But Joan Pleuss, RD, MS, CDE, CD, Bionutrition Research Manager at the Medical College of Wisconsin's General Clinical Research Center, urges consumers to take a dose of caution when using herbals.

"They're not regulated by the Food and Drug Administration (FDA), the same way prescription and over-the-counter medications are," she says. "They do not have to meet the same standards for safety, effectiveness, and what the FDA calls Good Manufacturing Practices." Currently, herbals fall under the FDA regulations as food.

Government Studies Now Under Way
Pleuss notes that a number of studies involving herbals are currently under way. "Right now we know that some herbals are not safe and can have harmful side effects. For example, the herbs kava and comfrey have been linked to serious liver damage. Other herbs can interact with prescription or over-the-counter medications. Consumers should always notify their health-care provider about what herbal medications they're taking or plan to take, especially if they are about to undergo surgery."

That includes some of the most widely used herbals - echinacea, garlic, ginkgo biloba, ginseng and St. John's Wort, among others, she says.

Other groups that should hesitate before using herbal remedies are women who are pregnant or breast-feeding, because herbals can act like drugs, Pleuss says, along with anyone under 18 and adults 65 and older. "Older people often metabolize medications, including herbals, differently than younger adults do. Herbals have not been widely tested for their effects on growing children." Several recent studies have been done on children to measure the efficacy of echinacea and garlic for their widely touted potential to relieve cold symptoms. Neither was found any more effective than a placebo.

In 1999, American Family Physician, a publication of the American Academy of Family Physicians (AAFP), published "Herbal Health Products - What You Should Know," for distribution to consumers. As a general guide, it stated: "Don't think that herbal health products are safer than other medicines just because they come from plants. Many plants are poisonous. Although herbal products are advertised as 'natural,' they aren't natural to the human body." AAFP notes that many prescription and over-the-counter medicines are derived from plant sources, too.

In its guidelines, AAFP warns patients with any of the following health conditions to consult their physicians before taking herbal medications:

• High blood pressure
• Thyroid problems
• Psychiatric problems
• Parkinson's disease
• Enlarged prostate gland
• Blood clotting problems
• Diabetes
• Heart disease
• Epilepsy
• Glaucoma
• History of stroke
• Liver problems

Buyer Beware
In addition, AAFP notes, because herbal products are not regulated like prescription and over-the-counter drugs, purity can be a problem. Herbals might be processed and manufactured with fillers and other ingredients such as plant pollen that could trigger allergies or adverse medical problems.

In December 2004, the Journal of the American Medical Association (JAMA) reported that some herbal products from India that are sold in the United States were found to contain dangerous levels of lead, mercury and arsenic. Some of these ayurvedic products are sold at health food and Indian grocery stores as remedies for arthritis and diabetes.

In 2003, the government banned the herbal ephedra, which had been promoted as a weight-loss and energy-boosting product.

"When people buy herbal medicines," Pleuss says, "they should buy a single product, not a product that is a mixture of more than one herbal." In addition to the studies she cited, a number of other national initiatives are under way that suggest that the health and medical establishment is willing to take a look at the potential benefits of herbal and other non-pharmaceutical remedies, as well as their risks.

In November 2004, the FDA announced it would work collaboratively with federal and other partners to improve the information FDA uses to make safety and enforcement decisions about dietary ingredients and dietary supplements. Those partners include the National Institutes of Health Office of Dietary Supplements and National Center for Complementary and Alternative Medicine (NCCAM), the National Toxicology Program in the Department of Health and Human Services, the University of Mississippi's National Center for Natural Products Research, FDA's National Center for Toxicological Research and others.

NCCAM, incidentally, is 1 of the 27 institutes and centers that make up the National Institutes of Health. It was established by Congress in 1998 to explore "complementary and alternative healing practices in the context of rigorous science, training complementary and alternative medicine researchers, and disseminating authoritative information to the public and professionals."

An estimated 1,500 herbal and botanical products are sold as dietary supplements or ethnic traditional medicines in pharmacies and supermarkets as well as health stores. In 1996, JAMA estimated that Americans spent $2.5 billion annually on herbs, and as much as $12 billion annually for all food supplements - and predicted the market would continue to grow.

By the end of 2003, according to the Natural Marketing Institute, the sales of vitamins, minerals, herbals and other dietary supplements in health stores rose 6%, to $19 billion. But according to the institute's Health and Wellness Trends Database, although this represents a market of more than 60 million adults, it also indicates a decline in usage over the previous five years.

What should consumers do until more study results are released? Currently, the National Center for Complementary and Alternative Medicine advises this: "If you use herbal supplements, it is best to do so under the guidance of a medical professional who has been properly trained in herbal medicine. This is especially important for herbs that are part of an alternative medical system, such as the traditional medicines of China, Japan, or India."

Barbara Abel
HealthLink Contributing Writer