Managing Cholesterol Naturally

New study pits statins against red yeast rice and fish oil.

By
Joanna Cosgrove
Online Editor


When patients are initially diagnosed with high cholesterol, the typical first course of action is a statin prescription, in addition to diet and exercise recommendations to prevent coronary artery disease. According to David Becker, MD, lead author of “Simvastatin vs. Therapeutic Lifestyle Changes and Supplements: Randomized Primary Prevention Trial” (Mayo Clinic Proceedings, July 2008), as many as 40% of patients quit taking their statins after less than one year with reasons ranging from adverse effects, cost and reluctance to take a prescription. In an effort to uncover a suitable alternative regimen, researchers affiliated with Chestnut Hill Hospital in Philadelphia, PA, tested the efficacy and safety of red yeast rice (RYR), fish oil and “therapeutic” lifestyle changes in comparison to a standard dose of the pharmaceutical cholesterol agent simvastatin, along with traditional diet and exercise counseling.

Dr. Becker’s interest in formally testing the RYR and fish oil alternative therapy emerged out of his own practice. “I have run a cardiac program for years called Change of Heart, which tries to get people to change their lifestyle in order to reduce cardiac risk,” he commented. “When people in the program would stop their statin, their cholesterol went up. At the same time, I saw patients in my office who had stopped their statins and were on red yeast rice and fish oil with great results in cholesterol reduction.”

After securing funding for the randomized study through the state of Pennsylvania, Dr. Becker and his team recruited 74 adult patients with hypercholesterolemia (or high blood cholesterol) ranging in age from 18-80 who met the criteria for statin therapy. Patients in the first group were given 40 mg per day of simvastatin and diet, exercise and lifestyle counseling based on recommendations from the American Heart Association.

The second study group received alternative therapy in the form of fish oil and RYR supplements. The fish oil used was Res-Q 1250 from N3 Oceanic of Palm, PA, and each patient took three capsules twice daily.

The RYR used was Res-Q LDL-X 600-mg, also from N3 Oceanic. Each capsule had a total monacolin content of 5.3 mg, of which 2.53 mg was monacolin K (lovastatin). Two strengths of RYR were used. If the patient’s initial LDL-C level measured higher than 160 mg/dL, a total dose of 3.6 grams was given in two divided doses. For LDL-C’s levels 160 mg/dL or less, a total dose of 2.4 grams was given in two divided doses.

The alternative therapy group was also enrolled in a 12-week multidisciplinary lifestyle program that involved weekly three-and-a-half hour meetings. The group was taught about the importance of lifestyle changes, while learning about coronary plaque formation, preventive measures and standard cardiac testing techniques, all taught by a board-certified cardiologist, a certified dietitian, an exercise physiologist and several alternative practitioners.

In addition to teaching the basic principles of nutrition, the dietitian encouraged the group to follow a Mediterranean diet, which was modified by reducing saturated fat and by limiting total fat to less than 25% of daily caloric intake. Sugars and simple carbohydrates were restricted, and participants were taught how to count calories, though there was no formal caloric restriction imposed on the group.

The Results

After 12 weeks, the research team noted a similar reduction in LDL-C levels for both study groups. And while the ratio of total cholesterol to HDL-C decreased equally in both groups, members of the alternative group also had a “substantial” reduction in triglycerides and lost more weight.

Although the study was small and single-center in nature, Dr. Becker was pleased at the study’s formalized results. “I was not surprised at the results, because it confirmed what I had been doing anecdotally for the last several years in my practice,” he said. “These alternative solutions, however, will only be successful if future studies show a benefit on mortality and morbidity similar to the statins, and if the products can be made more consistently.”

But for patients who might be tempted to ditch their pharmaceuticals in favor of alternative cholesterol lowering supplements, Dr. Becker warned that “the quality of different products is a real issue that needs to be addressed with more regulation.”

It was a sentiment echoed in the study, which said although RYR is widely available to consumers, in 2001 FDA determined that the RYR product Cholestin was a drug, not a dietary supplement, and asked companies to reformulate products to remove RYR. In fact, since completion of the current study, N3 Oceanic has replaced the RYR in Res-Q LDL-X with a “phytosterol ester complex and policosanol.” Policosanol was recently found to be no better than placebo in reducing lipid levels. (The chemical composition of the RYR used in the study was known and controlled.)

The study also warned that taking RYR without a physician’s supervision could cause unknown risks. “The lovastatin-like component could cause myopathy or transaminase elevations, and a potentially dangerous metabolite, citrinin, can form in poorly manufactured preparations,” it read. “Further, the safety of combining RYR and fish oil has not yet been studied in a large population.”

The study concluded by calling its results “intriguing,” and therefore demonstrating the potential benefit of an alternative, or naturopathic approach to a common medical condition, hyperlipidemia. “A larger, multicenter trial with longer follow-up is necessary, and the effects on cardiovascular outcomes will need to be established in the future,” it said. “The risks of this alternative therapy need to be balanced against a possible therapeutic benefit for a subset of motivated patients who are willing to adopt strict lifestyle changes and take over-the-counter supplements.”