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Research ArticleArticle

The Effects of Milk Thistle (Silybum marianum) on Human Cytochrome P450 Activity

Marina Kawaguchi-Suzuki, Reginald F. Frye, Hao-Jie Zhu, Bryan J. Brinda, Kenneth D. Chavin, Hilary J. Bernstein and John S. Markowitz
Drug Metabolism and Disposition October 2014, 42 (10) 1611-1616; DOI: https://doi.org/10.1124/dmd.114.057232
Marina Kawaguchi-Suzuki
Department of Pharmacotherapy and Translational Research (M.K.-S., R.F.F., B.J.B., J.S.M.) and Center for Pharmacogenomics (M.K.-S., R.F.F., J.S.M.), University of Florida, Gainesville, Florida; Department of Clinical, Social, and Administrative Sciences, University of Michigan College of Pharmacy, Ann Arbor, Michigan (H.-J.Z.); and Department of Surgery, Division of Transplantation (K.D.C.), and Department of Psychiatry and Behavioral Sciences (H.J.B.), Medical University of South Carolina, Charleston, South Carolina
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Reginald F. Frye
Department of Pharmacotherapy and Translational Research (M.K.-S., R.F.F., B.J.B., J.S.M.) and Center for Pharmacogenomics (M.K.-S., R.F.F., J.S.M.), University of Florida, Gainesville, Florida; Department of Clinical, Social, and Administrative Sciences, University of Michigan College of Pharmacy, Ann Arbor, Michigan (H.-J.Z.); and Department of Surgery, Division of Transplantation (K.D.C.), and Department of Psychiatry and Behavioral Sciences (H.J.B.), Medical University of South Carolina, Charleston, South Carolina
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Hao-Jie Zhu
Department of Pharmacotherapy and Translational Research (M.K.-S., R.F.F., B.J.B., J.S.M.) and Center for Pharmacogenomics (M.K.-S., R.F.F., J.S.M.), University of Florida, Gainesville, Florida; Department of Clinical, Social, and Administrative Sciences, University of Michigan College of Pharmacy, Ann Arbor, Michigan (H.-J.Z.); and Department of Surgery, Division of Transplantation (K.D.C.), and Department of Psychiatry and Behavioral Sciences (H.J.B.), Medical University of South Carolina, Charleston, South Carolina
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Bryan J. Brinda
Department of Pharmacotherapy and Translational Research (M.K.-S., R.F.F., B.J.B., J.S.M.) and Center for Pharmacogenomics (M.K.-S., R.F.F., J.S.M.), University of Florida, Gainesville, Florida; Department of Clinical, Social, and Administrative Sciences, University of Michigan College of Pharmacy, Ann Arbor, Michigan (H.-J.Z.); and Department of Surgery, Division of Transplantation (K.D.C.), and Department of Psychiatry and Behavioral Sciences (H.J.B.), Medical University of South Carolina, Charleston, South Carolina
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Kenneth D. Chavin
Department of Pharmacotherapy and Translational Research (M.K.-S., R.F.F., B.J.B., J.S.M.) and Center for Pharmacogenomics (M.K.-S., R.F.F., J.S.M.), University of Florida, Gainesville, Florida; Department of Clinical, Social, and Administrative Sciences, University of Michigan College of Pharmacy, Ann Arbor, Michigan (H.-J.Z.); and Department of Surgery, Division of Transplantation (K.D.C.), and Department of Psychiatry and Behavioral Sciences (H.J.B.), Medical University of South Carolina, Charleston, South Carolina
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Hilary J. Bernstein
Department of Pharmacotherapy and Translational Research (M.K.-S., R.F.F., B.J.B., J.S.M.) and Center for Pharmacogenomics (M.K.-S., R.F.F., J.S.M.), University of Florida, Gainesville, Florida; Department of Clinical, Social, and Administrative Sciences, University of Michigan College of Pharmacy, Ann Arbor, Michigan (H.-J.Z.); and Department of Surgery, Division of Transplantation (K.D.C.), and Department of Psychiatry and Behavioral Sciences (H.J.B.), Medical University of South Carolina, Charleston, South Carolina
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John S. Markowitz
Department of Pharmacotherapy and Translational Research (M.K.-S., R.F.F., B.J.B., J.S.M.) and Center for Pharmacogenomics (M.K.-S., R.F.F., J.S.M.), University of Florida, Gainesville, Florida; Department of Clinical, Social, and Administrative Sciences, University of Michigan College of Pharmacy, Ann Arbor, Michigan (H.-J.Z.); and Department of Surgery, Division of Transplantation (K.D.C.), and Department of Psychiatry and Behavioral Sciences (H.J.B.), Medical University of South Carolina, Charleston, South Carolina
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Abstract

Milk thistle (Silybum marianum) extracts are widely used as a complementary and alternative treatment of various hepatic conditions and a host of other diseases/disorders. The active constituents of milk thistle supplements are believed to be the flavonolignans contained within the extracts. In vitro studies have suggested that some milk thistle components may significantly inhibit specific cytochrome P450 (P450) enzymes. However, determining the potential for clinically significant drug interactions with milk thistle products has been complicated by inconsistencies between in vitro and in vivo study results. The aim of the present study was to determine the effect of a standardized milk thistle supplement on major P450 drug-metabolizing enzymes after a 14-day exposure period. CYP1A2, CYP2C9, CYP2D6, and CYP3A4/5 activities were measured by simultaneously administering the four probe drugs, caffeine, tolbutamide, dextromethorphan, and midazolam, to nine healthy volunteers before and after exposure to a standardized milk thistle extract given thrice daily for 14 days. The three most abundant falvonolignans found in plasma, following exposure to milk thistle extracts, were silybin A, silybin B, and isosilybin B. The concentrations of these three major constituents were individually measured in study subjects as potential perpetrators. The peak concentrations and areas under the time-concentration curves of the four probe drugs were determined with the milk thistle administration. Exposure to milk thistle extract produced no significant influence on CYP1A2, CYP2C9, CYP2D6, or CYP3A4/5 activities.

Footnotes

    • Received January 22, 2014.
    • Accepted July 15, 2014.
  • This work was supported by the National Institutes of Health National Center for Complementary and Alternative Medicine [Grant R21-AT02817] (to J.S.M.). The clinical study at the Medical University of South Carolina General Clinical Research Center was supported by National Institutes of Health National Center for Research Resources [Grant M01-RR01070-18].

  • dx.doi.org/10.1124/dmd.114.057232.

  • Copyright © 2014 by The American Society for Pharmacology and Experimental Therapeutics
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Drug Metabolism and Disposition: 42 (10)
Drug Metabolism and Disposition
Vol. 42, Issue 10
1 Oct 2014
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Research ArticleArticle

Milk Thistle and Drug-Drug Interactions

Marina Kawaguchi-Suzuki, Reginald F. Frye, Hao-Jie Zhu, Bryan J. Brinda, Kenneth D. Chavin, Hilary J. Bernstein and John S. Markowitz
Drug Metabolism and Disposition October 1, 2014, 42 (10) 1611-1616; DOI: https://doi.org/10.1124/dmd.114.057232

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Research ArticleArticle

Milk Thistle and Drug-Drug Interactions

Marina Kawaguchi-Suzuki, Reginald F. Frye, Hao-Jie Zhu, Bryan J. Brinda, Kenneth D. Chavin, Hilary J. Bernstein and John S. Markowitz
Drug Metabolism and Disposition October 1, 2014, 42 (10) 1611-1616; DOI: https://doi.org/10.1124/dmd.114.057232
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