Borison 1989.
Methods | Randomisation: randomised, no further details. Allocation: procedure not described. Blinding: double, no further details. Duration: 6 weeks. Design: parallel. Location: n.i., Setting: n.i., | |
Participants | Diagnosis: schizophrenia (DSM‐III). N = 10. Gender: n.i., Age: range 18‐60 years. History: duration stable ‐ n.i., duration ill ‐ n.i., nr. of prev. hospitalisations ‐ n.i., age at onset ‐ n.i., severity of illness ‐ min. 35 on BPRS, baseline antipsychotic dose ‐ n.i., |
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Interventions | 1. Haloperidol: flexible dose, allowed dose range 15 to 75 mg/t.i.d., mean dose n.i.. N = 8. 2. Thioridazine: flexible dose, allowed dose range 150 to 750 mg/t.i.d., mean dose n.i.. N = 8. Other medication: chloral hydrate. | |
Outcomes | Response to treatment: BPRS (no definition).
Mental state: BPRS. Relapse. Leaving the study early. Adverse events : movement disorders (akathisia, dystonia, rigor, use of antiparkinson medication), other adverse effects (hypotension, sedation). |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised, no further details. |
Allocation concealment (selection bias) | Unclear risk | Procedure not described. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double, no further details. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Double, no further details. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 1 out of 8 participants from the thioridazine group (13%) left the study early due to inefficacy of treatment. 3 out of 8 participants from the haloperidol group (38%) left the study early to due improvement and administrative reasons. Drop‐outs were not included in the final analysis. |
Selective reporting (reporting bias) | Low risk | No evidence for selective reporting. |
Other bias | Low risk | No clear other bias. |