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Dori Linnell of Eureka, Montana, would do anything for Tel, her 5-year-old son with diabetes. With diligence, knowledge and love, she has kept his HbA1cs in the nearly perfect range of 6.8 to 7.0 %. Linnell is obviously doing what works but always looking for something that may work better. She read about BetaFast, a product that is said to help people with diabetes control their blood sugars. BetaFast is made from the leaf extract of the herb Gymnema sylvestre, a climbing plant found in India. Always a believer in herbs, she wanted to try it with Tel.
A study performed in India, published in the Journal of Ethnopharmacology in 1990, showed that 27 people with type 1 diabetes reduced their insulin requirements after taking 400 mg Gymnema sylvestre per day.
Linnell asked Tel's physician about the herb. He had never heard of it but wanted to take a look at the product and the studies. She then called the manufacturer. She was impressed with the evidence but, because her doctor could not yet advise her, if she wanted to proceed, she would have to do it alone.
Linnell is not the only American examining herbs. The U.S. Food and Drug Administration (FDA)'s Web site says that half of American adults use dietary supplements, and that in 1996 they spent $6.5 billion to do so.
For people with type 1 diabetes, there is no herb that replaces insulin. For both type 1 and type 2, however, herbs and vitamins are said to help with general health, neuropathy, lowering of blood sugars and weight control. Some in the medical establishment say the claims of dietary supplement manufacturers are trickery. Many others say it should not be a choice of one over the other and that alternative remedies can be used as complementary medicine to traditional regimens.
Alternative Versus Traditional
"God cures and the doctor sends the bill." The American Herbalist Guild prominently displays this Mark Twain quote on its Web site, seeming to digitally spit in the medical establishment's face. Alternative and conventional medicine appear to be battling for the public's loyalty.
Some see herbs and vitamins as natural, clean ways to clear the body of the outside pollutants of the modern world. Yet a September 17, 1998 New England Journal of Medicine (NJOM) story told of an Israeli man who got lead poisoning from an Indian plant remedy for his type 2 diabetes.
In an editorial in the same issue, NJOM editors Marcia Angell, MD, and Jerome P. Kassirer, MD, contend that because some doctors are now using alternative medicine, the distinction between conventional and alternative is no longer valid. The doctors offered a new definition, declaring, "What most sets alternative medicine apart, in our view, is that it has not been scientifically tested and its advocates largely deny the need for such testing." There lies the danger, they say, because consumers are not protected by scientific clinical studies that prove a product works.
They conclude, "There cannot be two kinds of medicine-conventional and alternative. There is only medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work."
The Times They Are A-Changin'
People seem to agree with the NJOM doctors, believing that the key to good health is not choosing conventional or alternative treatments, but finding the safest combination of the two.
People are taking drugs derived from herbs whether or not they realize it. Some famous substances born as herbs include aspirin, morphine, codeine and a type 2 diabetes favorite, metformin.
Stephen Freed, RPh, CDE, of Deerfield, Illinois, says that along with his education program he recommends fiber products and antioxidant vitamins. Fiber and antioxidants help to lower HbA1c along with proper nutrition and exercise, he says. "There is no magic pill, so if taken to help and not to cure, natural alternatives have their place in helping to control blood sugars," concludes Freed.
"I take St. John's Wort for neuropathy and it seems to give me some relief without any side effects," testifies type 1 Susan Erickson of Minneapolis. "I have been on countless other drugs with no relief or horrible side effects."
Dave Hofstatter of Norfolk, Connecticut, takes a wide variety of traditional and alternative remedies, saying that, "I believe in the accuracy of science far more than folklore, but I don't believe that scientists adequately address folk remedies." Hofstatter takes alpha-lipoic acid, which "unquestionably" lowers his blood sugar. He also grinds flaxseeds for extra fiber, takes taurine for his kidneys, selenium because of its antioxidant properties, brewers' yeast tablets for a vitamin B supply, Gingko biloba and red wine.
Vitamins: A Clear-Cut Case?
Even taking vitamin supplements causes great debate among medical professionals. Some say that particular vitamins aid in diabetes management; others say you should be getting all you need from a proper diet with plenty of fresh fruits and vegetables. As with herbs, caution is dictated with vitamins.
Richard K. Bernstein, MD, FACE, FACN, author of "Dr. Bernstein's Diabetes Solution," prescribes the B vitamin niacin to his patients with diabetes who have certain cardiac risk factors that have remained despite normalization of blood sugars.
Steven Edelman, MD, an endocrinologist with Veterans Hospital in San Diego, says, "I think much of these vitamins are marketing scams." Edelman does see value in antioxidant supplements, as does Peter Lodewick, MD, of the Diabetes Care Center in Birmingham, Alabama, who emphasizes that only about one-quarter of Americans eat the right amount of fruits and vegetables. Lodewick prefers that these patients take a safe vitamin supplement.
With dietary supplements so goes the saying, Everyone has an opinion.
