Gupta 1997.
Methods | Design: randomised, placebo‐controlled, 3‐armed trial | |
Participants |
Number assigned: 60 adults and elderly (macrolide (3‐day course) n = 28, macrolide (6‐day course) n = 12, placebo n = 20) Age in years (mean ± SD): macrolide (both arms): 58 ± 7, placebo: 60 ± 9 Setting: secondary care |
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Interventions |
Indication: male survivors of myocardial infarction Type of macrolide: azithromycin Route: per oral Dose per day: 500 mg Duration of treatment: arm 1: 3 days, arm 2: 6 days Total treatment dose: arm 1: 1500 mg, arm 2: 3000 mg |
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Outcomes |
Adverse events stated as an outcome in trial registration/protocol/paper: yes Adverse events ascertainment: unclear Adverse events: data reported (note: do not report on "common adverse events") Antimicrobial resistance: not reported Death: data reported |
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Funding sources | Supported by the British Heart Foundation. Authors acknowledge supplying company (Pfizer Ltd). | |
Notes | Concomitant medication: yes | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Sequence generation not described. |
Allocation concealment (selection bias) | Unclear risk | Allocation not described. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Placebo and azithromycin supplied by the same company. However, unclear if placebo matched the single course of azithromycin (3 days) or the 2 courses (2 x 3 days). |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Only report on objective outcomes (death/myocardial infarction) not influenced by blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts. |
Selective reporting (reporting bias) | High risk | Adverse events stated as an outcome. Unclear ascertainment. Report on outcomes for the 2 treatment regimens as 1 group and do not report on common adverse events. |
Other bias | Low risk | None were identified. |