title: Effect of combination of montelukast and levocetirizine on otitis media with effusion: a prospective, placebo-controlled trial.
abstract: CONCLUSIONS
  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 (OME).
  
  
  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).
authors: Departments of Otorhinolaryngology/Head and Neck Surgery.
authors: Cigdem Kalaycik
authors: CK
authors: Ertugay
authors: Cemal
authors: C
authors: Cingi
authors: Aytekin
authors: A
authors: Yaz
authors: Turhan
authors: T
authors: San
authors: Seckin
authors: S
authors: Ulusoy
authors: Nagehan
authors: N
authors: Erdogmus
authors: Omer Cagatay
authors: OC
authors: Ertugay
mesh_terms: D000085:Acetates / Q000008:administration & dosage*; D000284:Administration, Oral; D017332:Cetirizine / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D003521:Cyclopropanes; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005500:Follow-Up Studies; D039563:Histamine H1 Antagonists, Non-Sedating / Q000008:administration & dosage; D006801:Humans; D020024:Leukotriene Antagonists / Q000008:administration & dosage; D008297:Male; D010034:Otitis Media with Effusion / Q000175:diagnosis / Q000188:drug therapy*; D038781:Otoscopy; D011446:Prospective Studies; D011804:Quinolines / Q000008:administration & dosage*; D013440:Sulfides; D016896:Treatment Outcome
chemical_list: D000085:Acetates; D003521:Cyclopropanes; D039563:Histamine H1 Antagonists, Non-Sedating; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; C472067:levocetirizine; C093875:montelukast; D017332:Cetirizine