רקע: Red yeast rice is a nutritional supplement that has an effect on lowering the level of low-density lipoprotein (LDL) cholesterol.
Aim of the study: to evaluate the efficacy and tolerability of red yeast rice and a therapeutic lifestyle change for treating dyslipidemia in patients who cannot receive statin treatment (cholesterol-lowering medications).
חולים: 62 patients with dyslipidemia and a history of stopping statin treatment due to various side effects.
התערבות: The patients were divided by software, in random allocation, to receive a red yeast rice supplement, at a dose of 1800 mg (31 patients), or placebo (31 patients), twice a day for 24 weeks. All patients were simultaneously enrolled in a 12-week therapeutic lifestyle change program.
מדדים: The primary outcome was the LDL cholesterol level, measured at the start of the study, at week 12, and at week 24. Secondary measures included the total cholesterol level, high-density lipoprotein (HDL) cholesterol, triglycerides, liver enzymes and creatine phosphokinase (CPK) and weight; the subjects were asked to fill out a short questionnaire on the subject of pain.
תוצאות: In the ‘red yeast rice’ group, LDL cholesterol decreased by 1.11 mmol/L (43 mg/dL) from the starting point at week 12 and by 0.90 mmol/L (35 mg/dL) at week 24.
In the placebo group, LDL cholesterol levels decreased by 0.28 mmol/L (11 mg/dL) at week 12 and by 0.39 mmol/L (15 mg/dL) at week 24. The low-density lipoprotein cholesterol level was significantly lower in the ‘red yeast rice’ group compared to 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, triglycerides, liver enzymes, or CPK; weight loss, and pain severity scores were not significantly different between the groups.
מסקנה: ‘Red yeast rice’ at a therapeutic level combined with lifestyle change led to a decrease in LDL cholesterol without increasing CPK levels or pain and may be a treatment option for patients with high levels of blood lipids and cholesterol who cannot tolerate statin treatment.