Fish Oil and Red Yeast Rice vs. Simvastatin to Reduce Cholesterol?
Lifestyle change, Fish oil, and Red Yeast Rice vs. Simvastatin:
High cholesterol is a serious risk factor for cardiovascular disease. Though the efficacy of statin type medications are well-established, the compliance rate of these drugs can be lowered by patient concerns over side-effects as well as medication costs.
Key Points:
- Lifestyle change (read Mediterranean diet/aerobic exercise), fish oil (dietary supplement), and red yeast rice (dietary supplement) lowered LDL cholesterol (bad cholesterol) similarly to medication (Simvastatin).
- The combined therapy with lifestyle change etc, also lowered trigylcerides more than Simvastatin.
- Both red yeast rice and Simvastatin have the potential to cause a dangerous side effect known as rhabdomyolysis (see comments).
- A recent, open-label trial, compared two interventions for people with hypercholesterolemia (Becker et al, 2008). The first group received conventional treatment with 40mg/d of Simvastatin while the second group received an intervention which included education on diet (mediterranean diet), exercise (aerobic), as well as daily consumption of red yeast rice (hong qu) and fish oil capsules.
Intervention:
- Group 1: 40 mg /day of Simvastatin
- Group 2: Mediterranean diet education, instructed to exercise (aerobic exercise) by an exercise physiologist., consume capsules of both red yeast rice
(Each capsule had a total monacolin content of 5.3 mg, of which 2.53 mg was monacolin K (lovastatin)] and fish oil (3 capsules daily).
Results:
- Statistically significant reduction in LDL-C levels in both the AG [alternative treatment group] (-42.4%+/-15%) (P<.001) and the simvastatin group (-39.6%+/-20%) (P<.001).
- No significant differences were noted between groups.
- The AG (alternative treatment group) also demonstrated significant reductions in triglycerides (-29% vs -9.3%; 95% confidence interval, -61 to -11.7; P=.003) and weight (-5.5% vs -0.4%; 95% confidence interval, -5.5 to -3.4; P<.001) compared with the simvastatin group.
Safety:
“In the simvastatin group, 3 patients experienced musculoskeletal symptoms. One completed the protocol, taking 40 mg of simvastatin daily until the end of the study. Two patients stopped their simvastatin regimen for 3 days, per protocol. Their CK levels were normal, and they completed the study taking 20 mg/d.”
“In the AG, one patient had a baseline CK level of 232 U/L, which increased to 1532 U/L on routine testing at the completion of the study. He was completely asymptomatic, was engaged in vigorous exercise the night before his blood test, and was taking 3 capsules of RYR twice daily. After the study was completed, medication and exercise were stopped, and his CK level returned to normal. Two patients noted heartburn that resolved when they were switched to equivalent doses of a liquid form of fish oil (ResQ 1250 liquid) from the same manufacturer.”
Conclusion:
“Lifestyle changes combined with ingestion of red yeast rice and fish oil reduced LDL-C in proportions similar to standard therapy with simvastatin.”
Limitations:
- The study authors also concluded that these results needed to be confirmed in larger trials.
- One issue with this study that clouds the results to some extent is the fact that the alternative treatment group involved several different interventions including implementing the Mediterranean diet, aerobic exercise as well as consuming capsules of both Chinese red yeast rice and fish oil. As a result, it is difficult to be certain how much of the cholesterol lowering achieved could be attributable to each separate intervention.
- The study itself was an open-label trial which essentially means that the study was not blinded or that both the patients as well as the study authors were aware of the interventions that the patients were receiving.
Reference:
- Becker DJ, Gordon RY, Morris PB, Yorko J, Gordon YJ, Li M, Iqbal N. Simvastatin vs therapeutic lifestyle changes and supplements: randomized primary prevention trial. Mayo Clin Proc. 2008 Jul;83(7):758-64.
