Understanding and Using Herbal Medicines, Part 2

The Complete Guide To Herbal Medicines
by Charles W. Fetrow, Pharm.D., Juan R. Avila, Pharm.D.

(Page 2 of 4)

Regulating herbal medicine

In the 19th century, many fake remedies were sold to gullible, desperate Americans. The federal government finally took action against disreputable purveyors of phony remedies by passing the Food and Drug Act of 1906. This law addressed problems of mislabeling and adulteration of plant remedies — but not safety and effectiveness.

Today, herbal remedies remain largely unregulated. The Food and Drug Administration (FDA) regulates herbal products only as dietary supplements, not drugs. This means that the FDA can recall herbal products that are shown to be harmful, but manufacturers aren't required to provide information about their products' contents or side effects or to prove their safety or efficacy. They need only provide "reasonable assurance" that the product contains no harmful ingredients.

What's more, although manufacturers can't claim a particular product cures or prevents a specific disease, they can make any other claim about the supposed benefits without providing supporting evidence. They need only add the following disclaimer: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease."

In essence, herbal remedies in the United States are sold on a buyer-beware basis. This highlights the importance of learning everything you can about any herbal products you plan to use.

European standards

In Europe, where millions of people use herbal and homeopathic remedies, governments and the scientific community are much more open to natural remedies, especially those with a long history of use. In Great Britain and France, traditional medicines that have been used for years with no serious side effects are approved for use under the "doctrine of reasonable certainty" when scientific evidence is lacking.

The European Economic Community has established guidelines that standardize the quality, dosage, and production of herbal remedies. These guidelines are based on the World Health Organization's Guidelines for the Assessment of Herbal Medicines, a 1991 publication that addressed concerns about the safety and effectiveness of herbal medicines.

Therapeutic uses of herbs

A plant's leaves, flowers, stems, berries, seeds, fruit, bark, roots, or any other part may be used for medicinal purposes. Most herbal remedies are used to treat minor health problems, such as nausea, colds, cough, flu, headache, aches and pains, stomach and intestinal disorders (such as constipation and diarrhea), menstrual cramps, insomnia, skin disorders, and dandruff.

Some herbalists have reported success in treating certain chronic conditions, including peptic ulcers, inflammation of the colon, rheumatoid arthritis, high blood pressure, and respiratory problems. Some use herbal remedies for illnesses usually treated only with prescription drugs, such as heart failure.

However, if you have a serious disorder and are considering an herbal remedy, don't discontinue ongoing medical treatment. Also be sure to tell your health care practitioner about any prescribed drugs you're taking, because these may interact with herbal remedies. (See Taking herbal remedies safely, pages 6 and 7.)

Research on herbal remedies

Numerous studies on herbal remedies have been done in Europe and Asia. European studies have shown benefits from such herbs as ginkgo, bilberry extract, and milk thistle in treating various chronic disorders. Chinese researchers have extensively studied many herbs, such as ginseng, fresh ginger rhizome, foxglove, licorice root, and wild chrysanthemum. Indian researchers using modem scientific methods have recently studied various Ayurvedic, herbs, including Indian gooseberry and turmeric.

Taking herbal remedies safely

Many people take for granted the safety of the drugs and foods they buy. But unlike drugs, herbal remedies aren't reviewed by any government agency for quality, dosage, safety, or efficacy. If you're thinking about taking an herb, know that the vast majority of botanical products sold in the United States haven't been scientifically tested. Their alleged benefits are based largely on word-of-mouth.

How herbal products are regulated

The Food and Drug Administration regulates herbal products as food supplements, not drugs. The labels on these products don't tell you about their ingredients, risks, side effects, or possible harmful interactions with other substances. Nor do they guarantee that the herb is in a form your body can absorb or that the recommended dosage has been tested on animals or humans.

Also, herbal products may contain ingredients other than those indicated on the label. For example, Siberian ginseng capsules were found to contain a weed full of male hormone-like chemicals. What's more, the amount of active ingredient in an herb varies from brand to brand and possibly from bottle to bottle within a particular brand.

