Written by Susan Sweeny Johnson, PhD, Biochem. Of the 62 patients with statin-induced myalgia, those who took 1800 mg per day of red yeast rice for 24 weeks had no significant changes in HDL cholesterol, triglycerides, markers for muscle degeneration, or pain.
In an effort to reduce LDL cholesterol and prevent heart disease, many people have taken statins that block the synthesis of cholesterol in the human liver. These statins are not without side effects that often cause people to seek alternative treatment. For example, statin users can develop intense muscle pain called statin-induced myalgia (SAM). The incidence of SAM may be as high as 10% (1) and may affect approximately 1.3 million people in the United States (2).
One of the most common alternatives statin-intolerant people turn to is red yeast rice. In 2006, American consumers spent $17 million on this dietary supplement, a 55% increase from 2005 (3). Red yeast rice contains a variety of statins, the most prevalent being lovastatin.
In this new study, 62 patients who had SAM and could not continue with regular statin therapy were randomly selected to receive either 1800 mg per day of red yeast rice containing 7.8 mg of monacolins (statins) or a placebo for 24 weeks. Both groups were also given therapeutic lifestyle counseling for 12 months and were regularly checked for compliance. The lifestyle counseling included instruction in Mediterranean diet (4,5), exercise and relaxation, which have been shown to reduce lipid levels (6).
The Center for Disease Control issued the following guidelines for LDL cholesterol (7):
- Optimal: < 100mg/dl
- Near optimal: 100-120 mg/dl
- High: 160-189 mg/dl
Results indicated that red yeast rice reduced LDL cholesterol significantly from baseline (163.3 mg/dl) to120.0 mg/dl (26.5%) at 12 weeks and to 128.3 mg/dl (21.3%) at 24 weeks. The placebo group LDL cholesterol was reduced somewhat from baseline (165.1 mg/dl) to 154.2 mg/dl at 12 weeks (6.8%) and to 149.8 mg/dl at 24 weeks (9.5%). The difference was statistically significant (p<0.001 and p<0.011 for 12 and 24 weeks respectively). Total cholesterol was significantly reduced at 12 weeks (20.8% with red yeast rice compared to 5.6% with placebo, p<0.001) and 24 weeks (p<0.016 for the difference). Note that a 10% decrease in total blood cholesterol levels can reduce the incidence of heart disease by as much as 30%(7).
The slight increase in LDL cholesterol at 24 weeks in the red yeast rice group may be due to decreased compliance with diet and exercise after 12 weeks. The cholesterol decreases seen with placebo use are thought to correlate with improved diet and exercise. No significant changes in HDL cholesterol, triglycerides, markers for muscle degeneration, or pain occurred during the study.
Although red yeast rice contains statins, it is apparently less likely to cause SAM, since typically a patient with SAM will develop myalgia in response to a new statin 57% of the time (8). In this case, no statistically significant change in pain was associated with red yeast rice ingestion, although two patients from the red yeast rice group and one from the placebo group developed intolerable myalgia and discontinued treatment. The established therapeutic dose of statin is 20 to 40 mg per day (9) but in red yeast rice the participants were getting only 7.8 mg per day at the most. The lower levels of statin may be responsible for reduced myalgia or perhaps some other components of the red yeast rice.
A larger trial with longer follow-up is needed to determine whether red yeast rice can offer an effective solution for the large group of statin-intolerant patients who need to reduce their cholesterol levels.
The American Heart Association estimates that the direct and indirect costs for cardiovascular disease caused by high LDL cholesterol will be $431.8 billion (7). This estimate includes costs of more than $151.6 billion annually for coronary heart disease. Statins alone vary in cost from $32 to $150 a month per patient (10).
Source: Becker, David J., et al. “Red yeast rice for dyslipidemia in statin-intolerant patients a randomized trial.” Annals of internal medicine 150.12 (2009): 830-839.
© 2009, The American College of Physicians
Posted July 9, 2009.
References:
- Kashani A, Phillips CO, Foody JM, Wang Y, Mangalmurti S, Ko DT, et al. Risks associated with statin therapy: a systematic overview of randomized clinical trials. Circulation. 2006;114:2788-97. [PMID: 17159064].
- Mitka M. Expanding statin use to help more at-risk patients is causing financial heartburn. JAMA. 2003;290:2243-5. [PMID: 14600168]
- NBJ’s Supplement Business Report 2007. Boulder, CO: Nutrition Business Journal; 2008:240.
- de Lorgeril M, Salen P, Martin JL, Monjaud I, Delaye J, Mamelle N.Mediterranean diet, traditional risk factors, and the rate of cardiovascular complications after myocardial infarction: final report of the Lyon Diet Heart Study. Circulation. 1999;99:779-85. [PMID: 9989963]
- Trichopoulou A, Orfanos P, Norat T, Bueno-de-Mesquita B, Ocke´ MC,Peeters PH, et al. Modified Mediterranean diet and survival: EPIC-elderly prospective cohort study. BMJ. 2005;330:991. [PMID: 15820966]
- Vogel JH, Bolling SF, Costello RB, Guarneri EM, Krucoff MW, Longhurst JC, et al; American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents (Writing Committee to Develop an Expert Consensus Document on Complementary and Integrative Medicine). Integrating
complementary medicine into cardiovascular medicine. A report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus. Cardiol. 2006;97:6C-26C. [PMID: 16581330] - See the Centers for Disease Control and Prevention website.
- Hansen KE, Hildebrand JP, Ferguson EE, Stein JH. Outcomes in 45 patients with statin-associated myopathy. Arch Intern Med. 2005;165:2671-6. [PMID: 16344427]
- Bradford RH, Shear CL, Chremos AN, Dujovne CA, Franklin FA, Grillo RB, et al. Expanded Clinical Evaluation of Lovastatin (EXCEL) study results:two-year efficacy and safety follow-up. Am J Cardiol. 1994;74:667-73. [PMID:7942524]
- Wikipedia
