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. 2021 Nov 15;2021(11):CD009286. doi: 10.1002/14651858.CD009286.pub4

Li 2004b.

Study characteristics
Methods Parallel design
Aim: to treat depression
Participants Country: China
Setting: inpatient
Stroke criteria: ischaemic stroke, clinical diagnosis plus imaging confirmation (though not clear that a relevant lesion had to be seen), stroke onset time ≤ 7 days
Depression criteria: HAMD score ≥ 8
Treatment: 37 people, age 48 to 87 years, 17 men
Control: 36 people, age 53 to 82 years, 15 men
Exclusion: previous depression or psychiatric interview, dementia (according to MMSE scores), aphasia, severe cardiac, pulmonary, hepatic, renal function impairment, consciousness disturbance
Interventions Treatment: fluoxetine 20 mg daily plus usual stroke care
Control: usual stroke care
Duration: 8 weeks
Duration of follow‐up (treatment end to study end): 0
Outcomes HAMD
CSS (cannot use as reported as a categorical variable)
MMSE (reported as a dichotomous variable)
BI (reported as a dichotomous variable)
Data for continuous variables not provided
Death reported
Side effects in treatment group only reported, not control group. Method of reporting side effects not stated
Funding source Source of funding not stated
Notes Note that the sum of numbers in each category of HAMD at 8 weeks in the control group adds up to 30, not 32
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method not described
Allocation concealment (selection bias) Unclear risk Method not described
Blinding of participants and personnel (performance bias)
All outcomes High risk No placebo
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not stated
Incomplete outcome data (attrition bias)
All outcomes High risk Dropouts: 6 in treatment and 4 in control group. Total dropouts = 10/73 (14%)
Selective reporting (reporting bias) Unclear risk No protocol
Other bias Unclear risk Baseline balanced