Effect of combination of montelukast and levocetirizine on otitis media with effusion: a prospective, placebo-controlled trial

Ertugay C. K., CİNGİ C., Yaz A., San T., Ulusoy S., Erdogmus N., ...More

ACTA OTO-LARYNGOLOGICA, vol.133, no.12, pp.1266-1272, 2013 (SCI-Expanded) identifier identifier identifier

  • Publication Type: Article / Article
  • Volume: 133 Issue: 12
  • Publication Date: 2013
  • Doi Number: 10.3109/00016489.2013.824113
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Page Numbers: pp.1266-1272
  • Keywords: Children, otoscopic sign score, tympanometric findings, EUSTACHIAN-TUBE OBSTRUCTION, PREVALENCE, CHALLENGE, CHILDREN
  • Eskisehir Osmangazi University Affiliated: Yes


Conclusion: This study demonstrated that treatment with montelukast in combination with levocetirizine may have a beneficial effect on clinical improvement of middle ear fluid in children with otitis media with effusion (OMB). Objective: To evaluate the effect of the combination of montelukast and levocetirizine on shortening the duration of effusion in successfully treated OME in children. Methods: This was a randomized, prospective, double-blind, placebo-controlled trial. The study group consisted of 120 children (age range 2-6 years), who were diagnosed with OME of at least 2 months duration. The children were randomized into one of four groups. The treatment packs containing montelukast 4 mg (tablet) and/or levocetirizine 2.5 mg/5 ml as the active drug or placebo were prepared, numbered, and distributed by the second author. Results: The amelioration of bilateral otoscopic sign scores in the combination therapy group was statistically significantly greater than in all the other groups (p < 0.05). Improvement in bilateral tympanometric findings in the combination therapy group and montelukast group was greater than in the other groups. However, this difference was not statistically significant (p > 0.05). When we compared the difference between otoscopic sign scores before and after treatment we found that it was statistically significant in every group (p > 0.05). However, the significant improvement in tympanometric findings occurred in all groups except the levocetirizine group (p > 0.05).