Gallant 1970a.
Methods | Allocation: random allocation (by random numbers). Blindness: double‐blind. Duration: 8 weeks (2 weeks of baseline evaluation + 6 weeks of medication + 2 weeks of drying out period). Setting: hospital. |
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Participants | Diagnosis: severe chronic schizophrenia. N = 26. Age: mean ˜ 44.7 years. Sex: male. History: free of significant disabilities of the cardiovascular, renal, and hepatic systems. Prior psychotherapeutic drug agents were discontinued for a minimum period of 4 weeks prior to initial doses of medication. |
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Interventions | 1. Chlorpromazine (liquid): initial dose of 120 mg/day, maximum dose: 1350 mg/day (N = 13). 2. Piperacetazine (liquid): initial dose 20 mg/day, maximum dose: 360 mg/day (N = 13). |
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Outcomes | Global state: clinically important change (psychiatrist‐rated). Adverse effects: specific effects. Unable to use: Mental state: BPRS, NOSIE score (no mean or SD). Global state: CGI score (no mean or SD). Behaviour: not outcome of interest in protocol, plus no mean or SD. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Subjects were selected and/or assigned to treatment by random numbers" |
Allocation concealment (selection bias) | Unclear risk | Further information regarding allocation concealment was not provided. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "in a controlled, double blind study" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information was provided regarding blinding of outcome assessors. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information was provided for missing values or attrition. |
Selective reporting (reporting bias) | Unclear risk | No information was provided for prespecified outcomes. |
Other bias | Low risk | The study was partially supported by a research grant. The drugs were supplied by a pharmaceutical company. |