Introduction:
Red yeast rice is made by fermenting a type of red yeast called Monascus purpureus over rice which contains Monacolin K. Monacolin K is chemically similar to lovastatin, a prescription drug used to treat high cholesterol. In the US, the Food and Drug Administration banned the sale of red yeast supplements containing lovastatin as over-the-counter supplements. Only red yeast supplements without Monacolin K were made available without a prescription. However, dietary supplements are not highly regulated and a review of 12 common brands of red yeast revealed the quantity of Monacolin K varied from 0.10 mg to 10.09 mg per capsule. (1) Red yeast rice is often used to lower cholesterol and tryglycerides. Unfortunately, red yeast rice products have been found to contain citrinin, a toxic by-product of the fermentation process.
Red yeast and cholesterol:
Cholesterol levels, red yeast rice, and phytosterols: Noting that many patients don’t take their cholesterol-lowering atins (a class of drugs used to lower cholesterol) because of side effects like muscle pain, researchers gave 18 people with high cholesterol an all-natural, cholesterol-lowering powdered shake (with almond, soy or low-fat milk) that contained 1,200 mg of red yeast rice and 1,250 mg of phytosterols. After six weeks of drinking the shake twice a day, total cholesterol dropped by an average of 19% and LDL ‘bad’ cholesterol by 33%. Other measures such as body mass index, triglyceride, HDL ‘good’ cholesterol levels, or systolic and diastolic blood pressure did not change significantly. (3)
Red yeast rice vs. statin medication: A randomized, double-blind trial compared the tolerability of red yeast rice with that of a statin drug (cholesterol lowering medications) in a population with statin-associated myalgia (ie, muscle pain, stiffness or cramps). A total of 43 adults with dyslipidemia (abnormal amount of cholesterol and/or fat in the blood) and a history of statin discontinuation due to myalgia were included. All patients were randomly assigned to either red yeast rice 4800 mg daily, taken as 4 x 600-mg capsules twice daily (Sylvan Bioproducts, Kittanning, PA) available at GNC, or pravastatin 20 mg twice daily. All participants were concurrently enrolled in a therapeutic lifestyle change program. After 12 weeks, both treatments were associated with a low incidence of treatment discontinuation due to myalgia, no evidence of muscle weakness, and a similar level of LDL (“bad”) cholesterol reduction. Mean LDL-C level decreased 30% in the red yeast rice group and 27% in the pravastatin group. Withdrawal due to myalgia was 5% in the red yeast rice group and 9% in the pravastatin group (p = 0.99). Hip flexor muscle strength did not differ between the 2 groups at week 4 (p =0.61), week 8 (p= 0.81), or week 12 (p= 0.82). This study shows that red yeast rice lowers LDL-cholesterol and may be better tolerated than pravastatin. (4)
Combination of natural agents vs. placebo for high cholesterol: Eighty elderly subjects over the age of 75 with high cholesterol were evaluated after taking red yeast rice. The subjects received either a placebo or a pill containing 500 mg of berberine, 10 mg of policosanol, 200 mg of red yeast rice, 0.2 mg of folic acid, 2 mg of CoQ10, and 0.5 mg of astaxanthin. Policosanol, a compound derived from sugar cane, has been shown to enhance healthy cholesterol metabolism. Berberine is derived from various plants used for immune and cardiovascular support. The subjects were assessed for lipid levels at the beginning of the study and again after 3, 6, and 12 months of supplementation. The results of the study showed that the supplement group showed a 20% improvement in total cholesterol, a 31% improvement in LDL ‘bad’ cholesterol, and a 10% improvement in insulin resistance. No change was seen in HDL. The study also demonstrated that safety, tolerability, and compliance were high. (2)
Red yeast rice adverse reactions, interactions:
A potentially harmful toxin has been found in red yeast rice. Citrinin is a potential cancer causing toxin found in a concentration of 0.2 to 17.1 micrograms per gram in all of the commercially produced samples of red yeast rice extract tested in a study by Sabater-Vilar M. et al. A standardized method of lab testing for cancer producing toxins was performed with the citrinin found. A dose dependent mutagenic response was noted to occur from citrinin. (5)
Purity concerns of red yeast rice: There are serious concerns about reliable purity and standardization of red yeast rice extract supplements. The total amount of active ingredients varied from 0% to 0.58%. Only 1 out of 9 brands had the full spectrum of active compounds. Citrinin is a mutagenic toxin was found to be present in 7 of the 9 preparations. (6)
Assessment and Plan: Red Yeast Rice
- Red yeast rice studies have yielded reductions (20-31%) of LDL (low density lipoprotein) and total cholesterol similar to pravastatin (a prescription cholesterol lowering statin drug). The studies mentioned had a wide variability in dosages between 200 mg to 4800 mg per day. The 1200 mg per day dose appears to be the most common.
- Unfortunately, the red yeast rice supplements tested by Sabater-Vilar M et al found that all of them contained the carcinogen citrinin (5) and Heber, D et al found that 7 of 9 brands contained citrinin (6). Citrinin is a carcinogen known to have a dose dependent mutagenicity (5). If red yeast rice is purchased for any reason, ensure that the product is tested to be citrinin free
- An additional concern is that the total amount of active ingredients varied from 0% to 0.58% in the red yeast rice products (6), and there is currently no accurate standardization for this product.
- Red yeast rice may also have adverse effects much like statin prescription drugs such as myalgias, and elevation of liver function tests.
- The risk of red yeast rice products (in spite of new citrinin-free products) outweigh the benefit until more thorough testing and standardization is completed.
References:
1.Cunningham E. Is red yeast rice safe and effective for lowering serum cholesterol? J Am Diet Assoc. 2011 Feb;111(2):324. http://www.sciencedirect.com/science/article/pii/S0002822310019917
2.Marazzi G, Cacciotti L, Pelliccia F, Iaia L, Volterrani M, Caminiti G, Sposato B, Massaro R, Grieco F, Rosano G. Long-term effects of nutraceuticals (berberine, red yeast rice, policosanol) in elderly hypercholesterolemic patients. Adv Ther. 2011 Dec;28(12):1105-13. http://www.ncbi.nlm.nih.gov/pubmed/22113535
3.Feuerstein JS, Bjerke WS, Powdered red yeast rice and plant stanols and sterols to lower cholesterol. J Diet Suppl. 2012 Jun;9(2):110-5. http://www.ncbi.nlm.nih.gov/pubmed/22531006
4.Halbert SC, French B, Gordon RY, et al. Tolerability of red yeast rice (2400 mg twice daily) versus pravastatin (20 mg twice daily) in patients with previous statin intolerance. Am J Cardiol 2010; 105:198-204. http://www.sciencedirect.com/science/article/pii/S000291490902325X
5.Sabater-Vilar M, Maas RF, Fink-Gremmels J. Mutagenicity of commercial Monascus fermentation products and the role of citrinin contamination. Mutat Res. 1999 Jul 21;444(1):7-16. http://www.ncbi.nlm.nih.gov/pubmed/10477335
6.Heber, D., Lembertas, A., Lu, Q. Y., Bowerman, S., and Go, V. L. 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):133-139. http://www.ncbi.nlm.nih.gov/pubmed/11327519