O´Brien 1974.
Methods | Randomisation: implied randomisation. Blinding: double‐blind. Duration: 3 weeks. Design: parallel. Location: Hospital of the University of Pennsylvania, Philadelphia Naval Hospital (two‐centre). Setting: inpatients. |
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Participants | Diagnosis (N = 24): paranoid schizophrenia (N = 20), paranoid personality (N = 2), paranoid state (N = 1), explosive personality (N = 1). N = 30. Gender: 22M, 2F. Age: mean 29.5 years. History: duration stable: not indicated, duration of illness: not indicated, 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: flexible dose, dose range: maximum dose 20 mg/day, mean dose: not indicated. N = 15. 2. Trifluoperazine: flexible dose, dose range: maximum dose 48 mg/day, mean dose: not indicated. N = 15. Rescue medication: “benztropine was given only when necessary to control extra pyramidal reactions.” “If parenteral medication was required, intramuscular sodium amytal was given.” |
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Outcomes | Examined: Clinically important response to treatment: Global clinical outcome rating. Leaving the study early due to any reason. Adverse effects: use of antiparkinson medication. Unable to use: Mental state general: Brief Psychiatric Rating Scale (BPRS) (no raw data available; only the average improvement was provided, no SDs available). Mental state specific: Hamilton Depression Rating Scale (HAM‐D) (no raw data available). Mental state specific: Global Hostility Scale (GH) (no raw data available; only the average improvement was provided, no SDs available). Mental state specific: Global Paranoia Scale (GP) (no raw data available; only the average improvement was provided, no SDs available). |
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Notes | Study participants were characterised as “hostile, suspicious, uncooperative patients” and a “population of hostile suspicious patients”. “Starting sample was 30 patients but 6 …. were dropped from study”. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No randomisation mentioned in the publication, but the trial was described as “double‐blind.” Thus it was implied that the study was randomised. |
Allocation concealment (selection bias) | Unclear risk | No further details. |
Blinding (performance bias and detection bias) (performance bias) | Low risk | “Double‐blind fashion”. “identically appearing pink capsules.” |
Blinding (performance bias and detection bias) (detection bias) | Unclear risk | “Double‐blind fashion”. No further details. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The attrition was moderate (3 of 15 participants (20%) in both study arms). Completers‐only analyses were used in the study. |
Selective reporting (reporting bias) | High risk | The outcome data were not fully addressed (no raw data for the BPRS, GH, GP, and HAM‐D). Adverse effects were not fully addressed. |
Other bias | High risk | “Milieu therapy, group therapy, and individual sessions with a psychiatrist” were allowed during the trial. |