The Journal of asthma : official journal of the Association for the Care of Asthma · 2026
Risk of neuropsychiatric adverse events with montelukast combined with inhaled corticosteroids (ICS) in the treatment of asthma in children and adolescents: a systematic review and meta-analysis.
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Yang Qingming, Guo Cheng, Yu Xiaoli, Liu Xinyuan, Xie Juan, Liu Kai
Аннотация
OBJECTIVE: To evaluate whether montelukast combined with inhaled corticosteroids (ICS) increases the risk of neuropsychiatric adverse events (NEs) compared with ICS monotherapy in pediatric and adolescent asthma patients.
METHODS: A systematic review and meta-analysis was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (PROSPERO registration: CRD420251070948). PubMed, Cochrane Library, Embase, Web of Science, and ClinicalTrials.gov were searched for studies comparing montelukast plus ICS with ICS alone. The primary outcome was the occurrence of NEs.
RESULTS: Six studies (three randomized controlled trials and three cohort studies) involving 559 pediatric patients were included. The incidence of NEs was 12.1% in the montelukast plus ICS group and 8.6% in the ICS-only group. The pooled risk ratio was 1.41 (95% CI: 0.89-2.22; p = 0.14), with an absolute risk difference of 3.5% (95% CI: -1.2% to 8.2%). This corresponded to approximately 35 additional events per 1000 children (95% CI: -12 to 82). Sensitivity analyses and risk-of-bias assessments supported the robustness of the findings. Subgroup analyses suggested possible increases in headache and sleep disturbances, although these differences were not statistically significant.
CONCLUSIONS: Montelukast combined with ICS may be associated with an increased risk of NEs in pediatric asthma patients; however, the current evidence remains uncertain. Clinicians should consider potential neuropsychiatric risks when prescribing combination therapy, particularly for susceptible children. Further prospective studies are warranted to confirm these findings.
METHODS: A systematic review and meta-analysis was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (PROSPERO registration: CRD420251070948). PubMed, Cochrane Library, Embase, Web of Science, and ClinicalTrials.gov were searched for studies comparing montelukast plus ICS with ICS alone. The primary outcome was the occurrence of NEs.
RESULTS: Six studies (three randomized controlled trials and three cohort studies) involving 559 pediatric patients were included. The incidence of NEs was 12.1% in the montelukast plus ICS group and 8.6% in the ICS-only group. The pooled risk ratio was 1.41 (95% CI: 0.89-2.22; p = 0.14), with an absolute risk difference of 3.5% (95% CI: -1.2% to 8.2%). This corresponded to approximately 35 additional events per 1000 children (95% CI: -12 to 82). Sensitivity analyses and risk-of-bias assessments supported the robustness of the findings. Subgroup analyses suggested possible increases in headache and sleep disturbances, although these differences were not statistically significant.
CONCLUSIONS: Montelukast combined with ICS may be associated with an increased risk of NEs in pediatric asthma patients; however, the current evidence remains uncertain. Clinicians should consider potential neuropsychiatric risks when prescribing combination therapy, particularly for susceptible children. Further prospective studies are warranted to confirm these findings.