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http://www.nytimes.com/2003/02/04/health/04BROD.html?tntemail0

Herbal Remedies: Natural Does Not Mean Safe

By JANE E. BRODY

woman who has been taking a prescription for her high blood pressure was advised by a friend to see an herbalist, who sold her a bag full of remedies. Now, the woman admits, she knows almost nothing about those remedies. Nor has she told her doctor about them.

Are they safe? Are they pure? What drug effects do they have? And what side effects? Will they interact badly with her prescriptions and cause her blood pressure to plunge dangerously low?

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She doesn't know, and, chances are, neither does her doctor.

No Assurance of Safety
 

The woman with high blood pressure is but one of many who wander blindly into the world of herbal remedies, a world that, unlike that of prescription and over-the-counter drugs, remains unregulated. The popularity of these products has soared. In 2001 alone, Americans spent $4.2 billion on herbs and other botanical remedies.

Herbal remedies don't have to meet the standards of safety and purity specified in the Federal Food, Drug and Cosmetic Act. The same applies to vitamins and minerals sold as dietary supplements. And, none of them have to be tested to define their medicinal effects.

This is not to say that all these remedies are unsafe, impure or ineffective. Some are made by reputable companies under near-pharmaceutical conditions. Some have been tested in well-designed clinical trials. Still, the consumer has no way to know exactly what is in the bottle and what effects the contents may have on health. Reports of disastrous effects abound, including mania, hemorrhage, coma, heart and kidney damage, liver failure and cancer.

In addition, herbal products may be contaminated with hazardous substances: dangerous plant chemicals, toxic metals, disease-causing micro-organisms, fumigants and pesticides. In some cases, none of them are listed on the label.

The reported cases of harmful effects represent just a fraction of what actually occurs, since there is no mandated reporting system. Even with prescription and over-the-counter remedies regulated by the government, only an estimated 10 percent of serious adverse effects are ultimately reported to the Food and Drug Administration, according to an inspector general's report.

With herbal remedies, according to the 1994 Dietary Supplement Health and Education Act, the burden of proof of hazard lies with the F.D.A., which lacks the resources to monitor these products properly.

Furthermore, only when a hazardous reaction occurs frequently and soon after an herbal remedy is used is the connection likely to be recognized. When ill effects occur infrequently, when they mimic symptoms of an underlying illness or when they develop over time, as liver damage and cancer do, the role of an herbal remedy may be overlooked.

Some herbs are deemed safe because they have been used seemingly safely by herbalists and other traditional healers for centuries.

But as Dr. Peter A. G. M. De Smet of the Netherlands recently stated in The New England Journal of Medicine, "If an herb caused an adverse reaction in 1 in 1,000 users, a traditional healer would have to treat 4,800 patients with that herb (i.e., one new patient every single working day for more than 18 years) to have a 95 percent chance of observing the reaction in more than one user."

Kava, long popular for its antianxiety effects, was ultimately found to be toxic to the liver, sometimes damaging it to the point that a transplant is needed. Aristolochia plants have been used for centuries, Dr. De Smet noted, but their ability to cause urothelial cancer has only recently become clear. Likewise, if an herb is toxic to an embryo or fetus, the effect may go unnoticed by a traditional healer, he wrote.

Dr. Stephen E. Straus, director of the National Center for Complementary and Alternative Medicine, wrote in the same journal, "Just because an herb is natural does not mean that it is safe, and claims of remarkable healing powers are rarely supported by evidence."

And, he noted, "With herbal medicines, what is on the label may not be what is in the bottle." In tests of ginseng products he cited, analyses showed that one contained only 12 percent of the amount of active ingredients listed on the label; another contained a whopping 328 percent.

Does Any Herb Work?
 

Not long ago, nearly half of all prescription drugs were derived from plants or synthesized to mimic a plant chemical. Clearly, plants contain thousands of ingredients with drug effects.

Congress established Dr. Straus's agency to foster studies of the actions and clinical effects of herbal remedies and other alternative medicines and to publicize the findings for doctors and consumers alike.

Studies of herbs, Dr. Straus admits, are not easy to do, in part because it is hard to find standardized sources of herbs, which, unlike manufactured drugs, are by nature complex mixtures of chemicals. Herbal contents can vary based on where, when and how the plants are harvested and how extracts are processed. Researchers cannot be certain which of the many chemicals in an herb contribute to its medicinal effects, if any, or which are harmful.

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In his journal review, Dr. De Smet notes that while ginkgo leaf extracts have been promoted for the treatment of dementia, peripheral vascular disease and neurosensory problems like tinnitus, well-designed studies have shown mixed results. The herb may sometimes cause headaches, nausea, gastric symptoms, diarrhea or skin reactions.

Hawthorn appears to improve mild cases of heart failure; saw palmetto improves urinary symptoms in men with benign prostatic enlargement; St. John's wort has helped to relieve mild to moderate depression; feverfew can help to prevent migraine headaches; and ginger can help counteract motion sickness and nausea in pregnancy.

To date, however, the data are inconclusive about the benefits of valerian to counter insomnia, echinacea to prevent and treat common colds and ginseng for any purpose.

In a third journal article, Dr. Donald M. Marcus of Baylor College of Medicine in Houston and Dr. Arthur P. Grollman of the State University of New York at Stony Brook called for new regulations of herbal remedies, which are now subject to lower safety standards than food additives.

They proposed, among other things, requiring the F.D.A. to approve dietary supplements for safety before they can be sold.

They also urged manufacturers to establish and abide by good manufacturing practices and to report all adverse effects promptly to the agency. And, they recommended that labels cite all constituents of products by their botanical and common names and list possible harmful effects, including herb-drug interactions.

Further, they suggested establishing expert panels to review the safety of dietary supplements.

Until the regulation of herbal remedies improves, however, it is caveat emptor — let the buyer beware.

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