Summary of findings for the main comparison. Antibiotics versus placebo for acute otitis media in children.
| Antibiotics versus placebo for acute otitis media in children | ||||||
| Patient or population: children with acute otitis media Settings: primary care and secondary care Intervention: antibiotics versus placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Control | Antibiotics versus placebo | |||||
| Pain ‐ pain at 24 hours | Study population | RR 0.89 (0.78 to 1.01) | 1394 (5 studies)1 | ⊕⊕⊕⊕ high | ||
| 426 per 1000 | 379 per 1000 (332 to 431) | |||||
| Pain ‐ pain at 2 to 3 days | Study population | RR 0.70 (0.57 to 0.86) | 2320 (7 studies) | ⊕⊕⊕⊕ high | ||
| 159 per 1000 | 111 per 1000 (90 to 137) | |||||
| Pain ‐ pain at 4 to 7 days | Study population | RR 0.76 (0.63 to 0.91) | 1347 (7 studies)1 | ⊕⊕⊕⊕ high | ||
| 241 per 1000 | 183 per 1000 (152 to 220) | |||||
| Pain ‐ pain at 10 to 12 days | Study population | RR 0.33 (0.17 to 0.66) | 278 (1 study) | ⊕⊕⊕⊝ moderate2 | ||
| 216 per 1000 | 71 per 1000 (37 to 142) | |||||
| Abnormal tympanometry ‐ 2 to 4 weeks | Study population | RR 0.82 (0.74 to 0.90) | 2138 (7 studies) | ⊕⊕⊕⊕ high | ||
| 481 per 1000 | 395 per 1000 (356 to 433) | |||||
| Abnormal tympanometry ‐ 3 months | Study population | RR 0.97 (0.76 to 1.24) | 809 (3 studies) | ⊕⊕⊕⊕ high | ||
| 241 per 1000 | 234 per 1000 (183 to 299) | |||||
| Vomiting, diarrhoea or rash | Study population | RR 1.38 (1.19 to 1.59) | 2107 (8 studies) | ⊕⊕⊕⊕ high | ||
| 196 per 1000 | 270 per 1000 (233 to 311) | |||||
| *The basis for the assumed risk for ‘Study population’ was the average risk in the control groups (i.e. total number of participants with events divided by total number of participants included in the meta‐analysis). The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||
1The number of studies reported in the 'Summary of findings' table for the outcomes 'Pain at 24 hours' and 'Pain at 4 to 7 days' differ slightly from those reported in the Data Analysis Table 1 ‐ Antibiotics versus placebo (five versus six studies and seven versus eight studies, respectively). This is due to the van Buchem trial. This trial is included as one study in our review (and in the 'Summary of findings' table), but we included data from two different comparisons from this 2 x 2 factorial design trial in our analyses (van Buchem 1981a; van Buchem 1981b).
2We downgraded the evidence for pain at days 10 to 12 from high quality as this outcome was not specified a priori in this trial (secondary analysis).