Is Red Yeast Rice safe?
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Safety of Red Yeast Rice: A Comprehensive Review
Introduction to Red Yeast Rice Safety
Red Yeast Rice (RYR) is a traditional Chinese supplement known for its cholesterol-lowering properties. It contains monacolin K, a compound chemically identical to lovastatin, a prescription statin. Despite its benefits, concerns about its safety have emerged, prompting numerous studies to evaluate its risk profile.
Musculoskeletal Disorders and Red Yeast Rice
A meta-analysis of 53 randomized controlled trials (RCTs) involving 8,535 subjects found that RYR supplementation did not increase the risk of musculoskeletal disorders (MuD) compared to control groups (odds ratio (OR) = 0.94, 95% confidence interval (CI) 0.53, 1.65) . This suggests that RYR is generally safe concerning musculoskeletal health.
Non-Musculoskeletal Adverse Events
The same meta-analysis reported a reduced risk of non-musculoskeletal adverse events (Non-MuD) and serious adverse events (SAE) in the RYR group compared to controls (OR = 0.59, 95% CI 0.50, 0.69 for Non-MuD; OR = 0.54, 95% CI 0.46, 0.64 for SAE) . This indicates a favorable safety profile for RYR in terms of general adverse events.
Liver and Kidney Safety
A systematic review and meta-analysis of 20 studies highlighted that the incidence of liver and kidney injury was low (0-5%) and not significantly different between RYR and control groups (risk difference -0.01 [-0.01; 0.0] for liver injury and 0.0 [-0.01; 0.02] for kidney injury). This suggests that RYR does not pose a significant risk to liver and kidney health when used appropriately.
Safety in Children
A study involving hypercholesterolemic children treated with a combination of RYR extract and policosanols found no adverse effects on liver and muscle enzymes (AST, ALT, and CK). This indicates that RYR can be safe for short-term use in children with dyslipidemia.
Regulatory Concerns and Quality Control
Despite its benefits, the US Food and Drug Administration (FDA) has prohibited the sale of RYR products containing monacolin K due to its similarity to lovastatin, classifying it as an unapproved drug . This highlights the need for standardized and regulated RYR products to ensure consumer safety.
Conclusion
Overall, Red Yeast Rice appears to be a safe and effective supplement for lowering cholesterol levels, with a low incidence of adverse effects. However, the variability in monacolin K content and the lack of long-term safety data necessitate caution. Regulatory measures and further rigorous studies are essential to confirm its safety profile and ensure consumer protection.
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