Bailine 1987.
Methods | Allocation: randomised. Blindness: blind for some outcomes. Duration: 72 hours. |
|
Participants | Diagnosis: Research Diagnostic Criteria (11) diagnosis of schizophrenia, any type, or manic depressive illness, manic type and grossly abnormal behavior. N = 34. Age: mean 25.2 years. Sex: 26 males, 8 females. History: "violent or assaultive or too psychologically disorganized to be maintained on a unit without significant extra supervision." (p.128). Excluded: not reported. Setting: inpatient, USA. |
|
Interventions | 1. Haloperidol IM: dose 5 mg or 10 mg/IM, maximum cumulative dose of 100 mg during 24 hours (mean number of IMs not reported). N = 20. 2. Chlorpromazine IM: dose 50 mg or 100 mg/IM, maximum cumulative dose of 500 mg during 24 hours (mean number of IMs not reported). N = 14. |
|
Outcomes | Adverse events: leaving the study early. Unable to use: Mental state: BPRS (mean and overall P value only for significant findings reported, SD/SE/CI not reported). Global state: GAS (not published, mean and overall P value only for significant findings reported, SD/SE/CI not reported). Global state: NOSIE (overall P value only for significantly findings reported, mean/SD/SE/CI not reported). Adverse events: SAS (overall P value only for significantly findings reported, mean/SD/SE/CI not reported). |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "random number sequence". |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not stated. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | BPRS was rater‐blinded. However, it is not clear whether other outcomes were blinded. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | It is reported that no one discontinued due to adverse effects, however it does not state if there were discontinuations due to any other reason. |
Selective reporting (reporting bias) | High risk | Only the significant findings/factors are reported for a number of outcomes. |
Other bias | High risk | Small short study. |