Dufresne 1993.
Methods | Randomisation: random, no further details. Allocation: procedure not described. Blinding: double, identical capsules. Duration: 6 weeks. Design: parallel. Location: n.i., Setting: n.i., | |
Participants | Diagnosis: schizophrenia (DSM‐III). N = 30. Gender: 20 F, 10 M. Age: mean 34 years. History: duration stable ‐ n.i., duration ill ‐ mean 13 years, nr. of prev. hospitalisations ‐ 7, age at onset ‐ mean 21 years, severity of illness ‐ BPRS at baseline 59.9 (SD12.3), baseline antipsychotic dose ‐ n.i., |
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Interventions | 1. Haloperidol: flexible dose, allowed dose range 5 to 40 mg/day, mean dose n.i.. N = 16. 2. Thioridazine: flexible dose, allowed dose range 100 to 800 mg/day, mean dose N = 14. Other medication: amantadine (antiparkinson medication), chloral hydrate. | |
Outcomes | Response to treatment: at least 20% reduction in BPRS total score. Leaving the study early. Adverse effects: at least one adverse effect, movement disorders (use of antiparkinson medication), other adverse effects (confusion, dry mouth, hypotension). Unable to use: Mental state: BPRS (incomplete data, no SD). Depression: HAM‐D (incomplete data, no SD). Global state: CGI (incomplete data, no SD). Adverse effects: weight (incomplete data). |
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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 | Low risk | Double, identical capsules. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double, identical capsules. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 25% of haloperidol participants left the study early. A completers‐only method was used in the study. |
Selective reporting (reporting bias) | High risk | No complete data for BPRS and HAM‐D, SDs are missing. |
Other bias | Low risk | No clear other bias. |