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. 2015 Jan 16;2015(1):CD009831. doi: 10.1002/14651858.CD009831.pub2

Tobin 1980.

Methods Randomisation: implied randomisation.
Blinding: double‐blind.
Duration: 12 weeks.
Design: parallel.
Location: not indicated.
Setting: outpatients.
Participants Diagnosis: paranoid schizophrenia (N = 33), schizoaffective schizophrenia (N = 7), undifferentiated schizophrenia (N = 5), hebephrenic schizophrenia (N = 3), catatonic schizophrenia (N = 2).
N = 50.
Gender: 18M, 32F.
Age: mean 32.5 years.
History: duration stable: not indicated, duration of illness: range 6 months to 42 years, number of previous hospitalisations: not indicated, age at onset: not indicated, severity of illness: not indicated, baseline antipsychotic dose: not indicated.
Interventions 1. Haloperidol: fixed/flexible dose: not indicated, dose range: 1 mg to 15 mg/day, mean dose: ˜ 4 mg/day. N = 25.
2. Thiothixene: fixed/flexible dose: not indicated, dose range: 2 mg to 30 mg/day, mean dose: ˜ 8 mg/day. N = 25.
“doses required to control symptoms based on clinical judgement. Various regimens were prescribed.”
Rescue medication: “Antiparkinsonian agents were given as required to control extrapyramidal reactions.”
Outcomes Examined:
Clinically important response to treatment: Global rating.
Mental state general: Brief Psychiatric Rating Scale (BPRS) (no SDs available).
Leaving the study early due to any reason.
Leaving the study early due to inefficacy of treatment.
Adverse effects: at least one adverse effect, akathisia, dyskinesia, dystonia, rigor, tremor, weight gain.
Unable to use:
Mental state general: Adaptation of the Katz Adjustment Scales (not published adaptive version of this rating scale).
Functioning: Evaluation of Social Functioning Rater (ESFR) (“was found unsatisfactory as an adequate measure of social functioning”).
Notes Exclusively outpatients included. “They were admitted to the study only if they had three or more of the following signs of schizophrenia: flat affect, thought disorder, delusions, auditory hallucinations, or catatonia.”
Baseline antipsychotic dose: 16 of the 50 participants “had been treated previously with psychotropic medications. Only 3 of the 16 had received antipsychotic compounds (not haloperidol or thiothixene).”
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No randomisation mentioned in the publication, but the trial was described as “double‐blind.” Thus it was implied that the study was randomised.
Allocation concealment (selection bias) Unclear risk No further details.
Blinding (performance bias and detection bias) 
 (performance bias) Low risk “Double‐blind”. “The test medications were supplied in identical capsules.” “Only the dispenser knew the actual drug assignment. And the primary investigator remained blind until all the analyses were completed.”
Blinding (performance bias and detection bias) 
 (detection bias) Low risk “Double‐blind”. “Only the dispenser knew the actual drug assignment. And the primary investigator remained blind until all the analyses were completed.”
Incomplete outcome data (attrition bias) 
 All outcomes High risk “Thirty‐six of the 50 patients completed the study.” Thus the overall attrition can be considered as being high: 28% (14 of 50 participants). 6 of 25 participants (24%) in the haloperidol group left the trial early and 8 of 25 participants (32%) in the bromperidol‐group. Modified completers‐only analyses were used.
Selective reporting (reporting bias) High risk Outcome data were not fully reported (no SDs for the BPRS; no usable results concerning the Katz Adjustment Scales). Data regarding the number of participants receiving rescue medication were missing.
Other bias High risk “44 patients had a history of psychiatric illness not necessarily diagnosed as schizophrenia.” “In one patient in each group, treatment was discontinued because of akathisia and was resumed when the akathisia abated.”