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Echinaforce® Hotdrink Is as Effective as Tamiflu® in Early Treatment of Influenza

Reviewed: Rauš K, Pleschka S, Klein P, Schoop R, Fisher P. Echinaforce Hotdrink versus oseltamivir in influenza: A randomized, double-blind, double dummy, multicenter, non-inferiority clinical trial [published online April 20, 2015]. Curr Ther Res. 2015. doi: 10.1016/j.curtheres.2015.04.001.

Editor’s note: This study was sponsored by A. Vogel Bioforce AG, manufacturer of Echinaforce Hotdrink. One of the authors (Schoop) is an employee of the company.

Influenza, commonly known as the flu, is a seasonal infectious disease with symptoms including cough, nasal congestion, headache, muscle pain, and fever that affects an estimated 25-50 million people each year in the United States alone. Complications occur frequently and can include life-threatening inflammatory events such as encephalitis, myelitis, myocarditis, septic shock, bronchitis, and pneumonia. The recommended medical treatment in early stages of the disease is the administration of neuraminidase inhibitors — e.g. oseltamivir (Tamiflu®; Hoffmann-La Roche; Basel, Switzerland) or zanamivir (Relenza®; GlaxoSmithKline; Philadelphia, Pennsylvania) — which has been shown in clinical trials to reduce flu duration and complications.

A total of 473 patients were enrolled in this randomized, double-blind, double-dummy, clinical trial carried out for 10 days at 29 general practices in the Prague area of the Czech Republic. Patients had been clinically diagnosed with influenza based on one or more respiratory symptom, systemic symptom, and a fever of at least 100°F (37.8°C), starting less than 48 hours prior to treatment. To be included in the study, participants were required to have good general health, a negative pregnancy test, body weight greater than 88 lbs (40 kg), and a signed consent form. Patients were excluded if they had been treated with antibiotics in the previous month; a flu vaccination; cardiovascular, liver, kidney, neurological, or endocrinological diseases; or allergies to acetaminophen, dextromethorphan, or plants in the family Asteraceae. The mean age of patients was 37 years. Also included in the study were nine children and adolescents between 12 and 17 years old.

A total of 237 patients received Echinaforce® Hotdrink syrup (A. Vogel Bioforce AG; Roggwil, Switzerland; containing 228 mg/ml Echinacea purpurea [Asteraceae] herb extract, 12 mg/ml E. purpurea root extract, 276.5 mg/ml Sambucus nigra [Adoxaceae] berry juice, and excipients) with oseltamivir placebo capsules. Patients in the second group (n=236) received Echinaforce Hotdrink placebo (containing the same excipients as the Echinaforce Hotdrink verum group plus colorants and flavors) and oseltamivir. Patients in the Echinaforce Hotdrink group received 5 ml syrup five times daily on the first three days, then 5 ml syrup three times daily for the remaining seven days of the study. At the same time, these patients received oseltamivir placebo capsules twice per day for each of the 10 days. In the oseltamivir verum group, the same regimen was followed with Echinaforce Hotdrink placebo and one capsule of oseltamivir twice daily (oseltamivir verum for the first five days, followed by oseltamivir placebo capsules for the next five days).

Treatment efficacy was evaluated using a symptom diary, in which patients recorded the severity of cough, nasal congestion, sore throat, fatigue, headache, muscle pain, feverishness, malaise, sweats, and/or chills using a scale from 0 to 3 (0=not present, 1=mild, 2=moderate, 3=severe). In addition, axillary body temperature was measured, and the occurrence of complications was recorded. The cumulative proportion of patients that recovered from influenza after one, five, and 10 days of treatment was chosen as the primary endpoint of the study. Recovery was defined as the first day when symptoms were mild in the evening or altogether absent. Other measured outcomes included days without sleep disturbance, duration until return to normal activity, use of rescue medication (acetaminophen or dextromethorphan), and additional contacts made to healthcare professionals. Patients and physicians also evaluated the tolerability and efficacy subjectively on a scale from 1 to 4 (1=very good, 2=good, 3=moderate, 4=poor).

Overall, both treatments were considered efficacious. After one, five, and 10 days, recovery was observed in 1.5% and 4.1%, 50.2% and 48.8%, and 90.1% and 84.4% of patients treated with Echinaforce Hotdrink and oseltamivir, respectively. There was no statistical difference in the clinical outcome between the two treatments, although the treatment failures after 10 days showed a non-statistically significant trend in favor of the patients receiving Echinaforce Hotdrink. There was also no significant difference in the efficacy judgement by physicians and patients.

The occurrence of complications and adverse side effects was higher in the oseltamivir group compared to the Echinaforce Hotdrink group. In the oseltamivir group, 14 complications were recorded, mainly of respiratory nature (pneumonia [n=2], sinusitis [n=4], bronchitis [n=2], and rhinopharyngitis [n=1]). The remaining five cases were gastrointestinal complications. Complications observed in the Echinaforce group (n=5) were all infections of the respiratory tract. A total of 44 adverse side effects occurred in patients treated with oseltamivir, while 31 adverse side effects were recorded in the Echinaforce Hotdrink group. The higher incidence of adverse side effects was mostly due to the occurrence of nausea and vomiting in the oseltamivir group. The exact nature of the adverse side effects other than gastrointestinal problems was not detailed in the publication, but the authors indicate that no serious adverse events were observed in either of the treatment groups. No limitations of the clinical study were reported.

In conclusion, the findings of this study suggest that the treatment outcomes of patients suffering from early influenza symptoms who are treated with oseltamivir or Echinaforce Hotdrink are equivalent in patients without concomitant diseases and who are not part of an “at-risk” population. The authors suggest that the lower incidence of complications and adverse side effects with Echinaforce Hotdrink make it an attractive alternative to standard treatment with neuraminidase inhibitors, and that the product’s availability as a nonprescription medicine makes it a suitable choice for the very early treatment of symptoms, a central factor in the successful management of flu infections.

—Stefan Gafner, PhD