Are herbs the natural cures we're missing in our high-tech world? Or are they potions developed by fly-by-night operations, banking that we'll try anything? People hear all kinds of stories about herbs or vitamins, from their friends, their doctors, various companies touting their drugs or herbs and government regulators. The challenge for people with diabetes is whom to trust.
Alexander O'Neil of Wiltshire, England, has type 2 diabetes and feels confused. He says, "There really seems to be a great shortage of specific information about whether any particular preparation is likely to be good or bad for you if you have diabetes," says O'Neil. "I'm not against herbal and vitamin-based products but it's not easy for us to find our way around the present situation."
Where Can We Turn?
Here in the United States, we count on our government regulations to protect us from unscrupulous businesses. The FDA's charge is to approve new drugs, applying standards which prove they are safe and that they work, protecting us from snake oil sales people. So how do dangerous substances get into supplements? Some would tell you it is the fault of the 1994 Dietary Supplement Health and Education Act (DSHEA).
DSHEA changed the way the FDA regulates dietary supplements. Under DSHEA, as long as a company does not claim its supplement cures a disease, the only premarket requirement is that the company have scientific proof that the product is safe. Once its product is on the market, a company has 30 days during which it must send to the FDA its structure-function claim, which replaces the disease claim.
Structure-function is "the bureaucratic way of saying you can make a claim for anything, just not a medical claim," says FDA spokesperson Judy Foulke. "You can't say your product treats a medical condition, but you can say how it affects the structure or function of the human body."
Thus, a drug can say it relieves migraine headaches (because it has presented to the FDA clinical studies as evidence), while a dietary supplement can only say it improves brain functioning. Once the claim is registered with the FDA, the agency then examines the wording so that a disease claim does not slip through by semantics. If the agency feels that a claim has overstepped its bounds, it notifies the company that it must change its wording or risk removal from the market.
DSHEA also decreed that all dietary supplement labels must contain a warning that the product has not been inspected by the FDA. The FDA only intervenes if a report comes in that someone has been harmed by a supplement. Once a complaint comes in, explains Foulke, the agency makes sure that the herb was taken as directed and that it was not taken with another substance, thus causing a bad reaction. If the product is deemed harmful, the FDA must then prove it should be taken off the market.
Varro Tyler, PhD, ScD, is a retired professor of pharmacology at Purdue University and author of the books "Herbs of Choice" and "The Honest Herbal." Before DSHEA, says Tyler, the head of the FDA, Dr. David Kessler, considered banning all herbal products from the market. Tyler jokes, "I kind of wish he had. Wouldn't it be wonderful if people were arrested for smuggling garlic from Illinois to Indiana?" Tyler says that the public fought Kessler's moves and the herbal industry then lobbied for the passage of DSHEA.
Now that it is here, herb advocates have mixed emotions about DSHEA. They are happy because now herbs are more widely available to the American public. Yet some say the structure-function claim is too limiting. Tyler complains, "You can't put on the label what the thing is good for. You can only put it in the most nebulous terms."
Mark Blumenthal, founder and executive director of the American Botanical Council, says getting from a disease claim to a structure-function claim requires only "verbal acrobatics." Blumenthal cites one case where an herb cannot declare it "supports the body's ability to resist infection," but can say it "supports the immune system."
The real danger of DSHEA, say those suspicious of herbal products, is that the manufacturing process is not standardized or regulated, so consumers do not know what truly is inside a supplement. The NJOM editorial reports that in an FDA analysis of ginseng products, "the amount of the active ingredient in each pill varied by as much as a factor of 10 among brands that were labeled as containing the same amount. Some brands contained none at all."
In March of 1999, counters Blumenthal, regulations of herbs will go into effect. As stipulated by DSHEA, Good Manufacturing Practices (GMPs) for dietary supplements will be set up as industry standards.
Tyler looks to Germany as a model for the proper government treatment of supplements. The German government's Commission E takes popular herbs which have been used for thousands of years and tests them to see if the tales are fact or fiction. Herbs can come to market if they are proven to be safe and effective. The commission uses what Tyler calls a "reasonable" proof of efficacy. He explains, "By reasonable, I don't mean the half-billion dollar variety that the FDA requires for a new chemical entity, but maybe only 1 or 2 million for clinical trials to show efficacy. After all, if the thing has been used for thousands of years and is still used for the same original purpose, it probably has some efficacy or people would have discarded it long ago."
Without more stringent rules like those in Germany, the American consumer has to beware the companies whose bottles claim a lot on the outside with very few effective ingredients on the inside.
Yet even proven ingredients can harm us. We also know that some drugs declared safe by FDA's strict inspectors later are found to be extremely dangerous. People with diabetes know Rezulin well. Not long ago the FDA approved it as an advanced new treatment for type 2 diabetes. Then, within a year, three people died and many more suffered from liver damage caused by Rezulin.
The FDA tries to make sure that supplement and drug companies stick to their scruples, but both are in the business of making money.
