Adenoidectomy versus chemoprophylaxis and placebo for recurrent acute otitis media in children aged under 2 years: randomised controlled trial. Effects of adenoidectomy: a controlled two-year follow-up.
To evaluate the efficacy of adenoidectomy compared with long term chemoprophylaxis and placebo in the prevention of recurrent acute otitis media in children aged between 10 months and 2 years.
                Randomised, double blind, controlled trial.
                Oulu University Hospital, a tertiary centre in Finland.
                180 children aged 10 months to 2 years with recurrent acute otitis media.
                Adenoidectomy, sulfafurazole (sulphisoxazole) 50 mg/kg body weight, given once a day for six months or placebo. Follow up lasted for two years, during which time all symptoms and episodes of acute otitis media were recorded.
                Intervention failure (two episodes in two months or three in six months or persistent effusion) during follow up, number of episodes of acute otitis media, number of visits to a doctor because of any infection, and antibiotic prescriptions Number of prescriptions, and days with symptoms of respiratory infection.
                Compared with placebo, interventions failed during both the first six months and the rest of the follow up period of 24 months similarly in the adenoidectomy and chemoprophylaxis groups (at six months the differences in risk were 10% (95% confidence interval -9% to 29%) and 18% (-2% to 38%), respectively). No significant differences were observed between the groups in the numbers of episodes of acute otitis media, visits to a doctor, antibiotic prescriptions, and days with symptoms of respiratory infection.
                Adenoidectomy, as the first surgical treatment of children aged 10 to 24 months with recurrent acute otitis media, is not effective in preventing further episodes. It cannot be recommended as the primary method of prophylaxis. A prospective controlled study was made on the effect of adenoidectomy performed on 105 children. For various reasons, mainly severe long-standing nasal obstruction, 29 children were omitted from the study. The remaining 76 children were randomly divided into two groups, one adenoidectomy, and one control. Both groups were slightly reduced in number due to drop out. Thus 36 adenoidectomized children were followed during one year and 35 children during two years. The corresponding numbers for the children in the control group were 37 and 33. The incidence of common cold, purulent and serous otitis media and moderate nasal obstruction was compared in the two groups. A considerable reduction in the incidence of these variables was observed in both groups. The occurrence of moderate nasal obstruction was reduced more among the operated than among the unoperated children. The difference was only slightly significant during the first and not at all during the second year. Regarding the other variables, the differences were not significant, implying that adenoidectomy seems to have no effect on the incidence of common cold, serous and purulent otitis media.
Current evidence regarding the effect of adenoidectomy on recurrent or chronic nasal symptoms or nasal obstruction alone is sparse, inconclusive and has a significant risk of bias.
High quality trials assessing the effectiveness of adenoidectomy in children with recurrent or chronic nasal symptoms should be initiated.