Zhang 2012.
Methods |
Allocation: parallel, randomised Blind: not stated Setting: hospital (inpatient) Country: China Length of study: 8 weeks |
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Participants |
Diagnosis: treatment‐resistant schizophrenia (CCMD‐3) Total N at randomisation = 84 Sex: male 37, female 47 Age (years): mean 38.4, SD not stated Length of illness (years): mean 18.6, SD not stated History: PANSS > 60; failure after 3 types of antipsychotics (at least 2 types of antipsychotics with different chemical structure) over the last 5 years. Exclusion criteria: patients with severe physical, organic brain disease; alcohol or drug abusers; patients with mental retardation or chronic decline schizophrenia; MECT contraindications. |
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Interventions |
ECT group (n = 42): MECT + olanzapine Content: the initial dose of olanzapine was 5 mg/d, increased to therapeutic dose (no more than 20 mg/d). The mean dose of olanzapine was 15.3 mg/d. On the day MECT was administered, olanzapine therapy was stopped at noon. The ECT device was Thymatron. Frequency: for ECT, 3 times a week for the first 4 weeks, then once a week for another 4 weeks; for olanzapine, twice daily Course of treatment (MECT): 16 sessions Treatment duration: 8 weeks Control group (n = 42): Olanzapine alone Content: the initial dose of olanzapine was 10 mg/d, increased to therapeutic dose (no more than 25 mg/d). The mean dose of olanzapine was 18.5 mg/d. Frequency: twice daily Treatment duration: 8 weeks |
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Outcomes | Response to treatment: clinically significant response to treatment* Mental state: assessed by PANSS Adverse events: assessed by TESS |
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Notes | *Clinically significant response according to the Chinese evaluation criteria for clinical efficacy of mental illness (Weng 1991, "Concise psychiatry"): 1) cure: reducing rate ≥ 75%; 2) significant improvement: reducing rate between 50% and 74%; 3) improvement: reducing rate between 25% and 49%; 4) no clinical response: reducing rate < 25%. The clinically significant response to treatment was defined as cure + significant improvement. Contact information: Brain III Department of People's Liberation Army 261 Hospital, Beijing, China |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "...were divided randomly into two groups..." (p.141) Comments: The author described a random component in the sequence generation process, but no details were provided on randomisation method. |
Allocation concealment (selection bias) | Unclear risk | Comments: The author did not describe the allocation concealment. Insufficient information to permit judgement of 'low risk' or 'high risk'. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comments: The participants and personnel could not be blinded as 1 group did not use ECT, and no sham‐ECT was used. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comments: The author did not describe the blinding of outcome assessment. Insufficient information to permit judgement of 'low risk' or 'high risk'. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comments: No missing outcome data. |
Selective reporting (reporting bias) | Low risk | Comments: The protocol is not available; all outcomes stated in methods reported in results. |
Other bias | Low risk | None obvious. |
BPRS: Brief Psychiatric Rating Scale (lower is better); CCMD: Chinese Classification of Mental Disorders; CGI‐I: Clinical Global Impression ‐ Improvement scale (lower is better); CGI‐S: Clinical Global Impression ‐ Severity scale (lower is better); DSM: Diagnostic and Statistical Manual of Mental Disorders; ECT: electroconvulsive therapy; GAF: Global Assessment of Functioning (higher is better); HAM‐D: Hamilton Depression Rating Scale (lower is better); ICD‐10: International Statistical Classification of Diseases and Related Health Problems 10th Revision; ITT: intention‐to‐treat; MECT: modified electroconvulsive therapy; MMSE: Mini‐Mental State Examination (higher is better); PANSS: Positive and Negative Syndrome Scale (lower is better); SANS: Scale for Assessment of Negative Symptoms (lower is better); SAPS: Scale for Assessment of Positive Symptoms (lower is better); SD: standard deviation; TESS: Treatment Emergent Symptom Scale (lower is better); WCST: Wisconsin Card Sorting Testing (lower is better); WMS: Wechsler Memory Scale (higher is better); WMS‐MQ: Wechsler Memory Scale ‐ Memory quotient (higher is better)