7. Valproate compared to quetiapine for acute mania in children and adolescents.
| Valproate compared to quetiapine for acute mania | ||||||
| Patient or population: Children and adolescents with acute mania Setting: Inpatient Intervention: Valproate Comparison: Quetiapine | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with quetiapine | Risk with valproate | |||||
| Response rate (primary efficacy outcome) | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| Number of participants with any adverse event (primary tolerability outcome) | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| Individual adverse events ‐ Increased appetite At 4 weeks |
Study population | OR 1.57 (0.24 to 10.30) | 50 (1 RCT) | ⊕⊕⊝⊝ LOWa,c | The evidence is uncertain about the relative effects of valproate and quetiapine on increasing appetite. | |
| 80 per 1000 | 120 per 1000 (20 to 472) | |||||
| Individual adverse events ‐ Sedation or lethargy At 4 weeks |
Study population | OR 0.38 (0.12 to 1.18) | 50 (1 RCT) | ⊕⊕⊝⊝ LOWa,c | The evidence is uncertain about the relative effects of valproate and quetiapine on sedation. | |
| 600 per 1000 | 363 per 1000 (153 to 639) | |||||
| Change in symptom severity at 4 weeks (secondary efficacy outcome) |
The mean change in symptom severity for quetiapine at 4 weeks was ‐23. | MD 4.00 (‐ 2.10 to 10.10) | ‐ | 50 (1 RCT) | ⊕⊕⊝⊝ LOWa | The evidence is uncertain about the relative effects of valproate and quetiapine on decreasing manic symptoms. |
| Dropout rate ‐ All‐cause at 4 weeks (secondary acceptability outcome) | Study population | OR 1.00 (0.27 to 3.66) | 50 (1 RCT) | ⊕⊕⊝⊝ LOWa | The evidence is uncertain about the relative effects of valproate and quetiapine on dropout rates. | |
| 240 per 1000 | 240 per 1000 (79 to 536) | |||||
| *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; OR: Odds ratio; RCT: randomised controlled trial | ||||||
| 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 | ||||||
aEvidence downgraded by two levels for imprecision, due to single study and small study size. bEvidence upgraded by one level for large effect, RR < 0.5. cEvidence downgraded by one level for imprecision, due to wide confidence interval; OR includes both 4 and 0.25.