Hanlon 1965.
Methods | Randomisation: randomly assigned, no further details. Allocation: procedure not described. Blinding: double ‐ drugs dispensed in standard unmarked pink capsules no. 1 & 0 size, but treating ward physicians were aware of the various drugs and dosages involved in the study. Duration: 30 days. Design: parallel. Location: n.i.. Setting: inpatients. | |
Participants | Diagnosis: psychotic (270) of which 232 were diagnosed as schizophrenic, 52 neurotics and/or personality disorder. Gender: 160 M, 162 F. Age: mean 36.3 years. History: duration stable ‐ n.i., duration ill ‐ n.i., number of previous hospitalisations ‐ n.i., age at onset ‐ n.i., severity of illness ‐ MSRPP mean 41.4 (15.3), MACC mean 37.5 (10.4), baseline antipsychotic dose ‐ n.i.. | |
Interventions | 1. Trifluoperazine: flexible dose, mean dose 11.49 mg/day N = 52. 2. Chlorpromazine: flexible dose, mean dose 395.56 mg/day. N = 52. 3. Thioridazine: flexible dose, mean dose 193.46 mg/day. N = 53. Rescue medication: antiparkinson medication (biperiden), mild sedation (phenobarbital glutethimide). |
|
Outcomes | Leaving the study early. Adverse events. Unable to use: Mental state: MMPI, MSRPP, IMPS (all incomplete data, no mean, no SD). Behaviour: Behavioral Adjustment Scale (incomplete data). Personality: MMPI (incomplete data). Ward observer measures: (incomplete data). |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomly assigned, no further details. |
Allocation concealment (selection bias) | Unclear risk | Procedure not described. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Double ‐ drugs dispensed in standard unmarked pink capsules no. 1 & 0 size, but treating ward physicians were aware of the various drugs and dosages involved in the study. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double ‐ drugs dispensed in standard unmarked pink capsules no. 1 & 0 size, but treating ward physicians were aware of the various drugs and dosages involved in the study. We conclude from this statement that raters were blinded. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 25% participants from the trifluoperazine group and 21% from the low‐potency group left the study early and were not included in the final analysis (completers only). |
Selective reporting (reporting bias) | High risk | MSRPP, MMPI, MACC (no usable data). Not all of the study´s prespecified outcomes have been reported (IMPS and PRP). |
Other bias | Unclear risk | Very short duration. |