RANDOMIZED CONTROLLED TRIAL OF TREATMENT OF CHRONIC SUPPURATIVE OTITIS-MEDIA IN KENYAN SCHOOLCHILDREN

Background The outcomes of treatment of chronic suppurative otitis med ia (CSOM) are disappointing and uncertain, especially in developing co untries. Because CSOM is the commonest cause of hearing impairment in children in these countries, an effective method of management that ca n be implemented on a wide scale is needed. We report a randomised, co ntrolled trial of treatment of CSOM among children in Kenya; unaffecte d schoolchildren were taught to administer the interventions. Methods We enrolled 524 children with CSOM, aged 5-15 years, from 145 primary schools in Kiambu district of Kenya. The schools were randomly assigne d treatments in clusters of five in a ratio of two to dry mopping alon e (201 children), two to dry mopping with topical and systemic antibio tics and topical steroids (221 children), and one to no specific treat ment (102 children). Schools were matched on factors thought to be rel ated to their socioeconomic status. The primary outcome measures were resolution of otorrhoea and healing of tympanic membranes on otoscopy by 8, 12, and 16 weeks after induction. Absence of perforation was con firmed by tympanometry, and hearing levels were assessed by audiometry . 29 children were withdrawn from the trial because they took non-tria l antibiotics. There was no evidence of differences in timing of withd rawals between the groups. Findings By the 16-week follow-up visit, ot orrhoea had resolved in a weighted mean proportion of 51% (95% CI 42-5 9) of children who received dry mopping with antibiotics, compared wit h 22% (14-31) of those who received dry mopping alone and 22% (9-35) o f controls. Similar differences were recorded by the 8-week and 12-wee k visits. The weighted mean proportions of children with healing of th e tympanic membranes by 16 weeks were 15% (10-21) in the dry-mopping p lus antibiotics group, 13% (5-20) in the dry-mopping alone group, and 13% (3-23) in the control group. The proportion with resolution in the dry-mopping alone group did not differ significantly from that in the control group at any time. Hearing thresholds were significantly bett er for children with no otorrhoea at 16 weeks than for those who had o torrhoea, and were also significantly better for those whose ears had healed than for those with otorrhoea at all times. Interpretation Our finding that dry mopping plus topical and systemic antibiotics is supe rior to dry mopping alone contrasts with that of the only previous com munity-based trial in a developing country, though it accords with fin dings of most other trials in developed countries. The potential role of antibiotics needs further investigation. Further, similar trials ar e needed to identify the most cost-effective and appropriate treatment regimen for CSOM in children in developing countries.