Liang 2004.
| Methods | Allocation: randomised Blinding: open label Duration: 4 weeks Design: parallel Country: China |
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| Participants | Diagnosis: CCMD‐3 schizophrenia n = 42 Sex: 31 M, 11 F Age: mean 37.85 ± 11.8 years History: mean duration of illness 5.3 ± 4.6 years Setting: inpatient |
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| Interventions | 1. Sodium valproate + routine antipsychotic medication: sodium valproate dosage = 600 mg/d, antipsychotic drugs mean dose 385 ± 119 mg/d; n = 21 2. Routine antipsychotic: antipsychotic drugs mean dose 390 ± 120 mg/d; n = 21 |
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| Outcomes | Clinically significant response: important change (PANSS reduction) Clinical response: mental state (PANSS total), positive symptoms, general pathology (PANSS subscales) Adverse events: various events Unable to use: Clinical response: mental state ‐ PANSS negative subscale (skewed data) Leaving the study early (no information provided) Adverse events: TESS score no means and SDs reported) |
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| Notes | Another paper (Ma 2010) with identical data as Liang 2004 was not included in the data analysis, the 2 references were combined and letters for clarification were sent to both study authors Valproate group & monotherapy group were not significantly different in sex, age, duration of illness and PANSS score (P > 0.05) Every participant received only one antipsychotic drug. In total there were 12 chlorpromazine, 10 clozapine, 10 risperidone, 4 perphenazine, and 6 haloperidol; participants continued with the same antipsychotic drug as they were given before study entry Valproate group & monotherapy group did not differ significantly in the mean dose of antipsychotic drugs (P > 0.05) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "randomly assigned", p151 |
| 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 outcome. |
| Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | No details 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 details 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 was measured, but not reported. Study authors only stated that there was no difference between groups on TESS score, but the actual measurements were not reported. Authors also selectively reported binary outcomes of a few adverse events, but didn't provide numbers for all adverse events |
| Other bias | Low risk | None obvious |