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. 2017 Jul 31;2017(7):CD009377. doi: 10.1002/14651858.CD009377.pub3

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.