Malfroid 1978.
Methods | Randomisation: “assigned at random”. Blinding: double‐blind. Duration: 4 weeks. Design: parallel Location: not indicated. Setting: not indicated. |
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Participants | Diagnosis: paranoid schizophrenia (N = 12), catatonic schizophrenia (N = 9), chronic psychosis (N = 3). N = 24. Gender: 24M. Age: mean 48.6 years. History: duration stable: not indicated, duration of illness: mean 25.3 years, number of previous hospitalisations: not indicated, age at onset: not indicated, severity of illness: not indicated, baseline antipsychotic dose: not indicated. |
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Interventions | 1. Haloperidol: fixed/flexible dose: not indicated, dose range: not indicated, mean dose: 6‐8 mg/day. N = 12. 2. Bromperidol: fixed/flexible dose: not indicated, dose range: not indicated, mean dose: 4‐8 mg/day: N = 12. Rescue medication: anticholinergics were allowed. |
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Outcomes | Examined: Clinically important response to treatment: Global efficacy scale. Adverse effects: dyskinesia, use of antiparkinson medication, hypotension. Unable to use: Mental state general: Psychiatric rating scale (designed by the “Wirtschafts‐Mathematik Zürich”) (no raw data available). |
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Notes | Study participants were 24 “chronic psychotic patients”. “Before the trial period, all patients were on a maintenance neuroleptic treatment”. No participant with first‐episode schizophrenia was enrolled. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “Randomly assigned”. No further details. |
Allocation concealment (selection bias) | Unclear risk | No further details. |
Blinding (performance bias and detection bias) (performance bias) | Unclear risk | “Double‐blind”. No further details. |
Blinding (performance bias and detection bias) (detection bias) | Unclear risk | “Double‐blind”. No further details. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The study did not address this outcome; insufficient information to permit judgment concerning incomplete outcome data. |
Selective reporting (reporting bias) | High risk | Outcome data were not fully addressed (no raw data for the psychiatric rating scale). Adverse effects reporting was incomplete. BPRS is mentioned in the abstract but no results were presented. |
Other bias | High risk | “Before the trial period, all patients were on a maintenance neuroleptic treatment.” |