Murph 1993.
| Methods | Double‐blind, placebo‐controlled study. A table of random numbers was used to generate a randomised sequence AOM was defined as evidence on otoscopic assessment of an inflamed tympanic membrane and presence of middle ear effusion |
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| Participants | 77 AOM children, aged 7 months to 12 years old, recruited from the Pediatric Child Health Clinic of the University of Iowa Hospitals and Clinics 10/77 (7.7%) children could not be evaluated because of failure to return for follow‐up or because they withdrew from the study; 33 and 34 children in the once and 3 times daily groups, respectively, were left for the analysis |
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| Interventions | 10 days of amoxicillin 40 mg/kg/day 1 versus 3 times daily | |
| Outcomes | Primary outcome 1. Clinical cure rate at the end of therapy (days 7 to 14) ‐ Resolved AOM with or without MEE at days 10 to 14 Secondary outcome 1. Clinical cure rate during therapy (days 2 to 3), in terms of resolution of otalgia and resolution of fever 2. Clinical cure rate at post‐treatment (1 to 3 months) ‐ not reported 3. AOM complications after completion of therapy: Recurrent AOM ‐ not reported 4. Adverse reactions to medication ‐ There were no differences in the 2 groups for the total number of complaints of diarrhoea (P = 0.30), vomiting (P = 0.66) or stomach pain (P = 0.23). No details were described Other outcome 1. Compliance rate |
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| Notes | No pharmaceutical industry support 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) | Low risk | Quote: "A table of random numbers was used to assign children to one of two treatment groups" Comment: probably done |
| Allocation concealment (selection bias) | Unclear risk | The authors did not mention allocation concealment |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "double‐blind, placebo‐controlled study" Comment: probably done |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "10 children (14.9%) could not be evaluated (failed to return for follow‐up or withdrew from the study)" Comment: no information on whether those lost to follow‐up or who withdrew were in the once or thrice daily dose group |
| Selective reporting (reporting bias) | High risk | Comments: clinical cure rate at follow‐up (1 to 3 months) and AOM complications were not reported |
| Other bias | Low risk | |