Zimbroff 2007.
Methods | Allocation: random, computer‐generated, centre blocked Blindness: double, dummy administration. Duration: four weeks. Location: multicentre. | |
Participants | Diagnosis: schizophrenia or schizoaffective disorder (DSM‐IV). N = 256. Age: 18‐70 years. Gender: 169 M, 57 F. History: duration of illness not reported, age at onset not reported, hospitalised > 14 consecutive days prior to screening, PANSS ≥ 80, 4/more on 2+ PANSS positive items, score of ≥ 4 on CGI‐S Setting: inpatient. | |
Interventions | 1. Aripiprazole: dose 15 mg/day first 14 days, up to 30 mg/day thereafter, mean 21 mg/day (SD 7). N = 129. 2. Ziprasidone: dose 80 mg/day on first 14 days, up to 160 mg/day thereafter mean 149 mg/day ( SD 25): N = 127. | |
Outcomes | Leaving the study early.
Global state: CGI‐S.
Mental state: BPRS, PANSS.
Adverse effects: system‐specific effects, AIMS, BAS, SAS. Unable to use ‐ Global state: ORDQ. Mental state: CDSS (no numerical data). Adverse effects: SAS (reported as zero difference with P value ‐ not credible data), weight, glucose, blood lipids (median reported with no other data). Adverse effects: AIMS, BAS (P values, and numbers that did allow calculation of SD).* |
|
Notes | * These data, although possible to report, carried assumptions on numbers of people from which they were derived, identical SDs per group, normality of data on top of other assumptions usually associated with scale‐derived numbers. We feel that these are assumptions too far. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random, computer‐generated, blocked by centre. |
Allocation concealment (selection bias) | Unclear risk | No further details. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double, double dummy administration. Whether blinding was successful has not been examined, but both compounds have similar adverse effects. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Objective outcomes such as laboratory measures or death are unlikely to have been much affected by lack of blinding. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | LOCF method used to account for people leaving the study early. |
Selective reporting (reporting bias) | High risk | Only adverse events with an incidence of more than 5% were reported. This procedure may have missed important adverse events. CDSS and ORDQ ‐ no numerical data reported because"no statistically significant differences were observed. . ." AIMS, BAS, SAS were portrayed very differently to other scales ‐ allowing computation of data but not giving clear person‐based numbers for the ratings. |
Other bias | High risk | Random sequence generation (selection bias) |