25/06/09 New research from two Philadelphia-area cardiologists finds that an over-the-counter dietary supplement sold at pharmacies and health food stores may be an alternative for patients who cannot take traditional statin medications to lower cholesterol because of statin-related muscle pain. The findings of their study, "Red Yeast Rice for Dyslipidemia in Statin-Intolerant Patients," appear in the June 16, 2009 issue of Annals of Internal Medicine.

Cardiologists David Becker, M.D., and Ram Gordon, M.D., Chestnut Hill Cardiology, studied 62 patients with high cholesterol in the first randomized, double-blinded placebo-controlled trial to evaluate red yeast rice in patients with a history of statin-associated myalgias (side effects that include muscle pain and weakness). Thirty-one of the patients took three 600-mg capsules of red yeast rice twice per day over the course of six months, and the other half received identical placebo tablets. The red yeast rice patients also participated in weekly meetings for the first three months, where they were taught about heart disease and how to incorporate heart-healthy nutrition, exercise and stress management into their lives.

At the conclusion of the study, the research found:

- Low-density lipoprotein cholesterol (also known as "bad cholesterol") levels decreased more in the patients receiving the red yeast rice (average decrease, 35 mg/dL) than in patients receiving the placebo (average decrease, 15 mg/dL).

- Total cholesterol levels improved more in the red yeast rice group than in the placebo group.

- Muscle pain scores, weight loss, HDL cholesterol (high-density lipoprotein or "good cholesterol") and liver or muscle enzyme levels did not differ between the two groups.

Red Yeast Rice, a staple of Chinese medicine for more than a thousand years, is derived from a fungus that grows on rice. A series of compounds within the red yeast rice have been found to slow the production of cholesterol in the liver. The medical community, however, has been slow to consider its potential use as an alternative treatment therapy for patients with statin-associated myalgias because the supplement is not regulated by the Food and Drug Administration.

"Every physician has patients who refuse to take statins or have significant side effects from them," says Dr. Becker. "One of the largest challenges in the medical community has been that there is no agreement or consensus on how to treat these patients. We are convinced that our research may lead to some answers."

Dr. Gordon remarked, "Statins have revolutionized the way doctors have taken care of cardiac patients over the past two decades. But for patients that cannot tolerate them, the side effects are considerable." Some studies have estimated that up to 15% of patients taking the cholesterol-lowering drugs have to stop because of muscle pain. According to IMS Health, a drug tracking company, more than 200 million statin prescriptions were filled in 2008.

Dr. Gordon added, "While red yeast rice isn't appropriate for everyone, the goal of our research was to see if it has potential to be an option for those patients who discontinue their statins because of the side effects. Often these patients with high cholesterol are left without lipid-lowering therapy. This is especially worrisome if the patient has a history of heart attacks, stents, bypass surgery or strokes."

Dr. Becker and Dr. Gordon are in private practice at Chestnut Hill Cardiology in Flourtown, Pennsylvania, a suburb of Philadelphia and are on the staff of Chestnut Hill Hospital and Abington Memorial Hospital. They also conduct an innovative cardiac prevention program called "Change of Heart," which was developed by Dr. Becker in 1993. The 10-week program takes a holistic approach to cardiac wellness, utilizing diet, exercise, stress management and traditional and alternative treatment therapies to help people reduce and even reverse the effects of coronary artery disease.

Dr. Becker said, "Our present medical system places very little emphasis on educating patients. We employ a team approach. Patients work closely with dietitians, fitness experts and stress management counselors, and we provide the physician perspective to help them evaluate and consider traditional treatment and alternative therapies. We passionately believe that patients need to take control of their cardiac destiny."

"Aside from its findings, this study is unique because it is truly rooted in our community rather than the commercial interests of pharmaceutical companies," says Brooks Turkel, CEO of Chestnut Hill Hospital. "The premise of the research was established because local patients inquired about alternatives to cholesterol lowering drugs and the potential undesirable side effects. Our cardiologists, motivated to provide their patients with alternatives, developed a life-style modification program, Change of Heart, which has served as a springboard for further research involving natural supplements. We at Chestnut Hill Hospital are very proud that the research by Drs. Becker, Gordon and their team has gained the recognition of the national medical community."

"Chestnut Hill Hospital has received funding for this study through a grant from the Commonwealth of Pennsylvania," notes Mr. Turkel. "We are grateful that our state representatives saw the value of the Change of Heart program."