Effect of combination of montelukast and levocetirizine on otitis media with effusion: a prospective, placebo-controlled trial
Abstract
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 (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). 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).
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 120 participants or records.
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