Lu 2006.
| Methods | Allocation: randomised Blinding: open label Duration: six weeks Design: not reported Country: China |
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| Participants | Diagnosis: CCMD‐3 schizophrenia (CCMD‐3) and schizoaffective disorder with excitement and agitation (schizophrenia: n = 78, schizoaffective disorder: n = 12) n = 90 Sex: 78 M, 12 F Age: mean 34.8 ± 13.8 years Setting: inpatient |
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| Interventions | 1. Sodium valproate + routine antipsychotic mediation: atypical antipsychotics titrated to target dose within 7‐10 days, mean dose: clozapine 308 ± 54 mg/d, olanzapine 12.6 ± 5.9 mg/d, risperidone 4.4 ± 0.81 mg/d, quetiapine 786 ± 221 mg/d; Depakine titrated to 1‐1.5 g/d within 5 days, mean dose 1.01 ± 0.46 g/d; n = 43 2. Routine antipsychotic medication: atypical antipsychotics titrated to target dose within 7‐10 days, mean dose: clozapine 366 ± 71 mg/d, olanzapine 15.2 ± 8.8 mg/d, risperidone 4.9 ± 0.80 mg/d, quetiapine 842 ± 263 mg/d; n = 47 |
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| Outcomes | Clinically significant response: important change Leaving the study early: acceptability/tolerability of treatment Clinical response: mental state (BPRS total), aggression/agitation (PANSS‐EC sub scale) Adverse events: various events Unable to use: Adverse events: TESS scores (no means and SDs reported) |
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| Notes | Valproate group and monotherapy group did not differ significantly in sex, age, schizophrenia subtypes (P > 0.05) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "randomly assigned", p1291 |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | We don't think blinding causes significant bias in objective outcomes |
| Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | No information 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 outcomes |
| Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | No information about blinding provided, assume open‐label |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Attrition was unaccounted for in the final analysis Valproate group 2 (out of 43), monotherapy group 8 (out of 47), no significant difference (P > 0.05) However, 2/43 = 4.6% BUT 8/47 = 17%. Also, due to inefficacy, it is 1/43 vs 6/47 Authors stated that they would use ITT in methods section but in analysis they used completers not ITT |
| Selective reporting (reporting bias) | High risk | TESS scores measured but no means and SDs reported |
| Other bias | Low risk | None obvious |