Howie 1972.
| Methods |
Randomised ‐ yes, method of randomisation not described Concealment of allocation ‐ adequate Double‐blind ‐ yes Intention‐to‐treat (ITT) ‐ unclear Loss to follow‐up ‐ not described Design ‐ parallel |
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| Participants |
N ‐ 280 children Age ‐ 2.5 years or younger Setting ‐ secondary care: general paediatric practice in Huntsville (USA) Inclusion criteria ‐ acute otitis media (AOM) as clinically diagnosed by the participating paediatricians Exclusion criteria ‐ if researchers felt that parents would not accept diagnostic aspiration, when condition of the patient required immediate antibiotic treatment Baseline characteristics ‐ not described |
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| Interventions |
Tx 1 ‐ erythromycin estolate 125 mg/5 mL ‐ triple sulphonamide suspension 0.5 g/5 mL; N = 80 Tx 2 ‐ ampicillin 250 mg/5 mL; N = 36 Tx 3 ‐ triple sulphonamide suspension 0.5 g/5 mL; N = 23 Tx 4 ‐ erythromycin estolate 125 mg/5 mL; N = 25 C 1 ‐ placebo ‐ equal parts acetaminophen (paracetamol) and chlorpheniramine maleate syrup; N = 33 C 2 ‐ placebo ‐ 4 parts Kaopectate and 1 part acetaminophen (paracetamol, Tylenol) plus food colouring; N = 83 Use of additional medication ‐ all children received decongestive nose drops for 7 days; analgesics (paracetamol, children < 1 year: 120 mg suppository, > 1 year: 240 mg suppository) was allowed |
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| Outcomes |
Primary outcomes ‐ (a) presence or absence of exudate while on medication; (b) bacteriological findings of the exudate when present; no patient‐relevant outcomes were described At baseline and before treatment was started, the middle‐ear exudate was aspirated. The decision whether to collect exudate on the first repeat visit was made with no knowledge of the drug regimen to which the patient had been assigned |
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| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method of randomisation not described |
| Allocation concealment (selection bias) | Low risk | Randomisation was performed by a collaborating pharmacist |
| Other bias | Unclear risk | ITT analysis ‐ unclear, baseline characteristics ‐ not described |
| Blinding of participants and personnel (performance bias) | Unclear risk | Identical taste and appearance to amoxicillin/clavulanate and placebo not described |
| Incomplete outcome data (attrition bias) | Unclear risk | Loss to follow‐up ‐ not described |