Marked Variability of Monacolin Levels in Commercial Red Yeast Rice Products: Buyer Beware! | Cardiology | JAMA Internal Medicine | JAMA Network
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1.
Knox  JGaster  B Dietary supplements for the prevention and treatment of coronary artery disease.  J Altern Complement Med 2007;13 (1) 83- 95PubMedGoogle ScholarCrossref
2.
Szapary  POWolfe  MLBloedon  LT  et al.  Guggulipid for the treatment of hypercholesterolemia: a randomized controlled trial.  JAMA 2003;290 (6) 765- 772PubMedGoogle ScholarCrossref
3.
Berthold  HKUnverdorben  SDegenhardt  RBulitta  MGouni-Berthold  I Effect of policosanol on lipid levels among patients with hypercholesterolemia or combined hyperlipidemia: a randomized controlled trial.  JAMA 2006;295 (19) 2262- 2269PubMedGoogle ScholarCrossref
4.
Caron  MFWhite  CM Evaluation of the antihyperlipidemic properties of dietary supplements.  Pharmacotherapy 2001;21 (4) 481- 487PubMedGoogle ScholarCrossref
5.
Praça  JMThomaz  ACaramelli  B Eggplant (Solanum melongena) extract does not alter serum lipid levels.  Arq Bras Cardiol 2004;82 (3) 269- 276PubMedGoogle ScholarCrossref
6.
Ulbricht  CBasch  ESzapary  P  et al. Natural Standard Research Collaboration, Guggul for hyperlipidemia: a review by the Natural Standard Research Collaboration.  Complement Ther Med 2005;13 (4) 279- 290PubMedGoogle ScholarCrossref
7.
Endo  AMonacolin  K A new hypocholesterolemic agent produced by a Monascus species.  J Antibiot (Tokyo) 1979;32 (8) 852- 854PubMedGoogle ScholarCrossref
8.
Huang  CFLi  TCLin  CCLiu  CSShih  HCLai  MM Efficacy of Monascus purpureus Went rice on lowering lipid ratios in hypercholesterolemic patients.  Eur J Cardiovasc Prev Rehabil 2007;14 (3) 438- 440PubMedGoogle ScholarCrossref
9.
Lin  CCLi  TCLai  MM Efficacy and safety of Monascus purpureus Went rice in subjects with hyperlipidemia.  Eur J Endocrinol 2005;153 (5) 679- 686PubMedGoogle ScholarCrossref
10.
Heber  DYip  IAshley  JMElashoff  DAElashoff  RMGo  VL Cholesterol-lowering effects of a proprietary Chinese red-yeast-rice dietary supplement.  Am J Clin Nutr 1999;69 (2) 231- 236PubMedGoogle Scholar
11.
Li  YGZhang  FWang  ZTHu  ZB Identification and chemical profiling of monacolins in red yeast rice using high-performance liquid chromatography with photodiode array detector and mass spectrometry.  J Pharm Biomed Anal 2004;35 (5) 1101- 1112PubMedGoogle ScholarCrossref
12.
Becker  DJGordon  RYHalbert  SCFrench  BMorris  PBRader  DJ Red yeast rice for dyslipidemia in statin-intolerant patients: a randomized trial.  Ann Intern Med 2009;150 (12) 830- 839, W147-W149PubMedGoogle ScholarCrossref
13.
Becker  DJGordon  RYMorris  PB  et al.  Simvastatin vs therapeutic lifestyle changes and supplements: randomized primary prevention trial.  Mayo Clin Proc 2008;83 (7) 758- 764PubMedGoogle ScholarCrossref
14.
Mast  C Red yeast rice research triggers (mostly) positive news for supplements. http://blog.nutritionbusinessjournal.com/nbj/2009/06/16/red-yeast-rice-research-triggers-mostly-positive-news-for-supplements/. Accessed July 3, 2009
15.
Gurley  BJGardner  SFHubbard  MA Content versus label claims in ephedra-containing dietary supplements.  Am J Health Syst Pharm 2000;57 (10) 963- 969PubMedGoogle Scholar
16.
ConsumerLab.com, Product review of red yeast rice supplements. http://www.consumerlab.com/reviews/Red_Yeast_Rice_Supplements-Lovastatin_Monacolin/Red_Yeast_Rice/. Accessed July 3, 2009
17.
Eisenberg  DMKessler  RCFoster  CNorlock  FECalkins  DRDelbanco  TL Unconventional medicine in the United States: prevalence, costs, and patterns of use.  N Engl J Med 1993;328 (4) 246- 252PubMedGoogle ScholarCrossref
18.
Cohen  PA American roulette—contaminated dietary supplements.  N Engl J Med 2009;361 (16) 1523- 1525PubMedGoogle ScholarCrossref
19.
Qato  DMAlexander  GCConti  RMJohnson  MSchumm  PLindau  ST Use of prescription and over-the-counter medications and dietary supplements among older adults in the United States.  JAMA 2008;300 (24) 2867- 2878PubMedGoogle ScholarCrossref
20.
Kaptchuk  TJEisenberg  DM The persuasive appeal of alternative medicine.  Ann Intern Med 1998;129 (12) 1061- 1065PubMedGoogle ScholarCrossref
