Chen 2012.
Methods |
Allocation: parallel, randomised Blind: not stated Setting: hospital (inpatient and outpatient), single centre Country: China Length of study: 12 weeks |
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Participants |
Diagnosis: treatment‐resistant schizophrenia (CCMD‐3) Total N at randomisation = 71 Sex: male 39, female 32 Age (years): mean 31.88, SD 9.2 Length of illness (years): mean 16.1, SD 11.6 Inclusion criteria: failure after 3 types of antipsychotics (at least 2 types of antipsychotics with different chemical structure; equivalent dose of chlorpromazine more than 600 mg/d, each drug used more than 6 weeks, no significant improvement or response) over the last 5 years; social adaptation dysfunction: PANSS score > 60. Exclusion criteria: people with severe physical or brain illness; alcohol or drug abusers. |
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Interventions |
ECT group (n = 36): MECT + clozapine Content: the mean dose of clozapine was 275 ± 25 mg/d when combined with MECT. The dosage of clozapine was 1/2 to 2/3 times that of 'clozapine alone' group. The ECT device was Thymatron. Participants did not receive benzodiazepines, antiepileptic drugs, haloperidol, or other treatment. Frequency: for MECT, 3 times a week (for first 3 weeks), then twice a week for the other weeks; not stated for clozapine Course of treatment (MECT): 12 sessions Treatment duration: 12 weeks Control group (n = 35): Clozapine alone Content: the mean dose of clozapine was 355 ± 65 mg/d. Frequency: not stated Treatment duration: 12 weeks |
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Outcomes | Response to treatment: clinically significant response to treatment* Mental state: assessed by PANSS Adverse events |
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Notes | *Clinically significant response assessed by the reducing score rate of PANSS: 1) cure: reducing rate ≥ 75%; 2) significant improvement: reducing rate between 50% and 75%; 3) improvement: reducing rate between 25% and 49%; 4) no clinical response: reducing rate < 25%. The clinically significant response to treatment defined as cure + significant improvement. Contact information: Shihezi Oasis Hospital, Shihezi, Xinjiang, 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.58) 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. |