Starreveld 1989.
Methods | Double‐blind placebo‐controlled cross‐over trial. Baseline = 8 weeks. No titration period. Treatment phase 1 and 2 = 16 weeks. | |
Participants | Single Canadian centre. Total randomised 34; all with drug‐resistant partial epilepsy; numbers of randomised participants into individual treatment sequence groups not available. 38% male. Age range within 15 to 60 years. Other AEDs: most participants on 1 to 2. Baseline seizure frequency: data not available. | |
Interventions | 1) Flunarizine 15 mg per day. 2) Placebo. |
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Outcomes | Following outcomes were reported: 1) Total seizure frequency on each treatment phase. 2) 25%, 25 to 49%, and 50% or greater reduction in seizure frequency. 3) Treatment withdrawal. 4) Adverse effects. 5) Serum concentration of flunarizine and concomitant AEDs. |
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Notes | We were not able to acquire the data from the first treatment phase for meta‐analyses for any of the outcomes. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote ‐ "randomised" Comment ‐ No details of method of randomisation therefore uncertain risk of bias |
Allocation concealment (selection bias) | Unclear risk | Quote ‐ "randomised" Comment ‐ No details of method of allocation concealment therefore uncertain risk of bias |
Blinding (performance bias and detection bias) Seizure Reduction | Unclear risk | Quote ‐ "Blinded" Comment ‐ No details of method of blinding therefore uncertain risk of bias |
Blinding of participants and personnel (performance bias) Seizure Reduction | Unclear risk | Quote ‐ "Blinded" Comment ‐ No details of method of blinding therefore uncertain risk of bias |
Blinding of outcome assessment (detection bias) Seizure Reduction | Unclear risk | Quote ‐ "Blinded" Comment ‐ No details of method of blinding therefore uncertain risk of bias |
Incomplete outcome data (attrition bias) Seizure Reduction | High risk | Comment ‐ Missing data was mentioned but no intention to treat analysis performed |
Selective reporting (reporting bias) | High risk | Comment‐ Did not report primary and secondary outcomes for first phase of the study |
Other bias | Low risk | None identified |
AED: antiepileptic drug BW: body weight