The Journal of Pediatrics
Volume 145, Issue 1 , Pages 135-136, July 2004

Efficacy and safety of echinacea in treating upper respiratory tract infections in children: a randomized controlled trial☆

Department of Family Medicine, University of Wisconsin–Madison Madison, WI 53706 USA

Taylor JA, Weber W, Standish L, Quinn H, Goesling J, McGann M, et al. JAMA 2003;290:2824-30

Article Outline

 

Context Echinacea is a widely used herbal remedy for treatment of upper respiratory tract infections (URIs). However, there are few data on the efficacy and safety of echinacea in treating URIs in children.

Objectives To determine if Echinacea purpurea is effective in reducing the duration and/or severity of URI symptoms in children and to assess its safety in this population.

Design Randomized, double-blind, placebo-controlled trial.

Setting Regional practice-based network and an alternative medical center.

Participants Healthy children 2 to 11 years old.

Interventions Study patients were randomized to receive either echinacea or placebo for up to 3 URIs over a 4-month period. Study medication was begun at the onset of symptoms and continued throughout the URI, for a maximum of 10 days.

Main outcome measures Duration and severity of symptoms and adverse events were recorded by parents. Secondary outcomes included peak severity of symptoms, number of days of peak severity, number of days of fever, and a global assessment of severity of symptoms by parents of study children.

Results Data were analyzed for 707 URIs that occurred in 407 children, including 337 URIs treated with echinacea and 370 treated with placebo. There were 79 children who completed the study period without having a URI. The median duration of URIs was 9 days (95% CI, 8-10 days); there was no difference in duration between URIs treated with echinacea or placebo (P=.89). There was also no difference in the overall estimate of severity of URI symptoms between the two treatment groups (median, 33 in both groups; P=.69). In addition, there were no statistically significant differences between the 2 groups for peak severity of symptoms (P=.68), number of days of peak symptoms (1.60 in the echinacea group and 1.64 in the placebo group; P=.97), number of days of fever (0.81 in the echinacea group vs 0.64 in the placebo group; P=.09), or parental global assessment of severity of the URI (P=.67). Overall, there was no difference in the rate of adverse events reported in the 2 treatment groups; however, rash occurred during 7.1% of the URIs treated with echinacea and 2.7% of those treated with placebo (P=.008).

Conclusions Echinacea purpurea, as dosed in this study, was not effective in treating URI symptoms in patients 2 to 11 years old, and its use was associated with an increased risk of rash.

Comment This well-designed double-blind randomized trial is the first to test the efficacy of echinacea as a treatment for children with the common cold. As such, the negative results are sufficient to recommend against using echinacea formulations for children aged 2 to 11. In this trial, children were pre-enrolled, allowing dosing to occur early in the onset of the cold, as is recommended with echinacea. Compliance was adequately monitored and was excellent. The intervention tested was the dried pressed juice of the above-ground portions of Echinacea purpurea mixed into a syrup. This was a reasonable choice in that several positively-reported trials in adults have had similar constituents.1., 2., 3., 4., 5. Power was sufficient to detect clinically significant improvement. Primary outcomes were prospectively chosen as severity and duration of symptoms, and were estimated and reported by parental proxy, using a variant of the widely used Jackson scale. No statistically significant differences were noted between the echinacea and placebo groups in any primary outcomes.

Two secondary findings may be worth noting: one negative, one positive. First, there was an increase in rash among those taking echinacea (7.1%) compared with those taking placebo (2.7%), suggesting that about 1 in 22 children taking echinacea might get a rash from it (P=.008). To my knowledge, this is the first evidence of harm that comes from a controlled trial of echiancea. The other notable finding was that the frequency of a second cold was lower in the echinacea group (52.3%) than in the placebo group (64.4%). This finding was statistically significant and suggestive of a 12% absolute reduction (NNT=8) in risk of next cold.

The bottom line? The echinacea formulation tested was not effective for this population. Although this is intriguing, the decreased risk of subsequent colds may be the result of chance, due to multiple comparisons (data dredging), or may be the result of beneficial immunostimulation. Although immunostimulating properties of echinacea preparations have been reported in a number of studies,6 the activity of specific constituents is still very much a matter of debate.7 A trial designed to test prevention may be indicated. The increased rate of rash could also be a red herring, but just as well could be an adverse effect of echinacea. Lamentably, there are still no proven effective treatments for children with common cold.

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References 

  1. Melchart D, Linde K, Fischer P, Kaesmayr J. Echinacea for preventing and treating the common cold. 1-23. 2000. Update Software. Cochrane Library, Issue 4.
  2. Goel V, Lovlin R, Barton R, Lyon MR, Bauer R, Lee TDG, et al.  Efficacy of a standardized echinacea preparation (Echinilin™) for the treatment of the common cold: a randomized, double-blind, placebo-controlled trial. J Clin Pharm Ther. 2004;29:75–83
  3. Brinkeborn RM, Shah DV, Degenring FH. Echinaforce® and other Echinacea fresh plant preparations in the treatment of the common cold. Phytomedicine. 1999;6:1–6
  4. Hoheisel O, Sandberg M, Bertram S, Bulitta M, Schäfer M. Echinagard treatment shortens the course of the common cold: a double-blind, placebo-controlled clinical trial. Eur J Clin Res. 1997;9:261–268
  5. Schulten B, Bulitta M, Ballering-Brühl B, Köster U, Schäfer M. Efficacy of Echinacea purpurea in patients with a common cold: a placebo-controlled, randomised, double-blind clinical trial. Arzneim - Forsch/Drug Res. 2001;51:563–568
  6. Barrett B. Medicinal properties of Echinacea: a critical review. Phytomedicine. 2003;10:66–86
  7. Matthias A, Blanchfield JT, Penman KG, Toth I, Lang C-S, DeVoss JJ, et al.  Permeability studies of alkylamides and caffeic acid conjugates from echinacea using a Caco-2 cell monolayer model. J Clin Pharm Ther. 2004;29:7–13

☆ Editor's Note: Journals reviewed for this issue: Archives of Pediatrics and Adolescent Medicine, British Medical Journal, Lancet, Journal of the American Medical Association, The Journal of Pediatrics, New England Journal of Medicine, Pediatric Infectious Diseases Journal, Pediatrics, and Archives of Disease in Childhood. Gurpreet K. Rana, BSc, MLIS, Taubman Medical Library, University of Michigan, contributed to the review and selection of this month's abstracts.—John G. Frohna, MD, MPH

PII: S0022-3476(04)00339-7

doi:10.1016/j.jpeds.2004.04.039

The Journal of Pediatrics
Volume 145, Issue 1 , Pages 135-136, July 2004

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