Mu 2010.
Methods | Allocation: Simple randomisation. Blindness: unclear. Duration: one week wash‐out period + eight weeks intervention. Design: parallel. Setting: inpatient, China. |
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Participants | Diagnosis: schizophrenia (CCMD‐3), BPRS total score of 35 or more.
N = 258, complete study: N=257. Age: aripiprazole group: mean = (38.12 ± 10.34) years; risperidone group: mean = (39.56 ± 10.67) years. Gender: aripiprazole group: 58 male, 71 female; risperidone group: 61 male, 66 female. History: aripiprazole group: mean = (6.92 ± 4.18) years; risperidone group: mean = (7.48 ± 4.37) years. Age at onset not reported. |
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Interventions | 1. Aripiprazole: Dose range: 5‐30 mg/day. Mean = (22.5 ± 3.6) mg/day. N = 129. 2. Risperidone: Dose range: 1‐6 mg/day. Mean = (3.7 ± 1.7) mg/day. N = 129. | |
Outcomes | Global state: BPRS score decreased rate (recovery: ≥ 75%, markedly improved: 50%‐74%, improved: 25%‐49%, no effect: < 25%). Mental state: BPRS total score. Leaving the study early. Adverse effects. Unable to use ‐ BPRS and TESS subscale scores ‐ unvalidated subscales. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Simple randomisation. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear if outcome was assessed blindly. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Two cases lost in risperidone group because of lactation. |
Selective reporting (reporting bias) | High risk | Data on blood and urine routine, ECG, liver function, use of benzodiazepines and other medicines were missing. |
Other bias | Low risk | None obvious. |