Hesslinger 1999.
Methods | Allocation: randomised Blinding: single (rater blind) Duration: 4 weeks (4‐day wash‐out) Design: not reported Country: Germany |
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Participants | Diagnosis: ICG‐10 schizophrenia and schizoaffective disorder, acute exacerbation within the last 7 days n = 27* Sex: no information Age: no information History: no evidence of serious medical conditions, substance abuse, organic psychosis, use of depot neuroleptics, antiepileptic drugs or serotonin reuptake inhibitors 3 months prior to trial Setting: inpatient |
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Interventions | 1. Haloperidol: mean dose 15.5 mg/d; n = 9 2. Haloperidol + valproate: haloperidol mean dose 15.5 mg/d, valproate dose 757.1 mg/d, target plasma level 50‐100 µg/ml; n = 9 3. Haloperidol + carbamazepine: haloperidol mean dose 15.5 mg/day, carbamazepine mean dose 567.3 mg/day, target plasma level 6‐12 µg/ml; n = 9* | |
Outcomes | Leaving the study early: acceptability/tolerability of treatment Clinical response: mental state (IMPS), positive symptoms (PANSS subscale) Unable to use: Use of additional medication: (skewed data) |
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Notes | *Data from intervention group 3 were not used for this review | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomly assigned" (p 311) |
Allocation concealment (selection bias) | Unclear risk | "sealed envelopes" |
Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | "psychiatrist (...) was blind to medication and drug levels. However, he had access to the nursing charts" (p 311). People with schizophrenia were not aware of the treatment (information received by letter) |
Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | "psychiatrist (...) was blind to medication and drug levels. However, he had access to the nursing charts" (p 311). People with schizophrenia were not aware of the treatment (information received by letter) |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | "psychiatrist (...) was blind to medication and drug levels. However, he had access to the nursing charts" (p 311). People with schizophrenia were not aware of the treatment (information received by letter) |
Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | "psychiatrist (...) was blind to medication and drug levels. However, he had access to the nursing charts" (p 311). People with schizophrenia were not aware of the treatment (information received by letter) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No participants left the study early. |
Selective reporting (reporting bias) | Low risk | No selective reporting |
Other bias | Low risk | No other bias |