Li 2006.
Methods | Allocation: randomised. Blindness: single. Duration: 72 hours. |
|
Participants | Diagnosis: CCMD‐3 diagnosis of schizophrenia with agitation/aggression. N = 231. Age: mean 34 (SD 12) years. Sex: males and females. History: mean length of illness, haloperidol group 30 (± 68) months, ziprasidone 18 (± 35) months. Excluded: severe physical or neurological impairment/diseases; drug or alcohol abuse, dependence, pregnant women. Setting: not reported. |
|
Interventions | 1. Haloperidol: flexible dose 5 mg/IM to 10 mg/IM, repeated every 4‐6 hours if necessary, maximum dose 30 mg during 24 hours. N = 116. 2. Ziprasidone: flexible dose 10 mg/IM to 20 mg/IM, repeated every 4‐6 hours if necessary, maximum dose 40 mg during 24 hours. N = 115. |
|
Outcomes | Mental state: PANSS endpoint. Agitation: PANSS‐EC. Adverse effects: TESS. |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised ‐ method of randomisation is not reported. |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Single‐blind – however the author did not state who had been blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Single‐blind – however the author did not state who had been blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No incomplete data. |
Selective reporting (reporting bias) | Unclear risk | TESS and SAS were used for assessment of adverse events. No continuous data were reported from either scales, but binary outcomes for adverse events were reported. |
Other bias | Unclear risk | None obvious. |