Wang 2011.
Methods |
Allocation: parallel, randomised Blind: not stated Setting: hospital (inpatient), single centre Country: China Length of study: 12 weeks |
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Participants |
Diagnosis: treatment‐resistant schizophrenia (CCMD‐3) Total N at randomisation = 74 Sex: male 37, female 37 Age (years): mean 26.5, SD 10.2 Length of illness (years): mean 15.7, SD 12.8 History: failure after more than 3 types of antipsychotics (at least 2 types of antipsychotics with different chemical structure; each drug with full dose used more than 6 weeks, no significant improvement or response) over the last 5 years; PANSS score > 60. Exclusion criteria: patients with severe physical illness or mental retardation; alcohol or drug abuser. |
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Interventions |
ECT group (n = 37): MECT + clozapine Content: keep the same dose of clozapine as previous (mean dose: 325 ± 45 mg/d). The ECT device was Thymatron. Frequency: once daily for the first 3 days, then 2 to 3 times a week for ECT; not stated for clozapine Course of treatment (MECT): 12 sessions Treatment duration: 12 weeks Control group (n = 37): Clozapine alone Content: the usage and dosage schedule of clozapine was same as above. 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 Unable to use: Memory assessed by WMS (data for control group not reported) |
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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 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: wangzhuawuhu@126.com; Fourth People's Hospital, Wuhu, Anhui, China No reply. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "...were randomly assigned to receive..." (p.252) 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) | Unclear risk | Comments: The protocol is not available; all outcomes stated in methods reported in results. However, data for memory in the control group were not reported. |
Other bias | Low risk | None obvious. |