Benzodiazepines for psychosis‐induced aggression or agitation

Donna Gillies; Alison Beck; Annie McCloud; John Rathbone

doi:10.1002/14651858.CD003079.pub2

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Analysis 1.1

Comparison 1 BENZODIAZEPINES vs PLACEBO, Outcome 1 Global impression: 1. Need for additional medication ‐ medium term.

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Analysis 1.2

Comparison 1 BENZODIAZEPINES vs PLACEBO, Outcome 2 Global impression: 2. Sedation ‐ medium term.

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Analysis 1.3

Comparison 1 BENZODIAZEPINES vs PLACEBO, Outcome 3 Global impression: 3. Average change ‐ medium term (CGI‐S, high = poor).

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Analysis 1.4

Comparison 1 BENZODIAZEPINES vs PLACEBO, Outcome 4 Global impression: 4. Leaving the study early ‐ medium term.

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Analysis 1.5

Comparison 1 BENZODIAZEPINES vs PLACEBO, Outcome 5 Mental state: 1. Remaining excited ‐ medium term (PANSS‐excited component).

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Analysis 1.6

Comparison 1 BENZODIAZEPINES vs PLACEBO, Outcome 6 Mental state: 2. Average change ‐ medium term (PANSS, high = poor).

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Analysis 1.7

Comparison 1 BENZODIAZEPINES vs PLACEBO, Outcome 7 Mental state: 3. Average change ‐ medium term (PANSS‐excited component, high = poor).

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Analysis 1.8

Comparison 1 BENZODIAZEPINES vs PLACEBO, Outcome 8 Adverse events: 1. Extrapyramidal effects.

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Analysis 1.9

Comparison 1 BENZODIAZEPINES vs PLACEBO, Outcome 9 Adverse events: 2. Requiring anticholinergic medication ‐ medium term.

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Analysis 1.10

Comparison 1 BENZODIAZEPINES vs PLACEBO, Outcome 10 Adverse events: 3. General.

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Analysis 2.1

Comparison 2 BENZODIAZEPINES vs ANTIPSYCHOTICS, Outcome 1 Global impression: 1. Need for additional medication ‐ medium term.

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Analysis 2.2

Comparison 2 BENZODIAZEPINES vs ANTIPSYCHOTICS, Outcome 2 Global impression: 2. Sedation ‐ medium term.

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Analysis 2.3

Comparison 2 BENZODIAZEPINES vs ANTIPSYCHOTICS, Outcome 3 Global impression: 3. Average score (CGI‐S, high = poor).

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Analysis 2.4

Comparison 2 BENZODIAZEPINES vs ANTIPSYCHOTICS, Outcome 4 Global impression: 4. Average change ‐ medium term (CGI‐S, high = poor).

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Study	Intervention	mean	SD	N
Chouinard 1993	Clonazepam	2.60	1.70	8
Chouinard 1993	haloperidol	2.80	0.60	8

Analysis 2.5

Comparison 2 BENZODIAZEPINES vs ANTIPSYCHOTICS, Outcome 5 Global impression: 5. Average score ‐ medium term (CGI‐S, skewed).

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Analysis 2.6

Comparison 2 BENZODIAZEPINES vs ANTIPSYCHOTICS, Outcome 6 Global impression: 6. Leaving the study early ‐medium term.

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Analysis 2.7

Comparison 2 BENZODIAZEPINES vs ANTIPSYCHOTICS, Outcome 7 Behaviour: 1. Not improved ‐ medium term (OAS).

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Study	Intervention	mean	SD	N
Subramaney 1998	Lorazepam	1.83	3.14	30
Subramaney 1998	Clothiapine	1.33	2.78	30

Analysis 2.8

Comparison 2 BENZODIAZEPINES vs ANTIPSYCHOTICS, Outcome 8 Behaviour: 2. Average aggression score ‐ medium term (OAS, skewed).

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Analysis 2.9

Comparison 2 BENZODIAZEPINES vs ANTIPSYCHOTICS, Outcome 9 Mental state: 1. Not improved ‐ medium term (IMPS).