21.
Eisenberg  DMDavis  RBEttner  SL  et al.  Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey.  JAMA 1998;280 (18) 1569- 1575PubMedGoogle ScholarCrossref
22.
Mast  C 2008 Nutrition industry overview.  Nutrition Business J 2008;13 (6/7) 3Google Scholar
23.
Heber  DLembertas  ALu  QYBowerman  SGo  VL An analysis of nine proprietary Chinese red yeast rice dietary supplements: implications of variability in chemical profile and contents.  J Altern Complement Med 2001;7 (2) 133- 139PubMedGoogle ScholarCrossref
24.
Kimpel  P The Cholestin case: drugs vs. supplements. http://iml.jou.ufl.edu/projects/Spring2000/Kimpel/cholestin.html. Accessed September 29, 2009
25.
Lu  ZKou  WDu  B  et al. Chinese Coronary Secondary Prevention Study Group, Effect of Xuezhikang, an extract from red yeast Chinese rice, on coronary events in a Chinese population with previous myocardial infarction.  Am J Cardiol 2008;101 (12) 1689- 1693PubMedGoogle ScholarCrossref
26.
Li  JJLu  ZLKou  WR  et al. Chinese Coronary Secondary Prevention Study Group, Beneficial impact of Xuezhikang on cardiovascular events and mortality in elderly hypertensive patients with previous myocardial infarction from the China Coronary Secondary Prevention Study (CCSPS).  J Clin Pharmacol 2009;49 (8) 947- 956PubMedGoogle ScholarCrossref
27.
Halbert  SCFrench  BGordon  RY  et al.  Tolerability of red yeast rice (2,400 mg twice daily) versus pravastatin (20 mg twice daily) in patients with previous statin intolerance.  Am J Cardiol 2010;105 (2) 198- 204PubMedGoogle ScholarCrossref
28.
Venero  CVVenero  JVWortham  DCThompson  PD Lipid-lowering efficacy of red yeast rice in a population intolerant to statins.  Am J Cardiol 2010;105 (5) 664- 666PubMedGoogle ScholarCrossref
29.
Department of Health and Human Services; US Food and Drug Administration, Current good manufacturing practice in manufacturing, production, labeling, or holding operations for dietary supplements. http://www.fda.gov/ohrms/dockets/98fr/cf0441.pdf. Accessed August 27, 2010
30.
Liu  JZhang  JShi  YGrimsgaard  SAlraek  TFønnebø  V Chinese red yeast rice (Monascus purpureus) for primary hyperlipidemia: a meta-analysis of randomized controlled trials.  Chin Med 2006;14PubMedGoogle ScholarCrossref
31.
Lapi  FGallo  EBernasconi  S  et al.  Myopathies associated with red yeast rice and liquorice: spontaneous reports from the Italian Surveillance System of Natural Health Products.  Br J Clin Pharmacol 2008;66 (4) 572- 574PubMedGoogle ScholarCrossref
32.
Mueller  PS Symptomatic myopathy due to red yeast rice.  Ann Intern Med 2006;145 (6) 474- 475PubMedGoogle ScholarCrossref
33.
Smith  DJOlive  KE Chinese red rice-induced myopathy.  South Med J 2003;96 (12) 1265- 1267PubMedGoogle ScholarCrossref
34.
Vercelli  LMongini  TOlivero  NRodolico  CMusumeci  OPalmucci  L Chinese red rice depletes muscle coenzyme Q10 and maintains muscle damage after discontinuation of statin treatment.  J Am Geriatr Soc 2006;54 (4) 718- 720PubMedGoogle ScholarCrossref
35.
Cartin-Ceba  RLu  LBKolpakchi  A A “natural” threat.  Am J Med 2007;120 (11) e3- e4PubMedGoogle ScholarCrossref
36.
Roselle  HEkatan  ATzeng  JSapienza  MKocher  J Symptomatic hepatitis associated with the use of herbal red yeast rice.  Ann Intern Med 2008;149 (7) 516- 517PubMedGoogle ScholarCrossref
37.
Prasad  GVWong  TMeliton  GBhaloo  S Rhabdomyolysis due to red yeast rice (Monascus purpureus) in a renal transplant recipient.  Transplantation 2002;74 (8) 1200- 1201PubMedGoogle ScholarCrossref
38.
Sabater-Vilar  MMaas  RFFink-Gremmels  J Mutagenicity of commercial Monascus fermentation products and the role of citrinin contamination.  Mutat Res 1999;444 (1) 7- 16PubMedGoogle ScholarCrossref
39.
Endo  AKuroda  M Citrinin, an inhibitor of cholesterol synthesis.  J Antibiot (Tokyo) 1976;29 (8) 841- 843PubMedGoogle ScholarCrossref
40.
Dönmez-Altuntas  HDumlupinar  GImamoglu  NHamurcu  ZLiman  BC Effects of the mycotoxin citrinin on micronucleus formation in a cytokinesis-block genotoxicity assay in cultured human lymphocytes.  J Appl Toxicol 2007;27 (4) 337- 341PubMedGoogle ScholarCrossref
Original Investigation
October 25, 2010

