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FACT
Focus on Alternative and Complementary Therapies

Clinical efficacy of Esberitox® in common cold - results of a (GCP) randomised double-blind placebo-controlled multicenter study

Hentschel C1, Zeppelin HH2, Kohnen R3, Köhler G2, Wüstenberg P3, Ernst E1
1Department of Complementary Medicine, University of Exeter, Exeter, EX2 4NT, UK
2Schaper & Brümmer GmbH & Co. KG, Salzgitter, Germany
3Institute of Psychology II, University of Erlangen-Nürnberg, Germany

Objective

Clinical efficacy of Esberitox® N (fluid extract of the medical plants radix echinaceae 15 mg, radix baptisiae 20 mg and herba thujae 4 mg) in the treatment of the common cold.

Methods

Patients attending to one of 15 study centres (family doctors) with an acute common cold were randomised in two groups (placebo/verum) treatment 9 days, patients documented 17 symptoms by the use of a 10-point scale.

Results

n=262 patients included, n=242 patients were evaluable (age 41 ± 13 years, 150 women/92 men). Stratification with regard to the initial severity of indicator symptoms and their development during the first three days after baseline (stable/progredient vs. remittent) resulted in four subgroups. In patients with a minimum extent of symptoms stable or worsening during first three days after baseline Esberitox® N had a superior efficacy as compared to placebo (p<0.05) four days after baseline until end of treatment in total score of symptoms and in patients’ overall rating of the cold intensity. In 24 patients (18%) receiving Esberitox® N and 21 patients (16%) receiving placebo adverse events were reported but not due to any specific effects. Serious adverse events did not occur.

Conclusion

This study shows that Esberitox® N is effective if the therapy starts as early as possible after occurrence of initial cold symptoms when the maximum of the cold has not yet been reached.

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