Leach 1997.
| Methods | Double‐blind, random order, cross‐over, placebo‐controlled study in the UK 12 weeks' treatment or placebo No baseline period, however all participants reported at least 4 seizures/month for 3 months and AED doses had remained unchanged for ≥ 3 months prior to study |
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| Participants | Single centre (Western Infirmary in Glasgow, UK) Adults with focal seizures refractory to 1 or 2 AEDs Total randomised: 27 participants; 23 analysed after withdrawals Aged 16‐67 years, mean 28.4 years 37% men prior to withdrawals |
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| Interventions | 3 sequential doses of gabapentin 400 mg, 600 mg and 800 mg TDS, each dose increase after 4 weeks) Placebo |
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| Outcomes | Seizure frequency Seizure freedom Adverse effects (scored, individual adverse effects not mentioned) Neuropsychological tests (psychomotor, memory, cognition, dysphoria, temper, fatigue, worry, tiredness) |
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| Notes | No baseline period, therefore not included in meta‐analysis | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details of randomisation provided |
| Allocation concealment (selection bias) | Unclear risk | No details provided |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Double‐blind and matched placebo but no further details provided. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 25% of participants excluded and not analysed on an ITT basis |
| 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 |