Haye 1998.
Methods | Design: randomised, placebo‐controlled, parallel‐group trial | |
Participants |
Number assigned: 169 adults and elderly (macrolide n = 87, placebo n = 82) Age in years (mean (range)): macrolide: 40.2 (21 to 70), placebo: 43.2 (18 to 68) Setting: primary care |
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Interventions |
Indication: acute maxillary sinusitis Type of macrolide: azithromycin Route: per oral Dose per day: 500 mg Duration of treatment: 3 days Total treatment dose: 1500 mg |
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Outcomes |
Adverse events stated as an outcome in trial registration/protocol/paper: unclear Adverse events ascertainment: participant asked Adverse events: data reported Antimicrobial resistance: not reported Death: not reported |
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Funding sources | None stated. | |
Notes | Concomitant medication: unclear | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Block randomisation |
Allocation concealment (selection bias) | Unclear risk | Allocation not described. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Identical‐appearing placebo used. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Participants and clinicians blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropout and no participants discontinued treatment due to adverse events |
Selective reporting (reporting bias) | Low risk | Adverse events not stated clearly as an outcome. However, standardised ascertainment and adverse events reported. |
Other bias | Low risk | None were identified. |