Treatment of Acute Bronchitis in Adults With a Pelargonium Sidoides Preparation (EPs® 7630): A Randomized, Double-Blind, Placebo-Controlled Trial

EXPLORE - Tập 1 - Trang 437-445 - 2005
A.G. Chuchalin1, B. Berman2, W. Lehmacher3
1Russian Research Institute of Pulmonology, Moscow, Russia
2University of Maryland, College Park, MD
3Institute for Medical Statistics, Informatics and Epidemiology of the University of Cologne, Cologne, Germany

Tài liệu tham khảo

Badura, 2000 Gonzales, 2000, Uncomplicated acute bronchitis, Ann Intern Med, 133, 981, 10.7326/0003-4819-133-12-200012190-00014 Altiner, 2001, Akute Bronchitis und Antibiotika, Z Allg Med, 77, 358 Fahey, 2001, Re-evaluation of a randomized controlled trial of antibiotics for minor respiratory illness in general practice, Fam Pract, 18, 246, 10.1093/fampra/18.3.246 Murray, 2000, Predictors of an antibiotic prescription by GPs for respiratory tract infections, Fam Pract, 17, 386, 10.1093/fampra/17.5.386 Bent, 1999, Antibiotics in acute bronchitis, Am J Med, 107, 62, 10.1016/S0002-9343(99)00167-9 Smucny, 2000, Antibiotics for acute bronchitis, Cochrane Database Syst Rev, CD000245 Knutson, 2002, Diagnosis and management of acute bronchitis, Am Fam Physician, 65, 2039 Kayser, 1997, Antibacterial activity of extracts and constituents of Pelargonium sidoides and Pelargonium reniforme, Planta Med, 63, 508, 10.1055/s-2006-957752 Kayser, 2001, Immunomodulatory principles of Pelargonium sidoides, Phytother Res, 15, 122, 10.1002/ptr.785 Kolodziej, 2003, Pharmacological profile of extracts of Pelargonium sidoides and their constituents, Phytomedicine, 10, 18, 10.1078/1433-187X-00307 Haidvogl, 1996, Akute Bronchitis im Kindesalter—Multizenter-Studie zur Wirksamkeit und Verträglichkeit des Phytotherapeutikums Umckaloabo, Z Phytotherapie, 17, 300 Heil, 1994, Atemwegs- and HNO-Infektionen. Therapeutische Erfahrungen mit dem Phytotherapeutikum Umckaloabo®, Therapiewoche Pädiatrie, 43, 412 Blochin, 1999, Umckaloabo im Vergleich zu Acetylcystein bei Kindern mit akuter Bronchitis, Der Kassenarzt, 49, 46 Matthys, 2003, 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, 7, 10.1078/1433-187X-00308 1997, Recommendations guiding physicians in biomedical research involving human subjects, JAMA, 277, 925, 10.1001/jama.1997.03540350075038 1997 Snow, 2001, Principles of appropriate antibiotic use for treatment of acute bronchitis in adults, Ann Intern Med, 134, 518, 10.7326/0003-4819-134-6-200103200-00020 Lehmacher, 1999, Adaptive sample size calculations in group sequential trials, Biometrics, 55, 1286, 10.1111/j.0006-341X.1999.01286.x Wassmer, 1999 Wassmer, 2001, Flexible interim analyses in clinical trials using multistage adaptive test designs, Drug Inf J, 35, 1131, 10.1177/009286150103500410 Ware, 1996, A 12-item short-form health survey. Construction of scales and preliminary tests of reliability and validity, Med Care, 34, 220, 10.1097/00005650-199603000-00003 Brooks, 1996, EuroQol, Health Policy, 37, 53, 10.1016/0168-8510(96)00822-6 Johnson, 1998, Comparison of the EQ-5D and SF-12 in an adult US sample, Qual Life Res, 7, 115, 10.1023/A:1008809610703 Johnson, 1998, Valuation of EuroQOL (EQ-5D) health states in an adult US sample, Pharmacoeconomics, 13, 421, 10.2165/00019053-199813040-00005 Kind, 1998, Variations in population health status, BMJ, 316, 736, 10.1136/bmj.316.7133.736 Kind, 2001, Measuring quality of life in evaluating clinical interventions, Ann Med, 33, 323, 10.3109/07853890109002085 European Agency for the Evaluation of Medicinal Products (EMEA). Note for Guidance on Good Clinical Practice. ICH-Guidelines (Human)-Efficacy—Topic E9. Step 4 Note for Guidance on Statistical Principles for Clinical Trials. CPMP/ICH/363/96 (adopted March 1998). Pocock, 1977, Group sequential methods in the design and analysis of clinical trials, Biometrika, 64, 191, 10.1093/biomet/64.2.191 Gonzales, 2001, Principles of appropriate antibiotic use for treatment of uncomplicated acute bronchitis, Ann Emerg Med, 37, 720, 10.1067/S0196-0644(01)70091-1 Williamson, 1984, A randomised, controlled trial of doxycycline in the treatment of acute bronchitis, J Fam Pract, 19, 481 Léophonte, 1998, The place of antimicrobial chemotherapy in the treatment of adults with acute bronchitis, Clin Microbiol Infect, 4, 436, 10.1111/j.1469-0691.1998.tb00391.x Evans, 2002, Azithromycin for acute bronchitis, Lancet, 359, 1648, 10.1016/S0140-6736(02)08597-5 Hueston, 1998, Acute bronchitis, Am Fam Physician, 57, 1270 Kolodziej, 2003, Umckaloabo—Von der traditionellen Anwendung zum modernen Phytotherapeutikum, Deutsche Apotheker Zeitung, 143, 55 Fahey, 1998, Quantitative systematic review of randomised controlled trials comparing antibiotic with placebo for acute cough in adults, BMJ, 316, 906, 10.1136/bmj.316.7135.906 Hirschmann, 2002, Antibiotics for common respiratory tract infections in adults, Arch Intern Med, 162, 256, 10.1001/archinte.162.3.256 Hall, 2003, Evaluation and treatment of acute bronchitis at an academic teaching clinic, Am J Med Sci, 325, 7, 10.1097/00000441-200301000-00002