Ikeoka 2007.
Methods | Design: randomised, placebo‐controlled, parallel‐group trial | |
Participants |
Number assigned: 90 adults and elderly (macrolide n = 42, placebo n = 40, excluded n = 8) Age in years (mean ± SD): macrolide: 62 ± 10, placebo: 59 ± 9 Setting: secondary care |
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Interventions |
Indication: stable coronary disease Type of macrolide: azithromycin Route: per oral Dose: 500 mg x 1 for 3 days in week 1, followed by 500 mg x 1 weekly for 12 weeks, then 500 mg x 1 for 3 days in week 14 Duration of treatment: 14 weeks Total treatment dose: 9000 mg |
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Outcomes |
Adverse events stated as an outcome in trial registration/protocol/paper: unclear Adverse events ascertainment: participants asked + clinical examination Adverse events: data reported Antimicrobial resistance: not reported Death: data reported |
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Funding sources | None stated. Authors acknowledge supplying company (Pfizer). | |
Notes | Concomitant medication: yes | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated, block randomisation |
Allocation concealment (selection bias) | Low risk | Central allocation |
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 | Low dropout, similar across groups |
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. |