Clinical Studies with Echinacin

The influence of Immune-Stimulating Effects of Pressed Juice from Echinacea purpurea on the Course and Severity of Colds - Results of a double-blind study

Forum Immunologie 8, pp 2-12, 1992

D. Schöneberger

Abstract:The influence of the immune-stimulating effect of freshly pressed juice from Echinacea purpurea (dosage: 2-4 ml daily) on the course and severity of colds in patients with increased susceptibility were studied over a period of 8 weeks in a placebo-controlled, double-blind, mono-centric clinical test. Furthermore, the effect of immunological parameters was appraised. A total of 108 patients (54 medication, 54 placebo) were evaluated in regard of effectiveness on the basis of this test system.

This clinical study shows that prophylactic treatment with Echinacin Liquidum resulted in a decreased frequency of infections. This was evident in the number of patients remaining healthy (medication 35,2%, placebo 25,9%) as well as in the length of time interval between infections (medication 40 days, placebo 25 days). Occuring infections were less severe in 78,6% of the medicated group as compared to 68% of the placebo group. Patients showing evidence of a weakened defence system, who before treatment had a T4/T8-ratio of less than 1.5, profited most from prophylactic treatment. These patients attained an additional notable reduction in the average duration of the infection (medicated group 5.34 days, placebo 7.54 days).

Echinagard treatment shortens the course of the common cold: a double-blind, placebo-controlled clinical trial

European Journal of Clinical Research 1997; 9: 261-269

O. Hoheisel(1), M. Sandberg(1), S. Bertram(2), M. Bulitta(2), M. Schäfer(2)
(1) Centralhälsan, Falköping, Sweden
(2) Research and Development, Medical Department, MADAUS AG, Cologne, Germany

Keywords: Common cold, Echinagard, Echinacin, Echinacea purpurea

Abstract: A randomised, double-blind, placebo-controlled, single-centre clinical trial was carried out to investigate the therapeutic efficacy of the phyto-pharmaceutical, Echinagard, in 120 patients with initial symptoms of acute, uncomplicated upper airways infection. Echinagard (20 drops every 2 hours for the first day and thereafter three times daily) or placebo was administered for up to 10 days, after which patients were questioned about the intensity of their illness, time to improvement and time until cessation of treatment.

Only two patients where excluded for protocol violation and all completed the study. An intention-to-treat analysis revealed that 24/60 patients (40.0%) in the Echinagard group, but 36/60 (60.0%) in the placebo group, experienced a "real" cold, i.e. fully expressed disease (p=0.044). The time taken to improvement (assigning zero time to improvement for patients without a "real" cold) was significantly shorter (p lt 0.0001) in the Echinagard group (median 0 days) than in the placebo group (median 5 days). In the sub-group of patients with a "real" cold, the median time taken to improvement was 4 days (Echinagard , n = 24) an 8 days placebo, n 0 36), respectivly. More patients taking Echinagard (31,7%) than placebo (18,3%) stopped treatment because of improvement. The time taken to cessation of treatment as a result of improvement in the sub-group of patients with a "real" cold was shorter with Echinagard (median 6 days) than with placebo (median 10 days). No specific adverse events were reported. In the Echinagard group, 53/60 (88.3%) reported the tolerability of the medication as good or very good, in comparison to 51/60 (85.0%) in the placebo group.

Echinagard is a safe an effective therapy when taken at the first signs of a common cold.

Efficacy of Echinacea purpurea in Patients with a Common cold

Arzneim.-Forsch./Drug Res. 51 (II), 563-568 (2001)

B. Schulten, M. Bulitta, B. Ballering-Brühl, U. Köster, M. Schäfer

Keywords: Common cold, EC31J0, Echinacea purpurea efficacy against common cold, phase IV clinical study, Echinacin, Echinagard, Immunomodulation

Abstract: Common colds are one of the most frequent acute illnesses with major economical impact. Echinaceae purpureae herba (Echinacin, EC31J0) has shown promising resuluts in the relief of common cold symptoms and the time taken to improvement compared to placebo. This study was aimed to confirm these findings by performing a randomised, double-blind, placebo-controlled clinical trial. A total of 80 adult male or female patients with first signs of a cold were recruited. The number of days of illness with a complete picture of the common cold (defined by the modified Jackson score of at least 5 points and experience of rhinorrhea and/or subjective sensation of having a cold) was the primary endpoint. In the verum group the median time of illness was 6.0 days compared to 9.0 days in the placebo group, assigning zero time for patients without a complete picture (one-sided p=0.0112). EC31J0 was well tolerated and clinically effective in allaviating symptoms more rapidly than placebo in patients with a common cold.

A supportive measure in the treatment of acute infections of the respiratory tract in children with recurring infections of the upper respiratory tract

päd (7) 2001

Klaudia Götte, I. Roschke

Abstract: The objective of this observation of use in children with recurring infections of the upper respiratory tract was to obtain findings on the tolerability and efficacy of Echinacin. A good to very good tolerability and efficacy was found in children above the age of two years and in young adults. The treating physician as well as the parents of the child or the young adult reached this conclusion in more than 95% of all treated cases.

The efficacy was rated by the physician as well as by the parents as very good or good in more than 80% of the cases. In comparison to treatment without the juice, the physician observed in this respiratory tract infection a shorter duration of disease in more than 60% and the course of disease was rated as less severe in more than 70% of all patients. The parents of the children and young adults made comparable assessments.