Fruensgaard 1977.

Methods	Allocation: randomised. Blindness: double. Duration: 72 hours.
Participants	Diagnosis: acute schizophrenia (N = 12), psychogenic psychosis (N = 18). N = 30. Age: range 19‐65 years. Sex: 7 males, 23 females. History: "newly admitted patients with a diagnosis of acute psychosis and characterized by symptoms such as agitation, excitement, aggressiveness, delusions and hallucinations." (p.257). Onset < 7 days (N = 14), 1 week ‐ 1 month (N = 13), 1‐6 months (N = 3). Excluded: "pregnancy, manic depressive illness, electroconvulsive therapy within the preceding 8 weeks, organic brain syndrome with marked dementia, convulsive disorders, alcoholism or drug dependence, serious impairment of renal, hepatic, cardiovascular or metabolic functions, and present or former increased intra‐ocular pressure."(p.257). Setting: psychiatric hospital, Denmark.
Interventions	1. Haloperidol: flexible dose 2.5 mg/IM to 5 mg/IM + biperiden: dose 2.5 mg/IM to 5 mg/IM (mean number of IMs not reported). N = 15. 2. Loxapine: flexible dose 25 mg/IM to 50 mg/IM + biperiden: dose 2.5 mg/IM (mean number of IMs not reported). N = 15.
Outcomes	Adverse effects: recording of side effects, laboratory tests.. Agitation: observation*. Not able to use: Mental state: BPRS (mean reported, SD/CI not reported). Global state: CGI (mean reported, SD/CI not reported). Adverse effects: blood pressure, pulse rate (reports a decrease in blood pressure/pulse rate in both groups but does not give N/mean/SD/CI).
Notes	* Scale derived data for agitation/excitation scores was not included as the measure was not validated.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Described as randomised ‐ method of randomisation is not reported.
Allocation concealment (selection bias)	Unclear risk	Not stated.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"Both drugs were supplied in ampules of identical appearance." (p.257).
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Described as double‐blind, however no further details reported regarding rater‐blinding.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No evidence of incomplete data.
Selective reporting (reporting bias)	Low risk	No evidence of selective reporting.
Other bias	High risk	Small study.