Summary of findings 11. HALOPERIDOL compared to OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE for psychosis‐induced aggression or agitation.
| HALOPERIDOL compared to OTHER ANTIPSYCHOTIC: i. ZIPRASIDONE for psychosis‐induced aggression or agitation | ||||||
| Patient or population: psychosis‐induced aggression or agitation Setting: inpatients; emergency room; multi‐centre. Intervention: HALOPERIDOL Comparison: OTHER ANTIPSYCHOTIC: i. ZIPRASIDONE | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with OTHER ANTIPSYCHOTIC: i. ZIPRASIDONE | Risk with HALOPERIDOL | |||||
| Tranquilisation or asleep ‐ not reported | ‐ | ‐ | ‐ | ‐ | ‐ | No trial reported this outcome. |
| Repeated need for tranquilisation assessed with: need for additional drugs for tranquillisation up to 24 hours | Study population | RR 1.64 (1.07 to 2.53) | 60 (1 RCT) | ⊕⊝⊝⊝ very low1 2 | ||
| 467 per 1.000 | 765 per 1.000 (499 to 1.000) | |||||
| Specific behaviour ‐ agitation assessed with: average endpoint scores at 2 hours on the PANSS‐EC follow up: 72 hours | MD 0.06 higher (1.13 lower to 1.25 higher) | ‐ | 231 (1 RCT) | ⊕⊕⊝⊝ low3 4 | ||
| Global outcome assessed with: CGI‐S ‐ average change score at 72 hours. | MD 0.34 higher (0.13 higher to 0.55 higher) | ‐ | 132 (1 RCT) | ⊕⊝⊝⊝ very low5 | ||
| Adverse effects: Specific ‐ dystonia during 72 hours | Low | RR 10.26 (1.67 to 63.17) | 508 (2 RCTs) | ⊕⊝⊝⊝ very low5 7 | ||
| 2 per 1.000 | 21 per 1.000 (3 to 126) | |||||
| Moderate | ||||||
| 4 per 1.000 | 41 per 1.000 (7 to 253) | |||||
| High | ||||||
| 10 per 1.000 | 103 per 1.000 (17 to 632) | |||||
| Adverse effects: Specific ‐ clinically significant abnormal ECG during 72 hours | Study population | RR 1.01 (0.60 to 1.71) | 376 (1 RCT) | ⊕⊝⊝⊝ very low3 9 | ||
| 127 per 1.000 | 128 per 1.000 (76 to 217) | |||||
| Economic outcome ‐ not reported | ‐ | ‐ | ‐ | ‐ | ‐ | No trial reported this outcome. |
| *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; RR: Risk ratio | ||||||
| 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 | ||||||
1 Risk of bias: rated 'serious' ‐ method of allocation concealment not stated, blinding of participants uneffective
2 Imprecision: rated 'very serious' ‐ less than 100 patients, 95% CI extends beyond the no effect point
3 Risk of bias: rated 'serious' ‐ method of randomisation is not described, allocation concealment is not stated, single‐blind.
4 Indirectness: rated 'serious' ‐ not threat or injury to self or others, therefore had to use scale derived data for agitation.
5 Risk of bias: rated 'very serious' ‐ allocation of concealment not stated, open trial, adverse effects only reported where they occurred in ≥10% of people, sponsored by drug company.
6 Publication bias: rated 'strongly suspected' ‐ sponsored by drug company.
7 Imprecision: rated 'serious' ‐ 95% confidence intervals are wide.
8 Moderate risk roughly is roughly equal to that of the control group.
9 Indirectness: rated 'serious' ‐ abnormal ECG ‐ not necessarily a serious adverse effect.