Abstract

Background: Recurrent acute otitis media (AOM) remains a common issue among pediatric populations, often leading to hearing impairment and developmental delays. Conventional treatments include antibiotics, which may not always be effective and contribute to antibiotic resistance. Immunotherapy, particularly with allergen immunotherapy (AIT) or other immune-modulating treatments, has been explored for its potential in reducing the frequency and severity of recurrent AOM.

Objective: This clinical trial investigates the efficacy of immunotherapy in pediatric patients with recurrent AOM to determine whether immune modulation can reduce the recurrence rate, severity, and reliance on antibiotics.

Methods: A randomized, double-blind, placebo-controlled trial was conducted involving 120 pediatric patients aged 2-8 years with a history of recurrent AOM. Participants were divided into two groups: one received immunotherapy (AIT or immune-modulating agents) and the other received placebo. Primary outcomes included the frequency of AOM episodes, duration, severity of symptoms, and need for antibiotics. Secondary outcomes focused on quality of life, immunological markers, and safety. Results: The immunotherapy group showed a significant reduction in the frequency of AOM episodes, reduced severity of symptoms, and lower antibiotic consumption compared to the placebo group. Immunological analysis revealed improved immune response, with a reduction in inflammatory markers associated with AOM. Conclusion: Immunotherapy shows promise as an effective treatment for reducing the recurrence of AOM in pediatric patients, presenting a potential alternative or adjunct to conventional antibiotic therapy. Further studies are needed to establish long-term safety and efficacy.