Meta-analysis of study outcomes of RCTs; non-randomised study pooled estimates as comparison
| End points Subgroup analysis | #RCTs | #RCT participants | RCT pooled relative risk (95% CI)* | I2 | GRADE (RCTs) | #Non-RCTs | #Non-RCT participants | Non-RCT pooled estimate (95% CI) | I2 | GRADE (non-RCTs) |
| 1. 50% or greater reduction in seizures | 2 | 291 | 1.74 (1.24 to 2.3) | 0.0 | ⨁⨁◯◯ LOW | 17 | 970 | 48.5% (39.0 to 58.1) | 78.2 | ⨁⨁◯◯ LOW |
| Age group | ||||||||||
| Paediatric | 1 | 120 | 1.57 (0.94 to 2.62) | ⨁⨁◯◯ LOW | 13 | 370 | 57.1% (39.2 to 74.4) | 81.1 | ⨁⨁◯◯ LOW | |
| Adult | 2 | 7 | 24.6% (0.0 to 74.1) | ⨁⨁◯◯ LOW | ||||||
| Paediatric and adult | 1 | 171 | 1.88 (1.24 to 2.43) | ⨁⨁◯◯ LOW | 4 | 637 | 42.7% (38.7 to 46.8) | 0.0 | ⨁⨁◯◯ LOW | |
| Epilepsy type | ||||||||||
| Dravet syndrome | 1 | 120 | 1.57 (0.94 to 2.62) | ⨁⨁◯◯ LOW | 6 | 78 | 46.9% (16.1 to 78.7) | 79.1 | ⨁⨁◯◯ LOW | |
| Lennox-Gastaut syndrome | 1 | 171 | 1.88 (1.20 to 2.95) | ⨁⨁◯◯ LOW | 4 | 59 | 63.8% (32.1 to 91.1) | 67.0 | ⨁⨁◯◯ LOW | |
| Secondary generalised epilepsy | ||||||||||
| Doose syndrome | 3 | 15 | 29.4% (0.0 to 73.9) | ⨁⨁◯◯ LOW | ||||||
| Mixed epilepsy syndromes | 7 | 580 | 46.9% (38.3 to 55.6) | 64.0 | ⨁⨁◯◯ LOW | |||||
| Tuberous sclerosis complex | 1 | 18 | 22.2% (9.0 to 45.2) | ⨁⨁◯◯ LOW | ||||||
| Febrile infection-related epilpesy syndrome | 1 | 5 | 100.0% (56.6 to 100.0) | ⨁⨁◯◯ LOW | ||||||
| Malignant migrating partial seizures | 1 | 1 | 100.0% (20.7 to 100.0) | ⨁⨁◯◯ LOW | ||||||
| 2. Complete seizure freedom | 3 | 306 | 6.17 (1.50 to 25.32) | 0.0% | ⨁⨁◯◯ LOW | 14 | 944 | 8.5% (3.8 to 14.5) | 77.3 | ⨁⨁◯◯ LOW |
| Age group | ||||||||||
| Paediatric | 1 | 120 | 6.77 (0.36 to 128.38) | ⨁⨁◯◯ LOW | 10 | 362 | 15.2% (5.2 to 28.0) | 80.4 | ⨁⨁◯◯ LOW | |
| Adult | 1 | 15 | 4.57 (0.66 to 31.89) | ⨁⨁◯◯ LOW | ||||||
| Paediatric and adult | 1 | 171 | 10.87 (0.61 to 193.64) | ⨁⨁◯◯ LOW | 4 | 582 | 5.5% (2.5 to 9.5) | 59.6 | ⨁⨁◯◯ LOW | |
| Epilepsy type | ||||||||||
| Dravet syndrome | 1 | 120 | 6.77 (0.36 to 128.38) | ⨁⨁◯◯ LOW | 3 | 48 | 6.3% (0.0 to 41.3) | ⨁⨁◯◯ LOW | ||
| Lennox-Gastaut syndrome | 1 | 171 | 10.87 (0.61 to 193.64) | ⨁⨁◯◯ LOW | 2 | 83 | 6.4% (1.7 to 13.0) | ⨁⨁◯◯ LOW | ||
| Secondary generalised epilepsy | 1 | 15 | 4.57 (0.66 to 31.89)] | ⨁⨁◯◯ LOW | ||||||
| Febrile infection-related epilepsy syndrome | 1 | 8 | 25.0% (7.1 to 59.1) | ⨁⨁◯◯ LOW | ||||||
| Mixed epilepsy syndromes | 8 | 634 | 7.6% (2.7 to 14.1) | 75.6 | ⨁⨁◯◯ LOW | |||||
| Tuberous sclerosis complex | 1 | 18 | 5.6% (1.0 to 25.8) | ⨁⨁◯◯ LOW | ||||||
| 3. Quality of life | 2 | 274 | 1.73 (1.33 to 2.26) | 0.0 | ⨁⨁◯◯ LOW | 12 | 440 | 55.9% (40.5 to 70.6) | 93.9 | ⨁◯◯◯ VERY LOW |
| Age group | ||||||||||
| Paediatric | 1 | 118 | 1.79 (1.19 to 2.69) | ⨁⨁◯◯ LOW | 8 | 292 | 30.1% (16.7 to 44.9) | 88.9 | ⨁◯◯◯ VERY LOW | |
| Adult | 2 | 126 | 89.3% (75.5 to 98.3) | 70.8 | ⨁◯◯◯ VERY LOW | |||||
| Paediatric and adult | 1 | 156 | 1.69 (1.19 to 2.41) | ⨁⨁◯◯ LOW | 2 | 13 | 89.9% (60.5 to 100.0) | ⨁◯◯◯ VERY LOW | ||
| Epilepsy type * | ||||||||||
| Dravet syndrome | 1 | 118 | 1.79 (1.19 to 2.69) | ⨁⨁◯◯ LOW | 2 | 4 | 100.0% (84.3 to 100.0) | 0.0 | ⨁◯◯◯ VERY LOW | |
| Lennox-Gastaut syndrome | 1 | 156 | 1.69 (1.19 to 2.41) | ⨁⨁◯◯ LOW | 1 | 1 | 100.0% (48.7 to 100.0) | ⨁◯◯◯ VERY LOW | ||
| Mixed epilepsy syndromes | 10 | 433 | 44.4% (29.6 to 59.5) | 95.2 | ⨁◯◯◯ VERY LOW | |||||
| Tuberous sclerosis complex | 2 | 27 | 66.8% (47.1 to 84.2) | ⨁◯◯◯ VERY LOW | ||||||
| Malignant migrating partial seizures | 1 | 1 | 100.0% (21.3 to 100.0) | ⨁◯◯◯ VERY LOW | ||||||
*Significant results indicate a greater likelihood of the event in the intervention group relative to controls, and are highlighted bold.
GRADE, Grades of Recommendation, Assessment, Development and Evaluation; RCT, randomised controlled trial.