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A Randomized, Double-blind, Placebo-Controlled Clinical Trial

Steven H. Yale, MD; Kejian Liu, PhD

Arch Intern Med. 2004;164:1237-1241.

Background  Echinacea purpurea stimulates the immune response and is promoted to reduce symptom severity and the duration of upper respiratory tract infections. We sought to determine the efficacy of a standardized preparation of E purpurea in reducing symptom severity and duration of the common cold.

Methods  A randomized, double-blind, placebo-controlled design was used. Patients received either 100 mg of E purpurea (freeze-dried pressed juice from the aerial portion of the plant) or a lactose placebo 3 times daily until cold symptoms were relieved or until the end of 14 days, whichever came first. Symptoms (sneezing, nasal discharge, nasal congestion, headache, sore or scratchy throat, hoarseness, muscle aches, and cough) were scored subjectively by the patient and recorded daily in a diary. Kaplan-Meier curves were used to estimate the survival function of time to resolution in each group. The Wilcoxon rank sum test was used to compare time to resolution between the 2 groups.

Results  One hundred twenty-eight patients were enrolled within 24 hours of cold symptom onset. Group demographic distribution was comparable for sex, age, time from symptom onset to enrollment in the study, average number of colds per year, and smoking history. No statistically significant difference was observed between treatment groups for either total symptom scores (P range, .29-.90) or mean individual symptom scores (P range, .09-.93). The time to resolution of symptoms was not statistically different (P = .73).

Conclusions  Some studies have concluded that Echinacea effectively reduces the symptoms and duration of the common cold. We were unable to replicate such findings. Further studies using different preparations and dosages of E purpurea are necessary to validate previous claims.

From the Department of Internal Medicine, Marshfield Clinic (Dr Yale), and the Biostatistics and Bioinformatics Core, Marshfield Clinic Research Foundation (Dr Liu), Marshfield, Wis. The authors have no relevant financial interest in this article.

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