Zhou 2014.
| Methods | Allocation: randomised. Blinding: not stated. Duration: 4 weeks*. |
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| Participants | Diagnosis: CCMD‐3 diagnosis of schizophrenia. N = 76. Age: range 16‐60 years. Sex: 39 males, 37 females. History: "excited/agitated symptoms of acute‐stage schizophrenia"; "length of Illness 1‐32 months". Excluded: "serious physical sickness, additive to alcohol and drugs, pregnant, history of taking long‐term schizophrenia medicine, suicide tendency and allergic to treatment". Setting: inpatients, China. |
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| Interventions | 1. Haloperidol: flexible dose 5 mg/IM/day to 30 mg/IM/day (mean dose 16.4 ± 6.1 mg/day). N = 38. 2. Ziprasidone: flexible dose 40 mg/oral/day to 160 mg/oral/day (mean dose 90.6 ± 20.8 mg/day) + clonazepam flexible dose 2 mg/oral/day to 6 mg/oral/day. N = 38. |
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| Outcomes | Mental state: PANSS total score, positive sub‐scale, negative sub‐scale, general psychopathology sub‐scale. Agitation: PANSS‐EC. Global outcome: CGI‐S. Leaving the study early. |
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| Notes | *Data were extracted only for the first 7 days because at the 8th day research group stopped clonazepam and switched from haloperidol to ziprasidone. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "randomised by using random number table". |
| Allocation concealment (selection bias) | Unclear risk | Not stated. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not stated. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | A total of 3 dropped out in haloperidol group (serious adverse events = 2, not following protocol = 1) and 2 dropped out in ziprasidone + clonazepam (lost to contact = 1, not following protocol = 1); missing data have not been imputed using appropriate methods such as LOCF. |
| Selective reporting (reporting bias) | Low risk | No evidence of selective reporting. |
| Other bias | Low risk | None obvious. |
ABS: Agitated Behaviour Scale ACES: Agitation‐Calmness Evaluation Scale AIMS: Abnormal Involuntary Movement Scale BARS: Behavioural Activity Rating Scale BAS: Barnes Akathisia Scale BDZ: benzodiazepine BPRS: Brief Psychiatric Rating Scale BRMS: CABS: Corrigan Agitated Behavior Scale CCMD: Chinese Classification of Mental Disorders CGI: Clinical Global Impression CGI‐I: Clinical Global Impression ‐ Improvement CGI‐S: Clinical Global Impression ‐ Severity CI: confidence interval COSTART: Coding Symbols and Thesaurus for Adverse Reaction Terms DAI‐10: Drug Attitude Inventory DSM: Diagnostic and Statistical Manual ECG: electrocardiogram EPS: Extrapyramidal Side Effects ESBE: GAS: Global Adjustment Scale ICD: International Classification of Diseases IM: intramuscular LOCF: last observation carried forward LS: MBPRS: Modified Brief Psychiatric Rating Scale NOSIE: Nurses Observation Scale for Inpatient Evaluation OAS: Overt Aggression Scale OASS: Overt Agitation Severity Scale PANSS: Positive and Negative Syndrome Scale PANSS‐EC: Positive and Negative Syndrome Scale Excited Component PANSS‐PAS: Positive and Negative Syndrome Scale Psychotic Agitation Component PANSS‐PES: p.o.: orally RSS: Ramsay Sedation Scale SAS: Simpson‐Angus Scale SD: standard deviation SE: standard error SGPT: serum glutamic pyruvic transaminase TCS: TESS: Treatment Emergent Symptom Scale TSRS: Target Rating Symptom Scale VAS: Visual analogue scale YMRS: Young Mania Rating Scale