Diazepam 1979, IL.
Study characteristics | ||
Methods | Allocation: randomised. Blinding: double blind. Design: not stated. Duration: 24 hours. Setting: Eitanim Psychiatric Hospital, Israel. |
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Participants | Diagnosis: paranoid schizophrenia (n = 9), schizoaffective schizophrenia (n = 9), schizophrenia subtypes (n = 5), paranoid states (n = 2), mania (n = 5), no diagnosis (n = 10). n = 40. Age: 20‐49 years (mean 33 years). Gender: 27 men, 13 women. Ethnicity: not stated. Consent: not stated. History: previous hospitalisation (mean 3 instances). Inclusion criteria: newly admitted psychotic people aged 20‐50 years after 2 days of drug‐free observation. Exclusion criteria: physical illness. |
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Interventions | Benzodiazepines vs antipsychotics. 1. Diazepam 30‐40 mg IV (n = 20). 2. Haloperidol 20‐35 mg IV (n = 20). In the haloperidol group, 10 participants received high‐dose haloperidol and 10 participants received moderately high‐dose haloperidol; these scores were analysed together. Doses were given over a 3‐hour period. All participants were free from neuroleptics for 48 hours before the study began. |
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Outcomes | Global impression: sedation; mean score (CGI). Mental state: mean score (BPRS). | |
Notes | Note: assumptions were made regarding missing SDs data ‐ SDs for the CGI‐S and BPRS mean scores were estimated from the range. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised "patients were randomly assigned" to treatment ‐ no further description provided. |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Observer blind ‐ it is unclear how trial authors remained blinded to alternation and decrease of haloperidol dosage. Rating scales: BPRS and CGI were performed by consensus of 2 physicians (trial authors EL and YL), who were "unaware of the treatment administered." |
Incomplete outcome data (attrition bias) All outcomes | High risk | Follow‐up: 50%. Reasons for dropout were reported; 16 due to treatment and 4 due to 'raters' being unavailable. |
Selective reporting (reporting bias) | Low risk | All measure outcomes were reported. |
Other bias | Low risk | Funding: supported by a grant from the Gralnick Foundation, High Point Hospital, Port Chester, NY. We did not detect any other bias. |