MYRTOL STANDARDIZED IN THE TREATMENT OF ACUTE AND CHRONIC RESPIRATORY-INFECTIONS IN CHILDREN - A MULTICENTER POSTMARKETING SURVEILLANCE STUDY

This multicenter post-marketing surveillance study examined the course of characteristic signs and symptoms and the tolerability of myrtol s tandardized (Gelomyrtol(R) / Gelomyrtol(R) forte) in 511 children (4 t o 12 years of age) with acute and chronic sinusitis, bronchitis and si nubronchitis. The choice of dose and formulation (120 mg or 300 mg myr tol stand) accounted for the patients' age and body weight. The follow ing signs and symptoms were evaluated before and after 1 and 2 weeks o f treatment: impaired nasal respiration (blocked-up nose), pain upon p ressure 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 ch ildren, trigeminal pain, headache, paranasal sensitivity, and mucus in the pharynx had disappeared after two weeks of treatment. In more tha n 60%, impaired nasal respiration and difficulty to evacuate sputum we re 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 th e capsules. It is therefore concluded that a 2-week treatment course w ith 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 j udged as good or excellent, whilst adverse drug reactions were very fe w.