Haloperidol for psychosis‐induced aggression or agitation (rapid tranquillisation)

Edoardo G Ostinelli; Melanie J Brooke‐Powney; Xue Li; Clive E Adams

doi:10.1002/14651858.CD009377.pub3

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Figure 1

Study flow diagram.

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Figure 2

Study flow diagram.

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Figure 3

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

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Analysis 1.1

Comparison 1 HALOPERIDOL vs PLACEBO/NIL, Outcome 1 Tranquillisation or asleep ‐ asleep.

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Analysis 1.2

Comparison 1 HALOPERIDOL vs PLACEBO/NIL, Outcome 2 Repeated need for tranquillisation.

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Analysis 1.3

Comparison 1 HALOPERIDOL vs PLACEBO/NIL, Outcome 3 Specific behaviour: 1a. Agitation ‐ various measures.

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Analysis 1.4

Comparison 1 HALOPERIDOL vs PLACEBO/NIL, Outcome 4 Specific behaviour: 1b. Agitation ‐ average scores ‐ i. up to 2 hours.

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Analysis 1.5

Comparison 1 HALOPERIDOL vs PLACEBO/NIL, Outcome 5 Specific behaviour: 1c. Agitation ‐ average scores ‐ ii. up to 24 hours.

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Analysis 1.6

Comparison 1 HALOPERIDOL vs PLACEBO/NIL, Outcome 6 Global outcome: 1. Not improved.

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Analysis 1.7

Comparison 1 HALOPERIDOL vs PLACEBO/NIL, Outcome 7 Global outcome: 2. Need for benzodiazepine up to 24 hours.

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Analysis 1.8

Comparison 1 HALOPERIDOL vs PLACEBO/NIL, Outcome 8 Global outcome: 3a. Average scores ‐ i. up to 2 hours.

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Analysis 1.9

Comparison 1 HALOPERIDOL vs PLACEBO/NIL, Outcome 9 Global outcome: 3b. Average scores ‐ ii. up to 24 hours.

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Analysis 1.10

Comparison 1 HALOPERIDOL vs PLACEBO/NIL, Outcome 10 Mental state: 1a. Average scores ‐ i. up to 2 hours.

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Analysis 1.11

Comparison 1 HALOPERIDOL vs PLACEBO/NIL, Outcome 11 Mental state: 1b. Average scores ‐ ii. up to 24 hours.

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Analysis 1.12

Comparison 1 HALOPERIDOL vs PLACEBO/NIL, Outcome 12 Adverse effects: 1a. General.

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Analysis 1.13

Comparison 1 HALOPERIDOL vs PLACEBO/NIL, Outcome 13 Adverse effects: 1b. General ‐ serious.

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Analysis 1.14

Comparison 1 HALOPERIDOL vs PLACEBO/NIL, Outcome 14 Adverse effects: 2a. Specific ‐ arousal level.

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Analysis 1.15

Comparison 1 HALOPERIDOL vs PLACEBO/NIL, Outcome 15 Adverse effects: 2b. Specific ‐ cardiovascular ‐ miscellaneous outcomes.

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Analysis 1.16

Comparison 1 HALOPERIDOL vs PLACEBO/NIL, Outcome 16 Adverse effects: 2c. Specific ‐ cardiovascular ‐ QTc interval (average change at 24 hours).

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Analysis 1.17

Comparison 1 HALOPERIDOL vs PLACEBO/NIL, Outcome 17 Adverse effects: 2d. Specific ‐ movement disorders.

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Analysis 1.18

Comparison 1 HALOPERIDOL vs PLACEBO/NIL, Outcome 18 Adverse effects: 2e. Specific ‐ movement disorders: i. average scores ‐ i. up to 24 hours.

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Analysis 1.19

Comparison 1 HALOPERIDOL vs PLACEBO/NIL, Outcome 19 Adverse effects: 2f. Specific ‐ miscellaneous.

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Analysis 1.20

Comparison 1 HALOPERIDOL vs PLACEBO/NIL, Outcome 20 Leaving the study early.

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Analysis 2.1

Comparison 2 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: a. ARIPIPRAZOLE, Outcome 1 Repeated need for rapid tranquillisation: needing additional injection.

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Analysis 2.2

Comparison 2 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: a. ARIPIPRAZOLE, Outcome 2 Specific behaviour: 1a. Agitation ‐ PANSS‐EC response up to 2 hours (at least 40% change on PANSS‐EC from baseline).

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Analysis 2.3

Comparison 2 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: a. ARIPIPRAZOLE, Outcome 3 Specific behaviour: 1b. Agitation ‐ average scores ‐ up to 2 hours.

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Analysis 2.4

Comparison 2 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: a. ARIPIPRAZOLE, Outcome 4 Global outcome: 1. Need for benzodiazepine.

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Analysis 2.5

Comparison 2 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: a. ARIPIPRAZOLE, Outcome 5 Global outcome: 2. Average scores ‐ up to 2 hours.

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Analysis 2.6

Comparison 2 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: a. ARIPIPRAZOLE, Outcome 6 Mental state: 1. Average scores ‐ up to 2 hours.

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Analysis 2.7

Comparison 2 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: a. ARIPIPRAZOLE, Outcome 7 Adverse effects: 1a. General.

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Analysis 2.8

Comparison 2 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: a. ARIPIPRAZOLE, Outcome 8 Adverse effects: 1b. General ‐ serious.

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Analysis 2.9

Comparison 2 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: a. ARIPIPRAZOLE, Outcome 9 Adverse effects: 2a. Specific ‐ arousal level.

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Analysis 2.10

Comparison 2 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: a. ARIPIPRAZOLE, Outcome 10 Adverse effects: 2b. Specific ‐ cardiac.

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Analysis 2.11

Comparison 2 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: a. ARIPIPRAZOLE, Outcome 11 Adverse effects: 2c. Specific ‐ gastrointestinal.

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Analysis 2.12

Comparison 2 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: a. ARIPIPRAZOLE, Outcome 12 Adverse effects: 2d. Specific ‐ movement disorder.

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Analysis 2.13

Comparison 2 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: a. ARIPIPRAZOLE, Outcome 13 Adverse effects: 2e. Specific ‐ miscellaneous.

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Analysis 2.14

Comparison 2 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: a. ARIPIPRAZOLE, Outcome 14 Leaving the study early: 1. For specific reasons.

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Analysis 3.1

Comparison 3 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: b. CHLORPROMAZINE, Outcome 1 Tranquillisation or asleep ‐ asleep.

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Analysis 3.2

Comparison 3 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: b. CHLORPROMAZINE, Outcome 2 Repeated need for rapid tranquillisation.

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Analysis 3.3

Comparison 3 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: b. CHLORPROMAZINE, Outcome 3 Global outcome: 1. Not improved.

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Analysis 3.4

Comparison 3 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: b. CHLORPROMAZINE, Outcome 4 Adverse effects: any serious or specific adverse effects.

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Analysis 3.5

Comparison 3 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: b. CHLORPROMAZINE, Outcome 5 Leaving the study early.

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Analysis 4.1

Comparison 4 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: c. DROPERIDOL, Outcome 1 Tranquillisation or asleep: 1. Not asleep.

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Analysis 4.2

Comparison 4 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: c. DROPERIDOL, Outcome 2 Tranquillisation or asleep: 2. Time to sleep.

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Analysis 4.3

Comparison 4 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: c. DROPERIDOL, Outcome 3 Repeated need for rapid tranquillisation.

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Analysis 4.4

Comparison 4 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: c. DROPERIDOL, Outcome 4 Global outcome: 1. Need for benzodiazepine.

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Analysis 4.5

Comparison 4 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: c. DROPERIDOL, Outcome 5 Adverse effects: 1. General.

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Analysis 4.6

Comparison 4 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: c. DROPERIDOL, Outcome 6 Adverse effects: 2a. Specific ‐ arousal level.

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Analysis 4.7

Comparison 4 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: c. DROPERIDOL, Outcome 7 Adverse effects: 2b. Specific ‐ cardiovascular.

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Analysis 4.8

Comparison 4 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: c. DROPERIDOL, Outcome 8 Adverse effects: 2c. Specific ‐ movement disorders.

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Analysis 4.9

Comparison 4 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: c. DROPERIDOL, Outcome 9 Adverse effects: 2d. Specific ‐ miscellaneous.

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Analysis 5.1

Comparison 5 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: d. LOXAPINE, Outcome 1 Tranquillisation or asleep ‐ not asleep up to 24 hours.

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Analysis 5.2

Comparison 5 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: d. LOXAPINE, Outcome 2 Specific behaviour: 2. Aggression ‐ various measures.

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Analysis 5.3

Comparison 5 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: d. LOXAPINE, Outcome 3 Global outcome: 1. General ‐ no change ‐ i. over 24 hours.

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Analysis 5.4

Comparison 5 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: d. LOXAPINE, Outcome 4 Global outcome: 2a. Specific ‐ not sedated ‐ i. by 30 minutes.

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Analysis 5.5

Comparison 5 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: d. LOXAPINE, Outcome 5 Global outcome: 2b. Specific ‐ not sedated ‐ ii. up to 2 hours.

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Analysis 5.6

Comparison 5 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: d. LOXAPINE, Outcome 6 Mental state: 1. Average scores.

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Analysis 5.7

Comparison 5 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: d. LOXAPINE, Outcome 7 Adverse effects: 1. General.

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Analysis 5.8

Comparison 5 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: d. LOXAPINE, Outcome 8 Adverse effects: 2a. Specific ‐ anticholinergic.

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Analysis 5.9

Comparison 5 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: d. LOXAPINE, Outcome 9 Adverse effects: 2b. Specific ‐ arousal level.

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Analysis 5.10

Comparison 5 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: d. LOXAPINE, Outcome 10 Adverse effects: 2c. Specific ‐ cardiovascular.

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Analysis 5.11

Comparison 5 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: d. LOXAPINE, Outcome 11 Adverse effects: 2d. Specific ‐ movement disorders.

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Analysis 5.12

Comparison 5 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: d. LOXAPINE, Outcome 12 Adverse effects: 2e. Specific ‐ miscellaneous.

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Analysis 5.13

Comparison 5 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: d. LOXAPINE, Outcome 13 Leaving the study early: 1. For general reasons.

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Analysis 5.14

Comparison 5 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: d. LOXAPINE, Outcome 14 Leaving the study early: 2. Specific reasons.

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Analysis 6.1

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 1 Tranquillisation or asleep ‐ asleep.

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Analysis 6.2

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 2 Repeated need for tranquillisation ‐ needing additional injection.

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Analysis 6.3

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 3 Specific behaviour: 1a. Agitation ‐ various measures.

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Analysis 6.4

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 4 Specific behaviour: 1b. Agitation ‐ average scores ‐ i. by 30 minutes.

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Analysis 6.5

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 5 Specific behaviour: 1c. Agitation ‐ average scores ‐ ii. up to 2 hours.

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Analysis 6.6

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 6 Specific behaviour: 1d. Agitation ‐ average scores ‐ iii. up to 4 hours.

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Analysis 6.7

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 7 Specific behaviour: 1e. Agitation ‐ average scores ‐ iv. up to 24 hours.

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Analysis 6.8

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 8 Specific behaviour: 2a. Aggression ‐ average scores ‐ i. up to 2 hours.

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Analysis 6.9

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 9 Specific behaviour: 2b. Aggression ‐ average scores ‐ ii. up to 4 hours.

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Analysis 6.10

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 10 Specific behaviour: 2c. Aggression ‐ average scores ‐ iii. up to 24 hours.

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Analysis 6.11

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 11 Specific behaviour: 3. Hostility.

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Analysis 6.12

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 12 Global outcome: 1a. General ‐ need for additional measures.

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Analysis 6.13

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 13 Global outcome: 1b. General ‐ time and doses.

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Analysis 6.14

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 14 Global outcome: 1c. General ‐ average scores ‐ up to 2 hours.

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Analysis 6.15

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 15 Global outcome: 1d. General ‐ average scores ‐ over 24 hours.

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Analysis 6.16

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 16 Global outcome: 2a. Specific ‐ alert ‐ i. up to 2 hours.

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Analysis 6.17

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 17 Global outcome: 2b. Specific ‐ alert ‐ ii. up to 4 hours.

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Analysis 6.18

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 18 Global outcome: 2c. Specific ‐ alert ‐ iii. up to 24 hours.

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Analysis 6.19

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 19 Global outcome: 2d. Specific ‐ tranquil ‐ i. up to 2 hours.

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Analysis 6.20

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 20 Global outcome: 2e. Specific ‐ tranquil ‐ ii. up to 4 hours.

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Analysis 6.21

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 21 Global outcome: 2f. Specific ‐ tranquil ‐ iii. up to 24 hours.

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Analysis 6.22

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 22 Global outcome: 2g. Specific ‐ sedated ‐ i. up to 2 hours.

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Analysis 6.23

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 23 Global outcome: 2h. Specific ‐ sedated ‐ ii. up to 4 hours.

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Analysis 6.24

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 24 Global outcome: 2i. Specific ‐ sedated ‐ iii. up to 24 hours.

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Analysis 6.25

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 25 Global outcome: 2j. Specific ‐ asleep ‐ i. up to 2 hours.

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Analysis 6.26

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 26 Global outcome: 2k. Specific ‐ asleep ‐ ii. up to 4 hours.

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Analysis 6.27

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 27 Global outcome: 2l. Specific ‐ asleep ‐ iii. up to 24 hours.

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Analysis 6.28

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 28 Service use: 1. Average days to discharge.

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Study	Intervention	Mean	SD	N
days 1‐7
Kinon 2001d	Haloperidol	2.59	6.79	48
Kinon 2001d	Olanzapine	1.57	5.52	52
days 8‐14
Kinon 2001d	Haloperidol	0.92	4.05	48
Kinon 2001d	Olanzapine	0.33	2.23	52
days 15‐21
Kinon 2001d	Haloperidol	0.55	2.74	48
Kinon 2001d	Olanzapine	0	0	52

Analysis 6.29

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 29 Service use: 2. Average patient‐hours used during 24 hours (skewed data).

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Analysis 6.30

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 30 Mental state: 1. Various outcomes reported as 'adverse events'.

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Analysis 6.31

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 31 Mental state: 2a. Average scores ‐ i. by 30 minutes.

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Analysis 6.32

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 32 Mental state: 2b. Average scores ‐ ii. up to 2 hours.

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Analysis 6.33

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 33 Mental state: 2c. Average scores ‐ iii. up to 24 hours.

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Analysis 6.34

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 34 Mental state: 2d. Average scores ‐ iv. over 24 hours.

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Analysis 6.35

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 35 Adverse effects: 1a. General.

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Analysis 6.36

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 36 Adverse effects: 1b. General ‐ serious.

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Analysis 6.37

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 37 Adverse effects: 2a. Specific ‐ anticholinergic.

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Analysis 6.38

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 38 Adverse effects: 2b. Specific ‐ arousal level ‐ i. various.

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Analysis 6.39

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 39 Adverse effects: 2c. Specific ‐ arousal level ‐ ii. average scores ‐ i. up to 2 hours.

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Analysis 6.40

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 40 Adverse effects: 2d. Specific ‐ arousal level ‐ ii. average scores ‐ ii. up to 4 hours.

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Analysis 6.41

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 41 Adverse effects: 2e. Specific ‐ arousal level ‐ ii. average scores ‐ iii. up to 24 hours.

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Analysis 6.42

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 42 Adverse effects: 2f. Specific ‐ cardiovascular i. binary.

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Analysis 6.43

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 43 Adverse effects: 2g. Specific ‐ cardiovascular ii. continuous.

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Analysis 6.44

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 44 Adverse effects: 2h. Specific ‐ gastrointestinal.

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Analysis 6.45

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 45 Adverse effects: 2i. Specific ‐ movement disorder ‐ i. various.

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Analysis 6.46

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 46 Adverse effects: 2j. Specific ‐ movement disorder ‐ ii. average scores ‐ i. up to 24 hours.

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Study	Intervention	Mean	SD	N	Notes
endpoint score at 24 hours (SAS, high=worse) ‐ (skewed data)
Eli Lilly 2004	Haloperidol	1.4	2.8	22
Eli Lilly 2004	Olanzapine	2.2	3.5	20
endpoint score at 24 hours (BAS, high=worse) ‐ (skewed data)
Eli Lilly 2004	Haloperidol	1.5	1.7	22
Eli Lilly 2004	Olanzapine	1.7	2.6	20

Analysis 6.47

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 47 Adverse effects: 2k. Specific ‐ movement disorder ‐ iii. average scores ‐ i. up to 24 hours.

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Analysis 6.48

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 48 Adverse effects: 2l. Specific ‐ movement disorder ‐ vi. average scores ‐ i. over 24 hours.

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Analysis 6.49

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 49 Adverse effects: 2m. Specific ‐ miscellaneous.

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Analysis 6.50

Comparison 6 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE, Outcome 50 Leaving the study early.

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Analysis 7.1

Comparison 7 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: f. PERPHENAZINE, Outcome 1 Global outcome: No improvement.

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Analysis 7.2

Comparison 7 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: f. PERPHENAZINE, Outcome 2 Adverse effects: 1. General.

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Analysis 7.3

Comparison 7 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: f. PERPHENAZINE, Outcome 3 Adverse effects: 2. Specific.

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Analysis 7.4

Comparison 7 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: f. PERPHENAZINE, Outcome 4 Leaving the study early: 1. Specific reasons.

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Analysis 8.1

Comparison 8 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: g. QUETIAPINE, Outcome 1 Specific behaviour: 1a. Agitation ‐ average scores ‐ i. up to 24 hours.

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Analysis 8.2

Comparison 8 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: g. QUETIAPINE, Outcome 2 Specific behaviour: 1b. Agitation ‐ average scores ‐ ii. over 24 hours.

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Analysis 8.3

Comparison 8 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: g. QUETIAPINE, Outcome 3 Mental state: Average scores ‐ i. over 24 hours.

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Analysis 8.4

Comparison 8 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: g. QUETIAPINE, Outcome 4 Adverse effects: 1. General.

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Analysis 8.5

Comparison 8 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: g. QUETIAPINE, Outcome 5 Adverse effects: 2. Specific ‐ movement disorder ‐ i. average scores.

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Analysis 8.6

Comparison 8 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: g. QUETIAPINE, Outcome 6 Leaving the study early.

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Analysis 9.1

Comparison 9 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: h. RISPERIDONE, Outcome 1 Tranquillisation or asleep ‐ i. by 30 minutes.

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Analysis 9.2

Comparison 9 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: h. RISPERIDONE, Outcome 2 Tranquillisation or asleep ‐ ii. up to 2 hours.

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Analysis 9.3

Comparison 9 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: h. RISPERIDONE, Outcome 3 Specific behaviour: 1a. Agitation ‐ various measures.

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Analysis 9.4

Comparison 9 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: h. RISPERIDONE, Outcome 4 Specific behaviour: 1b. Agitation ‐ average scores ‐ i. up to 2 hours.

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Analysis 9.5

Comparison 9 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: h. RISPERIDONE, Outcome 5 Specific behaviour: 2a. Aggression ‐ average scores ‐ i. by 30 minutes.

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Analysis 9.6

Comparison 9 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: h. RISPERIDONE, Outcome 6 Specific behaviour: 2b. Aggression ‐ average scores ‐ ii. up to 2 hours.

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Analysis 9.7

Comparison 9 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: h. RISPERIDONE, Outcome 7 Global outcome: 1. Binary measures.

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Analysis 9.8

Comparison 9 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: h. RISPERIDONE, Outcome 8 Global outcome: 2. Continuous measures.

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Analysis 9.9

Comparison 9 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: h. RISPERIDONE, Outcome 9 Adverse effects: 1a. General ‐ one or more adverse effects.

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Analysis 9.10

Comparison 9 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: h. RISPERIDONE, Outcome 10 Adverse effects: 2a. Specific ‐ arousal.

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Analysis 9.11

Comparison 9 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: h. RISPERIDONE, Outcome 11 Adverse effects: 2b. Specific ‐ cardiovascular ‐ i. binary outcomes.

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Analysis 9.12

Comparison 9 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: h. RISPERIDONE, Outcome 12 Adverse effects: 2c. Specific ‐ cardiovascular ‐ ii. pulse rate ‐ i. up to 2 hours.

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Analysis 9.13

Comparison 9 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: h. RISPERIDONE, Outcome 13 Adverse effects: 2d. Specific ‐ cardiovascular ‐ ii. pulse rate ‐ ii. up to 24 hours.

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Analysis 9.14

Comparison 9 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: h. RISPERIDONE, Outcome 14 Adverse effects: 2e. Specific ‐ movement disorder ‐ i. binary outcomes.

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Analysis 9.15

Comparison 9 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: h. RISPERIDONE, Outcome 15 Adverse effects: 2f. Specific ‐ movement disorders ‐ ii. average scores ‐ i. up to 24 hours.

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Analysis 9.16

Comparison 9 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: h. RISPERIDONE, Outcome 16 Adverse effects: 2g. Specific ‐ movement disorder ‐ ii. average scores ‐ ii. over 24 hours.

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Analysis 9.17

Comparison 9 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: h. RISPERIDONE, Outcome 17 Adverse effects: 2h. Specific ‐ miscellaneous.

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Analysis 9.18

Comparison 9 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: h. RISPERIDONE, Outcome 18 Leaving the study early ‐ i. up to 24 hours.

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Analysis 9.19

Comparison 9 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: h. RISPERIDONE, Outcome 19 Leaving the study early ‐ ii. over 24 hours.

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Analysis 10.1

Comparison 10 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: i. THIOTHIXENE, Outcome 1 Repeated need for rapid tranquillisation.

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Analysis 10.2

Comparison 10 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: i. THIOTHIXENE, Outcome 2 Specific behaviour: 1. Agitation ‐ rated as 'adverse effect'.

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Analysis 10.3

Comparison 10 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: i. THIOTHIXENE, Outcome 3 Global outcome.

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Analysis 10.4

Comparison 10 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: i. THIOTHIXENE, Outcome 4 Adverse effects: 1. General ‐ one or more adverse effects.

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Analysis 10.5

Comparison 10 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: i. THIOTHIXENE, Outcome 5 Adverse effects: 2a. Specific ‐ movement disorders.

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Analysis 10.6

Comparison 10 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: i. THIOTHIXENE, Outcome 6 Adverse effects: 2b. Specific ‐ others.

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Analysis 11.1

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 1 Repeated need for tranquillisation ‐ need for additional drugs for tranquillisation.

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Analysis 11.2

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 2 Specific behaviour: 1a. Agitation ‐ average scores ‐ i. up to 2 hours.

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Analysis 11.3

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 3 Specific behaviour: 1b. Agitation ‐ average scores ‐ ii. up to 4 hours.

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Analysis 11.4

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 4 Specific behaviour: 1c. Agitation ‐ average scores ‐ iii. up to 24 hours.

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Analysis 11.5

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 5 Specific behaviour: 1d. Agitation ‐ average scores ‐ iv. over 24 hours.

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Analysis 11.6

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 6 Specific behaviour: 2a. Aggression ‐ average scores ‐ i. up to 2 hours.

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Analysis 11.7

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 7 Specific behaviour: 2b. Aggression ‐ average scores ‐ ii. up to 4 hours.

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Analysis 11.8

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 8 Specific behaviour: 2c. Aggression ‐ average scores ‐ iii. up to 24 hours.

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Analysis 11.9

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 9 Global outcome: 1. General ‐ need for additional measures.

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Analysis 11.10

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 10 Global outcome: 2. Average scores ‐ i. over 24 hours.

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Analysis 11.11

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 11 Mental state: 1a. Average scores ‐ i. up to 2 hours.

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Analysis 11.12

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 12 Mental state: 1b. Average scores ‐ ii. up to 4 hours.

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Analysis 11.13

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 13 Mental state: 1c. Average scores ‐ iii. up to 24 hours.

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Analysis 11.14

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 14 Mental state: 1d. Average scores ‐ iv. over 24 hours.

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Analysis 11.15

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 15 Adverse effects: 1a. General ‐ i. up to 24 hours.

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Analysis 11.16

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 16 Adverse effects: 1b. General ‐ ii. over 24 hours.

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Analysis 11.17

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 17 Adverse effects: 1c. General ‐ serious.

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Analysis 11.18

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 18 Adverse effects: 2a. Specific ‐ anticholinergic.

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Analysis 11.19

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 19 Adverse effects: 2b. Specific ‐ arousal level ‐ i. various.

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Analysis 11.20

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 20 Adverse effects: 2c. Specific ‐ arousal level ‐ ii. average scores ‐ i. up to 2 hours.

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Analysis 11.21

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 21 Adverse effects: 2d. Specific ‐ arousal level ‐ ii. average scores ‐ ii. up to 4 hours.

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Analysis 11.22

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 22 Adverse effects: 2e. Specific ‐ arousal level ‐ ii. average scores ‐ iii. up to 24 hours.

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Analysis 11.23

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 23 Adverse effects: 2f. Specific ‐ cardiovascular.

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Analysis 11.24

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 24 Adverse effects: 2g. Specific ‐ gastrointestinal.

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Analysis 11.25

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 25 Adverse effects: 2h. Specific ‐ hematological tests.

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Analysis 11.26

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 26 Adverse effects: 2i. Specific ‐ movement disorders ‐ i. binary measures.

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Analysis 11.27

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 27 Adverse effects: 2j. Specific ‐ movement disorders ‐ ii. average scores ‐ i. over 24 hours.

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Analysis 11.28

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 28 Adverse effects: 2k. Specific ‐ miscellaneous.

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Analysis 11.29

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 29 Leaving the study early: 1. For any reason ‐ i. over 24 hours.

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Analysis 11.30

Comparison 11 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE, Outcome 30 Leaving the study early: 2. For specific reasons ‐ i. over 24 hours.

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Analysis 12.1

Comparison 12 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: k. ZUCLOPENTHIXOL ACETATE, Outcome 1 Repeated need for tranquillisation: more than 3 injections.

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Analysis 12.2

Comparison 12 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: k. ZUCLOPENTHIXOL ACETATE, Outcome 2 Adverse effects: 1a. Specific ‐ movement disorders.

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Analysis 12.3

Comparison 12 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: k. ZUCLOPENTHIXOL ACETATE, Outcome 3 Adverse effects: 1b. Specific ‐ miscellaneous.

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Analysis 12.4

Comparison 12 HALOPERIDOL vs OTHER ANTIPSYCHOTIC: k. ZUCLOPENTHIXOL ACETATE, Outcome 4 Leaving the study early.

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Analysis 13.1

Comparison 13 HALOPERIDOL vs BENZODIAZEPINE: a. FLUNITRAZEPAM, Outcome 1 Specific behaviour: 1. Aggression ‐ binary measures ‐ i. up to 2 hours.

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Analysis 13.2

Comparison 13 HALOPERIDOL vs BENZODIAZEPINE: a. FLUNITRAZEPAM, Outcome 2 Global outcome: 1. Need for seclusion or restraint.

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Analysis 13.3

Comparison 13 HALOPERIDOL vs BENZODIAZEPINE: a. FLUNITRAZEPAM, Outcome 3 Adverse effects: 1. Specific ‐ movement disorders ‐ i. binary measures ‐ i. by 30 minutes.

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Analysis 14.1

Comparison 14 HALOPERIDOL vs BENZODIAZEPINE: b. LORAZEPAM, Outcome 1 Tranquillisation or asleep ‐ not asleep.

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Analysis 14.2

Comparison 14 HALOPERIDOL vs BENZODIAZEPINE: b. LORAZEPAM, Outcome 2 Repeated need for rapid tranquillisation.

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Analysis 14.3

Comparison 14 HALOPERIDOL vs BENZODIAZEPINE: b. LORAZEPAM, Outcome 3 Global outcome: 1. No overall improvement.

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Analysis 14.4

Comparison 14 HALOPERIDOL vs BENZODIAZEPINE: b. LORAZEPAM, Outcome 4 Mental state: 1a. Average scores ‐ i. up to 2 hours.

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Analysis 14.5

Comparison 14 HALOPERIDOL vs BENZODIAZEPINE: b. LORAZEPAM, Outcome 5 Mental state: 1b. Average scores ‐ ii. up to 4 hours.

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Analysis 14.6

Comparison 14 HALOPERIDOL vs BENZODIAZEPINE: b. LORAZEPAM, Outcome 6 Adverse effects: 1a. General.

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Analysis 14.7

Comparison 14 HALOPERIDOL vs BENZODIAZEPINE: b. LORAZEPAM, Outcome 7 Adverse effects: 1b. General ‐ serious.

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Analysis 14.8

Comparison 14 HALOPERIDOL vs BENZODIAZEPINE: b. LORAZEPAM, Outcome 8 Adverse effects: 2a. Specific ‐ anticholinergic.

