A DEADLY COMBINATION
The majority of people who use herbal supplements fail to tell their health care providers what they are taking, which could prove to be a deadly mistake.
Written by Melody Ragland
During the past two decades, the use of dietary and herbal supplements has increased dramatically. Currently 29,000 herbal supplements are available for sale over-the-counter in the United States. With the increase of consumption of these products, the majority of people using these products fail to tell their health care providers what they are taking, which could prove to be a fatal mistake.
Alan Kaye, M.D., Ph.D, professor and chairperson of the Department of Anesthesiology at the Texas Tech University Health Sciences Center, recently found that one in three patients use a dietary or herbal supplement. In his survey, of those patients who admitted to taking a supplement, 70 percent failed to tell their doctor they were taking a nutraceutical. Nutraceuticals include all herbal medications, medicinal foods and vitamins.
Kaye's purpose in doing the research was to create awareness among patients and doctors that a number of these nutraceuticals are known to cause drug interactions and serious health problems. Some problems include variations in blood pressure, increased bleeding tendencies and herb-anesthetic interactions.
"We know about some documented interactions, but what are the interactions we don't know about?" Kaye said. "No one is telling their doctor what they are on. Patients need to tell their doctor what they're taking, and they need to work with them. If the doctor is not willing to read, learn and be educated on the subject, maybe they need another doctor." With the availability of information on the Internet, he said patients also could educate themselves about herbal supplements.
For Kaye's study members of the anesthesiology staff and residents at Texas Tech University Health Sciences Center evaluated patients. After patients were given a pre-anesthetic evaluation, a simple survey was administered. The survey listed 12 different neutraceuticals and the patients were asked to circle all that applied. The surveys were given over a period of five months to 1,017 different patients. Some were discarded because they were incomplete. Of the remaining 755 valid surveys, Kaye found that of the patients who admitted to taking a nutraceutical, 90 percent of the patients were using vitamins, 43 percent garlic extracts, 32 percent ginkgo biloba, 30 percent St. John's Wort, 18 percent ma huang, 12 percent echinacea, 10 percent aloe, 8 percent cascara and 3 percent licorice.
Kaye's research indicated that most of the herbs being taken by patients surveyed could cause drug interactions or alter bleeding time, which can increase the risk of bleeding during surgery. The herbs not only can have an interaction with anesthetics, but also can have adverse effects.
According to Kaye's pulmonary and cardiovascular laboratory studies, garlic derivatives can cause a dose-dependent decrease in mean arterial and pulmonary vascular pressure. It may also cause bad breath, prolong bleeding time and cause low blood pressure. If taken, ginko biloba can cause platelet dysfunction, increase bleeding during surgery, and it may decrease the effectiveness of intravenous barbiturates. St. John's Wort can cause dry mouth, dizziness, constipation and nausea. Kaye also said if St. John's Wort is taken with certain anti-depressants, it could cause a lethal interaction. Ma huang or ephedra, can cause hypertension, stroke, myocardial infarction, cardiomyopathy, cardiac arrythmias or sudden death. Combining echinacea with anesthetic may increase barbiturate toxicity and can cause unpleasant taste sensation, tachyphylaxis, or potential liver toxicity. Currently, Kaye's laboratory is studying the effects of ma huang.
"Our statistics make sense because people who come to the operating room all have a problem," Kaye said. "That's why they are in the hospital or need certain surgeries. So you would think we have just a little bit more nutraceutical use than the general population."
Kaye believes the No. 1 way to prevent potential dangers related to herbal medicines and induced drug interactions is communication. He said doctors also need to familiarize themselves with all the herbs currently available. He said patients do not need to be afraid of telling their doctors every medication they use.
According to Charles Seifert, Pharm.D., Texas Tech professor of pharmacy practice and regional dean for Lubbock programs, the Food and Drug Administration does not have to approve nutraceuticals for sale.
"Normal pharmaceuticals have to be approved safe and effective," he said. "Herbal and dietary supplements fall under the food category. The Food and Drug Administration steps in when herbals are shown to be dangerous."
Herbal supplements are protected by the 1994 Dietary Supplement Health and Education Act. According to the Food and Drug Administration's Web site, the agency defines a dietary supplement as a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by humans to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract or combinations of these ingredients.
The Food and Drug Administration also considers the following a dietary supplement: if the supplement is intended for ingestion in pill, capsule, tablet or liquid form. A dietary supplement is not represented for use as a conventional food or as the sole item of a meal or diet. Supplements must be labeled as a "dietary supplement." The Dietary Supplement Health and Education Act includes products such as an approved new drug, certified antibiotic, or licensed biologic that was marketed as a dietary supplement or food before approval, certification, or license as a supplement (unless the Secretary of Health and Human Services waives this provision).
The act also states that herbal manufacturers cannot claim their product prevents, mitigates, treats or cures a specific disease (unless approved under the drug provisions of the Federal Food, Drug and Cosmetic Act). As far as labeling, supplements containing herbal and botanical ingredients must state what part of the plant from which the ingredient derived.
Both Kaye and Seifert agree that herbal and dietary products may have some benefit, but the problem is that not enough research has been done on them.
"We need to do more and more studies to show whether or not herbals work," Kaye said. "We need to sort out which agents are therapeutic, which are not and which are dangerous."
Seifert said that because products do not have to be approved by Food and Drug Administration, some products might have other additives in their ingredients. "You never know what you are getting," he said.
Kaye said there are hundreds of documented cases of deaths across the United States due to complications with herbal supplements. He also said there are many lethal interactions that are not documented. Ma huang, a component in Metabolife, has reportedly caused 58 deaths and 900 cases of adverse affects in the past few years. He said since ma huang is often an ingredient in weight loss pills, medical professionals are very worried about that particular herb.
"We think herbals are drugs. They are drugs," he said. "Some herbals have good effects, some have no effects, and some of them have bad effects. We are not being judgmental and saying these are bad. What we think is that the Food and Drug Administration should standardize and ensure purity to protect society. I'm not against them. I just want them to be looked at under the same standards as any other medications."
Seifert said people who choose to take herbs are looking to self-cure. Kaye said some patients believe traditional medicine will not cure their illnesses, but herbals will. He also said because herbals are available almost everywhere, patients believe herbals are more convenient and cheaper than traditional medications.
"If you are sick, seek medical attention," Seifert said. "Just because an herb worked for your neighbor, doesn't mean it will work for you. Everyone is different. There need to be studies to find the benefits and dangers."
He said one of the reasons the Food and Drug Administration has yet to standardize supplements is due to the political pressure from lobbyists, manufacturers and the general public.
"The marketing and advertising for these products is misleading and deceptive," Seifert said.
According to Seifert, there is no clear-cut guide to how much dosage of an herb actually has to be in the supplement. This means, some people may not be taking an herb with enough active ingredients. For example, he said what makes garlic lower some people's blood cholesterol is the smell component. There are garlic products for sale over-the-counter that say "odor free." According to Seifert, if someone is taking an "odor free" garlic tablet, it is probably not doing what is says it does.
Kaye said it is important that the benefits and risks of herbal supplements be taught in medical education. According to Kaye, the American Society of Anthesiologists recommends anyone going for elective surgery should discontinue all herbal products two to three weeks prior to their surgery. "That's pretty simple," he said. "That way all of the herbals will leave the patients' systems before their surgical procedures."
(For more information about the Dietary Supplement Health and Education Act of 1994, see the Food and Drug Administration's Web site.)
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