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Analysis 2.10

Comparison 2 BENZODIAZEPINES vs ANTIPSYCHOTICS, Outcome 10 Mental state: 2. Average score (BPRS, high = poor).

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Analysis 2.11

Comparison 2 BENZODIAZEPINES vs ANTIPSYCHOTICS, Outcome 11 Mental state: 3. Average change ‐ medium term (BPRS, high = poor).

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Analysis 2.12

Comparison 2 BENZODIAZEPINES vs ANTIPSYCHOTICS, Outcome 12 Mental state: 4. Average change ‐ medium term (BPRS‐psychosis subscale, high score = poor).

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Analysis 2.13

Comparison 2 BENZODIAZEPINES vs ANTIPSYCHOTICS, Outcome 13 Mental state: 5. Remaining excited ‐ medium term (PANSS‐excited component).

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Analysis 2.14

Comparison 2 BENZODIAZEPINES vs ANTIPSYCHOTICS, Outcome 14 Mental state: 6. Average change ‐ medium term (PANSS, high = poor).

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Analysis 2.15

Comparison 2 BENZODIAZEPINES vs ANTIPSYCHOTICS, Outcome 15 Mental state: 7. Average change ‐ medium term (PANSS‐Excited component, high = poor).

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Analysis 2.16

Comparison 2 BENZODIAZEPINES vs ANTIPSYCHOTICS, Outcome 16 Adverse events: 1. Extrapyramidal effects.

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Analysis 2.17

Comparison 2 BENZODIAZEPINES vs ANTIPSYCHOTICS, Outcome 17 Adverse events: 2. Requiring anticholinergic medication ‐ medium term.

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Analysis 2.18

Comparison 2 BENZODIAZEPINES vs ANTIPSYCHOTICS, Outcome 18 Adverse events: 3. General.

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Analysis 3.1

Comparison 3 BENZODIAZEPINES + ANTIPSYCHOTICS vs BENZODIAZEPINES, Outcome 1 Global impression: 1. Need for additional medication ‐ medium term.

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Analysis 3.2

Comparison 3 BENZODIAZEPINES + ANTIPSYCHOTICS vs BENZODIAZEPINES, Outcome 2 Global impression: 2. Not improved ‐ short term (CGI).

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Analysis 3.3

Comparison 3 BENZODIAZEPINES + ANTIPSYCHOTICS vs BENZODIAZEPINES, Outcome 3 Global impression: 3. Leaving the study early ‐ medium term.

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Analysis 3.4

Comparison 3 BENZODIAZEPINES + ANTIPSYCHOTICS vs BENZODIAZEPINES, Outcome 4 Behaviour: 1. Not improved ‐ short term (OAS).

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Study	Intervention	mean	SD	N
Battaglia 1997	Lorazepam + haloperidol	17.50	10.18	32
Battaglia 1997	Lorazepam	24.20	10.02	31

Analysis 3.5

Comparison 3 BENZODIAZEPINES + ANTIPSYCHOTICS vs BENZODIAZEPINES, Outcome 5 Mental state: 1. Average change ‐ medium term (BPRS‐psychosis subscale, high = poor, skewed).

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Analysis 3.6

Comparison 3 BENZODIAZEPINES + ANTIPSYCHOTICS vs BENZODIAZEPINES, Outcome 6 Adverse events: 1. Extrapyramidal effects.

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Analysis 3.7

Comparison 3 BENZODIAZEPINES + ANTIPSYCHOTICS vs BENZODIAZEPINES, Outcome 7 Adverse events: 2. General.

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Analysis 4.1

Comparison 4 BENZODIAZEPINES + ANTIPSYCHOTICS vs ANTIPSYCHOTICS, Outcome 1 Global impression: 1. Need for additional medication ‐ medium term.

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Analysis 4.2

Comparison 4 BENZODIAZEPINES + ANTIPSYCHOTICS vs ANTIPSYCHOTICS, Outcome 2 Global impression: 2. Leaving the study early ‐ medium term.

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Analysis 4.3

Comparison 4 BENZODIAZEPINES + ANTIPSYCHOTICS vs ANTIPSYCHOTICS, Outcome 3 Mental state: 1. Average score ‐ medium term (BPRS, high = poor).

