Red yeast rice (Monascus purpureus), a traditional Chinese medication, has been used for many years to effectively lower cholesterol.1,2 As a natural alternative to treat dyslipidemia, red yeast rice has the same chemical identity as lovastatin.1 Lovastatin along with the other HMG Co-A reductase inhibitors (statins) have been associated with statin-associated myopathy (SAM). This clinical syndrome can occur in 5% to 10% of statin users.2,3 Myopathy may be further categorized as myalgias (muscle pain), myositis (enzyme leak with increased creatine kinase levels), or rhabdomyolysis (creatine kinase elevations >10,000 u/L associated with acute renal failure). There is no consensus on how to treat dyslipidemias in patients who cannot tolerate statin therapy due to SAM. While, red yeast rice has been associated with the development of symptomatic myopathies only in case reports, it is perceived by some to be a ”real” alternative to statin therapy.4 A recent clinical trial evaluated the effectiveness and tolerability of red yeast rice for lipid management in statin-intolerant patients.
Becker et al published the results of what is believed to be the first randomized control trial that looked at the lipid lowering effects of red yeast rice in 62 statin-intolerant patients over a period of 24 weeks. The study included adult patients with known hypercholesterolemia, who had discontinued at least 1 statin because of myalgias, with resolution of muscle pain upon discontinuation of medication. The participants were randomly assigned to received either three 600mg red yeast rice capsules twice a day (n=31) or three similar placebo capsules twice a day (n=31). All participants were enrolled in a 12 week therapeutic lifestyle change program that was initiated and completed in the first half of the study. Patients were excluded if they had received either a statin or red yeast rice one month prior to random assignment or had a history of statin-associated myositis, rhabdomyolysis, chronic pain or inability to exercise.
The primary outcome was low-density lipoprotein cholesterol level, measured at baseline, week 12, and week 24. Secondary outcomes included total cholesterol, high-density lipoprotein cholesterol, triglyceride, liver enzyme, and creatinine kinase levels, weight, and a Brief Pain Inventory Score (BPI-sf).3 The scores range from 0 (no pain) to 10 (worst pain imaginable). Of the 174 patients assessed to be a part of the study only 62 were randomized to receive either red yeast rice or placebo. The average age was 61. Forty (65%) of the 62 patients were female. Baseline characteristics were similar except in BPI-sf score, which was significantly higher in the placebo group (mean score = 2.6) versus the red yeast rice group (mean score = 1.4) (P = 0.026).
The baseline LDL level was 163 mg/dL in the red yeast rice group and 165 mg/dL in the placebo group. After 24 weeks the LDL levels were 128 mg/dL and 150 mg/dL respectively. The mean percentage change in LDL cholesterol from baseline in the red yeast rice group was –21% at week 24 compared to ...