Summary of findings for the main comparison. Flunarizine versus placebo for drug‐resistant epilepsy.
| Flunarizine versus placebo for drug‐resistant epilepsy | ||||||
| Patient or population: patients with drug‐resistant epilepsy Settings: Out‐patient Intervention: Flunarizine versus placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Control | Flunarizine versus placebo | |||||
| 50% or greater reduction in seizure frequency Number of seizures | 13 per 100 | 20 per 100 (8 to 51) | RR 1.53 (0.59 to 3.96) | 93 (1 study) | ⊕⊕⊕⊕ high | 1 Study did not find a significant difference in seizure reduction |
| Treatment withdrawal Number of withdrawals | 2 per 100 | 12 per 100 (3 to 49) | RR 7.11 (1.73 to 29.30) | 247 (4 studies) | ⊕⊕⊕⊝ moderate1 | 1 study found a significant difference in treatment withdrawal. 3 did not find a significant difference in treatment withdrawal. |
| Adverse effects ‐ Blurred vision No of patients with blurred vision | 6 per 100 | 26 per 100 (5 to 100) | RR 4.09 (0.85 to 19.73) | 93 (1 study) | ⊕⊕⊕⊕ high | 1 study did not find a significant difference in blurred vision. |
| Adverse effects ‐ Dizziness No of patients with dizziness | 19 per 100 | 35 per 100 (14 to 88) | RR 1.82 (0.72 to 4.61) | 93 (1 study) | ⊕⊕⊕⊕ high | 1 study did not find a significant difference in dizziness. |
| Adverse effects ‐ Fatigue No of patients with fatigue | 17 per 100 | 28 per 100 (10 to 79) | RR 1.66 (0.59 to 4.64) | 93 (1 study) | ⊕⊕⊕⊕ high | 1 study did not find a significant difference in fatigue |
| Adverse effects ‐ Irritability No of patients with irritability | 6 per 100 | 20 per 100 (4 to 100) | RR 3.07 (0.6 to 15.68) | 93 (1 study) | ⊕⊕⊕⊕ high | 1 study did not find a significant difference in Irritablity. |
| Adverse effects ‐ Vomiting No of patients with vomiting | 4 per 100 | 17 per 100 (2 to 100) | RR 4.09 (0.57 to 29.16) | 93 (1 study) | ⊕⊕⊕⊕ high | 1 study did not find a significant difference in vomiting. |
| *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% 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; RR: Risk ratio. | ||||||
| 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. | ||||||
1 3 studies did not report outcomes adequately and intention‐to‐treat analysis not employed adequately