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Analysis 4.4

Comparison 4 BENZODIAZEPINES + ANTIPSYCHOTICS vs ANTIPSYCHOTICS, Outcome 4 Mental state: 2. Average score ‐ medium term (BPRS‐psychosis subscale, high = poor).

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Study	Intervention	mean	SD	N
Battaglia 1997	Lorazepam + haloperidol	17.50	10.18	32
Battaglia 1997	Haloperidol	24.50	7.69	35

Analysis 4.5

Comparison 4 BENZODIAZEPINES + ANTIPSYCHOTICS vs ANTIPSYCHOTICS, Outcome 5 Mental state: 3. Average change ‐ medium term (BPRS‐psychosis subscale, high = poor, skewed).

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Analysis 4.6

Comparison 4 BENZODIAZEPINES + ANTIPSYCHOTICS vs ANTIPSYCHOTICS, Outcome 6 Adverse events: 1. Extrapyramidal effects.

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Analysis 4.7

Comparison 4 BENZODIAZEPINES + ANTIPSYCHOTICS vs ANTIPSYCHOTICS, Outcome 7 Adverse events: 2. Requiring anticholinergic medication ‐ medium term.

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Analysis 4.8

Comparison 4 BENZODIAZEPINES + ANTIPSYCHOTICS vs ANTIPSYCHOTICS, Outcome 8 Adverse events: 3. General.

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Analysis 4.9

Comparison 4 BENZODIAZEPINES + ANTIPSYCHOTICS vs ANTIPSYCHOTICS, Outcome 9 Hospital and service outcome: Unfit for early discharge.

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Analysis 5.1

Comparison 5 SENSITIVITY ANALYSIS: 1. HIGH vs LOW ATTRITION, Outcome 1 Global impression: 1. Sedation ‐ medium term.

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Analysis 5.2

Comparison 5 SENSITIVITY ANALYSIS: 1. HIGH vs LOW ATTRITION, Outcome 2 Global impression: 2. Leaving the study early ‐ medium term.

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Analysis 5.3

Comparison 5 SENSITIVITY ANALYSIS: 1. HIGH vs LOW ATTRITION, Outcome 3 Adverse events: Extrapyramidal effects.

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Analysis 6.1

Comparison 6 SENSITIVITY ANALYSIS: 2. RANDOMISED vs UNKNOWN, Outcome 1 Global impression: Sedation ‐ medium term.

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Analysis 6.2

Comparison 6 SENSITIVITY ANALYSIS: 2. RANDOMISED vs UNKNOWN, Outcome 2 Adverse events: 1. Extrapyramidal effects.

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Table 1. Drugs for rapid tranquillisation in London survey

Drug of choice	Mean dose
diazepam*	27 (10‐80)
haloperidol	22 (10‐60)
chlorpromazine	162 (50‐400)
droperidol	14 (10‐20)
paraldehyde	U/K
amytal	U/K
lorazepam	U/K
nitrazepam**	U/K
*most frequent
** least frequent

Table 1. Drugs for rapid tranquillisation in London survey

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Table 2. Preferred medication for rapid tranquillisation in Rio de Janeiro

Drug of choice	Mean dose	Frequency of use
haloperidol + promethazine	5 (2.5‐10) + 50 (25‐100)	61%
haloperidol + promethazine + diazepam	5 (2.5‐10) + 50 (25‐100) +10	15%
diazepam	10	9%
haloperidol + promethazine + chlorpromazine	5 + 50 + 25	7%
chlorpromazine + diazepam + promethazine	25 + 10 + 50	1%
chlorpromazine + promethazine	25 + 50	1%
chlorpromazine	25	1%
diazepam + promethazine	10 + 50	1%
haloperidol + diazepam	5 + 10	1%
promethazine	50	1%

Table 2. Preferred medication for rapid tranquillisation in Rio de Janeiro

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Table 3. High and low attrition studies

