Subscribe to RSS
DOI: 10.1055/s-0034-1377332
Assessment of the Effect of Pharmacotherapy in Common Cold/Acute Bronchitis – the Bronchitis Severity Scale (BSS)
Beurteilung der Wirksamkeit von Pharmakotherapie bei Erkältungen/akuter Bronchitis: Bronchitis Severity Scale (BSS)Publication History
received10 April 2014
accepted after revision30 April 2014
Publication Date:
08 July 2014 (online)
Abstract
Background: Acute bronchitis (AB) is a highly contagious infection of the airways, presenting mostly in connection with common cold (CC). There is a high variance in duration and course of symptoms which, sooner or later, also may disappear spontaneously and change during the course of the disease. Therefore, assessment of treatment outcome is difficult.
Methods: Composite outcome measures are commonly used to examine the effects of pharmacotherapy in complex diseases. We discuss the features of the Bronchitis Severity Scale (BSS) on the basis of the available literature.
Results: For the BSS the five most important symptoms of AB are rated by the patient and the physician. Since its introduction in 1996, the BSS has been used in many clinical trials evaluating treatment effects of AB. Its score correlates well with clinical findings. As thorough validation analyses revealed, this applies even more to the BSS subscales “cough domain” and “sputum domain”.
Conclusion: The validated BSS appears to be a reliable tool to assess therapeutic effects in CC/AB. The BSS and its subscales are recommended as outcome measures for future drug trials in CC/AB, but also help physicians to focus their consultation in patients with CC/AB.
Zusammenfassung
Hintergrund: Akute Bronchitis (AB) ist eine Entzündung der Atemwege. Sie tritt meist im Rahmen eines Erkältungsinfektes auf (engl. common cold; CC). Die klinische Symptomatik ist in Dauer und Verlauf äußerst variabel, früher oder später spontan abklingend und kann sich im Krankheitsverlauf ändern, was die Beurteilung der Wirksamkeit von Therapiemaßnahmen erschwert.
Methode: Zur Einschätzung von Behandlungsmaßnahmen bei komplexen Krankheiten werden oft zusammengesetzte Ratingskalen eingesetzt. Wir stellen die Bronchitis Severity Scale (BSS) vor und diskutieren sie anhand vorhandener Literatur.
Ergebnisse: Für die BSS werden die 5 wichtigsten Symptome bei AB von Patient und Arzt eingeschätzt. Seit ihrer Einführung 1996 wurde die BSS in vielen klinischen Studien zur Einschätzung von Therapieeffekten bei AB genutzt. Ihre Resultate stimmten stets gut mit der klinischen Situation überein. Die Validierungsanalyse zeigte, dass die BSS-Unterskalen „Hustendomäne“ und „Sputumdomäne“ die klinischen Gegebenheiten noch genauer widerspiegeln.
Schlussfolgerungen: Die validierte BSS und ihre Unterskalen eignen sich zur Einschätzung von Therapieeffekten bei CC/AB. Sie werden als Zielparameter für klinische Studien empfohlen und erleichtern auch Ärzten die Diagnose.
