Download PDF
Drug Res (Stuttg) 2013; 63(01): 19-27
DOI: 10.1055/s-0032-1331182
Original Article
© Georg Thieme Verlag KG Stuttgart · New York

A Multi-centre, Randomised, Double-blind, Placebo-controlled Clinical Trial on the Efficacy and Tolerability of GeloMyrtol® forte in Acute Bronchitis

A. Gillissen
1   Department of Pulmonary Medicine, General Hospital Kassel, Kassel, Germany
,
Th. Wittig
2   G. Pohl-Boskamp GmbH & Co. KG, Hohenlockstedt, Germany
,
M. Ehmen
2   G. Pohl-Boskamp GmbH & Co. KG, Hohenlockstedt, Germany
,
H. G. Krezdorn
3   Internist, Munich, Germany
,
C. de Mey
4   ACPS-Network GmbH, Applied Clinical Pharmacology Services, Mainz-Kastel, Germany
› Author Affiliations
Further Information

Publication History

received 06 September 2012

accepted 07 November 2012

Publication Date:
08 January 2013 (online)

Also available at
   Permissions and Reprints

Abstract

GeloMyrtol® forte (Myrtol®) is a phytomedicine obtained by distillation from essential oils. The trial was conducted to confirm the efficacy of Myrtol® in the treatment of acute bronchitis.

Methods:

Patients with acute bronchitis and without confounding co-morbidity or co-medication were randomly assigned to treatment with either Myrtol® 300 mg 4 times daily or matched placebo in double-blind, parallel-group fashion. Signs and symptoms were evaluated by the investigator at baseline and after 7, 10 and 14 days of treatment; intake of medication, wellbeing and symptoms were recorded daily by the patient in the patients’ diaries.

Findings:

413 patients were enrolled and randomised (Myrtol®: 202; Placebo: 211); 398 had at least one on-treatment efficacy evaluation (Myrtol®: 196; Placebo: 202). The mean change in coughing fits from D01 (baseline) to D07-D09 (after about one week treatment) was 62.1% (95% CI: 57.6–66.6%) and 49.8% (95% CI: 44.6–55.0%) for treatment with Myrtol® and placebo, respectively (p<0.0001). With Myrtol®, the median time to 50% reduction in coughing fits was statistically significantly shorter and there were more patients without day-time coughing fits; there also were statistically significantly less day-time coughing fits, less difficulty coughing up, less sleep disturbance due to night-time coughing; with Myrtol® there was less symptomatic impairment (composite bronchitis severity score and subscores) and significant more patients had a clinically satisfying response to the investigational treatment.

Both treatments were generally well tolerated.

Conclusions:

Myrtol® is statistically significantly superior to placebo in treating acute bronchitis.

Key words

acute bronchitis - clinical trial - Myrtol® - GeloMyrtol® forte
 

  • References

  • 1 Wenzel RP, Fowler AA. Acute bronchitis. N Engl J Med 2006; 355: 2125-2130
    CrossrefPubMedSearch in Google Scholar
  • 2 Kroening-Roche JC, Soroudi A, Castillo EM et al. Antibiotic and Bronchodilator Prescribing for Acute Bronchitis in the Emergency Department. J Emerg Med Aug 2012; 43 (02) 221-227
    CrossrefPubMedSearch in Google Scholar
  • 3 Roisin RR, Vestbo J. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2011 Available from: http://www.goldcopd.org/
    PubMedSearch in Google Scholar
  • 4 Matthys H, de Mey C, Carls C et al. Efficacy and Tolerability of Standardized in Acute Bronchitis. A multi-centre, randomised, double-blind, placebo-controlled parallel group clinical trial vs. cefuroxime and ambroxol. Arzneim-Forsch/Drug Res 2000; 50 (II) 8 700-711
    PubMedSearch in Google Scholar
  • 5 Verheij TJM, Kaptein AA, Mulder JD. Acute bronchitis: aetiology, symptoms and treatment. Fam Pract 1989; 6: 66-69
    CrossrefPubMedSearch in Google Scholar
  • 6 Braman SS. Chronic cough due to acute bronchitis: ACCP evidence-based clinical practice guidelines. Chest 2006; 129 (01) 95S-103S
    CrossrefPubMedSearch in Google Scholar
  • 7 German Summary of Product Characteristics (Fachinformation) GeloMyrtol®/GeloMyrtol® forte Aug 2010
    PubMed
  • 8 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. Arzneim.-Forsch./Drug Res 2006; 56 (09) 652-660
    PubMedSearch in Google Scholar
  • 9 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. Arzneim -Forsch/Drug Res 2007; 57 (09) 607-615
    PubMedSearch in Google Scholar
  • 10 Matthys H, Heger M. Treatment of acute bronchitis with a liquid herbal drug preparation from Pelargonium sidoides (EP 7630): a randomised, double-blind, placebo-controlled, multicenter study. Current Medical research and Opinions 2007; 23 (02) 323-331
    CrossrefPubMedSearch in Google Scholar
  • 11 Gruenwald J, Graubaum HJ, Busch R. Efficacy and tolerability of a fixed combination of thyme and primrose root in patients with acute bronchitis. Arzneim.-Forsch./Drug Res 2005; 55 (11) 669-676
    PubMedSearch in Google Scholar
  • 12 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. Arzneim -Forsch/Drug Res 2006; 56 (No. 8) 574-581
    PubMedSearch in Google Scholar
  • 13 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 2004; 58: 570-602
    Thieme ConnectPubMedSearch in Google Scholar
  • 14 Gillissen A. Akute Bronchitis. In Reuter P. Hrsg Springer Lexikon Diagnose & Therapie. 1. Auflage Springer; Berlin Heidelberg: 2006. Part 1, Part 2, Seiten 165-174
    CrossrefSearch in Google Scholar
  • 15 Macfarlane JT, Holmes WF, Macfarlane RM et al. Contemporary use of antibiotics in 1089 adults presenting with acute lower respiratory tract illness in primary care in the UK: implications for developing management guidelines. Respir Med 1997; 91: 427-434
    CrossrefPubMedSearch in Google Scholar
  • 16 Macfarlane J, Holmes W, Macfarlane R et al. Influence of patients’ expectations on antibiotic management of acute lower respiratory tract illness in general practice: questionnaire study. BMJ 1997; 315: 1211-1214
    CrossrefPubMedSearch in Google Scholar
  • 17 Kardos P, Berck H, Fuchs KH et al. Leitlinie der Deutschen Gesellschaft für Pneumologie und Beatmungsmedizin zur Diagnostik und Therapie von erwachsenen Patienten mit akutem und chronischem Husten. Pneumologie 2010; 64: 336-373
    Thieme ConnectPubMedSearch in Google Scholar
  • 18 Knutson D, Braun C. Diagnosis and Management of Acute Bronchitis. Am Fam Physician 2002; 65: 2039-2045
    PubMedSearch in Google Scholar
  • 19 Gwaltney Jr JM. Acute bronchitis. In: Mandell GL, Bennett JE, Dolin R. (eds.) Principles and practice of infectious diseases. 4th ed. New York: Churchill Livingstone; 1995: 606-608
    Search in Google Scholar
  • 20 Hueston WJ, Mainous IIIrd AG. Acute Bronchitis. Am Fam Physician Mar 15 1998; 57 (06) 1270-1276 1281–1282
    PubMedSearch in Google Scholar
  • 21 Adam D, Bodmann KF, Elies W et al. Praxisorientierte Empfehlungen zur kalkulierten Initialtherapie bakterieller Erkrankungen der Atemwege und des HNO-Bereichs bei Erwachsenen. Arzneimitteltherapie 2005; 23: 247-255
    PubMedSearch in Google Scholar
  • 22 Arzneimittelkommission der deutschen Ärzteschaft: Handlungsleitlinie Atemwegsinfektionen aus Empfehlungen zur Therapie akuter Atemwegsinfektionen Arzneiverordnung in der Praxis, Sonderheft, 2. Auflage; 2002
    PubMed
  • 23 Vogel F, Worth H, Adam D et al. Rationale Therapie bakterieller Atemwegsinfektionen. Chemotherapie Journal 2000; 9 (01) 3-23
    PubMedSearch in Google Scholar
  • 24 Orr PH, Scherer K, Macdonald A et al. Randomized Placebo-controlled trials of antibiotics for acute bronchitis: a critical review of the literature. J Fam Pract 1993; 36: 507-512
    PubMedSearch in Google Scholar
  • 25 Smith SM, Fahey T, Smucny J et al. Editorial Group: Cochrane Acute Respiratory Infections Group Antibiotics for acute bronchitis. 2009 Jan 21: CD000245
