Tobin 1980.
Methods | Randomisation: implied randomisation. Blinding: double‐blind. Duration: 12 weeks. Design: parallel. Location: not indicated. Setting: outpatients. |
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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. |
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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.” |
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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”). |
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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).” |
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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.” |