Guo 2007.
| Methods | Allocation: randomised Blinding: open Duration: 2 weeks Design: Parallel Country: China |
|
| Participants | Diagnosis: CCMD‐3 schizophrenia, with excitement and agitation symptoms n = 60 Sex: 40 M, 20 F Age: range 18‐60 years, mean 34.5 ± 2.4 years History: duration of illness (total) ‐ mean 4.75 ± 0.6 years Setting: inpatient |
|
| Interventions | 1. Magnesium valproate + quetiapine: valproate 0.5‐1 g/d, mean dose 0.8 g ± 5.7 mg/d, maximum 1.0 g/d, quetiapine 100‐800 mg (517 ± 4 mg/d); n = 30 2. Haloperidol: IM. injection, 5‐30 mg/d (15.8 ± 3.8 mg/d); n = 30 Co‐medication: 11 participants in valproate group given IM injection of clonazepam 1‐2 mg/d |
|
| Outcomes | Clinically significant response: important change (PANSS reduction) Clinical response: aggression/agitation (PANSS subscale) Use of additional medication Unable to use: Leaving the study early: (no information provided) Clinical response: global state ‐ CGI (data not reported) Adverse events: TESS (data not reported) |
|
| Notes | Valproate group & monotherapy group do not differ significantly in demographic data (P > 0.05) Quetiapine initial dose 100 mg/day; valproate initial dose 0.5 g/day; haloperidol days 1‐3, 5‐10 mg/d, and days 4‐7, 10‐30 mg/d |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "randomly assigned", p183 |
| 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 | "opening", personnel and participants not blinded |
| 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 | Unclear risk | Not stated |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not stated |
| Selective reporting (reporting bias) | High risk | CGI, TESS score were measured, but not reported |
| Other bias | Low risk | None obvious |