Attrition	Study	% loss	Duration	Notes
High	Barbee 1992	31	72 hours
	Chouinard 1993	12	2 hours
	Salzman 1991	33	48 hours	‐ for EPS outcome; 12% loss for 'sedation'
Low	Bienek 1998	0	7 days
	Meehan 2001	4	24 hours
	Solomon 1990	0	7 days
	Subramaney 1998	0	7 days

Table 3. High and low attrition studies

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Comparison 1. BENZODIAZEPINES vs PLACEBO

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global impression: 1. Need for additional medication ‐ medium term Show forest plot	1	102	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.66, 1.40]

2 Global impression: 2. Sedation ‐ medium term Show forest plot	1	102	Risk Ratio (M‐H, Fixed, 95% CI)	1.67 [0.42, 6.61]

3 Global impression: 3. Average change ‐ medium term (CGI‐S, high = poor) Show forest plot	1	76	Mean Difference (IV, Fixed, 95% CI)	0.07 [‐0.46, 0.60]

4 Global impression: 4. Leaving the study early ‐ medium term Show forest plot	1	102	Risk Ratio (M‐H, Fixed, 95% CI)	0.6 [0.15, 2.38]

5 Mental state: 1. Remaining excited ‐ medium term (PANSS‐excited component) Show forest plot	1	102	Risk Ratio (M‐H, Fixed, 95% CI)	0.62 [0.40, 0.97]

6 Mental state: 2. Average change ‐ medium term (PANSS, high = poor) Show forest plot	1	99	Mean Difference (IV, Fixed, 95% CI)	‐2.57 [‐6.23, 1.09]

7 Mental state: 3. Average change ‐ medium term (PANSS‐excited component, high = poor) Show forest plot	1	101	Mean Difference (IV, Fixed, 95% CI)	‐1.91 [‐3.83, 0.01]

8 Adverse events: 1. Extrapyramidal effects Show forest plot	1	94	Risk Ratio (M‐H, Fixed, 95% CI)	0.32 [0.03, 2.96]

9 Adverse events: 2. Requiring anticholinergic medication ‐ medium term Show forest plot	1	102	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.04, 3.10]

10 Adverse events: 3. General Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

10.1 dizziness	1	102	Risk Ratio (M‐H, Fixed, 95% CI)	7.0 [0.89, 54.87]
10.2 nausea	1	102	Risk Ratio (M‐H, Fixed, 95% CI)	9.0 [0.50, 162.97]
10.3 vomiting	1	102	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.32, 27.89]

Comparison 1. BENZODIAZEPINES vs PLACEBO

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Comparison 2. BENZODIAZEPINES vs ANTIPSYCHOTICS

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global impression: 1. Need for additional medication ‐ medium term Show forest plot	2	216	Risk Ratio (M‐H, Random, 95% CI)	1.28 [0.51, 3.22]

2 Global impression: 2. Sedation ‐ medium term Show forest plot	6	324	Risk Ratio (M‐H, Fixed, 95% CI)	0.76 [0.48, 1.21]

3 Global impression: 3. Average score (CGI‐S, high = poor) Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

3.1 Short term	1	16	Mean Difference (IV, Fixed, 95% CI)	0.70 [‐0.58, 1.98]
3.2 Medium term	1	37	Mean Difference (IV, Fixed, 95% CI)	‐0.62 [‐1.36, 0.12]
4 Global impression: 4. Average change ‐ medium term (CGI‐S, high = poor) Show forest plot	2	189	Mean Difference (IV, Fixed, 95% CI)	0.20 [‐0.07, 0.47]

5 Global impression: 5. Average score ‐ medium term (CGI‐S, skewed) Show forest plot			Other data	No numeric data

6 Global impression: 6. Leaving the study early ‐medium term Show forest plot	4	254	Risk Ratio (M‐H, Random, 95% CI)	1.70 [0.11, 27.35]

7 Behaviour: 1. Not improved ‐ medium term (OAS) Show forest plot	1	28	Risk Ratio (M‐H, Fixed, 95% CI)	2.6 [0.31, 22.05]

8 Behaviour: 2. Average aggression score ‐ medium term (OAS, skewed) Show forest plot			Other data	No numeric data

9 Mental state: 1. Not improved ‐ medium term (IMPS) Show forest plot	1	16	Risk Ratio (M‐H, Fixed, 95% CI)	1.5 [0.34, 6.70]