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Analysis 14.9

Comparison 14 HALOPERIDOL vs BENZODIAZEPINE: b. LORAZEPAM, Outcome 9 Adverse effects: 2b. Specific ‐ arousal.

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Analysis 14.10

Comparison 14 HALOPERIDOL vs BENZODIAZEPINE: b. LORAZEPAM, Outcome 10 Adverse effects: 2c. Specific ‐ cardiovascular.

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Analysis 14.11

Comparison 14 HALOPERIDOL vs BENZODIAZEPINE: b. LORAZEPAM, Outcome 11 Adverse effects: 2d. Specific ‐ movement disorder.

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Study	Intervention	Average	SD	N	Notes
average time to sedation
Nobay 2004	Haloperidol	28.3	25	42
Nobay 2004	Midazolam	18.3	14	42
average time to arousal
Nobay 2004	Haloperidol	126.6	85	42
Nobay 2004	Midazolam	81.9	66	42

Analysis 15.1

Comparison 15 HALOPERIDOL vs BENZODIAZEPINE: c. MIDAZOLAM, Outcome 1 Tranquillisation or asleep: average times in minutes ‐ (skewed data).

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Analysis 15.2

Comparison 15 HALOPERIDOL vs BENZODIAZEPINE: c. MIDAZOLAM, Outcome 2 Global outcome: 1. Need for rescue drug.

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Analysis 15.3

Comparison 15 HALOPERIDOL vs BENZODIAZEPINE: c. MIDAZOLAM, Outcome 3 Adverse effects: 1. General ‐ one or more drug related adverse effect.

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Analysis 15.4

Comparison 15 HALOPERIDOL vs BENZODIAZEPINE: c. MIDAZOLAM, Outcome 4 Adverse effects: 2. Specific.

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Analysis 16.1

Comparison 16 HALOPERIDOL vs COMBINATIONS: a. HALOPERIDOL + LEVOMEPROMAZINE, Outcome 1 Global outcome: 1. No overall improvement.

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Analysis 17.1

Comparison 17 HALOPERIDOL vs COMBINATIONS: b. HALOPERIDOL + LORAZEPAM, Outcome 1 Tranquillisation or asleep ‐ asleep.

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Analysis 17.2

Comparison 17 HALOPERIDOL vs COMBINATIONS: b. HALOPERIDOL + LORAZEPAM, Outcome 2 Repeated need for rapid tranquillisation.

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Analysis 17.3

Comparison 17 HALOPERIDOL vs COMBINATIONS: b. HALOPERIDOL + LORAZEPAM, Outcome 3 Global outcome: 1. No overall improvement.

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Analysis 17.4

Comparison 17 HALOPERIDOL vs COMBINATIONS: b. HALOPERIDOL + LORAZEPAM, Outcome 4 Adverse effects: 1. General.

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Analysis 17.5

Comparison 17 HALOPERIDOL vs COMBINATIONS: b. HALOPERIDOL + LORAZEPAM, Outcome 5 Adverse effects: 2a. Specific ‐ anticholinergic.

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Analysis 17.6

Comparison 17 HALOPERIDOL vs COMBINATIONS: b. HALOPERIDOL + LORAZEPAM, Outcome 6 Adverse effects: 2b. Specific ‐ cardiovascular.

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Analysis 17.7

Comparison 17 HALOPERIDOL vs COMBINATIONS: b. HALOPERIDOL + LORAZEPAM, Outcome 7 Adverse effects: 2c. Specific ‐ movement disorders.

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Analysis 18.1

Comparison 18 HALOPERIDOL vs COMBINATIONS: c. HALOPERIDOL + MIDAZOLAM, Outcome 1 Repeated need for tranquillisation.

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Analysis 18.2

Comparison 18 HALOPERIDOL vs COMBINATIONS: c. HALOPERIDOL + MIDAZOLAM, Outcome 2 Specific behaviour: 1a. Agitation ‐ average scores ‐ i. up to 2 hours.

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Analysis 18.3

Comparison 18 HALOPERIDOL vs COMBINATIONS: c. HALOPERIDOL + MIDAZOLAM, Outcome 3 Specific behaviour: 1b. Agitation ‐ average scores ‐ ii. up to 4 hours.

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Analysis 18.4

Comparison 18 HALOPERIDOL vs COMBINATIONS: c. HALOPERIDOL + MIDAZOLAM, Outcome 4 Specific behaviour: 1c. Agitation ‐ average scores ‐ iii. up to 24 hours.

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Analysis 18.5

Comparison 18 HALOPERIDOL vs COMBINATIONS: c. HALOPERIDOL + MIDAZOLAM, Outcome 5 Specific behaviour: 2a. Aggression ‐ average scores ‐ i. up to 2 hours.

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Analysis 18.6

Comparison 18 HALOPERIDOL vs COMBINATIONS: c. HALOPERIDOL + MIDAZOLAM, Outcome 6 Specific behaviour: 2b. Aggression ‐ average scores ‐ ii. up to 4 hours.

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Analysis 18.7

Comparison 18 HALOPERIDOL vs COMBINATIONS: c. HALOPERIDOL + MIDAZOLAM, Outcome 7 Specific behaviour: 2c. Aggression ‐ average scores ‐ iii. up to 24 hours.

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Analysis 18.8

Comparison 18 HALOPERIDOL vs COMBINATIONS: c. HALOPERIDOL + MIDAZOLAM, Outcome 8 Global outcomes: 1. General ‐ need for additional measures.

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Analysis 18.9

Comparison 18 HALOPERIDOL vs COMBINATIONS: c. HALOPERIDOL + MIDAZOLAM, Outcome 9 Adverse effects: 1b. General ‐ one or more adverse events.

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Analysis 18.10

Comparison 18 HALOPERIDOL vs COMBINATIONS: c. HALOPERIDOL + MIDAZOLAM, Outcome 10 Adverse effects: 1a. General ‐ serious.

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Analysis 18.11

Comparison 18 HALOPERIDOL vs COMBINATIONS: c. HALOPERIDOL + MIDAZOLAM, Outcome 11 Adverse effects: 2a. Specific ‐ arousal ‐ i. various.

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Analysis 18.12

Comparison 18 HALOPERIDOL vs COMBINATIONS: c. HALOPERIDOL + MIDAZOLAM, Outcome 12 Adverse effects: 2b. Specific ‐ arousal ‐ ii. average scores ‐ i. up to 2 hours.

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Analysis 18.13

Comparison 18 HALOPERIDOL vs COMBINATIONS: c. HALOPERIDOL + MIDAZOLAM, Outcome 13 Adverse effects: 2c. Specific ‐ arousal ‐ ii. average scores ‐ ii. up to 4 hours.

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Analysis 18.14

Comparison 18 HALOPERIDOL vs COMBINATIONS: c. HALOPERIDOL + MIDAZOLAM, Outcome 14 Adverse effects: 2d. Specific ‐ arousal ‐ iii. average scores ‐ iii. up to 24 hours.

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Analysis 18.15

Comparison 18 HALOPERIDOL vs COMBINATIONS: c. HALOPERIDOL + MIDAZOLAM, Outcome 15 Adverse effects: 2e. Specific ‐ cardiovascular.

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Analysis 18.16

Comparison 18 HALOPERIDOL vs COMBINATIONS: c. HALOPERIDOL + MIDAZOLAM, Outcome 16 Adverse effects: 2f. Specific ‐ movement disorders.

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Analysis 19.1

Comparison 19 HALOPERIDOL vs COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE, Outcome 1 Tranquillisation or asleep ‐ not tranquil or asleep ‐ i. by 30 minutes.

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Analysis 19.2

Comparison 19 HALOPERIDOL vs COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE, Outcome 2 Tranquillisation or asleep ‐ not tranquil or asleep ‐ ii. up to 2 hours.

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Analysis 19.3

Comparison 19 HALOPERIDOL vs COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE, Outcome 3 Repeated need for tranquillisation ‐ need for additional drugs for tranquillisation.

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Analysis 19.4

Comparison 19 HALOPERIDOL vs COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE, Outcome 4 Specific behaviour: 1a. Agitation ‐ average scores ‐ i. up to 2 hours.

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Analysis 19.5

Comparison 19 HALOPERIDOL vs COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE, Outcome 5 Specific behaviour: 1b. Agitation ‐ average scores ‐ ii. up to 4 hours.

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Analysis 19.6

Comparison 19 HALOPERIDOL vs COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE, Outcome 6 Specific behaviour: 1c. Agitation ‐ average scores ‐ iii. up to 24 hours.

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Analysis 19.7

Comparison 19 HALOPERIDOL vs COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE, Outcome 7 Specific behaviour: 2a. Aggression ‐ average scores ‐ i. up to 2 hours.

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Analysis 19.8

Comparison 19 HALOPERIDOL vs COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE, Outcome 8 Specific behaviour: 2b. Aggression ‐ average scores ‐ ii. up to 4 hours.

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Analysis 19.9

Comparison 19 HALOPERIDOL vs COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE, Outcome 9 Specific behaviour: 2c. Aggression ‐ average scores ‐ iii. up to 24 hours.

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Analysis 19.10

Comparison 19 HALOPERIDOL vs COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE, Outcome 10 Specific behaviour: 2d. Aggression ‐ further aggressive episode ‐ i. up to 24 hours.

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Analysis 19.11

Comparison 19 HALOPERIDOL vs COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE, Outcome 11 Global outcomes: 1. General ‐ need for additional measures.

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Analysis 19.12

Comparison 19 HALOPERIDOL vs COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE, Outcome 12 Global outcomes: 2. Specific.

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Analysis 19.13

Comparison 19 HALOPERIDOL vs COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE, Outcome 13 Adverse effects: 1a. General.

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Analysis 19.14

Comparison 19 HALOPERIDOL vs COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE, Outcome 14 Adverse effects: 1b. General ‐ serious.

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Analysis 19.15

Comparison 19 HALOPERIDOL vs COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE, Outcome 15 Adverse effects: 2a. Specific ‐ arousal ‐ i. various.

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Analysis 19.16

Comparison 19 HALOPERIDOL vs COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE, Outcome 16 Adverse effects: 2b. Specific ‐ arousal ‐ ii. average scores ‐ i. up to 2 hours.

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Analysis 19.17

Comparison 19 HALOPERIDOL vs COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE, Outcome 17 Adverse effects: 2c. Specific ‐ arousal ‐ ii. average scores ‐ ii. up to 4 hours.

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Analysis 19.18

Comparison 19 HALOPERIDOL vs COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE, Outcome 18 Adverse effects: 2d. Specific ‐ arousal ‐ ii. average scores ‐ iii. up to 24 hours.

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Analysis 19.19

Comparison 19 HALOPERIDOL vs COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE, Outcome 19 Adverse effects: 2e. Specific ‐ cardiovascular.

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Analysis 19.20

Comparison 19 HALOPERIDOL vs COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE, Outcome 20 Adverse effects: 2f. Specific ‐ movement disorders.

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Analysis 19.21

Comparison 19 HALOPERIDOL vs COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE, Outcome 21 Service outcomes: 1. Not discharged by 14 days.

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Analysis 19.22

Comparison 19 HALOPERIDOL vs COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE, Outcome 22 Leaving the study early.

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Analysis 20.1

Comparison 20 HALOPERIDOL vs COMBINATIONS: e. HALOPERIDOL + RISPERIDONE, Outcome 1 Specific behaviour: 1a. Agitation ‐ average scores ‐ i. up to 24 hours.

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Analysis 20.2

Comparison 20 HALOPERIDOL vs COMBINATIONS: e. HALOPERIDOL + RISPERIDONE, Outcome 2 Specific behaviour: 1b. Agitation ‐ average scores ‐ ii. over 24 hours.

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Analysis 20.3

Comparison 20 HALOPERIDOL vs COMBINATIONS: e. HALOPERIDOL + RISPERIDONE, Outcome 3 Global outcome: No improvement.

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Analysis 20.4

Comparison 20 HALOPERIDOL vs COMBINATIONS: e. HALOPERIDOL + RISPERIDONE, Outcome 4 Adverse effects: 1a. Specific ‐ arousal level ‐ i. various.

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Analysis 20.5

Comparison 20 HALOPERIDOL vs COMBINATIONS: e. HALOPERIDOL + RISPERIDONE, Outcome 5 Adverse effects: 1b. Specific ‐ movement disorders ‐ i. various.

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Analysis 20.6

Comparison 20 HALOPERIDOL vs COMBINATIONS: e. HALOPERIDOL + RISPERIDONE, Outcome 6 Adverse effects: 1c. Specific ‐ miscellaneous.

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Analysis 21.1

Comparison 21 HALOPERIDOL vs COMBINATIONS: f. OLANZAPINE + MAGNESIUM VALPROATE, Outcome 1 Specific behaviour: 1. Agitation ‐ average scores ‐ over 24 hours.

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Analysis 21.2

Comparison 21 HALOPERIDOL vs COMBINATIONS: f. OLANZAPINE + MAGNESIUM VALPROATE, Outcome 2 Global outcome: No improvement.

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Analysis 21.3

Comparison 21 HALOPERIDOL vs COMBINATIONS: f. OLANZAPINE + MAGNESIUM VALPROATE, Outcome 3 Mental state: Average scores ‐ i. over 24 hours.

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Analysis 21.4

Comparison 21 HALOPERIDOL vs COMBINATIONS: f. OLANZAPINE + MAGNESIUM VALPROATE, Outcome 4 Adverse effects: General ‐ over 24 hours.

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Analysis 22.1

Comparison 22 HALOPERIDOL vs COMBINATIONS: g. QUETIAPINE + MAGNESIUM VALPROATE, Outcome 1 Specific behaviour: 1a. Agitation ‐ binary measures.

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Analysis 22.2

Comparison 22 HALOPERIDOL vs COMBINATIONS: g. QUETIAPINE + MAGNESIUM VALPROATE, Outcome 2 Specific behaviour: 1b. Agitation ‐ average scores ‐ i. over 24 hours.

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Analysis 23.1

Comparison 23 HALOPERIDOL vs COMBINATIONS: h. RISPERIDONE + CLONAZEPAM, Outcome 1 Tranquillisation or asleep.

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Analysis 23.2

Comparison 23 HALOPERIDOL vs COMBINATIONS: h. RISPERIDONE + CLONAZEPAM, Outcome 2 Specific behaviour: 1a. Agitation ‐ average scores ‐ i. up to 2 hours.

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Analysis 23.3

Comparison 23 HALOPERIDOL vs COMBINATIONS: h. RISPERIDONE + CLONAZEPAM, Outcome 3 Specific behaviour: 1b. Agitation ‐ average scores ‐ i. up to 4 hours.

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Analysis 23.4

Comparison 23 HALOPERIDOL vs COMBINATIONS: h. RISPERIDONE + CLONAZEPAM, Outcome 4 Specific behaviour: 1c. Agitation ‐ average scores ‐ iii. up to 24 hours.

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Analysis 23.5

Comparison 23 HALOPERIDOL vs COMBINATIONS: h. RISPERIDONE + CLONAZEPAM, Outcome 5 Specific behaviour: 1d. Agitation ‐ average scores ‐ iv. over 24 hours.

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Analysis 23.6

Comparison 23 HALOPERIDOL vs COMBINATIONS: h. RISPERIDONE + CLONAZEPAM, Outcome 6 Global outcome: No improvement.

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Analysis 23.7

Comparison 23 HALOPERIDOL vs COMBINATIONS: h. RISPERIDONE + CLONAZEPAM, Outcome 7 Mental state: 1. Average scores ‐ i. over 24 hours.

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Analysis 23.8

Comparison 23 HALOPERIDOL vs COMBINATIONS: h. RISPERIDONE + CLONAZEPAM, Outcome 8 Adverse effects: 1. General.

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Analysis 23.9

Comparison 23 HALOPERIDOL vs COMBINATIONS: h. RISPERIDONE + CLONAZEPAM, Outcome 9 Adverse effects: 2a. Specific ‐ arousal ‐ i. various.

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Analysis 23.10

Comparison 23 HALOPERIDOL vs COMBINATIONS: h. RISPERIDONE + CLONAZEPAM, Outcome 10 Adverse effects: 2b. Specific ‐ cardiovascular ‐ i. various.

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Analysis 23.11

Comparison 23 HALOPERIDOL vs COMBINATIONS: h. RISPERIDONE + CLONAZEPAM, Outcome 11 Adverse effects: 2c. Specific ‐ movement disorders ‐ i. various.

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Analysis 23.12

Comparison 23 HALOPERIDOL vs COMBINATIONS: h. RISPERIDONE + CLONAZEPAM, Outcome 12 Adverse effects: 2d. Specific ‐ miscellaneous.

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Analysis 24.1

Comparison 24 HALOPERIDOL vs COMBINATIONS: i. ZIPRASIDONE + CLONAZEPAM, Outcome 1 Specific behaviour: 1a. Agitation ‐ average scores ‐ i. up to 24 hours.

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Analysis 24.2

Comparison 24 HALOPERIDOL vs COMBINATIONS: i. ZIPRASIDONE + CLONAZEPAM, Outcome 2 Specific behaviour: 1b. Agitation ‐ average scores ‐ ii. over 24 hours.

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Analysis 24.3

Comparison 24 HALOPERIDOL vs COMBINATIONS: i. ZIPRASIDONE + CLONAZEPAM, Outcome 3 Global outcome: 1. Average scores ‐ i. over 24 hours.

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Analysis 24.4

Comparison 24 HALOPERIDOL vs COMBINATIONS: i. ZIPRASIDONE + CLONAZEPAM, Outcome 4 Mental state: 1. Average scores ‐ i. over 24 hours.

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Analysis 24.5

Comparison 24 HALOPERIDOL vs COMBINATIONS: i. ZIPRASIDONE + CLONAZEPAM, Outcome 5 Leaving the study early.

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Table 3. Suggested design for a trial

Methods	Allocation: randomised, clearly described, concealed. Blindness: double, described and tested. Duration: 2 weeks.
Participants	Diagnosis: thought to have psychoses. N = 300.* Age: any. Sex: both. History: acutely ill, aggressive.
Interventions	1. Haloperidol IM: dose flexible within recommended limits. N = 150. 2. Benzodiazepine IM: dose flexible within recommended limits. N = 150.
Outcomes	All outcomes are grouped by time: by 30 minutes, up to two hours, up to four hours, up to 24 hours and finally over 24 hours. Tranquillisation or asleep (measured at 30 minutes, 2 hours, 4 hours and 24 hours). Mortality. Specific behaviours ‐ self‐harm, including suicide, injury to others, aggression. Global outcomes ‐ overall improvement, use of additional medication, use of restraints/seclusion. Service outcomes ‐ duration of hospital stay, re‐admission. Mental state ‐ no clinically important change in general mental state. Adverse effects ‐ clinically important adverse effects. Leaving the study early ‐ why. Economic outcomes.
Notes	* Powered to be able to identify a difference of ˜20% between groups for primary outcome with adequate degree of certainty.
IM: intramuscular

Table 3. Suggested design for a trial

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Summary of findings for the main comparison. HALOPERIDOL compared to PLACEBO/NIL for psychosis‐induced aggression or agitation

HALOPERIDOL compared with PLACEBO/NIL for psychosis‐induced aggression or agitation
Patient or population: patients with psychosis‐induced aggression or agitation Setting: inpatients; multi‐centre. Intervention: HALOPERIDOL Comparison: PLACEBO/NIL
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	PLACEBO/NIL	HALOPERIDOL
Tranquillisation or asleep not asleep at 2 hours	Low¹		RR 0.88 (0.82 to 0.95)	220 (2 studies)	⊕⊝⊝⊝ very low^2,3,4
	965 per 1000	849 per 1000 (791 to 917)
	Moderate¹
	980 per 1000	862 per 1000 (804 to 931)
	High¹
	995 per 1000	876 per 1000 (816 to 945)
Repeated need for tranquillisation needing additional injection within 24 hours	Low¹		RR 0.51 (0.42 to 0.62)	660 (4 studies)	⊕⊕⊝⊝ low^2,4
	400 per 1000	204 per 1000 (168 to 248)
	Moderate¹
	600 per 1000	306 per 1000 (252 to 372)
	High¹
	800 per 1000	408 per 1000 (336 to 496)
Specific behaviour ‐ threat or injury to self or others average change score (ABS, high = worse) at 2 hours		The mean specific behaviour ‐ threat or injury to self or others in the intervention groups was 4.48 lower (5.78 to 3.18 lower)		474 (3 studies)	⊕⊝⊝⊝ very low^2,4,5
Global outcome ‐ overall improvement (not any improvement)	Low¹		RR 0.28 (0.08 to 1.07)	40 (1 study)	⊕⊕⊝⊝ low^2,6
	200 per 1000	56 per 1000 (8 to 414)
	Moderate¹
	350 per 1000	98 per 1000 (14 to 724)
	High¹
	500 per 1000	140 per 1000 (20 to 1000)
Adverse effects: Specific ‐ dystonia within 24 hours	Moderate¹		RR 7.49 (0.93 to 60.21)	207 (2 studies)	⊕⊝⊝⊝ very low^2,4,6
	0 per 1000	0 per 1000 (0 to 0)
	High¹
	10 per 1000	75 per 1000 (9 to 602)
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 Control risk ‐ 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, incomplete outcome data, sponsored by drug company. ³ Indirectness: rated 'serious' ‐ no measure for tranquil or asleep at 30 minutes, therefore had to use not asleep at 2 hours. ⁴ Publication bias: rated 'strongly suspected' ‐ sponsored by drug company. ⁵ Indirectness: rated 'serious' ‐ not threat of injury to self or others, scale derived data. ⁶ Imprecision: rated 'serious' ‐ 95% confidence interval is wide.

Summary of findings for the main comparison. HALOPERIDOL compared to PLACEBO/NIL for psychosis‐induced aggression or agitation

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Summary of findings 2. HALOPERIDOL compared to OTHER ANTIPSYCHOTIC: a. ARIPIPRAZOLE for psychosis‐induced aggression or agitation

HALOPERIDOL compared with OTHER ANTIPSYCHOTICS: a. ARIPIPRAZOLE for psychosis‐induced aggression or agitation
Patient or population: patients with psychosis‐induced aggression or agitation Setting: multi‐centre. Intervention: HALOPERIDOL Comparison: OTHER ANTIPSYCHOTICS: a. ARIPIPRAZOLE
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: a. ARIPIPRAZOLE	HALOPERIDOL
Tranquillisation or asleep ‐ not reported	See comment	See comment	Not estimable	‐	See comment	No study reported this outcome.
Repeated need for rapid tranquillisation ‐ needing additional injection	Low¹		RR 0.78 (0.62 to 0.99)	473 (2 studies)	⊕⊕⊝⊝ low^2,3
	200 per 1000	156 per 1000 (124 to 198)
	Moderate¹
	400 per 1000	312 per 1000 (248 to 396)
	High¹
	650 per 1000	507 per 1000 (403 to 644)
Specific behaviours ‐ agitation: CABS average change score at 2 hours		The mean specific behaviours ‐ agitation: average change score at 2 hours in the intervention groups was 0.55 lower (2.10 lower to 1.01 higher)		470 (2 studies)	⊕⊝⊝⊝ very low^1,2,4
Global outcomes: need for benzodiazepine ²	Low¹		RR 1.26 (0.74 to 2.16)	477 (2 studies)	⊕⊝⊝⊝ very low^2,3,5
	50 per 1000	63 per 1000 (37 to 108)
	Moderate¹
	100 per 1000	126 per 1000 (74 to 216)
	High¹
	200 per 1000	252 per 1000 (148 to 432)
Adverse effects: any serious, specific ‐ dystonia during 24 hours	Low⁶		RR 6.63 (1.52 to 28.86)	477 (2 studies)	⊕⊝⊝⊝ very low^3,7,8
	0 per 1000	0 per 1000 (0 to 0)
	Moderate⁶
	50 per 1000	332 per 1000 (76 to 1000)
	High⁶
	100 per 1000	663 per 1000 (152 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 roughly equates with that of the trial control group. ² Risk of bias: rated 'severe' ‐ method of randomisation not described, possible that blinding was broken in Bristol Myers 2005, adverse effects only reported when reported by 5% of participants, sponsored by drug company. ³ Publication bias: rated 'strongly suspected' ‐ sponsored by drug company. ⁴ Indirectness: rated 'serious' ‐ scale‐derived data, not threat or injury to self or others as stated in protocol. ⁵ Indirectness: rated 'serious' ‐ no measure for global outcome, overall improvement, therefore global improvement is inferred by need for benzodiazepine. ⁶ Low risk equates with that of trial control group. ⁷ Risk of bias: rated 'serious' ‐ method of randomisation not described, incomplete outcome data, adverse effects only reported when reported by at least 5% of participants, sponsored by drug company. ⁸ Imprecision: rated 'very serious' ‐ 95% confidence intervals are wide.

Summary of findings 2. HALOPERIDOL compared to OTHER ANTIPSYCHOTIC: a. ARIPIPRAZOLE for psychosis‐induced aggression or agitation

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Summary of findings 3. HALOPERIDOL compared to OTHER ANTIPSYCHOTIC: b. CHLORPROMAZINE for psychosis‐induced aggression or agitation

HALOPERIDOL compared with OTHER ANTIPSYCHOTIC: b. CHLORPROMAZINE for psychosis‐induced aggression or agitation
Patient or population: patients with psychosis‐induced aggression or agitation Setting: inpatients. Intervention: HALOPERIDOL Comparison: OTHER ANTIPSYCHOTIC: b. CHLORPROMAZINE
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 ANTIPSYCHOTIC: b. CHLORPROMAZINE	HALOPERIDOL
Tranquillisation or asleep Not tranquil or asleep	Low¹		RR 1.93 (1.04 to 3.60)	39 (1 study)	⊕⊝⊝⊝ very low^2,3,4
	200 per 1000	386 per 1000 (208 to 720)
	Moderate¹
	500 per 1000	965 per 1000 (520 to 1000)
	High¹
	700 per 1000	1000 per 1000 (728 to 1000)
Repeated need for rapid tranquillisation ‐ more that 1 injection	Low¹		RR 1.07 (0.89 to 1.28)	30 (1 study)	⊕⊝⊝⊝ very low^2,3,4
	800 per 1000	856 per 1000 (712 to 1000)
	Moderate¹
	900 per 1000	963 per 1000 (801 to 1000)
	High¹
	990 per 1000	1000 per 1000 (881 to 1000)
Specific behaviour ‐ threat or injury of harm to self or others ‐ not reported	See comment	See comment	Not estimable	‐	See comment	No study reported this outcome.
Global outcome ‐ not any improvement	Low¹		RR 0.15 (0.05 to 0.49)	89 (2 studies)	⊕⊝⊝⊝ very low^2,3
	1000 per 1000	150 per 1000 (50 to 490)
	Moderate¹
	300 per 1000	45 per 1000 (15 to 147)
	High¹
	500 per 1000	75 per 1000 (25 to 245)
Adverse effects: specific ‐ cardiovascular ‐ hypotension	Low¹		RR 0.51 (0.01 to 2.60)	30 (1 study)	⊕⊝⊝⊝ very low^2,3,4
	50 per 1000	10 per 1000 (0 to 192)
	Moderate¹
	150 per 1000	30 per 1000 (1 to 577)
	High¹
	250 per 1000	50 per 1000 (2 to 962)
Adverse effects: specific ‐ central nervous system ‐ seizures	Low¹		RR 0.33 (0.01 to 7.58)	30 (1 study)	⊕⊝⊝⊝ very low^2,3,4
	10 per 1000	3 per 1000 (0 to 76)
	Moderate¹
	50 per 1000	17 per 1000 (0 to 379)
	High¹
	150 per 1000	50 per 1000 (1 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 Control risk ‐ moderate risk roughly equates to that of the control group ² Risk of bias: rated 'serious' ‐ not explicitly described as randomised, missing data was not imputed using appropriate methods such as LOCF, small study. ³ Imprecision: rated 'serious' ‐ small study. ⁴ Publication bias: rated 'strongly suspected' ‐ small study (15 participants per group).

