Zhang 2011.
Methods | Randomised, placebo‐controlled trial 2 treatment arms: 1 placebo, 1 topiramate Pre‐randomisation baseline period: 8 weeks Treatment period: 12 weeks |
|
Participants | A single‐centre study (Shanghai, China) 86 participants were randomised (documented drug‐resistant focal epilepsy) Age range: > 65 years old eligible Mean age: 73.4 years 57% males 8 patients on 1 AED, 37 on 2 AEDs, 41 on 3 AEDs Median baseline monthly seizure frequency: 17.3 for placebo group, 16.9 for topiramate group |
|
Interventions | 200 mg per day topiramate or placebo | |
Outcomes |
|
|
Notes | None No trial sponsorship information provided |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "were randomly assigned, according to a computer‐generated randomization schedule" |
Allocation concealment (selection bias) | Unclear risk | Comment: no information provided |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Comment: no information provided |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: no information provided |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: no information provided |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no dropouts (data available for all patients) |
Selective reporting (reporting bias) | Low risk | Comment: protocol unavailable, but appears all expected and prespecified outcomes are reported |
Other bias | Low risk | Comment: the study appears to be free of other sources of bias |
AED: antiepileptic drug