Kulkarni 1972.
Methods | Allocation: randomised. Blindness: double‐blind (but it was not possible to disguise the drugs). Duration: 72 hours. Setting: hospital. |
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Participants | Diagnosis: schizophrenia. N = 182. Age:14‐76 years. Sex: male and female. History: uncooperative, aggressive, agitated, hyperactive, and unmanageable behaviour. Excluded: condition is a result of acute alcoholism or drug addiction were excluded. Evidence or a history of kidney or liver dysfunctions. |
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Interventions | 1. Chlorpromazine (liquid form): initial dose of 25 mg/ml (N = 92). 2. Piperacetazine (liquid form): initial dose of 2 mg/ml (N = 90). |
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Outcomes | Global state: clinically important change (psychiatrist‐rated), improved (CGI). Global state: improvement due to the first injection (this outcome was reported for a sample of 26 participants). Mental state: improved (BPRS, TSRS). Leaving the study early due to adverse effects. Adverse effects: specific. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “using a randomization scheme” |
Allocation concealment (selection bias) | Unclear risk | Further information regarding allocation concealment not provided |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: “all other measures were taken to maintain a double‐blind status. The rating physicians and the nurses were blinded from the identity of the assigned medication, but the patients were not blind because the drugs were not disguisable.” |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: “all other measures were taken to maintain a double‐blind status. The rating physicians and the nurses were blinded from the identity of the assigned medication.” |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data and attrition addressed and reported |
Selective reporting (reporting bias) | Low risk | All prestated outcomes are reported. |
Other bias | Unclear risk | Source of funding not reported |