Giordana 1984.
Methods | Randomisation: randomised (participants were drawn by lots into two groups of treatment, with always 4 participants balanced). Blinding: double‐blind. Duration: 3 weeks. Design: parallel. Location: not indicated. Setting: inpatients and outpatients. |
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Participants | Diagnosis: paranoid schizophrenia (N = 16), hebephrenic schizophrenia (N = 5), simple schizophrenia (N = 5), dysthymic schizophrenia (N = 4). N = 30. Gender: male and female, no further details available. Age: mean 36.8 years. History: duration stable: not indicated, duration of illness: mean 11 years, number of previous hospitalisations: not indicated, age at onset: not indicated, severity of illness: mean BPRS at baseline 65, baseline antipsychotic dose: not indicated. |
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Interventions | 1. Haloperidol: flexible dose, dose range: "initial dose 15 mg/day", mean dose: not indicated. N = 15. 2. Pipotiazine: flexible dose, dose range: "initial dose 15 mg/day", mean dose: not indicated. N = 15. |
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Outcomes | Examined: Clinically important response to treatment: Global evaluation of the efficacy of both drugs. Mental state specific: Psychopathology according to the AMDP‐system (depersonalisation, conceptual disorganisation, delusional and hallucinatory syndrome). |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised (participants were drawn by lots into two groups of treatment, with always 4 participants balanced). |
Allocation concealment (selection bias) | Unclear risk | No further details. |
Blinding (performance bias and detection bias) (performance bias) | Low risk | “Double‐blind”. indistinguishable medication. |
Blinding (performance bias and detection bias) (detection bias) | Unclear risk | “Double‐blind”. No further details. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The study did not address this outcome; insufficient information to permit judgment concerning incomplete outcome data. |
Selective reporting (reporting bias) | Unclear risk | The outcome data were not fully addressed (no SDs were available regarding the hallucinatory syndrome measured by the AMDP system). |
Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias exists. |