Summary of findings 3. HALOPERIDOL compared to OTHER ANTIPSYCHOTIC: b. CHLORPROMAZINE for psychosis‐induced aggression or agitation

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Summary of findings 4. HALOPERIDOL compared to OTHER ANTIPSYCHOTIC: c. DROPERIDOL for psychosis‐induced aggression or agitation

HALOPERIDOL compared to OTHER ANTIPSYCHOTIC: c. DROPERIDOL for psychosis‐induced aggression or agitation
Patient or population: psychosis‐induced aggression or agitation Setting: inpatients; emergency room. Intervention: HALOPERIDOL Comparison: OTHER ANTIPSYCHOTIC: c. DROPERIDOL
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with OTHER ANTIPSYCHOTIC: c. DROPERIDOL	Risk with HALOPERIDOL
Tranquillisation or asleep ‐ not asleep up to 2 hours	Study population		RR 1.07 (0.44 to 2.60)	228 (1 RCT)	⊕⊕⊕⊝ moderate¹
	82 per 1.000	88 per 1.000 (36 to 213)
Repeated need for rapid tranquillisation ‐ more than 1 injection	Low		RR 2.38 (1.27 to 4.47)	255 (2 RCTs)	⊕⊕⊕⊝ moderate²
	50 per 1.000	119 per 1.000 (64 to 224)
	Moderate
	70 per 1.000	167 per 1.000 (89 to 313)
	High
	360 per 1.000	857 per 1.000 (457 to 1.000)
Specific behaviour ‐ threat or injury to self or others ‐ not reported	‐	‐	‐	‐	‐	No study reported this outcome.
Global outcome ‐ need for benzodiazepine	Study population		RR 0.31 (0.07 to 1.44)	228 (1 RCT)	⊕⊕⊕⊝ moderate¹
	59 per 1.000	18 per 1.000 (4 to 85)
Adverse effects: specific ‐ dystonia	Study population		RR 0.86 (0.11 to 6.56)	255 (2 RCTs)	⊕⊕⊕⊝ moderate⁵
	8 per 1.000	7 per 1.000 (1 to 51)
Economic outcome ‐ not reported	‐	‐	‐	‐	‐	No study 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 CI include no effect ² Risk of bias: rated 'serious' ‐ method of randomisation not reported, described as double blind but no further information given regarding rater blinding, small short study. ³ Publication bias: rated 'strongly suspected' ‐ small study. ⁴ Moderate risk roughly equates with that of the trial control group, ⁵ Adverse effects ‐ imprecision ‐ 95% confidence interval. ⁶ Adverse effects ‐ publication bias ‐ small study.

Summary of findings 4. HALOPERIDOL compared to OTHER ANTIPSYCHOTIC: c. DROPERIDOL for psychosis‐induced aggression or agitation

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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 low^2,3,4
	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 low^2,4,5,6	* 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 low^2,4,6,7
	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)	⊕⊕⊝⊝ low^2,4
	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 low^2,4
	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 low^2,4,6
	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.

Summary of findings 5. HALOPERIDOL compared to OTHER ANTIPSYCHOTIC: d. LOXAPINE for psychosis‐induced aggression or agitation

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Summary of findings 6. HALOPERIDOL compared to OTHER ANTIPSYCHOTIC: e. OLANZAPINE for psychosis induced aggression or agitation

HALOPERIDOL compared to OTHER ANTIPSYCHOTIC: e. OLANZAPINE for psychosis induced aggression or agitation
Patient or population: psychosis induced aggression or agitation Setting: Emergency room; multi‐centre. Intervention: HALOPERIDOL Comparison: OTHER ANTIPSYCHOTIC: e. OLANZAPINE
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with OTHER ANTIPSYCHOTIC: e. OLANZAPINE	Risk with HALOPERIDOL
Tranquilisation or asleep assessed with: not asleep up to 2 hours	Low		RR 1.16 (1.02 to 1.32)	257 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{2 3}
	200 per 1.000	232 per 1.000 (204 to 264)
	Moderate
	700 per 1.000	812 per 1.000 (714 to 924)
	High
	900 per 1.000	1000 per 1.000 (918 to 1.000)
Repeated need for tranquillisation assessed with: needing an additional injection by 24 hours	Low		RR 1.06 (0.75 to 1.51)	392 (3 RCTs)	⊕⊝⊝⊝ VERY LOW ²
	50 per 1.000	53 per 1.000 (38 to 76)
	Moderate
	200 per 1.000	212 per 1.000 (150 to 302)
	High
	350 per 1.000	371 per 1.000 (262 to 529)
Specific behaviour ‐ threat or injury to self or others assessed with: less than 40% reduction in PANSS‐EC rated at 2 hours	Low		RR 0.96 (0.58 to 1.58)	45 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{2 5}
	200 per 1.000	192 per 1.000 (116 to 316)
	Moderate
	400 per 1.000	384 per 1.000 (232 to 632)
	High
	600 per 1.000	576 per 1.000 (348 to 948)
Global outcome ‐ need for benzodiazepine during 24 hours	Low		RR 1.05 (0.63 to 1.74)	343 (2 RCTs)	⊕⊝⊝⊝ VERY LOW ^{6 7}
	50 per 1.000	53 per 1.000 (32 to 87)
	Moderate
	150 per 1.000	158 per 1.000 (95 to 261)
	High
	250 per 1.000	263 per 1.000 (158 to 435)
Adverse effects: Specific ‐ dystonia during 24 hours	Low		RR 12.92 (1.67 to 99.78)	343 (2 RCTs)	⊕⊝⊝⊝ VERY LOW ^{6 7}
	0 per 1.000	0 per 1.000 (0 to 0)
	Moderate
	0 per 1.000	0 per 1.000 (0 to 0)
	High
	5 per 1.000	65 per 1.000 (8 to 499)
Economic outcome ‐ not reported	‐	‐	‐	‐	‐	No studies 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; OR: Odds 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 Moderate risk is roughly equal to that of the control group. ² Risk of bias: rated 'very serious' ‐ method of randomisation not reported, allocation concealment not stated, described as double blind but no further details are given regarding blinding, selective reporting, sponsored by drug company. ³ Indirectness: rated 'serious' ‐ tranquil at 30 minutes is not measured, therefore used not asleep at 2 hour. ⁴ Publication bias: rated 'strongly suspected' ‐ sponsored by drug company. ⁵ Indirectness: rated 'serious' ‐ not threat or injury to self or others as stated in protocol, therefore inferred further aggressive behaviour by less than a 40% reduction in PANSS‐EC score. ⁶ Risk of bias: rated 'serious' ‐ method of randomisation is not reported, allocation concealment not stated, described as double blind but no further information given, incomplete outcome data, selective reporting, sponsored by drug company. ⁷ Imprecision: rated 'serious' ‐ 95% confidence interval is wide.

Summary of findings 6. HALOPERIDOL compared to OTHER ANTIPSYCHOTIC: e. OLANZAPINE for psychosis induced aggression or agitation

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Summary of findings 7. HALOPERIDOL compared to OTHER ANTIPSYCHOTIC: f. PERPHENAZINE for psychosis‐induced aggression or agitation

HALOPERIDOL compared with OTHER ANTIPSYCHOTIC: f. PERPHENAZINE for psychosis‐induced aggression or agitation
Patient or population: patients with psychosis‐induced aggression or agitation Setting: inpatients. Intervention: HALOPERIDOL Comparison: OTHER ANTIPSYCHOTIC: f. PERPHENAZINE
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 ANTIPSYCHOTIC: f. PERPHENAZINE	HALOPERIDOL
Tranquillisation or asleep ‐ not reported	See comment	See comment	Not estimable	‐	See comment	No study reported this outcome.
Repeated need for rapid tranquillisation ‐ not reported	See comment	See comment	Not estimable	‐	See comment	No study reported this outcome.
Specific behaviour ‐ injury or threat of self to others ‐ not reported	See comment	See comment	Not estimable	‐	See comment	No study reported this outcome.
Global outcome: general ‐ no improvement	Low¹		RR 0.46 (0.04 to 4.68)	44 (1 study)	⊕⊝⊝⊝ very low^2,3
	10 per 1000	5 per 1000 (0 to 47)
	Moderate¹
	100 per 1000	46 per 1000 (4 to 468)
	High¹
	200 per 1000	92 per 1000 (8 to 936)
Adverse effect: Specific ‐ hypotensive episode	Low¹		RR 0.31 (0.01 to 7.12)	44 (1 study)	⊕⊝⊝⊝ very low^2,3,4
	10 per 1000	3 per 1000 (0 to 71)
	Moderate¹
	50 per 1000	15 per 1000 (0 to 356)
	High¹
	100 per 1000	31 per 1000 (1 to 712)
Adverse effect ‐ discontinued due to EPS	Low¹		RR 1.83 (0.18 to 18.7)	44 (1 study)	⊕⊝⊝⊝ very low^2,3,5
	10 per 1000	18 per 1000 (2 to 187)
	Moderate¹
	50 per 1000	92 per 1000 (9 to 935)
	High¹
	100 per 1000	183 per 1000 (18 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 'serious' ‐ method or randomisation not described, allocation concealment not stated, described as double‐blind but no further details given regarding rater blinding, author suspects that only the adverse effects severe enough to warrant discontinuation were reported. ³ Publication bias: rated 'strongly suspected' ‐ small study. ⁴ Imprecision: rated 'serious' ‐ 95% confidence interval is wide, small study. ⁵ Indirectness: rated 'serious' ‐ not specific adverse effect ‐ only have data for the number of people discontinued due to EPS, not the number of people who had EPS in general.

Summary of findings 7. HALOPERIDOL compared to OTHER ANTIPSYCHOTIC: f. PERPHENAZINE for psychosis‐induced aggression or agitation

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Summary of findings 8. HALOPERIDOL compared to OTHER ANTIPSYCHOTICS: g. QUETIAPINE for psychosis‐induced aggression or agitation

HALOPERIDOL compared to OTHER ANTIPSYCHOTICS: g. QUETIAPINE for psychosis‐induced aggression or agitation
Patient or population: psychosis‐induced aggression or agitation Setting: inpatients. Intervention: HALOPERIDOL Comparison: OTHER ANTIPSYCHOTICS: g. QUETIAPINE
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with OTHER ANTIPSYCHOTICS: g. QUETIAPINE	Risk with HALOPERIDOL
Tranquillisation or asleep ‐ not reported	‐	‐	‐	‐	‐	No study reported this outcome.
Repeated need for tranquillisation ‐ not reported	‐	‐	‐	‐	‐	No study reported this outcome.
Specific behaviour ‐ agitation assessed with: change score at 24 hours on the PANSS‐EC		MD 0.10 higher (0.56 lower to 0.76 higher)	‐	80 (1 RCT)	⊕⊕⊝⊝ low¹
Global outcome ‐ not reported	‐	‐	‐	‐	‐	No study reported this outcome.
Adverse effects assessed with: one or more drug‐related adverse events	Low		RR 1.81 (1.19 to 2.77)	80 (1 RCT)	⊕⊕⊝⊝ low¹
	200 per 1.000	362 per 1.000 (238 to 554)
	Moderate
	400 per 1.000	724 per 1.000 (476 to 1.000)
	High
	600 per 1.000	1000 per 1.000 (714 to 1.000)
Economic outcome ‐ not reported	‐	‐	‐	‐	‐	No study 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 Imprecision: rated 'very serious' ‐ small study, 95% CI are wide.

Summary of findings 8. HALOPERIDOL compared to OTHER ANTIPSYCHOTICS: g. QUETIAPINE for psychosis‐induced aggression or agitation

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Summary of findings 9. HALOPERIDOL compared to OTHER ANTIPSYCHOTIC: h. RISPERIDONE for psychosis‐induced aggression or agitation

HALOPERIDOL compared with OTHER ANTIPSYCHOTIC: g. RISPERIDONE for psychosis‐induced aggression or agitation
Patient or population: patients with psychosis‐induced aggression or agitation Setting: inpatients; emergency room; multi‐centre. Intervention: HALOPERIDOL Comparison: OTHER ANTIPSYCHOTIC: g. RISPERIDONE
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 ANTIPSYCHOTIC: g. RISPERIDONE	HALOPERIDOL
Tranquillisation or asleep ‐ not asleep	Low¹		RR 0.84 (0.74 to 0.95)	162 (1 study)	⊕⊕⊕⊝ moderate²
	700 per 1000	588 per 1000 (518 to 665)
	Moderate¹
	900 per 1000	756 per 1000 (666 to 855)
	High¹
	1000 per 1000	840 per 1000 (740 to 950)
Repeated need for rapid tranquillisation ‐ needing additional benzodiazepine	Low		RR 0.98 (0.65 to 1.47)	286 (2 studies)	⊕⊕⊝⊝ low^2,3
	100 per 1000	98 per 1000 (65 to 147)
	Moderate
	200 per 1000	196 per 1000 (130 to 294)
	High
	300 per 1000	294 per 1000 (195 to 441)
Specific behaviours ‐ agitation >50% reduction in PANSS‐EC score Follow‐up: 1 days	Low¹		RR 1.15 (0.6 to 2.22)	124 (1 study)	⊕⊕⊝⊝ low^2,4
	50 per 1000	58 per 1000 (30 to 111)
	Moderate¹
	200 per 1000	230 per 1000 (120 to 444)
	High¹
	350 per 1000	402 per 1000 (210 to 777)
Global outcome ‐ rated as severe ‐ CGI‐S Follow‐up: 1 days	Low¹		RR 0.89 (0.51 to 1.58)	162 (1 study)	⊕⊝⊝⊝ very low^2,3,4
	100 per 1000	89 per 1000 (51 to 158)
	Moderate¹
	200 per 1000	178 per 1000 (102 to 316)
	High¹
	300 per 1000	267 per 1000 (153 to 474)
Adverse effects: Specific ‐ EPS during 24 hours	Low¹		RR 1.6 (0.55 to 4.62)	124 (1 study)	⊕⊕⊝⊝ low^2,4
	10 per 1000	16 per 1000 (6 to 46)
	Moderate¹
	100 per 1000	160 per 1000 (55 to 462)
	High¹
	200 per 1000	320 per 1000 (110 to 924)
Adverse effects: Specific ‐ acute dystonia during 24 hours	Low¹		RR 5 (0.24 to 102.07)	286 (2 studies)	⊕⊝⊝⊝ very low^2,3,4
	10 per 1000	50 per 1000 (2 to 1000)
	Moderate¹
	20 per 1000	100 per 1000 (5 to 1000)
	High¹
	30 per 1000	150 per 1000 (7 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 'serious' ‐ method of randomisation not described, single blind, sponsored by drug company. ³ Imprecision: rated 'serious' ‐ few data and confidence intervals wide. ⁴ Publication bias: rated 'strongly suspected ‐ sponsored by drug company.

Summary of findings 9. HALOPERIDOL compared to OTHER ANTIPSYCHOTIC: h. RISPERIDONE for psychosis‐induced aggression or agitation

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Summary of findings 10. HALOPERIDOL compared to OTHER ANTIPSYCHOTIC: i. THIOTHIXENE for psychosis‐induced aggression or agitation

HALOPERIDOL compared to OTHER ANTIPSYCHOTIC: h. THIOTHIXENE for psychosis‐induced aggression or agitation
Patient or population: patients with psychosis‐induced aggression or agitation Setting: inpatients; emergency room. Intervention: HALOPERIDOL Comparison: OTHER ANTIPSYCHOTIC: h. THIOTHIXENE
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 ANTIPSYCHOTIC: h. THIOTHIXENE	HALOPERIDOL
Tranquillisation or asleep ‐ not reported	See comment	See comment	Not estimable	‐	See comment	No study reported this outcome.
Repeated need for rapid tranquillisation	Low¹		RR 1.07 (0.89 to 1.28)	30 (1 study)	⊕⊝⊝⊝ very low^2,3
	850 per 1000	910 per 1000 (756 to 1000)
	Moderate¹
	900 per 1000	963 per 1000 (801 to 1000)
	High¹
	950 per 1000	1000 per 1000 (845 to 1000)
Specific behaviour ‐ threat or injury to self or others ‐ not reported	See comment	See comment	Not estimable	‐	See comment	No study reported this outcome.
Global outcome No improvement at 1 hour	Low¹		RR 0.50 (0.14 to 1.84)	44 (1 study)	⊕⊝⊝⊝ very low^2,3,4
	50 per 1000	25 per 1000 (7 to 92)
	Moderate¹
	250 per 1000	125 per 1000 (35 to 460)
	High¹
	450 per 1000	225 per 1000 (63 to 828)
Adverse effects: specific ‐ hypotensive episode	Low		Not estimable	30 (1 study)	⊕⊝⊝⊝ very low^2,3,4
	0 per 1000	0 per 1000 (0 to 0)
Adverse effects: specific ‐ tachycardia	Low¹		RR 0.28 (0.01 to 6.52)	44 (1 study)	⊕⊝⊝⊝ very low^2,3,4
	10 per 1000	3 per 1000 (0 to 65)
	Moderate¹
	50 per 1000	14 per 1000 (0 to 326)
	High¹
	100 per 1000	28 per 1000 (1 to 652)
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 Control risk ‐ moderate risk roughly equates to that of the trial control group. ² Risk of bias: rated 'serious' ‐ method of sequence generation not clear, allocation concealment not reported, small study, sponsored by drug company. ³ Publication bias: rated 'strongly suspected' ‐ small study, sponsored by drug company. ⁴ Imprecision: rated 'serious' ‐ small study, wide confidence intervals.

Summary of findings 10. HALOPERIDOL compared to OTHER ANTIPSYCHOTIC: i. THIOTHIXENE for psychosis‐induced aggression or agitation

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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 low^{1 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)	⊕⊕⊝⊝ low^{3 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 low^{5 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 low^{3 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.

Summary of findings 11. HALOPERIDOL compared to OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE for psychosis‐induced aggression or agitation

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Summary of findings 12. HALOPERIDOL compared to OTHER ANTIPSYCHOTIC: k. ZUCLOPENTHIXOL ACETATE for psychosis‐induced aggression or agitation

HALOPERIDOL compared with OTHER ANTIPSYCHOTICS: j. ZUCLOPENTHIXOL ACETATE for psychosis‐induced aggression or agitation
Patient or population: patients with psychosis‐induced aggression or agitation Setting: inpatients. Intervention: HALOPERIDOL Comparison: OTHER ANTIPSYCHOTICS: j. ZUCLOPENTHIXOL ACETATE
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: j. ZUCLOPENTHIXOL ACETATE	HALOPERIDOL
Tranquillisation or asleep ‐ not reported	See comment	See comment	Not estimable	‐	See comment	No study reported this outcome.
Repeated need for rapid tranquillisation ‐ more than 3 injections	Low¹		RR 2.54 (1.19 to 5.46)	70 (1 study)	⊕⊝⊝⊝ very low^2,3,4
	50 per 1000	127 per 1000 (60 to 273)
	Moderate¹
	200 per 1000	508 per 1000 (238 to 1000)
	High¹
	350 per 1000	889 per 1000 (417 to 1000)
Specific behaviour ‐ threat or injury to self or others ‐ not reported	See comment	See comment	Not estimable	‐	See comment	No study reported this outcome.
Global outcome ‐ not reported	See comment	See comment	Not estimable	‐	See comment	No study reported this outcome.
Adverse effects: specific ‐ tremor by 7 days	Low¹		RR 4.16 (0.93 to 18.62)	70 (1 study)	⊕⊝⊝⊝ very low^2,4,5
	10 per 1000	42 per 1000 (9 to 186)
	Moderate¹
	50 per 1000	208 per 1000 (47 to 931)
	High¹
	100 per 1000	416 per 1000 (93 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 reported, open label, author suspects that rater was only blind for some outcomes. ³ Indirectness: rated 'serious' ‐ measures more than 3 injections, not just more than 1 injection. ⁴ Imprecision: rated 'serious' ‐ small study. ⁵ Indirectness: rated 'serious' ‐ no serious specific adverse effect, therefore used tremor.

Summary of findings 12. HALOPERIDOL compared to OTHER ANTIPSYCHOTIC: k. ZUCLOPENTHIXOL ACETATE for psychosis‐induced aggression or agitation

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Summary of findings 13. HALOPERIDOL compared to BENZODIAZEPINE: a. FLUNITRAZEPAM for psychosis‐induced aggression or agitation

HALOPERIDOL compared with BENZODIAZEPINE: a. FLUNITRAZEPAM for psychosis‐induced aggression or agitation
Patient or population: patients with psychosis‐induced aggression or agitation Setting: inpatients. Intervention: HALOPERIDOL Comparison: BENZODIAZEPINE: a. FLUNITRAZEPAM
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: a. FLUNITRAZEPAM	HALOPERIDOL
Tranquillisation or asleep ‐ not reported	See comment	See comment	Not estimable	‐	See comment	No study reported this outcome.
Repeated need for tranquillisation within 24 hours ‐ not reported	See comment	See comment	Not estimable	‐	See comment	No study reported this outcome.
Specific behaviours ‐ aggression 50% reduction in OAS score at 90 minutes	Low¹		RR 1.15 (0.86 to 1.55)	28 (1 study)	⊕⊝⊝⊝ very low^2,3,4
	650 per 1000	747 per 1000 (559 to 1000)
	Moderate¹
	800 per 1000	920 per 1000 (688 to 1000)
	High¹
	950 per 1000	1000 per 1000 (817 to 1000)
Global outcome ‐ need for restraint or seclusion	See comment	See comment	Not estimable	28 (1 study)	⊕⊝⊝⊝ very low^2,4,5,6	No events in either group.
Adverse effects: specific ‐ EPS	See comment	See comment	Not estimable	28 (1 study)	⊕⊝⊝⊝ very low^2,4,6,7	No events in either group.
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' ‐ allocation concealment not stated, described as double‐blind, however the blinding of participants and personnel are not reported, it is not clear whether all side effects are reported, small short study. ³ Indirectness: rated 'serious' ‐ not threat or injury to self or others, inferred from OAS rating scale. ⁴ Publication bias: rated 'strongly suspected' ‐ small study. ⁵ Indirectness: rated 'serious' ‐ there is no measure for overall improvement, therefore inferred no overall improvement by need for restraints. ⁶ Imprecision: rated 'serious' ‐ small study. ⁷ Indirectness: rated 'serious' ‐ EPS can refer to a number of different symptoms rather than one specific side effect.

Summary of findings 13. HALOPERIDOL compared to BENZODIAZEPINE: a. FLUNITRAZEPAM for psychosis‐induced aggression or agitation

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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 low^2,3,4,5
	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 low^4,5,6
	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 low^2,4
	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 low^4,5,6
	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 low^4,5,6
	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.

Summary of findings 14. HALOPERIDOL compared to BENZODIAZEPINE: b. LORAZEPAM for psychosis‐induced aggression or agitation

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Summary of findings 15. HALOPERIDOL compared to BENZODIAZEPINE: c. MIDAZOLAM for psychosis‐induced aggression or agitation

HALOPERIDOL compared with BENZODIAZEPINE: c. MIDAZOLAM for psychosis‐induced aggression or agitation
Patient or population: patients with psychosis‐induced aggression or agitation Setting: emergency room. Intervention: HALOPERIDOL Comparison: BENZODIAZEPINE: c. MIDAZOLAM
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: c. MIDAZOLAM	HALOPERIDOL
Tranquillisation or asleep ‐ not reported	See comment	See comment	Not estimable	‐	See comment	No study reported this outcome.
Repeated need for rapid tranquillisation ‐ not reported	See comment	See comment	Not estimable	‐	See comment	No study reported this outcome.
Specific behaviour ‐ threat or injury to self or others ‐ not reported	See comment	See comment	Not estimable	‐	See comment	No study reported this outcome.
Global outcome Need for rescue drug	Low¹		RR 1.14 (0.46 to 2.87)	84 (1 study)	⊕⊕⊝⊝ low^2,3
	50 per 1000	57 per 1000 (23 to 143)
	Moderate¹
	150 per 1000	171 per 1000 (69 to 430)
	High¹
	250 per 1000	285 per 1000 (115 to 717)
Adverse effects ‐ general ‐ one or more drug‐related adverse effect	Low⁴		RR 5.00 (0.25 to 101.11)	84 (1 study)	⊕⊕⊝⊝ low^3,5
	0 per 1000	0 per 1000 (0 to 0)
	Moderate⁴
	50 per 1000	250 per 1000 (12 to 1000)
	High⁴
	100 per 1000	500 per 1000 (25 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 Medium risk is roughly equal to that of the trial control group. ² Indirectness: rated 'serious' ‐ no measure for overall improvement, no overall improvement inferred from need for rescue drug. ³ Imprecision: rated 'serious' ‐ 95% confidence interval is wide. ⁴ Low risk is roughly equal to that of the trial control group. ⁵ Indirectness: rated 'serious' ‐ no serious adverse effect, therefore used one or more adverse effects.

Summary of findings 15. HALOPERIDOL compared to BENZODIAZEPINE: c. MIDAZOLAM for psychosis‐induced aggression or agitation

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Summary of findings 16. HALOPERIDOL compared to COMBINATIONS: a. HALOPERIDOL + LEVOMEPROMAZINE for psychosis‐induced aggression or agitation

HALOPERIDOL compared with 1. COMBINATIONS ‐ HALOPERIDOL + LEVOMEPROMAZINE for psychosis‐induced aggression or agitation
Patient or population: patients with psychosis‐induced aggression or agitation Setting: inpatients. Intervention: HALOPERIDOL Comparison: COMBINATIONS: a. HALOPERIDOL + LEVOMEPROMAZINE
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	COMBINATIONS: a. HALOPERIDOL + LEVOMEPROMAZINE	HALOPERIDOL
Tranquillisation or asleep ‐ not reported	See comment	See comment	Not estimable	‐	See comment	No study reported this outcome.
Repeated need for tranquillisation ‐ not reported	See comment	See comment	Not estimable	‐	See comment	No study reported this outcome.
Specific behaviours ‐ threat or injury to self or others ‐ not reported	See comment	See comment	Not estimable	‐	See comment	No study reported this outcome.
Global outcome: general ‐ no overall improvement	Low¹		RR 8.18 (0.5 to 133.66)	19 (1 study)	⊕⊝⊝⊝ very low^2,3,4
	0 per 1000	0 per 1000 (0 to 0)
	Moderate¹
	200 per 1000	1000 per 1000 (100 to 1000)
	High¹
	400 per 1000	1000 per 1000 (200 to 1000)
Adverse effect: any serious, specific ‐ not reported	See comment	See comment	Not estimable	‐	See comment	No study reported this outcome.
Economic outcome ‐ not measured	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 Low risk is roughly equal to that of the trial control group. ² Risk of bias: rated 'very serious' ‐ method of randomisation not described, allocation concealment not stated, open trial, no reporting of the presence or absence of adverse effects in the results, small study. ³ Imprecision: rated 'very serious' ‐ very small study (n = 19), 95% confidence interval is wide. ⁴ Publication bias: rated 'strongly suspected' ‐ small study.

Summary of findings 16. HALOPERIDOL compared to COMBINATIONS: a. HALOPERIDOL + LEVOMEPROMAZINE for psychosis‐induced aggression or agitation

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Summary of findings 17. HALOPERIDOL compared to COMBINATIONS: b. HALOPERIDOL + LORAZEPAM for psychosis‐induced aggression or agitation

HALOPERIDOL compared with COMBINATIONS: b. HALOPERIDOL + LORAZEPAM for psychosis‐induced aggression or agitation
Patient or population: patients with psychosis‐induced aggression or agitation Setting: inpatients; emergency room. Intervention: HALOPERIDOL Comparison: COMBINATIONS: b. HALOPERIDOL + 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
	COMBINATIONS: b. HALOPERIDOL + LORAZEPAM	HALOPERIDOL
Tranquillisation or asleep ‐ not asleep by 3 hours	Low¹		RR 1.83 (1.11 to 3.02)	67 (1 study)	⊕⊝⊝⊝ very low^2,3,4,5
	200 per 1000	366 per 1000 (222 to 604)
	Moderate¹
	400 per 1000	732 per 1000 (444 to 1000)
	High¹
	600 per 1000	1000 per 1000 (666 to 1000)
Repeated need for rapid tranquillisation ‐ needing additional injection during 24 hours	Low¹		RR 1.05 (0.87 to 1.27)	67 (1 study)	⊕⊝⊝⊝ very low^2,4,5
	750 per 1000	788 per 1000 (653 to 952)
	Moderate¹
	850 per 1000	892 per 1000 (740 to 1000)
	High¹
	950 per 1000	997 per 1000 (827 to 1000)
Specific behaviour ‐ threat or injury to self or others ‐ not reported	See comment	See comment	Not estimable	‐	See comment
Global outcome: no overall improvement ‐ at 30 minutes	Low¹		RR 2.67 (1.25 to 5.68)	45 (1 study)	⊕⊝⊝⊝ very low^4,6
	50 per 1000	134 per 1000 (62 to 284)
	Moderate¹
	250 per 1000	668 per 1000 (312 to 1000)
	High¹
	450 per 1000	1000 per 1000 (562 to 1000)
Adverse effects: Specific ‐ dystonia (only reported if occurred in ≥9%) during 24 hours	Low⁷		RR 8.25 (0.46 to 147.45)	67 (1 study)	⊕⊝⊝⊝ very low^2,4,5,8
	0 per 1000	0 per 1000 (0 to 0)
	Moderate⁷
	50 per 1000	412 per 1000 (23 to 1000)
	High⁷
	100 per 1000	825 per 1000 (46 to 1000)
Adverse effects: Specific ‐ hypertonia/rigidity (only reported if occurred in ≥9%) during 24 hours	Low¹		RR 2.74 (0.30 to 25.05)	67 (1 study)	⊕⊝⊝⊝ very low^2,4,5,8
	10 per 1000	27 per 1000 (3 to 250)
	Moderate¹
	30 per 1000	82 per 1000 (9 to 751)
	High¹
	50 per 1000	137 per 1000 (15 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' ‐ allocation concealment not stated, 2 people excluded from the efficacy analysis following randomisation, adverse effects only reported if they occurred in ≥9% of participants, sponsored by drug company. ³ Indirectness: rated 'serious' ‐ there are no data for 30 minutes, only 3 hours. ⁴ Imprecision: rated 'serious' ‐ relatively small number of participants in each treatment arm. ⁵ Publication bias: rated 'strongly suspected' ‐ sponsored by drug company. ⁶ Risk of bias: rated 'very serious' ‐ method of randomisation not described, allocation concealment not described, open trial, no reporting regarding the presence or absence of adverse effects, duration of the study is not reported. ⁷ Low risk is roughly equal to that of the control group. ⁸ Indirectness: rated 'severe' ‐ not reported as 'severe' in this study.

Summary of findings 17. HALOPERIDOL compared to COMBINATIONS: b. HALOPERIDOL + LORAZEPAM for psychosis‐induced aggression or agitation

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Summary of findings 18. HALOPERIDOL compared to COMBINATIONS: c. HALOPERIDOL + MIDAZOLAM for psychosis‐induced aggression or agitation

HALOPERIDOL compared to COMBINATIONS: c. HALOPERIDOL + MIDAZOLAM for psychosis‐induced aggression or agitation
Patient or population: psychosis‐induced aggression or agitation Setting: emergency room. Intervention: HALOPERIDOL Comparison: COMBINATIONS: c. HALOPERIDOL + MIDAZOLAM
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with COMBINATIONS: c. HALOPERIDOL + MIDAZOLAM	Risk with HALOPERIDOL
Tranquillisation or asleep ‐ not reported	‐	‐	‐	‐	‐	No study reported this outcome.
Repeated need for tranquillisation assessed with: need for additional drugs for tranquilisation by 12 hours	Study population		RR 0.88 (0.69 to 1.13)	60 (1 RCT)	⊕⊝⊝⊝ very low^{1 2}
	867 per 1.000	763 per 1.000 (598 to 979)
Specific behaviour ‐ agitation assessed with: average endpoint scores at 12 hours on OASS		MD 11.20 lower (12.24 lower to 10.16 lower)	‐	60 (1 RCT)	⊕⊝⊝⊝ very low^{1 2}
Global outcome assessed with: additional restraint, seclusion or special observation during 12 hours	Low		RR 0.29 (0.13 to 0.61)	60 (1 RCT)	⊕⊝⊝⊝ very low^{1 2}
	350 per 1.000	102 per 1.000 (46 to 214)
	Moderate
	700 per 1.000	203 per 1.000 (91 to 427)
	High
	950 per 1.000	275 per 1.000 (124 to 580)
Adverse effects assessed with: EPS by 12 hours	Study population		RR 1.67 (0.44 to 6.36)	60 (1 RCT)	⊕⊝⊝⊝ very low^{1 2}
	100 per 1.000	167 per 1.000 (44 to 636)
Economic outcome ‐ not reported	‐	‐	‐	‐	‐	No study 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 'very serious' ‐ method of allocation not stated, patients instructed to not reveal their allocation although the trial is described as double blind, selective reporting, small study. ² Imprecision: rated 'very serious' ‐ small study, 95% CI cross the no effect line.

Summary of findings 18. HALOPERIDOL compared to COMBINATIONS: c. HALOPERIDOL + MIDAZOLAM for psychosis‐induced aggression or agitation

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Summary of findings 19. HALOPERIDOL compared to COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE for psychosis‐induced aggression or agitation

HALOPERIDOL compared to COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE for psychosis‐induced aggression or agitation
Patient or population: psychosis‐induced aggression or agitation Setting: emergency room. Intervention: HALOPERIDOL Comparison: COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE	Risk with HALOPERIDOL
Tranquillisation or asleep assessed with: Not tranquil or asleep at 20 minutes	Study population		RR 1.60 (1.18 to 2.16)	316 (1 RCT)	⊕⊕⊕⊝ moderate¹
	281 per 1.000	450 per 1.000 (332 to 608)
Repeated need for tranquillisation assessed with: need for additional drugs for tranquillisation by 2 hours	Low		RR 0.78 (0.43 to 1.41)	376 (2 RCTs)	⊕⊝⊝⊝ very low^{1 3 4}
	50 per 1.000	39 per 1.000 (22 to 71)
	Moderate
	120 per 1.000	94 per 1.000 (52 to 169)
	High
	450 per 1.000	351 per 1.000 (194 to 635)
Specific behaviours ‐ aggression assessed with: Further aggressive episode within 24 hours	Study population		RR 1.06 (0.68 to 1.65)	316 (1 RCT)	⊕⊕⊕⊝ moderate¹
	194 per 1.000	205 per 1.000 (132 to 320)
Global outcomes assessed with: restraints needed by 120 minutes	Study population		RR 1.21 (0.84 to 1.76)	316 (1 RCT)	⊕⊕⊕⊝ moderate^{1 5}
	238 per 1.000	287 per 1.000 (199 to 418)
Adverse effects: specific ‐ acute dystonia	Low		RR 19.48 (1.14 to 331.92)	316 (1 RCT)	⊕⊕⊝⊝ low^{1 6}
	0 per 1.000	0 per 1.000 (0 to 0)
	Moderate
	50 per 1.000	974 per 1.000 (57 to 1.000)
	High
	100 per 1.000	1000 per 1.000 (114 to 1.000)
Adverse effects: specific ‐ seizure	Study population		RR 2.05 (0.19 to 22.39)	316 (1 RCT)	⊕⊕⊝⊝ low^{1 6}
	6 per 1.000	13 per 1.000 (1 to 140)
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' ‐ open trial. ² Moderate risk is roughly equal to that of the trial control group. ³ Inconsistency: rated 'very serious' ‐ I² 86%. ⁴ Publication bias: rated 'strongly suspected' ‐ visual inspection of the funnel plot. ⁵ Indirectness: overall improvement not reported, therefore global improvement inferred from need for restraints at by 120 minutes. ⁶ Imprecision: rated 'serious' ‐ 95% confidence intervals are wide. ⁷ Low risk is roughly equal to that of the trial control group.

Summary of findings 19. HALOPERIDOL compared to COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE for psychosis‐induced aggression or agitation

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Summary of findings 20. HALOPERIDOL compared to COMBINATIONS: e. HALOPERIDOL + RISPERIDONE for psychosis‐induced aggression or agitation

HALOPERIDOL compared to COMBINATIONS: e. HALOPERIDOL + RISPERIDONE for psychosis‐induced aggression or agitation
Patient or population: psychosis‐induced aggression or agitation Setting: inpatients. Intervention: HALOPERIDOL Comparison: COMBINATIONS: e. HALOPERIDOL + RISPERIDONE
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with COMBINATIONS: e. HALOPERIDOL + RISPERIDONE	Risk with HALOPERIDOL
Tranquillisation or asleep ‐ not reported	‐	‐	‐	‐	‐	No study reported this outcome.
Repeated need for tranquillisation ‐ not reported	‐	‐	‐	‐	‐	No study reported this outcome.
Specific behaviour ‐ agitation assessed with: average endpoint scores at 24 hours on PANSS‐EC		MD 3.82 higher (1.35 higher to 6.29 higher)	‐	100 (1 RCT)	⊕⊕⊝⊝ low^{1 2}
Global outcome assessed with: no improvement at 72 hours	Study population		RR 0.38 (0.11 to 1.33)	100 (1 RCT)	⊕⊕⊝⊝ low^{1 2}
	160 per 1.000	61 per 1.000 (18 to 213)
Adverse effects: specific assessed with akathisia during 14 days	Study population		RR 0.88 (0.48 to 1.60)	100 (1 RCT)	⊕⊕⊝⊝ low^{1 2}
	320 per 1.000	282 per 1.000 (154 to 512)
Economic outcome ‐ not reported	‐	‐	‐	‐	‐	No study 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' ‐ allocation concealment procedures not stated, blinding procedures not stated. ² Imprecision: rated 'serious' ‐ 95% CIs are wide.

Summary of findings 20. HALOPERIDOL compared to COMBINATIONS: e. HALOPERIDOL + RISPERIDONE for psychosis‐induced aggression or agitation

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Summary of findings 21. HALOPERIDOL compared to COMBINATIONS: f. OLANZAPINE + MAGNESIUM VALPROATE for psychosis‐induced aggression or agitation

HALOPERIDOL compared to COMBINATIONS: f. OLANZAPINE + MAGNESIUM VALPROATE for psychosis‐induced aggression or agitation
Patient or population: psychosis‐induced aggression or agitation Setting: inpatients. Intervention: HALOPERIDOL Comparison: COMBINATIONS: f. OLANZAPINE + MAGNESIUM VALPROATE
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with COMBINATIONS: f. OLANZAPINE + MAGNESIUM VALPROATE	Risk with HALOPERIDOL
Tranquillisation or asleep ‐ not reported	‐	‐	‐	‐	‐	No study reported this outcome.
Repeated need for tranquillisation ‐ not reported	‐	‐	‐	‐	‐	No study reported this outcome.
Specific behaviour ‐ agitation assessed with: average endpoint scores at 72 hours on PANSS‐EC		MD 0.04 lower (1.33 lower to 1.25 higher)	‐	64 (1 RCT)	⊕⊝⊝⊝ very low^{1 2}
Global outcome assessed with: no improvement	Study population		RR 1.06 (0.38 to 2.95)	64 (1 RCT)	⊕⊝⊝⊝ very low^{1 2}
	182 per 1.000	193 per 1.000 (69 to 536)
Adverse effects assessed with: one or more drug‐related adverse events	Low		RR 3.06 (1.62 to 5.79)	64 (1 RCT)	⊕⊝⊝⊝ very low^{1 2}
	100 per 1.000	306 per 1.000 (162 to 579)
	Moderate
	240 per 1.000	734 per 1.000 (389 to 1.000)
	High
	500 per 1.000	1000 per 1.000 (810 to 1.000)
Economic outcome ‐ not reported	‐	‐	‐	‐	‐	No study 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' ‐ allocation concealment procedures not stated, blinding procedures not stated, small study. ² Imprecision: rated 'very serious' ‐ small study, 95% CI cross the no effect area.

Summary of findings 21. HALOPERIDOL compared to COMBINATIONS: f. OLANZAPINE + MAGNESIUM VALPROATE for psychosis‐induced aggression or agitation

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Summary of findings 22. HALOPERIDOL compared to COMBINATIONS: g. QUETIAPINE + MAGNESIUM VALPROATE for psychosis‐induced aggression or agitation

HALOPERIDOL compared with COMBINATIONS: d. QUETIAPINE + MAGNESIUM VALPROATE for psychosis‐induced aggression or agitation
Patient or population: patients with psychosis‐induced aggression or agitation Setting: inpatients. Intervention: HALOPERIDOL Comparison: COMBINATIONS: d. QUETIAPINE + MAGNESIUM VALPROATE
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	COMBINATIONS: d. QUETIAPINE + MAGNESIUM VALPROATE	HALOPERIDOL
Tranquillisation or asleep ‐ not reported	See comment	See comment	Not estimable	‐	See comment	No study reported this outcome.
Repeated need for tranquillisation ‐ not reported	See comment	See comment	Not estimable	‐	See comment	No study reported this outcome.
Specific behaviours ‐ agitation at 3 days average endpoint score (PANSS‐EC) Follow‐up: 8 weeks		The mean specific behaviours ‐ agitation at 3 days in the intervention groups was 0.02 higher (2.31 lower to 2.35 higher)		60 (1 study)	⊕⊝⊝⊝ very low^1,2
Global effect Specific behaviour ‐ agitation ‐ no effect based on PANSS‐EC (< 25% decrease)	Low³		RR 1.17 (0.44 to 3.06)	60 (1 study)	⊕⊝⊝⊝ very low^1,4
	50 per 1000	58 per 1000 (22 to 153)
	Moderate³
	200 per 1000	234 per 1000 (88 to 612)
	High³
	350 per 1000	409 per 1000 (154 to 1000)
Adverse effects ‐ any specific, serious ‐ not reported	See comment	See comment	Not estimable	‐	See comment	No study reported this outcome.
Economic outcome ‐ not reported	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.
¹ Risk of bias: rated 'very serious' ‐ method of randomisation is not reported, allocation concealment not stated, open‐label, selective reporting. ² Indirectness: rated 'very serious' ‐ no data for aggressive outburst with 24 hours, therefore had to use scale‐derived data for agitation at 72 hours. ³ Moderate risk is roughly equal to that of the trial control group. ⁴ Indirectness: rated 'serious' ‐ no measure for overall improvement, therefore inferred no overall improvement from "no effect" based on the PANSS‐EC.

Summary of findings 22. HALOPERIDOL compared to COMBINATIONS: g. QUETIAPINE + MAGNESIUM VALPROATE for psychosis‐induced aggression or agitation

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Summary of findings 23. HALOPERIDOL compared to COMBINATIONS: h. RISPERIDONE + CLONAZEPAM for psychosis induced aggression or agitation

HALOPERIDOL compared to COMBINATIONS: h. RISPERIDONE + CLONAZEPAM for psychosis induced aggression or agitation
Patient or population: psychosis induced aggression or agitation Setting: inpatients. Intervention: HALOPERIDOL Comparison: COMBINATIONS: h. RISPERIDONE + CLONAZEPAM
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with COMBINATIONS: h. RISPERIDONE + CLONAZEPAM	Risk with HALOPERIDOL
Tranquillisation or asleep assessed with: not asleep at 4 hours	Study population		RR 0.82 (0.66 to 1.03)	205 (1 RCT)	⊕⊝⊝⊝ very low^{1 2}
	673 per 1.000	552 per 1.000 (444 to 693)
Repeated need for tranquillisation ‐ not reported	‐	‐	‐	‐	‐	No study reported this outcome.
Specific behaviour ‐ agitation assessed with: average change scores at 2 hours on PANSS‐EC		MD 0.50 lower (3.8 lower to 2.8 higher)	‐	108 (1 RCT)	⊕⊝⊝⊝ very low^{1 2}
Global outcome assessed with: no improvement at 72 hours	Study population		RR 0.60 (0.15 to 2.38)	100 (1 RCT)	⊕⊕⊝⊝ low^{3 4}
	100 per 1.000	60 per 1.000 (15 to 238)
Adverse effects assessed with: akathisia during 5 days (only reported if occurred ≥50%)	Low		RR 1.63 (1.12 to 2.38)	205 (1 RCT)	⊕⊝⊝⊝ very low^{1 5}
	150 per 1.000	244 per 1.000 (168 to 357)
	Moderate
	300 per 1.000	489 per 1.000 (336 to 714)
	High
	500 per 1.000	815 per 1.000 (560 to 1.000)
Economic outcome ‐ not reported	‐	‐	‐	‐	‐	No study 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 'very serious' ‐ open study, evidence of reporting bias, sponsored trial. ² Imprecision: rated 'serious' ‐ 95% CI cross the no effect area. ³ Risk of bias: rated 'serious' ‐ allocation concealment and blinding procedures not stated. ⁴ Imprecision: rated 'serious' ‐ 95% CI are wide. ⁵ Imprecision: rated 'serious' ‐ 95% CI are wide.

Summary of findings 23. HALOPERIDOL compared to COMBINATIONS: h. RISPERIDONE + CLONAZEPAM for psychosis induced aggression or agitation

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Summary of findings 24. HALOPERIDOL compared to COMBINATIONS: i. ZIPRASIDONE + CLONAZEPAM for psychosis‐induced aggression or agitation

HALOPERIDOL compared to COMBINATIONS: i. ZIPRASIDONE + CLONAZEPAM for psychosis‐induced aggression or agitation
Patient or population: psychosis‐induced aggression or agitation Setting: inpatients. Intervention: HALOPERIDOL Comparison: COMBINATIONS: i. ZIPRASIDONE + CLONAZEPAM
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Outcomes	Risk with COMBINATIONS: i. ZIPRASIDONE + CLONAZEPAM	Risk with HALOPERIDOL	Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Tranquillisation or asleep ‐ not reported	‐	‐	‐	‐	‐	No study reported this outcome.
Repeated need for tranquillisation ‐ not reported	‐	‐	‐	‐	‐	No study reported this outcome.
Specific behaviour ‐ agitation assessed with: average endpoint scores at 12 hours on PANSS‐EC		MD 0.28 lower (1.80 lower to 1.24 higher)	‐	71 (1 RCT)	⊕⊝⊝⊝ very low^{1 2}
Global outcome ‐ no improvement ‐ not reported	‐	‐	‐	‐	‐	No study reported this outcome.
Adverse effects ‐ not reported	‐	‐	‐	‐	‐	No study reported this outcome.
Economic outcome ‐ not reported	‐	‐	‐	‐	‐	No study 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 'very serious' ‐ randomisation, allocation and blinding procedures not stated, evidence of attrition bias, small study. ² Imprecision: rated 'very serious' ‐ small study, 95% CI are wide.

Summary of findings 24. HALOPERIDOL compared to COMBINATIONS: i. ZIPRASIDONE + CLONAZEPAM for psychosis‐induced aggression or agitation

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Table 1. Other relevant Cochrane reviews

Focus of review	Reference
Completed and maintained reviews
'As required' medication regimens for seriously mentally ill people in hospital	Douglas‐Hall 2015
Benzodiazepines for psychosis‐induced aggression or agitation	Gillies 2013
Chlorpromazine for psychosis induced aggression or agitation	Ahmed 2010
Clotiapine for acute psychotic illnesses	Berk 2004
Containment strategies for people with serious mental illness	Muralidharan 2006
Droperidol for acute psychosis	Khokhar 2016
Haloperidol plus promethazine for psychosis‐induced aggression	Huf 2016
Olanzapine IM or velotab for acutely disturbed/agitated people with suspected serious mental illnesses	Belgamwar 2005
Seclusion and restraint for serious mental illnesses	Sailas 2000
Zuclopenthixol acetate for acute schizophrenia and similar serious mental illnesses	Jayakody 2012
Reviews in the process of being completed
Risperidone for psychosis induced aggression or agitation	Ahmed 2011
Haloperidol for long term aggression in psychosis	Khushu 2016
Loxapine inhaler for psychosis‐induced aggression	Vangala 2012
Quetiapine for psychosis‐induced aggression	Wilkie 2012
De‐escalation techniques for psychosis‐induced aggression	Du 2017

Table 1. Other relevant Cochrane reviews

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Table 2. Variations on blinding

Description	Study
Explicitly referred to how participants, study personnel and raters were blinded + tested blinding.	Stotsky 1977
Explicitly referred to how participants, study personnel and raters were blinded.	Breier 2002, Calver 2015, Nobay 2004
Report that drugs had identical appearance ‐ no further details regarding rater blinding.	Fitzgerald 1969, Fruensgaard 1977, Paprocki 1977, Resnick 1984, Ritter 1972
Explicitly state that rater was blinded ‐ no reference to participant blinding. Not all study personnel could have been blinded because person preparing drug (not blinded), often administered drug.	Bristol‐Myers 2005b
Study personnel and raters blinded, not clear if attempts made to blind participants.	Battaglia 1997, Battaglia 2002
Raters blinded ‐ not clear if study personnel and participants were blinded.	Dorevitch 1999, Foster 1997, Salzman 1991
"Double blind" ‐ no further information regarding blinding of participants, study personnel and raters.	Eli Lilly 2004, Kewala 1984, Kinon 2001d, Man 1973
Described as double‐blind, but during oral phase haloperidol described as being in capsule form, and aripiprazole in tablet form, therefore unclear whether drugs had identical appearance. Not explicit if raters were blinded.	Bristol Myers 2004a
Described as double‐blind during IM phase ‐ open during oral phase ‐ no further information given regarding blinding.	Reschke 1974
Described as "modified double", whereby staff administering drugs were not blinded, but raters were ‐ not clear if participants were blinded.	Tuason 1986
Single‐blind studies ‐ "open label, rater blind".	Baldacara 2011, Currier 2004, Lim 2010, Shu 2010, Yin 2012
Reported to be single‐blind, but unclear who was blind.	Li 2006
Open‐label and rater blinding for some outcomes (BPRS).	Taymeeyapradit 2002
Rater blinding for assessment of BPRS, but unclear regarding rater blinding for other outcomes and whether participants and study personnel were blind.	Bailine 1987
Open studies	Brook 2000, Fang 2012, Garza‐Trevino 1989, Guo 2007, Higashima 2004, Huf 2007
Not stated	Liang 2013, Liu 2012, Shi 2010, Walther 2014, Zhou 2014
BPRS ‐ Brief Psychiatric Rating Scale

Table 2. Variations on blinding

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Comparison 1. HALOPERIDOL vs PLACEBO/NIL

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Tranquillisation or asleep ‐ asleep Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 not asleep up to 2 hours	2	220	Risk Ratio (M‐H, Fixed, 95% CI)	0.88 [0.82, 0.95]
2 Repeated need for tranquillisation Show forest plot	4		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.1 needing additional injection during 24 hours (agitation only)	4	660	Risk Ratio (M‐H, Fixed, 95% CI)	0.51 [0.42, 0.62]
3 Specific behaviour: 1a. Agitation ‐ various measures Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.1 PANSS‐EC response at 2 hours (at least 40% change on PANSS‐EC from baseline)	2	395	Risk Ratio (M‐H, Fixed, 95% CI)	1.62 [1.28, 2.07]
4 Specific behaviour: 1b. Agitation ‐ average scores ‐ i. up to 2 hours Show forest plot	4		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

4.1 change score (ABS, high=worse)	3	474	Mean Difference (IV, Fixed, 95% CI)	‐4.48 [‐5.78, ‐3.18]
4.2 change score (ACES, low=agitated, high=sedated)	2	390	Mean Difference (IV, Fixed, 95% CI)	0.83 [0.39, 1.26]
4.3 score (PANSS‐EC, high=worse)	3	514	Mean Difference (IV, Fixed, 95% CI)	‐3.67 [‐4.75, ‐2.59]
4.4 change score (PANSS‐EC, high=worse, schizophrenia subgroup)	1	199	Mean Difference (IV, Fixed, 95% CI)	‐2.57 [‐4.05, ‐1.09]
4.5 change score (PANSS‐EC, high=worse, non‐sedated patients subgroup based on ACES)	1	240	Mean Difference (IV, Fixed, 95% CI)	‐2.64 [‐3.95, ‐1.33]
4.6 change score (PANSS‐EC, high=worse, non‐sedated patients subgroup based on ACES)	1	263	Mean Difference (IV, Fixed, 95% CI)	‐2.97 [‐4.27, ‐1.67]
5 Specific behaviour: 1c. Agitation ‐ average scores ‐ ii. up to 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

5.1 change score (ABS, high=worse)	1	85	Mean Difference (IV, Fixed, 95% CI)	‐2.4 [‐4.13, ‐0.67]
5.2 change score (PANSS‐EC, high=worse)	1	85	Mean Difference (IV, Fixed, 95% CI)	‐1.4 [‐2.97, 0.17]
6 Global outcome: 1. Not improved Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

6.1 not marked improvement	1	40	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.44, 0.84]
6.2 not any improvement	1	40	Risk Ratio (M‐H, Fixed, 95% CI)	0.28 [0.08, 1.07]
7 Global outcome: 2. Need for benzodiazepine up to 24 hours Show forest plot	4		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

7.1 need for benzodiazepine up to 24 hours	4	660	Risk Ratio (M‐H, Fixed, 95% CI)	0.44 [0.31, 0.62]
8 Global outcome: 3a. Average scores ‐ i. up to 2 hours Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

8.1 endpoint score (CGI‐I, high=worse)	2	390	Mean Difference (IV, Fixed, 95% CI)	‐0.73 [‐0.96, ‐0.51]
8.2 change score (CGI‐I, high=worse, schizophrenia subgroup)	1	199	Mean Difference (IV, Fixed, 95% CI)	‐0.64 [‐0.98, ‐0.30]
8.3 change score (CGI‐S, high=worse)	2	390	Mean Difference (IV, Fixed, 95% CI)	‐0.48 [‐0.78, ‐0.18]
9 Global outcome: 3b. Average scores ‐ ii. up to 24 hours Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

9.1 change score (CGI‐I, high=worse)	1	169	Mean Difference (IV, Fixed, 95% CI)	‐0.4 [‐0.62, ‐0.18]
9.2 change score (CGI‐S, high=worse)	1	85	Mean Difference (IV, Fixed, 95% CI)	‐0.2 [‐0.46, 0.06]
10 Mental state: 1a. Average scores ‐ i. up to 2 hours Show forest plot	3		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

10.1 change score up to 2 hours (BPRS positive sub‐scale, high=worse)	3	372	Mean Difference (IV, Fixed, 95% CI)	‐1.04 [‐1.54, ‐0.54]
10.2 change score up to 2 hours (BPRS total, high=worse)	3	371	Mean Difference (IV, Fixed, 95% CI)	‐5.69 [‐7.38, ‐4.00]
11 Mental state: 1b. Average scores ‐ ii. up to 24 hours Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

11.1 change score up to 24 hours (BPRS positive sub‐scale, high=worse)	2	264	Mean Difference (IV, Fixed, 95% CI)	‐1.61 [‐2.34, ‐0.89]
11.2 change score up to 24 hours (BPRS total, high=worse)	2	264	Mean Difference (IV, Fixed, 95% CI)	‐4.81 [‐6.82, ‐2.81]
12 Adverse effects: 1a. General Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

12.1 one or more drug related adverse events during 24 hours	2	395	Risk Ratio (M‐H, Fixed, 95% CI)	1.64 [1.22, 2.20]
12.2 increased severity of adverse effects after 2nd injection	1	273	Risk Ratio (M‐H, Fixed, 95% CI)	3.25 [1.88, 5.63]
12.3 overall adverse events during 72 hours	1	273	Risk Ratio (M‐H, Fixed, 95% CI)	1.78 [1.23, 2.59]
13 Adverse effects: 1b. General ‐ serious Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

13.1 death	1	273	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
13.2 rated as serious	1	122	Risk Ratio (M‐H, Fixed, 95% CI)	0.34 [0.01, 8.29]
13.3 tonic clonic seizure	1	117	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
14 Adverse effects: 2a. Specific ‐ arousal level Show forest plot	4		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

14.1 insomnia during 24 hours (only reported if occurred in ≧5%)	1	273	Risk Ratio (M‐H, Fixed, 95% CI)	1.31 [0.61, 2.82]
14.2 "over" sedated	2	313	Risk Ratio (M‐H, Fixed, 95% CI)	3.36 [1.42, 7.99]
14.3 somnolence during 24 hours	4	615	Risk Ratio (M‐H, Fixed, 95% CI)	2.28 [0.97, 5.36]
15 Adverse effects: 2b. Specific ‐ cardiovascular ‐ miscellaneous outcomes Show forest plot	4		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

15.1 dizziness during 24 hours (only reported if occurred in ≧5%)	2	392	Risk Ratio (M‐H, Fixed, 95% CI)	1.33 [0.48, 3.65]
15.2 hypotension during 24 hours	2	125	Risk Ratio (M‐H, Fixed, 95% CI)	1.2 [0.05, 27.44]
15.3 QTc abnormality	1	122	Risk Ratio (M‐H, Fixed, 95% CI)	3.1 [0.33, 28.98]
15.4 sinus tachycardia during 24 hours (only reported if occurred in ≥5%)	1	122	Risk Ratio (M‐H, Fixed, 95% CI)	3.1 [0.33, 28.98]
15.5 tachycardia during 24 hours (only reported if occurred in ≥5%)	1	122	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.07, 16.15]
16 Adverse effects: 2c. Specific ‐ cardiovascular ‐ QTc interval (average change at 24 hours) Show forest plot	2	265	Mean Difference (IV, Fixed, 95% CI)	3.63 [‐2.67, 9.93]

17 Adverse effects: 2d. Specific ‐ movement disorders Show forest plot	5		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

17.1 akathisia during 24 hours (only reported if occurred in ≥5%)	1	122	Risk Ratio (M‐H, Fixed, 95% CI)	13.43 [0.77, 233.23]
17.2 dystonia during 24 hours	2	207	Risk Ratio (M‐H, Fixed, 95% CI)	7.49 [0.93, 60.21]
17.3 extrapyramidal effects ‐ use of antiparkinson drugs during 24 hours	1	180	Risk Ratio (M‐H, Fixed, 95% CI)	5.57 [1.37, 22.65]
17.4 EPS during 24 hours	3	398	Risk Ratio (M‐H, Fixed, 95% CI)	6.79 [2.19, 21.07]
18 Adverse effects: 2e. Specific ‐ movement disorders: i. average scores ‐ i. up to 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

