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Despite health claims by manufacturers, little oversight for homeopathic products.

RECENT US FOOD AND DRUG ADministration (FDA) warnings that a popular over-the-counter cold remedy could cause loss of sense of smell in users have drawn attention to potential risks associated with socalled homeopathic remedies. Such products are usually allowed to be marketed as remedies for an array of health conditions without first demonstrating their safety and efficacy to the FDA. However, in June the FDA warned consumers that zinc-containing Zicam products (Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size) could cause anosmia, and warned the manufacturer, Matrixx Initiatives (Scottsdale, Ariz), to stop marketing them. The children’s product was no longer being sold at the time of the warning, and Matrixx Initiatives has since voluntarily recalled the other 2 products, but disputed that they pose a risk. The warnings have renewed debate about the safety and efficacy of homeopathic products and whether they should be subjected to closer oversight. Homeopathic products are based on a controversial centuries-old theory that a disease can be cured by highly diluted solutions of a substance that causes similar symptoms in healthy individuals. To create such a homeopathic remedy, a substance is serially diluted and shaken, a process that proponents claim leaves an “imprint” or “memory” of the substance in the water, according to the National Center for Complementary and Alternative Medicine (NCCAM) (http://nccam.nih .gov/health/homeopathy). However, the theory conflicts with the current understanding of chemistry and physics, according to NCCAM, and few studies have demonstrated any effect of homeopathic remedies. Yet a substantial number of consumers report using these products. In 2007, US adults spent nearly $3 billion on such products, according to data from the National Health Interview Survey published in July. And while homeopathic products had traditionally been distributed by individuals trained in homeopathy, data suggest that US consumers are now also purchasing homeopathic remedies over the counter to treat themselves, said Josephine P. Briggs, MD, director of NCCAM. “It’s an area we are concerned about,” said Briggs, noting that there is little evidence supporting the practice. A 2005 analysis of more than 100 homeopathic drug trials compared with more than 100 conventional medical trials concluded that the evidence for beneficial effects of such drugs is weak and that the existence of few robust trials with positive results may suggest a placebo effect (Shang A et al. Lancet. 2005; 366[9487]:726-732). Briggs explained that many trials of homeopathic drugs have methodological flaws, such as not having an appropriate placebo control. As a result, few of the trial proposals submitted to the agency are funded.