Skip to main content
. 2015 Sep 3;2015(9):CD005399. doi: 10.1002/14651858.CD005399.pub3

Gigli 1988.

Methods RCT, cross‐over
Participants Total randomised: 26
 Age range of patients = 11.7 to 18.3
 Patients were divided into 2 groups according to seizure type and severity
 Group I: 6 patients had secondary generalised epilepsy and 9 patients had partial epilepsy with or without secondary generalisation
 Group II: 7 patients had secondary generalised epilepsy and 4 had partial epilepsy with or without secondary generalisation
 3 patients had slight mental retardation, 7 had moderate mental retardation, 15 patients had serious mental retardation
 Number of concomitant AEDs were not specified, however, patients were maintained on the drugs they were taking prior to the start of the study
 Baseline period = 3 months, each cross‐over leg = 3 months, washout period = 3 months
Interventions Flunarizine versus placebo
Outcomes Primary efficacy variable not stated. Alterations in seizure frequency were recorded together with behavioural observations
 In group I additional data were obtained, in patients with the ability to respond, on AEDs, EEG, attention test (Toulouse modified)
Notes Numbers used in data analysis = 26
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Does not say how patients were randomised
Allocation concealment (selection bias) Unclear risk Insufficient information
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Although it states that the trial was blinded, there is insufficient information regarding how blinding was achieved
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Although it states that the trial was blinded, there is insufficient information regarding how blinding was achieved
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No participants withdrew from the study
Selective reporting (reporting bias) Unclear risk Insufficient information
Other bias Unclear risk Insufficient information