Kramer 1975.
Methods | Allocation: randomly assigned by block ‐ no further description. Blindness: double ‐ identical capsules. Duration: 4 weeks. Design: parallel. Country: USA. Setting: hospital. |
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Participants | Diagnosis: acute schizophrenia (presence of clinical symptoms according to BPRS). n = 90. Age: range 18 to 54 years, mean ˜ 33 years. Sex: 70 men, 20 women. History: newly admitted to hospital. Excluded: history of brain, cardiovascular, hepatic or renal disorders; history of alcoholism or drug addiction; mental retardation; history or clinical evidence of glaucoma. |
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Interventions | 1. Metiapine: range 25 mg/day to 600 mg/day, mean 219 mg/day. n = 30.* 2. Chlorpromazine: range 50 mg/day to 1200 mg/day, mean 427 mg/day. n = 30. 3. Combination of butabarbital + atropine: between butabarbital sodium 225 mg/day + atropine sulphate 0.26 mg/day and butabarbital sodium 180 mg/day + atropine sulphate 2.04 mg/day. Mean butabarbital sodium 78 mg/day + atropine sulphate 1.17 mg/day. n = 30. |
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Outcomes | Global state: clinical improvement (CGI), nurse's evaluation (change score NOSIE). Adverse effects: movement disorders, hepatic problems, 'severe reactions', cardiovascular problems. Leaving the study early. Unable to use: Mental state: BPRS (no SD). |
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Notes | * Only 5 of the metiapine participants, 1 of chlorpromazine participants and 1 of the butabarbital + atropine participants received maximal dosage. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "recently hospitalized schizophrenics who were randomized into three groups." "Patients were assigned in blocks of six, with two patients being assigned to each of the three groups." |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "a four‐week double‐blind study." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data were addressed in the study. Full‐analysis‐set, used to assess efficacy measures. All‐participants‐treated‐set, used to assess safety measures. |
Selective reporting (reporting bias) | Unclear risk | All expected outcomes reported, some means and SDs omitted. |
Other bias | Unclear risk | Metiapine supplied by Merrell‐National Laboratories. No source of funding reported. |