Touboul 1988.
Study characteristics | ||
Methods | Parallel design (3 arms) Country: France Follow‐up period: 24 hours | |
Participants | 112 enrolled Randomly assigned: N = 89
Age, years
Gender, male, % (n/N)
Inclusion criteria
Exclusion criteria
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Interventions | Lidocaine: intravenous as a bolus injection of 100 mg, followed by an infusion of 2 mg/min Propafenone: bolus of 105 mg, followed by 300 mg orally every 8 hours Placebo: no details of its nature given Co‐intervention group: not reported |
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Outcomes | Suppression of complex arrhythmias, couples and ventricular tachycardia | |
Notes | Sample size calculation a priori: not reported
Sponsor: not reported Trial conduction dates: April 1985 to March 1986 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "... were randomly assigned to treatments" (page 1189) Insufficient information about the sequence generation process to permit judgement of ‘low risk’ or ‘high risk’ |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement of ‘low risk’ or ‘high risk’ |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "A double blind, placebo‐controlled trial" (page 1188) Insufficient information to permit judgement of ‘low risk’ or ‘high risk’ |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to permit judgement of ‘low risk’ or ‘high risk’ |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Withdrawals from study
Excluded from analysis: 20% (23/112)
Comment: It is unknown whether these exclusions were treated Reasons No myocardial infarction; defective Holter recording By comparison groups: not reported Withdrawals among remaining participants: 8% (7/89)
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Selective reporting (reporting bias) | Low risk | The study protocol is not available, but it is clear that published reports describe all expected outcomes, including those that were pre‐specified (convincing text of this nature may be uncommon) |
Other bias | High risk | Design bias and bias in data presentation (Porta 2008) |