The value of Ems Mineral Salts in the treatment of rhinosinusitis in children. Prospective study on the efficacy of mineral salts versus xylometazoline in the topical nasal treatment of children.

UNLABELLED: The treatment of rhinosinusitis seen in the light of uncertain pathogenesis and variable symptoms is under discussion and ranges from the administration of antibiotics, decongestants and anti-allergic agents to no treatment. In this randomized, prospective, double-blind and controlled study the effect of a 14-day treatment (1-2 sprays into each nostril t.d.) with either isotonic Ems Mineral Salts (EMS) solution (Siemens &; Co., Bad Ems, Germany) or xylometazoline solution (0.05%) was tested in children (n=66) aged 2-6 years. MAIN OUTCOMES: the degree of mucosal inflammation, nasal patency, general state of health, condition of the middle ear, auditory function as well as an assessment of complaints by the parents. With the exception of the hearing defects, all parameters showed a clear improvement in both treatment groups at the end of the observation period (p>0.001). The hearing defects showed only a trend towards improvement. At the end of the study no differences between the treatment groups could be determined. However, at the intermediate examination after the first 7 days of treatment more favourable results were seen in the group treated with EMS. No undesired medicinal effects were observed, although in 7 out of 34 cases the nasal spray was improperly used in the group treated with xylometazoline. The results of the study show that there is no difference in efficacy between an exclusive treatment by EMS solution in children aged 2-6 years and a treatment with xylometazoline, but with the distinction that with EMS the length of use was not restricted, there were not the potential side effects of nasal decongestants, and there was no contraindication in the newborn and infants.

RCT Entities:   Population Interventions Outcomes