Sinuclean Nebules treatment in children suffering from otitis media with effusion.
OBJECTIVE
Otitis media with effusion (OME) is an ear disorder defined by the presence of fluid in the middle ear without signs or symptoms of acute infection. The current randomized, double-blind, controlled study aimed to evaluate whether Sinuclean Nebules treatment, administered by nasal douche (Rinowash), could induce ear healing better than isotonic saline in children with OME.


METHODS
The study was randomized, double-blind, and controlled. Group A (30 children) was treated with Sinuclean Nebules 45 and Group B (31 children) was treated with isotonic saline; both compounds were administered by nasal nebulization with Rinowash nasal douche twice/day in the morning and in the evening for 10 days, followed by a one-week suspension, and after by a second course as the first. Tympanogram and audiometry were performed at baseline and after treatment.


RESULTS
Considering the global evaluation of the treatment: in Group A, 28 (93.3%) patients had complete resolution and 2 (6.7%) had partial resolution; in Group B, all patients had failure of treatment. There was a significant difference between groups (p < 0.0001).


CONCLUSIONS
The current randomized-controlled study demonstrated that Sinuclean Nebules was effective and in the treatment of children with OME.
UOSD Videondoscopia delle vas ASL-Napoli1-Centro, P.O. S.Gennaro, Naples, Italy.
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Varricchio
UOC ORL, A.O.R.N. Santobono-Pausilipon, Naples, Italy.
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De Lucia
UOC ORL, A.O.R.N. Santobono-Pausilipon, Naples, Italy.
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Varricchio
UOSD Chirurgia Protesica della Sorditá Infantile, A.O.R.N. Santobono-Pausilipon, Naples, Italy.
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Della Volpe
UOC ORL, A.O.R.N. Santobono-Pausilipon, Naples, Italy.
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Mansi
UOSD Chirurgia Protesica della Sorditá Infantile, A.O.R.N. Santobono-Pausilipon, Naples, Italy.
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Pastore
Department of Medicine, Istituto di Ricovero e Cura a Carattere Scientifico (I.R.C.C.S.) - Azienda Ospedaliera Universitaria San Martino - IST, Genoa, Italy. Electronic address: gio.cip@libero.it.
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Ciprandi
D000281:Administration, Intranasal; D001299:Audiometry; D002648:Child; D002675:Child, Preschool; D019662:Cucurbitaceae; D054728:Cucurbitacins / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006320:Hearing Tests; D006801:Humans; D008297:Male; D009330:Nebulizers and Vaporizers; D010034:Otitis Media with Effusion / Q000188:drug therapy* / Q000628:therapy; D010936:Plant Extracts / Q000008:administration & dosage / Q000627:therapeutic use*; D007507:Therapeutic Irrigation
D010936:Plant Extracts; D054728:Cucurbitacins
Children; Cucurbitacines; Otitis media with effusion