The Business of Herbs and Pharmaceuticals
The unscrupulous herbal remedy or nutritional supplement companies are usually fly-by-nighters. It takes a relatively small investment to put an herb on the market compared to the money that goes into a new pharmaceutical.
Many pharmaceuticals are made from herbs. American companies hear about folk remedies in other parts of the world, use science to figure out which part of the herb works, patent it and make it into a drug. The company has to put up the millions for clinical studies, but if it works, it owns exclusive rights and can reap much more in profits from the drug.
Glucophage, the popular treatment for type 2 diabetes made by Bristol-Myers Squibb, is an example. Glucophage, the brand name for the drug metformin, comes from goat's rue, a plant native to Europe. According to Life magazine, goat's rue has been used since the Renaissance to lower blood sugars and in 1958 it was converted into the pharmaceutical Glucophage in France. The U.S. FDA approved Glucophage in 1995 and in 1997 it generated $579 million in sales for Bristol-Myers Squibb.
No one can own a plant, so those who manufacture herbs in forms closer to their natural states cannot get a corner on the market. Herein lies the problem with herbs, says Stephen Barrett, MD, a retired psychiatrist and consumer advocate who masters a Web site called "Quackwatch," through which he warns consumers of medical fraud. Barrett tells people to avoid any Web sites which market herbs, commenting, "Although some are useful I do not believe it is possible to run a profitable business selling them without some form of deception."
Tyler disagrees and names a German herb company, Lichtwer, as an example. Tyler says that Lichtwer's herbal products work, as proven by the company's research, and, furthermore, profits have more than covered the research costs.
Successful herb companies do exist, because people are buying herbal products. People with diabetes are willing to see if St. John's Wort or chromium picolinate can improve their body's functioning or help ward off diabetes complications. With the industries and doctors arguing amongst themselves, at least for the near future, it seems that consumers will continue their solo searches for reliable products.
Seek Help on the Spectrum of Possibilities
Because people can find vitamins and herbs almost anywhere at relatively affordable prices, they often do not seek a doctor's advice. The NJOM reported in 1993 that 72 percent of patients who use alternative remedies do not tell their doctors. Yet people with diabetes must tell their doctors what they are taking. Besides possible dangers, supplements are like food and can affect diabetes management. Also, taking too much of one supplement or mixing it with the wrong thing can cause great harm.
The FDA can still provide consumers with information about dietary supplements. Every complaint the FDA hears about a supplement is posted on its Web site. If a person with diabetes is considering a particular product, Judy Foulke recommends that he or she do a word search on the Web site to get any scoop on that product. The FDA's Web address is www.fda.gov. Dietary supplements fall under the foods category.
Another federal agency, the National Institutes of Health (NIH), is testing herbal medicine through its National Center for Complementary and Alternative Medicine (NCCAM). Formerly called the Office of Alternative Medicine, NCCAM's mission is to evaluate "unconventional medical practices," mainly through sponsoring research, such as its current three-year study of St. John's Wort and its effect on depression. To get the word on any NCCAM research, call its clearinghouse at (888) 644-6226 or visit its Web site, altmed.od.nih.gov/nccam.
Many herbalist organizations' missions are to promote the truth about herbs. The American Botanical Council has published the German Commission E monographs in book form to assist American consumers. It also puts out a quarterly journal, reviewed by scientists, called HerbalGram. The council's Web site, www.herbalgram.org, provides more information. Another source of information is the American Herbal Products Association, at (301) 588-1171.
The United States Pharmacopeia, a nonprofit, voluntary group, has been setting standards of quality for medicines since 1820. Products which follow these standards have the USP notation on their labels. Its Web site is www.usp.org. For some general guidelines to weeding out many different false or pseudoscientific medical claims, look at Barrett's Quackwatch Web site at www.quackwatch.com.
Although health care professionals may not be familiar with some dietary supplements, they should always be informed of any change in a diabetes management plan.
Getting Through the Spectrum of Possibilities Takes Time and Resources
Dori Linnell is continuing her solo experiment with BetaFast. "I am sure that Tel is requiring less insulin," says Linnell. She says that since taking BetaFast Tel no longer requires an insulin injection before bed. She does warn people, however, that Tel has experienced some very low readings on BetaFast. She says, "Tel's BGs are still too low, so we continue to cut back on his insulin. It's trial and, unfortunately, error for now."
Linnell's doctor is still examining the product and the studies. She says she is lucky because she has the time it takes to keep a very close eye on Tel's glucose levels, and she has the resources to keep plenty of glucose sources around for Tel's hypos. She realizes that some people do not have these luxuries and could be in danger from all of this trial and error.
Even as the line between traditional and alternative care blurs, the main goal of diabetes care remains the same. Whether you are type 1 or type 2, the goal of a diabetes regimen should be normalization of blood sugars. Those who choose to include herbal or vitamin supplements to achieve this goal must realize that although the guidance may be sparse, they must get all that is out there. They must combine ancient wisdom with modern science.
0 comments - Dec 1, 1998