-
References
- 1 Hueston WJ, Mainous 3rd AG, Dacus EN et al. Does acute bronchitis really exist? A reconceptualization of acute viral respiratory infections. J Fam Pract 2000; 49: 401-406
- 2 Allen LV. Colds & cough. Int J Pharm Compd 2012; 16: 480-483
- 3 Singh M, Singh M. Heated, humidified air for the common cold. Cochrane Database Syst Rev 2013; 6 CD001728
- 4 Wenzel RP, Fowler 3rd AA. Clinical practice. Acute bronchitis. N Engl J Med 2006; 355: 2125-2130
- 5 Gulliford MC, van Staa T, McDermott L et al. Cluster randomised trial in the General Practice Research Database: 1. Electronic decision support to reduce antibiotic prescribing in primary care (eCRT study). Trials 2011; 12: 115
- 6 Butler CC, Hood K, Verheij T et al. Variation in antibiotic prescribing and its impact on recovery in patients with acute cough in primary care: prospective study in 13 countries. BMJ 2009; 338: b2242
- 7 Llor C, Moragas A, Bayona C et al. Efficacy of anti-inflammatory or antibiotic treatment in patients with non-complicated acute bronchitis and discoloured sputum: randomised placebo controlled trial. BMJ 2013; 347: f5762
- 8 Smith SM, Fahey T, Smucny J et al. Antibiotics for acute bronchitis. Cochrane Database Syst Rev 2014; 3 CD000245
- 9 Lemiengre MB, van Driel ML, Merenstein D et al. Antibiotics for clinically diagnosed acute rhinosinusitis in adults. Cochrane Database Syst Rev 2012; 10 CD006089
- 10 McCallum GB, Morris PS, Chang AB. Antibiotics for persistent cough or wheeze following acute bronchiolitis in children. Cochrane Database Syst Rev 2012; 12 CD009834
- 11 Birring SS, Fleming T, Matos S et al. The Leicester Cough Monitor: preliminary validation of an automated cough detection system in chronic cough. Eur Respir J 2008; 31: 1013-1018
- 12 Matos S, Birring SS, Pavord ID et al. An automated system for 24-h monitoring of cough frequency: the leicester cough monitor. IEEE Trans Biomed Eng 2007; 54: 1472-1479
- 13 Lee KK, Matos S, Evans DH et al. A longitudinal assessment of acute cough. Am J Respir Crit Care Med 2013; 187: 991-997
- 14 Thompson M, Vodicka TA, Blair PS et al. Duration of symptoms of respiratory tract infections in children: systematic review. BMJ 2013; 347: f7027
- 15 Hobbs KF, Cohen MD. Rheumatoid arthritis disease measurement: a new old idea. Rheumatology (Oxford) 2012; 51 (Suppl. 06) vi21-27
- 16 Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23: 56-62
- 17 Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry 1979; 134: 382-389
- 18 Guskiewicz KM, Register-Mihalik J, McCrory P et al. Evidence-based approach to revising the SCAT2: introducing the SCAT3. Br J Sports Med 2013; 47: 289-293
- 19 Albrecht H, Vernon M, Solomon G. Patient-reported outcomes to assess the efficacy of extended-release guaifenesin for the treatment of acute respiratory tract infection symptoms. Respir Res 2012; 13: 118
- 20 Mwachari C, Nduba V, Nguti R et al. Validation of a new clinical scoring system for acute bronchitis. Int J Tuberc Lung Dis 2007; 11: 1253-1259
- 21 Nduba VN, Mwachari CW, Magaret AS et al. Placebo found equivalent to amoxicillin for treatment of acute bronchitis in Nairobi, Kenya: a triple blind, randomised, equivalence trial. Thorax 2008; 63: 999-1005
- 22 Dome L, Schuster R. Umckaloabo – eine phytotherapeutische Alternative bei akuter Bronchitis im Kindesalter?. Ärztezeitschrift für Naturheilverfahren 1996; 37: 216-222
- 23 Holmes WF, Macfarlane JT, Macfarlane RM et al. Symptoms, signs, and prescribing for acute lower respiratory tract illness. Br J Gen Pract 2001; 51: 177-181
- 24 Kamin W, Ilyenko LI, Malek FA et al. Treatment of acute bronchitis with EPs 7630: randomized, controlled trial in children and adolescents. Pediatr Int 2012; 54: 219-226
- 25 Kamin W, Maydannik V, Malek FA et al. Efficacy and tolerability of EPs 7630 in children and adolescents with acute bronchitis – a randomized, double-blind, placebo-controlled multicenter trial with a herbal drug preparation from Pelargonium sidoides roots. Int J Clin Pharmacol Ther 2010; 48: 184-191
