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

Chemotherapy

Volumn 48, Issue 4-5, 2002, Pages 259-266

  Hauke, Wilfried ^a   Köhler, Gert ^b   Henneicke von Zepelin, Hans Heinrich ^b   Freudenstein, Johannes ^b  

^a EPA Europharma Auftragsforschung   (Germany)

^b Schaper & Brummer GmbH & Co KG   (Germany)

Author keywords

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

Indexed keywords

AZITHROMYCIN; CLARITHROMYCIN; ESBERITOX; MACROLIDE; PLACEBO; ROXITHROMYCIN; ANTIINFECTIVE AGENT; IMMUNOLOGICAL ADJUVANT; PLANT EXTRACT;

ADULT; AGED; ANTIBIOTIC THERAPY; ANTIMICROBIAL THERAPY; ARTICLE; BACTERIAL INFECTION; CHRONIC BRONCHITIS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE EXACERBATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERANCE; FEMALE; FOLLOW UP; FORCED EXPIRATORY VOLUME; HUMAN; HUMAN EXPERIMENT; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZATION; STATISTICAL ANALYSIS; TREATMENT OUTCOME; ADJUVANT THERAPY; ADOLESCENT; CHILD; DRUG TOLERABILITY; HOST RESISTANCE; INFANT; PRACTICE GUIDELINE; RANDOMIZED CONTROLLED TRIAL; UNSPECIFIED SIDE EFFECT; CHRONIC DISEASE; CHRONIC OBSTRUCTIVE LUNG DISEASE; COMPARATIVE STUDY; DRUG COMBINATION; PATHOLOGY; PILOT STUDY; TIME;

ADJUVANTS, IMMUNOLOGIC; ADULT; ANTI-BACTERIAL AGENTS; AZITHROMYCIN; BACTERIAL INFECTIONS; BRONCHITIS, CHRONIC; CHRONIC DISEASE; CLARITHROMYCIN; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; HUMANS; LUNG DISEASES, OBSTRUCTIVE; PILOT PROJECTS; PLANT EXTRACTS; ROXITHROMYCIN; TIME FACTORS;

EID: 19044367689     PISSN: 00093157     EISSN: None     Source Type: Journal    
DOI: 10.1159/000066763     Document Type: Article

References (42)

