MONDAY, June 15, 2009 (HealthDay News) -- A new study revives a running controversy about the purported cholesterol-lowering effects of the centuries-old natural product called red yeast rice.
Red yeast rice is produced when a yeast, Monascus purpureus, is grown on rice. It has been used in Asian countries for more than a thousand years as food and medicine. In the United States and Europe, it has been proposed as an alternative cholesterol-lowering treatment for people who cannot take statins because of severe side effects, mainly muscle wasting and weakness.
The new study, from physicians in Pennsylvania and reported in the June 16 issue of the Annals of Internal Medicine, found a significant cholesterol-lowering effect of a commercially available nonprescription red yeast rice product in a small group of such people.
The study included 62 people who stopped taking statins because of side effects. All of them followed a lifestyle change program, including education on nutrition, exercise and relaxation techniques. Half also took 1,800 milligrams twice a day of a red yeast rice product for 24 weeks, while the others took an inactive substance.
"In the group that took red yeast rice, the average drop in cholesterol was 43 points at 12 weeks," said Dr. Ram Y. Gordon, a cardiologist in private practice who was a member of the research group. "The drop in the placebo group was only 11 points. In the longer run, the drop was 35 versus 15 points. We think the difference narrowed because after 12 weeks we told people to keep on doing it, but maybe some stopped."
There are, however, complications related to the product. Red yeast rice is under a regulatory cloud at the U.S. Food and Drug Administration because it contains a natural statin, lovastatin, sold as a prescription drug named Mevacor. The FDA moved against several red yeast rice products -- not the one used in the Pennsylvania study -- on the grounds that they were unlicensed pharmaceuticals, a move which was upheld after a court tussle.
The product used in the study does contain lovastatin, Gordon said, but not enough to explain the reduction seen in the trial. Trial participants took three 600-milligram vials of red yeast rice twice a day.
"Each vial had one milligram of lovastatin. So the total was six milligrams a day, which is really a tiny amount," Gordon said. "And lovastatin is one of the weaker statins. The cholesterol drop was much more than what you'd expect from that low dose of lovastatin."
Some statin-related side effects, such as muscle pain and liver problems, were reported in the study, by two people who took red yeast rice and one who took the inactive substance, but they were not severe, Gordon said.
The beneficial effect might be due to compounds related to lovastatin, one of whose many designations is monacolin K. There are "nine or 10" other monacolins in red yeast rice, "and our theory is that these other monacolins affect cholesterol production in the liver," Gordon said.
The hopeful aspect of the study is that "we may actually have found a product that may be useful for patients and clinicians to deal with this problem, statin myalgia [muscle pain]," he said.
But it was a small study, and "much more testing needs to be done in many more people for a longer time period," Gordon said. And taking red yeast rice "absolutely should not be done without a physician's consent, and because it contains a small amount of a statin, you should be tested for liver problems," he said.
There are potential perils in taking red yeast rice because the marketed products are essentially unregulated, as illustrated by the research group's experience after a similar study, which got similar results, that they did last year.
That study used a different unregulated red yeast rice product. After the study was completed, the manufacturer changed the product formula, eliminating the lovastatin content and substituting ordinary sugar, Gordon said.
"There is real potential here, but a lot of problems because of the sources of red yeast rice not being too reliable," Gordon noted.
But the major problem with the study is that it was too small to disclose the inevitable side effects that afflict a small percentage of the people who take statins such as lovastatin, said Dr. Paul S. Phillips, director of interventional cardiology at Scripps Mercy Hospital in San Diego, who wrote an accompanying editorial.
Phillips said he often prescribed statins to patients in his cardiology practice. But he also is head of a statin myalgia clinic that treats more than 600 people suffering from side effects of the drugs.
Because red yeast rice contains lovastatin, "it has potentially significant risks and no greater benefits than conventional medications, and I would not advise anyone to take it," Phillips said.
A guide to red yeast rice is offered by the U.S. National Library of Medicine.