A rice extract that was unsuccessfully challenged by the
government because it closely resembles a prescription
medicine has been shown to be a powerful means of lowering
cholesterol.
The results of one of the first two U.S. studies of the
substance, called Cholestin, were presented Thursday in
Orlando at a medical conference sponsored by the American
Heart Association.
It showed that people with mildly elevated levels can drop
their cholesterol about 35 points by taking four capsules of
Cholestin a day.
Cholestin is made from red yeast that has been fermented on
rice. Its chief ingredient is a naturally occurring form of
lovastatin, a prescription cholesterol-lowering medicine.
In the Grey Area
Cholestin’s introduction in 1997 blurred the already fuzzy
line between food supplements, which can be sold without a
prescription, and drugs that require approval of the Food and
Drug Administration.
The FDA declared Cholestin to be an unapproved drug and
attempted to block its sale. Cholestin’s manufacturer,
Pharmanex Inc. of Simi Valley, Calif., sued and won.
Last month, a federal judge in Salt Lake City ruled that
Cholestin fits the definition of a dietary supplement and can
stay on the market. The FDA has not said whether it will
challenge that decision.
Until now, all of the data on Cholestin’s health effects
have come from China, where the rice extract has been used for
centuries as a spice in such foods as Peking duck.
Test Done on 83 Volunteers
Last month, Dr. David Heber of the University of California
at Los Angeles published a report in the American Journal of
Clinical Nutrition on 83 volunteers. He found that eight weeks
of Cholestin lowered their cholesterol an average of 17
percent.
The latest study was directed by Dr. James Rippe of Tufts
University School of Medicine in Boston and found similar
results. Doctors in 12 medical practices across the country
put 233 people on Cholestin for eight weeks. Their cholesterol
levels fell from an average of 242 to 206.
Both studies were financed by Pharmanex, and both Heber and
Rippe are members of the company’s medical advisory board.
"This is a promising new development worthy of further
research," said Dr. Thomas A. Pearson of the University of
Rochester, speaking for the heart association.
Part of ‘Overall Health Plan’
However, he cautioned against going on Cholestin without
getting a doctor’s advice. "This should be integrated into the
overall care plan," he said.
Lovastatin, sold by Merck Inc. as Mevacor, was the first of
a powerful new class of cholesterol-lowering medicines known
as statins. The smallest lovastatin pill on the market is 10
milligrams, while a daily four-pill regimen of Cholestin adds
up to 5 milligrams of lovastatin.
Cholestin can be bought without a prescription, but the
price is similar to Mevacor. A month’s supply of Cholestin
costs about $30. A month of 40 milligram Mevacor pills costs
about $150. But these pills can be cut into four pieces,
bringing a 10 milligram-a-day dose down to $37 monthly.
Still, Rippe said many people may prefer Cholestin because
it is a natural rather than synthetic form of the drug, and it
offers one more option for those who need to lower their
cholesterol.
"I’m not saying, `Eat a cheeseburger for lunch and than
take Cholestin,"‘ he said. "It should be used in conjunction
with exercise, diet and weight reduction."
Pharmanex’s sponsorship of scientific research to back up
its health claims is relatively unusual among supplement
makers. Another study nearing completion will look at the
effects of Cholestin when eaten in a twice-daily power bar.
The company recently was bought by Nu Skin International of
Provo, Utah. Nu Skin is withdrawing the supplement from chain
drugstores and will sell it exclusively through mail order and
independent pharmacies.
