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. 2016 Nov 25;2016(11):CD005146. doi: 10.1002/14651858.CD005146.pub3

Summary of findings 2. HALOPERIDOL + PROMETHAZINE compared to ANTIPSYCHOTIC ‐ OLANZAPINE for psychosis‐induced aggression.

HALOPERIDOL + PROMETHAZINE compared to ANTIPSYCHOTIC ‐ OLANZAPINE for psychosis‐induced aggression
Patient or population: people with psychosis‐induced aggression
 Settings:Intervention: HALOPERIDOL + PROMETHAZINE
 Comparison: ANTIPSYCHOTIC ‐ OLANZAPINE
Outcomes Illustrative comparative risks* (95% CI) Relative effect
 (95% CI) No of Participants
 (studies) Quality of the evidence
 (GRADE) Comments
Assumed risk Corresponding risk
ANTIPSYCHOTIC ‐ OLANZAPINE HALOPERIDOL + PROMETHAZINE
Tranquil or asleep: Not tranquil or asleep ‐ by 30 mins Moderate1 RR 0.60 
 (0.22 to 1.61) 300
 (1 study) ⊕⊕⊕⊕
 high  
100 per 1000 60 per 1000 
 (22 to 161)
Global state:Needing restraints or seclusion by 12 hours Moderate RR 5.00 
 (0.62 to 40.28) 60
 (1 study) ⊕⊕⊝⊝
 low2,3  
50 per 10001 250 per 1000 
 (31 to 1000)
Adverse effects: Specific and serious adverse effects by 24 hours 
 Central nervous system ‐ excessive sedation. Moderate RR 0.67 
 (0.12 to 3.84) 116
 (2 studies) ⊕⊕⊝⊝
 low4,5  
100 per 10001 64 per 1000 
 (11 to 364)
Adverse effect: Specific ‐ Death See comment See comment Not estimable 0
 (0) See comment No study reported this outcome
Service outcomes: Not discharged ‐ by 4 hours Moderate RR 0.94 
 (0.77 to 1.16) 300
 (1 study) ⊕⊕⊕⊕
 high  
600 per 10001 564 per 1000 
 (462 to 696)
Specific behaviours: Average aggression score ‐ by 12 hours 
 Overt Aggression Scale   The mean specific behaviours: average aggression score in the intervention groups was
 2 lower 
 (2.21 to 1.79 lower)   60
 (1 study) ⊕⊕⊝⊝
 low5,6  
Economics: Costs of care7 See comment See comment Not estimable 0
 (0) 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.

1Moderate control risk approximates to that of the included trial(s).
 2Indirectness: rated 'serious' ‐ pre‐stated outcome was 'another episode of aggression' ‐ proxy outcome used.
 3Imprecision: rated 'serious' as sample size too small and confidence interval too wide.
 4Indirectness: rated 'serious' ‐ pre‐stated outcome was 'serious adverse effect' ‐ proxy outcome used.
 5Imprecision: rated 'serious' ‐ sample size too small and confidence interval wide.
 6Indirectness: rated 'serious' ‐ pre‐stated outcome was 'specific behaviours' ‐ proxy outcome used.