Skip to main content
. 2018 Oct 24;2018(10):CD001415. doi: 10.1002/14651858.CD001415.pub3

Sivenius 1991.

Methods Randomised, double‐blind, placebo‐controlled, parallel‐group study in Finland
3 treatment arms: 1 placebo and 2 gabapentin
Prospective pre‐randomisation baseline period: 12 weeks
Treatment period: 12 weeks
Participants All adults
Total randomised: 45 participants; all with drug‐resistant focal epilepsy
18 placebo; 18 gabapentin 900 mg/day; 9 gabapentin 1200 mg/day
47% men
Aged 16‐59 years
Other AEDs: ≤ 2
Median baseline seizure frequency per 12‐week baseline period: 36 placebo; 26 gabapentin 900 mg/day; 23 gabapentin 1200 mg/day
Interventions Gabapentin 900 mg/day
Gabapentin 1200 mg/day
Placebo
All treatments and packaging were identical in appearance
Outcomes Median change in seizure frequency
% change in seizure frequency
Adverse effects
Notes 2 people in the gabapentin 900 mg group were excluded from analysis, both excluded 2 weeks' postrandomisation.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Allocated sequentially, sealed, numbered packages
Allocation concealment (selection bias) Low risk Random permuted blocks
Blinding (performance bias and detection bias) 
 All outcomes Low risk Tablets and packaging identical in appearance. Identical analysis of results
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No reasons reported for exclusion of 2 participants in gabapentin 900 mg group
Selective reporting (reporting bias) Low risk Quote: "... seizure frequency was recorded"
Unclear how, otherwise included all prespecified expected outcomes
Other bias High risk Trial sponsored by Parke Davis
Study appeared free of other sources of bias