A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Clinical Trial on the Efficacy and Tolerability of GeloMyrtol® Forte in Acute Bronchitis

Drug Res (Stuttg). 2013 Jan;63(1):19-27. doi: 10.1055/s-0032-1331182. Epub 2013 Jan 8.

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Acute Disease
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Bronchitis / drug therapy*
  • Double-Blind Method
  • Drug Combinations
  • Female
  • Humans
  • Male
  • Menthol / adverse effects
  • Menthol / analogs & derivatives*
  • Menthol / therapeutic use
  • Middle Aged

Substances

  • Drug Combinations
  • gelomyrtol
  • Menthol