10 Mental state: 2. Average score (BPRS, high = poor) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

10.1 Short term	1	37	Mean Difference (IV, Fixed, 95% CI)	‐3.26 [‐10.65, 4.13]
10.2 Medium term	1	37	Mean Difference (IV, Fixed, 95% CI)	‐4.07 [‐10.76, 2.62]
11 Mental state: 3. Average change ‐ medium term (BPRS, high = poor) Show forest plot	1	20	Mean Difference (IV, Fixed, 95% CI)	‐7.60 [‐13.87, ‐1.33]

12 Mental state: 4. Average change ‐ medium term (BPRS‐psychosis subscale, high score = poor) Show forest plot	1	66	Mean Difference (IV, Fixed, 95% CI)	‐0.30 [‐4.65, 4.05]

13 Mental state: 5. Remaining excited ‐ medium term (PANSS‐excited component) Show forest plot	1	150	Risk Ratio (M‐H, Fixed, 95% CI)	1.84 [1.06, 3.18]

14 Mental state: 6. Average change ‐ medium term (PANSS, high = poor) Show forest plot	1	146	Mean Difference (IV, Fixed, 95% CI)	5.64 [2.20, 9.08]

15 Mental state: 7. Average change ‐ medium term (PANSS‐Excited component, high = poor) Show forest plot	1	149	Mean Difference (IV, Fixed, 95% CI)	2.85 [1.14, 4.56]

16 Adverse events: 1. Extrapyramidal effects Show forest plot	7	391	Risk Ratio (M‐H, Fixed, 95% CI)	0.17 [0.06, 0.43]

17 Adverse events: 2. Requiring anticholinergic medication ‐ medium term Show forest plot	1	150	Risk Ratio (M‐H, Fixed, 95% CI)	0.24 [0.03, 1.89]

18 Adverse events: 3. General Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

18.1 ataxia	1	66	Risk Ratio (M‐H, Fixed, 95% CI)	2.26 [0.22, 23.71]
18.2 dizziness	2	216	Risk Ratio (M‐H, Fixed, 95% CI)	1.39 [0.63, 3.07]
18.3 dry mouth	1	66	Risk Ratio (M‐H, Fixed, 95% CI)	1.88 [0.49, 7.24]
18.4 nausea	1	150	Risk Ratio (M‐H, Fixed, 95% CI)	7.76 [0.89, 67.67]
18.5 speech disorder	1	66	Risk Ratio (M‐H, Fixed, 95% CI)	0.56 [0.11, 2.87]
18.6 vomiting	1	150	Risk Ratio (M‐H, Fixed, 95% CI)	13.46 [0.71, 255.70]

Comparison 2. BENZODIAZEPINES vs ANTIPSYCHOTICS

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Comparison 3. BENZODIAZEPINES + ANTIPSYCHOTICS vs BENZODIAZEPINES

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global impression: 1. Need for additional medication ‐ medium term Show forest plot	2	83	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.79, 1.32]

2 Global impression: 2. Not improved ‐ short term (CGI) Show forest plot	1	20	Risk Ratio (M‐H, Fixed, 95% CI)	1.47 [0.66, 3.25]

3 Global impression: 3. Leaving the study early ‐ medium term Show forest plot	1	20	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

4 Behaviour: 1. Not improved ‐ short term (OAS) Show forest plot	1	20	Risk Ratio (M‐H, Fixed, 95% CI)	0.11 [0.01, 1.74]

5 Mental state: 1. Average change ‐ medium term (BPRS‐psychosis subscale, high = poor, skewed) Show forest plot			Other data	No numeric data

6 Adverse events: 1. Extrapyramidal effects Show forest plot	2	83	Risk Ratio (M‐H, Fixed, 95% CI)	1.94 [0.18, 20.30]

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

7.1 ataxia	1	63	Risk Ratio (M‐H, Fixed, 95% CI)	1.45 [0.26, 8.11]
7.2 dizziness	1	63	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.12, 3.61]
7.3 dry mouth	1	63	Risk Ratio (M‐H, Fixed, 95% CI)	0.58 [0.15, 2.23]
7.4 speech disorder	1	63	Risk Ratio (M‐H, Fixed, 95% CI)	1.45 [0.26, 8.11]

