5. Valproate compared to oxcarbazepine for acute mania in adults.
| Valproate compared to oxcarbazepine for acute mania | ||||||
| Patient or population: Adults (aged 18 and over) with acute mania Setting: Inpatient Intervention: Valproate Comparison: Oxcarbazepine | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with oxcarbazepine | Risk with valproate | |||||
| Response rate (primary efficacy outcome) | ‐ | ‐ | ‐ | ‐ | ‐ | Not measured. |
| Number of participants with any adverse event at 3 weeks (primary tolerability outcome) | Study population | OR 4.67 (1.57 to 13.87) | 60 (1 RCT) | ⊕⊕⊝⊝ LOWa,b,d | Oxcarbazepine may cause fewer side effects than valproate, but the evidence is uncertain. | |
| 300 per 1000 | 667 per 1000 (402 to 856) | |||||
| Individual adverse events ‐ Nausea At 3 weeks |
Study population | OR 1.80 (0.39 to 8.32) |
60 (1 RCT) | ⊕⊝⊝⊝ VERY LOWa,b | The evidence is very uncertain about the relative effects of valproate compared to oxcarbazepine on sedation. | |
| 100 per 1000 | 167 per 1000 (42 to 480) |
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| Change in symptom severity at 3 weeks (secondary efficacy outcome) | The mean in symptom severity for oxcarbazepine at 3 weeks was 23.9. | MD 0.73 (‐ 2.17 to 3.63 ) | ‐ | 60 (1 RCT) | ⊕⊝⊝⊝ VERY LOWa,b | The evidence is very uncertain about the relative effects of valproate and oxcarbazepine on reducing manic symptoms at 3 weeks. |
| Dropout ‐ All‐cause (secondary acceptability outcome) |
‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| *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 one level as > 30% of trials at serious risk of bias. Kakkar 2009 was at serious risk of bias, as selection, detection, performance, reporting and other biases were all at unclear risk of bias. bEvidence downgraded by two levels for imprecision, due to single study and small study size. cEvidence downgraded by one level for imprecision, due to wide confidence interval ‐ Includes both no effect and OR of 4/0.25. dEvidence upgraded by one level due to large effect ‐ RR > 2.