Cholesterol-lowering supplements.

"Reduce Your Cholesterol up to 15% in 4 weeks!"

"Literally flush cholesterol out of cell membranes."

Cholest-Away, Cholest-Off, Cholest-Arrest. The list goes Cholest-on-and-on.

Interested in lowering your high cholesterol "naturally" with a pill or powder? Want to avoid the bother and expense of a doctor, a prescription, or lab tests?

Then you're a candidate for one of the hot new "cholesterol-lowering" supplements made from exotic gums, soybean byproducts, grains, trace metals, garlic, and anything else that shows the slightest hint of working. They're as close as your favorite drug store.

But being cheaper and more easily available comes at a price. Prescription and over-the-counter drugs are tested for effectiveness--and safety--in thousands of people, often for years, before the Food and Drug Administration approves them.

Supplements, which don't need FDA approval, are tested on dozens--occasionally hundreds--of people, seldom for more than six months.

In some of those limited tests, a few supplements seem to lower cholesterol levels. Should you take them? Not before you read this article.

We start with supplements that are supported by the most evidence and end with those supported by the least.

Niacin 

Niacin is the only supplement that's been proven--in tests as rigorous as those for a prescription drug--to lower cholesterol.

Two to three grams (2,000 to 3,000 ma) a day can lower LDL ("bad") cholesterol by 20 to 30 percent and raise HDL ("good") cholesterol by 20 to 35 percent. The National Cholesterol Education Program recommends niacin as one of the primary treatments for high cholesterol.

But don't even think about taking it without talking to your doctor.

"Large doses of niacin are not supplements, but drugs," says Louis Lasagna, dean of the Sackler School of Graduate Biomedical Sciences at Tufts University in Boston.

"Niacin is capable of damaging the liver, activating peptic ulcers, impairing glucose tolerance, and precipitating gouty attacks," he adds. And many niacin-takers suffer from flushing, headaches, nausea, heartburn, and diarrhea.

Soluble Fibers

A diet rich in beans, whole grains, fruit, and other foods high in soluble fiber can help lower cholesterol levels. There's no question about that.

But what about skipping the foods and taking just the fiber?

"More than 50 studies have found that certain soluble fiber supplements significantly lower cholesterol levels, including LDL, in those with elevated cholesterol," says Stephen Glore of the University of Oklahoma Health Sciences Center in Oklahoma City.

The most-studied fibers: guar gum, pectin, and psyllium. "The research shows that consuming from six to 40 grams of pectin, eight to 36 grams of gums such as guar gum, or ten to 30 grams of psyllium each day can have this effect," says Glore.

But not all soluble fiber supplements are equal, says fiber expert Gene Spiller of the Center for Health Research and Studies in Los Altos, California.

"The effectiveness of a soluble fiber depends, in part, on the strength of the gel it forms," he explains. Some methods of processing the raw fiber may break up its carbohydrate strands, weakening the gel.

"That means that you really have to test each soluble fiber product to make sure it works effectively."

A search through the medical literature turned up only two brands with good, published research showing that they can lower cholesterol.

* Metamucil, made by Procter & Gamble, contains the soluble fiber psyllium. While it has been approved for sale only as a laxative, Metamucil also seems to lower cholesterol.

For example, in six studies, ten grams a day (about three teaspoons of regular flavor) for 1 1/2 to four months dropped cholesterol by four to fifteen percent--and LDL by six to twenty percent--in 169 men and women who began with an average cholesterol of around 250.[1]

There's a downside, though. Some people are allergic to psyllium. If you're in that group (and there's no way to tell), eating Metamucil--or any other product that contains psyllium--could cause wheezing, chest tightness, or rashes. In rare cases, it sends people into life-threatening anaphylactic shock.

(You can also find psyllium in Kellogg's Bran Buds cereal. But to get ten grams of psyllium you'd have to eat almost three servings. The company has asked the FDA for permission to make a health claim that foods with psyllium can help lower cholesterol. Given the possible allergic reactions, the fact that the cereal has only been tested on about 250 people for three months or less, and the danger of portraying foods as "magic bullets," we've opposed putting health claims on psyllium-containing foods.)

* Fiber Plan, from Shaklee Corporation, is a mixture of the soluble fibers psyllium, pectin, guar gum, and locust bean gum. In two good studies, Fiber Plan lowered cholesterol. In the longer of the two, 15 grams a day for six months lowered LDL by 14 percent in 24 men and women with average cholesterol of 235.[2]

Phytosterols

Plants like soybeans, wheat, and rice can make compounds called phytosterols, which resemble cholesterol so closely that our digestive tracts can't distinguish one from the other.

