Reardon 1966.
Methods | Randomisation: randomly placed and assigned to one of three drugs, no further details. Allocation: randomly assigned by pharmacy. Blinding: not mentioned but assumed (“neither the ward personnel nor the investigators knew which drug the patients received”). Duration: 12 weeks. Design: parallel. Location: multicentre. Setting: inpatients. |
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Participants | Diagnosis: paranoid schizophrenia (Bleuler concept). N = 34. Gender: 22 M, 12 F. Age: n.i.. History: duration stable – n.i., duration ill ‐ n.i., number of previous hospitalisations ‐ n.i., age at onset ‐ n.i., severity of illness ‐ n.i., baseline antipsychotic dose ‐ n.i.. |
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Interventions | 1. Trifluoperazine: flexible dose, allowed dose range 20‐40 mg/day, mean dose n.i.. N = 11. 2. Chlorpromazine: flexible dose, allowed dose range 300‐600 mg/day, mean dose n.i.. N = 11. Rescue medication: intramuscular barbiturates, 10 mg Artane. |
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Outcomes | Leaving the study early. Unable to use: Psychological: Minnestota Multiphasic Personality Inventory (incomplete data, no mean, no SD). Intelligence: Wechsler Adult Intelligence Scale; Shipley Hartford (incomplete data, no mean, no SD). |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomly placed and assigned to one of three drugs, no further details. |
Allocation concealment (selection bias) | Unclear risk | Randomly assigned by pharmacy, no further details. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not indicated, but assumed (“neither the ward personnel nor the investigators knew which drug the patients received”). |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not indicated, but assumed (“neither the ward personnel nor the investigators knew which drug the patients received”). |
Incomplete outcome data (attrition bias) All outcomes | High risk | Drop‐outs were excluded from the final analysis (completers only). 3 out of 11 trifluoperazine (27%) and 2 out of 11 chlorpromazine (18%) participants left the study early. |
Selective reporting (reporting bias) | High risk | Incomplete reporting of scale of interest. |
Other bias | Low risk | No clear other bias. |