Herbal update: Echinacea shown ineffective, ephedra to be banned by FDA - News And Comment

Despite claims from proponents and manufacturers of supplements containing the herb Echinacea, a recent study published in the December 3, 2003, Journal of the American Medical Association shows that it has little effect in the treatment of upper-respiratory infections (U.R.I.s) in children.

The randomized, double-blind study, performed by James E. Taylor, M.D. et al., treated 337 (of707) U.R.I.s in 407 children with a compound containing Echinacea purpurea (purple cone flower), while the remaining 370 cases received a control placebo. (Two other forms of Echinacea, E. angustifolia and E. pallida, for which similar claims are made, were not included in the study.) Treatment was begun at the onset of symptoms and continued either to their resolution or for ten days, whichever came first. The study was designed primarily to examine Echinacea's influence on the illnesses' duration and severity as well as any adverse effects. The secondary outcomes of the study include when the severity of symptoms peaked and how long the peaks lasted, the number of days when fever was present, and what was termed a parental "global assessment of severity of symptoms." Statistically, the study showed no significant difference between the Echinacea compound and the placebo for any of the outcome measures except for one item in the adverse events category: The incidence of rashes (possibly due to unreported allergies) among the study's subjects was significantly higher among those who received the Echinacea (7.1 percent) against those who received the placebo (2.7 percent).

The study may, however, show a reduction in the rate of the subsequent incidence of U.R.I.s among the children who received the Echinacea, indicating a possible preventive benefit. But the study's principal author cautions that more research is needed before a definitive conclusion can be reached on that point. It should also be noted that there is little scientific evidence that most conventional cold therapies commonly used to treat adult U.R.I.s are effective when used on children, a factor that may have led to the reported increased use of alternative therapies, such as Echinacea, on children.

In related news, the FDA has announced its intention to publish a rule that will effectively ban the manufacture and sale of products containing the herbal supplement ephedra, an unsynthesized form of the drug ephedrine. These compounds are commonly used to speed weight loss and enhance athletic performance. Ephedra, a natural alkaloid that stimulates metabolism by speeding the heart rate while simultaneously constricting blood vessels, has been linked to a number of dangerous health effects including stroke, heart attack, and seizure.

According to its Consumer Alert dated December 30, 2003, the FDA is basing this ban on "an exhaustive and highly resource-intensive process" involving numerous studies and the evaluation of "a prodigious amount of evidence," which showed that ephedrine "presents a significant and unreasonable risk to human health." The alert is available at www.fda.gov/oc /initiatives/ephedra/december2003/advisory.html.

This action comes after a steep drop in the sale of ephedrine-based products, which followed a wave of publicity over the death of Steve Bechler, a professional baseball player. According to an article on the Web site of ABC News (http://abcnews.go.com/wire/Living/ap 20031230_1237.html), as many as 155 deaths have been attributed to the use of ephedra. The FDA has been studying the herb and the effects of its use since 1994, and a number of states, including New York, California, and Illinois, had already proposed or enacted bans on the supplement prior to the FDA's announcement. Because of intense lobbying by the herbal industry and alternative medicine proponents, the FDA has no legal authority to regulate herbs and supplements. (See "The Politics and Bad Science of Alternative Medicine," SI 27[5], September/ October 2003.)

David Park Musella is an editorial assistant

with SKEPTICAL INQUIRER.

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