Evidence Based Critically Appraised Topic

Evidence Based Critically Appraised Topic

Benefit of Red Yeast Rice

Jacque Liffrig

March 8, 2013

Clinical Scenario

A 76 year old female presents to the clinic for a women’s wellness check. She has a history of hypertension for which she takes Metoprolol 25mg daily. A lipid panel is performed and revealed total cholesterol is 317 and LDL 150. The patient had tried simvastatin in the past where she developed severe myalgia. She refuses to try another medication due to the horrible muscle aches she experienced. It is recommended to try red yeast rice, an over the counter supplement

Clinical Question

In statin intolerant patients, does taking the supplement red yeast rice as compared to not taking the supplement have an effect on reducing total cholesterol and LDL levels?

Articles

Becker, D., Gordon, R., Halbert, S., French, B., Morris, P., & Rader, D. (2009). Red yeast rice for

dyslipidemia in statin-intolerant patients: a randomized trial. Annals of Internal Medicine, 150(12), 830.

Venero, C., Venero, J., Wortham, D., & Thompson, P. (2010). Lipid-lowering efficacy of red yeast rice in a

population intolerant to statins. American Journal of Cardiology, 105(5), 664-666.

Summary and Appraisal of Key Evidence for Article 1

Becker et al. (2009) conducted a randomized controlled trial to evaluate the effectiveness and tolerability of red yeast rice and therapeutic lifestyle changes to treat dyslipidemia in patients who are intolerant to statin therapy. This article is classified as level II since it consisted of a randomly controlled trial. This study assessed 62 patients with dyslipidemia and a history of intolerance to at least one statin medication. 31 patients received 1800mg of red yeast rice twice daily while the other 31 patients received a placebo for 24 weeks. In the red yeast rice group, LDL cholesterol decreased by 43mg/dL from baseline at week 12 and by 35mg/dL by week 24. In the placebo group, LDL cholesterol decreased by 11mg/dL at week 12 and 15mg/Dl at week 24. Levels of HDL, cholesterol, triglycerides, liver enzyme and CPK did not differ between the two groups. The article is one of the first randomized double blinded, placebo controlled trail to evaluate red yeast rice in patients with a history of myopathy. The dosing of red yeast rice was equivalent to a daily lovastatin dose of 6mg (therapeutic dose 20-40mg). One limitation in this study is that low density lipoprotein cholesterol level slightly increased in the red yeast rice group between 12 and 24 weeks possibly due to nonadherance. The study also did not require the medication to be distributed from the same manufacture for all patients which could alter outcomes. This study also assessed lifestyle changes making it difficult to distinguish which factor contributed more to the reduction in levels.

Summary and Appraisal of Key Evidence for Article 2

Venero, Worthham and Thompson (2010) conducted a retrospective observational study with a clinical population highly intolerant to daily statin use. The study reviewed 1,400 clinical charts identifying 25 patients that were treated with red yeast rice for four weeks. This article is classified as level III since it compared before and after values. Patients were included if they had pre and post treatment lipid values without a change in lipid lowering medications. Patients assessed experienced myalgias, gastrointestinal intolerance and/or elevated alanine aminotransferase when previously using other lipid lowering agents. The results concluded that the total cholesterol levels decreased by 13% and LDL levels decreased by 19%. However, there were several limitations in this study which included a small patient population, unblinded, uncontrolled and retrospective study. Adherence was not monitored and patients were able to select the red yeast preparation. This is a weaker study due to the limitations listed. However, this study still provides evidence that over the counter preparations are effective at lowering LDL levels.

Results

The results of these articles indicate that red yeast rice may be a suitable option to lower cholesterol and LDL levels in those patients who cannot tolerate statin medication. However, the exact understanding of why red yeast rice is better tolerated than statins is unclear.

Clinical Bottom Line

According to these two articles, statins are the most effective lipid lowering agent and are the most commonly used prescription medication to lower lipid levels despite their adverse effects. However, there is not a specific treatment regime for those patients who develop myalgias and cannot tolerate statin therapy. It has been proven that red yeast rice has an effect on lowering cholesterol and LDL levels; however further research and trials should be conducted to identify the proper dosing that can be utilized without causing myalgias.

Implication for practice

I would recommend the use of red yeast rice in patients who are intolerant to statin therapy and closely monitor triglycerides, cholesterol, LDL and HDL levels. In addition to red yeast rice, I would also recommend therapeutic lifestyle changes such as exercising and dietary measures. I would suggest at least 30-45 minutes of aerobic exercise such as walking, swimming of jogging three or four times a week. I would also suggest a Mediterranean diet encouraging foods such as fish, poultry, nuts, legumes, vegetables while limiting consumption of red meat. I would also include reducing saturated fat and limiting total fat to less than 25% of their daily caloric intake. Sugars and carbohydrates should be restricted (Becker et al., 2009). I would follow up with the patient in 3-6 months to reevaluate their lipid panel.