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8 Comments
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Jarret Morrow
Oh, there was a recent 'letter to the editor' published in the British Journal of Pharmacology which discussed case reports of rhabdomyolysis from red yeast rice [Monascus purpureus] (Lapi et al, 2008). Key points: ***1. Patients who have had a previous 'statin intolerance' should be cautioned about using red yeast rice! ***2. Do not take red yeast rice if you're currently taking a statin type medication! ***3. If you're taking either a statin medication or red yeast rice and you experience unexplained muscle pain, tenderness, or weakness, seek medical care immediately and have your CK (creatine kinase) levels checked. Read: If you have had previous a previous statin myopathy or rhabdomyolysis, taking red yeast rice is a very bad idea! Reference: Lapi F, Gallo E, Bernasconi S, Vietri M, Menniti-Ippolito F, Raschetti R, Gori L, Firenzuoli F, Mugelli A, Vannacci A. Myopathies associated with red yeast rice and liquorice: spontaneous reports from the Italian Surveillance System of Natural Health Products. Br J Clin Pharmacol. 2008 Oct;66(4):572-4. Epub 2008 May 21.
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Dr. Nicole Sundene
Recently Consumer Labs also found some serious issues with consistency in lovastatin concentrations found in red yeast rice. As much as I prefer to use natural medicines when at all possible, I am not that big of a fan of red yeast rice unless it is a buy a pharmaceutical grade company, as lack of regulation could likely cause rhadomyloysis or similar side effects of statins. People think that just because a statin is "natural" that it is safer. However, although the flaw in this study is that a variety of therapeutics were used, really that is the only way to be successful with cholesterol control using natural means. Diet, exercise, fish oil, therapeutic foods and supplements are all needed to work in synergy to get those numbers down.
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Don Levasseur PharmD
An important point here is the ingredient in red yeast rice (lovastatin) is marketed in the US as a pharmaceutical. It is a statin like the simvastatin used in this study. The FDA prohibits the sale of red yeast rice which have more than trace amounts of lovastatin and has sent warning letters to manufactures who market the product. Two things come to mind here. First, just because the source of lovastatin here is natural does not make it a safer product. Lovastatin as a higher frequency of side effects than simvastatin. Second, how much of the cholesterol lowering seen here was due to the lovastatin? I would like to see this study without the red yeast rice because I believe there are huge benefits to lifestyle modifications and they are too frequently overlooked in t he medical community.
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Jeff Korhorn
A few thoughts from me: 1. Simvastatin is derived from a fungus. 2. Taking Simvastatin is much less expensive and reliable than taking RYR & fish oil. 3. Lifestyle modification should be done regardless. 4. Is taking RYR & fish oil somehow better than taking Simvastatin (which is from something natural also... from Aspergillus terreus). Any thoughts, or am I missing something?
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Jarret Morrow
Don, thank you for your insightful comments. I agree that given that the AG group had more than one type of intervention, it makes it difficult to ascertain how much cholesterol lowering was due to the red yeast rice or more specifically the lovastatin.
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Angelo
[(Each capsule had a total monacolin content of 5.3 mg, of which 2.53mg was monacolin K (lovastatin)] and fish oil (3 capsules daily) What is the name of the product above that was used in the study? Who was the manufacturer?
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Jarret Morrow, M.D.
Angelo, From the study: "The fish oil (Res-Q 1250; N3 Oceanic, Palm, PA) was purchased directly from the manufacturer, and each patient took 3 capsules twice daily (Table 1). The RYR (Res-Q LDL-X, 600-mg [by weight] capsules, N3 Oceanic) was also purchased directly from the manufacturer." N3 Oceanic is the manufacturer of these products. It appears that they have a product website: http://www.n3inc.com/
Comments are closed.
Jarret Morrow
Hi Dr. Nicole, thanks again for your comment. With any dietary supplement, the industry is poorly regulated to some extent and consumers should make their best effort to buy top quality supplements. My advice is to at least look for supplements that adhere to some form of 3rd party testing to ensure that the label claims are accurate. With respect to the comment about rhabdomyolysis (rapid break down of skeletal muscle tissue), as you mentioned, statin type medications also carry a risk of this serious adverse side effect. Symptoms often include severe muscle aching, muscle weakness, and dark colored urine. Statin myopathy is less severe, but more common than rhabdomyolysis. I've had numerous patients complain of statin myopathy type symptoms which generally subside when the drug is discontinued. I agree with you that from a therapeutic standpoint, combined treatment including diet, exercise, and fish oil certainly makes sense. However, from a research standpoint, it's impossible to conclude from this particular study what, if any effect, the red yeast rice may actually have on lowering cholesterol. cheers, Jarret