- 26 Kamin W, Maydannik VG, Malek FA et al. Efficacy and tolerability of EPs 7630 in patients (aged 6-18 years old) with acute bronchitis. Acta Paediatr 2010; 99: 537-543
- 27 Matthys H, Funk P. EPs 7630 improves acute bronchitic symptoms and shortens time to remission. Results of a randomised, double-blind, placebo-controlled, multicentre trial. Planta Med 2008; 74: 686-692
- 28 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: 323-331
- 29 Matthys H, Heger M. EPs 7630-solution--an effective therapeutic option in acute and exacerbating bronchitis. Phytomedicine 2007; 14 (Suppl. 06) 65-68
- 30 Matthys H, Kamin W, Funk P et al. Pelargonium sidoides preparation (EPs 7630) in the treatment of acute bronchitis in adults and children. Phytomedicine 2007; 14 (Suppl. 06) 69-73
- 31 Matthys H, Lizogub VG, Malek FA et al. 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. Curr Med Res Opin 2010; 26: 1413-1422
- 32 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 2003; 10 (Suppl. 04) 7-17
- 33 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 (NY) 2005; 1: 437-445
- 34 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. 06) 60-64
- 35 Cwientzek U, Ottillinger B, Arenberger P. Acute bronchitis therapy with ivy leaves extracts in a two-arm study. A double-blind, randomised study vs. an other ivy leaves extract. Phytomedicine 2011; 18: 1105-1109
- 36 Gruenwald J, Graubaum HJ, Busch R. Efficacy and tolerability of a fixed combination of thyme and primrose root in patients with acute bronchitis. A double-blind, randomized, placebo-controlled clinical trial. Arzneimittelforschung 2005; 55: 669-676
- 37 Gruenwald J, Graubaum HJ, Busch R. Evaluation of the non-inferiority of a fixed combination of thyme fluid- and primrose root extract in comparison to a fixed combination of thyme fluid extract and primrose root tincture in patients with acute bronchitis. A single-blind, randomized, bi-centric clinical trial. Arzneimittelforschung 2006; 56: 574-581
- 38 Kemmerich B. Evaluation of efficacy and tolerability of a fixed combination of dry extracts of thyme herb and primrose root in adults suffering from acute bronchitis with productive cough. A prospective, double-blind, placebo-controlled multicentre clinical trial. Arzneimittelforschung 2007; 57: 607-615
- 39 Gillissen A, Wittig T, Ehmen M et al. A multi-centre, randomised, double-blind, placebo-controlled clinical trial on the efficacy and tolerability of GeloMyrtol(R) forte in acute bronchitis. Drug Res (Stuttg) 2013; 63: 19-27
- 40 Kemmerich B, Eberhardt R, Stammer H. 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. Arzneimittelforschung 2006; 56: 652-660
- 41 Marzian O. Treatment of acute bronchitis in children and adolescents. Non-interventional postmarketing surveillance study confirms the benefit and safety of a syrup made of extracts from thyme and ivy leaves [Article in German]. MMW Fortschritte der Medizin 2007; 149 (Suppl. 27) 69-74
- 42 Steinsbekk A, Biolchini J, Heger M et al. Data Collection in Homeopathic Practice - A Proposal for an International Standard. 1999: 1-24 Available at: http://wwwhomeopathyeuropeorg/publications/guidelines/data-collection/datacollhompracpdf [last accessed 03-02-2014]
- 43 Lehrl S. Report on the validity of the Bronchitis Severity Scale (BSS) – a scale for acute bronchitis. Internal Report for Dr Willmar Schwabe GmbH & Co KG. Karlsruhe: 2012: 1-78
- 44 Moosbrugger H, Kelava A. Testtheorie und Fragebogenkonstruktion. 2. ed. Berlin: Springer; 2007
- 45 European Medicines Agency. Committee on Herbal Medicinal Products (HMPC) meeting report on Community herbal monographs, guidelines and other activities. EMA/HMPC/301544/2013
- 46 Matthys H, Kamin W. Positioning of the Bronchitis Severity Score (BSS) for standardised use in clinical studies. Current medical research and opinion 2013; 29: 1383-1390