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Review: limited evidence on effects of haloperidol alone for rapid tranquillisation in psychosis-induced aggression

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Question: Is haloperidol alone effective in reducing psychosis-induced agitation or aggression?

Outcomes: Primary outcomes: not being asleep or tranquil; needing repeated rapid tranquillisation.


Design: Systematic review with meta-analysis.

Data sources: The Cochrane Schizophrenia Group Trials Register was searched for randomised controlled trials (RCTs) from inception to 1 June 2011. The register is populated from searches major databases, hand searches of journals and conference proceedings. Reference lists of identified studies were hand searched. Authors of included studies were contacted for information on unpublished trials.

Study selection and analysis: Two reviewers appraised and selected RCTs in adults with acute exacerbation of psychosis-induced agitation or aggression that compared rapid use of haloperidol (any dose or route) with other antipsychotics, benzodiazepines, anticonvulsants, drug combinations, placebo or no intervention. Random effect meta-analyses were conducted using RevMan software. Trials were excluded if 50% or more data were lost. Heterogeneity was assessed using the I2 statistic.

Main results

Thirty-two RCTs met inclusion criteria (n=3877). Most trials were small, had considerable risk of bias, and did not reflect real life clinical practice. Haloperidol and …

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  • Sources of funding: University of Nottingham, Nottinghamshire Healthcare NHS Trust, National Institute for Health Research, UK.


  • Competing interests In the past 36 months, LC has engaged in collaborative research with, or received consulting or speaking fees, from: Alexza, Alkermes, AstraZeneca, Avanir, Bristol-Myers Squibb, Eli Lilly, Envivo, Forest, Genentech, Janssen, Lundbeck, Merck, Mylan, Novartis, Noven, Otsuka, Pfizer, Shire, Sunovion and Valeant.

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