UK Gabapentin 1990.
| Methods | Randomised, double‐blind, placebo‐controlled, parallel‐group study (cross‐continent) Prospective pre‐randomisation baseline period: 12 weeks Treatment period: 14 weeks |
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| Participants | All adults Cross‐continent study Total randomised: 127; all with drug‐resistant focal epilepsy Placebo: 66 participants; gabapentin 1200 mg/day: 61 participants 39% men Age range: 14‐73 years Other AEDs: ≤ 2 Median baseline seizure frequency/28 days: gabapentin 13 (range 3 to 368); placebo 13 (range 1 to 216) |
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| Interventions | Gabapentin 1200 mg/day Placebo All treatments and packaging identical in appearance |
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| Outcomes | Proportion with a 50% reduction in seizure frequency Response ratio Adverse effects |
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| Notes | 14 participants excluded from published analyses: 5 from the placebo group; 9 from the gabapentin 1200 mg/day group Additional unpublished data allowed the inclusion of participants excluded despite completing the treatment phase with adequate seizure data. The following participants contribute to the best‐case and worst‐case sensitivity analyses in this review. Placebo: 2; gabapentin 1200 mg: 8 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Used random permuted blocks to generate sequence for randomisation |
| Allocation concealment (selection bias) | Low risk | Allocated sequentially, sealed, numbered packages |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Used tablets and packaging identical in appearance |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Attrition rate reported, 14 participants who withdrew were not included in published analyses. Report withdrawals and gave reasons for withdrawal. |
| Selective reporting (reporting bias) | Low risk | Included all prespecified, expected outcomes |
| Other bias | High risk | Trial sponsored by Parke Davis Study appeared free of other sources of bias |