Silverstone 1984.
Methods | Randomisation: “randomly allocated”. Blinding: double‐blind. Duration: 28 days. Design: parallel. Location: not indicated. Setting: inpatients. |
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Participants | Diagnosis: acute schizophrenia. N = 22. Gender: 11M, 11F. Age: mean 38.5 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: fixed/flexible dose: not indicated, dose range: not indicated, mean final dose: 22.2 mg/day. N = 12. 2. Pimozide: fixed/flexible dose: not indicated, dose range: not indicated, mean final dose 21.6 mg/day. N = 10. Rescue medication: i.m. chlorpromazine “when the clinical situation demanded”. “Extrapyramidal side effects were treated with procyclidine. Temazepam or nitrazepam was prescribed if night sedation was required.” |
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Outcomes | Examined: Leaving the study early due to any reason. Adverse effects: dystonia, tremor, use of antiparkinson medication, hypotension, sedation. Unable to use: Mental state general: Montgomery Rating Scale (MRS) (no SDs available and no imputation method could be applied). Leaving the study early due to adverse effects (data only for the haloperidol group available). |
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Notes | Study participants were “22 patients with acute schizophrenic illness” (18 completers). 8 participants with first episode. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “Randomly allocated”. No further details. |
Allocation concealment (selection bias) | Unclear risk | No further details. |
Blinding (performance bias and detection bias) (performance bias) | Low risk | “Double‐blind”. “pimozide or haloperidol in matching capsules”. |
Blinding (performance bias and detection bias) (detection bias) | Unclear risk | “Double‐blind”. No further details. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | There were 3 drop‐outs in the haloperidol‐group (25%), and 1 participant left the trial early in the pimozide‐group (10%). The overall‐attrition was 18.2% (4 of 22 participants). Altogether the attrition was moderate. The trial authors provided the results of the completers‐only analysis. |
Selective reporting (reporting bias) | High risk | The outcome data were not fully addressed (no SDs for the MRS). No usable data were provided in terms of premature discontinuation of the trial due to adverse effects. |
Other bias | High risk | Additional antipsychotic pharmacological treatment with i.m. chlorpromazine was allowed (used in 3 participants). |