MESSAGE ON A BOTTLE:

By Sheri McGregor

In our ceaseless quest to lose weight the easy way, more and more Americans are turning to herbal diet aids as a “natural” way to shed pounds. The makers of one such product, Metabolife 356, have seen sales boom from $12 million in 1995 to $900 million last year. Other companies have seen similar increases. And it’s easy to see why. If the implied messages on the bottles are to be believed, we can eat, drink, and be merry, and still lose weight. “Isn’t that the American way? We want to have our cake and eat it too,” says Ara DerMarderosian, Ph.D., a professor at the University of Sciences College of Pharmacy in Philadelphia.

Herbal diet products, which usually contain the ephedra herb ma huang and natural caffeine sources such as guarana (brand names include Metabolife 356, Met-RX, AM-300, Power Trim and a long list of others), claim to increase metabolism and make weight loss easy. Some also contain aspirin, and consequently are often called ECAs (for ephedrine, caffeine, and aspirin).

Proponents of such diet aids believe the calories that we consume are either used by our body to meet its energy needs, stored as fat, or burned by cells called brown adipose tissue (BAT). This expending of calories by BAT is called thermogenesis, the burning of fat through the generation of heat. It is through thermogenesis that herbal diet aids are thought to aid in weight loss. However, though experts universally agree that BAT exists in newborn babies, the evidence of its ability to make a difference in adult energy expenditure--and its existence in adults to begin with--is not clear.

In the 1980s, some research confirmed that a mix of ephedrine and caffeine raises metabolic rate. Ephedrine and caffeine also suppress appetite, says Daniel Mowrey, Ph.D., president of the American Phytotherapy Research Laboratory in Utah. Mowrey says that adding aspirin to this mix gives an even better thermogenic response.

  The idea that overweight people have BAT cells just waiting for the right stimulation to burn off unwanted pounds is undeniably appealing. Unfortunately, the research supporting this notion is scant. A study in 1993 conducted at Harvard Medical School and Northwestern University concluded that subjects taking a mixture of ECA for eight weeks, without exercising and dieting, lost an average of 4.8 pounds--more than three times that of individuals on a placebo, but hardly a significant change in nearly two months. Still, its researchers were upbeat about the result, concluding: “The most limiting factor in the use of thermogenic agents for the treatment of obesity is the perception by the public and by the medical profession that obesity is a problem of gluttony and sloth.”

  Last year, another study followed overweight people who took an herbal formula, Hydroxycut, basically an ECA. The product contains ephedra and caffeine, along with willow bark, which is a natural source of salicin, the chemical precursor to aspirin. The study of 24 subjects, conducted by Carlon Colker, M.D., a researcher at Peak Wellness Inc., a private traditional and integrative medical center in Greenwich, Conn., found that the average weight loss of those who took Hydroxycut and also exercised three times a week for eight weeks was more than 8 pounds. Subjects who exercised and took a placebo stayed within a pound of their starting weight, as did those who took Hydroxycut but did not exercise. Doctors monitored blood pressure, EKGs, and other factors, and found no significant changes or cause for concern. 

“There’s little question that ECA aids weight loss,” Colker says. But even he has concerns. Colker warns, “Each and every time a person considers taking an ECA product, he should see his physician first.”

Why the strong directive? Basically because of the stimulant properties in ephedrine and caffeine. The areas of concern are the cardiovascular system and the central nervous system, Coker says. “ECA can increase blood pressure and cause agitation in some people.”

Many American consumers are unaware that a possibly dangerous product could be on the shelves. Unlike pharmaceuticals and food additives, the FDA does not have the authority to review and approve the ingredients in supplements. And while the FDA does try to make sure dosages match the amount promised on the bottle, the system is not foolproof. A recent study conducted at the University of Arkansas found that the total ephedra content in weight-loss supplements can vary from as little as none to more than 154% of the amount claimed on the label. And once an herbal product is on the market, the task then falls on the FDA to show that it is unsafe before any restrictions on the product’s use can be made.

Since 1993, the FDA has received more than 1,300 adverse event reports (based on consumer complaints) connected to products that contain ephedrine. It was these reports of anxiety, hypertension, cardiac arrest, insomnia, psychosis, skin rash, and other symptoms that caused the FDA to propose the 1997 ruling that would limit dosage and use duration of ephedrine products.

  The reports don’t surprise Katherine Gundling, M.D., associate professor of internal medicine at the University of California, Davis. Gundling, who specializes in the study of complementary therapies, including herbs, says, “Molecularly, ephedrine is nearly identical to amphetamines, which can cause strokes and heart attacks.” On a strength scale of 1 to 10, Gundling says, “Amphetamines are at 9 or 10. Ephedrine would be a 3 or 4. Pseudoephedrine, which is often found in over-the-counter medications, falls at 1 or 2.”

At the Obesity Research Center at St. Luke’s-Roosevelt Hospital in New York City, researchers studied the use of Metabolife 356. Several of the subjects dropped out early because of a rise in blood pressure, heart palpitations, or irritability. Of those who finished, people using Metabolife 356 lost significantly more weight than the placebo groups. Doctors concluded that the product worked, but noted the need for further research to study potential side effects in some people.

  In July, 1999, the U.S. General Accounting Office questioned the science behind the FDA’s proposal to limit dosage of ephedrine products. The GAO acknowledged the many consumer complaints, but was wary of relying on those reports to support restrictions. In February, 1999, the FDA announced its intent to withdraw the dosage and duration provisions from their proposal until after studying this issue more thoroughly. A public hearing on the subject is expected in the coming months.

Mowrey believes the FDA had no choice but to withdraw their proposed restrictions. In his opinion the adverse event reports are flawed. “What wasn’t looked at is how many of these adverse reactions might have been reported by bodybuilders and others who take too much of the substances,” Mowrey says. “Also, consumers who don’t carefully read labels may not realize ephedra is in more than one product they use.” So cumulatively, he says, they may take too much.

So, what’s a weight- and health-conscious individual to conclude?

“Used appropriately under the direct supervision of a physician, these products may be beneficial for certain patients,” says Gundling. “But I would not recommend them to anyone needing to lose just 10 or 15 pounds.”

“One must remember that the effect of herbal diet aids is often temporary anyway,” DerMarderosian says. “In the short term, the herbs may diminish appetite, but over time, it will take more and more to achieve the desired effect. To lose weight for good, you need to eat less and exercise more.” DerMarderosian adds: “These products may help you get started, but there is no miracle pill.”

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* It is a secret cure, a breakthrough, a magical cure, a new discovery.

* It detoxifies, purifies, or energizes.

* It can cure a wide range of unrelated diseases.

* It's backed by scientific studies (but has no list of references).

* It is only beneficial and has no side effects.

Think before you buy.
To be an educated consumer, keep the following in mind:

* Look for products with ingredients with the U.S.P. notation. (This indicates that it met standards that were established by the U.S. Pharmacopoeia.)

* Remember that "natural" does not always mean safe.

* Look for supplements that are made by nationally known food and drug manufacturers.

* Write and ask companies for more information on their products.