8. Valproate + risperidone compared to risperidone alone for acute mania in adults.
| Valproate + risperidone compared to risperidone alone for acute mania | ||||||
| Patient or population: Adults (aged 18 and over) with acute mania Setting: Inpatient Intervention: Valproate and risperidone Comparison: Risperidone alone | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with risperidone alone | Risk with valproate + risperidone | |||||
| Response rate (primary efficacy outcome) |
‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| Number of participants with any adverse event at 7 weeks (primary tolerability outcome) | Study population | OR 0.93 (0.27 to 3.16) | 48 (1 RCT) | ⊕⊝⊝⊝ VERY LOWa,b | The evidence is very uncertain about the relative effects of risperidone and valproate compared to risperidone alone on total number with any adverse event. | |
| 320 per 1000 | 304 per 1000 (113 to 598) | |||||
| Change in symptom severity (secondary efficacy outcome) | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| Dropout rate (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 studies at serious risk of bias. Moosavi 2014 at serious risk of bias, as performance bias at high risk of bias and all other biases assessed were at unclear risk of bias except other biases. 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; OR includes both 4 and 0.25.