Benefits
Lower LDL cholesterol versus placebo
In randomized placebo-controlled trials in adults with raised cholesterol, red yeast rice lowered LDL cholesterol more than placebo. A meta-analysis of 13 placebo-controlled trials (804 participants) found an average LDL reduction of 0.87 mmol/L. LDL is a blood marker, and the effect depends on monacolin K content, which varies widely between products.
LDL cholesterol over 24 weeks with a lifestyle program
In a 24-week randomized trial of 62 adults who had stopped statins because of muscle aches, red yeast rice (1,800 mg twice daily) plus a lifestyle program lowered LDL cholesterol more than placebo plus the same program. Pain scores and creatine kinase did not differ between groups. The trial was small, single-site and short.
Total cholesterol and triglyceride lowering
In a 12-week placebo-controlled trial in 83 US adults on a lower-fat diet, red yeast rice (2.4 g/day) lowered total cholesterol, LDL cholesterol and triglycerides more than placebo, while HDL cholesterol did not change. A meta-analysis of placebo-controlled trials also found lower triglycerides but no significant HDL change.
Mechanism of action
HMG-CoA reductase inhibition
Monacolin K in lactone form is identical to lovastatin and acts by inhibiting HMG-CoA reductase, an enzyme in the liver's cholesterol synthesis pathway.
Other monacolins
Red yeast rice contains 14 monacolins that inhibit cholesterol synthesis. In one analysis of 12 products, monacolin KA ranged from 0.00 to 2.30 mg per capsule alongside monacolin K, so total monacolin content differs from monacolin K alone.
Variable standardization
Monacolin K ranged from 0.10 to 10.09 mg per capsule across 12 products in one analysis. In 28 US brands, it was absent from 2 and ranged more than 60-fold (0.09 to 5.48 mg per 1,200 mg) in the rest, so the dose a consumer takes is unpredictable.
Citrinin contamination
Some Monascus strains can produce citrinin, a mycotoxin that can damage the kidneys. Four of 12 tested products had elevated citrinin. NCCIH reports that in a 37-product analysis only one product had citrinin below the EU maximum, and four contaminated products were labeled citrinin-free.
Clinical trials
Randomized, double-blind, placebo-controlled 12-week trial of 2.4 g/day with a lower-fat diet; the abstract describes a proprietary Chinese product and does not name the supplier; PubMed lists US Public Health Service and non-government support, and maker funding could not be checked (Heber et al. 1999, Am J Clin Nutr)
83 adults (46 men, 37 women, aged 34 to 78) with raised cholesterol, not taking lipid-lowering drugs.
Total cholesterol fell from 254 to 208 mg/dL by week 8 on red yeast rice, a significant difference from placebo (P < 0.001). LDL cholesterol and triglycerides were also lower than placebo; HDL cholesterol did not change significantly.
Randomized controlled trial, 1,800 mg twice daily or placebo for 24 weeks, with a 12-week lifestyle program in both groups; single community cardiology practice, NIH and non-government support listed (Becker et al. 2009, Ann Intern Med)
62 adults with dyslipidemia who had stopped statins because of muscle aches.
LDL cholesterol (primary outcome) fell by 43 mg/dL at week 12 and 35 mg/dL at week 24 on red yeast rice vs 11 and 15 mg/dL on placebo, significantly lower at both time points. HDL, triglycerides, liver enzymes, creatine kinase, weight and pain scores did not differ between groups.
Three-arm, double-blind randomized trial; red yeast rice standardized to 5 mg monacolins per day compared with phytosterols 800 mg (active control, no placebo arm); funded by University of Bologna institutional funds and the authors declared no competing interests (Cicero et al. 2017, Nutr Metab (Lond))
90 adults with moderately raised cholesterol.
LDL cholesterol fell 20.5% from baseline on red yeast rice, a significantly larger change than on phytosterols alone, which produced no significant lipid change. The combination lowered LDL more than red yeast rice alone.
Randomized, placebo-controlled multicenter trial for an average of 4.5 years of Xuezhikang, a partially purified red yeast rice extract and a different product from consumer red yeast rice supplements; a treatment result in people with established disease (Lu et al. 2008, Am J Cardiol)
Nearly 5,000 Chinese adults with a previous myocardial infarction and average LDL cholesterol at baseline.
The primary end point (nonfatal myocardial infarction or coronary death) occurred in 5.7% on Xuezhikang vs 10.4% on placebo. Cardiovascular and total mortality were 30% and 33% lower, and total and LDL cholesterol were lower.