A Cochrane review [Abstract] 1 included 13 studies with a total of 3 401 children from high income countries. Included studies compared antibiotics with placebo or immediate antibiotic treatment with expectant observation (including delayed antibiotic prescribing) in children with acute otitis media (AOM). By 24 hours from the start of treatment, 60% of the children had recovered whether or not they had placebo or antibiotics. Pain was not reduced by antibiotics at 24 hours or at four to seven days but almost a third fewer had residual pain at 2 to 3 days (table T1). Two-thirds fewer were likely to have pain at 10 to 12 days compared with placebo (RR 0.33, 95% CI 0.17 to 0.66; NNTB 7). Antibiotics reduced the number of children with abnormal tympanometry findings at 2 to 4 weeks (RR 0.83, 95% CI 0.72 to 0.96; NNTB 11), slightly reduced the number of children with tympanic membrane perforations (RR 0.43, 95% CI 0.21 to 0.89; NNTB 33), and halved contralateral otitis episodes (RR 0.49, 95% CI 0.25 to 0.95; NNTB 11) compared with placebo. However, antibiotics neither reduced the number of children with abnormal tympanometry findings at 6 to 8 weeks (RR 0.89, 95% CI 0.70 to 1.13) and at 3 months (table T1) nor the number of children with late AOM recurrences (RR 0.94, 95% CI 0.79 to 1.11). Severe complications were rare and did not differ between antibiotics and placebo groups. Adverse events (such as vomiting, diarrhoea or rash) occurred more often in children taking antibiotics.
Individual patient data meta-analysis of a subset of included trials (6 studies, n=1 643) found antibiotics to be most beneficial in children aged less than 2 years with bilateral AOM (NNTB 4), and in children with both AOM and otorrhoea (NNTB 3).
| Outcome | Participants (studies) | Relative effect (95% CI) | Assumed risk - placebo | Corresponding risk - antibiotics (95% CI) | NNTB/NNTH (95% CI) |
|---|---|---|---|---|---|
| Pain at 24 hours | 1394(5 studies) | RR 0.89 (0.78 to 1.01) | 426 per 1000 | 379 per 1000 (332 to 431) | - |
| Pain at 2 to 3 days | 2320(7 studies) | RR 0.71 (0.58 to 0.88) | 159 per 1000 | 113 per 1000 (92 to 140) | NNTB 20 (14 to 50) |
| Pain at 4 to 7 days | 1264(7 studies) | RR 0.76 (0.50 to 1.14) | 248 per 1000 | 189 per 1000 (124 to 283) | - |
| Abnormal tympanometry - 3 months | 809(3 studies) | RR 0.94 (0.66 to 1.34) | 241 per 1000 | 227 per 1000 (159 to 323) | - |
| Vomiting, diarrhoea or rash | 2107(8 studies) | RR 1.38 (1.16 to 1.63) | 196 per 1000 | 270 per 1000 (227 to 319) | NNTH 14 (9 to 26) |
| NNTB = number needed to treat for an additional beneficial outcome; NNTH = number needed to treat for an additional harmful outcome | |||||
| For the review of immediate antibiotics against expectant observation, six trials (1556 children) reported outcome data that could be used for the review. Immediate antibiotics may result in a reduction of pain at two to three days (RR 0.53, 95% CI 0.35 to 0.79; NNTB 8) but not at 3 to 7 days (RR 0.75, 95% CI 0.50 to 1.12) and 11 to 14 days (RR 0.91, 95% CI 0.75 to 1.10) compared with expectant observation (observation with or without an antibiotic prescription). No serious complications occurred in either the antibiotic group or the expectant observation group. Additionally, no differences in the number of children with abnormal tympanometry findings at 4 weeks, tympanic membrane perforations and AOM recurrence were observed between groups. Immediate antibiotics increased the risk of vomiting, diarrhoea or rash as compared with expectant observation (RR 1.87, 95% CI 1.39 to 2.51; NNTH 10).
Clinical comment: The benefits of antibiotic treatment must be weighed against the possible harms: for every 14 children treated with antibiotics, one child experiences an adverse event (such as vomiting, diarrhoea or rash) that would not have occurred if antibiotics had been withheld. For most children with mild disease, an expectant observational approach seems justified. References
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