Summary of findings 14. HALOPERIDOL compared to BENZODIAZEPINE: b. LORAZEPAM for psychosis‐induced aggression or agitation.
HALOPERIDOL compared with BENZODIAZEPINE: b. LORAZEPAM for psychosis‐induced aggression or agitation | ||||||
Patient or population: patients with psychosis‐induced aggression or agitation Setting: inpatients; emergency room. Intervention: HALOPERIDOL Comparison: BENZODIAZEPINE: b. LORAZEPAM | ||||||
Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
BENZODIAZEPINE: b. LORAZEPAM | HALOPERIDOL | |||||
Tranquillisation or asleep not asleep at 60 minutes | Low1 | RR 1.05 (0.76 to 1.44) | 60 (1 study) | ⊕⊝⊝⊝ very low2,3,4,5 | ||
500 per 1000 | 525 per 1000 (380 to 720) | |||||
Moderate1 | ||||||
700 per 1000 | 735 per 1000 (532 to 1000) | |||||
High1 | ||||||
900 per 1000 | 945 per 1000 (684 to 1000) | |||||
Repeated need for rapid tranquillisation more than 1 injection | Low1 | RR 1.14 (0.91 to 1.43) | 66 (1 study) | ⊕⊝⊝⊝ very low4,5,6 | ||
500 per 1000 | 570 per 1000 (455 to 715) | |||||
Moderate1 | ||||||
750 per 1000 | 855 per 1000 (683 to 1000) | |||||
High1 | ||||||
900 per 1000 | 1000 per 1000 (819 to 1000) | |||||
Specific behaviour ‐ threat or injury to self or others within 24 hours ‐ not reported | See comment | See comment | Not estimable | ‐ | See comment | No study reported this outcome. |
Global outcome: no overall improvement ‐ at 60 minutes | Low1 | RR 1.64 (0.54 to 5.03) | 44 (1 study) | ⊕⊝⊝⊝ very low2,4 | ||
50 per 1000 | 82 per 1000 (27 to 252) | |||||
Moderate1 | ||||||
150 per 1000 | 246 per 1000 (81 to 755) | |||||
High1 | ||||||
100 per 1000 | 164 per 1000 (54 to 503) | |||||
Adverse effects: specific ‐ dystonia (only reported if occurred in ≥9% during 24 hours) | Low1 | RR 3.54 (0.42 to 30.03) | 66 (1 study) | ⊕⊝⊝⊝ very low4,5,6 | ||
10 per 1000 | 35 per 1000 (4 to 300) | |||||
Moderate1 | ||||||
30 per 1000 | 106 per 1000 (13 to 901) | |||||
High1 | ||||||
50 per 1000 | 177 per 1000 (21 to 1000) | |||||
Adverse effects: specific ‐ hypertonia/rigidity (only reported if occurred in ≥9%) during 24 hours | Low7 | RR 6.22 (0.33 to 115.91) | 66 (1 study) | ⊕⊝⊝⊝ very low4,5,6 | ||
0 per 1000 | 0 per 1000 (0 to 0) | |||||
Moderate7 | ||||||
50 per 1000 | 311 per 1000 (17 to 1000) | |||||
High7 | ||||||
100 per 1000 | 622 per 1000 (33 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 trial control group. 2 Risk of bias: rated 'very serious' ‐ not explicitly described as randomised, allocation concealment not stated, incomplete outcome data, sponsored by drug company. 3 Indirectness: rated 'serious' ‐ no measure for tranquillisation or asleep at 30 minutes, therefore had to use 60 minutes. 4 Imprecision: rated 'serious' ‐ small study. 5 Publication bias: rated 'strongly suspected' ‐ small study, sponsored by drug company. 6 Risk of bias: rated 'serious' ‐ allocation concealment is not stated, incomplete outcome data, selective reporting, sponsored by drug company. 7 Low risk is roughly equal to that of the trial control group.