Principi 1986.
| Methods | Randomised controlled study conducted in the outpatient ward of the Pediatric Department IV of the University of Milan between October 1984 and 1985 AOM was defined on clinical data (fever or otalgia or both), otoscopic finding of ear drum, and presence of ear effusion shown by tympanograms. Children with spontaneously perforated ear drums were also included only if the ear had been draining for no longer than 12 hours |
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| Participants | 55 AOM children in each treatment group (total 110), aged 6 months to 12 years | |
| Interventions | 10 days of amoxicillin 60 mg/kg/day 2 or 3 times daily | |
| Outcomes | Primary outcome
1. Clinical cure rate at the end of therapy ‐ Clinical cure (normalisation of clinical or relief of acute signs and symptoms of AOM) assessed at day 15 Secondary outcome 1. Clinical cure rate during therapy (days 2 to 3), in terms of resolution of otalgia and resolution of fever: not reported 2. Clinical cure rate at post‐treatment (1 to 3 months) ‐ Clinical cure at days 30, 60 and 90 3. AOM complications after completion of therapy: recurrent AOM ‐ Recurrent at days 30, 60 and 90 4. Adverse reactions to medication ‐ Diarrhoea which necessitated discontinuation of treatment ‐ Generalised rash ‐ Urticaria 5.Other outcomes ‐ Compliance: mentioned to be assessed but not reported |
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| Notes | Supported in part by a Farmitalia‐Carlo Erba SpA Milano grant Intention‐to‐treat principle analysis was not mentioned |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "randomly assigned" Comment: method of randomisation was not described |
| Allocation concealment (selection bias) | Unclear risk | Comment: allocation concealment methods were not mentioned |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Comment: no information |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: low rate of loss to follow‐up |
| Selective reporting (reporting bias) | Low risk | Comment: all important outcomes were reported |
| Other bias | Unclear risk | Comment: no report of compliance rate |