Date of Award
Selective Evidence-Based Medicine Review
Master of Science in Health Sciences - Physician Assistant
Physician Assistant Studies
John Cavenagh, MBA, PhD, PA-C
Objective: The objective of this selective EBM review is to determine whether or not patients who have statin-associated myalgia have improved tolerability for red yeast rice (RYR) as an alternative treatment.
Study Design: This review consists of three double blinded randomized controlled trials published in English in 2009, 2010, 2013.
Data Sources: Three randomized, controlled, double blinded clinical trials on the tolerability of red yeast rice were found on PubMed and Ebsco Host. Two trials comparing red yeast rice to placebo and the third trial comparing red yeast rice to pravastatin.
Outcomes Measured: Each of the three articles analyzed whether patients with statin-associated myalgia could tolerate red yeast rice in lowering serum cholesterol levels without adverse effects of myalgia. The outcomes measured were based on a structured questionnaire form that assessed the presence of myalgia as well as a brief pain inventory short form (BPI-sf) which assessed pain on a scale of 0-10.
Results: In Becker et al, the RYR group and placebo group did not significantly differ at baseline except in BPI-sf scores which was significantly higher in the placebo group P=0.026. In the RYR group, 2 of 29 patients developed persistent intolerable myalgia and discontinued treatment. In Halbert et al, 67% (14 of 21) in the RYR group reported pain whereas 68% (15 of 22) in the pravastatin group reported pain. The incidence of treatment discontinuation due to myalgia was 5% (1 of 21) in the RYR group and 9% (2 of 22) in the pravastatin group (p=0.99). In Verhoeven et al, 4 participants in the RYR group and 2 participants from the placebo group reported myalgia.
Conclusions: Based on the systematic reviews of the three randomized controlled trials, it is inconclusive whether red yeast rice is a tolerable method for statin-intolerant patients. It has been proposed that patients are able to tolerate the lower doses of monacolin K (lovastatin) than in statins. However, it is unclear of the maximum threshold patients are able to tolerate.
Lam, Carie, "Is Red Yeast Rice Tolerable in Treating Patients With Dyslipidemia Who Have Statin-Associated Myalgia?" (2015). PCOM Physician Assistant Studies Student Scholarship. 232.