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. 2019 Mar 19;2019(3):CD011847. doi: 10.1002/14651858.CD011847.pub2

Chanpattana 1999.

Methods Allocation: parallel, randomised
Blind: single‐blind to assessor
Setting: hospital (inpatient and outpatient), multicentre
Country: Thailand
Length of study: 26 months
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).
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
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)
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.