Upper respiratory tract infections (URIs) are a significant health burden in childhood, according to background information in the article. The average child has six to eight colds each year, each lasting seven to nine days. While children are frequently given drugs such as decongestants, antihistamines, and cough suppressants to reduce symptoms, there is little evidence that these medications are effective in children younger than 12 years. The authors add that it has been estimated that 11 percent to 21 percent of children in the United States and Canada who are receiving care from conventional physicians are also using alternative therapies. Echinacea, one of the most commonly used herbal remedies in the U.S., has been used extensively for the prevention and treatment of URIs in adults.
James A. Taylor, M.D., from the University of Washington, Seattle, and colleagues, conducted a randomized controlled trial to determine the effectiveness and safety of Echinacea purpurea (a type of echinacea used for medicinal purposes) in treating URIs in children two to 11 years old. A total of 524 children were included in the study. The patients were randomized to receive either echinacea or placebo for up to three URIs over a four-month period. The echinacea or placebo was started at the onset of symptoms and continued for a maximum of ten days.
Data were analyzed on 707 URIs that occurred in 407 children, including 337 who were treated with echinacea and 370 with placebo. There were 79 children who completed the study period without getting a URI. The median (half were more; half were less) duration of the URIs was 9 days.
"There was no difference in duration between upper respiratory tract infections treated with echinacea or placebo," the authors report. "There was also no difference in the overall estimate of severity of upper respiratory tract infection symptoms between the two treatment groups (median, 33 in both groups). In addition, there were no statistically significant differences between the two groups for peak severity of symptoms, number of days of peak symptoms (1.60 in the echinacea group and 1.64 in the placebo group), number of days of fever (0.81 in the echinacea group vs. 0.64 in the placebo group), or parental global assessment of severity of the upper respiratory tract infection." The authors note there was no difference in the rate of adverse events (unwanted side effects) reported in the two treatment groups. However, rashes occurred during 7.1 percent of the upper respiratory tract infections treated with echinacea and 2.7 percent of those treated with placebo.
"Given its lack of documented efficacy and an increased risk for the development of rash, our results do not support the use of echinacea for treatment of URIs (upper respiratory tract infections) in children 2 to 11 years old. Further studies using different echinacea formulations, doses, and dosing frequencies are needed to delineate any possible role for this herb in treating colds in young patients," the authors conclude.
(JAMA. 2003;290:2824-2830. Available post-embargo at JAMA.com)
Editor's Note: The project described was supported by a grant from the National Center for Complementary and Alternative Medicine. Study medication and placebo were provided by Madaus AG, Cologne, Germany. The formulation of echinacea used in the study (EC31J2) is marketed as Echinacin Saft.