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Research & Reports

  • A Meta-Analysis of Red Yeast Rice

    Objective
    To explore whether red yeast rice is a safe and effective alternative approach for dyslipidemia.

    Results
    A total of 13 randomized, placebo-controlled trials containing 804 participants were analyzed. Red yeast rice exhibited significant lowering effects on serum TC [WMD = −0.97 (95% CI: −1.13, −0.80) mmol/L, P<0.001], TG [WMD = −0.23 (95% CI: −0.31, −0.14) mmol/L, P<0.001], and LDL-C [WMD = −0.87 (95% CI: −1.03, −0.71) mmol/L, P<0.001] but no significant increasing effect on HDL-C [WMD = 0.08 (95% CI: −0.02, 0.19) mmol/L, P = 0.11] compared with placebo. No serious side effects were reported in all trials.The meta-analysis suggests that red yeast rice is an effective and relatively safe approach for dyslipidemia. However, further long-term, rigorously designed randomized controlled trials are still warranted before red yeast rice could be recommended to patients with dyslipidemia.

    Source
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4045580.

  • Scientific Opinion on the Substantiation of Health Claims Related to Monacolin K from Red Yeast Rice and Maintenance of Normal Blood LDL Cholesterol Concentrations

    Objective
    Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to monacolin K from red yeast rice and maintenance of normal blood LDL cholesterol concentrations. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders.

    Results
    The food that is the subject of the health claim is red yeast rice (i.e. rice fermented with the red yeast Monascus purpureus). The Panel considers that, whereas red yeast rice is not sufficiently characterised in relation to the claimed effect, the food constituent, monacolin K from red yeast rice, is sufficiently characterised.

    The claimed effects are “cholesterol” and “cholesterol management/heart health”. The target population is assumed to be adults in the general population. In the context of the proposed wordings, the Panel assumes that the claimed effect refers to maintenance of normal blood LDL cholesterol concentrations. The Panel considers that maintenance of normal blood LDL cholesterol concentrations is a beneficial physiological effect.

    On the basis of the data presented, the Panel concludes that a cause and effect relationship has been established between the consumption of monacolin K from red yeast rice and maintenance of normal blood LDL cholesterol concentrations.

    The Panel considers that in order to obtain the claimed effect, 10 mg of monacolin K from fermented red yeast rice preparations should be consumed daily. The target population is adults in the general population.

    In relation to restrictions of use, the Panel refers to the Summary of Product Characteristics of lovastatin containing medicinal products available on the EU market.

    Source
    http://www.efsa.europa.eu/en/efsajournal/pub/2304.htm.

  • Scientific Opinion on the Substantiation of a Health Claim Related to SYLVAN BIO Red Yeast Rice and Maintenance of Normal Blood LDL-Cholesterol Concentrations

    Objective
    Following an application from Sylvan Bio Europe BV, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to monacolin K in SYLVAN BIO red yeast rice and maintenance of normal blood LDL-cholesterol concentrations.

    Results
    The food, monacolin K in SYLVAN BIO red yeast rice, that is the subject of the health claim is sufficiently characterised. The claimed effect, maintenance of normal blood LDL cholesterol concentrations, is a beneficial physiological effect. A claim on monacolin K from red yeast rice and maintenance of normal blood LDL-cholesterol concentrations has already been assessed with a favourable outcome at daily intakes of 10 mg monacolin K from any red yeast rice preparation (which would include SYLVAN BIO red yeast rice). The evidence provided by the applicant for the present application does not establish that monacolin K in SYLVAN BIO red yeast rice is different from monacolin K in other red yeast rice preparations with respect to its effect on blood LDL-cholesterol concentrations.

    Source
    Suggested citation: EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA). Scientific Opinion on the substantiation of a health claim related to monacolin K in SYLVAN BIO red yeast rice and maintenance of normal blood LDL-cholesterol concentrations pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 2013;11(2):3084. [13 pp.]. doi:10.2903/j.efsa.2013.3084. Available online:www.efsa.europa.eu/efsajournal.

  • Red Yeast Rice & Therapeutic Lifestyles

    Objective
    A randomized, controlled trial through a community based cardiology practice found that Red Yeast Rice and therapeutic lifestyle change decreases LDL cholesterol level without increasing CPK or pain levels and may be a treatment option for dyslipidemic patients who cannot tolerate statin therapy. Below are the results and a link to the original article.

    Results
    In the red yeast rice group, LDL cholesterol decreased by 1.11 mmol/L (43 mg/dL) from baseline at week 12 and by 0.90 mmol/L (35 mg/dL) at week 24. In the placebo group, LDL cholesterol decreased by 0.28 mmol/L (11 mg/dL) at week 12 and by 0.39 mmol/L (15 mg/dL) at week 24. Low-density lipoprotein cholesterol level was significantly lower in the red yeast rice group than in the placebo group at both weeks 12 (P < 0.001) and 24 (P = 0.011). Significant treatment effects were also observed for total cholesterol level at weeks 12 (P < 0.001) and 24 (P = 0.016). Levels of HDL cholesterol, triglyceride, liver enzyme, or CPK; weight loss; and pain severity scores did not significantly differ between groups at either week 12 or week 24.

    Source 
    David J. Becker, Ram Y. Gordon, Steven C. Halbert, Benjamin French, Patti B. Morris, Daniel J. Rader; Red Yeast Rice for Dyslipidemia in Statin-Intolerant PatientsA Randomized Trial. Annals of Internal Medicine. 2009 Jun;150(12):830-839.  http://annals.org/article.aspx?articleid=744541.

  • Simvastatin vs Therapeutic Lifestyle Changes and Supplements

    Objective
    The goal of this study was to compare the lipid-lowering effects of an alternative regimen (lifestyle changes, red yeast rice, and fish oil) with a standard dose of a 3-hydroxy-3-methylglutaryl coenzyme A reduc-tase inhibitor (statin). The randomized, controlled study concluded that lifestyle changes combined with ingestion of Red Yeast Rice and fish oil is a promising alternative approach to the standard therapy of Simvastatin.

    Results
    There was a statistically significant reduction in LDL-C levels in both the AG (-42.4%±15%) (P<.001) and the simvastatin group (-39.6%±20%) (P<.001). No significant differences were noted between groups. The AG also demonstrated significant reductions in triglycerides (-29% vs -9.3%; 95% confidence interval, -61 to -11.7; P=.003) and weight (-5.5% vs -0.4%; 95% confidence interval, -5.5 to -3.4; P<.001) compared with the simvastatin group.

    Source
    David J. Becker, Ram Y. Gordon, Patti B. Morris, Jacqueline Yorko, Y. Jerold Gordon, Mingyao Li, Nayyar Iqbal. Simvastatin vs Therapeutic Lifestyle Changes and Supplements: Randomized Primary Prevention Trial. Mayo Clinic Proceedings - July 2008 (Vol. 83, Issue 7, Pages 758-764, DOI: 10.4065/83.7.758) http://www.mayoclinicproceedings.org/article/S0025-6196(11)60914-2/abstract.

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