1 Clinical Research Development Center of Children Hospital, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.

2 Herbal & Traditional Medicines Research Center, Kerman University of Medical Sciences, Kerman, Iran.


Acute otitis media (AOM) is very common in children. In spite of spontaneously relief, some cases suffer from the recurrence and other complications occurring after AOM. Animal studies have proved that persistence of leukotrienes in the middle ear may play a role in the development of AOM. Based on this statement, treatment with leukotriene modifiers may be effective in the treatment of OM. The aim of this study was to examine the effect of adjunction of montelukast to antibacterial agents in treatment of AOM.
Materials and Methods
One hundred patients aged 2-6 years were randomly divided into two groups. One of the groups (53%) were treated with "amoxicillin alone", 80-90 mg/kg amoxicillin for 10 days, and the other group (47%), received "amoxicillin and montelukast" 5 mg per day orally for 10 days. Patients were evaluated for resolution and complications of AOM at 2 post enrollment visits (days 2-4 and 10-14).
The patient followed-up for one month and results showed that, treatment with montelukast had beneficial effects on resolution of AOM. In monotherapy (amoxicillin alone) group, 66% of patients and in the montelukast (amoxicillin and montelukast) group, 85.1% were treated.
In this study, the montelukast receiving group showed a better response to treatment. Based on this and previous studies, it is recommended to consider the role of inflammatory mediators in AOM. Prescribing montelukast and other leukotriene receptor antagonists may have benefits for the patients.