Callaghan 1982.
Methods | Randomised, parallel open study designed to compare ESM with VPS treatment. Followed up for 18 months to 4 years, mean 3 years. | |
Participants | 28 drug‐naive participants (13 male, 15 female), aged between 4 to 15 years. All participants with typical AS. | |
Interventions | Monotherapy with ESM or VPS. | |
Outcomes | Complete or partial (50% to 90%) remission of seizures confirmed by 6 hours telemetry and observation by parents and teachers. | |
Notes | The report acknowledged support from Warner‐Lambert Pharmaceuticals, manufacturers of ethosuximide. One patient in the ethosuximide group was subsequently treated with valproate, but failed to respond to either single drug and did not improve when both drugs were used in combination. The outcomes of this patient on combined treatment were therefore counted twice ("no remission"). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information to permit judgement. |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement. |
Blinding (performance bias and detection bias) All outcomes | High risk | No blinding. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data. |
Selective reporting (reporting bias) | Low risk | The study protocol is not available but it is clear that the published reports include all expected outcomes. |