Reimold 1993.
Methods | RCT Open‐label Loss to follow‐up reported: yes |
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Participants | Any symptomatic AF or AFl. Type: paroxysmal 47%, persistent 53% (mean duration: 36 months). n = 100 Men: 64% Age (mean): 61 (SD 12) years Structural heart disease: 81%. LAD: 46 mm. LVEF: 59% |
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Interventions | Propafenone 675 mg/day vs sotalol 320 mg/day Method of AF cardioversion: both pharmacological and electrical, % NS Warfarin discretionary |
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Outcomes | At 12 months: Mortality Proarrhythmia Adverse effects AF recurrence |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation stratification scheme using a permuted blocks design generated before initiation of the trial. |
Allocation concealment (selection bias) | Low risk | Drug assignment provided in sealed envelopes by a research pharmacist. |
Blinding (performance bias and detection bias) All outcomes | High risk | Not described as a blind study. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Participants lost to follow‐up were not clearly detailed but seemed to be few. Analysis was intention‐to‐treat. |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes and expected outcomes were well reported. |
Other bias | Low risk | No other bias apparent. |