Van Wyk 1971.
Methods | Allocation: randomised Blindness: not blind Duration: 12 weeks Design: parallel Setting: hospital Country: South Africa |
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Participants | Diagnosis: schizophrenia and "toxic psychoses" N = 101 Age: adults (no further information provided) Sex: male History: acute psychoses, no epilepsy or depressive psychoses |
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Interventions | 1. Clotiapine: 40 mg/d orally. N = 36 2. Chlorpromazine: 200 mg/d orally. N = 34 3. Thioridazine: 200 mg/d orally. N = 31 |
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Outcomes | Service use: number discharged by 12 weeks Unable to use Mental state: general ‐ average endpoint score (scale not named ‐ unsure if peer reviewed) Adverse effects: adverse effects mentioned in text, but no data reported to support statements |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Allocation to either of the 3 drug groups was at random" |
Allocation concealment (selection bias) | Unclear risk | No information provided for allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Because of the administrative and staff shortage problems we could not introduce· any 'blind' procedures into the trial" |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "Because of the administrative and staff shortage problems we could not introduce· any 'blind' procedures into the trial" |
Incomplete outcome data (attrition bias) All outcomes | High risk | No information was provided for attrition and missing data |
Selective reporting (reporting bias) | Unclear risk | No information was provided for pre‐specified outcomes |
Other bias | Unclear risk | Clotiapine was supplied by a researcher from Switzerland. No source of funding reported |
EPS: extrapyramidal symptoms F: female M: male N: number SD: standard deviation
Scales
PANSS: Positive and negative syndrome scale S‐Scale: Marten's Symptom scale CGI: Clinical Global Impression NOSIE: Nurses' Observational Scale for Inpatient Evaluation