Efficacy and tolerability of a fluid extract combination of thyme herb and ivy leaves and matched placebo in adults suffering from acute bronchitis with productive cough: A prospective, double-blind, placebo-controlled clinical trial

Arzneimittel-Forschung/Drug Research

Volumn 56, Issue 9, 2006, Pages 652-660

  Kemmerich, Bernd ^a,c   Eberhardt, Reinhild ^b   Stammer, Holger ^b  

^a Pharmalog Institute for Clinical Research GmbH ^*

^b Pharmalog GmbH Institute for Clinical Research   (Germany)

^c NONE   (Germany)

Author keywords

Acute bronchitis; Bronchipret Saft; Bronchitis Severity Score; Coughing fits; Double blind, randomised, placebo controlled phase IV clinical trial; Ivy leaves (hederae helicis folium), combination with thyme herb (thymi herba)

Indexed keywords

BRONCHIPRET; PLANT EXTRACT; THYME IVY EXTRACT; UNCLASSIFIED DRUG;

ADULT; ARTICLE; BRONCHITIS; BRONCHUS MUCUS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DEMOGRAPHY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG DOSAGE FORM; DRUG EFFICACY; DRUG TOLERABILITY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICAL DOCUMENTATION; MULTICENTER STUDY; OUTCOME ASSESSMENT; PHASE 4 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; REGRESSION ANALYSIS; SCORING SYSTEM; SYMPTOMATOLOGY; SYRUP; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT;

EID: 33749499848     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1296767     Document Type: Article

References (34)

1. Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF): Leitlinie "Akute Bronchitis". July 1998; www.uni-duesseldorf.de/WWW/AWMF/ii/ppneu-07.htm
2. Snow, V., Mottur-Pilson, C., Gonzales, R., Principles of appropriate antibiotic use for treatment of acute bronchitis in adults. Position paper. Clinical practice guideline. Part 1 of the American College of Physicians (ACP). Ann. Intern. Med. 134, 518 (2001)
3. Gruenwald, J., Graubaum, H.-J., Busch, R., Efficacy and tolerability of a fixed combination of thyme and primrose root in patients with acute bronchitis. Arzneim.-Forsch./Drug Res. 55, 669 (2005)
4. Matthys, H., de Mey, C., Carls, C. et al., Efficacy and tolerability of myrtol standardised in acute bronchitis. A multicentre, randomised, double-blind, placebo-controlled parallel group clinical trial vs. cefuroxime and ambroxol. Arzneim.-Forsch./Drug Res. 50, 700 (2000)
5. Matthys, H., Eisebitt, R., Seith, B. et al., Efficacy and safety of an extract of Pelargonium sidoides (Eps 7630) in adults with acute bronchitis. A randomised, double-blind, placebo-controlled trial. Phytomedicine 10, Suppl. IV, 7 (2003)
6. Martinez, F. J., Acute bronchitis: state of the art diagnosis and therapy. Compr. Ther. 30, 55 (2004)
7. Alberta Clinical Practice Guideline Working Group, Guideline for the management of acute bronchitis. December 2000, revised: November 2001; www.albertadoctors.org
8. Vogel, F., Scholz, H., Al-Nawas, B. et al., Rationaler Einsatz oraler Antibiotika bei Erwachsenen. Med. Monatsschr. Pharm. 25, 193 (2002)
9. Irwin, R. S., Boulet, L.-P., Cloutier, M. M. et al., Managing cough as a defense mechanism and as a symptom. A consensus panel report of the American College of Chest Physicians. Chest 114 (1998)
10. Kardos, P., Cegla, U., Gillissen, A. et al., Leitlinie der Deutschen Gesellschaft für Pneumologie zur Diagnostik und Therapie von Patienten mit akutem und chronischem Husten. Pneumologie 58, 570 (2004)
11. Bionorica AG: Fachinformation [summary of product characteristics] Bronchipret® Saft; as of July 2002; Bundesverband der Pharmazeutischen Industrie e.V., Fachinfo-Service
12. ESCOP Monograph, Thymi herba (Thyme). European Scientific Cooperation on Phytomedicine, Elburg (2003)
13. Hagers Handbuch der pharmazeutischen Praxis, 5the ed., Springer, Berlin - Heidelberg etc. (1995)
14. ESCOP Monograph, Hedera helices folium (Ivy Leaf). European Scientific Cooperation on Phytomedicine, Elburg (2003)
15. Aliprandi, P., Cima, L., Carrara, M., Therapeutic use of levocloperastine as an antitussive agent. An overview of pre-clinical data and clinical trials in adults and children. Clin. Drug Invest. 22, 209 (2002)
16. Bauer, P., Köhne, K., Evaluation of experiments with adaptive interim analysis. Biometrics 50, 10291 (1994)
17. Fein, A., Grossmann, R., Ost, D. et al., Bronchitis. In: Diagnosis and management of pneumonia and other respiratory tract infections, 1st ed., pp 245-266, Professional Communication, USA (1999)
18. Höffken, G., Lorenz, L., Kern, W. et al., S3-Leitlinie zu ambulant-erworbener Pneumonie und tiefen Atemwegsinfektionen. Pneumonologie 59, 612 (2005)
19. Fahey, T., Stocks, N., Thomas, T., Quantitative systematic review of randomised controlled trials comparing antibiotic with placebo for acute cough in adults. BMJ 316, 906 (1998)
20. Gonzales, R., Steiner, J. F., Sande, M. A., Antibiotic prescribing for adults with colds, upper respiratory tract infections, and bronchitis by ambulatory care physicians. JAMA 278, 901 (1997)
21. Gonzales, R., Steiner, J. F., Lum, A. et al., Decreasing antibiotic use in ambulatory practice: impact of a multidimensional intervention on the treatment of uncomplicated acute bronchitis in adults. JAMA 281, 1512 (1999)
22. Orr, PH., Scherer, K., Macdonald, A. et al., Randomised placebo-controlled trials of antibiotics for acute bronchitis: A critical review of the literature. J. Fam. Pract. 36, 507 (1993)
23. Evans, A. T., Husain, S., Durairaj, L. et al., Azithromycin for acute bronchitis: a randomised, double blind, controlled trial. Lancet 359, 1648 (2002)
24. Raherison, C., Poirier, R., Daures, J. P. et al., Lower respiratory tract infections in adults: non-antibiotic prescriptions by GPs. Respir. Med. 97, 995 (2003)
25. Stocks, N. P., McElroy, H., Sayer, G. P. et al., Acute bronchitis in Australian general practice. A prescription too far? Aust. Fam. Physician 33, 91 (2004)
26. McIsaac, W. J., To, T., Antibiotics for lower respiratory tract infections. Still too frequently prescribed? Can. Fam. Physician 50, 569 (2004)
27. Curie, P. F., Fraibault, V., Prevot, A., The evaluation of five Bionorica drugs and bromhexine on tracheo-bronchial phenol red secretion in rats; Report. Batelle Europe, Geneva, Switzerland (1991)
28. Haen, E., Pharmakologische Aktivitäten von Thymus vulgaris und Hedera helix. Proceedings of the 2nd Int. Congress on Phytomedicine. Sep. 11-14, 1996, Munich. Phytomedicine 3, Suppl. I (1996/97)
29. Leslie, G. B., A pharmacometric evaluation of nine biostrath herbal remedies. Medita 10, 31 (1978)
30. Smucny, J., Fahey, T., Becker, L. et al., Antibiotics for acute bronchitis. Cochrane database Syst Rev. 4, CD000245 (2004)
31. Verspohl, E. J., Press discussion "Virale Atemwegsinfekte: Vom Schnupfen bis zur Vogelgrippe" [Viral airway infections: From rhinitis to avian flu], Munich, 7 Dec. 2005; Komitee Forschung Naturmedizin, Munich
32. Gillissen, A., Gessner, C., Hammerschmidt, S. et al., Acute bronchitis: when are antibiotics, and when is symptomatic treatment indicated? MMW Fortschr Med. 148, 26 (2006)
33. Goos, K. H., Albrecht, U., Schneider, B., Efficacy and safety profile of a herbal drug containing nasturtium herb and horseradish root in acute sinusitis, acute bronchitis and acute urinary tract infection in comparison with other treatments in the daily practice/results of a prospective cohort study. Arzneim.-Forsch./Drug Res. 56, 249 (2006)
34. Gill, J. M., Fleischut, P., Haas, S. et al., Use of antibiotics for adult upper respiratory infections in outpatient settings: a national ambulatory network study. Fam. Med. 38, 349 (2006)