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. 2015 Aug 21;2015(8):CD008553. doi: 10.1002/14651858.CD008553.pub2

Touboul 1988.

Study characteristics
Methods Parallel design (3 arms)
Country: France
Follow‐up period: 24 hours
Participants 112 enrolled
Randomly assigned: N = 89
  • Propafenone: 36

  • Lidocaine: 28

  • Placebo: 25


Age, years
  • Lidocaine: 57

  • Propafenone: 51

  • Placebo: 56


Gender, male, % (n/N)
  • Overall: 90.62 (90/112)

  • Lidocaine: 82.2 (25/28)

  • Propafenone: 92 (33/36)

  • Placebo: 92 (23/25)


Inclusion criteria
  • Chest pain < 24 hours before hospitalisation

  • Electrocardiographic changes (modifications of ST‐T segment whether or not associated with abnormal Q waves)

  • Serum enzyme criteria (elevation of creatine phosphokinase and transaminase serum glutamic oxaloacetic transaminase)


Exclusion criteria
  • Patients > 75 years of age

  • Various severe diseases (neurological, renal, hepatic, bronchopulmonary)

  • Valvular or myocardial cardiopathy, current antiarrhythmic treatment

  • Complications on entry, including heart failure (Killip's classes 3 and 4)

  • Hypotension (< 90 mmHg)

  • Bradycardia (< 50 beats/min), second‐ or third‐degree atrioventricular block

  • Complete bundle branch block

  • Sustained ventricular tachycardia

  • Ventricular fibrillation

  • Hypokalemia

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
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
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)
  • Gastrointestinal Intolerance (placebo; n = 1)

  • Marked bradycardia (placebo; n = 1)

  • Right bundle branch block (placebo; n = 1)

  • Severe heart failure (lidocaine; n = 2)

  • Neuropsychiatric disturbance (lidocaine; n = 1)

  • Bilateral bundle branch block (propafenone; n = 1)

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)