabetes mellitus patients as add on therapy. Natl J Physiol Pharm Pharmacol. 7(11):1159. doi:10.5455/njppp.2017.7.0517510062017.
  • Smith KW, White CM. 2022. Inclisiran: a novel small interfering RNA drug for low-density lipoprotein reduction. J Clin Pharmacol. 62(9):1079–1085. doi:10.1002/jcph.2045.
  • Solà R, Valls R-M, Puzo J, Calabuig J-R, Brea A, Pedret A, Moriña D, Villar J, Millán J, Anguera A, et al. 2014. Effects of poly-bioactive compounds on lipid profile and body weight in a moderately hypercholesterolemic population with low cardiovascular disease risk: a multicenter randomized trial. PLoS One. 9(8):e101978. Published 2014 Aug 1. doi:10.1371/journal.pone.0101978.
  • Spigoni V, Aldigeri R, Antonini M, Micheli M, Fantuzzi F, Fratter A, Pellizzato M, Derlindati E, Zavaroni I, Bonadonna R, et al. 2017. Effects of a new nutraceutical formulation (berberine, red yeast rice and chitosan) on non-HDL cholesterol levels in individuals with dyslipidemia: results from a randomized, double blind, placebo-controlled study. IJMS. 18(7):1498. Published 2017 Jul 12. doi:10.3390/ijms18071498.
  • Sterne JAC, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, Cates CJ, Cheng H-Y, Corbett MS, Eldridge SM, et al. 2019. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 366:l4898. doi:10.1136/bmj.l4898.
  • Veroniki AA, Jackson D, Viechtbauer W, Bender R, Bowden J, Knapp G, Kuss O, Higgins JPT, Langan D, Salanti G, et al. 2016. Methods to estimate the between-study variance and its uncertainty in meta-analysis. Res Synth Methods. 7(1):55–79. doi:10.1002/jrsm.1164.
  • Wei W, Zhao H, Wang A, Sui M, Liang K, Deng H, Ma Y, Zhang Y, Zhang H, Guan Y, et al. 2012. A clinical study on the short-term effect of berberine in comparison to metformin on the metabolic characteristics of women with polycystic ovary syndrome. Eur J Endocrinol. 166(1):99–105. doi:10.1530/EJE-11-0616.
  • White CM. 2002. HMG CoA reductase inhibitor-induced muscle toxicity: risks, monitoring, and management. Formulary. 37:205–221. https://go.gale.com/ps/i.do?id=GALE%7CA95176587.
  • White CM. 2015. Dec Therapeutic potential and critical analysis of the PCSK9 monoclonal antibodies evolocumab and alirocumab. Ann Pharmacother. 49(12):1327–1335. doi:10.1177/1060028015608487.
  • White CM. 2018. The pharmacologic role and clinical utility of PCSK9 inhibitors for the treatment of hypercholesterolemia. J Cardiovasc Pharmacol Ther. 23(4):301–308. doi:10.1177/1074248418769040.
  • White CM. 2022. Using national guidelines to determine hyperlipidemia treatment. Pharm Pract News; [accessed 2022 Nov 11]. https://www.pharmacypracticenews.com/Clinical/Article/06-22/Using-National-Guidelines-to-Determine-Hyperlipidemia-Treatment/67209.
  • Zeman M, Vecka M, Perlík F, Hromádka R, Staňková B, Tvrzická E, Žák A. 2015. Niacin in the treatment of hyperlipidemias in light of new clinical trials: has niacin lost its place? Med Sci Monit. 21:2156–2162. doi:10.12659/MSM.893619.
  • Zhao JV, Yeung W-F, Chan Y-H, Vackova D, Leung JYY, Ip DKM, Zhao J, Ho W-K, Tse H-F, Schooling CM, et al. 2021. Effect of berberine on cardiovascular disease risk factors: A mechanistic randomized controlled trial. Nutrients. 13(8):2550. Published 2021 Jul 26. doi:10.3390/nu13082550.

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