Villani 1992.
Methods | RCT Open‐label Loss to follow‐up reported: yes |
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Participants | Symptomatic recent‐onset AF lasting > 1 hour, being at least the second episode. n = 76 Men: 49% Age (mean): 65 (range 37–85) years Structural heart disease: 86%. LAD: 38 mm. LVEF: NS |
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Interventions | Amiodarone 200 mg/day vs disopyramide 500 mg/day Method of AF cardioversion: pharmacological 74%, electrical 26% Warfarin discretionary |
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Outcomes | At 14 months: Mortality Adverse effects AF recurrence Symptomatic recurrence |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Reported that participants were randomised, but method employed not described. |
Allocation concealment (selection bias) | Unclear risk | Method of concealment not described. |
Blinding (performance bias and detection bias) All outcomes | High risk | Open‐label study. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Withdrawals and reasons for withdrawals well described. No participants lost to follow‐up. |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes of interest and all expected outcomes adequately reported. |
Other bias | Low risk | No other bias apparent. |