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. 2016 Dec 15;2016(12):CD001904. doi: 10.1002/14651858.CD001904.pub3

Heller 1995

Methods Randomised, parallel group, open‐label study conducted in 2 centres in the UK
4 treatment arms: CBZ, sodium valproate, phenytoin, PB
Participants Adults with newly diagnosed epilepsy (2 or more untreated partial or generalised tonic‐clonic seizures in the 12 months preceding the study)
Number randomised: PB = 58, CBZ = 61
49 participants (41%) with partial epilepsy
55 (46%) male participants
Mean age (range): 32 (13 to 77) years
Range of follow‐up: 1 to 91 months
Interventions Monotherapy with PB or CBZ. Median daily dose achieved: PB = 105 mg/day; CBZ = 600 mg/day
Outcomes

  • Time to first seizure recurrence after start of therapy

  • Time to 12‐month remission from all seizures

  • Adverse effects and withdrawals due to adverse events
Notes We received IPD for all outcomes of this review.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation list generated using permuted blocks of size 8 or 16 with stratification for centre, seizure type and presence of neurological signs.
Allocation concealment (selection bias) Low risk Allocation concealed via 4 batches of concealed opaque envelopes.
Blinding of participants and personnel (performance bias) All outcomes High risk Unblinded, authors state masking of treatment would not be “practical” and would have “introduced bias due to a very large dropout rate.” Lack of blinding may have lead to more withdrawals of PB.
Blinding of outcome assessment (detection bias) All outcomes High risk Unblinded, authors state masking of treatment would not be “practical” and would have “introduced bias due to a very large dropout rate.” Lack of blinding may have lead to more withdrawals of PB which is likely to have influenced the overall results.
Incomplete outcome data (attrition bias) All outcomes Low risk Attrition rates reported, all randomised participants analyses from IPD provided²
Selective reporting (reporting bias) Low risk All outcomes reported or calculated with IPD provided²
Other bias Low risk No other bias detected