Summary of findings 1. Add‐on stiripentol compared with add‐on placebo for drug‐resistant focal epilepsy.
| Add‐on stiripentol compared with add‐on placebo for drug‐resistant focal epilepsy | ||||||
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Patient or population: people with drug‐resistant focal epilepsy Settings: community Intervention: add‐on stiripentol Comparison: add‐on placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No. of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Placebo | Stiripentol | |||||
| ≥ 50% reduction in seizure frequency | 467 per 1000 | 705 per 1000 (378 to 1000) | RR 1.51 (0.81 to 2.82) | 32 (1) | ⊕⊕⊖⊖ Lowa |
— |
| Seizure freedom | 200 per 1000 | 236 per 1000 (62 to 886) | RR 1.18 (0.31 to 4.43) | 32 (1) | ⊕⊕⊖⊖ Lowa |
— |
| ≥ 1 adverse effects | 267 per 1000 | 707 per 1000 (288 to 1000) | RR 2.65 (1.08 to 6.47) | 32 (1) | ⊕⊕⊖⊖ Lowa | — |
| Neurological adverse effects | 200 per 1000 | 530 per 1000 (176 to 1000) | RR 2.65 (0.88 to 8.01) | 32 (1) | ⊕⊕⊖⊖ Lowa | — |
| Gastrointestinal adverse effects | 0 events occurred in the placebo group | 6 events occurred in the stiripentol group | Not estimable | 32 (1) | See comment | 0 participants receiving placebo developed gastrointestinal adverse effects. |
| Dropouts | 533 per 1000 | 352 per 1000 (160 to 784) | RR 0.66 (0.30 to 1.47) | 32 (1) | ⊕⊕⊖⊖ Lowa | — |
| Quality of life | See comment | See comment | See comment | See comment | See comment | The included study did not assess quality of life. |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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) and is calculated according to the following formula: corresponding intervention risk, per 1000 = 1000 × ACR × RR. CI: confidence interval; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of effect, but there is a possibility that it is substantially different. Low certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of effect, but there is a possibility that it is substantially different. Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect. | ||||||
aDowngraded one level for risk of bias due to high number of dropouts (high risk of attrition bias) and probable carry‐over effect, and one level for imprecision due to small sample size.