    PubMed
  • 26 Belongia EA, Schwartz B. Strategies for promoting judicious use of antibiotics by doctors and patients. BMJ 1998; 317: 668-671
    CrossrefPubMedSearch in Google Scholar
  • 27 Huovinen P, Cars O. Editorials – Control of antimicrobial resistance: time for action. BMJ 1998; 317: 613-614
    CrossrefPubMedSearch in Google Scholar
  • 28 Wise R, Hart T, Cars O et al. Antimicrobial resistance is a major threat to public health. BMJ 1998; 317: 609-610
    CrossrefPubMedSearch in Google Scholar
  • 29 Webb S, Lloyd M. Prescribing and referral in general practice: a study of patients’ expectations and doctors’ actions. Br J Gen Pract 1994; 44: 165-169
    PubMedSearch in Google Scholar
  • 30 Rapaport J. Patients’ expectations and intention to self medicate. J R Coll Gen Pract 1979; 29: 468-472
    PubMedSearch in Google Scholar
  • 31 Meister R, Wittig Th, Beuscher N et al. Wirksamkeit und Verträglichkeit von Myrtol standardisiert bei der Langzeitbehandlung der chronischen Bronchitis, Arzneim.-Forsch./Drug Res. 1999; 49 (0I) 4: 351-358
    PubMedSearch in Google Scholar
  • 32 Federspil P, Wulkow R, Zimmermann Th et al. Efficacy of Myrtol Standardized in the Therapy of Acute Sinusitis – Results of a Double-Blind, Randomized, Placebo-Controlled, Multicentric Study. Laryngo-Rhino-Otol 2000; 79: 1-5
    PubMedSearch in Google Scholar
  • 33 Wittig Th. Myrtol standardisiert – Eine klinische Dokumentation, Ergebnisse Verlag. 5. Auflage 2010
    PubMedSearch in Google Scholar
  • 34 Behrbohm H, Kaschke O, Sydow K. Der Einfluß des pflanzlichen Sekretolytikums Gelomyrtol® forte auf die mukoziliäre Clearance der Kieferhöhle. Laryngo-Rhino-Otol 1995; 74: 733-737
    PubMedSearch in Google Scholar
  • 35 App EM. Stellenwert der Mukusclearance für das Bronchialsystem – Pathophysiologie und therapeutische Ansätze. in: Meister R. Entzündliche Erkrankungen des Bronchialsystems. Springer Verlag; 1st Edition 2000: 27-53
    CrossrefSearch in Google Scholar
  • 36 Behrbohm H, Kaschke O, Sydow K. The influence of a secretolytic drug on mucociliary clearance of the maxillary sinus. J Rhinol 1997; 4 (01) 29-33
    PubMedSearch in Google Scholar
  • 37 Cao L, Chen Y, Zhao Y et al. Effect of Myrtol standardized on mucus hypersecretion and clearance of Pseudomonas aeruginosa in a rat model of chronic obstructive pulmonary disease. Arzneim Forsch/Drug Research 2011; 61 (12) 685-692
    PubMedSearch in Google Scholar
  • 38 Dorow P, Th Weiss, Felix R et al. Einfluß eines Sekretolytikums und einer Kombination von Pinen, Limonen und Cineol auf die mukoziliare Clearance bei Patienten mit chronisch obstruktiver Atemwegserkrankung. Arzneim Forsch/Drug Research 1987; 37 (11) 1378-1381
    PubMedSearch in Google Scholar
  • 39 Begrow F, Böckenholt C, Ehmen M et al. Effect of Myrtol Standardized and Other Substances on the Respiratory Tract: Ciliary Beat Frequency and Mucociliary Clearance as Parameters. Adv Ther 2012;
    PubMedSearch in Google Scholar
  • 40 Kwok RP. The effects of Gelomyrtol forte® on human ciliary beat frequency and intracellular cyclic adenosine monophosphate in vitro. Dissertation for the degree of Master of Research in Medicine. Division of Respiratory Medicine, Department of Medicine, Queen Mary Hospital, Hong Kong: 2007
    PubMedSearch in Google Scholar
  • 41 Rantzsch U, Vacca G, Dück R et al. Anti-inflammatory effects of Myrtol standardized and other essential oils on alveolar macrophages from patients with chronic obstructive pulmonary disease. Eur J Med Res 2009; 14 (Suppl. 04) 205-209
    CrossrefPubMedSearch in Google Scholar
  • 42 Juergens UR, Stöber M, Vetter H. Steroidartige Hemmung des monozytären Arachidonsäuremetabolismus und der IL-1ß-Produktion durch 1.8-Cineol. Atemw-Lungenkrkh 1998; 24: 3-11
    PubMedSearch in Google Scholar
  • 43 Beuscher N, Kietzmann M, Bien E et al. Interference of Myrtol standardised with inflammatory and allergic mediators. Arzneim-Forsch/Drug Res 1998; 48 (0I) 985-989
    PubMedSearch in Google Scholar
  • 44 Beuscher N, Bien E, Elstner EF et al. Myrtol standardized in treatment of sinusitis and bronchitis – Pharmacodynamics and pharmacokinetics, Zeitschrift für Phytotherapie. Abstractband, Kongress der Gesellschaft für Phytotherapie 1997; 9-10
    PubMedSearch in Google Scholar
  • 45 Graßmann J, Hippeli S, Dornisch K et al. Antioxidant Properties of Essential Oils. Arzneim-Forsch/Drug Res 2000; 50 (0I) 135-139
    PubMedSearch in Google Scholar
  • 46 Christoph F, Kaulfers P-M, Stahl-Biskup E. In vitro evaluation of the antibacterial activity of β-triketones admixed to Melaleuca oils. Planta Medica 2001; 67 (08) 768-771
    Thieme ConnectPubMedSearch in Google Scholar
  • 47 Beuscher N, Bien E, Vierling TH. Myrtol standardized in treatment of sinusitis and bronchitis – Safety and Toxicology. Zeitschrift für Phytotherapie, Abstract Volume, Congress of the Gesellschaft für Phytotherapie 1997; 7-8
    PubMedSearch in Google Scholar