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 |