1. Morris S, Anderson P, Irwin DE: Acute exacerbations of chronic bronchitis - A pharmacoeconomic review of antibacterial use. Pharmacoeconomics 2002;20:153-168.
2. Ball P, Make B: Acute exacerbations of chronic bronchitis. Chest 1998;113(suppl):199-204.
3. American Thoracic Society: Standards for the diagnosis and care of subjects with chronic obstructive pulmonary disease. Am Rev Respir Dis 1995;152:78-83.
4. Grossmann RF: Management of acute exacerbation of chronic bronchitis. Can Respir J 1999;6(suppl A):40A-45A.
5. Destache CJ, Dewan N, O'Donohue WJ, Campbell JC, Angelillo VA: Clinical and economic considerations in the treatment of acute exacerbations of chronic bronchitis. J Antimicrob Chemother 1999;43(suppl A):107-113.
6. Doll H, Grey-Amante P, Duprat-Lomon I, Sagnier PP, Thate-Waschke I, Lorenz J, Rychlik R, Pfeil T: Quality of life in acute exacerbation of chronic bronchitis: Results from a German population study. Respir Med 2002;96:39-51.
7. Chodosh S: Treatment of acute exacerbations of chronic bronchitis: State of the art. Am J Med 1991;91:87-92.
8. Saint S, Bent S, Vittinghof E, Grady D: Antibiotics in chronic obstructive pulmonary disease exacerbations. A meta-analysis. JAMA 1995; 273:957-960.
9. Worth H, Adam D, Handrick W, Leupold W, Lode H, Loos U, Marre R, Mauch H, Schaberg T, Shah P, Sill V, Wettengel R: Prophylaxe und therapie von bronchialen infektionen. Empfehlungen der Deutschen atemwegsliga in der Deutschen gesellschaft für pneumologie. Pneumologie 1998;52:232-237.
10. Wettengel R, Böhning W, Cegla C, Criée C, Fichter J, Geisler L, Fabel H, Köhler D, Konietzko N, Lindemann H, Magnussen H, Matthys H, Meister R, Morr H, Nolte D, Petro W, Schultze-Werninghaus G, Sill V, Sybrecht G, Weisner B, Worth H: Empfehlungen der Deutschen atemwegsliga zur behandlung von patienten mit chronisch obstruktiver bronchitis und lungenemphysem. Med Klin 1995;90:3-7.
11. Macfarlane J, Lewis SA, Macfarlane R, Holmes W: Contemporary use of antibiotics in 1089 adults presenting with acute lower respiratory tract illness in general practice in the U.K.: Implications for developing management guidelines. Respir Med 1997;91:427-434.
12. Tager I, Speizer TE: The role of infection in chronic bronchitis. Engl J Med 1975;292:563-571.
13. Anthonisen NR, Manfreda J, Warren CPW, Hershfield ES, Harding GKM, Nelson NA: Antibiotic therapy in exacerbations of chronic obstructive pulmonary disease. Ann Intern Med 1987;106:196-204.
14. Eller J, Ede A, Schaberg T, Niedermann MS, Mauch H, Lode H: Infective exacerbations of chronic bronchitis. Chest 1998;113:1542-1548.
15. Anzueto A, Niedermann MS, Tillotson GS: Etiology, susceptibility, and treatment of acute bacterial exacerbations of complicated chronic bronchitis in the primary care setting: Ciprofloxacin 750 mg BID versus clarithromycin 500 mg BID. The Bronchitis Study Group. Clin Ther 1998;20:885-900.
16. Zuck P, Petitpretz P, Geslin P, Rio Y, Leblanc F: Bacteriological eradication ofStreptococcus pneumoniaefrom patients with acute exacerbations of chronic bronchitis: Cefuroxime axetil versus cefixime. Int J Clin Pract 1999;53:437-443.
17. Chodosh S, McCarty J, Farkas S, Drehobl M, Tosiello R, Shan M, Aneiro L, Kowalsky S: Randomized, double-blind study of ciprofloxacin and cefuroxime axetil for treatment of acute bacterial exacerbations of chronic bronchitis. The Bronchitis Study Group. Clin Infect Dis 1998;27:722-729.
18. Reynolds HY: Chronic bronchitis and acute infectious exacerbations; in Mandell GL, Bennett JE, Dolin R (eds): Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases, Ed 4. New York, Churchill Livingstone, 1995, pp 608-612.
19. Breiman RF, Butler JC, Tenover FC, Elliot JA, Facklam RR: Emergence of drug-resistant pneumococcal infections in the United States. JAMA 1994;271:1831-1835.
20. Dorsch W: Klinische anwendung von extrakten aus echinacea purpurea oder echinacea pallida. Z Ärztl Fortbild (Jena) 1996;90:117-122.
