Reardon 1966.
Methods | Allocation: random. Blinding: double. Duration: 4 ‐ 12 weeks. Setting: inpatient (USA). Design: parallel (3 groups), single centre. |
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Participants | Diagnosis: acute paranoid schizophrenia (Bleuler criteria). N = 34 *(n = 23 included in the analysis ‐ see interventions). Age: no data. Sex: 22M,12F ("number of males and females in each group were comparable"). Ethnicity: not stated. History: not stated. Included: those who demonstrated a thinking and affect disturbance, and who admitted the presence of persecutory delusions and hallucinations within 10 days prior to admission were selected. Exclusion: not stated. Consent: not stated. |
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Interventions | 1. Trifluoperazine: 20 mg/day for first week, increased to 40 mg/day for the remainder of the study, n = 11. 2. Placebo: either 2 to 4 cc. or 5 to 10 cc 'as though it were one of the active drugs', n = 12. *(3. Chlorpromazine: 300 mg/day for first week, increased to 600 mg until completion of study, n = 11 ‐ this group was not included in the analysis). (IM barbiturates were administered 'on occasion' to deal with aggressive or assaultive behaviour). |
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Outcomes | Leaving the study early: any reason; due to adverse effects (relapse/ worsening ‐ ECT). Extrapyramindal adverse effects: Parkinsonism. Mental state: clinically significant response in positive symptoms (exhibited delusions and hallucinations); clinically significant response in psychotic symptoms (defined as exhibiting delusions and hallucinations). Hospital and service utilisation outcomes: hospital transfer/ home leave. Unable to use ‐ Global state and cognitive response: MMPI, Shipley Hartford and four sub tests of WAIS rating scores ‐ only P values given. Use of anti‐Parkinson drugs: Artane (10 mg) daily was given to all patients. No data and no Parkinsonian symptoms were observed. Behaviour: no usable data. |
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Notes | ITT used for outcomes not relating to adverse effects (leaving the study early and service utilisation outcomes only). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised ‐ the pharmacy controlled the allocation ‐ quote, “each subject was placed on a ward and randomly assigned trifluoperazine, chlorpromazine or placebo by the pharmacy” (p266) ‐ no further details. |
Allocation concealment (selection bias) | Low risk | Allocation was controlled by the pharmacy; ward personnel and investigators did not know which drug each participant received. Participants were placed in active treatment wards in order to quote: "avoid the therapeutic milieu effect that might occur with placement on a special research unit" (p266). |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double ‐ allocation was controlled by the pharmacy; ward personnel and investigators did not know which drug each participant received. Placebo administered quote: "as though it were one of the active drugs" (p266). |
Incomplete outcome data (attrition bias) All outcomes | High risk | Follow‐up: 74%. Six participants were excluded from the investigation because they were given ECT (n = 2 receiving trifluoperazine; n = 1 receiving chlorpromazine; n = 3 receiving placebo) with an addition n = 3 (one from each group) removed from the study after transfer or home leave. Limited data provided and subjective clinical observations used. |
Selective reporting (reporting bias) | Unclear risk | MMPI, Shipley Hartford WAIS ‐ no scale data or SDs reported. |
Other bias | Unclear risk | Funding: Smith, Kline and French supplied the drugs and placebo. Rating scales: not clear whether nurses or other raters were independent of treatment. |