Cai 2008.
Methods |
Allocation: parallel, randomised Blind: not stated Setting: hospital (inpatient), single centre Country: China Length of study: 8 weeks |
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Participants |
Diagnosis: treatment‐resistant schizophrenia (CCMD‐3) Total N at randomisation = 100 Sex: male 57, female 43 Age (years): range 18 to 60 Length of illness (years): range 1 to 10 History: BPRS score > 50; received at least 3 types of resistance psychiatric drug therapy, of which at least 2 different classes of chemical structures; dose of each drug equivalent to chlorpromazine 600 mg/d or more, failure after more than 4 weeks of treatment, or failure after 4 weeks of treatment when receiving clozapine (≥ 450 mg/d) ('failure' was defined as the reduction rate of BPRS score ≤ 20%). Exclusion criteria: people with severe heart, liver, kidney disease, chronic body diseases, epilepsy, alcohol or drug abusers, MECT contraindications. |
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Interventions |
ECT group (n = 50): MECT + clozapine Content: participants who received clozapine before enrolment continued to use clozapine. Participants who received other antipsychotics before enrolment needed a 1‐week wash‐out period and then received clozapine. The initial dose of clozapine was 50 mg/d, increased to 50 to 100 mg/d alternate days. The maximum dose of clozapine was no more than 300 mg/d when combined with MECT. Frequency: 3 times a week for MECT, not stated for clozapine Course of treatment (MECT): 6 to 12 sessions Treatment duration: 8 weeks Control group (n = 50): Clozapine alone Content: the usage and dosage of clozapine was same as above. The maximum dose ranged from 300 mg/d to 700 mg/d. Frequency: not stated Treatment duration: 8 weeks |
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Outcomes | Response to treatment: clinically significant response to treatment* Mental state: assessed by BPRS Adverse events: assessed by TESS |
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Notes | *Clinically significant response assessed by the reducing score rate of BPRS: 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%. Clinically significant response to treatment was defined as cure + significant improvement. Contact information: Third People's Hospital of Yuebei, Lechang, Guangdong, 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.1423) 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: 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 were reported in results. |
Other bias | Low risk | None obvious. |