Prien 1969*.
Methods | Allocation: random. Blinding: double. Duration: 24 weeks, 4 week observation period pre‐trial. Setting: inpatient, 6 hospitals ‐ Broughton State Hospital, NC, Dorothea Dix State Hospital, NC, Kentucky State Hospital, KY, Manhattan State Hospital, NY, St. Louis Hospital, MO, Springfield State Hospital, MD (USA). Design: parallel (3 groups), single centre. |
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Participants | Diagnosis: chronic schizophrenia. N = 3411. Age: 18‐55 (mean age 41.8 years, 60% were 45+ years old). Sex: 180M, 180F (30M, 30F from each hospital). Ethnicity: not stated. History: chronic schizophrenics with length of hospitalisation 2‐33 years with mean 15 years. 55% of patients were hospitalised 10+ years. Inclusion: a primary diagnosis of schizophrenia, age between 18‐55, continuous hospitalisation for at least 2 years. Exclusion: organic brain disease, mental deficiency or medical conditions that would otherwise put the patient at increased risk when taking high dose drugs. Consent: not stated. |
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Interventions | 1. Trifluoperazine: (high dose) 80 mg/day, gradual increase from previous dose to 80 mg/day after 35 days, n = 117. 2. Trifluoperazine: (low dose) 15 mg/day, n = 113. 3. Placebo: n = 111. |
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Outcomes | Global state: clinical improvement (defined a 'markedly improved' using the Doctor's Global Improvement Scale) ‐ together and by high dose and low dose. Extrapyramidal adverse effects: akathisia; Parkinsonian reaction; dystonia ‐ together and by high dose and low dose. 2Other adverse effects: specific ‐ seizures; hypotension; dizziness; fainting; nausea/vomiting; skin rashes; photosensitivity; insomnia; drowsiness; decreased appetite ‐ together and by high dose and low dose. Leaving the study early: any reason; due to severe adverse effects; due to relapse or worsening ‐ together and by high dose and low dose. Unable to use: Mental state: BPRS; IMPS ‐ no usable data. Behaviour: NOSIE ‐ no usable data. Hospital and service utilisation outcomes: follow‐up ‐ discharge ‐ not enough data. |
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Notes |
1Study paper reads: "approximately 60 chronic schizophrenics...were selected at each hospital [and] each treatment group consisted of approximately 120 patients" (p54). No concrete data were found for true participant numbers; however, we used the data available to us that represented n = 117 in high‐dose trifluoperazine; n = 113 in low‐dose trifluoperazine; and n = 111 in placebo groups (N = 341). 2All adverse effect data and numbers leaving the study early were calculated from percentages. High and low doses were combined as well as reported separately versus placebo. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised ‐ quote, "patients were randomly assigned to one of three groups” (p306). |
Allocation concealment (selection bias) | Unclear risk | No description. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double ‐ “all medication was administered in capsule form under double‐blind conditions for 24 weeks” (p306). |
Incomplete outcome data (attrition bias) All outcomes | High risk | Where the study only gives an approximation as to the original number of randomised participants (N = 360), it is hard to identify the true number of participants that dropped out or that were included in the final analysis. |
Selective reporting (reporting bias) | Unclear risk | No data provided for IMPS, BPRS, NOSIE, Global Improvement Scale, or Discharge‐Readiness Inventory (DRI). |
Other bias | Unclear risk | Funding: Public Health Service grants: MH‐10292, MH‐10332, MH‐11384, MH‐10989, MH‐11046, MH‐11047 and contract SA‐43‐ph‐3064 all from the National Institute of Mental Health. Rating Scales: scales were administered by the research physician; unclear whether they were independent of treatment. |