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 (eFirst)

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.