Myrtol standardized in the treatment of acute and chronic respiratory infections in children. A multicenter post-marketing surveillance study
Sengespeik, H.C.; Zimmermann, T.; Peiske, C.; de Mey, C.
Arzneimittel-Forschung 48(10): 990-994
1998
ISSN/ISBN: 0004-4172 PMID: 9825116 Document Number: 495354
This multicenter post-marketing surveillance study examined the course of characteristic sips and symptoms and the tolerability of myrtol standardized (Gelomyrtoll/Gelomyrtol forte) in 511 children (4 to 12 years of age) with acute and chronic sinusitis, bronchitis and sinubronchitis. The choice of dose and formulation (120 mg or 300 mg myrtol stand) accounted for the patients' age and body weight. The following signs and symptoms were evaluated before and after 1 and 2 weeks of treatment: impaired nasal respiration (blocked-up nose), pain upon pressure on the trigeminal nerve endings, headache, sensitivity of the paranasal sinuses, presence of mucus in the pharynx. At the end of the observation period, the physicians, the patients themselves and their parents judged efficacy of the medication. In more than 90% of the children, trigeminal pain, headache, paranasal sensitivity, and mucus in the pharynx had disappeared after two weeks of treatment. In more than 60%, impaired nasal respiration and difficulty to evacuate sputum were no longer observed. The incidence of adverse drug reactions was low: less than 1%. The efficacy was judged to be very good or good by the majority of physicians, patients and parents. In spite of their young age, most children (> 80%) experienced no difficulty in swallowing the capsules. It is therefore concluded that a 2-week treatment course with myrtol stand. was beneficial in acute and chronic diseases of the upper and lower respiratory tract in children. It was associated with the rapid and evident reduction and/or disappearance of characteristic signs and symptoms. Therefore, the symptomatic improvement could be judged as good or excellent, whilst adverse drug reactions were very few.