Chanpattana 1999.
Methods |
Allocation: parallel, randomised Blind: single‐blind to assessor Setting: hospital (inpatient and outpatient), multicentre Country: Thailand Length of study: 26 months |
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Participants |
Diagnosis: treatment‐resistant schizophrenia (DSM‐IV) Total N at randomisation = 51 The following characteristics are based on completers (n = 45). Sex: male 21, female 24 Age (years): mean 32.7, SD 8.4 Length of illness (years): mean 11.9, SD 6.8 History: with acute psychotic exacerbation; no serious medical condition, as assessed by history, physical examination, and pertinent laboratory tests Exclusion criteria: known hypersensitivity to the medications used in modified ECT (thiopental sodium and succinylcholine). |
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Interventions |
ECT group (n = 15): ECT alone Content: the ECT devices were a MECTA SR1 and Thymatron DGx. The traditional bilateral electrode placement was used throughout. Flexibility was allowed to schedule each treatment within a 3‐day window. Participants who did not receive treatment within this window were considered early leavers Frequency: once a week for 1 month (4 treatments), then twice a week for 5 months (10 treatments) Course of treatment (ECT): 14 sessions Treatment duration: 6 months Control group A (n = 15): ECT + flupenthixol Content: ECT used same as above; the dosage schedule of flupenthixol was fixed after 8 weeks of beginning treatment: 12 mg/d during the first week and increased up to 24 mg/d depending on tolerability. Frequency: same as above for ECT, not stated for flupenthixol Treatment duration: 6 months Control group B (n = 15): Flupenthixol alone Content: the usage and dosage of flupenthixol was same as above. Frequency: not stated Treatment duration: 6 months |
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Outcomes | Mental state: assessed by BPRS, MMSE General functioning: assessed by GAF Unable to use: relapse (number for compared groups not reported); results of the parametric regression analysis of the relapse time (not predefined in the protocol) |
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Notes | Contact information: Department of Psychiatry, Srinakharinwirot University, Vajira Hospital, Samsen, Dusit, Bangkok 10300, Thailand | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "...were randomized to three treatment groups..." (p.182) 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 | Low risk | Quote: "Five psychiatric nurses served as raters, and they were blind to the treatment modality." (p.181) Comments: The blinding of outcome assessment was ensured. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comments: A total of 6 participants (11.8%) dropped out or withdrew consent due to fear of ECT or denial of illness. Intention‐to‐treat analysis was used, but the number of participants randomised to each group was not stated. Consequently, only completer data could be used. |
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. |