Tuason 1986.
Methods | Allocation: randomised ‐ no further details. Blinding: "modified double" ‐ staff administering drugs not blinded, assessments blind. Duration: 24‐72 hours (IM phase) ‐ oral phase data not included. Setting: single centre. | |
Participants | Diagnosis: schizophrenia, acutely psychotic (DSM‐III used beyond 3 days). N=54. Age: mean ˜35 years (SD ˜ 10), range 18‐65 years. Sex: 33 M, 19 F, 2 not reported. History: newly admitted. Inclusion criteria: > 7 on BPRS hostility & uncooperativeness, behaviour = hostile/aggressive/uncooperative/unmanageable. Exclusion: ill health, co‐existing mental illness condition. | |
Interventions | 1. Loxapine: dose 25 mg IM, then 12.5‐25 mg/hour IM, max. 250 mg/day. N=25.
2. Haloperidol: dose 5mg IM, then 2.5‐5mg/hour IM, max. 100 mg/day. N=29. Antiparkinsonian drugs and chlorayl hydrate as required. |
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Outcomes | General effect (requiring extended period of medication > 24 hours).
Mental state: BPRS.*
Side effects (sedation ‐ ESBE, use of antiparkinsonian drugs).
Dropped from analysis.
Leaving the study early. Unable to use ‐ Global effect: CGI (no data). |
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Notes | 2 people withdrawn from analysis ‐ original group unclear. * BPRS scores reported with SD. Data thought not to be SD but standard error and reviewers have converted to SD. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |