| Clobazam compared to Placebo in the management of drug‐resistant epilepsy |
| Patient or population: children or adults with drug‐resistant epilepsy
Setting: outpatients
Intervention: clobazam
Comparison: placebo |
| 50% reduction in seizure frequency
Follow up (range): 9 weeks to 12 weeks | In both studies, more than half of the patients experienced a 50% or greater reduction in seizure frequency when receiving clobazam. One study reported that a significantly larger proportion of patients received a 50% or greater reduction whilst receiving clobazam, compared to placebo, whilst the other specifically reported that no patients receiving placebo experienced this outcome. | ‐ | 47
(2 RCTs) | ⊕⊝⊝⊝
VERY LOW1, 2 | Clobazam may increase the likelihood of a 50% or greater reduction in seizure frequency but we are very uncertain. |
| Seizure Freedom
Follow up (range): 8 weeks to 12 weeks | 3 studies reported that multiple patients (27/175, collectively) achieved seizure freedom when receiving clobazam. Two studies specifically stated that no patients achieved seizure freedom when receiving placebo. One study did not report the incidence of seizure freedom amongst patients taking placebo. | ‐ | 175
(3 RCTs) | ⊕⊝⊝⊝
VERY LOW1, 2 | Clobazam may increase the likelihood of achieving seizure freedom but we are very uncertain. |
| Treatment withdrawal
Follow up (range): 8 weeks to 12 weeks | All 4 studies reported treatment withdrawal. 2 studies reported a higher occurrence of treatment withdrawal during the clobazam arm compared to the placebo arm (5/26 vs. 1/26 participants and 2/21 vs. 0/21 participants for each study, respectively), one reported a higher prevalence during placebo (11/129 vs. 10/129 participants). The fourth study did not specify which arm the patient was participating in when withdrawn. | ‐ | 197
(4 RCTs) | ⊕⊝⊝⊝
VERY LOW1, 2 | Clobazam may slightly increase the risk of treatment withdrawal but we are very uncertain. |
| Treatment withdrawal due to adverse events
Follow up: 12 weeks | Two studies reported incidence of treatment withdrawal due to AEs during the clobazam treatment arm (2/21 and 3/129). No patients withdrew due to AEs during the placebo arm. | ‐ | 150
(2 RCTs) | ⊕⊝⊝⊝
VERY LOW1, 2 | Clobazam may increase treatment withdrawal due to adverse events but we are very uncertain. |
| 50% reduction in generalised‐onset seizure frequency Not measured | This outcome was not reported by any of the included studies and could not be calculated from the available data. | ‐ | ‐ | ‐ | |
| 50% reduction in focal‐onset seizure frequency Not measured | This outcome was not reported by any of the included studies and could not be calculated from the available data. | ‐ | ‐ | ‐ | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval |
| GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect |
