Planta Med 2008; 74(6): 686-692
DOI: 10.1055/s-2008-1074519
Workshop - State of the art in clinical and preclinical studies EPs® 7630 (Umckaloabo®)
Original Paper
© Georg Thieme Verlag KG Stuttgart · New York

EPs 7630 Improves Acute Bronchitic Symptoms and Shortens Time to Remission. Results of a Randomised, Double-Blind, Placebo-Controlled, Multicentre Trial

Heinrich Matthys1 , Petra Funk2
  • 1Department of Pneumology, University Hospital Freiburg, Freiburg, Germany
  • 2Clinical Research Department, Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany
Further Information

Publication History

Received: February 5, 2008 Revised: March 19, 2008

Accepted: March 31, 2008

Publication Date:
30 April 2008 (online)

Abstract

Acute bronchitis commonly associated with cough is predominantly caused by viral infections. The burden on health-care systems and society is enormous. A randomised, placebo-controlled, multicentre clinical trial to investigate the efficacy and safety of a liquid herbal drug preparation from the roots of Pelargonium sidoides (EPs 7630) was conducted in 217 adult outpatients with acute bronchitis. The primary efficacy variable was the bronchitis symptom score (BSS) ranging from 0 to 20. Primary data of this study were already published in 2007. Now, we present further analyses of these already published data combined with new results in order to focus on both the most important features of acute bronchitis and pharmaco-economic aspects of the disease. The BSS decreased by 7.6 ± 2.2 (mean ± SD) points for the active treatment group and 5.3 ± 3.2 points for placebo (p < 0.0001). As compared with placebo, a marked improvement has been shown for EPs 7630 for all disease symptoms (cough, sputum, rales, dyspnoe, pain on coughing, hoarseness, headache, fatigue, fever, limb pain) categorised in severity classes by the patient. Especially strong antitussive and ”anti-fatigue” effects with an early onset during treatment were observed. Patients in the EPs 7630 group were sooner able to work and to a lesser extent confined to bed. In both treatment groups, 3 × 30 drops of the trial medication administered for 7 days were well tolerated. No serious adverse events have been observed. In conclusion, EPs 7630 is superior to placebo in the treatment of acute bronchitis and leads to faster remission of bronchitis related symptoms.

