OBJECTIVE: To study the effect of short-term ventilation tubes in children aged 1 to 2 yr with screening-detected, bilateral otitis media with effusion (OME) persisting for 4 to 6 mo, as compared with watchful waiting. DESIGN: Multi-center randomized controlled trial (N = 187) with two treatment arms: short-term ventilation tubes versus watchful waiting. Young children underwent auditory screening; those with persistent (4 to 6 mo) bilateral OME were recruited. RESULTS: The mean duration of effusion over 1-yr follow-up was 142 days (36%) in the ventilation tube (VT) group versus 277 days (70%) in the watchful waiting (WW) group. After 6 mo of follow-up, the pure-tone average in the VT group was 5.6 dB A better than that in the WW group. After 12 mo, most of the advantage in the VT group had disappeared. After the insertion of ventilation tubes, the children with poorer hearing levels at randomization improved more than the children with better hearing levels. The largest difference in hearing levels was found between the children in the VT group whose ventilation tubes remained in situ and the children in the WW group. In the VT children with recurrence of OME, the hearing levels again increased, but remained slightly lower than those in the infants with persistent OME in the WW group. CONCLUSIONS: Ventilation tubes have a beneficial effect on hearing in the short run (6 mo); this effect, however, largely disappears in the long run (12 mo). This is probably due to partial recurrent OME in the VT group and to partial spontaneous recovery in the WW group.
RCT Entities:
OBJECTIVE: To study the effect of short-term ventilation tubes in children aged 1 to 2 yr with screening-detected, bilateral otitis media with effusion (OME) persisting for 4 to 6 mo, as compared with watchful waiting. DESIGN: Multi-center randomized controlled trial (N = 187) with two treatment arms: short-term ventilation tubes versus watchful waiting. Young children underwent auditory screening; those with persistent (4 to 6 mo) bilateral OME were recruited. RESULTS: The mean duration of effusion over 1-yr follow-up was 142 days (36%) in the ventilation tube (VT) group versus 277 days (70%) in the watchful waiting (WW) group. After 6 mo of follow-up, the pure-tone average in the VT group was 5.6 dB A better than that in the WW group. After 12 mo, most of the advantage in the VT group had disappeared. After the insertion of ventilation tubes, the children with poorer hearing levels at randomization improved more than the children with better hearing levels. The largest difference in hearing levels was found between the children in the VT group whose ventilation tubes remained in situ and the children in the WW group. In the VTchildren with recurrence of OME, the hearing levels again increased, but remained slightly lower than those in the infants with persistent OME in the WW group. CONCLUSIONS: Ventilation tubes have a beneficial effect on hearing in the short run (6 mo); this effect, however, largely disappears in the long run (12 mo). This is probably due to partial recurrent OME in the VT group and to partial spontaneous recovery in the WW group.
Authors: Maroeska M Rovers; Gert Jan van der Wilt; Sjoukje van der Bij; Huub Straatman; Koen Ingels; Gerhard A Zielhuis Journal: Eur J Epidemiol Date: 2005 Impact factor: 8.082