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Ephedra: Potent Herb, Potential Problem

 

Ma-Huang

By Mark Blumenthal

Commonly used in weight loss and asthma products, ephedra, or ma huang, has received a great deal of attention. Is it a health boon or hazard ? 

Few herbs have been misunderstood as the classic Chinese herb ma huang, commonly known as ephedra. This herb has been commercially cultivated for its therapeutic properties longer than any other medicinal plant—almost 5,000 years, according to some accounts.

    However, ma huang has become one of the most controversial herbs in the printed States. Concerns over the potency and safety of this herb and especially of its isolated alkaloids, ephedrine and pseudoephedrine, have prompted increased regulatory scrutiny and an herb industry-sponsored label warning. While pseudoephedrine is currently approved by the Food and Drug Administration (FDA) as a safe and effective ingredient in over-the-counter (OTC) drugs used as decongestants for colds and as bronchodilators for asthma, the FDA has banned the use of ephedrine in OTC products. However, many commercial herb products still contain the whole herb ma huang or its extracts and are used for energy and diet products that aren't currently FDA approved.

    Ma huang (Ephedra sinica) is native to China, Mongolia, India and parts of the Mediterranean. The dried stems of the ephedra plant have been used in traditional Chinese medicine for more than 5,000 years for colds and flu, fever, chills, headache, edema, bronchial asthma, nasal congestion, aching joints and bones, coughs and wheezing.

    Ma huang contains alkaloids generally referred to as ephedra alkaloids. Its dominant alkaloid is called ephedrine. In the 1920s, pharmacologists started using pseudoephedrine, a naturally occurring isolated alkaloid of ephedra, as a nasal decongestant, central nervous system stimulant and treatment for bronchial asthma.

    Ephedrine is a potent compound. It excites the sympathetic nervous system, causes constriction of blood vessels and stimulation of the heart, and produces effects similar to those of adrenaline, causing a rise in blood pressure and dilation of pupils in the eyes. The FDA approves of pseudoephedrine as a decongestant for oral ingestion in cases of common cold, hay fever, allergic rhinitis, upper respiratory allergies and sinusitis.

 

Related to the horsetail plant, ephedra (also known as ma huang or Mormon tea) has long been used as a stimulant.

For topical use for nasal congestion (in the form of nasal sprays), ephedrine is also approved. Milder acting pseudoephedrine has strong diuretic activity and dilates the bronchi in cases of asthmatic spasms. Pseudoephedrine is the preferred OTC drug ingredient. It produces less potential for adverse reactions because its hypertensive and central nervous system stimulation effects are weaker.

Why Ephedra Is Problematic

In the past few years concern has increased among health professionals about the adverse effects of large doses of the isolated alkaloid ephedrine. It can cause nervousness, headaches, insomnia, dizziness, palpitations, skin flushing, tingling and vomiting. An FDA advisory review panel on nonprescription cough, cold, allergy, bronchodilator and antiasthmatic drug products has recommended that people with heart disease, hyper-tension, thyroid disease, diabetes or difficult urination due to enlarged prostate avoid taking ephedrine containing medicines.

    As with all drugs and many foods, the relative safety of a substance is partly dependent on the amount consumed and frequency' of use. The abuse and misuse of isolated ephedrine by consumers as a diet or energy enhancing product cause concern over the sale of all products containing ephedra alkaloids, and thus, the herb ma huang.

    In response to concerns over the potential adverse reactions arising from use and misuse of herbal products containing ma huang, the American Herbal Products Association recommends a warning be affixed to all herbal products containing this herb. This policy is consistent with the usual medical precautions concerning the use of ephedra's isolated alkaloids, which states: "Seek advice from a health care practitioner prior to use if you are pregnant or nursing, or if you have high blood pressure, heart or thyroid disease, diabetes, difficulty in urination due to prostate enlargement, or if taking an MAO inhibitor (antidepressant) or any other prescription drug. Reduce or discontinue use if nervousness, tremor, sleeplessness, loss of appetite or nausea occur. Not for children under 18. Keep out of reach of children."

    Know your own medical condition before attempting to use ma huang products. Read the product labels and abide by any warnings. If you feel it's advisable, consult with your physician before using ma huang.