To help prevent problems caused by herbal medicine, follow these guidelines.

General precautions

• Check with your health care practitioner before using any herbal product especially if you're taking a prescription drug. Tell your practitioner about all drugs you're taking, including nonprescription medications and vitamins. Many herbal remedies can interact with other drugs.

• Make sure your health care practitioner is aware of your medical history, including allergies.

• When taking an herb, follow the instructions exactly. If you take too much of an herb or take it inappropriately, you may get no benefit from taking it — or put yourself at risk for potentially dangerous side effects.

• Never ignore symptoms you're experiencing. Contact your health care practitioner if you experience side effects of an herbal agent or if you have other health concerns that would normally require medical attention.

• Be sure to call your health care practitioner if you experience abdominal cramping, abnormal bleeding or bruising, changes in your pulse or heart rhythm; vision changes, dizziness or fainting; hair loss; hallucinations, inability to concentrate or other mental changes, hives, itching, rash, or other allergic symptoms, appetite loss, or dramatic weight loss.

• Don't use herbal agents to delay seeking more appropriate therapy. Keep in mind that herbs aren't necessarily a substitute for proven medical therapy.

• If you're a parent or other caregiver, consider each of the preceding precautions before giving herbal medicines to a child or an elderly debilitated person.

• Discontinue herbs at least 2 weeks before before surgery. They can interfere with anesthesia and cause heart and blood vessel problems.

When to avoid herbs

• Avoid herbal preparations if you're pregnant or breast-feeding. Most herbs' effects on the fetus are unknown. If you're a woman of childbearing age, use birth control when taking herbs.

• Don't use herbs for serious or potentially serious medical conditions, such as heart disease or bleeding disorders.

• Never let other people take your herbs or other medicine. Store herbal agents out of reach of children and pets.

• If you have questions about the herb you're taking, seek advice from a qualified health care provider. If your practitioner isn't knowledgeable about herbs, ask for a referral to someone who is.

Buying herbal products

• Be wary of products that promise to cure specific health problems.

• Read labels carefully when buying herbal products. Check for the term standardized on the label. Standardized means that the dose of medicine in each tablet or capsule in that package is the same. Also make sure the label states specific percentages, amounts, and strengths of active ingredients.

• Avoid herbal "cocktails" that contain more than one ingredient. Experts know little about the effects of combining herbs.

• Buy your herbs from reputable companies. Avoid products sold through magazines, brochures, the broadcast media, or the Internet.

• Consider buying organically grown herbs. Some people believe herbs that grow naturally in the wild are subject to contamination from pesticides, polluted water, and automobile exhaust fumes.

• Remember that the clerk at the health food store is a salesperson, not a trained health care practitioner.

The United States lags behind other countries in herbal medicine research for several reasons. Until the Office of Alternative Medicine (OAM) was established in 1992, such research lacked federal support. Also, pharmaceutical companies have no financial incentive to develop herb-based drugs because botanical products can't be patented. That means the companies could never recoup their research investment.

The inherent difficulty in studying herbs according to Western pharmaceutical standards has posed another obstacle to herbal research. Western standards favor isolating a single active ingredient. However, herbs may contain several active ingredients that work together to produce a specific effect.

Although large gaps remain in research, many clinical trials of herbs used as medication are currently underway. Since 1995, the OAM has collected more than 60,000 research citations on complementary and alternative health care practices, including 2,500 clinical trials that have been compiled in a computer database system.

Copyright © 2000 by Springhouse Corporation

About the Author

Charles W. Fetrow, Pharm.D., is coordinator of pharmacokinetics, outpatient anticoagulation, and drug evaluation services at St. Francis Medical Center in Pittsburgh. Dr. Fetrow teaches pharmacology topics at St. Francis and at Duquesne University.

Juan R. Avila, Pharm.D., Formerly an assistant professor at Shenandoah University and Duquesne University and a clinical pharmacy specialist at St. Francis Medical Center in Pittsburgh, is now medical therapeutics liaison for Sanofi-Synthelabo Pharmaceuticals in New York.