Li 2004b.
Study characteristics | ||
Methods | Parallel design Aim: to treat depression |
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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 |
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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 |
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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 |
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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 |