Efficacy and tolerability of EPs 7630 tablets in patients with acute bronchitis: A randomised, double-blind, placebo-controlled dose-finding study with a herbal drug preparation from Pelargonium sidoides

Current Medical Research and Opinion

Volumn 26, Issue 6, 2010, Pages 1413-1422

  Matthys, H ^a   Lizogub, V G ^b   Malek, F A ^c   Kieser, M ^d  

^a UNIVERSITY OF FREIBURG   (Germany)

^b BOGOMOLETS NATIONAL MEDICAL UNIVERSITY   (Ukraine)

^c DR WILLMAR SCHWABE GMBH AND CO KG   (Germany)

^d UNIVERSITY OF HEIDELBERG   (Germany)

Author keywords

Acute bronchitis; Bronchitis specific symptoms; EPs 7630; Herbal drug preparation

Indexed keywords

PELARGONIUM SIDOIDES EXTRACT; PLACEBO;

ADULT; ARTICLE; BODY TEMPERATURE; BRONCHITIS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIASTOLIC BLOOD PRESSURE; DISEASE SEVERITY; DOSE CALCULATION; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG TOLERABILITY; FEMALE; GASTROINTESTINAL DISEASE; HUMAN; LABORATORY TEST; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PATIENT COMPLIANCE; PLANT ROOT; PULSE RATE; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SIDE EFFECT; SYSTOLIC BLOOD PRESSURE; TABLET;

ADULT; BRONCHITIS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG TOLERANCE; FEMALE; HUMANS; MALE; MIDDLE AGED; PELARGONIUM; PHYTOTHERAPY; PLACEBOS; PLANT EXTRACTS; PLANT ROOTS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 77952504788     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1185/03007991003798463     Document Type: Article

References (30)

1. Fendrick AM, Monto AS, Nightengale B, et al. The economic burden of non-influenza-related viral respiratory tract infection in the United States. Arch Intern Med 2003;163:487-494
2. Hueston WJ, Mainous III AG. Acute bronchitis. Am Fam Physician 1998; 57:1270-1276
3. File Jr TM, Hadley JA. Rational use of antibiotics to treat respiratory tract infections. Am J Manag Care 2002;8:713-727
4. Flaherty KR, Saint S, Fendrick AM, et al. The spectrum of acute bronchitis. Using baseline factors to guide empirical therapy. Postgrad Med 2001; 109:39-47
5. Kolodziej H. Fascinating metabolic pools of Pelargonium sidoides and Pelargonium reniforme, traditional and phytomedicinal sources of the herbal medicine Umckaloabo®. Phytomedicine 2007;14(Suppl VI):9-17
6. Germer S, Hauer H, Erdelmeier C, et al. A detailed view on the constituents of EPs® 7630. Planta Med 2007;73:821
7. Kolodziej H, Kiderlen AF. In vitro evaluation of antibacterial and immunomod-ulatory activities of Pelargonium reniforme, Pelargonium sidoides and the related herbal drug preparation EPs® 7630. Phytomedicine 2007;14 (Suppl VI):18-26
8. Thäle C, Kiderlen AF, Kolodziej H. Anti-infective mode of action of EPs® 7630 at the molecular level. Planta Med 2007;73:821
9. Beil W, Kilian P. EPs® 7630, an extract from Pelargonium sidoides roots inhibits adherence of Helicobacter pylori to gastric epithelial cells. Phytomedicine 2007;14(Suppl VI):5-8
10. Kayser O, Kolodziej H. Antibacterial activity of extracts and constituents of Pelargonium sidoides and Pelargonium reniforme. Planta Med 1997; 63:508-510
11. Kayser O, Kolodziej H, Kiderlen AF. Immunomodulatory principles of Pelargonium sidoides. Phytother Res 2001;15:122-126
12. Kolodziej H, Kayser O, Radtke OA, et al. Pharmacological profile of extracts of Pelargonium sidoides and their constituents. Phytomedicine 2003;10 (Suppl IV):18-24
13. Conrad A, Hansmann C, EngelsI, etal. Extract of Pelargonium sidoides (EPs® 7630) improves phagocytosis, oxidative burst, and intracellular killing of human peripheral blood phagocytes in vitro. Phytomedicine 2007;14 (Suppl VI):46-51
14. Conrad A, Engels I, Frank U. Extract of Pelargonium sidoides (EPs® 7630) displays anti-infective properties by enhanced phagocytosis and differential modulation of host-bacteria interactions. Planta Med 2007;73:822
15. Neugebauer P, Mickenhagen A, Siefer O, et al. A new approach to pharmacological effects on ciliary beat frequency in cell cultures-exemplary measurements under Pelargonium sidoides extract (EPs 7630). Phytomedicine 2005;12:46-51
16. Conrad A, Jung I, TiouaD, etal. Extract of Pelargonium sidoides (EPs® 7630) inhibits the interactions of group A-streptococci and host epithelia in vitro. Phytomedicine 2007;14 (Suppl VI):52-59
17. Nöldner M, Schötz K. Inhibition of lipopolysaccharide-induced sickness behavior by a dry extract from the roots of Pelargonium sidoides (EPs® 7630) in mice. Phytomedicine 2007;14(Suppl VI):27-31
18. Koch E, Biber A. Treatment of rats with the Pelargonium sidoides extract EPs® 7630 has no effect on blood coagulation parameters or on the phar-macokinetics of warfarin. Phytomedicine 2007;14(Suppl VI):40-45
19. Chuchalin AG, 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 2005;1:437-445
20. 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 Opinion 2007; 23:323-331
21. Bachert C, Schapowal A, Funk P, et al. Treatment of acute rhinosinusitis with the preparation from Pelargonium sidoides EPs 7630: a randomized, double-blind, placebo-controlled trial. Rhinology 2009;47:51-58
22. Schapowal A, Heger M. EPs® 7630 Lösung (Umckaloabo®) bei Sinusitis. Z Phytotherapie 2007;28:58-65
23. Williamson Jr HA. A randomized, controlled trial of doxycycline in the treatment of acute bronchitis. J Fam Pract 1984;19:481-486
24. Macfarlane J, Holmes W, Gard P, et al. Reducing antibiotic use for acute bronchitis in primary care: blinded, randomised controlled trial of patient information leaflet. BMJ 2002;324:91-94
25. Bartholomew DJ. Ordered tests in the analysis of variance. Biometrika 1961;48:325-332
26. Bauer P, Kö hne K. Evaluation of experiments with adaptive interim analyses. Biometrics 1994;50:1029-1041
27. Kieser M, Bauer P, Lehmacher W. Inference on multiple endpoints in clinical trials with adaptive interim analyses. Biom J 1999;41: 261-277
28. Alberta Clinical Practice Guideline Working Group. Guideline for the management of acute bronchitis. Reviewed and revised, January 2008 [cited 2010 January 15]. Available from: URL: http://www.topalbertadoctors.org/informed- practice/clinical-practice-guidelines/complete%20set/Bronchitis/ acute-bronchitis-guideline.pdf
29. Gonzales R, Sande MA. Uncomplicated acute bronchitis. Ann Intern Med 2000;133:981-991
30. Pullar T, Kumar S, Tindall H, et al. Time to stop counting the tablets?. Clin Pharmacol Ther 1989;46:163-168