"We've known for more than 40 years that if you're given enough concentrated plant sterols along with a meal, then most of the cholesterol in the food you eat at the same meal won't be absorbed," says David Kritchevsky of the Wistar Institute in Philadelphia.

How much phytosterol does the job?

"You usually need at least 3,000 milligrams (3 grams) a day to lower cholesterol levels significantly," says Peter Jones of McGill University in Montreal. That's also what Kritchevsky and his colleagues concluded after looking at results from dozens of studies involving close to 2,000 people.[3]

But getting 3,000 mg of phytosterols from your food isn't easy. Vegetarians top out at only about 400 mg a day.

As for supplements: Each tablet of Cholestatin, for example, contains just 380 ma. So you'd have to take at least eight a day--at a cost of $35 a month--to get your 3,000 ma. (The manufacturer, Future biotics, recommends only three to six pills a day.)

Switch to Phytoquest, from KCD Holdings, and you'll also be taking eight caplets a day. Monthly bill: $90. (The package recommends one before each meal.) Company president Buzz Holcomb concedes that he doesn't have enough scientific evidence that the amount of phytosterols in his product really works. "We're arranging for a research firm to find out for us."

On the horizon is a new generation of hydrogenated phytosterols from trees, which are more potent. One, sitostanol, is the key ingredient in a Finnish margarine called Benecol, which lowered LDL cholesterol by 14 percent in 102 people.[4]

The expensive margarine isn't yet available in the U.S., although a subsidiary of Johnson & Johnson has purchased the rights to market sitostanol in North America.

Garlic

"Proven to Lower Cholesterol," say the magazine advertisements for the garlic supplement Kwai.

"A majority of the research does show that some garlic supplements lower cholesterol," says Bruce Holub of the University of Guelph in Canada. "But some studies haven't found any effect, and why that is we don't know for sure."

For example: "Taking 900 mg a day of Kwai for three months lowered LDL by 14 percent in 12 men with elevated cholesterol levels," says Holub.[5]

But in two other good studies (only one has been published), the same amount of Kwai did nothing.[6]

In 1996, Manfred Steiner of the East Carolina University School of Medicine in Greenville, North Carolina, found that LDL levels of 41 men with high cholesterol dropped by five percent when they took Kyolic supplements for four to six months.[7] (Kyolic is garlic that has been fermented in alcohol for 20 months.)

But they took more than seven grams a day--six times the amount recommended on most Kyolic boxes--which would cost about $75 a month. Forty percent of the men refused to take all the pills they were given. Others dropped out, complaining of intestinal discomfort, unusual body odor, and other problems.

Why such a big dose? "You don't see an effect with lower amounts," says Steiner. Kyolic's Web site (www.kyolic.com) neglects to mention the huge dose and side effects.

Tocotrienols

"Evolve is the next great chapter in cardiovascular health," gushed Robert Kowalski in TV ads this summer. Kowalski was the oat-bran-and-niacin guru of the 1980s.

Evolve, from Bionutrics Health Products of Phoenix, Arizona, is a mixture of tocotrienols, which are vitamin-E-like compounds found naturally in foods like rice, oat bran, and barley. "They seem to interfere with the liver's ability to make cholesterol, " says Judith Marlett of the University of Wisconsin.

In the only published study on Evolve in humans, Asaf Qureshi and his colleagues at Advanced Medical Research in Madison, Wisconsin, found that taking 200 mg a day for a month lowered LDL by 16 percent in 20 middle-aged men and women with high cholesterol.[8]

But 200 mg is four to eight times greater than the dosage recommended on Evolve's package.

"We have new data showing that 25 mg works, too," says Bionutrics CEO Ronald Lane. That research hasn't been published.

And there's another problem with Evolve.

Some people take vitamin E because there's evidence that it may prevent heart disease by keeping LDL cholesterol from becoming oxidized. But "taking vitamin E negates the effect of the tocotrienols," says Qureshi. "That's why we have our volunteers stop taking the vitamin before they participate in our experiments."

Company head Lane believes that the interaction hasn't been proven and needs to be studied further. Too bad Evolve's customers aren't privy to that debate.

Asian Botanicals

* Cholestin is a dietary supplement that's made from yeast and rice. Mevacor is a prescription drug that's extracted from a mold.

Each contains the active ingredient lovastatin, one of the "statin" drugs that interfere with the liver's ability to make cholesterol. Each warns those who have a serious disease or physical disorder not to take it.

Confused about their differences? You're not alone. When ads in Newsweek magazine earlier this year claimed that Cholestin was "clinically proven to lower cholesterol levels an average of 25 to 40 points in just eight weeks," the FDA thought that sounded too much like a drug and stepped in. The case is now in court.

