Dieterle 1991.
Methods | Allocation: randomised ‐ no further details. Blindness: double ‐ identical capsules. Duration: 28 days. Raters: not stated to be independent of treatment. Design: single‐centre. | |
Participants | Diagnosis: schizophrenia (ICD‐9). Excluded: substance dependence, epilepsy, neurological diseases, hypotension, history of adverse events. N = 40. Sex: 27F, 13M. Age: mean ˜ 33 years (range: 20‐64). History: 16 participants were hospitalised for the first time. Setting: unclear. | |
Interventions | 1. Perazine: dose mean 350 mg/frequency not reported (SD 100, range 75‐675). N = 20. 2. Zotepine: dose mean 240 mg/frequency not reported (SD 70, range 50‐450). N = 20. | |
Outcomes | Leaving the study early.
Mental state: BPRS.
Adverse effects: vegetative side‐effects. Unable to use ‐ Global state: CGI (only P value). Mental state: SANS, AMDP (only P value). |
|
Notes | Jadad = 3 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomised" (p18) |
Allocation concealment (selection bias) | Unclear risk | Not indicated |
Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | "double blind"; "identical capsules" (p.18) |
Blinding of participants and personnel (performance bias) Subjective outcomes | Low risk | "double blind"; "identical capsules" (p.18) |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | "double blind" (p.18) |
Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | "double blind" (p.18) |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 50% dropout rate, not evenly distributed (12/20 and 8/20) |
Selective reporting (reporting bias) | High risk | No SDs for CGI, SANS |
Other bias | Low risk | No other bias |