Marked Variability of Monacolin Levels in Commercial Red Yeast Rice Products: Buyer Beware!

Author Affiliations

Author Affiliations: Division of Cardiology, Chestnut Hill Hospital, University of Pennsylvania Health System, Philadelphia, and Abington Memorial Hospital, Abington, Pennsylvania (Drs Gordon and Becker); and ConsumerLab.com, White Plains, New York (Drs Cooperman and Obermeyer).

Arch Intern Med. 2010;170(19):1722-1727. doi:10.1001/archinternmed.2010.382
Abstract

Background  Red yeast rice (RYR) is a widely available dietary supplement used by millions of patients as an alternative therapy for hyperlipidemia. It contains 14 active compounds called monacolins that inhibit hepatic cholesterol synthesis. Although studies have suggested that some formulations of RYR may be effective and safe for lipid lowering, monacolin levels are not standardized among marketed products and are generally not published on labels. We evaluated monacolin levels in 12 commercial RYR formulations and tested for citrinin, a mycotoxin that is nephrotoxic in animals.

Methods  Each formulation of RYR was labeled “600 mg/capsule” of active product. Analyses for monacolins and citrinin were performed between August 2006 and June 2008 using high-performance liquid chromatography with mass spectroscopy–mass spectroscopy detection. Laboratory analyses of RYR products were conducted by ConsumerLab.com, White Plains, New York.

Results  There was marked variability in the 12 RYR products in total monacolins (0.31-11.15 mg/capsule), monacolin K (lovastatin) (0.10-10.09 mg/capsule), and monacolin KA (0.00-2.30 mg/capsule). Four products had elevated levels of citrinin.

Conclusions  We found striking variability in monacolin content in 12 proprietary RYR products and the presence of citrinin in one-third of the formulations tested. Although RYR may have potential as an alternative lipid-lowering agent, our findings suggest the need for improved standardization of RYR products and product labeling. Until this occurs, physicians should be cautious in recommending RYR to their patients for the treatment of hyperlipidemia and primary and secondary prevention of cardiovascular disease.

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