ABSTRACT

Elevated low-density lipoprotein (LDL) cholesterol is a significant risk factor for cardiovascular disease. It is estimated that 42% of females and 34% of males in the USA have elevated total cholesterol. The current mainstay of lipid-lowering therapy utilizes 3-hydroxy-3-methylglutaryl-coezyme A (HMG-CoA) reductase inhibitor (i.e., statin) medications that lower total cholesterol and LDL cholesterol by an average of 20% and 28%, respectively. However, due to the significant side effects of statin medications, many patients seek alternative therapies to help manage their hypercholesterolemia. Red yeast rice (Monascus purpureus) has been used as a food and as an herbal medication in China for centuries. Phytosterols are foods that are similar in structure and function to animal cholesterol. Both of these compounds have been shown in clinical studies to significantly lower LDL cholesterol. We report on a case series of 18 patients with hypercholesterolemia despite therapeutic lifestyle change through diet and exercise who took a proprietary product combining red yeast rice and phytosterols as a powdered shake in an effort to improve their cholesterol indices. Statistically significant reduction (p < .05) in the following mean variables was seen: total cholesterol 19% (46 mg/dL) and LDL 33% (53 mg/dL) after 6 weeks using the blend. There was no significant difference in body mass index (BMI), triglyceride, high-density lipoprotein (HDL) cholesterol levels, or systolic and diastolic blood pressure over the same period. This magnitude of reduction in LDL cholesterol is significantly greater than the 28% reduction observed in the 1999 Journal of the American Medical Association (JAMA) meta-analysis on the average effectiveness of statin medications in lowering cholesterol levels. None of the participants in our study reported any muscle pains, and no abnormal liver function tests were seen while taking the product. Though this case series is limited by small sample size, study duration, and lack of control group, the product's significant reduction in LDL cholesterol without severe side effects indicates that this product may be a clinically effective and well tolerated alternative treatment to using statin medications to treat hypercholesterolemia.