Summary of findings 5. HALOPERIDOL compared to OTHER ANTIPSYCHOTIC: d. LOXAPINE for psychosis‐induced aggression or agitation.
| HALOPERIDOL compared with OTHER ANTIPSYCHOTICS: d. LOXAPINE for psychosis‐induced aggression or agitation | ||||||
| Patient or population: patients to psychosis‐induced aggression or agitation Setting: inpatients; emergency room. Intervention: HALOPERIDOL Comparison: OTHER ANTIPSYCHOTICS: d. LOXAPINE | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| OTHER ANTIPSYCHOTICS: d. LOXAPINE | HALOPERIDOL | |||||
| Tranquillisation or asleep ‐ not asleep by 12 hours | Low1 | RR 4.31 (0.54 to 34.48) | 54 (1 study) | ⊕⊝⊝⊝ very low2,3,4 | ||
| 10 per 1000 | 43 per 1000 (5 to 345) | |||||
| Moderate1 | ||||||
| 50 per 1000 | 215 per 1000 (27 to 1000) | |||||
| High1 | ||||||
| 100 per 1000 | 431 per 1000 (54 to 1000) | |||||
| Global outcome: specific Not sedated at 60 minutes * | Low1 | RR 3.50 (0.86 to 14.18) | 30 (1 study) | ⊕⊝⊝⊝ very low2,4,5,6 | * data for prespecified outcome Repeated need for rapid tranquillisation were not reported | |
| 10 per 1000 | 57 per 1000 (9 to 345) | |||||
| Moderate1 | ||||||
| 100 per 1000 | 569 per 1000 (94 to 1000) | |||||
| High1 | ||||||
| 200 per 1000 | 1000 per 1000 (188 to 1000) | |||||
| Specific behaviour ‐ aggression ‐ no overall improvement | Low1 | RR 1.10 (0.69 to 1.76) | 30 (1 study) | ⊕⊝⊝⊝ very low2,4,6,7 | ||
| 500 per 1000 | 550 per 1000 (345 to 880) | |||||
| Moderate1 | ||||||
| 650 per 1000 | 715 per 1000 (448 to 1000) | |||||
| High1 | ||||||
| 800 per 1000 | 880 per 1000 (552 to 1000) | |||||
| Global outcome: no change at 48 hours CGI | Low1 | RR 0.93 (0.14 to 6.15) | 56 (1 study) | ⊕⊕⊝⊝ low2,4 | ||
| 10 per 1000 | 9 per 1000 (1 to 62) | |||||
| Moderate1 | ||||||
| 70 per 1000 | 65 per 1000 (10 to 431) | |||||
| High1 | ||||||
| 140 per 1000 | 130 per 1000 (20 to 861) | |||||
| Adverse effects: Specific ‐ dystonia between 0‐3 days (IM phase) | Low1 | RR 0.94 (0.06 to 13.93) | 35 (1 study) | ⊕⊝⊝⊝ very low2,4 | ||
| 10 per 1000 | 9 per 1000 (1 to 139) | |||||
| Moderate1 | ||||||
| 50 per 1000 | 47 per 1000 (3 to 697) | |||||
| High1 | ||||||
| 100 per 1000 | 94 per 1000 (6 to 1000) | |||||
| Adverse effects: Specific ‐ rigidity between 0‐3 days (IM phase) | Low1 | RR 0.88 (0.65 to 1.19) | 35 (1 study) | ⊕⊝⊝⊝ very low2,4,6 | ||
| 750 per 1000 | 660 per 1000 (487 to 893) | |||||
| Moderate1 | ||||||
| 850 per 1000 | 748 per 1000 (552 to 1000) | |||||
| High1 | ||||||
| 950 per 1000 | 836 per 1000 (617 to 1000) | |||||
| Economic outcome ‐ not reported | See comment | See comment | Not estimable | ‐ | See comment | No study reported this outcome. |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||
1 Moderate risk is roughly equal to that of the control group. 2 Risk of bias: rated 'serious' ‐ method of randomisation not described, allocation concealment not stated, staff administering medication were not blind to the intervention, the number of participants reported as leaving the study at certain time points is inconsistent. 3 Indirectness: rated 'serious' ‐ reported at 12 hours rather than 30 minutes as stated in protocol. 4 Imprecision: rated 'serious' ‐ 95% confidence interval is wide. 5 Indirectness: rated 'serious' ‐ no data on repeated need for rapid tranquillisation, therefore inferred from the data 'not sedated at 60 minutes'. 6 Publication bias: rated 'strongly suspected' ‐ small study. 7 Indirectness: rated 'serious' ‐ not able to use threat or injury to self or others as stated in the protocol because this was not reported.