A Cochrane review [Abstract] 1 included 25 studies with a total of 3 663 subjects. Participants, interventions and outcome measures varied widely across studies. The age of children varied from 5 months to 16 years; 14 of the 23 trials (61%) included children below 2 years of age. Eleven of the 23 studies only randomised children with persistent otitis media with effusion (OME), present on at least 2 occasions 2 or 3 months apart, and in the remaining studies the duration of OME prior to randomisation varied widely. The proportion of children with bilateral OME also varied widely. Antibiotics were compared with placebo, no treatment or therapy of unproven effectiveness for OME. The primary outcome was complete resolution of OME at 2 to 3 months. There was moderate quality evidence that children treated with oral antibiotics are more likely to have complete resolution than those allocated to the control treatment but also more likely to experience diarrhoea, vomiting or skin rash, see table T1 below. Oral antibiotics were not associated with a decrease in the rate of ventilation tube insertion. None of the trials reported data on speech, language and cognitive development or quality of life.
| Outcome | Risk difference (95 % CI) | Number of participants (studies) | Number needed to treat (NNT) |
|---|---|---|---|
| Complete resolution of otitis media with effusion (OME) | |||
| at more than 6 months | RR 1.75(1.41 to 2.18) | 606(5) | 5 |
| at 2 to 4 weeks | RR 1.98(1.47 to 2.67) | 2091(14) | 5 |
| at 2 to 3 months | RR 2.00(1.58 to 2.53) | 484(6) | 5 |
| Adverse effects and insertion of ventilation tubes | |||
| Adverse effects | RR 2.15(1.29 to 3.60) | 742(5) | 20 |
| Insertion of ventilation tubes | RR 0.90(0.46 to 1.78) | 121(2) | - |
Even if clear and relevant benefits of antibiotics had been demonstrated, these must be balanced against potential adverse effects when making treatment decisions.
Date of latest search: 14 April 2016
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