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. 2017 Dec 8;2017(12):CD003079. doi: 10.1002/14651858.CD003079.pub4

Lorazepam 1997b, USA.

Study characteristics
Methods Allocation: randomised.
Blinding: double blind.
Design: not stated.
Duration: 4 hours.
Setting: Psychiatric Emergency Service, Eastern Pennsylvania Psychiatric Institute, US.
Participants Diagnosis: schizophrenia (n = 13), bipolar (n = 13), schizoaffective (n = 4), psychotic disorder not otherwise specified (n = 7).
n = 37.
Age: 18‐61 years.
Gender: 26 men, 11 women.
Ethnicity: white (n = 21), African‐American (n = 14), Hispanic (n = 2).
Consent: need for informed consent waived.
History: drug abuse or dependence n = 10.
Inclusion criteria: highly agitated people exhibiting psychotic symptoms, judged by emergency department staff to be an imminent danger to themselves, required restraint, scored ≥ 5 on ≥ 3 BPRS items and ≥ 4 on CGI.
Exclusion criteria: not stated.
Interventions Benzodiazepines vs antipsychotics.
1. Lorazepam 2 mg oral or IM (n = 17).
2. Haloperidol 5 mg oral or IM (n = 20).
Medication administered every 30 minutes for 4 hours 'as needed' until the participant was sedated or no longer posed a danger to themselves or staff.
Outcomes Global impression: sedation; mean endpoint score (CGI‐S).
Mental state: mean endpoint score (BPRS).
Adverse effects/events: EPS.
Notes More bipolar participants received lorazepam (n = 10) than haloperidol (n = 3).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomised; however, no further description of randomisation provided.
Allocation concealment (selection bias) Unclear risk Not stated.
Blinding (performance bias and detection bias)
All outcomes Unclear risk Double blind; however, no further description of blinding provided.
Rating scales: symptom ratings were conducted by 1 of 4 raters (psychiatry residents or psychiatric nursing staff). Raters were trained by trial author SF.
Incomplete outcome data (attrition bias)
All outcomes Low risk Follow‐up: 100%.
Selective reporting (reporting bias) Low risk All measure outcomes were reported.
Other bias Low risk Funding: supported in part by a grant from the National Alliance for Research on Schizophrenia and Depression. We detect no other bias.