18.1 change score at 24 hours (BAS, high=worse)	1	168	Mean Difference (IV, Fixed, 95% CI)	0.09 [‐0.17, 0.35]
18.2 change score at 24 hours (SAS, high=worse)	1	167	Mean Difference (IV, Fixed, 95% CI)	1.89 [0.77, 3.01]
19 Adverse effects: 2f. Specific ‐ miscellaneous Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

19.1 agitation during 24 hours (only reported if occurred in ≧5%)	2	395	Risk Ratio (M‐H, Fixed, 95% CI)	0.80 [0.29, 2.19]
19.2 dry mouth	1	40	Risk Ratio (M‐H, Fixed, 95% CI)	3.6 [0.21, 61.86]
19.3 headache during 24 hours (only reported if occurred in ≧5%)	2	395	Risk Ratio (M‐H, Fixed, 95% CI)	1.28 [0.55, 3.00]
19.4 pain at injection site	1	122	Risk Ratio (M‐H, Fixed, 95% CI)	0.21 [0.01, 4.22]
19.5 pain (1st injection)	1	273	Risk Ratio (M‐H, Fixed, 95% CI)	0.10 [0.00, 1.97]
19.6 pain (2nd injection)	1	273	Risk Ratio (M‐H, Fixed, 95% CI)	3.25 [1.88, 5.63]
19.7 nausea during 24 hours (only reported if occurred in ≧5%)	2	395	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.13, 3.67]
19.8 vomiting during 24 hours (only reported if occurred in ≧5%)	1	122	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.07, 16.15]
20 Leaving the study early Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

20.1 any reason	3	435	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [0.53, 2.11]
20.2 lack of efficacy	3	435	Risk Ratio (M‐H, Fixed, 95% CI)	0.12 [0.03, 0.49]
20.3 withdrew	1	273	Risk Ratio (M‐H, Fixed, 95% CI)	3.35 [0.17, 64.15]
20.4 consent	2	395	Risk Ratio (M‐H, Fixed, 95% CI)	6.2 [0.77, 49.98]
20.5 adverse effects	3	435	Risk Ratio (M‐H, Fixed, 95% CI)	1.78 [0.21, 15.39]
20.6 could not be evaluated due to being asleep	1	40	Risk Ratio (M‐H, Fixed, 95% CI)	1.2 [0.05, 27.44]
20.7 other	2	395	Risk Ratio (M‐H, Fixed, 95% CI)	1.81 [0.27, 12.07]

Comparison 1. HALOPERIDOL vs PLACEBO/NIL

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Comparison 2. HALOPERIDOL vs OTHER ANTIPSYCHOTIC: a. ARIPIPRAZOLE

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Repeated need for rapid tranquillisation: needing additional injection Show forest plot	2	473	Risk Ratio (M‐H, Fixed, 95% CI)	0.78 [0.62, 0.99]

2 Specific behaviour: 1a. Agitation ‐ PANSS‐EC response up to 2 hours (at least 40% change on PANSS‐EC from baseline) Show forest plot	2	477	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.92, 1.26]

3 Specific behaviour: 1b. Agitation ‐ average scores ‐ up to 2 hours Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

3.1 change score (ACES, low=agitated, high=sedated)	2	470	Mean Difference (IV, Fixed, 95% CI)	0.12 [‐0.30, 0.55]
3.2 change score (CABS, high=worse)	2	470	Mean Difference (IV, Fixed, 95% CI)	‐0.55 [‐2.10, 1.01]
3.3 change score (PANSS‐EC, high=worse)	1	357	Mean Difference (IV, Fixed, 95% CI)	‐0.48 [‐2.12, 1.16]
3.4 change score (PANSS‐EC, high=worse, schizophrenia subgroup)	1	257	Mean Difference (IV, Fixed, 95% CI)	‐0.26 [‐1.48, 0.96]
3.5 change score (PANSS‐EC, high=worse, non‐sedated patients subgroup based on ACES)	1	316	Mean Difference (IV, Fixed, 95% CI)	‐0.33 [‐1.42, 0.76]
3.6 change score (PANSS‐EC, high=worse, non‐sedated patients subgroup based on AEs)	1	346	Mean Difference (IV, Fixed, 95% CI)	‐0.34 [‐1.40, 0.72]
4 Global outcome: 1. Need for benzodiazepine Show forest plot	2	477	Risk Ratio (M‐H, Fixed, 95% CI)	1.26 [0.74, 2.16]

5 Global outcome: 2. Average scores ‐ up to 2 hours Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

5.1 change score (CGI‐S, high=worse)	2	470	Mean Difference (IV, Fixed, 95% CI)	0.07 [‐0.22, 0.36]
5.2 endpoint score (CGI‐I, high=worse)	2	470	Mean Difference (IV, Fixed, 95% CI)	‐0.02 [‐0.23, 0.19]
5.3 change score (CGI‐I, high=worse, schizophrenia subgroup)	1	257	Mean Difference (IV, Fixed, 95% CI)	‐0.02 [‐0.30, 0.26]
6 Mental state: 1. Average scores ‐ up to 2 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

6.1 change score at 2 hours (BPRS positive sub‐scale, high=worse)	1	103	Mean Difference (IV, Fixed, 95% CI)	‐0.23 [‐1.28, 0.82]
6.2 change score at 2 hours (BPRS total, high=worse)	1	102	Mean Difference (IV, Fixed, 95% CI)	‐2.03 [‐5.76, 1.70]
7 Adverse effects: 1a. General Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

7.1 one or more drug related adverse effects during 24 hours	2	477	Risk Ratio (M‐H, Fixed, 95% CI)	1.18 [0.95, 1.46]
7.2 increased severity of adverse effects after 2nd injection	1	360	Risk Ratio (M‐H, Fixed, 95% CI)	1.34 [1.03, 1.74]
7.3 overall adverse events during 72 hours	1	360	Risk Ratio (M‐H, Fixed, 95% CI)	1.33 [1.04, 1.70]
8 Adverse effects: 1b. General ‐ serious Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

8.1 any	2	477	Risk Ratio (M‐H, Fixed, 95% CI)	0.57 [0.18, 1.81]
8.2 tonic clonic seizure	1	117	Risk Ratio (M‐H, Fixed, 95% CI)	0.32 [0.01, 7.62]
8.3 death	1	360	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
9 Adverse effects: 2a. Specific ‐ arousal level Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

9.1 insomnia ‐ between 0‐1 days (IM phase) (only reported if occurred in ≥5%)	1	360	Risk Ratio (M‐H, Fixed, 95% CI)	2.08 [1.01, 4.27]
9.2 insomnia ‐ between 3 ‐ 7 days (oral phase) (only reported if occurred in ≥ 2%)	1	360	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.47, 1.44]
9.3 "over" sedated	1	360	Risk Ratio (M‐H, Fixed, 95% CI)	1.66 [0.93, 2.95]
9.4 somnolence ‐ between 0‐1 days	1	360	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.25, 2.00]
9.5 somnolence ‐ between 0‐1 days (IM phase) (only reported if occurred in ≥5%)	1	117	Risk Ratio (M‐H, Fixed, 95% CI)	2.22 [0.60, 8.16]
9.6 somnolence ‐ between 3 ‐ 7 days (oral phase) (only reported if occurred in ≥ 2%)	1	360	Risk Ratio (M‐H, Fixed, 95% CI)	2.84 [0.30, 27.02]
10 Adverse effects: 2b. Specific ‐ cardiac Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

10.1 dizziness ‐ between 0 ‐1 day (IM phase) (only reported if occurred in ≥5%)	2	477	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.33, 1.48]
10.2 sinus tachycardia ‐ between 0 ‐1 day (IM phase) (only reported if occurred in ≥5%)	1	117	Risk Ratio (M‐H, Fixed, 95% CI)	6.66 [0.35, 126.06]
10.3 tachycardia ‐ between 0 ‐1 day (IM phase) (only reported if occurred in ≥5%)	1	117	Risk Ratio (M‐H, Fixed, 95% CI)	0.24 [0.03, 2.06]
11 Adverse effects: 2c. Specific ‐ gastrointestinal Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

11.1 dyspepsia ‐ between 3 ‐ 7 days (oral phase) (only reported if occurred in ≥ 2%)	1	360	Risk Ratio (M‐H, Fixed, 95% CI)	10.41 [1.36, 79.76]
11.2 diarrhoea ‐ between 3 ‐ 7 days (oral phase) (only reported if occurred in ≥ 2%)	1	360	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.28, 3.21]
11.3 nausea ‐ between 0‐1 days (IM phase) (only reported if occurred in ≥5%)	2	477	Risk Ratio (M‐H, Fixed, 95% CI)	0.18 [0.05, 0.60]
11.4 nausea ‐ between 3 ‐ 7 days (oral phase) (only reported if occurred in ≥ 2%)	1	360	Risk Ratio (M‐H, Fixed, 95% CI)	0.14 [0.02, 1.09]
11.5 vomiting ‐ between 0‐1 days (IM phase) (only reported if occurred in ≥5%)	1	117	Risk Ratio (M‐H, Fixed, 95% CI)	0.48 [0.04, 5.10]
11.6 vomiting ‐ between 3 ‐ 7 days (oral phase) (only reported if occurred in ≥ 2%)	1	360	Risk Ratio (M‐H, Fixed, 95% CI)	0.38 [0.07, 1.92]
12 Adverse effects: 2d. Specific ‐ movement disorder Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

12.1 akathisia ‐ between 0 ‐1 day (IM phase) (only reported if occurred in ≥5%)	2	477	Risk Ratio (M‐H, Fixed, 95% CI)	2.85 [0.94, 8.61]
12.2 akathisia ‐ between 3 ‐ 7 days (oral phase) (only reported if occurred in ≥ 2%)	1	360	Risk Ratio (M‐H, Fixed, 95% CI)	2.21 [0.58, 8.40]
12.3 dystonia ‐ between 0 ‐1 day (IM phase) (only reported if occurred in ≥5%)	2	477	Risk Ratio (M‐H, Fixed, 95% CI)	6.63 [1.52, 28.86]
12.4 EPS ‐ between 0 ‐1 day (IM phase) (only reported if occurred in ≥5%)	1	360	Risk Ratio (M‐H, Fixed, 95% CI)	9.46 [1.22, 73.13]
12.5 EPS ‐ between 3 ‐ 7 days (oral phase) (only reported if occurred in ≥ 2%)	1	360	Risk Ratio (M‐H, Fixed, 95% CI)	7.09 [1.65, 30.58]
12.6 Use of antiparkinson drugs ‐ between 3 ‐ 7 days (oral phase)	1	360	Risk Ratio (M‐H, Fixed, 95% CI)	4.94 [2.50, 9.78]
12.7 dystonia	1	360	Risk Ratio (M‐H, Fixed, 95% CI)	2.84 [0.12, 69.22]
13 Adverse effects: 2e. Specific ‐ miscellaneous Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

13.1 agitation ‐ between 0 ‐1 day (IM phase) (only reported if occurred in ≥5%)	2	477	Risk Ratio (M‐H, Fixed, 95% CI)	1.22 [0.46, 3.22]
13.2 agitation ‐ between 3 ‐ 7 days (oral phase) (only reported if occurred in ≥ 2%)	1	360	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.68, 1.74]
13.3 anxiety ‐ between 3 ‐ 7 days (oral phase) (only reported if occurred in ≥ 2%)	1	360	Risk Ratio (M‐H, Fixed, 95% CI)	1.30 [0.54, 3.16]
13.4 headache ‐ between 0 ‐1 day (IM phase) (only reported if occurred in ≥5%)	2	477	Risk Ratio (M‐H, Fixed, 95% CI)	0.85 [0.45, 1.59]
13.5 headache ‐ between 3 ‐ 7 days (oral phase) (only reported if occurred in ≥ 2%)	1	360	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [0.57, 1.97]
13.6 pain at injection site	1	117	Risk Ratio (M‐H, Fixed, 95% CI)	0.32 [0.01, 7.62]
13.7 pain (1st injection)	1	360	Risk Ratio (M‐H, Fixed, 95% CI)	0.32 [0.06, 1.54]
13.8 pain (2nd injection)	1	360	Risk Ratio (M‐H, Fixed, 95% CI)	1.34 [1.03, 1.74]
14 Leaving the study early: 1. For specific reasons Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

14.1 any	2	480	Risk Ratio (M‐H, Fixed, 95% CI)	2.07 [0.86, 4.98]
14.2 lack of efficacy	1	360	Risk Ratio (M‐H, Fixed, 95% CI)	2.84 [0.12, 69.22]
14.3 adverse effects	2	480	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.17, 5.59]
14.4 withdrew	1	360	Risk Ratio (M‐H, Fixed, 95% CI)	1.42 [0.24, 8.39]
14.5 consent	2	480	Risk Ratio (M‐H, Fixed, 95% CI)	6.0 [0.74, 48.34]
14.6 other	2	480	Risk Ratio (M‐H, Fixed, 95% CI)	1.36 [0.27, 6.75]

Comparison 2. HALOPERIDOL vs OTHER ANTIPSYCHOTIC: a. ARIPIPRAZOLE

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Comparison 3. HALOPERIDOL vs OTHER ANTIPSYCHOTIC: b. CHLORPROMAZINE

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Tranquillisation or asleep ‐ asleep Show forest plot	1	39	Risk Ratio (M‐H, Fixed, 95% CI)	1.93 [1.04, 3.60]

1.1 not asleep up to 2 hours	1	39	Risk Ratio (M‐H, Fixed, 95% CI)	1.93 [1.04, 3.60]
2 Repeated need for rapid tranquillisation Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.1 more that 1 injection	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.89, 1.28]
2.2 more than 3 injections	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	1.5 [0.53, 4.26]
3 Global outcome: 1. Not improved Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.1 not marked improvement	2	89	Risk Ratio (M‐H, Fixed, 95% CI)	0.79 [0.61, 1.02]
3.2 not any improvement	2	89	Risk Ratio (M‐H, Fixed, 95% CI)	0.15 [0.05, 0.49]
4 Adverse effects: any serious or specific adverse effects Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

4.1 allergy ‐ haematological ‐ leucopenia ‐ mild	1	50	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.13, 70.30]
4.2 allergy ‐ hepatic ‐ glutamic pyruvic transaminase elevated	1	50	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 7.81]
4.3 allergy ‐ skin irritation ‐ local	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.4 anticholinergic ‐ dry mouth	1	39	Risk Ratio (M‐H, Fixed, 95% CI)	1.38 [0.17, 10.93]
4.5 arousal ‐ drowsy but asleep	1	39	Risk Ratio (M‐H, Fixed, 95% CI)	0.06 [0.01, 0.42]
4.6 arousal ‐ drowsy but awake	1	39	Risk Ratio (M‐H, Fixed, 95% CI)	9.17 [0.59, 142.10]
4.7 cardiovascular ‐ hypotension	2	69	Risk Ratio (M‐H, Fixed, 95% CI)	0.51 [0.10, 2.60]
4.8 central nervous system ‐ seizures	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 7.58]
4.9 movement disorders ‐ extrapyramidal adverse effects	2	69	Risk Ratio (M‐H, Fixed, 95% CI)	2.07 [0.28, 15.15]
5 Leaving the study early Show forest plot	4		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

5.1 any reason/general reasons	4	153	Risk Ratio (M‐H, Fixed, 95% CI)	0.21 [0.07, 0.71]
5.2 could not be evaluated due to being asleep	1	39	Risk Ratio (M‐H, Fixed, 95% CI)	0.07 [0.01, 0.52]
5.3 severe hypotensive reaction	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.2 [0.01, 3.85]
5.4 deviation from protocol	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.13, 68.26]

Comparison 3. HALOPERIDOL vs OTHER ANTIPSYCHOTIC: b. CHLORPROMAZINE

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Comparison 4. HALOPERIDOL vs OTHER ANTIPSYCHOTIC: c. DROPERIDOL

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Tranquillisation or asleep: 1. Not asleep Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 up to 2 hours	1	228	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.44, 2.60]
2 Tranquillisation or asleep: 2. Time to sleep Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

2.1 up to 2 hours	1	114	Mean Difference (IV, Fixed, 95% CI)	5.20 [‐6.05, 16.45]
3 Repeated need for rapid tranquillisation Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.1 more than 1 injection	2	255	Risk Ratio (M‐H, Fixed, 95% CI)	2.38 [1.27, 4.47]
3.2 more than 3 injections	1	27	Risk Ratio (M‐H, Fixed, 95% CI)	2.12 [0.09, 47.68]
4 Global outcome: 1. Need for benzodiazepine Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

4.1 up to 2 hours	1	228	Risk Ratio (M‐H, Fixed, 95% CI)	0.31 [0.07, 1.44]
5 Adverse effects: 1. General Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

5.1 overall adverse events up to 2 hours	1	228	Risk Ratio (M‐H, Fixed, 95% CI)	0.15 [0.02, 1.23]
5.2 patients with one or more AEs	1	228	Risk Ratio (M‐H, Fixed, 95% CI)	0.18 [0.02, 1.46]
6 Adverse effects: 2a. Specific ‐ arousal level Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

6.1 "over" sedated	1	228	Risk Ratio (M‐H, Fixed, 95% CI)	0.36 [0.01, 8.68]
7 Adverse effects: 2b. Specific ‐ cardiovascular Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

7.1 hypotension up to 2 hours	1	228	Risk Ratio (M‐H, Fixed, 95% CI)	0.27 [0.03, 2.36]
8 Adverse effects: 2c. Specific ‐ movement disorders Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

8.1 dystonia	2	255	Risk Ratio (M‐H, Fixed, 95% CI)	0.86 [0.11, 6.56]
9 Adverse effects: 2d. Specific ‐ miscellaneous Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

9.1 desaturation	1	228	Risk Ratio (M‐H, Fixed, 95% CI)	0.36 [0.01, 8.68]

Comparison 4. HALOPERIDOL vs OTHER ANTIPSYCHOTIC: c. DROPERIDOL

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Comparison 5. HALOPERIDOL vs OTHER ANTIPSYCHOTIC: d. LOXAPINE

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Tranquillisation or asleep ‐ not asleep up to 24 hours Show forest plot	1	54	Risk Ratio (M‐H, Fixed, 95% CI)	4.31 [0.54, 34.48]

2 Specific behaviour: 2. Aggression ‐ various measures Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.1 no overall improvement	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	1.1 [0.69, 1.76]
3 Global outcome: 1. General ‐ no change ‐ i. over 24 hours Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.1 up to 48 hours (CGI‐I, high=worse)	1	56	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.14, 6.15]
3.2 up to 72 hours (CGI‐I, high=worse)	1	54	Risk Ratio (M‐H, Fixed, 95% CI)	0.39 [0.04, 3.49]
3.3 at endpoint (CGI‐I, high=worse)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	0.40 [0.12, 1.32]
4 Global outcome: 2a. Specific ‐ not sedated ‐ i. by 30 minutes Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

4.1 at 30 minutes	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	1.29 [0.65, 2.54]
5 Global outcome: 2b. Specific ‐ not sedated ‐ ii. up to 2 hours Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

5.1 at 1 hour	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	3.5 [0.86, 14.18]
5.2 at 2 hours	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	7.0 [0.98, 50.16]
6 Mental state: 1. Average scores Show forest plot	1	52	Mean Difference (IV, Fixed, 95% CI)	6.10 [4.48, 7.72]

6.1 endpoint score (BPRS, high=worse)	1	52	Mean Difference (IV, Fixed, 95% CI)	6.10 [4.48, 7.72]
7 Adverse effects: 1. General Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

7.1 one or more drug related adverse effect	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.8 [0.44, 1.45]
8 Adverse effects: 2a. Specific ‐ anticholinergic Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

8.1 constipation ‐ between 3‐28 days (Oral phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	0.32 [0.01, 7.26]
8.2 salivation ‐ too little ‐ between 0‐3 days (IM phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	2.83 [0.33, 24.66]
8.3 salivation ‐ too little ‐ between 3‐28 days (Oral phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.22, 4.05]
8.4 salivation ‐ too much ‐ between 0‐3 days (IM phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.33, 2.69]
8.5 salivation ‐ too much ‐ between 0‐10 days	1	54	Risk Ratio (M‐H, Fixed, 95% CI)	0.43 [0.04, 4.48]
8.6 salivation ‐ too much ‐ between 3‐28 days (Oral phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.57, 1.93]
8.7 polyuria ‐ between 3‐28 days (Oral phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	2.84 [0.12, 65.34]
8.8 sweating ‐ between 0‐3 days (IM phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.15, 5.97]
8.9 sweating ‐ between 3‐28 days (Oral phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	2.84 [0.12, 65.34]
9 Adverse effects: 2b. Specific ‐ arousal level Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

9.1 asleep ‐ by 12 hours	1	54	Risk Ratio (M‐H, Fixed, 95% CI)	0.86 [0.72, 1.04]
9.2 drowsiness ‐ between 0‐3 days (IM phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.70, 1.12]
9.3 drowsiness ‐ between 3‐28 days (Oral phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	33.16 [2.15, 511.57]
9.4 drowsiness during 72 hours	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.75 [0.20, 2.79]
9.5 insomnia ‐ between 0‐3 days (IM phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	0.32 [0.01, 7.26]
9.6 insomnia ‐ between 3‐28 days (Oral phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	6.63 [0.37, 119.59]
10 Adverse effects: 2c. Specific ‐ cardiovascular Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

10.1 blood pressure ‐ increased ‐ between 0‐10 days	1	54	Risk Ratio (M‐H, Fixed, 95% CI)	0.17 [0.01, 3.45]
10.2 dizziness ‐ between 3‐28 days	2	65	Risk Ratio (M‐H, Fixed, 95% CI)	0.38 [0.09, 1.52]
10.3 dyspnoea ‐ between 3‐28 days (Oral phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	2.84 [0.12, 65.34]
10.4 palpitations during 72 hours	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 7.58]
10.5 pulse rate ‐ increased ‐ between 0‐10 days	1	54	Risk Ratio (M‐H, Fixed, 95% CI)	0.29 [0.01, 6.79]
11 Adverse effects: 2d. Specific ‐ movement disorders Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

11.1 akathisia between 0‐3 days (IM phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	0.57 [0.16, 2.02]
11.2 akathisia between 0‐10 days	1	54	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.26, 1.61]
11.3 akathisia between 3‐28 days (Oral phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	1.18 [0.62, 2.27]
11.4 dysarthria between 3‐28 days (Oral phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	0.14 [0.01, 2.44]
11.5 dyskinesia between 0‐10 days	1	54	Risk Ratio (M‐H, Fixed, 95% CI)	0.29 [0.01, 6.79]
11.6 dystonia between 0‐3 days (IM phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.06, 13.93]
11.7 dystonia between 0‐10 days	1	54	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.26, 1.61]
11.8 involuntary movement between 3‐28 days (Oral phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	0.32 [0.01, 7.26]
11.9 motor retardation between 3‐28 days (Oral phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.06, 13.93]
11.10 muscle spasms between 0‐3 days (IM phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	1.26 [0.33, 4.82]
11.11 oculogyric crisis between 0‐10 days	1	54	Risk Ratio (M‐H, Fixed, 95% CI)	2.6 [0.11, 61.11]
11.12 rigidity between 0‐3 days (IM phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	0.88 [0.65, 1.19]
11.13 rigidity between 0‐10 days	1	54	Risk Ratio (M‐H, Fixed, 95% CI)	0.86 [0.13, 5.68]
11.14 rigidity during between 3‐28 days (Oral phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	1.13 [0.93, 1.38]
11.15 tremor between 0‐3 days (IM phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.42, 2.13]
11.16 tremor during between 3‐28 days (Oral phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	1.12 [0.71, 1.76]
11.17 tremor between 0‐10 days	1	54	Risk Ratio (M‐H, Fixed, 95% CI)	2.6 [0.11, 61.11]
11.18 use of antiparkinson medication	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	2.83 [0.66, 12.16]
11.19 dystonia during 72 hours	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	5.0 [0.26, 96.13]
11.20 extrapyramidal effects ‐ use of antiparkinson drugs during 72 hours	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.6 [0.17, 2.07]
11.21 EPS during 72 hours	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	7.0 [0.98, 50.16]
11.22 thick tongue ‐ between 0‐10 days	1	54	Risk Ratio (M‐H, Fixed, 95% CI)	0.29 [0.01, 6.79]
12 Adverse effects: 2e. Specific ‐ miscellaneous Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

12.1 allergy ‐ itch ‐ between 3‐28 days (Oral phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	2.84 [0.12, 65.34]
12.2 allergy ‐ tissue reaction at injection site ‐ between 0‐10 days	1	54	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
12.3 nervousness ‐ between 0‐10 days	1	54	Risk Ratio (M‐H, Fixed, 95% CI)	0.29 [0.01, 6.79]
12.4 pain ‐ during 24 hours	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.13, 3.44]
12.5 pain ‐ headache ‐ between 0‐3 days (IM phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	0.32 [0.01, 7.26]
12.6 pain ‐ myalgia ‐ between 3‐28 days (Oral phase)	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	2.84 [0.12, 65.34]
13 Leaving the study early: 1. For general reasons Show forest plot	2		Risk Ratio (M‐H, Fixed, 90% CI)	Subtotals only

13.1 by 72 hours	1	35	Risk Ratio (M‐H, Fixed, 90% CI)	0.63 [0.21, 1.85]
13.2 by 10 days	1	54	Risk Ratio (M‐H, Fixed, 90% CI)	1.18 [0.67, 2.07]
13.3 by endpoint	1	35	Risk Ratio (M‐H, Fixed, 90% CI)	0.94 [0.42, 2.13]
14 Leaving the study early: 2. Specific reasons Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

14.1 adverse effects by 72 hours	1	35	Risk Ratio (M‐H, Fixed, 95% CI)	2.84 [0.12, 65.34]

Comparison 5. HALOPERIDOL vs OTHER ANTIPSYCHOTIC: d. LOXAPINE

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Comparison 6. HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Tranquillisation or asleep ‐ asleep Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 not asleep up to 2 hours	1	257	Risk Ratio (M‐H, Fixed, 95% CI)	1.16 [1.02, 1.32]
2 Repeated need for tranquillisation ‐ needing additional injection Show forest plot	4		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.1 by 2 hours	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	4.0 [0.47, 33.73]
2.2 by 12 hours	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	3.29 [1.67, 6.47]
2.3 by 24 hours	3	392	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [0.75, 1.51]
3 Specific behaviour: 1a. Agitation ‐ various measures Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.1 response ‐ up to 2 hours (≥40% reduction in PANSS‐EC)	1	45	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.58, 1.58]
3.2 agitation ‐ reported as 'adverse effect'	1	49	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.07, 15.73]
3.3 agitation during 21 days (if occurred in ≧10% at P < 0.05) ‐ reported as 'adverse effect'	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	1.08 [0.33, 3.51]
4 Specific behaviour: 1b. Agitation ‐ average scores ‐ i. by 30 minutes Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

4.1 change score at 15 minutes (ACES, low=agitated, high=sedated)	1	46	Mean Difference (IV, Fixed, 95% CI)	0.5 [‐0.35, 1.35]
4.2 change scores at 15 minutes (PANSS‐EC, high=worse)	1	46	Mean Difference (IV, Fixed, 95% CI)	0.30 [‐1.64, 2.24]
4.3 change score at 30 minutes (ACES, low=agitated, high=sedated)	1	46	Mean Difference (IV, Fixed, 95% CI)	0.90 [‐0.06, 1.86]
4.4 change scores at 30 minutes (PANSS‐EC, high=worse)	1	46	Mean Difference (IV, Fixed, 95% CI)	1.30 [‐1.16, 3.76]
5 Specific behaviour: 1c. Agitation ‐ average scores ‐ ii. up to 2 hours Show forest plot	5		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

5.1 change score (ABS, high=worse)	1	85	Mean Difference (IV, Fixed, 95% CI)	2.7 [0.38, 5.02]
5.2 change score at 1 hour (ACES, low=agitated, high=sedated)	1	46	Mean Difference (IV, Fixed, 95% CI)	1.2 [0.06, 2.34]
5.3 endpoint score at 1 hour (OASS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	2.00 [1.18, 2.82]
5.4 change score at 1 hour (PANSS‐EC, high=worse)	1	46	Mean Difference (IV, Fixed, 95% CI)	2.2 [‐0.50, 4.90]
5.5 change score at 2 hours (ACES, low=agitated, high=sedated)	1	46	Mean Difference (IV, Fixed, 95% CI)	0.30 [‐0.74, 1.34]
5.6 endpoint score at 2 hours (OASS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	4.20 [3.54, 4.86]
5.7 score at 2 hours (PANSS‐EC, high=worse)	3	332	Mean Difference (IV, Fixed, 95% CI)	‐0.31 [‐1.49, 0.86]
5.8 endpoint score at 2 hours (PANSS‐PAS, high=worse)	1	29	Mean Difference (IV, Fixed, 95% CI)	2.10 [‐2.56, 6.76]
6 Specific behaviour: 1d. Agitation ‐ average scores ‐ iii. up to 4 hours Show forest plot	1	60	Mean Difference (IV, Fixed, 95% CI)	0.20 [‐0.05, 0.45]

