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. 2016 Nov 24;2016(11):CD004028. doi: 10.1002/14651858.CD004028.pub4

Hesslinger 1999.

Methods Allocation: randomised
Blinding: single (rater blind)
Duration: 4 weeks (4‐day wash‐out)
Design: not reported
Country: Germany
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
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)
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