Ephedra: The Herb That Failed

On April 12, 2004 the United States Food and Drug Administration officially banned the sale of any and all supplements containing ephedra from the shelves of pharmacies. What is Ephedra and why has it garnered so much concern?

Traditionally the herb ephedra was used by Chinese doctors as a primary treatment for asthma, bronchiti, swelling in the joints and the bones. In contemporary China, ephedra is often a component of a multi-herb cold formula made by boiling ephedra with cinnamon twig, licorice root, and almond. In Germany, it is a major ingredient in licensed prepared medicine for respiratory conditions.

The World Health Organization (WHO) has found the following uses of ephedra preparations to be supported by clinical data: treatment of nasal congestion due to hay fever, allergic rhinitis, common cold, sinusitis, and as a bronchodilator in treatment of bronchial asthma. In the United States, ephedra is considered a dietary supplement under the Dietary Supplement Health and Education Act of 1994 (DSHEA).

With such support from traditional and conventional medicines and numerous research studies the herb gradually grew in popularity. Ephedra was sold in health food stores as an infusion, tincture, or extract in capsules or tablets and prescribed by licensed acupuncturists, herbalists, and naturopathic doctors.

Ephedra is also found in common conventional cold medications.

Aside from its proven use, ephedra is a main component of many herbal preparations for weight loss, athletic performance, and physical and mental stimulation What then happened?

Ephedra sinica , a species of ephedra (Ma huang), contains the alkaloids ephedrine and pseudoephedrine, which have been found to induce central nervous system stimulation, bronchodilation, and vasoconstriction. In combination with caffeine, ephedrine appears to elicit weight loss (in trials of 1-12 months duration). However, studies of ephedra or ephedrine monotherapy have been equivocal.

The majority of human trials of weight loss have been small with methodological weaknesses including large dropout rates due to adverse effects, and incomplete reporting of blinding or randomization. Numerous trials have documented the efficacy of ephedrine in the management of asthmatic bronchoconstriction and hypotension. However, commercial preparations of non-prescription supplements containing ephedra have not been systematically studied for these indications.

Major safety concerns have been associated with ephedra or ephedrine use, including hypertension, tachycardia, CNS excitation, arrhythmia, myocardial infarction, and stroke. In 1997, due to over 800 U.S. reports of serious toxicity (and many more worldwide) including at least 22 deaths in adolescents and young adults, the U.S.

Food and Drug Administration (FDA) adopted a policy that ephedra-containing products must: (1) be labeled with all possible adverse effects, including death; (2) contain no more than 8mg of ephedrine per serving; and (3) be used for no more than seven days. The FDA also proposed a maximum daily dose of 24mg, and a ban on ephedra-caffeine combination products (these proposed limits were subsequently withdrawn)