6.1 endpoint score at 4 hours (OASS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	0.20 [‐0.05, 0.45]
7 Specific behaviour: 1e. Agitation ‐ average scores ‐ iv. up to 24 hours Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

7.1 change score (ABS, high=worse)	1	86	Mean Difference (IV, Fixed, 95% CI)	2.40 [0.01, 4.79]
7.2 change score (PANSS‐EC, high=worse)	1	86	Mean Difference (IV, Fixed, 95% CI)	1.40 [‐0.55, 3.35]
7.3 endpoint score at 6 hours (OASS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	0.20 [0.05, 0.35]
7.4 endpoint score at 12 hours (OASS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	0.9 [0.82, 0.98]
8 Specific behaviour: 2a. Aggression ‐ average scores ‐ i. up to 2 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

8.1 endpoint score at 1 hour (OAS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	0.90 [0.13, 1.67]
8.2 endpoint score at 2 hours (OAS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	0.5 [‐0.41, 1.41]
9 Specific behaviour: 2b. Aggression ‐ average scores ‐ ii. up to 4 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

9.1 endpoint score at 4 hours (OAS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐0.11, 0.31]
10 Specific behaviour: 2c. Aggression ‐ average scores ‐ iii. up to 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

10.1 endpoint score at 6 hours (OAS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐0.10 [‐0.26, 0.06]
10.2 endpoint score at 12 hours (OAS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐0.20 [‐0.39, ‐0.01]
11 Specific behaviour: 3. Hostility Show forest plot	1	49	Risk Ratio (M‐H, Fixed, 95% CI)	0.35 [0.01, 8.12]

12 Global outcome: 1a. General ‐ need for additional measures Show forest plot	4		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

12.1 need for benzodiazepine during 24 hours	2	343	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.63, 1.74]
12.2 need for benzodiazepine during 7 days	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.79, 1.27]
12.3 additional restraint, seclusion or special observation	2	160	Risk Ratio (M‐H, Fixed, 95% CI)	1.49 [0.70, 3.17]
13 Global outcome: 1b. General ‐ time and doses Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

13.1 time to discontinuation	1	100	Mean Difference (IV, Fixed, 95% CI)	‐3.48 [‐6.28, ‐0.68]
13.2 dose of adjunctive lorazepam	1	100	Mean Difference (IV, Fixed, 95% CI)	0.34 [‐0.14, 0.82]
14 Global outcome: 1c. General ‐ average scores ‐ up to 2 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

14.1 endpoint score (CGI‐I, high=worse)	1	42	Mean Difference (IV, Fixed, 95% CI)	‐0.10 [‐0.65, 0.45]
15 Global outcome: 1d. General ‐ average scores ‐ over 24 hours Show forest plot	3		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

15.1 change score (CGI‐I, high=worse)	1	243	Mean Difference (IV, Fixed, 95% CI)	0.0 [‐0.20, 0.20]
15.2 change score (CGI‐S, high=worse)	1	86	Mean Difference (IV, Fixed, 95% CI)	0.0 [‐0.24, 0.24]
15.3 change score by 21 days (CGI‐I, high=worse)	1	100	Mean Difference (IV, Fixed, 95% CI)	0.36 [‐0.18, 0.90]
16 Global outcome: 2a. Specific ‐ alert ‐ i. up to 2 hours Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

16.1 alert at 1 hour	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	1.24 [0.99, 1.55]
17 Global outcome: 2b. Specific ‐ alert ‐ ii. up to 4 hours Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

17.1 alert at 4 hours	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.66, 1.42]
18 Global outcome: 2c. Specific ‐ alert ‐ iii. up to 24 hours Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

18.1 alert at 8 hours	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.67, 1.60]
18.2 alert at 16 hours	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.58, 1.78]
18.3 alert at 24 hours	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	0.85 [0.60, 1.20]
19 Global outcome: 2d. Specific ‐ tranquil ‐ i. up to 2 hours Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

19.1 tranquil at 1 hour	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	0.62 [0.29, 1.34]
20 Global outcome: 2e. Specific ‐ tranquil ‐ ii. up to 4 hours Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

20.1 tranquil at 4 hours	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	1.84 [0.94, 3.62]
21 Global outcome: 2f. Specific ‐ tranquil ‐ iii. up to 24 hours Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

21.1 tranquil at 8 hours	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.55, 1.87]
21.2 tranquil at 16 hours	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	0.72 [0.36, 1.45]
21.3 tranquil at 24 hours	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	1.50 [0.83, 2.72]
22 Global outcome: 2g. Specific ‐ sedated ‐ i. up to 2 hours Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

22.1 sedated at 1 hour	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	0.22 [0.01, 4.39]
23 Global outcome: 2h. Specific ‐ sedated ‐ ii. up to 4 hours Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

23.1 sedated at 4 hours	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	0.43 [0.18, 1.03]
24 Global outcome: 2i. Specific ‐ sedated ‐ iii. up to 24 hours Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

24.1 sedated at 8 hours	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	1.08 [0.49, 2.37]
24.2 sedated at 16 hours	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	0.84 [0.47, 1.50]
24.3 sedated at 24 hours	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	0.62 [0.19, 1.98]
25 Global outcome: 2j. Specific ‐ asleep ‐ i. up to 2 hours Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

25.1 asleep at 1 hour	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	0.36 [0.02, 8.64]
26 Global outcome: 2k. Specific ‐ asleep ‐ ii. up to 4 hours Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

26.1 asleep at 4 hours	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	1.08 [0.07, 16.84]
27 Global outcome: 2l. Specific ‐ asleep ‐ iii. up to 24 hours Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

27.1 asleep at 8 hours	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	0.27 [0.03, 2.34]
27.2 asleep at 16 hours	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	4.33 [0.97, 19.40]
27.3 asleep at 24 hours	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	3.24 [0.14, 77.79]
28 Service use: 1. Average days to discharge Show forest plot	1	100	Mean Difference (IV, Fixed, 95% CI)	‐0.60 [‐1.85, 0.65]

29 Service use: 2. Average patient‐hours used during 24 hours (skewed data) Show forest plot			Other data	No numeric data

29.1 days 1‐7			Other data	No numeric data
29.2 days 8‐14			Other data	No numeric data
29.3 days 15‐21			Other data	No numeric data
30 Mental state: 1. Various outcomes reported as 'adverse events' Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

30.1 anxiety	1	49	Risk Ratio (M‐H, Fixed, 95% CI)	0.35 [0.01, 8.12]
30.2 anxiety during 21 days (if occurred in ≧10% at P < 0.05)	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	0.36 [0.08, 1.70]
30.3 delusions	1	49	Risk Ratio (M‐H, Fixed, 95% CI)	0.35 [0.01, 8.12]
30.4 nervousness during 21 days (if occurred in ≧10% at P < 0.05)	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	2.17 [0.70, 6.74]
31 Mental state: 2a. Average scores ‐ i. by 30 minutes Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

31.1 change score at 15 minutes (BPRS positive sub‐scale, high=worse)	1	46	Mean Difference (IV, Fixed, 95% CI)	‐0.30 [‐2.11, 1.51]
31.2 change score at 30 minutes (BPRS positive sub‐scale, high=worse)	1	46	Mean Difference (IV, Fixed, 95% CI)	‐0.40 [‐2.70, 1.90]
31.3 change score at 15 minutes (BPRS total, high=worse)	1	46	Mean Difference (IV, Fixed, 95% CI)	‐0.70 [‐5.42, 4.02]
31.4 change score at 30 minutes (BPRS total, high=worse)	1	46	Mean Difference (IV, Fixed, 95% CI)	‐0.30 [‐7.35, 6.75]
32 Mental state: 2b. Average scores ‐ ii. up to 2 hours Show forest plot	3		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

32.1 change score at 1 hour (BPRS positive sub‐scale, high=worse)	1	46	Mean Difference (IV, Fixed, 95% CI)	0.60 [‐2.74, 3.94]
32.2 change score at 2 hours (BPRS positive sub‐scale, high=worse)	3	385	Mean Difference (IV, Fixed, 95% CI)	0.28 [‐0.34, 0.89]
32.3 change score at 1 hour (BPRS total, high=worse)	1	46	Mean Difference (IV, Fixed, 95% CI)	4.70 [‐5.03, 14.43]
32.4 change score at 2 hours (BPRS total, high=worse)	3	385	Mean Difference (IV, Fixed, 95% CI)	1.75 [‐0.12, 3.62]
33 Mental state: 2c. Average scores ‐ iii. up to 24 hours Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

33.1 change score at 24 hours (BPRS positive sub‐scale, high=worse)	2	340	Mean Difference (IV, Fixed, 95% CI)	‐0.30 [‐0.97, 0.37]
33.2 change score at 24 hours (BPRS total, high=worse)	2	340	Mean Difference (IV, Fixed, 95% CI)	0.47 [‐1.34, 2.29]
34 Mental state: 2d. Average scores ‐ iv. over 24 hours Show forest plot	1	100	Mean Difference (IV, Fixed, 95% CI)	4.70 [‐0.18, 9.58]

34.1 change score at 21 days (PANSS total, high=worse)	1	100	Mean Difference (IV, Fixed, 95% CI)	4.70 [‐0.18, 9.58]
35 Adverse effects: 1a. General Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

35.1 one or more drug related adverse events	3	209	Risk Ratio (M‐H, Fixed, 95% CI)	1.38 [1.09, 1.76]
36 Adverse effects: 1b. General ‐ serious Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

36.1 one or more treatment emergent adverse events	1	49	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.36, 1.83]
36.2 treatment emergent adverse events ‐ all	1	49	Risk Ratio (M‐H, Fixed, 95% CI)	1.23 [0.69, 2.19]
36.3 overall serious adverse effects	1	49	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
36.4 death	3	138	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
37 Adverse effects: 2a. Specific ‐ anticholinergic Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

37.1 increased salivation during 21 days (if occurred in ≧10% at P < 0.05)	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	9.73 [0.54, 176.18]
38 Adverse effects: 2b. Specific ‐ arousal level ‐ i. various Show forest plot	4		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

38.1 insomnia	1	49	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.39, 2.78]
38.2 insomnia during 21 days (if occurred in ≧10% at P < 0.05)	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	2.17 [0.57, 8.19]
38.3 somnolence at 24 hours	1	257	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.45, 2.41]
38.4 somnolence during 21 days (if occurred in ≧10% at P < 0.05)	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	1.44 [0.67, 3.12]
38.5 excessive sedation during 24 hours	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.33, 27.23]
39 Adverse effects: 2c. Specific ‐ arousal level ‐ ii. average scores ‐ i. up to 2 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

39.1 endpoint score at 1 hour (RSS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	0.30 [‐0.13, 0.73]
39.2 endpoint score at 2 hours (RSS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	0.0 [‐0.36, 0.36]
40 Adverse effects: 2d. Specific ‐ arousal level ‐ ii. average scores ‐ ii. up to 4 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

40.1 endpoint score at 4 hours (RSS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐0.20 [‐0.61, 0.21]
41 Adverse effects: 2e. Specific ‐ arousal level ‐ ii. average scores ‐ iii. up to 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

41.1 endpoint score at 6 hours (RSS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐0.10 [‐0.38, 0.18]
41.2 endpoint score at 12 hours (RSS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	0.0 [‐0.26, 0.26]
42 Adverse effects: 2f. Specific ‐ cardiovascular i. binary Show forest plot	3	195	Risk Ratio (M‐H, Fixed, 95% CI)	0.27 [0.03, 2.38]

42.1 clinically significant ECG change	1	49	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
42.2 hypotension during 24 hours	2	146	Risk Ratio (M‐H, Fixed, 95% CI)	0.27 [0.03, 2.38]
43 Adverse effects: 2g. Specific ‐ cardiovascular ii. continuous Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

43.1 QT interval: average change at 24 hours	1	257	Mean Difference (IV, Fixed, 95% CI)	1.8 [‐3.81, 7.41]
43.2 QT interval: average endpoint score at 24 hours	1	86	Mean Difference (IV, Fixed, 95% CI)	8.5 [‐3.28, 20.28]
44 Adverse effects: 2h. Specific ‐ gastrointestinal Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

44.1 abdominal pain	1	49	Risk Ratio (M‐H, Fixed, 95% CI)	3.12 [0.13, 73.04]
44.2 vomiting	1	49	Risk Ratio (M‐H, Fixed, 95% CI)	5.2 [0.26, 103.03]
45 Adverse effects: 2i. Specific ‐ movement disorder ‐ i. various Show forest plot	5		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

45.1 dystonia during 24 hours	2	343	Risk Ratio (M‐H, Fixed, 95% CI)	12.92 [1.67, 99.78]
45.2 dystonia during 21 days (if occurred in ≧10% at P < 0.05)	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	9.73 [0.54, 176.18]
45.3 hypertonia during 21 days (if occurred in ≧10% at P < 0.05)	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	9.73 [0.54, 176.18]
45.4 EPS during 24 hours	3	403	Risk Ratio (M‐H, Fixed, 95% CI)	8.35 [2.27, 30.63]
45.5 EPS during study	1	49	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.07, 15.73]
45.6 extrapyramidal effects ‐ use of antiparkinson drugs during 24 hours	1	257	Risk Ratio (M‐H, Fixed, 95% CI)	4.51 [1.92, 10.58]
45.7 extrapyramidal effects ‐ use of antiparkinson drugs during 21 days	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	9.73 [0.54, 176.18]
45.8 extrapyramidal effects ‐ use of antiparkinson drugs during study	1	49	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.07, 15.73]
46 Adverse effects: 2j. Specific ‐ movement disorder ‐ ii. average scores ‐ i. up to 24 hours Show forest plot	1	483	Mean Difference (IV, Fixed, 95% CI)	0.34 [0.16, 0.53]

46.1 change score at 24 hours (SAS, high=worse)	1	242	Mean Difference (IV, Fixed, 95% CI)	1.31 [0.56, 2.06]
46.2 change score at 24 hours (BAS, high=worse)	1	241	Mean Difference (IV, Fixed, 95% CI)	0.28 [0.09, 0.47]
47 Adverse effects: 2k. Specific ‐ movement disorder ‐ iii. average scores ‐ i. up to 24 hours Show forest plot			Other data	No numeric data

47.1 endpoint score at 24 hours (SAS, high=worse) ‐ (skewed data)			Other data	No numeric data
47.2 endpoint score at 24 hours (BAS, high=worse) ‐ (skewed data)			Other data	No numeric data
48 Adverse effects: 2l. Specific ‐ movement disorder ‐ vi. average scores ‐ i. over 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

48.1 endpoint score at 96 hours (AIMS, high=worse)	1	29	Mean Difference (IV, Fixed, 95% CI)	0.20 [‐0.87, 1.27]
48.2 endpoint score at 96 hours (BARS, high=worse)	1	29	Mean Difference (IV, Fixed, 95% CI)	0.8 [‐0.01, 1.61]
48.3 endpoint score at 96 hours (SAS, high=worse)	1	29	Mean Difference (IV, Fixed, 95% CI)	2.2 [‐0.07, 4.47]
49 Adverse effects: 2m. Specific ‐ miscellaneous Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

49.1 pain	1	49	Risk Ratio (M‐H, Fixed, 95% CI)	3.12 [0.13, 73.04]
49.2 pain during 21 days (if occurred in ≧10% at P < 0.05)	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	1.08 [0.33, 3.51]
49.3 pain ‐ headache during 21 days (if occurred in ≧10% at P < 0.05)	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	2.17 [0.88, 5.32]
49.4 other ‐ nose bleed	1	49	Risk Ratio (M‐H, Fixed, 95% CI)	3.12 [0.13, 73.04]
49.5 other ‐ clinically relevant laboratory changes	2	149	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
50 Leaving the study early Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

50.1 any reason	2	148	Risk Ratio (M‐H, Fixed, 95% CI)	1.66 [1.04, 2.65]
50.2 adverse effects	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	8.67 [1.13, 66.75]
50.3 lack of efficacy	2	129	Risk Ratio (M‐H, Fixed, 95% CI)	0.36 [0.09, 1.44]
50.4 lost at follow‐up	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	0.54 [0.10, 2.82]
50.5 participants decision	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	2.17 [0.57, 8.19]
50.6 non compliance	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	2.17 [0.42, 11.30]
50.7 physician decision	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	4.33 [0.50, 37.42]
50.8 sponsor decision	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	0.36 [0.02, 8.64]

Comparison 6. HALOPERIDOL vs OTHER ANTIPSYCHOTIC: e. OLANZAPINE

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Comparison 7. HALOPERIDOL vs OTHER ANTIPSYCHOTIC: f. PERPHENAZINE

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global outcome: No improvement Show forest plot	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	0.46 [0.04, 4.68]

2 Adverse effects: 1. General Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.1 one or more adverse effect	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	1.30 [0.61, 2.80]
2.2 clinically significant laboratory changes	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Adverse effects: 2. Specific Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.1 hypotensive episode	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	0.31 [0.01, 7.12]
3.2 require antiparkinson medication	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	2.74 [0.62, 12.12]
3.3 discontinued due to EPS	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	1.83 [0.18, 18.70]
3.4 discontinued due to drowsiness/tension and no therapeutic effect	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	2.75 [0.12, 64.04]
4 Leaving the study early: 1. Specific reasons Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

4.1 discontinued due to EPS	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	1.83 [0.18, 18.70]
4.2 discontinued due to drowsiness/tension and no therapeutic effect	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	2.75 [0.12, 64.04]

Comparison 7. HALOPERIDOL vs OTHER ANTIPSYCHOTIC: f. PERPHENAZINE

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Comparison 8. HALOPERIDOL vs OTHER ANTIPSYCHOTIC: g. QUETIAPINE

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Specific behaviour: 1a. Agitation ‐ average scores ‐ i. up to 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

1.1 change score at 24 hours (PANSS‐EC, high=worse)	1	80	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐0.56, 0.76]
2 Specific behaviour: 1b. Agitation ‐ average scores ‐ ii. over 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

2.1 change score at 72 hours (PANSS‐EC, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.2 change score at 7 days (PANSS‐EC, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.3 change score at 10 days (PANSS‐EC, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.4 change score at 14 days (PANSS‐EC, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.5 change score at 28 days (PANSS‐EC, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Mental state: Average scores ‐ i. over 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

3.1 change score at 28 days (PANSS total, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.2 change score at 28 days (PANSS positive sub‐scale, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.3 change score at 28 days (PANSS negative sub‐scale, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Adverse effects: 1. General Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4.1 one or more drug related adverse events by 28 days	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5 Adverse effects: 2. Specific ‐ movement disorder ‐ i. average scores Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

5.1 endpoint score at 28 days (SAS, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
6 Leaving the study early Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

6.1 any reason	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.2 adverse event	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.3 lost at follow‐up	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 8. HALOPERIDOL vs OTHER ANTIPSYCHOTIC: g. QUETIAPINE

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Comparison 9. HALOPERIDOL vs OTHER ANTIPSYCHOTIC: h. RISPERIDONE

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Tranquillisation or asleep ‐ i. by 30 minutes Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 not asleep at 30 minutes	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	0.84 [0.74, 0.95]
2 Tranquillisation or asleep ‐ ii. up to 2 hours Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.1 not asleep at 1 hour	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.59, 0.92]
2.2 not asleep at 2 hours	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.51, 0.99]
3 Specific behaviour: 1a. Agitation ‐ various measures Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.1 ≥50% reduction in PANSS‐EC score up to 24 hours	1	124	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.79, 1.16]
3.2 discontinued due to severe agitation up to 24 hours	1	124	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 8.03]
4 Specific behaviour: 1b. Agitation ‐ average scores ‐ i. up to 2 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

4.1 endpoint score at 2 hours (PANSS‐PAS, high=worse)	1	28	Mean Difference (IV, Fixed, 95% CI)	‐0.40 [‐5.22, 4.42]
5 Specific behaviour: 2a. Aggression ‐ average scores ‐ i. by 30 minutes Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

5.1 change score at 30 minutes (OAS total aggression, high=worse)	1	147	Mean Difference (IV, Fixed, 95% CI)	‐0.5 [‐0.58, ‐0.42]
6 Specific behaviour: 2b. Aggression ‐ average scores ‐ ii. up to 2 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

6.1 change score at 1 hour (OAS total aggression, high=worse)	1	146	Mean Difference (IV, Fixed, 95% CI)	‐0.20 [‐0.27, ‐0.13]
6.2 change score at 2 hours (OAS total aggression, high=worse)	1	145	Mean Difference (IV, Fixed, 95% CI)	‐0.10 [‐0.13, ‐0.07]
7 Global outcome: 1. Binary measures Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

7.1 needing additional benzodiazepine	2	286	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.65, 1.47]
7.2 rated as severe at 24 hours (CGI‐S)	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.51, 1.58]
8 Global outcome: 2. Continuous measures Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

8.1 dose of lorazapam	1	147	Mean Difference (IV, Fixed, 95% CI)	‐0.10 [‐0.49, 0.29]
8.2 time to additional dose	1	147	Mean Difference (IV, Fixed, 95% CI)	0.20 [‐2.17, 2.57]
9 Adverse effects: 1a. General ‐ one or more adverse effects Show forest plot	2	286	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.84, 1.23]

9.1 up to 24 hours	2	286	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.84, 1.23]
10 Adverse effects: 2a. Specific ‐ arousal Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

10.1 sedated at 30 minutes	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	1.90 [1.39, 2.59]
10.2 sedated at 60 minutes	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	1.41 [1.15, 1.72]
10.3 sedated at 120 minutes	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	1.10 [0.98, 1.23]
10.4 somnolence during 24 hours (only reported if occurred in ≥5%)	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.43, 2.12]
10.5 somnolence during 24 hours	1	124	Risk Ratio (M‐H, Fixed, 95% CI)	0.78 [0.31, 1.96]
10.6 insomnia ‐ severe	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	0.35 [0.01, 8.47]
10.7 somnolence ‐ severe	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	3.15 [0.13, 76.20]
11 Adverse effects: 2b. Specific ‐ cardiovascular ‐ i. binary outcomes Show forest plot	2	286	Risk Ratio (M‐H, Fixed, 95% CI)	1.46 [0.45, 4.70]

11.1 dizziness during 24 hours	1	124	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.26, 3.82]
11.2 orthostatic hypertension	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	5.25 [0.26, 107.67]
12 Adverse effects: 2c. Specific ‐ cardiovascular ‐ ii. pulse rate ‐ i. up to 2 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

12.1 heartbeat change at 60 minutes	1	162	Mean Difference (IV, Fixed, 95% CI)	‐9.4 [‐9.99, ‐8.81]
13 Adverse effects: 2d. Specific ‐ cardiovascular ‐ ii. pulse rate ‐ ii. up to 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

13.1 heartbeat change at 8 hours	1	162	Mean Difference (IV, Fixed, 95% CI)	‐8.8 [‐9.75, ‐7.85]
14 Adverse effects: 2e. Specific ‐ movement disorder ‐ i. binary outcomes Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

14.1 dystonia during 24 hours	2	286	Risk Ratio (M‐H, Fixed, 95% CI)	1.44 [0.28, 7.28]
14.2 dyskinesia during 24 hours	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	3.15 [0.13, 76.20]
14.3 hyperkinesia during 24 hours (only reported if occurred in ≥5%)	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	4.20 [0.48, 36.79]
14.4 hypertonia/rigidity during 24 hours	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	0.35 [0.01, 8.47]
14.5 tremor during 24 hours	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	5.25 [0.26, 107.67]
14.6 movement disorder	1	124	Risk Ratio (M‐H, Fixed, 95% CI)	1.6 [0.55, 4.62]
15 Adverse effects: 2f. Specific ‐ movement disorders ‐ ii. average scores ‐ i. up to 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

15.1 change score at 24 hours (BAS akathisia, high=worse)	1	162	Mean Difference (IV, Fixed, 95% CI)	0.3 [0.24, 0.36]
15.2 change score at 24 hours (SAS movement disorders, high=worse)	1	162	Mean Difference (IV, Fixed, 95% CI)	0.4 [0.34, 0.46]
16 Adverse effects: 2g. Specific ‐ movement disorder ‐ ii. average scores ‐ ii. over 24 hours Show forest plot	1	84	Mean Difference (IV, Fixed, 95% CI)	0.58 [‐0.32, 1.47]

16.1 endpoint score at 96 hours (AIMS, high=worse)	1	28	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
16.2 endpoint score at 96 hours (BARS, high=worse)	1	28	Mean Difference (IV, Fixed, 95% CI)	0.60 [‐0.36, 1.56]
16.3 endpoint score at 96 hours (SAS, high=worse)	1	28	Mean Difference (IV, Fixed, 95% CI)	0.40 [‐2.20, 3.00]
17 Adverse effects: 2h. Specific ‐ miscellaneous Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

17.1 agitation during 24 hours (only reported if occurred in ≥5%)	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.27, 4.06]
17.2 agitation ‐ severe	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	2.10 [0.19, 22.72]
17.3 anxiety ‐ severe	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	3.15 [0.13, 76.20]
17.4 headache during 24 hours (only reported if occurred in ≥5%)	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	1.31 [0.37, 4.71]
17.5 headache during 24 hours	1	124	Risk Ratio (M‐H, Fixed, 95% CI)	1.33 [0.31, 5.71]
18 Leaving the study early ‐ i. up to 24 hours Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

18.1 due to severe agitation	1	124	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 8.03]
18.2 due to acute dystonia	1	124	Risk Ratio (M‐H, Fixed, 95% CI)	5.0 [0.24, 102.07]
18.3 due to adverse effects	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.07, 16.51]
18.4 unspecified general reasons	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	0.77 [0.42, 1.44]
19 Leaving the study early ‐ ii. over 24 hours Show forest plot	1	28	Risk Ratio (M‐H, Fixed, 95% CI)	0.11 [0.01, 1.89]

19.1 Lack of efficacy at 96 hours	1	28	Risk Ratio (M‐H, Fixed, 95% CI)	0.11 [0.01, 1.89]

Comparison 9. HALOPERIDOL vs OTHER ANTIPSYCHOTIC: h. RISPERIDONE

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Comparison 10. HALOPERIDOL vs OTHER ANTIPSYCHOTIC: i. THIOTHIXENE

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Repeated need for rapid tranquillisation Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 more than 1 injection	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.89, 1.28]
1.2 more than 3 injections	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	2.5 [0.57, 10.93]
2 Specific behaviour: 1. Agitation ‐ rated as 'adverse effect' Show forest plot	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	0.28 [0.01, 6.52]

3 Global outcome Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.1 no response to 1st injection	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	2.5 [0.57, 11.05]
3.2 no improvement at 1 hour	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	0.5 [0.14, 1.84]
3.3 no improvement at 2 hours	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	0.17 [0.01, 3.31]
3.4 no improvement at 3 hours	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.06, 12.49]
3.5 no improvement at 4 hours	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.06, 12.49]
3.6 no improvement at 5 hours	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	4.2 [0.21, 82.72]
4 Adverse effects: 1. General ‐ one or more adverse effects Show forest plot	2	74	Risk Ratio (M‐H, Fixed, 95% CI)	1.47 [0.97, 2.22]

5 Adverse effects: 2a. Specific ‐ movement disorders Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

5.1 ataxia	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.06, 12.49]
5.2 thick tongue	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	2.52 [0.11, 58.67]
5.3 use of antiparkinson drugs	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6 Adverse effects: 2b. Specific ‐ others Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

6.1 anticholinergic ‐ blurred vision	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	4.2 [0.21, 82.72]
6.2 anticholinergic ‐ dry mouth	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	0.17 [0.01, 3.31]
6.3 arousal ‐ drowsiness	2	74	Risk Ratio (M‐H, Fixed, 95% CI)	1.72 [1.02, 2.90]
6.4 arousal ‐ lightheadedness	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	4.2 [0.21, 82.72]
6.5 cardiac ‐ chest pain	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	0.28 [0.01, 6.52]
6.6 cardiac ‐ dizziness	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	2.5 [0.28, 22.20]
6.7 cardiac ‐ hypotensive crisis	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.8 cardiac ‐ orthostatic hypotension	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.06, 12.49]
6.9 cardiac ‐ tachycardia	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	0.28 [0.01, 6.52]
6.10 other ‐ depressed mood	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	2.52 [0.11, 58.67]
6.11 other ‐ diaphoresis	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	0.28 [0.01, 6.52]
6.12 other ‐ weakness	2	74	Risk Ratio (M‐H, Fixed, 95% CI)	2.75 [0.30, 25.21]
6.13 other ‐ unsteadiness	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.13, 68.26]

