Clinical Study

Esberitox^® N as Supportive Therapy when Providing Standard Antibiotic Treatment in Subjects with a Severe Bacterial Infection (Acute Exacerbation of Chronic Bronchitis)
A Multicentric, Prospective, Double-Blind, Placebo-Controlled Study
Wilfried Hauke^a, Gert Köhler^b, Hans-Heinrich Henneicke-von Zepelin^b, Johannes Freudenstein<sup>b

a</sup>EPA-Europharma Auftragsforschung, Kronberg, and
^bSchaper & Brümmer, Salzgitter, Germany

Address of Corresponding Author

Chemotherapy 2002;48:259-266 (DOI: 10.1159/000066763)

  Key Words

• Chronic obstructive pulmonary disease
• Acute exacerbation
• Immunomodulation
• Antibiotic treatment
• Echinacea
• Thuja-Babtisia-Phytomedicine
• Herbal treatment
• Echinacea purpureae
• Echinacea pallida
• Bacterial infection

  Abstract

53 patients with planned antibiotic therapy for the treatment of acute exacerbation of chronic bronchitis as an example of a severe bacterial infection requiring antibiotics were included in a prospective, multicentre, double-blind, placebo-controlled study. The chronic bronchitis was staged by forced expiratory volume of the 1st second (FEV₁) measured in the infection-free interval prior to the current episode and had to be between 35 and 75% for the predicted value. Patients were randomly assigned to receive newer macrolide antibiotics plus either Esberitox^® N or placebo. Antibiotic therapy was administered according to generally accepted guidelines and Esberitox N or placebo was given for 28 days. The baseline-adjusted means for FEV₁ (%) on day 10 were 68.7 points for the Esberitox N group and 59.2 points for the placebo group (p = 0.0303). For FEV₁ the difference between the two treatment groups was 267 ml (p = 0.0499). The time to half maximal improvement was 5.7 days in the Esberitox N group compared to 12.8 days in the placebo group. The treatment was well tolerated; no serious adverse events were documented. In conclusion, comedication of antibiotics with Esberitox N in subjects with acute exacerbation of chronic bronchitis seems to be of benefit for the patient. Apparently, therapy with Esberitox N leads to a faster recovery from this severe bacterial infection, possibly via preventing an impairment of the host's immune system which might otherwise occur as a consequence of aggressive antimicrobial therapeutics.

Copyright © 2002 S. Karger AG, Basel

  Author Contacts

Dr. Gert Köhler
Schaper & Brümmer GmbH & Co. KG
Bahnhofstrasse 35
D-38259 Salzgitter (Germany)
Tel. +49 5341 307 510, Fax +49 5341 307 524, E-Mail gert.koehler@schaper-bruemmer.de

  Article Information

Investigators: H.-P. Mayer-Anhalt, Marburg (20 patients), H.-P. Wendl, Annweiler (20 patients), W. Ihl-Beste, Ober-Mörlen (6 patients), P. Schöpe, Mörfelden-Walldorf (4 patients), K. Weyland, Ingelheim (2 patients), and C. Kunz, Frankfurt am Main (1 patient).

Number of Figures : 2, Number of Tables : 4, Number of References : 42