Clinical Brief

With Comments from Russell H. Greenfield, MD

Echinacea for Kids with Colds

Source: Taylor JA, et al. Efficacy and safety of echinacea in treating upper respiratory tract infections in children. JAMA 2003; 290:2824-2830.

Goal: To evaluate the safety and effectiveness of a preparation of Echinacea purpurea in reducing the duration or severity of cold symptoms in children.

Design: Prospective, randomized, placebo-controlled, double-blind trial performed over two years.

Subjects: A total of 524 healthy children ages 2-11 years were recruited in four-month periods from an alternative medicine center (n = 213) and a regional practice-based network (n = 311). Data from 407 children were included in the final analysis.

Methods: Subjects were randomized to receive either echinacea or placebo at the onset of symptoms and throughout the duration of upper respiratory tract infection (URTI) for a maximum of 10 days. Data were collected on up to three episodes of URTI over a four-month period. Measured outcomes included severity and duration of symptoms (sneezing, coughing, nasal congestion, and runny nose), adverse effects, peak severity of symptoms, number of days of peak severity, number of days of fever (measured or tactile), and a global assessment of symptom severity.

Results: A total of 337 URTIs were treated with echinacea and 370 with placebo. There was no significant difference in any of the measured outcomes between the two groups, except for a higher incidence of rash in the children who received echinacea.

Conclusion: Echinacea purpurea does not effectively relieve the symptoms of URTI in children.

Study strengths: Sample size; frequent telephone contact; used both conventional and alternative medicine providers to lessen the effect of bias; only one child per family was allowed to participate; effective blinding; sub-analyses performed in the 2-5 year and 6-11 year age groups.

Study weaknesses: Employ of alcohol-free extract; twice-daily dosing, which is far less frequent than typically recommended; records unavailable for more than 5% of participants.

Of note: Most practitioners believe that extracts of echinacea containing alcohol are safe and more effective than alcohol-free preparations (even in children), and dosing is commonly four times a day; 79 children who completed the study did so without contracting a URTI, and were thus not included in the final analysis; reported annual sales of echinacea exceed $300 million; published studies performed in adults suggest a beneficial effect from use of echinacea in lessening both severity and duration of URTI symptoms, but not in preventing URTI; fewer children in the echinacea group experienced second and third URTIs during the study period compared with the placebo group; vitamin and mineral supplementation occurred more commonly in the placebo group; two children in the echinacea group developed stridor after receiving a dose of the study medication and required treatment with steroids.

We knew that: Three species of echinacea are used medicinally: Echinacea purpurea (best studied), Echinacea pallida var angustifolia, and Echinacea pallida var pallida; echinacea is commonly considered to be an immune-enhancing agent; the average child annually contracts 6-8 colds, each lasting 7-9 days; during winter months nearly 40% of children ages 1-5 years seeing their pediatrician do so for URTI symptoms; little evidence exists that antihistamines, decongestants, or cough suppressants are effective in children.

Clinical import: A significant number of parents turn to alternative therapies to lessen the symptoms of URTI in their children due to a lack of effective cold therapies. Experience suggests that echinacea has a place in the treatment of uncomplicated childhood URTI, and this well-done trial advises otherwise for a specific preparation. While important to emphasize that an alcohol-free preparation of aerial parts was used, and that the dosing schedule employed was perhaps 50% less frequent than what is commonly recommended, these data strongly suggest that a non-alcoholic preparation of Echinacea purpurea, the form of echinacea most commonly used, is not effective in reducing URTI symptoms in children when administered as described.

What to do with this article: Make hard copies to hand out to your peers.

Dr. Greenfield, Medical Director, Carolinas Integrative Health, Carolinas HealthCare System, Charlotte, NC, is Executive Editor of Alternative Medicine Alert.