Medical Journal of The Islamic Republic of Iran (MJIRI)

  Abstract

  Objective: To determine the effect of oral zinc sulfate supplementation given with

  coamoxiclav when compared with coamoxiclav alone for treatment of otitis media

  with effusion (OME). The efficacy of the drug was assessed 3 and 6 weeks after administration .

  Methods: In a double-blind, randomized trial 4 to 14 years old children with OME

  who referred to ear, nose and throat clinic, were randomly assigned into two groups :

  1) Zinc group: Zinc sulfate + Coamoxiclav + Pseudoephedrine + Nacl nasal drop

  2) Placebo group: Placebo + Coamoxiclav + Pseudoephedrine + Nacl nasal drop .

  Atotal of 52 children were studied consisting zinc group 29 and placebo group 23

  children. Children were examined by otoscopy and tympanometry at entry and after

  3 weeks of treatment. For children who had not been cured completely after 3 weeks ,

  treatment continued for more 3 weeks (total of 6 weeks ( .

  Results: At the end of the first course of treatment (3 weeks) 62.1% of children in

  the zinc group had clinical improvement compared with 43.5% of children in placebo

  group. Tympanometrically, 70.9% of children in zinc group had improvement

  compared with 65.5% for placebo group with no statistically significant difference .

  There was no significant difference between the two groups at the end of second

  course of treatment (6 weeks). But the response rate of zinc group was better than the

  placebo group (43.8% versus 12.5% clinically and 56.3% versus 40% tympanometricall). Zinc administration and cycles of treatment had no significant relationship .

  Conclusion: Although in this study oral zinc sulfate supplementation had not significant effect on treatment of OME, the response rate was better in zinc group compared to placebo group specially in longer administration . According to the findings, it seems more studies about oral zinc supplementation

  in the treatment of OME is needed .