Comparison 3. BENZODIAZEPINES + ANTIPSYCHOTICS vs BENZODIAZEPINES

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Comparison 4. BENZODIAZEPINES + ANTIPSYCHOTICS vs ANTIPSYCHOTICS

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global impression: 1. Need for additional medication ‐ medium term Show forest plot	1	67	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.79, 1.15]

2 Global impression: 2. Leaving the study early ‐ medium term Show forest plot	1	28	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

3 Mental state: 1. Average score ‐ medium term (BPRS, high = poor) Show forest plot	1	28	Mean Difference (IV, Fixed, 95% CI)	0.01 [‐7.26, 7.28]

4 Mental state: 2. Average score ‐ medium term (BPRS‐psychosis subscale, high = poor) Show forest plot	1	28	Mean Difference (IV, Fixed, 95% CI)	‐1.93 [‐5.73, 1.87]

5 Mental state: 3. Average change ‐ medium term (BPRS‐psychosis subscale, high = poor, skewed) Show forest plot			Other data	No numeric data

6 Adverse events: 1. Extrapyramidal effects Show forest plot	2	95	Risk Ratio (M‐H, Fixed, 95% CI)	0.45 [0.22, 0.94]

7 Adverse events: 2. Requiring anticholinergic medication ‐ medium term Show forest plot	1	28	Risk Ratio (M‐H, Fixed, 95% CI)	0.56 [0.25, 1.24]

8 Adverse events: 3. General Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

8.1 ataxia	1	67	Risk Ratio (M‐H, Fixed, 95% CI)	3.28 [0.36, 29.97]
8.2 dizziness	1	67	Risk Ratio (M‐H, Fixed, 95% CI)	0.73 [0.13, 4.09]
8.3 dry mouth	1	67	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.24, 5.04]
8.4 speech disorder	1	67	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.20, 3.39]
9 Hospital and service outcome: Unfit for early discharge Show forest plot	1	28	Risk Ratio (M‐H, Fixed, 95% CI)	0.9 [0.54, 1.50]

Comparison 4. BENZODIAZEPINES + ANTIPSYCHOTICS vs ANTIPSYCHOTICS

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Comparison 5. SENSITIVITY ANALYSIS: 1. HIGH vs LOW ATTRITION

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global impression: 1. Sedation ‐ medium term Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 high	1	16	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.02, 7.14]
1.2 low	2	203	Risk Ratio (M‐H, Fixed, 95% CI)	0.90 [0.47, 1.73]
2 Global impression: 2. Leaving the study early ‐ medium term Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.1 high	1	16	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.02, 7.14]
2.2 low	1	150	Risk Ratio (M‐H, Fixed, 95% CI)	5.82 [0.62, 54.58]
3 Adverse events: Extrapyramidal effects Show forest plot	4		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.1 high	2	56	Risk Ratio (M‐H, Fixed, 95% CI)	0.12 [0.02, 0.62]
3.2 low	2	204	Risk Ratio (M‐H, Fixed, 95% CI)	0.22 [0.05, 0.95]

Comparison 5. SENSITIVITY ANALYSIS: 1. HIGH vs LOW ATTRITION

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Comparison 6. SENSITIVITY ANALYSIS: 2. RANDOMISED vs UNKNOWN

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global impression: Sedation ‐ medium term Show forest plot	6		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 randomised	4	231	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.34, 1.49]
1.2 unknown	2	93	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.45, 1.44]
2 Adverse events: 1. Extrapyramidal effects Show forest plot	7		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.1 randomised	6	351	Risk Ratio (M‐H, Fixed, 95% CI)	0.21 [0.07, 0.63]
2.2 unknown	1	40	Risk Ratio (M‐H, Fixed, 95% CI)	0.09 [0.01, 0.65]

Comparison 6. SENSITIVITY ANALYSIS: 2. RANDOMISED vs UNKNOWN

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