Comparison 10. HALOPERIDOL vs OTHER ANTIPSYCHOTIC: i. THIOTHIXENE

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Comparison 11. HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Repeated need for tranquillisation ‐ need for additional drugs for tranquillisation Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 up to 2 hours	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.36 [0.13, 1.01]
1.2 up to 24 hours	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	1.64 [1.07, 2.53]
2 Specific behaviour: 1a. Agitation ‐ average scores ‐ i. up to 2 hours Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

2.1 endpoint score at 1 hour (OASS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐7.70 [‐9.41, ‐5.99]
2.2 endpoint score at 2 hours (OASS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐3.90 [‐6.38, ‐1.42]
2.3 endpoint score at 2 hours (PANSS‐EC, high=worse)	1	231	Mean Difference (IV, Fixed, 95% CI)	0.06 [‐1.13, 1.25]
3 Specific behaviour: 1b. Agitation ‐ average scores ‐ ii. up to 4 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

3.1 endpoint score at 4 hours (OASS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	0.20 [‐0.05, 0.45]
4 Specific behaviour: 1c. Agitation ‐ average scores ‐ iii. up to 24 hours Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

4.1 endpoint score at 6 hours (OASS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	0.20 [0.05, 0.35]
4.2 endpoint score at 6 hours (PANSS‐EC, high=worse)	1	231	Mean Difference (IV, Fixed, 95% CI)	‐0.47 [‐1.68, 0.74]
4.3 endpoint score at 12 hours (OASS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	0.9 [0.82, 0.98]
4.4 endpoint score at 24 hours (PANSS‐EC, high=worse)	1	231	Mean Difference (IV, Fixed, 95% CI)	‐0.21 [‐1.36, 0.94]
5 Specific behaviour: 1d. Agitation ‐ average scores ‐ iv. over 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

5.1 endpoint scores at 48 hours (PANSS‐EC, high=worse)	1	231	Mean Difference (IV, Fixed, 95% CI)	0.06 [‐1.03, 1.15]
5.2 endpoint scores at 72 hours (PANSS‐EC, high=worse)	1	231	Mean Difference (IV, Fixed, 95% CI)	0.62 [‐0.45, 1.69]
6 Specific behaviour: 2a. Aggression ‐ average scores ‐ i. up to 2 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

6.1 endpoint score at 1 hour (OAS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	0.0 [‐0.77, 0.77]
6.2 endpoint score at 2 hours (OAS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	0.70 [‐0.25, 1.65]
7 Specific behaviour: 2b. Aggression ‐ average scores ‐ ii. up to 4 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

7.1 endpoint score at 4 hours (OAS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	0.30 [‐0.04, 0.64]
8 Specific behaviour: 2c. Aggression ‐ average scores ‐ iii. up to 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

8.1 endpoint score at 6 hours (OAS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	0.70 [0.60, 0.80]
8.2 endpoint score at 12 hours (OAS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	0.20 [0.07, 0.33]
9 Global outcome: 1. General ‐ need for additional measures Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

9.1 need for anxiolytic during 7 days	1	132	Risk Ratio (M‐H, Fixed, 95% CI)	1.11 [0.84, 1.48]
9.2 need for hypnotics for night time sedation during 7 days	1	132	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.20, 2.50]
9.3 additional restraint, seclusion or special observation during 12 hours	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.6 [0.25, 1.44]
10 Global outcome: 2. Average scores ‐ i. over 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

10.1 change score at 72 hours (CGI‐S, high=worse)	1	132	Mean Difference (IV, Fixed, 95% CI)	0.34 [0.13, 0.55]
10.2 change score at 7 days (CGI‐S, high=worse)	1	132	Mean Difference (IV, Fixed, 95% CI)	0.51 [0.07, 0.95]
11 Mental state: 1a. Average scores ‐ i. up to 2 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

11.1 endpoint score at 2 hours (BPRS, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
12 Mental state: 1b. Average scores ‐ ii. up to 4 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

12.1 endpoint score at 4 hours (BPRS, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
13 Mental state: 1c. Average scores ‐ iii. up to 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

13.1 endpoint score at 24 hours (BPRS, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
14 Mental state: 1d. Average scores ‐ iv. over 24 hours Show forest plot	4		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

14.1 endpoint score at 48 hours (BPRS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐2.05 [‐6.45, 2.35]
14.2 endpoint score at 72 hours (PANSS total, high=worse)	1	231	Mean Difference (IV, Fixed, 95% CI)	2.45 [‐2.19, 7.09]
14.3 endpoint score at 72 hours (PANSS positive sub‐scale, high=worse)	1	231	Mean Difference (IV, Fixed, 95% CI)	1.11 [‐0.45, 2.67]
14.4 endpoint score at 72 hours (PANSS negative sub‐scale, high=worse)	1	231	Mean Difference (IV, Fixed, 95% CI)	‐4.19 [‐5.71, ‐2.67]
14.5 endpoint score at 72 hours (PANSS general pathology score, high=worse)	1	231	Mean Difference (IV, Fixed, 95% CI)	0.0 [‐2.27, 2.27]
14.6 score at 72 hours (BPRS, high=worse)	3	511	Mean Difference (IV, Fixed, 95% CI)	‐0.43 [‐1.93, 1.07]
14.7 change score at 7 days (BPRS, high=worse)	1	132	Mean Difference (IV, Fixed, 95% CI)	2.93 [‐0.81, 6.67]
15 Adverse effects: 1a. General ‐ i. up to 24 hours Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

15.1 one or more drug related adverse effects ‐ by 12 hours	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	1.38 [0.64, 2.93]
16 Adverse effects: 1b. General ‐ ii. over 24 hours Show forest plot	4		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

16.1 one or more drug related adverse effects ‐ by 72 hours	4	799	Risk Ratio (M‐H, Fixed, 95% CI)	1.74 [1.47, 2.06]
16.2 one or more drug related adverse effects ‐ by 7 days	1	132	Risk Ratio (M‐H, Fixed, 95% CI)	1.31 [0.93, 1.83]
17 Adverse effects: 1c. General ‐ serious Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

17.1 severe adverse effect ‐ by 72 hours	1	376	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
17.2 death	2	436	Risk Ratio (M‐H, Fixed, 95% CI)	0.14 [0.01, 2.78]
18 Adverse effects: 2a. Specific ‐ anticholinergic Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

18.1 blurred vision by 72 hours	1	231	Risk Ratio (M‐H, Fixed, 95% CI)	3.97 [1.15, 13.68]
18.2 constipation by 72 hours	1	376	Risk Ratio (M‐H, Fixed, 95% CI)	0.40 [0.08, 2.06]
18.3 dry mouth by 72 hours	1	231	Risk Ratio (M‐H, Fixed, 95% CI)	2.97 [1.22, 7.22]
18.4 hypersalivation by 72 hours	1	231	Risk Ratio (M‐H, Fixed, 95% CI)	2.55 [1.11, 5.87]
19 Adverse effects: 2b. Specific ‐ arousal level ‐ i. various Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

19.1 excessive sedation at 12 hours	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.22, 4.56]
19.2 insomnia ‐ by 72 hours	1	376	Risk Ratio (M‐H, Fixed, 95% CI)	0.51 [0.05, 5.53]
19.3 lethargy ‐ by 72 hours	1	231	Risk Ratio (M‐H, Fixed, 95% CI)	1.26 [0.67, 2.35]
19.4 somnolence ‐ by 72 hours	1	376	Risk Ratio (M‐H, Fixed, 95% CI)	1.16 [0.43, 3.12]
20 Adverse effects: 2c. Specific ‐ arousal level ‐ ii. average scores ‐ i. up to 2 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

20.1 endpoint score at 1 hour (RSS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	0.0 [‐0.46, 0.46]
20.2 endpoint score at 2 hours (RSS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	0.0 [‐0.46, 0.46]
21 Adverse effects: 2d. Specific ‐ arousal level ‐ ii. average scores ‐ ii. up to 4 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

21.1 endpoint score at 4 hours (RSS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐0.40 [‐0.83, 0.03]
22 Adverse effects: 2e. Specific ‐ arousal level ‐ ii. average scores ‐ iii. up to 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

22.1 endpoint score at 6 hours (RSS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐0.10 [‐0.40, 0.20]
22.2 endpoint score at 12 hours (RSS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐0.10 [‐0.40, 0.20]
23 Adverse effects: 2f. Specific ‐ cardiovascular Show forest plot	4		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

23.1 hypotension at 12 hours	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.08 [0.00, 1.31]
23.2 dizziness ‐ by 72 hours	2	607	Risk Ratio (M‐H, Fixed, 95% CI)	0.58 [0.28, 1.19]
23.3 ECG ‐ abnormal ‐ by 72 hours	2	607	Risk Ratio (M‐H, Fixed, 95% CI)	0.38 [0.17, 0.84]
23.4 ECG change ‐ clinically significant ‐ by 72 hours	1	376	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.60, 1.71]
23.5 tachycardia ‐ by 72 hours	3	739	Risk Ratio (M‐H, Fixed, 95% CI)	0.49 [0.23, 1.04]
24 Adverse effects: 2g. Specific ‐ gastrointestinal Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

24.1 nausea by 72 hours	1	376	Risk Ratio (M‐H, Fixed, 95% CI)	0.40 [0.08, 2.06]
24.2 vomiting by 72 hours	1	132	Risk Ratio (M‐H, Fixed, 95% CI)	0.30 [0.02, 5.72]
24.3 vomiting by 7 days	1	132	Risk Ratio (M‐H, Fixed, 95% CI)	0.16 [0.01, 2.82]
25 Adverse effects: 2h. Specific ‐ hematological tests Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

25.1 abnormal lab results ‐ by 72 hours	2	508	Risk Ratio (M‐H, Fixed, 95% CI)	0.90 [0.69, 1.17]
25.2 abnormal lab results ‐ by 7 days	1	132	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.47, 2.15]
25.3 aspartate aminotransference ‐ by 72 hours	1	376	Risk Ratio (M‐H, Fixed, 95% CI)	11.12 [0.62, 199.64]
25.4 glucose increased ‐ by 24 hours	1	132	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.31, 2.92]
25.5 haemogram abnormal ‐ by 72 hours	1	231	Risk Ratio (M‐H, Fixed, 95% CI)	0.17 [0.02, 1.35]
25.6 lactate dehydrogenase increase ‐ by 72 hours	1	231	Risk Ratio (M‐H, Fixed, 95% CI)	0.50 [0.05, 5.39]
25.7 liver function abnormal ‐ by 72 hours	1	231	Risk Ratio (M‐H, Fixed, 95% CI)	0.50 [0.05, 5.39]
25.8 triglyceride increase ‐ by 72 hours	1	231	Risk Ratio (M‐H, Fixed, 95% CI)	4.96 [0.24, 102.14]
26 Adverse effects: 2i. Specific ‐ movement disorders ‐ i. binary measures Show forest plot	4		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

26.1 akathisia ‐ by 72 hours	3	739	Risk Ratio (M‐H, Fixed, 95% CI)	2.32 [1.34, 4.01]
26.2 akathisia ‐ by 7 days	1	132	Risk Ratio (M‐H, Fixed, 95% CI)	4.29 [1.13, 16.31]
26.3 dystonia ‐ by 72 hours	2	508	Risk Ratio (M‐H, Fixed, 95% CI)	10.26 [1.67, 63.17]
26.4 dystonia ‐ by 7 days	1	132	Risk Ratio (M‐H, Fixed, 95% CI)	2.68 [0.76, 9.47]
26.5 EPS ‐ by 12 hours	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	11.0 [0.64, 190.53]
26.6 EPS ‐ by 72 hours	2	508	Risk Ratio (M‐H, Fixed, 95% CI)	19.13 [7.59, 48.21]
26.7 EPS ‐ by 7 days	1	132	Risk Ratio (M‐H, Fixed, 95% CI)	34.29 [4.70, 250.02]
26.8 extrapyramidal effects ‐ use of antiparkinson drugs ‐ by 7 days	1	132	Risk Ratio (M‐H, Fixed, 95% CI)	3.30 [1.82, 5.97]
26.9 hypertonia/rigidity ‐ by 72 hours	1	132	Risk Ratio (M‐H, Fixed, 95% CI)	14.81 [0.78, 280.47]
26.10 hypertonia ‐ by 7 days	1	132	Risk Ratio (M‐H, Fixed, 95% CI)	3.57 [0.90, 14.25]
26.11 myotonia ‐ by 72 hours	1	231	Risk Ratio (M‐H, Fixed, 95% CI)	3.84 [1.85, 8.00]
26.12 pyramidal tract syndrome ‐ by 72 hours	1	376	Risk Ratio (M‐H, Fixed, 95% CI)	17.18 [1.00, 295.55]
26.13 reduced movement ‐ by 72 hours	1	231	Risk Ratio (M‐H, Fixed, 95% CI)	2.14 [1.17, 3.91]
26.14 torsional spasm ‐ by 72 hours	1	231	Risk Ratio (M‐H, Fixed, 95% CI)	3.30 [0.93, 11.70]
26.15 tremor ‐ by 72 hours	2	363	Risk Ratio (M‐H, Fixed, 95% CI)	2.64 [1.37, 5.11]
26.16 tremor ‐ by 7 days	1	132	Risk Ratio (M‐H, Fixed, 95% CI)	4.29 [0.82, 22.48]
27 Adverse effects: 2j. Specific ‐ movement disorders ‐ ii. average scores ‐ i. over 24 hours Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

27.1 change score at 72 hours (BAS, high=worse)	1	131	Mean Difference (IV, Fixed, 95% CI)	0.47 [0.18, 0.76]
27.2 score at 72 hours (SAS, high=worse)	2	191	Mean Difference (IV, Fixed, 95% CI)	3.59 [2.15, 5.03]
27.3 change score at 7 days (BAS, high=worse)	1	131	Mean Difference (IV, Fixed, 95% CI)	0.9 [0.51, 1.29]
27.4 change score at 7 days (SAS, high=worse)	1	131	Mean Difference (IV, Fixed, 95% CI)	6.1 [3.91, 8.29]
28 Adverse effects: 2k. Specific ‐ miscellaneous Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

28.1 physical examination significant changes ‐ by 72 hours	1	376	Risk Ratio (M‐H, Fixed, 95% CI)	27.29 [1.63, 455.72]
29 Leaving the study early: 1. For any reason ‐ i. over 24 hours Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

29.1 by 72 hours	1	376	Risk Ratio (M‐H, Fixed, 95% CI)	1.77 [0.53, 5.94]
29.2 by 7 days	1	132	Risk Ratio (M‐H, Fixed, 95% CI)	2.14 [0.86, 5.32]
30 Leaving the study early: 2. For specific reasons ‐ i. over 24 hours Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

30.1 adverse events ‐ by 72 hours	2	508	Risk Ratio (M‐H, Fixed, 95% CI)	2.40 [0.45, 12.75]
30.2 adverse events ‐ by 7 days	1	132	Risk Ratio (M‐H, Fixed, 95% CI)	0.54 [0.06, 4.65]
30.3 withdrew consent ‐ by 72 hours	1	376	Risk Ratio (M‐H, Fixed, 95% CI)	5.05 [0.24, 104.55]
30.4 other ‐ by 72 hours	1	376	Risk Ratio (M‐H, Fixed, 95% CI)	0.20 [0.01, 4.18]

Comparison 11. HALOPERIDOL vs OTHER ANTIPSYCHOTIC: j. ZIPRASIDONE

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Comparison 12. HALOPERIDOL vs OTHER ANTIPSYCHOTIC: k. ZUCLOPENTHIXOL ACETATE

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Repeated need for tranquillisation: more than 3 injections Show forest plot	1	70	Risk Ratio (M‐H, Fixed, 95% CI)	2.54 [1.19, 5.46]

2 Adverse effects: 1a. Specific ‐ movement disorders Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.1 movement disorder ‐ tremor by 7 days	1	70	Risk Ratio (M‐H, Fixed, 95% CI)	4.16 [0.93, 18.62]
3 Adverse effects: 1b. Specific ‐ miscellaneous Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.1 pain/allergy ‐ reaction at injection site	1	70	Risk Ratio (M‐H, Fixed, 95% CI)	3.55 [0.15, 84.14]
4 Leaving the study early Show forest plot	1	70	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 12. HALOPERIDOL vs OTHER ANTIPSYCHOTIC: k. ZUCLOPENTHIXOL ACETATE

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Comparison 13. HALOPERIDOL vs BENZODIAZEPINE: a. FLUNITRAZEPAM

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Specific behaviour: 1. Aggression ‐ binary measures ‐ i. up to 2 hours Show forest plot	1	28	Risk Ratio (M‐H, Fixed, 95% CI)	1.15 [0.86, 1.55]

1.1 ≥50% reduction at 90 minutes (OAS)	1	28	Risk Ratio (M‐H, Fixed, 95% CI)	1.15 [0.86, 1.55]
2 Global outcome: 1. Need for seclusion or restraint Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3 Adverse effects: 1. Specific ‐ movement disorders ‐ i. binary measures ‐ i. by 30 minutes Show forest plot	1	28	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

3.1 EPS by 30 minutes	1	28	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 13. HALOPERIDOL vs BENZODIAZEPINE: a. FLUNITRAZEPAM

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Comparison 14. HALOPERIDOL vs BENZODIAZEPINE: b. LORAZEPAM

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Tranquillisation or asleep ‐ not asleep Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 at 1 hour	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.76, 1.44]
1.2 by 3 hours	1	66	Risk Ratio (M‐H, Fixed, 95% CI)	1.93 [1.14, 3.27]
2 Repeated need for rapid tranquillisation Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.1 more than 1 injection	1	66	Risk Ratio (M‐H, Fixed, 95% CI)	1.14 [0.91, 1.43]
2.2 more than 3 injections	1	66	Risk Ratio (M‐H, Fixed, 95% CI)	1.11 [0.50, 2.45]
3 Global outcome: 1. No overall improvement Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.1 by 30 minutes	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	1.10 [0.70, 1.71]
3.2 at 1 hour	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	1.64 [0.54, 5.03]
3.3 at > 1 hour	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Mental state: 1a. Average scores ‐ i. up to 2 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

4.1 endpoint score at 1 hour (BPRS, high=worse)	1	37	Mean Difference (IV, Fixed, 95% CI)	3.26 [‐4.13, 10.65]
4.2 endpoint score at 2 hours (BPRS, high=worse)	1	37	Mean Difference (IV, Fixed, 95% CI)	4.07 [‐2.62, 10.76]
5 Mental state: 1b. Average scores ‐ ii. up to 4 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

5.1 endpoint score at 3 hours (BPRS, high=worse)	1	37	Mean Difference (IV, Fixed, 95% CI)	5.03 [‐2.98, 13.04]
5.2 endpoint score at 4 hours (BPRS, high=worse)	1	37	Mean Difference (IV, Fixed, 95% CI)	1.73 [‐6.14, 9.60]
6 Adverse effects: 1a. General Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

6.1 one or more drug‐related adverse effect up to 24 hours	1	66	Risk Ratio (M‐H, Fixed, 95% CI)	1.13 [0.60, 2.10]
7 Adverse effects: 1b. General ‐ serious Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

8 Adverse effects: 2a. Specific ‐ anticholinergic Show forest plot	1	66	Risk Ratio (M‐H, Fixed, 95% CI)	0.53 [0.14, 2.04]

8.1 dry mouth up to 24 hours (only reported if occurred ≥9%)	1	66	Risk Ratio (M‐H, Fixed, 95% CI)	0.53 [0.14, 2.04]
9 Adverse effects: 2b. Specific ‐ arousal Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

9.1 asleep ‐ at 1 hour	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.40, 1.99]
10 Adverse effects: 2c. Specific ‐ cardiovascular Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

10.1 dizziness (only reported if occurred in ≧9%) ‐ during 24 hours	1	66	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.19, 4.07]
10.2 hypertension ‐ use of additional clonidine ‐ during 24 hours	1	66	Risk Ratio (M‐H, Fixed, 95% CI)	2.67 [0.11, 63.17]
11 Adverse effects: 2d. Specific ‐ movement disorder Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

11.1 ataxia (only reported if occurred in ≧9%) ‐ during 24 hours	1	66	Risk Ratio (M‐H, Fixed, 95% CI)	0.44 [0.04, 4.65]
11.2 dystonia (only reported if occurred in ≧9%) ‐ during 24 hours	1	66	Risk Ratio (M‐H, Fixed, 95% CI)	3.54 [0.42, 30.03]
11.3 EPS	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	15.0 [2.11, 106.49]
11.4 hypertonia/rigidity (only reported if occurred in ≧9%) ‐ during 24 hours	1	66	Risk Ratio (M‐H, Fixed, 95% CI)	6.22 [0.33, 115.91]
11.5 speech disorder (only reported if occurred in ≧9%) ‐ during 24 hours	1	66	Risk Ratio (M‐H, Fixed, 95% CI)	1.77 [0.35, 9.01]
11.6 tremor (only reported if occurred in ≧9%) ‐ during 24 hours	1	66	Risk Ratio (M‐H, Fixed, 95% CI)	1.77 [0.17, 18.60]
11.7 use of additional benztropine ‐ during 24 hours	1	66	Risk Ratio (M‐H, Fixed, 95% CI)	1.99 [0.68, 5.83]

Comparison 14. HALOPERIDOL vs BENZODIAZEPINE: b. LORAZEPAM

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Comparison 15. HALOPERIDOL vs BENZODIAZEPINE: c. MIDAZOLAM

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Tranquillisation or asleep: average times in minutes ‐ (skewed data) Show forest plot			Other data	No numeric data

1.1 average time to sedation			Other data	No numeric data
1.2 average time to arousal			Other data	No numeric data
2 Global outcome: 1. Need for rescue drug Show forest plot	1	84	Risk Ratio (M‐H, Fixed, 95% CI)	1.14 [0.46, 2.87]

3 Adverse effects: 1. General ‐ one or more drug related adverse effect Show forest plot	1	84	Risk Ratio (M‐H, Fixed, 95% CI)	5.0 [0.25, 101.11]

4 Adverse effects: 2. Specific Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

4.1 hypotensive	1	84	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.13, 71.61]
4.2 apnoea	1	84	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.13, 71.61]

Comparison 15. HALOPERIDOL vs BENZODIAZEPINE: c. MIDAZOLAM

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Comparison 16. HALOPERIDOL vs COMBINATIONS: a. HALOPERIDOL + LEVOMEPROMAZINE

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global outcome: 1. No overall improvement Show forest plot	1	19	Risk Ratio (M‐H, Fixed, 95% CI)	8.18 [0.50, 133.66]

Comparison 16. HALOPERIDOL vs COMBINATIONS: a. HALOPERIDOL + LEVOMEPROMAZINE

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Comparison 17. HALOPERIDOL vs COMBINATIONS: b. HALOPERIDOL + LORAZEPAM

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Tranquillisation or asleep ‐ asleep Show forest plot	1	67	Risk Ratio (M‐H, Fixed, 95% CI)	1.83 [1.11, 3.02]

1.1 not asleep by 3 hours	1	67	Risk Ratio (M‐H, Fixed, 95% CI)	1.83 [1.11, 3.02]
2 Repeated need for rapid tranquillisation Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.1 needing additional injection during 24 hours	1	67	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.87, 1.27]
2.2 more than 3 injections during 24 hours	1	67	Risk Ratio (M‐H, Fixed, 95% CI)	3.05 [0.92, 10.10]
3 Global outcome: 1. No overall improvement Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.1 by 30 minutes	1	45	Risk Ratio (M‐H, Fixed, 95% CI)	2.67 [1.25, 5.68]
3.2 at 1 hour	1	45	Risk Ratio (M‐H, Fixed, 95% CI)	14.77 [0.88, 247.54]
3.3 at > 1 hour	1	45	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Adverse effects: 1. General Show forest plot	1	67	Risk Ratio (M‐H, Fixed, 95% CI)	1.16 [0.62, 2.18]

4.1 one or more drug‐related adverse effect during 24 hours	1	67	Risk Ratio (M‐H, Fixed, 95% CI)	1.16 [0.62, 2.18]
5 Adverse effects: 2a. Specific ‐ anticholinergic Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

5.1 dry mouth (only reported if occurred in ≧9%) during 24 hours	1	67	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.20, 4.21]
6 Adverse effects: 2b. Specific ‐ cardiovascular Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

6.1 dizziness (only reported if occurred in ≧9%) during 24 hours	1	67	Risk Ratio (M‐H, Fixed, 95% CI)	1.37 [0.24, 7.69]
6.2 hypertension ‐ use of additional clonidine during 24 hours	1	67	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.06, 14.02]
7 Adverse effects: 2c. Specific ‐ movement disorders Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

7.1 ataxia (only reported if occurred in >9%) during 24 hours	1	67	Risk Ratio (M‐H, Fixed, 95% CI)	0.30 [0.03, 2.78]
7.2 dystonia (only reported if occurred in >9%) during 24 hours	1	67	Risk Ratio (M‐H, Fixed, 95% CI)	8.25 [0.46, 147.45]
7.3 hypertonia/rigidity (only reported if occurred in >9%) during 24 hours	1	67	Risk Ratio (M‐H, Fixed, 95% CI)	2.74 [0.30, 25.05]
7.4 tremor (only reported if occurred in >9%) during 24 hours	1	67	Risk Ratio (M‐H, Fixed, 95% CI)	1.83 [0.17, 19.21]
7.5 speech disorder (only reported if occurred in >9%) during 24 hours	1	67	Risk Ratio (M‐H, Fixed, 95% CI)	1.22 [0.30, 5.03]
7.6 use of additional benztropine during 24 hours	1	67	Risk Ratio (M‐H, Fixed, 95% CI)	2.74 [0.81, 9.25]

Comparison 17. HALOPERIDOL vs COMBINATIONS: b. HALOPERIDOL + LORAZEPAM

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Comparison 18. HALOPERIDOL vs COMBINATIONS: c. HALOPERIDOL + MIDAZOLAM

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Repeated need for tranquillisation Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 need for additional drugs for tranquillisation up to 2 hours	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.27 [0.10, 0.71]
1.2 need for additional drugs for tranquillisation by 12 hours	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.88 [0.69, 1.13]
2 Specific behaviour: 1a. Agitation ‐ average scores ‐ i. up to 2 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

2.1 endpoint score at 1 hour (OASS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐8.5 [‐9.93, ‐7.07]
2.2 endpoint score at 2 hours (OASS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐6.7 [‐7.46, ‐5.94]
3 Specific behaviour: 1b. Agitation ‐ average scores ‐ ii. up to 4 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

3.1 endpoint score at 4 hours (OASS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐5.5 [‐6.48, ‐4.52]
4 Specific behaviour: 1c. Agitation ‐ average scores ‐ iii. up to 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

4.1 endpoint score at 6 hours (OASS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐3.70 [‐4.56, ‐2.84]
4.2 endpoint score at 12 hours (OASS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐11.2 [‐12.24, ‐10.16]
5 Specific behaviour: 2a. Aggression ‐ average scores ‐ i. up to 2 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

5.1 endpoint score at 1 hour (OAS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐1.20 [‐2.44, 0.04]
5.2 endpoint score at 2 hours (OAS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐2.40 [‐4.21, ‐0.59]
6 Specific behaviour: 2b. Aggression ‐ average scores ‐ ii. up to 4 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

6.1 endpoint score at 4 hours (OAS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐0.10 [‐0.68, 0.48]
7 Specific behaviour: 2c. Aggression ‐ average scores ‐ iii. up to 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

7.1 endpoint score at 6 hours (OAS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	0.40 [0.30, 0.50]
7.2 endpoint score at 12 hours (OAS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐1.9 [‐2.58, ‐1.22]
8 Global outcomes: 1. General ‐ need for additional measures Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

8.1 additional restraint, seclusion or special observation during 12 hours	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.29 [0.13, 0.61]
9 Adverse effects: 1b. General ‐ one or more adverse events Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

9.1 during 12 hours	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.73 [0.41, 1.32]
10 Adverse effects: 1a. General ‐ serious Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

10.1 death	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
11 Adverse effects: 2a. Specific ‐ arousal ‐ i. various Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

11.1 excessive sedation by 12 hours	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.25 [0.08, 0.80]
12 Adverse effects: 2b. Specific ‐ arousal ‐ ii. average scores ‐ i. up to 2 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

12.1 endpoint score at 1 hour (RSS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐0.5 [‐1.01, 0.01]
12.2 endpoint score at 2 hours (RSS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐0.10 [‐0.56, 0.36]
13 Adverse effects: 2c. Specific ‐ arousal ‐ ii. average scores ‐ ii. up to 4 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

