Kurland 1961.
Methods | Randomisation: random selection, no further details. Allocation: procedure not described. Blinding: double. Dispensed in unmarked capsules of #0 and #1 size coloured pink to mask all identifying consistencies and colours of the drugs. Duration: 6 weeks. Design: parallel. Location: single centre. Setting: inpatients. |
|
Participants | Diagnosis: predominantly schizophrenia (clinical diagnosis). N = 69. Gender: n.i.. Age: mean 39 years. History: duration stable – n.i., duration ill – n.i., number of previous hospitalisations – n.i., age at onset – n.i., severity of illness – n.i., baseline antipsychotic dose – n.i.. |
|
Interventions | 1. Perphenazine: flexible dose, allowed dose range 24 to 96 mg/day, mean dose 30.83 mg/day. N = 36. 2. Chlorpromazine: flexible dose, allowed dose range 300 to 1200 mg/day, mean dose 401.35 mg/day. N = 33. Rescue medication: n.i.. |
|
Outcomes | Leaving the study early. Adverse effects: at least one adverse effect, movement disorders (MD) (at least one MD, akathisia, dyskinesia), adverse effects ‐ other (leucopenia, neurologic symptoms, rash, vasomotor episodes). Unable to use: Mental state: MSRPP (no SD), PSTS (no SD) Behaviour: PRP (no usable data, no SD). |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Random selection, no further details. |
Allocation concealment (selection bias) | Unclear risk | Procedure not described. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double. Dispensed in unmarked capsules of #0 and #1 size coloured pink to mask all identifying consistencies and colours of the drugs. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double. Dispensed in unmarked capsules of #0 and #1 size coloured pink to mask all identifying consistencies and colours of the drugs. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 32 out of 36 from the perphenazine group left the study early (89%) of which 22% dropped out due to EPS. 26 out of 33 from the low‐potency group left early (79%). LOCF was applied. |
Selective reporting (reporting bias) | High risk | MSRPP (no SD), PRP and PSTS (no usable data). |
Other bias | Unclear risk | On the first two days of the study, participants received intramuscular medication, after that they were given oral mediations. |