A Multi-centre, Randomised, Double-blind, Placebo- controlled Clinical Trial on the Effi cacy and Tolerability of GeloMyrtol

▼ GeloMyrtol ® forte (Myrtol ® ) is a phytomedicine obtained by distillation from essential oils. The trial was conducted to confi rm the effi cacy 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 effi cacy evaluation (Myrtol ® : 196; Placebo: 202). The mean change in coughing fi ts 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 fi ts was statistically signifi cantly shorter and there were more patients without day-time coughing fi ts; there also were statistically signifi cantly less day-time coughing fi ts, less diffi culty coughing up, less sleep disturbance due to night-time coughing; with Myrtol ® there was less symptomatic impairment (composite bronchitis severity score and subscores) and signifi cant more patients had a clinically satisfying response to the investigational treatment. Both treatments were generally well tolerated. Conclusions: Myrtol ® is statistically signifi cantly superior to placebo in treating acute bronchitis. a GeloMyrtol ® forte – G. Pohl-Boskamp GmbH & Co. KG, Hohenlockstedt, Germany b GeloMyrtol ® forte and Myrtol ® are registered trademarks of G. Pohl-Boskamp GmbH & Co. KG, Hohenlockstedt, Germany T hi s do cu m en t w as d ow nl oa de d fo r pe rs on al u se o nl y. U na ut ho riz ed d is tr ib ut io n is s tr ic tly p ro hi bi te d.