Abbreviations

AE:adverse event

BSS:bronchitis symptom score

GCP:good clinical practice

IMOS:integrative medicine outcomes sclae

IMPSS:integrative medicine patient satisfaction scale

MedDRA:medical dictionary for regulatory activities

SOC:system organ class

TNF:tumour necrosis factor

References

  • 1 Knutson D, Braun C. Diagnosis and management of acute bronchitis.  Am Fam Physician. 2002;  65 2039-44
  • 2 Hueston W J, Mainous AG I II. Acute bronchitis.  Am Fam Physician. 1998;  57 1270-6
  • 3 Classen M, Diehl V, Kochsiek K. Innere Medizin, 4th edition. München-Wien-Baltimore; Urban und Schwarzenberg 1998: 1392
  • 4 Von Harnack G A, Koletzko B, Belohradsky B H. Kinderheilkunde, 11th edition. Berlin-Heidelberg-New York; Springer 2000: 436
  • 5 Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF). Epidemiologie, Diagnostik, antimikrobielle Therapie und Management von erwachsenen Patienten mit ambulant erworbenen tiefen Atemwegsinfektionen (akute Bronchitis, akute Exazerbation einer chronischen Bronchitis, Influenza und andere respiratorische Virusinfektionen) sowie ambulant erworbener Pneumonie (Nr. 082/001). Available at http://leitlinien.net. Accessed November 3, 2007
  • 6 Chesnutt M S, Prendergast T J. Lung. In: Tierney LM, McPhee SJ, Papadakis MA, editors Current medical diagnosis & treatment, 41st edition. New York; McGraw-Hill 2002: 269-362
  • 7 Gonzales R, Sande M A. Uncomplicated acute bronchitis.  Ann Intern Med. 2000;  133 981-91
  • 8 van Amelsvoort L G, Kant I J, Beurskens A J, Schroer C A, Swaen G M. Fatigue as a predictor of work disability.  Occup Environ Med. 2002;  59 712-3
  • 9 Oeffinger K C, Snell L M, Foster B M, Panico K G, Archer R K. Diagnosis of acute bronchitis in adults: a national survey of family physicians.  J Fam Pract. 1997;  45 402-9
  • 10 Birnbaum H G, Morley M, Greenberg P E, Colice G L. Economic burden of respiratory infections in an employed population.  Chest. 2002;  122 603-11
  • 11 Schappert S M, Burt C W. Ambulatory care visits to physician offices, hospital outpatient departments, and emergency departments: United States, 2001 - 02.  Vital Health Stat 13. 2006;  159 1-66
  • 12 Gonzales R, Bartlett J G, Besser R E, Cooper R J, Hickner J M, Hoffman J R. et al . Principles of appropriate antibiotic use for treatment of uncomplicated acute bronchitis: background.  Ann Emerg Med. 2001;  37 720-7
  • 13 Gillissen A, Gessner C, Hammerschmidt S, Hoheisel G, Wirtz H. Acute bronchitis: when are antibiotics, and when is symptomatic treatment indicated?.  MMW Fortschr Med. 2006;  148 26-8
  • 14 Kolodziej H, Kiderlen A F. In vitro evaluation of antibacterial and immunomodulatory activities of Pelargonium reniforme, Pelargonium sidoides and the related herbal drug preparation EPs® 7630.  Phytomedicine. 2007;  14 (Suppl 6) 18-26
  • 15 Chuchalin A G, Berman B, Lehmacher W. Treatment of acute bronchitis in adults with a pelargonium sidoides preparation (EPs® 7630): a randomized, double-blind, placebo-controlled trial.  Explore (NY). 2005;  1 437-45
  • 16 Matthys H, Kamin W, Funk P, Heger M. Pelargonium sidoides preparation (EPs® 7630) in the treatment of acute bronchitis in adults and children.  Phytomedicine. 2007;  14 (Suppl 6) 69-73
  • 17 Haidvogl M, Heger M. Treatment effect and safety of EPs® 7630-solution in acute bronchitis in childhood: report of a multicentre observational study.  Phytomedicine. 2007;  14 (Suppl 6) 60-4
  • 18 Matthys H, Heger M. Treatment of acute bronchitis with a liquid herbal drug preparation from Pelargonium sidoides (EPs 7630): a randomised, double-blind, placebo-controlled, multicentre study.  Curr Med Res Opin. 2007;  23 323-31
  • 19 Williamson HA J r. A randomized, controlled trial of doxycycline in the treatment of acute bronchitis.  J Fam Pract. 1984;  19 481-6
  • 20 Macfarlane J, Holmes W, Gard P, Thornhill D, Macfarlane R, Hubbard R. Reducing antibiotic use for acute bronchitis in primary care: blinded, randomised controlled trial of patient information leaflet.  BMJ. 2002;  324 91-4
  • 21 Ware J J r, Kosinski M, Keller S D. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity.  Med Care. 1996;  34 220-33
  • 22 Johnson J A, Coons S J. Comparison of the EQ-5 D and SF-12 in an adult US sample.  Qual Life Res. 1998;  7 155-66
  • 23 Lehmacher W, Wassmer G. Adaptive sample size calculations in group sequential trials.  Biometrics. 1999;  55 1286-90
  • 24 Wassmer G, Eisebitt R, Coburger S. Flexible interim analyses in clinical trials using multistage adaptive test designs.  Drug Inf J. 2001;  35 1131-46
  • 25 Fendrick A M, Monto A S, Nightengale B, Sarnes M. The economic burden of non-influenza-related viral respiratory tract infection in the United States.  Arch Intern Med. 2003;  163 487-94
  • 26 Martinez F J. Acute bronchitis: state of the art diagnosis and therapy.  Compr Ther. 2004;  30 55-69
  • 27 Smucny J J, Becker L A, Glazier R H, McIsaac W. Are antibiotics effective treatment for acute bronchitis. A meta-analysis?.  J Fam Pract. 1998;  47 453-60
  • 28 Bent S, Saint S, Vittinghoff E, Grady D. Antibiotics in acute bronchitis: a meta-analysis.  Am J Med. 1999;  107 62-7
  • 29 Fahey T, Stocks N, Thomas T. Quantitative systematic review of randomised controlled trials comparing antibiotic with placebo for acute cough in adults.  BMJ. 1998;  316 906-10
  • 30 Weinberger S E. Cough and hemoptysis. In: Kasper DL, Braunwald E, Fauci AS, Hauser SL, Longo DL, Jameson JL, editors Harrison’s principles of internal medicine, 16th edition. Columbus; Mc Graw Hill 2006: 205-9

Prof. Dr. med. Heinrich Matthys

Department of Pneumology

University Hospital Freiburg

Hugstetterstrasse 55

79106 Freiburg

Germany

Phone: +49-761-628-22

Fax: +49-761-600-8580

Email: hmatthys@t-online.de

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