Serafetinides 1972.
Methods | Randomisation: randomly assigned, no further details. Allocation: procedure not described. Blinding: double, all medications prepared in identically appearing capsules. Duration: 12 weeks. Design: parallel. Location: single centre. Setting: inpatients. | |
Participants | Diagnosis: chronic schizophrenia, clinical diagnosis. N = 28. Gender: 25 M, 32 F. Age: mean 41.5 years. History: duration stable ‐ n.i., duration ill ‐ mean 15 years, number of previous hospitalisations ‐ 10.5, age at onset ‐ mean 26.5 years, severity of illness ‐ n.i., baseline antipsychotic dose ‐ n.i., |
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Interventions | 1. Haloperidol: flexible dose, allowed dose range n.i., mean dose 12.3 mg/day. N = 14.
2. Chlorpromazine: flexible dose, allowed dose range n.i., mean dose 830 mg/day. N = 14. Other medication: concomitant medications for Parkinsonism, bedtime sedation. |
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Outcomes | Response to treatment: CGI Scale (no definition). Relapse. Leaving the study early. Adverse effects: at least one movement disorder, adverse effects ‐ other (ankle oedema, constipation, excitement, photosensitivity, sedation, weight gain, weight loss). Unable to use: Mental state: BPRS (incomplete data). Global state: CGI scale for Severity of Illness and Severity of Improvement (incomplete data). Behaviour: NOSIE, OBRS (all analysed by single items, no total score). Cognitive: Purdue Pegboard Test, Digit Symbol test (incomplete data) |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomly assigned, no further details. |
Allocation concealment (selection bias) | Unclear risk | Procedure not described. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double, all medications prepared in identically appearing capsules. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double, all medications prepared in identically appearing capsules. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 3 out of 14 participants in the CPZ group (21%) left the study early due to worsening and were not included in the final analysis (completers only). No participant from the HAL group left the study early. |
Selective reporting (reporting bias) | High risk | Incomplete data for BPRS, NOSIE and OBRS (no SD´s). |
Other bias | Low risk | No evidence for other bias. |