title: A nasal spray with alpha-haemolytic streptococci as long term prophylaxis against recurrent otitis media.
abstract: Previous studies have shown that children with recurrent acute otitis media (rAOM) have significantly lower quantities of alpha-haemolytic streptococci (AHS) in the nasopharynx than healthy children. Furthermore children with otitis media have AHS with lower inhibitory activity in vitro on Streptococcus pneumoniae and non-typable Haemophilus influenzae compared with healthy children. A randomised, placebo controlled and double blind clinical study among children with rAOM was designed to determine whether or not a nasal spray, containing AHS with very good inhibitory activity on the three most common OM pathogens, could be an alternative to tympanostomy tube insertion. Forty three children under 4 years of age were included in the study. The children sprayed once daily for 4 months and were monitored for 6 months. Sixteen children in the active group and 20 children in the placebo group were evaluated. The result showed no significant differences regarding the number of episodes of AOM, with seven recurrences in the active group and eight in the placebo group. No significant changes of the nasopharyngeal flora could be detected during the study period regarding the OM pathogens. Nasal spray according to the performed schedule is not yet an alternative to tympanostomy tubes in children with rAOM. The possibility of increasing the efficacy of this ecological treatment, by using pre-treatment antibiotics, more adhesive bacteria and alternative treatment schedules is discussed.
authors.affiliation: Department of Clinical Sciences, Otorhinolaryngology, Umeå University, S-971 80, Luleå, Sweden. krister.tano@nll.se
authors.forename: Krister
authors.initials: K
authors.lastname: Tano
authors.forename: Eva
authors.initials: E
authors.lastname: Grahn Håkansson
authors.forename: Stig E
authors.initials: SE
authors.lastname: Holm
authors.forename: Sten
authors.initials: S
authors.lastname: Hellström
mesh_terms: D000208:Acute Disease; D000281:Administration, Intranasal; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007223:Infant; D008297:Male; D009305:Nasopharynx / Q000382:microbiology*; D010033:Otitis Media / Q000453:epidemiology / Q000517:prevention & control*; D011336:Probability; D012016:Reference Values; D018570:Risk Assessment; D055502:Secondary Prevention; D018709:Statistics, Nonparametric; D013291:Streptococcus; D013548:Sweden / Q000453:epidemiology; D016896:Treatment Outcome