2. Valproate compared to endoxifen for acute mania in adults.
| Valproate compared to endoxifen for acute mania | ||||||
| Patient or population: Adults (aged 18 and over) with acute mania Setting: Inpatient Intervention: Valproate Comparison: Endoxifen | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with endoxifen | Risk with valproate | |||||
| Response rate at 3 weeks (primary efficacy outcome) | Study population | OR 2.19 (0.83 to 5.78) | 84 (1 RCT) | ⊕⊝⊝⊝ VERY LOW a,b,c | The evidence is very uncertain about the relative effects of valproate and endoxifen on response rates. | |
| 545 per 1000 | 724 per 1000 (499 to 874) | |||||
| Number of participants with any adverse event at 3 weeks (primary tolerability outcome) | Study population | OR 1.88 (0.73 to 4.86) | 84 (1 RCT) | ⊕⊝⊝⊝ VERY LOWa,b,c | The evidence is very uncertain about the relative effects of valproate and endoxifen on causing adverse effects. | |
| 273 per 1000 | 413 per 1000 (215 to 646) | |||||
| Individual adverse events ‐ Nausea At 3 weeks |
Study population | OR 5.52 (1 to 30.5) |
84 (1 RCT) | ⊕⊕⊝⊝ LOWa,b,c,d | Valproate may cause more people to have less nausea than endoxifen, but the evidence is uncertain. | |
| 36 per 1000 | 172 per 1000 (36 to 535) |
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| Change in symptom severity (secondary efficacy outcome) |
‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| Dropout rate – 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 two levels for imprecision, due to single study and small study size. bEvidence downgraded by one level as > 30% of trials at serious risk of bias. Ahmad 2016 at serious risk of bias, at high risk of other bias and at unclear risk of detection and reporting biases. 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 two levels as large effect, RR > 4.