Shalev 1993.
| Methods | Randomisation: randomly assigned, no further details. Allocation: treating psychiatrists were blind to the sequence in which the drugs were to be given to the patient. Blinding: not described, probably open. Duration: 4 weeks. Design: parallel (second part cross‐over). Location: single centre. Setting: inpatients. | |
| Participants | Diagnosis: chronic or subchronic schizophrenia (DSM‐III). N = 42. Gender: 35 F, 25 M. Age: mean 33 years. History: duration stable ‐ n.i., duration ill ‐ mean 4.8 years, number of previous hospitalisations ‐ mean 4.2, age at onset ‐ mean 28.2 years, severity of illness ‐ n.i., baseline antipsychotic dose ‐ n.i.. |
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| Interventions | 1. Perphenazine: flexible dose, allowed dose range n.i., mean dose = 35.8 mg/day (SD 11.4). N = 21. 2. Levomepromazine: flexible dose, allowed dose range n.i., mean dose 379 mg/day (SD 128). N = 21. Rescue medication: antiparkinson medication. | |
| Outcomes | Response to treatment: clinical judgement by psychiatrist. Unable to use: Mental state: BPRS (incomplete data, analysed by responders and non‐responders, not by medication). |
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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) | Low risk | "Treating psychiatrists were blind to the sequence in which the drugs were to be given to the patient." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not described, probably open. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Not described, probably open. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 15 participants left the study early but it is not mentioned how many from which drug group. |
| Selective reporting (reporting bias) | Low risk | No evidence for selective outcome reporting. |
| Other bias | Low risk | No evidence for other bias. |
General Abbreviations n.i. ‐ not indicated mg ‐ milligram M ‐ male F ‐ female SD ‐ standard deviation LOCF ‐ Last‐observation‐carried‐forward DSM ‐ Diagnostic and Statistical Manual of Mental Disorders EPS ‐ extrapyramidal symptoms
Rating scales BPRS ‐ Brief Psychiatric Rating Scale IMPS ‐ Inpatient Multidimensional Psychiatric Rating Scale MACC ‐ Behavioral Adjustment Scale MMPI ‐ Minnesota Multiphasic Personality Inventory MSRPP ‐ Multidimensional Scale for Rating Psychiatric Patients PRP ‐ Psychotic Reaction Profile PSTS ‐ Psychiatric Scale of Target Symptoms