Heikkilä 1992.
Methods | Randomisation: “randomised”. Blinding: double‐blind. Duration: 8 weeks. Design: parallel. Location: four Finnish mental hospitals (multicentre). Setting: inpatients. |
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Participants | Diagnosis (38 completers of at least 4 weeks): chronic schizophrenia (N = 34), paranoid states (N = 2), reactive paranoid psychosis (N = 2). N = 49. Gender: 19M, 19F. Age: mean 36 years. 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: flexible dose, dose range: 2 mg to 30 mg/day, mean dose: 10.3 mg/day. N = 23. 2. Zuclopenthixol: flexible dose, dose range: 10 mg to 75 mg/day, mean dose: 33.5 mg/day. N = 26. “The doses were chosen on the basis of the condition of the patients.” “According to the protocol, the doses should be individually adjusted according to the patient´s response to treatment.” Rescue medication: “Biperiden could be prescribed in case of extrapyramidal side‐effects and nitrazepam or chloral hydrate could be given as a hypnotic.” |
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Outcomes | Examined: Clinically important response to treatment: “a slightly modified version of the Clinical Global Impressions Scale (CGI)”. Mental state general: 16‐item Brief Psychiatric Rating Scale (BPRS). Leaving the study early due to any reason. Adverse effects: use of antiparkinson medication. Unable to use: Global state general: CGI (modified version). Adverse effects: UKU Side‐Effekt Rating Scale (no information regarding the occurrence of adverse effects over the whole trial duration). |
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Notes | Study participants were 49 participants “with acute psychotic states” (38 completers of at least 4 weeks drug treatment). Criteria for study inclusion were “diagnosis of acute schizophrenia or an exacerbation of chronic schizophrenia, paranoid states or reactive paranoid psychosis” and a 16‐item BPRS total score >25. “All patients treated for at least 4 weeks were included in the statistical analyses of the results.” |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “Randomised”. No further details. |
Allocation concealment (selection bias) | Unclear risk | No further details. |
Blinding (performance bias and detection bias) (performance bias) | Low risk | “Double‐blind”. “tablets of identical appearance” |
Blinding (performance bias and detection bias) (detection bias) | Unclear risk | “Double‐blind”. No further details. |
Incomplete outcome data (attrition bias) All outcomes | High risk | The overall‐attrition was high: 38 of 49 participants (77.6%) left the trial early. The trial authors indicated that 18 of 23 participants (78.3%) in the haloperidol‐group and 20 of 26 participants (76.9%) in the zuclopenthixol‐group discontinued the drug treatment prematurely. |
Selective reporting (reporting bias) | Unclear risk | The reported adverse effects data were not usable for this systematic review. |
Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias exists. |