 

FDA Soon To Regulate Ephedra

Proposed Food and Drug Administration (FDA) regulations on the sale of the herb ephedra, or ma huang, are forthcoming. The herbal extract, used in dietary supplements as a bronchial dilator, stimulant, performance enhancer and for weight loss, was blamed in the deaths of several people. The herb is also being sold and used in formulas considered alternatives for street drugs such as Ecstasy.

    The U.S. Centers for Disease Control (CDC) issued a statement in mid-August that ephedrine can dangerously affect the heart and nervous system, resulting even in death, and warned consumers to use caution if using ephedrine -containing supplements.

    Members of the Food Advisory Committee and the FDA's working group on ma huang met in Washington, D.C., in August to make recommendations on federal regulation of ephedra products. The group was charged by FDA Commissioner David Kessler and Elizabeth Yetley, director of the FDA's Office of Special Nutritionals, to consider only safety issues. Yetley posed three questions to committee members: whether they could identify a safe level of ephedra in dietary supplements, what margin of safety should be used, and whether there are conditions of use that entail no risk of significant harm.

    About half the group said there wasn't enough data to establish safe intake levels for ephedra, and some recommended ephedra be regulated as a drug or banned. The other half said safe limits can be identified, with a per dose limit ranging from 2 to 10 mg. All committee members agreed strict labeling is required and that manufacturers of formulas that include ephedra shouldn't include other stimulants in the product.

    The National Nutritional Foods Association, the Council for Responsible Nutrition and the American Herbal Products Association (AHPA) presented a plan for regulating ephedra-containing supplements. The plan calls for labels with warnings and contraindications and dosage limits below 15 mg. per dose. "We believe these products can be safely used," says Michael McGuffin, AHPA president. At press time, a month after the meeting, there's been no decision on ephedra from the FDA. Yet, many supplement manufacturers are preparing ephedra-free formulations of their products.

Source: Delicious! November 1996.

Responsible Use

Because the herb ma huang contains only about I to 2 percent alkaloids, its proper use by many people is relatively safe. However, as with any other potent plant product such as coffee or other caffeine-containing botanical such as kola nut, consumers should exercise intelligence and responsibility when taking ephedra. The FDA advisory panel cautions against taking more than 150 mg. of ephedrine per day (equivalent to 6 doses at 25 mg. each).

    Due to its chemical structure, ephedrine can be utilized as a precursor material for the illegal manufacture of methamphetamine, or "speed." For this reason, several states have recently passed regulations or legislation that restrict the sale of ephedrine and pseudoephedrine products. Consequently, the herb ma huang, because it contains small amounts of these alkaloids, has sometimes been restricted. A few states have proposed laws that restrict the nonprescription availability of ephedra alkaloids. However, some states have exempted ma huang if it contains no more than 25 mg. of total alkaloids.

    Yet, some experts disagree with these restrictions. "In view of the difficulties involved in extracting and purifying the relatively small concentrations of ephedrine from the ephedra herb, and the fact that the plant serves only as a minor source of the alkaloid anyway [i.e., in the commercial pharmaceutical market, ephedrine and pseudoephedrine are primarily chemically synthesized], restricting the availability of the herb seems an excessive measure:' says Varro Tyler, Ph.D., of Purdue University.

    The FDA has shown signs of wanting to remove ma huang from the market based on safety concerns. The agency recently told an herbal product manufacturer that its product was "adulterated" and thus misbranded because it contains ma huang, which the agency doesn't consider safe for food use.

    Although there are many questions about the use of ma huang, the real issue is one of responsible usage. Will consumers heed label warnings and other directions for responsible use? Fortunately, the Dietary Supplement Health and Education Act of 1994 now allows herb manufacturers to put more safety information and instructions for responsible use directly on product labels. We can expect to see ma huang products with ample warnings.

Mark Blumenthal is executive director of the American Botanical Council, a nonprofit research and education organization in Austin, Texas. He's also the editor of HerbalGram, a quarterly magazine dealing with herbal research and related issues. For more information contact PO. Box 201660, Austin, TX 78720-1660; 512-331-8868. visit http://www.newhope.com on the World Wide Web for more information on herbs.

Reprinted with permission from the January 1996 issue of Delicious! Magazine, a publication of New Hope Communications, Boulder, CO.

Ephedra or Ma-huang