How well does Cholestin work? The only information available is summaries of Chinese research provided by its U.S. manufacturer, Pharmanex of Simi Valley, California.

According to the company, cholesterol dropped by around 20 percent in 425 people with levels above 230 who took Cholestin for two months.

"These results have now been matched by a new study we've just completed at the UCLA School of Medicine in Los Angeles," says Michael Chang of Pharmanex. The details are not yet available.

* Gum guggul (GOO-gull) is a resin extracted from an herb that grows in India, where it has traditionally been used to treat arthritis and obesity.

In one Indian study, six months of an extract called guggulipid lowered cholesterol by 12 percent.[9]

"All of the research has been done in India, using different extracts, different quantities, and different research designs," notes Timothy Johns of McGill University.

"Their standards for effectiveness are not as rigorous as ours in North America," he cautions. "So it's difficult to know what to conclude."

Chromium

"Research shows that daily supplements with at least 200 micrograms of chromium picolinate help to... reduce elevated cholesterol levels." That's what you'll read on Global Nutrients' Web site (www.nutrient.com).

Unfortunately, it's not what the good research shows.

"We found that 900 micrograms of chromium picolinate a day for three months had absolutely no effect on the cholesterol levels of 18 out-of-shape middle-aged adults," reports Wayne Campbell, who is now at the University of Arkansas.

Another chromium preparation, ChromeMate, combines chromium with a small amount of niacin. According to its Web site (www.interhealthusa.com), the "patented form of chromium" is "an essential mineral for...lower cholesterol."

But in two recent studies on people with cholesterol of around 200, about 200 micrograms a day of ChromeMate or another chromium-niacin supplement for two to three months did nothing.[10,11]

[1] Ann. Intern. Med. 119: 545, 1993.

[2] Amer. J. Cardiol. 79: 34, 1997.

[3] O. J. Pollak & D. Kritchevsky, Sitosterol (New York: Karger, 1981).

[4] New Eng. J. Med. 333: 1308, 1995.

[5] Amer. J. Clin. Nutr. 65: 445, 1997.

[6] J. Royal Coll. Phys. London 30: 329, 1996.

[7] Amer. J. Clin. Nutr. 64: 866, 1996.

[8] J. Nutr. Biochem. 8: 290, 1997.

[9] Cardio. Drugs Therapy 8: 659, 1994.

[10] Diab. Res. Clin. Prac. 28: 179, 1995.

[11] Biol. Trace Elem. Res. 55: 297, 1996.

RELATED ARTICLE: BUYER BEWARE

Why not save money and use dietary supplements to lower your cholesterol? For one thing, we know far less about their safety and effectiveness than we know about drugs.

"The extensive testing of prescription and non-prescription drugs develops a safety profile of them, so that we can get a good idea of how safe they are, who shouldn't take them, and who should be monitored when using them," says Ralph D'Agostino of Boston University. D'Agostino chairs the Food and Drug Administration's Nonprescription Drugs Advisory Committee.

Many dietary supplements are tested on no more than a few dozen people for a month or two. "That's not nearly enough people or time to find out who shouldn't be taking them," notes D'Agostino.

Take the supplement Cholestin. Its label says that it shouldn't be used by those who have a serious infection, serious disease, physical disorder, unexplained muscle pain, tenderness or weakness; those who consume more than two drinks a day; or those who have had organ transplants.

Where did those warnings come from? Not from studies of Cholestin, concedes Michael Chang of Pharmanex, its U.S. manufacturer. The company's studies, all conducted in China, didn't detect those risks. Rather, Cholestin's warnings are based on the research on prescription statin drugs like lovastatin, which have been tested on almost 30,000 people for up to five years.

That's possible because Cholestin has the same active ingredient as lovastatin. Most other supplements don't have the luxury of borrowing safety information from similar prescription drugs.

If you have high cholesterol, says James Cleeman, head of the National Cholesterol Education Program, "you really need to be in the hands of a knowledgeable physician for the overall assessment of your coronary risk--for the proper interpretation of not just your total cholesterol, but also your LDL, HDL, and triglycerides--and for the appropriate treatment.

"For example, if you have both a high LDL and a low HDL, we're going to recommend lowering the LDL and simultaneously raising the HDL. This isn't something you can really know by yourself or learn from some booth at a shopping mall.

"If someone wants to try a well-studied dietary supplement like soluble fiber or garlic to lower cholesterol," Cleeman adds, "it should only be done in addition to following a low-saturated-fat, low-cholesterol diet.

"This type of diet not only reduces cholesterol, but can lower blood pressure, help control weight, improve insulin resistance, inhibit clotting, and provide foods rich in antioxidants--which also reduce the risk of heart disease."