Combining mometasone furoate with montelukast markedly improves adenoid size and symptom scores in children with adenoid hypertrophy when compared to mometasone furoate monotherapy.
A systematic review and meta-analysis of 5 randomized clinical trials (RCTs) shows that the mometasone furoate (MF) + montelukast provides considerably greater relief from symptoms of adenoid hypertrophy (AH) in children than MF alone. However, the absence of reported safety data on montelukast’s known neuropsychiatric adverse effects remains a critical concern.
The review included 416 children (under 15 years of age) diagnosed with AH and treated with either MF monotherapy or MF-montelukast combination therapy. A greater reduction in adenoid size was observed with the combination therapy, with a significant decrease in the x-ray adenoids/nasopharynx ratio (mean difference -7.01). Total symptom scores dropped more with the combination therapy (mean difference -1.05), with notable improvements in rhinorrhea, mouth breathing, and endoscopic Grade 4 adenoid obstruction.
However, no meaningful differences were noted between the two groups for nasal obstruction, snoring, or endoscopic Grade 3 adenoid obstruction. Despite the promising symptom control, none of the studies systematically evaluated Montelukast's neuropsychiatric adverse effects, such as depression, behavioral changes, or suicidal ideation—risks that prompted a black box warning from the U.S. FDA.
While MF-montelukast combination shows superior efficacy in easing pediatric AH symptoms, the lack of safety evaluation highlights a major research gap. Experts emphasize the urgent need for well-designed, long-term studies that comprehensively assess both therapeutic benefits and potential risks.
International Journal of Pediatric Otorhinolaryngology
Comparative efficacy of intranasal mometasone furoate monotherapy or combination therapy with montelukast in pediatric adenoid hypertrophy: A systematic review and meta-analysis of randomized clinical trials
Rahaf H Almutairi et al.
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