ORIGINAL ARTICLE   

Otorhinolaryngology 2021 March;71(1):7-11

DOI: 10.23736/S2724-6302.20.02318-8

Copyright © 2020 EDIZIONI MINERVA MEDICA

language: English

Efficacy of pidotimod for recurrent acute otitis treatment: observational study on 30 children

Valeria BOGGIO ¹ ✉, Federica PERADOTTO ², Pamela GIORDANO ², Matteo SENSINI ², Paolo TAVORMINA ²

¹ Department of Otorhinolaryngology, ASL Cuneo 1, Ospedale Maggiore Santissima Annunziata, Savigliano, Cuneo, Italy; ² Department of Pediatric Otorhinolaryngology, Regina Margherita Children’s Hospital, Città della Salute e della Scienza, Turin, Italy

BACKGROUND: Acute otitis media is one of the most frequent pathologies in children. Pidotimod is an immunomodulating molecule successfully used in the prevention of recurrent infections. The purpose of the study was to evaluate the effectiveness of preventive treatment with pidotimod in a cohort of 30 children with recurrent acute otitis media (3 episodes in 6 months or 4 episodes in 12 months).
METHODS: Thirty patients were enrolled and treated with pidotimod 400 mg/day for 60 days, combined with topical mometasone furoate for 15 days a month. Bimonthly visits were carried out monitoring the number of acute otitis media episodes, quality of life (OM-6 score) and the need for antibiotic therapy by filling it in a daily diary. Statistical analysis was performed using the Wilcoxon test and Student’s t-test.
RESULTS: The statistical comparison between the number of otitis at V0 and the cumulative data (V1+V2+V3) showed a statistically significant difference (P≤0.001) (4.4 episodes at V0; 1.2 at V1+V2+V3), similarly the OM-6 score was significantly reduced (3.7 to V0; 2.4 to V1; 2.1 to V2; 1.9 to V3 with P≤0.001), as the use of antibiotic therapy (8 cases at V1; 2 cases at V2, 1 case at V3).
CONCLUSIONS: Pidotimod significantly reduced the number of otitis episodes with less use of antibiotic therapy and improved quality of life; however, it should be considered that all patients were also prescribed topical steroid treatment, as well as the small number and the favorable seasonality. Therefore, further studies will be needed.

KEY WORDS: Therapy; Pidotimod; Otitis media