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. 2017 Feb 27;2017(2):CD001911. doi: 10.1002/14651858.CD001911.pub3

Summary of findings 3.

Summary of findings ‐ Time to first seizure after randomisation

Carbamazepine compared with phenytoin for epilepsy
Patient or population: adults and children with new‐onset partial or generalised epilepsy
Settings: outpatients
Intervention: carbamazepine
Comparison: phenytoin
Outcomes Illustrative comparative risks* (95% CI) Relative effect (95% CI)1 No of Participants (studies) Quality of the evidence (GRADE) Comments
Assumed risk Corresponding risk
Phenytoin Carbamazepine
Time to first seizure ‐ stratified by epilepsy type
Range of follow‐up (all participants): 0 days to 4589 days
65 per 100 71 per 100 (63 to 77) HR 0.85
(0.70 to 1.04)
582
(4 studies)
⊕⊕⊝⊝
low2,3,4
HR > 1 indicates a clinical advantage for carbamazepine
Time to first seizure ‐ partial epilepsy
Range of follow‐up (all participants): 0 days to 4589 days
63 per 100 68 per 100 (60 to 77) HR 0.86
(0.68 to 1.08)
432
(4 studies)
⊕⊕⊝⊝
low2,3,4
HR > 1 indicates a clinical advantage for carbamazepine
Time to first seizure ‐ generalised epilepsy
Range of follow‐up (all participants): 2 days to 4070 days
69 per 100 75 per 100 (61 to 87) HR 0.84
(0.57 to 1.24)
150
(3 studies)
⊕⊕⊝⊝
low2,3,4
HR > 1 indicates a clinical advantage for carbamazepine
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The assumed risk is calculated as the event rate in the Phenytoin treatment group The corresponding risk in the carbamazepine treatment group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
The corresponding risk is calculated as the assumed risk x the relative risk (RR) of the intervention where RR = (1 ‐ exp(HR x ln(1 ‐ assumed risk)) ) / assumed risk CI: Confidence interval; HR: Hazard Ratio; exp: exponential
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.

1Pooled HR for all participants adjusted for seizure type.

2Risk of bias unclear for one element of all of the three studies included in the analysis. De Silva 1996 and Heller 1995 are open‐label and it is unclear whether the lack of masking impacted upon the results; and we do not know how allocation was concealed in Mattson 1985.

348 adult participants in Heller 1995 and Ogunrin 2005 may have had their seizure type wrongly classified as generalised onset; sensitivity analyses show misclassification is unlikely to have had an impact on results and conclusions.

4Ogunrin 2005 is a short study (12 weeks) and has a small sample size of 37 compared to the other three studies of duration 3 ‐ 10 years and sample sizes of around 100 to 300 participants (De Silva 1996; Heller 1995; Mattson 1985). Ogunrin 2005 is less precise with wide CIs, and there is evidence that the treatment effect in this study changes over time.