Wang 2005a.
| Methods | Allocation: randomised ‐ no further description Blinding: open label Duration: 4 weeks Design: not reported Country: China |
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| Participants | Diagnosis: CCMN‐3 schizophrenia, with aggressive behaviours according to scores of MOAS > = 4 n = 60. Sex: 35 M, 25 F Age: total range 18‐56 years, mean 32.2 ± 7.3 years History: mean duration of illness Settings: inpatients |
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| Interventions | 1. Antipychotics + magnesium valproate: magnesium valproate starting dose 400 mg/d, increased to 800‐1200 mg/d after 7 days; antipsychotic drugs same as before study entry; n = 30 2. Antipychotics + placebo: antipsychotic drugs same as before study; n = 30 | |
| Outcomes | Clinical response: mental state (BPRS total) negative symptoms (BPRS subscale), aggression/agitation (MOAS, BPRS subscale), depression (BPRS subscale) Adverse events: at least one adverse event, various events Unable to use: Leaving the study early: acceptability/tolerability of treatment (no information provided) Adverse events: TESS score (not reported) |
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| Notes | No information about blinding provided, assume open‐label Valproate group & monotherapy group no significant differences in demographic data |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "randomly divided" (p 10) |
| Allocation concealment (selection bias) | Unclear risk | Not indicated |
| Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | We don't think blinding causes significant bias in objective outcome. No information provided about blinding provided, assume open‐label. |
| Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | No information provided about blinding provided, assume open‐label |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | We don't think blinding causes significant bias in objective outcome. |
| Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | No information provided about blinding provided, assume open‐label |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not stated |
| Selective reporting (reporting bias) | High risk | TESS score measured but not reported |
| Other bias | Low risk | No other bias |