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Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
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Figure 1

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

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Comparison 1 CHLORPROMAZINE vs HALOPERIDOL, Outcome 1 Global outcome: number of additional injections.
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Analysis 1.1

Comparison 1 CHLORPROMAZINE vs HALOPERIDOL, Outcome 1 Global outcome: number of additional injections.

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Comparison 1 CHLORPROMAZINE vs HALOPERIDOL, Outcome 2 Adverse effects.
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Analysis 1.2

Comparison 1 CHLORPROMAZINE vs HALOPERIDOL, Outcome 2 Adverse effects.

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Comparison 1 CHLORPROMAZINE vs HALOPERIDOL, Outcome 3 Leaving the study early.
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Analysis 1.3

Comparison 1 CHLORPROMAZINE vs HALOPERIDOL, Outcome 3 Leaving the study early.

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Table 2. Suggested design for a study

Methods

Allocation: randomised, clearly described.
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. Chlorpromazine IM: dose flexible within recommended limits. N=150.
2. Haloperidol + promethazine 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.
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.

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Table 2. Suggested design for a study
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Summary of findings for the main comparison. CHLORPROMAZINE compared to HALOPERIDOL for psychosis induced aggression or agitation

CHLORPROMAZINE compared to HALOPERIDOL for psychosis induced aggression or agitation

Patient or population: patients with psychosis induced aggression or agitation
Settings: in hospitals of over 30 years ago
Intervention: CHLORPROMAZINE
Comparison: HALOPERIDOL

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

HALOPERIDOL

CHLORPROMAZINE

Global outcome: Number of additional injections ‐ 2‐4 injections

Study population

RR 0.9
(0.52 to 1.55)

30
(1 study)

⊕⊝⊝⊝
very low1,2

667 per 1000

600 per 1000
(347 to 1000)

Medium risk population

667 per 1000

600 per 1000
(347 to 1000)

Global outcome: Number of additional injections ‐ 5 or more

Study population

RR 0.75
(0.2 to 2.79)

30
(1 study)

⊕⊝⊝⊝
very low1,2

267 per 1000

200 per 1000
(53 to 745)

Medium risk population

267 per 1000

200 per 1000
(53 to 745)

Adverse effects ‐ cardiovascular ‐ hypotension

Study population

RR 5
(0.26 to 96.13)

30
(1 study)

⊕⊝⊝⊝
very low1,2

Serious adverse event

0 per 1000

0 per 1000
(0 to 0)

Medium risk population

0 per 1000

0 per 1000
(0 to 0)

Adverse effects ‐ movement disorders ‐ extrapyramidal side effects

See comment

See comment

Not estimable

30
(1 study)

See comment

No events3

Adverse effects ‐ seizures

Study population

RR 3
(0.13 to 68.26)

30
(1 study)

⊕⊝⊝⊝
very low1,2

0 per 1000

0 per 1000
(0 to 0)

Medium risk population

0 per 1000

0 per 1000
(0 to 0)

Leaving the study early

Study population

RR 2
(0.2 to 19.78)

30
(1 study)

⊕⊝⊝⊝
very low1,2

67 per 1000

134 per 1000
(13 to 1000)

Medium risk population

67 per 1000

134 per 1000
(13 to 1000)

*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 Randomisation not well described, blindness unlikely, selective reporting
2 Small study
3 Unusual not to experience any such effects, even in short term

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Summary of findings for the main comparison. CHLORPROMAZINE compared to HALOPERIDOL for psychosis induced aggression or agitation
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Table 1. Other relevant Cochrane Reviews

Focus of review

Reference

Benzodiazepines

Volz 2007

Containment strategies

Muralidharan 2006

Haloperidol + promethazine

Huf 2009

Loxapine

Chakrabarti 2007

Olanzapine IM

Belgamwar 2005

Seclusion and restraint

Sailas 2000

Zuoclopenthixol acetate

Gibson 2004

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Table 1. Other relevant Cochrane Reviews
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Comparison 1. CHLORPROMAZINE vs HALOPERIDOL

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Global outcome: number of additional injections Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 One additional injection

1

30

Risk Ratio (M‐H, Fixed, 95% CI)

3.0 [0.13, 68.26]

1.2 Two ‐ four injections

1

30

Risk Ratio (M‐H, Fixed, 95% CI)

0.9 [0.52, 1.55]

1.3 Five or more injections

1

30

Risk Ratio (M‐H, Fixed, 95% CI)

0.75 [0.20, 2.79]

2 Adverse effects Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 Cardiovascular ‐ hypotension

1

30

Risk Ratio (M‐H, Fixed, 95% CI)

5.0 [0.26, 96.13]

2.2 Movement disorders ‐ extrapyramidal adverse effects

1

30

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.3 Seizures

1

30

Risk Ratio (M‐H, Fixed, 95% CI)

3.0 [0.13, 68.26]

2.4 Local irritation

1

30

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Leaving the study early Show forest plot

1

30

Risk Ratio (M‐H, Fixed, 95% CI)

2.0 [0.20, 19.78]
Figuras y tablas -
Comparison 1. CHLORPROMAZINE vs HALOPERIDOL
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