Placencia 1993.
| Methods | Randomised, parallel‐group trial conducted in the context of existing community health care in a rural highland area of a developing country (Ecuador) 2 treatment arms: CBZ and PHB |
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| Participants | Participants with a history of at least 2 afebrile seizures and no previous AED treatment in the 4 weeks preceding the trial were eligible Number randomised: PHB = 97, CBZ = 95 67 male participants (35%) 133 participants with partial epilepsy (69%) Mean age (range): 29 (2‐68) years |
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| Interventions | Monotherapy with PHB or CBZ Minimum maintenance doses by age groups: 2‐5 years: PHB: 15 mg/d, CBZ: 150 mg/d; 6‐0 years: PHB: 30 mg/d, CBZ: 300 mg/d; 11‐15 years: PHB: 45 mg/d, CBZ: 500 mg/d; > 16 years: PHB: 60 mg/d, CBZ: 600 mg/d. Doses gradually increased Doses achieved not stated |
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| Outcomes | Proportion seizure‐free at 3‐, 6‐, and 12‐month follow‐ups Proportion seizure‐free, with more than 50% seizure reduction and no change in seizure frequency in 6‐ to 12‐month follow‐up period Incidence of adverse effects Trial duration: 12 months Range of follow‐up: 3.5‐23 months |
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| Notes | We received IPD for all outcomes used in this review from the trial author. Results in the published paper were given for 139 participants who completed 6 months' follow‐up, but we received IPD for all 192 participants randomised | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Participants randomised with random number list, no information provided on method of generating random list |
| Allocation concealment (selection bias) | High risk | Allocation concealed using sealed, opaque envelopes but method not used for all participants (information provided by trial author) |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information provided |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition rates reported, all randomised participants analysed from IPD provided (see footnote 2) |
| Selective reporting (reporting bias) | Low risk | All outcomes were reported or calculated with the IPD provided (see footnote 2) |
| Other bias | High risk | Inconsistencies between number and reasons of withdrawals between the data and the published paper, which could not be resolved by the author |