21. Melchart D, Linde K, Fischer P, Kaesmayr J: Echinacea for the prevention and treatment of the common cold. Cochrane Libr 1999;1:1-14.
22. Henneicke-von Zepelin HH, Hentschel C, Schnitker J, Kohnen R, Köhler G, Wüstenberg P: Efficacy and safety of a fixed combination phytomedicine in the treatment of the common cold (acute viral respiratory tract infection): Results of a randomised, double blind, placebo controlled, multicentre study. Curr Med Res Opin 1999;15:214-227.
23. Wüstenberg P, Henneicke-von Zepelin HH, Köhler G, Stammwitz U: Efficacy and mode of action of an immunomodulator herbal preparation containing echinacea, wild indigo, and white cedar. Adv Ther 1999;16:51-70.
24. Bauer R: Echinacea-Drogen - Wirkungen und wirksubstanzen. Z Ärztl Fortbild (Jena) 1996; 90:111-115.
25. Grimm W, Müller HH: A randomized controlled trial of the effect of fluid extract of Echinacea purpureaon the incidence and severity of colds and respiratory infections. Am J Med 1999;106:138-143.
26. Melchart D, Linde K, Worku F, Sarkady L, Holzmann M, Jurcic K, Wagner H: Results of five randomised studies on the immunomodulatory activity of preparations of Echinacea. J Altern Complement Med 1995;1/2:145-160.
27. von Blumröder WO: Angina lacunaris. Eine untersuchung zum thema «Steigerung der körpereigenen Abwehr». Z Allgemeinmed 1985;8:271-273.
28. Reitz HD, Hergarten H: Immunmodulatoren mit pflanzlichen Wirkstoffen. 2. Eine wissenschaftliche studie am beispiel Esberitox® N. Notabene Medici 1990;20:304-306.
29. Zimmer M: Gezielte konservative therapie der akuten sinusitis in der HNO-Praxis. Therapiewoche 1985;36:4024-4028.
30. Stolze H, Forth H: Eine antibiotikabehandlung kann durch zusätzliche immunstimulierung optimiert werden. Kassenarzt 1983;23: 43-48.
31. Chodosh S, Schreurs A, Siami G, Barkman HW, Anzeto A, Shan M, Moesker H, Stack T, Kowalsky S: Efficacy of oral ciprofloxacin vs. clarithromycin for treatment of acute bacterial exacerbations of chronic bronchitis. The Bronchitis Study Group. Clin Infect Dis 1998;27: 730-738.
32. Rocha RT, Awad CE, Ali A, Matyas R, Vital ACC, Silva C, Dainesi SM, Salazar MS, Nakatani J: Comparison of spiramycin and clarithromycin for community-acquired lower respiratory tract infections. Int J Clin Pract 1999; 53:433-436.
33. Mador MJ, Rodis A, Ulysses J, Magalang J: Reproducibility of Borg scale measurements of dyspnea during exercise in patients with COPD. Chest 1995;107:1590-1597.
34. Celli BR, Snider GL, Heffner J, Tiep B, Ziment I, Make B, Braman S, Olsen G, Phillips Y: Standards for the diagnosis and care of patients with chronic obstructive pulmonary disease. American Thoracic Society. Am J Respir Crit Care Med 1995;152(suppl):77-120.
35. Rychlik R, Pfeil T, Daniel D, Pfeil B, Mast O, Thate-Waschke I, Lorenz J: Zur sozioökonomischen relevanz akuter exazerbationen der chronischen bronchitis in der bundesrepublik Deutschland. Dtsch Med Wochenschr 2001; 126:353-359.
36. Adams SG, Anzueto A: Antibiotic therapy in acute exacerbations of chronic bronchitis. Semin Respir Infect 2000;15:234-247.
37. Ball P, Harris JM, Lowson D, Tillotson G, Wilson R: Acute infective exacerbations of chronic bronchitis. Q J Med 1995;88:61-68.
38. Shimizu T, Kato M, Mochizuko H, Tokuyama K, Morikawa A, Kuroume T: Roxithromycin reduces the degree of bronchial hyperrespon-siveness in children with asthma. Chest 1994;106:448-461.
39. Nishimura K, Izumi T, Tsukino M, Oga T: Dyspnea is a better predictor of 5-year survival than airway obstruction in patients with COPD. Chest 2002;121:1434-1440.
40. Wood-Baker R, Walters EH, Gibson P: Oral corticosteroids for acute exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2001;2:CD001288.
41. Barr RG, Rowe BH, Camargo CA Jr: Methylxanthines for exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2001;1:CD002168.
42. Sestini P, Renzoni E, Robinson S, Poole P, Ram FSF: Short-acting beta 2 agonists for stable chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2000;3:CD001495.