When 61-year-old Mark Aloe learned that he had high cholesterol and a family history of heart disease nearly 20 years ago, he immediately set out on the standard course of treatment for heart patients with high cholesterol: He began taking a prescription statin.
But after a few years of taking statin drugs, Aloe began to realize he either needed to find another treatment option for lowering his cholesterol or he would have to surrender his quality of life to the statin drugs, which were causing him unbearable muscle pain.
"It got to point with some of the statins that ... you feel like you were in an automobile wreck and you're sore all over and nothing can relieve it until you stop taking the statins," Aloe explained. "It got to point where I couldn't even sleep because I was so sore."
For about 15 years after initially being diagnosed with high cholesterol, Aloe switched back and forth between different forms of statin drugs -- from Lipitor to Crestor and back again.
"I think I must have tried just about all of the statins," Aloe said.
Finally, in 2003, Aloe's doctor at the University of Pittsburgh offered him an unlikely alternative to the prescription statin -- a Chinese herbal supplement.
Only a month and a half after dropping the statin drugs and replacing them with a Chinese supplement called red yeast rice extract, Aloe experienced a drop in his cholesterol levels without any noticeable side effects.
Before taking the red yeast extract pills, Aloe's cholesterol level was at 260; anything above 240 is considered to be "very high risk" by the American Heart Association. About 45 days later, his cholesterol had dropped to 180; anything below 200 is considered to be safe and healthy by the AHA.
"I wish I had heard about this 20 years ago," Aloe said. "I would have started this regimen and wouldn't have had so many years of muscle pain."
New research finds that for heart patients like Aloe -- who are unable or unwilling to tolerate a statin drug to lower their cholesterol levels -- taking a Chinese supplement purchased from a local grocery store might be just as effective at lowering their heart risks.
Chinese red yeast rice extract, it turns out, is a natural source of an active ingredient in many statin drugs called lovastatin.
In a study of 5,000 Chinese heart attack patients, researchers at Thomas Jefferson University's Myrna Brind Center of Integrative Medicine compared red yeast rice extract pills to a placebo treatment. They found those subjects taking the red yeast rice pills cut their risk of repeat heart attacks by nearly one half.
These patients also reduced their chances of having a heart procedure, such as bypass surgery or angioplasty, and their risk of dying from cancer also appeared to be reduced by as much as two-thirds.
The results were a surprise, the researchers wrote in their article. But they cautioned that their findings deserve more study. And they also urged those with high cholesterol not rush out to buy these supplements, as the pills may contain unsafe doses of lovastatin or contain harmful ingredients.
Heart Experts Split
Heart experts were divided on whether the extract should be suggested as a treatment option to heart patients who could not tolerate statins.
"The supplement does not provide a standardized dosage ... [which is] very dangerous. You don't know exactly how much statin you are getting," said Dr. Steve Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic Foundation.
"Why would any sane human take dietary supplement containing an uncontrolled dosage of a statin, when the purified form of the statin is available as an inexpensive generic?" he added.
Unlike prescription drugs, herbal extracts such as the red yeast pills do not undergo any formal safety evaluation. Because of the risk that some off-brands of red yeast extract may contain an unsafe dose of lovastatin or even some other unknown contaminants, many doctors remain wary in recommending the extract to their heart patients.
The U.S. Food and Drug Administration even released a warning to consumers in August 2007 not to buy or eat three specific red yeast rice products promoted and sold on Web sites. The FDA found that since these products contained the same active ingredient as a prescription medicine, they are unauthorized to be sold over-the-counter or online.
"We do not have a reliable product at this time containing red rice yeast in the U.S. dietary supplement market," said Dr. Nicole Nisly, director of the complementary medicine program at the University of Iowa. Nisly said that for this reason, she would never recommend that one of her patients try red yeast rice extract to lower cholesterol.
But some experts said that as long as patients seek out "reliable" brands of red yeast rice extract, such as those sold in grocery stores or reputable nutritional supplement chains, they can safely lower their cholesterol just as well as they would be taking a statin drug.
Dr. Daniel Edmundowicz, director of the preventive cardiology operations at the University of Pittsburgh's Cardiovascular Institute, said that he often recommends the red yeast rice extract to his heart patients who are reluctant to take prescription drugs or are unable to tolerate statins.
"The end justifies the means here," Edmundowicz said. "For some of my patients, I'd rather get them to their cholesterol goal than see them avoid medication altogether."
However, Edmundowicz admitted that it's still a challenge to make sure that patients opting for this extract over the traditional statin are choosing a reliable product that doesn't contain contaminants.
"The biggest challenge about recommending the extract to my patients is figuring out where they get it from and what's in it," Edmundowicz said. "What we'll do is tell patients to go with the nationally known brands -- for instance, something bought at GNC."
"I tell them stay away from the Internet and vitamin houses they've never heard of," Edmundowicz added.