Wetzel 1991.
| Methods | Allocation: randomised ‐ no further details. Blindness: double ‐ no further details. Raters: not stated to be independent of treatment. Design: single‐centre. | |
| Participants | Diagnosis: schizophrenia 'with positive symptoms' (ICD‐9). Excluded: people with substance dependence, epilepsy, pregnancy, organic psychoses, relevant other diseases or people currently treatment with depot antipsychotics. N = 41. Sex: 16M, 25F. Age: mean ˜ 40 years. History: not indicated. Setting: hospital. | |
| Interventions | 1. Perazine: dose starting at 50 mg/day then flexible dose (max. 900 mg/day). N = 21.
2. Zotepine: dose starting at 100 mg/day, then flexible dose (max. 600 mg/day). N = 20. Chloralhydrate (sleep medication), flurazepam, diazepam and biperiden (anticholinergic) were allowed as concomitant medication. |
|
| Outcomes | Leaving the study early.
Global state: GAS.
Mental state: BPRS.
Extrapyramidal side effects.
Vital signs: EEG, ECG, laboratory. Unable to use ‐ Mental state: AMDP, FSCL‐NL, FSUCL (no mean or no SD, or no usable data). Global state: CGI (no usable data). Adverse effects: AIMS, Gerlach scale (no mean or no SD). |
|
| Notes | Jadad = 3 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | randomized ("Zufallsprinzip") (p.24) |
| Allocation concealment (selection bias) | Unclear risk | Not indicated |
| Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | "Double blind" (p.23) |
| Blinding of participants and personnel (performance bias) Subjective outcomes | Unclear risk | "Double blind" (p.23) |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | "Double blind" (p.23) |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | "Double blind" (p.23) |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 20% dropout rate, not evenly distributed (3/21 and 5/20) |
| Selective reporting (reporting bias) | High risk | No SDs or mean values provided |
| Other bias | Low risk | No other bias |
General abbreviations: HPL = haloperidol EPS = extrapyramidal side‐effects. M = males F = females N = number mg = milligram SD = standard deviation ECG = electrocardiogram EEG = electroencephalogram
Diagnostic tools: DSM‐III‐R = Diagnostic and Statistical Manual of Mental disorders, third edition, revised ICD‐9 = International Classification of Diseases, ninth revision
Global effect scales: CGI = Clinical Global Impression (Guy 1976) GAS = Global Assessment of Symptoms Scale (Endicott 1976)
Mental state scales: AMDP = Arbeitsgemeinschaft für Methodik und Dokumentation in der Psychiatrie (AMDP 1981) BPRS = Brief Psychiatric Rating Scale (Overall and Gorham 1970) FSCL‐NL = Collegium Internationale Psychiatricae Scalarum, CIPS 1986 FSUCL = Collegium Internationale Psychiatricae Scalarum, CIPS 1986 SANS = Scale for Assessment of Negative Symptoms (Andreasen 1989)
Adverse effects scales: AIMS = Abnormal Involuntary Movement Scale (Guy 1976) EWL = Eigenschaftswörterliste (Janke 1977) Gerlach Scale (Gerlach 1983) NGI = (no reference) SAS = Simpson and Angus Scale (Simpson and Angus 1970) Webster Scale (no reference)