Kariya 1983.
Methods | Randomisation: “assigned at random”. Blinding: double‐blind. Duration: 12 weeks. Design: parallel. Location: “multi‐clinic” (29 institutes). Setting: “mainly inpatients”. |
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Participants | Diagnosis: schizophrenia. N = 212. Gender (N = 206): 109M, 97F. Age: not indicated. History: duration stable: not indicated, duration of illness: not indicated, 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 method", dose range: maximum dose 18 mg/day, mean dose: not indicated. N = 106 (study completers). 2. Timiperone: "fixed‐flexible method", dose range: maximum dose 12 mg/day, mean dose: not indicated. N = 100 (study completers). Rescue medication: anti‐Parkinsonian and hypnotics were allowed. |
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Outcomes | Examined: Clinically important response to treatment: Global improvement rating. Adverse effects: at least one movement disorder, akathisia, dyskinesia, rigor. Unable to use: Mental state general: Keio University Psychiatric Symptoms Rating Scale (no raw data available). |
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Notes | Of the 212 participants “206 cases were finally subjected to the statistical analysis”. "The patients were relatively fresh cases with the clinical state of deficiency of initiative, blunted affect, hallucinations and delusions”. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “Patients were assigned at random to either the timiperone or the haloperidol group”. No further details. |
Allocation concealment (selection bias) | Unclear risk | No further details. |
Blinding (performance bias and detection bias) (performance bias) | Low risk | “Double‐blind”. “Both drugs were confirmed as being indistinguishable from each other, having an identical appearance, and identical colour shades and weights, by two controllers.” |
Blinding (performance bias and detection bias) (detection bias) | Unclear risk | “Double‐blind”. No further details. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | With missing data of 6 of the 212 randomised participants (2.8%), the overall attrition was rather low. The analyses were based on completers‐only data, but due to the small drop‐out rate, the risk of bias might be considered as being low. |
Selective reporting (reporting bias) | High risk | The numbers of participants randomised to each treatment group (haloperidol or timiperone) were not indicated. These data were only available for the completers of the trial. The outcome data were not fully addressed (no raw data for the Keio University Psychiatric Symptoms Rating Scale). No information regarding the number of participants that received a medication with antiparkinson drugs. |
Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias exists. |