13.1 endpoint score at 4 hours (RSS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐0.30 [‐0.78, 0.18]
14 Adverse effects: 2d. Specific ‐ arousal ‐ iii. average scores ‐ iii. up to 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

14.1 endpoint score at 6 hours (RSS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐0.10 [‐0.40, 0.20]
14.2 endpoint score at 12 hours (RSS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐0.26, 0.46]
15 Adverse effects: 2e. Specific ‐ cardiovascular Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

15.1 hypotension by 12 hours	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.09 [0.01, 1.57]
16 Adverse effects: 2f. Specific ‐ movement disorders Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

16.1 EPS by 12 hours	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	1.67 [0.44, 6.36]

Comparison 18. HALOPERIDOL vs COMBINATIONS: c. HALOPERIDOL + MIDAZOLAM

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Comparison 19. HALOPERIDOL vs COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Tranquillisation or asleep ‐ not tranquil or asleep ‐ i. by 30 minutes Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 at 20 minutes	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	1.60 [1.18, 2.16]
2 Tranquillisation or asleep ‐ not tranquil or asleep ‐ ii. up to 2 hours Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.1 at 40 minutes	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	1.26 [0.83, 1.91]
2.2 at 1 hour	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	1.42 [0.85, 2.37]
2.3 at 2 hours	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	1.32 [0.68, 2.56]
3 Repeated need for tranquillisation ‐ need for additional drugs for tranquillisation Show forest plot	2	436	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.68, 1.29]

3.1 by 2 hours	2	376	Risk Ratio (M‐H, Fixed, 95% CI)	0.78 [0.43, 1.41]
3.2 by 12 hours	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	1.10 [0.81, 1.49]
4 Specific behaviour: 1a. Agitation ‐ average scores ‐ i. up to 2 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

4.1 endpoint score at 1 hour (OASS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐24.5 [‐27.32, ‐21.68]
4.2 endpoint score at 2 hours (OASS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐9.40 [‐10.39, ‐8.41]
5 Specific behaviour: 1b. Agitation ‐ average scores ‐ ii. up to 4 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

5.1 endpoint score at 4 hours (OASS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	3.80 [3.27, 4.33]
6 Specific behaviour: 1c. Agitation ‐ average scores ‐ iii. up to 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

6.1 endpoint score at 6 hours (OASS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	2.6 [2.13, 3.07]
6.2 endpoint score at 12 hours (OASS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	0.80 [0.55, 1.05]
7 Specific behaviour: 2a. Aggression ‐ average scores ‐ i. up to 2 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

7.1 endpoint score at 1 hour (OAS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐4.50 [‐6.28, ‐2.72]
7.2 endpoint score at 2 hours (OAS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐0.70 [‐1.89, 0.49]
8 Specific behaviour: 2b. Aggression ‐ average scores ‐ ii. up to 4 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

8.1 endpoint score at 4 hours (OAS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	0.60 [0.49, 0.71]
9 Specific behaviour: 2c. Aggression ‐ average scores ‐ iii. up to 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

9.1 endpoint score at 6 hours (OAS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	1.1 [0.91, 1.29]
9.2 endpoint score at 12 hours (OAS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	1.8 [1.67, 1.93]
10 Specific behaviour: 2d. Aggression ‐ further aggressive episode ‐ i. up to 24 hours Show forest plot	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [0.68, 1.65]

11 Global outcomes: 1. General ‐ need for additional measures Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

11.1 restraints needed by 2 hours	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	1.21 [0.84, 1.76]
11.2 additional restraint, seclusion or special observation during 12 hours	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	1.2 [0.41, 3.51]
12 Global outcomes: 2. Specific Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

12.1 doctor called to see patient	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	1.50 [1.05, 2.14]
12.2 refuse oral drugs	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.61, 1.60]
13 Adverse effects: 1a. General Show forest plot	2	376	Risk Ratio (M‐H, Fixed, 95% CI)	2.01 [1.07, 3.80]

13.1 one or more adverse effects up to 24 hours	2	376	Risk Ratio (M‐H, Fixed, 95% CI)	2.01 [1.07, 3.80]
14 Adverse effects: 1b. General ‐ serious Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

14.1 seizure	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	2.05 [0.19, 22.39]
14.2 death	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
15 Adverse effects: 2a. Specific ‐ arousal ‐ i. various Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

15.1 excessive sedation by 12 hours	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.33, 27.23]
16 Adverse effects: 2b. Specific ‐ arousal ‐ ii. average scores ‐ i. up to 2 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

16.1 endpoint score at 1 hour (RSS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐0.38, 0.58]
16.2 endpoint score at 2 hours (RSS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐0.10 [‐0.50, 0.30]
17 Adverse effects: 2c. Specific ‐ arousal ‐ ii. average scores ‐ ii. up to 4 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

17.1 endpoint score at 4 hours (RSS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐0.30 [‐0.78, 0.18]
18 Adverse effects: 2d. Specific ‐ arousal ‐ ii. average scores ‐ iii. up to 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

18.1 endpoint score at 6 hours (RSS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐0.20 [‐0.48, 0.08]
18.2 endpoint score at 12 hours (RSS, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	0.0 [‐0.28, 0.28]
19 Adverse effects: 2e. Specific ‐ cardiovascular Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

19.1 hypotension by 12 hours	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.14 [0.01, 2.65]
20 Adverse effects: 2f. Specific ‐ movement disorders Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

20.1 acute dystonia	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	19.48 [1.14, 331.92]
20.2 EPS by 12 hours	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.32, 3.10]
21 Service outcomes: 1. Not discharged by 14 days Show forest plot	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	0.87 [0.72, 1.05]

22 Leaving the study early Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

22.1 any reason	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.54, 1.94]
22.2 absconded before receiving drug	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	0.21 [0.01, 4.24]
22.3 incomplete information in notes	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	1.12 [0.51, 2.46]
22.4 seizure before drug was given	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	3.08 [0.13, 74.95]
22.5 transfer to another hospital/notes lost	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.21, 5.00]
22.6 withdrew consent	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.06, 16.25]

Comparison 19. HALOPERIDOL vs COMBINATIONS: d. HALOPERIDOL + PROMETHAZINE

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Comparison 20. HALOPERIDOL vs COMBINATIONS: e. HALOPERIDOL + RISPERIDONE

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Specific behaviour: 1a. Agitation ‐ average scores ‐ i. up to 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

1.1 endpoint score at 24 hours (PANSS‐EC, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Specific behaviour: 1b. Agitation ‐ average scores ‐ ii. over 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

2.1 endpoint score at 3 days (PANSS‐EC, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.2 endpoint score at 5 days (PANSS‐EC, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.3 endpoint score at 1 week (PANSS‐EC, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.4 endpoint score at 2 weeks (PANSS‐EC, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Global outcome: No improvement Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3.1 at 72 hours	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.2 at 5 days	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.3 at 1 week	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.4 at 2 weeks	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Adverse effects: 1a. Specific ‐ arousal level ‐ i. various Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4.1 insomnia during 14 days	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.2 somnolence during 14 days	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5 Adverse effects: 1b. Specific ‐ movement disorders ‐ i. various Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

5.1 tremor during 14 days	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.2 akathisia during 14 days	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6 Adverse effects: 1c. Specific ‐ miscellaneous Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

6.1 Dry mouth during 14 days	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.2 Constipation during 14 days	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.3 Increased salivation during 14 days	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 20. HALOPERIDOL vs COMBINATIONS: e. HALOPERIDOL + RISPERIDONE

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Comparison 21. HALOPERIDOL vs COMBINATIONS: f. OLANZAPINE + MAGNESIUM VALPROATE

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Specific behaviour: 1. Agitation ‐ average scores ‐ over 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

1.1 endpoint score at 72 hours (PANSS‐EC, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.2 endpoint score at 7 days (PANSS‐EC, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.3 endpoint score at 14 days (PANSS‐EC, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Global outcome: No improvement Show forest plot	1	64	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [0.38, 2.95]

3 Mental state: Average scores ‐ i. over 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

3.1 endpoint score at 72 hours (PANSS total, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.2 endpoint score at 7 days (PANSS total, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.3 endpoint score at 14 days (PANSS total, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Adverse effects: General ‐ over 24 hours Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4.1 one or more drug related adverse effects ‐ by 14 days	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 21. HALOPERIDOL vs COMBINATIONS: f. OLANZAPINE + MAGNESIUM VALPROATE

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Comparison 22. HALOPERIDOL vs COMBINATIONS: g. QUETIAPINE + MAGNESIUM VALPROATE

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Specific behaviour: 1a. Agitation ‐ binary measures Show forest plot	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	1.17 [0.44, 3.06]

1.1 <25% reduction, no effect (PANSS‐EC)	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	1.17 [0.44, 3.06]
2 Specific behaviour: 1b. Agitation ‐ average scores ‐ i. over 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

2.1 endpoint score at 3 days (PANSS‐EC, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	0.02 [‐2.31, 2.35]
2.2 endpoint score at 7 days (PANSS‐EC, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	1.16 [‐0.98, 3.30]
2.3 endpoint score at 14 days (PANSS‐EC, high=worse)	1	60	Mean Difference (IV, Fixed, 95% CI)	1.24 [‐0.49, 2.97]

Comparison 22. HALOPERIDOL vs COMBINATIONS: g. QUETIAPINE + MAGNESIUM VALPROATE

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Comparison 23. HALOPERIDOL vs COMBINATIONS: h. RISPERIDONE + CLONAZEPAM

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Tranquillisation or asleep Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 not asleep at 2 hours	1	205	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.82, 1.39]
1.2 not asleep at 4 hours	1	205	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.66, 1.03]
2 Specific behaviour: 1a. Agitation ‐ average scores ‐ i. up to 2 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

2.1 change score at 2 hours (PANSS‐EC, high=worse)	1	108	Mean Difference (IV, Fixed, 95% CI)	‐0.5 [‐3.80, 2.80]
3 Specific behaviour: 1b. Agitation ‐ average scores ‐ i. up to 4 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

3.1 change score at 4 hours (PANSS‐EC, high=worse)	1	126	Mean Difference (IV, Fixed, 95% CI)	‐2.40 [‐5.20, 0.40]
4 Specific behaviour: 1c. Agitation ‐ average scores ‐ iii. up to 24 hours Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

4.1 score at 24 hours (PANSS‐EC, high=worse)	2	305	Mean Difference (IV, Fixed, 95% CI)	0.71 [‐0.56, 1.98]
5 Specific behaviour: 1d. Agitation ‐ average scores ‐ iv. over 24 hours Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

5.1 score at 3 days (PANSS‐EC, high=worse)	2	305	Mean Difference (IV, Fixed, 95% CI)	‐0.41 [‐1.66, 0.83]
5.2 score at 5 days (PANSS‐EC, high=worse)	2	305	Mean Difference (IV, Fixed, 95% CI)	0.14 [‐1.24, 1.52]
5.3 endpoint score at 1 week (PANSS‐EC, high=worse)	1	100	Mean Difference (IV, Fixed, 95% CI)	‐2.56 [‐4.57, ‐0.55]
5.4 endpoint score at 2 weeks (PANSS‐EC, high=worse)	1	100	Mean Difference (IV, Fixed, 95% CI)	‐0.88 [‐2.34, 0.58]
6 Global outcome: No improvement Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

6.1 at 72 hours	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.2 at 5 days	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.3 at 1 week	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.4 at 2 weeks	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7 Mental state: 1. Average scores ‐ i. over 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

7.1 change score at 120 hours (PANSS total, high=worse)	1	205	Mean Difference (IV, Fixed, 95% CI)	‐3.5 [‐7.07, 0.07]
8 Adverse effects: 1. General Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

8.1 overall adverse events during 120 hours	1	205	Risk Ratio (M‐H, Fixed, 95% CI)	1.72 [1.29, 2.29]
9 Adverse effects: 2a. Specific ‐ arousal ‐ i. various Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

9.1 insomnia during 5 days (only reported if occurred in ≥5%)	1	205	Risk Ratio (M‐H, Fixed, 95% CI)	1.54 [0.45, 5.31]
9.2 insomnia during 14 days	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	0.5 [0.20, 1.23]
9.3 somnolence during 14 days	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	2.75 [0.94, 8.06]
10 Adverse effects: 2b. Specific ‐ cardiovascular ‐ i. various Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

10.1 tachycardia during 120 hours (only reported if occurred in ≥5%)	1	205	Risk Ratio (M‐H, Fixed, 95% CI)	1.29 [0.36, 4.66]
11 Adverse effects: 2c. Specific ‐ movement disorders ‐ i. various Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

11.1 akathisia during 5 days (only reported if occurred in ≥5%)	1	205	Risk Ratio (M‐H, Fixed, 95% CI)	1.63 [1.12, 2.38]
11.2 akathisia during 14 days	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	2.33 [0.98, 5.58]
11.3 EPS during 5 days (only reported if occurred in ≥5%)	1	205	Risk Ratio (M‐H, Fixed, 95% CI)	2.22 [1.52, 3.23]
11.4 tremor during 14 days	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	3.2 [1.27, 8.07]
12 Adverse effects: 2d. Specific ‐ miscellaneous Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

12.1 Dry mouth during 14 days	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
12.2 Constipation during 14 days	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
12.3 Increased salivation during 14 days	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 23. HALOPERIDOL vs COMBINATIONS: h. RISPERIDONE + CLONAZEPAM

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Comparison 24. HALOPERIDOL vs COMBINATIONS: i. ZIPRASIDONE + CLONAZEPAM

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Specific behaviour: 1a. Agitation ‐ average scores ‐ i. up to 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

1.1 endpoint score at 12 hours (PANSS‐EC, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Specific behaviour: 1b. Agitation ‐ average scores ‐ ii. over 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

2.1 endpoint score at 48 hours (PANSS‐EC, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.2 endpoint score at 3 days (PANSS‐EC, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.3 endpoint score at 5 days (PANSS‐EC, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.4 endpoint score at 7 days (PANSS‐EC, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Global outcome: 1. Average scores ‐ i. over 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

3.1 endpoint score at 7 days (CGI‐S, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Mental state: 1. Average scores ‐ i. over 24 hours Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.1 endpoint score at 7 days (PANSS total, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.2 endpoint score at 7 days (PANSS positive sub‐scale, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.3 endpoint score at 7 days (PANSS negative sub‐scale, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.4 endpoint score at 7 days (PANSS general psychopathology sub‐scale, high=worse)	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
5 Leaving the study early Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

5.1 any reason	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.2 adverse effects	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.3 lost at follow‐up	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.4 non compliance	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 24. HALOPERIDOL vs COMBINATIONS: i. ZIPRASIDONE + CLONAZEPAM

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Table 4. Adverse effects for 1 mg, 5 mg, 15 mg aripiprazole (Bristol‐Myers 2005)

AE	Dose	1 mg (N = 57)	5 mg (N = 63)	15 mg (N = 58)
At least 1 AE		28	30	27
AE rated as serious		1	2	0
Tachycardia		3	2	0
Sinus tachycardia		1	0	0
Vomiting		1	0	3
Nausea		0	6	2
Dizziness		4	7	7
Headache		4	11	8
Somnolence		3	5	6
Akathisia		0	2	0
Dystonia		0	0	1
Agitation		0	0	3
Pain at injection site		Not reported	1	1
QTC abnormality		4	4	3
AE: adverse event

Table 4. Adverse effects for 1 mg, 5 mg, 15 mg aripiprazole (Bristol‐Myers 2005)

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Table 5. Global outcome ‐ data for olanzapine 2.5 mg, 5 mg and 7.5 mg (Breier 2001)

Outcome	Dose	Mean	SD	N
Mean dose of study drug	2.5 mg	4	1.5	48
	5 mg	6.9	2.7	45
	7.5 mg	9.8	3.8	46
Mean dose of benzodiazepines	2.5 mg	3.2	1.1	48
	5 mg	2.0	0	45
	7.5 mg	3.0	1.4	46

Table 5. Global outcome ‐ data for olanzapine 2.5 mg, 5 mg and 7.5 mg (Breier 2001)

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Table 6. Continuous skewed data rated at 2 hours for olanzapine 2.5 mg, 5 mg and 7.5 mg (Breier 2001)

Rating scale (Mean change at 2 hr)	Dose	Mean	SD	N
Specific behaviour: ACES	2.5 mg	1.3	1.5	48
	5 mg	2.3	1.9	45
	7.5 mg	2.4	1.7	46
Specific behaviour: ABS	2.5 mg	‐5.8	5.5	48
	5 mg	‐9.0	5.5	45
	7.5 mg	‐10.5	5.6	46
Specific behaviour: PANSS‐EC	2.5 mg	‐5.5	4.6	48
	5 mg	‐8.1	5.3	45
	7.5 mg	‐8.7	5	46
Mental state: BPRS Total	2.5 mg	‐8.2	9.1	48
	5 mg	‐10.4	7.5	45
	7.5 mg	‐12.0	7	46
Mental state: BPRS Positive	2.5 mg	‐1.5	3.1	48
	5 mg	‐1.7	2.8	45
	7.5 mg	‐2.1	2.9	46
ABS: Agitated Behavior Scale ACES: Agitation‐Calmness Evaluation Scale BPRS: Brief Psychiatric Rating Scale PANSS‐EC: Positive and Negative Syndrome Scale Excited Component

Table 6. Continuous skewed data rated at 2 hours for olanzapine 2.5 mg, 5 mg and 7.5 mg (Breier 2001)

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Table 7. Continuous skewed data for olanzapine 2.5 mg, 5 mg and 7.5 mg rated at 24 hours (Breier 2001)

Rating scale (mean change at 24 hr)	Dose	Mean	SD	N
Specific behaviour: ACES	2.5 mg	0.9	0.8	48
	5 mg	1.1	1.1	45
	7.5 mg	1	1	46
Specific behaviour: ABS	2.5 mg	‐5.7	4.2	48
	5 mg	‐6.7	5.9	45
	7.5 mg	‐7.7	5.8	46
Specific behaviour: PANSS‐EC	2.5 mg	‐4.9	4.3	48
	5 mg	‐5.5	4.9	45
	7.5 mg	‐5.5	4.1	46
Global outcomes: CGI‐S (24 hr)	2.5 mg	‐0.3	0.5	48
	5 mg	‐0.5	0.8	45
	7.5 mg	‐0.6	0.7	46
Mental state: BPRS Total	2.5 mg	‐8.4	7.4	48
	5 mg	‐9.2	7.8	45
	7.5 mg	‐9.6	7.5	46
Mental state: BPRS Positive	2.5 mg	‐1.5	2.3	48
	5 mg	‐2.0	2.6	45
	7.5 mg	‐1.9	2.7	46
ABS: Agitated Behavior Scale ACES: Agitation‐Calmness Evaluation Scale BPRS: Brief Psychiatric Rating Scale CGI‐S: Clinical Global Impression – Severity PANSS‐EC: Positive and Negative Syndrome Scale Excited Component

Table 7. Continuous skewed data for olanzapine 2.5 mg, 5 mg and 7.5 mg rated at 24 hours (Breier 2001)

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Table 8. Binary data for olanzapine 2.5 mg, 5 mg, 7.5 mg (Breier 2001)

	Dose	2.5 mg	5 mg	7.5 mg
Outcome		N = 48	N = 45	N = 46
Global outcome: > 1 injection		25	17	14
Leaving the study early: lack of efficacy		0	2	0
Adverse effects: EPS		0	0	0
Adverse effects: akathisia		0	2	0
Adverse effects: QT abnormality		0	4	2
EPS: Extrapyramidal Side Effects

Table 8. Binary data for olanzapine 2.5 mg, 5 mg, 7.5 mg (Breier 2001)

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Table 9. Continous skewed data for aripiprazole 1 mg, 5 mg, 15 mg (Bristol‐Myers 2005)

Rating scale (Mean change 2 hr after 1^st injection)	Dose	Mean	SD	N
Specific behaviour: ACES	1 mg	0.65	1.64	56
	5 mg	1.01	1.65	62
	15 mg	0.99	1.73	58
Specific behaviour: CABS	1 mg	‐5.15	6.8	56
	5 mg	‐5.97	6.81	62
	15 mg	‐7.04	7.01	58
Global outcomes: CGI‐I	1 mg	3.07	0.98	56
	5 mg	2.82	1.10	62
	15 mg	2.66	1.07	58
Global outcomes: CGI‐S	1 mg	‐0.63	1.15	56
	5 mg	‐0.82	1.12	62
	15 mg	‐0.99	1.17	58
Mental state: BPRS Total	1 mg	‐6.53	9.61	55
	5 mg	‐8.16	9.66	61
	15 mg	‐8.88	9.89	56
Mental state: BPRS Positive	1 mg	‐1.20	2.72	55
	5 mg	‐1.47	2.71	61
	15 mg	‐1.86	2.82	57
ACES: Agitation‐Calmness Evaluation Scale BPRS: Brief Psychiatric Rating Scale CABS: CABS ‐ Corrigan Agitated Behavior Scale CGI‐I: Clinical Global Impression – Improvement CGI‐S: Clinical Global Impression – Severity

Table 9. Continous skewed data for aripiprazole 1 mg, 5 mg, 15 mg (Bristol‐Myers 2005)

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Table 10. Binary data for 1 mg, 5 mg and 15 mg aripiprazole (Bristol‐Myers 2005)

	Dose	1 mg	5 mg	15 mg
Outcome	N	N = 57	N = 63	N = 58
PEC response ≥ 40%		21	31	32
Need for rescue medication		11	5	12
Discontinued for any reason		2	3	1
Discontinued due to adverse event		0	0	1
Withdrew consent		2	2	0
Discontinued due to other known cause		0	1	0
PEC: Psychiatric Emergency Centre

Table 10. Binary data for 1 mg, 5 mg and 15 mg aripiprazole (Bristol‐Myers 2005)

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Table 4. Adverse effects for 1 mg, 5 mg, 15 mg aripiprazole (Bristol‐Myers 2005)

AE	Dose	1 mg (N = 57)	5 mg (N = 63)	15 mg (N = 58)
At least 1 AE		28	30	27
AE rated as serious		1	2	0
Tachycardia		3	2	0
Sinus tachycardia		1	0	0
Vomiting		1	0	3
Nausea		0	6	2
Dizziness		4	7	7
Headache		4	11	8
Somnolence		3	5	6
Akathisia		0	2	0
Dystonia		0	0	1
Agitation		0	0	3
Pain at injection site		Not reported	1	1
QTC abnormality		4	4	3
AE: adverse event

Table 4. Adverse effects for 1 mg, 5 mg, 15 mg aripiprazole (Bristol‐Myers 2005)

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Table 5. Global outcome ‐ data for olanzapine 2.5 mg, 5 mg and 7.5 mg (Breier 2001)

Outcome	Dose	Mean	SD	N
Mean dose of study drug	2.5 mg	4	1.5	48
	5 mg	6.9	2.7	45
	7.5 mg	9.8	3.8	46
Mean dose of benzodiazepines	2.5 mg	3.2	1.1	48
	5 mg	2.0	0	45
	7.5 mg	3.0	1.4	46

Table 5. Global outcome ‐ data for olanzapine 2.5 mg, 5 mg and 7.5 mg (Breier 2001)

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Table 6. Continuous skewed data rated at 2 hours for olanzapine 2.5 mg, 5 mg and 7.5 mg (Breier 2001)

Rating scale (Mean change at 2 hr)	Dose	Mean	SD	N
Specific behaviour: ACES	2.5 mg	1.3	1.5	48
	5 mg	2.3	1.9	45
	7.5 mg	2.4	1.7	46
Specific behaviour: ABS	2.5 mg	‐5.8	5.5	48
	5 mg	‐9.0	5.5	45
	7.5 mg	‐10.5	5.6	46
Specific behaviour: PANSS‐EC	2.5 mg	‐5.5	4.6	48
	5 mg	‐8.1	5.3	45
	7.5 mg	‐8.7	5	46
Mental state: BPRS Total	2.5 mg	‐8.2	9.1	48
	5 mg	‐10.4	7.5	45
	7.5 mg	‐12.0	7	46
Mental state: BPRS Positive	2.5 mg	‐1.5	3.1	48
	5 mg	‐1.7	2.8	45
	7.5 mg	‐2.1	2.9	46
ABS: Agitated Behavior Scale ACES: Agitation‐Calmness Evaluation Scale BPRS: Brief Psychiatric Rating Scale PANSS‐EC: Positive and Negative Syndrome Scale Excited Component

Table 6. Continuous skewed data rated at 2 hours for olanzapine 2.5 mg, 5 mg and 7.5 mg (Breier 2001)

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Table 7. Continuous skewed data for olanzapine 2.5 mg, 5 mg and 7.5 mg rated at 24 hours (Breier 2001)

Rating scale (mean change at 24 hr)	Dose	Mean	SD	N
Specific behaviour: ACES	2.5 mg	0.9	0.8	48
	5 mg	1.1	1.1	45
	7.5 mg	1	1	46
Specific behaviour: ABS	2.5 mg	‐5.7	4.2	48
	5 mg	‐6.7	5.9	45
	7.5 mg	‐7.7	5.8	46
Specific behaviour: PANSS‐EC	2.5 mg	‐4.9	4.3	48
	5 mg	‐5.5	4.9	45
	7.5 mg	‐5.5	4.1	46
Global outcomes: CGI‐S (24 hr)	2.5 mg	‐0.3	0.5	48
	5 mg	‐0.5	0.8	45
	7.5 mg	‐0.6	0.7	46
Mental state: BPRS Total	2.5 mg	‐8.4	7.4	48
	5 mg	‐9.2	7.8	45
	7.5 mg	‐9.6	7.5	46
Mental state: BPRS Positive	2.5 mg	‐1.5	2.3	48
	5 mg	‐2.0	2.6	45
	7.5 mg	‐1.9	2.7	46
ABS: Agitated Behavior Scale ACES: Agitation‐Calmness Evaluation Scale BPRS: Brief Psychiatric Rating Scale CGI‐S: Clinical Global Impression – Severity PANSS‐EC: Positive and Negative Syndrome Scale Excited Component

Table 7. Continuous skewed data for olanzapine 2.5 mg, 5 mg and 7.5 mg rated at 24 hours (Breier 2001)

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Table 8. Binary data for olanzapine 2.5 mg, 5 mg, 7.5 mg (Breier 2001)

	Dose	2.5 mg	5 mg	7.5 mg
Outcome		N = 48	N = 45	N = 46
Global outcome: > 1 injection		25	17	14
Leaving the study early: lack of efficacy		0	2	0
Adverse effects: EPS		0	0	0
Adverse effects: akathisia		0	2	0
Adverse effects: QT abnormality		0	4	2
EPS: Extrapyramidal Side Effects

Table 8. Binary data for olanzapine 2.5 mg, 5 mg, 7.5 mg (Breier 2001)

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Table 9. Continous skewed data for aripiprazole 1 mg, 5 mg, 15 mg (Bristol‐Myers 2005)

Rating scale (Mean change 2 hr after 1^st injection)	Dose	Mean	SD	N
Specific behaviour: ACES	1 mg	0.65	1.64	56
	5 mg	1.01	1.65	62
	15 mg	0.99	1.73	58
Specific behaviour: CABS	1 mg	‐5.15	6.8	56
	5 mg	‐5.97	6.81	62
	15 mg	‐7.04	7.01	58
Global outcomes: CGI‐I	1 mg	3.07	0.98	56
	5 mg	2.82	1.10	62
	15 mg	2.66	1.07	58
Global outcomes: CGI‐S	1 mg	‐0.63	1.15	56
	5 mg	‐0.82	1.12	62
	15 mg	‐0.99	1.17	58
Mental state: BPRS Total	1 mg	‐6.53	9.61	55
	5 mg	‐8.16	9.66	61
	15 mg	‐8.88	9.89	56
Mental state: BPRS Positive	1 mg	‐1.20	2.72	55
	5 mg	‐1.47	2.71	61
	15 mg	‐1.86	2.82	57
ACES: Agitation‐Calmness Evaluation Scale BPRS: Brief Psychiatric Rating Scale CABS: CABS ‐ Corrigan Agitated Behavior Scale CGI‐I: Clinical Global Impression – Improvement CGI‐S: Clinical Global Impression – Severity

Table 9. Continous skewed data for aripiprazole 1 mg, 5 mg, 15 mg (Bristol‐Myers 2005)

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Table 10. Binary data for 1 mg, 5 mg and 15 mg aripiprazole (Bristol‐Myers 2005)

	Dose	1 mg	5 mg	15 mg
Outcome	N	N = 57	N = 63	N = 58
PEC response ≥ 40%		21	31	32
Need for rescue medication		11	5	12
Discontinued for any reason		2	3	1
Discontinued due to adverse event		0	0	1
Withdrew consent		2	2	0
Discontinued due to other known cause		0	1	0
PEC: Psychiatric Emergency Centre

Table 10. Binary data for 1 mg, 5 mg and 15 mg aripiprazole (Bristol‐Myers 2005)

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