He 2004.
Methods | Parallel group Analysis: according to treatment allocation |
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Participants | Location: China Setting: inpatient Inclusion criteria: all pathological types of stroke, clinical diagnosis plus confirmation by imaging (did not state that a visible lesion was needed to make the diagnosis), first ever stroke Depression diagnosis: 'HAMD scores'. Translation of paper: did not have to have depression at recruitment Treatment: 36 people, mean age 70.8 ± 6.7 years, 25 men Control: 35 people, mean age 70.4 ± 6.8 years, 23 men Exclusion: psychiatric disorders, dysphasia, consciousness disturbance, agnosia, severe dementia |
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Interventions | Treatment: fluoxetine 20 mg daily plus usual stroke care Control: usual stroke care Duration of treatment: 8 weeks Duration of follow‐up (treatment end to study end): 0 |
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Outcomes | HAMD SSS No description of how side effects were collected |
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Funding source | Funded by local scientific academic fund | |
Notes | Reported that there were no AEs, so we have assumed no seizures or GI side effects | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No placebo |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Outcome assessors blind" |
Incomplete outcome data (attrition bias) All outcomes | High risk | 13 dropped out after randomisation |
Selective reporting (reporting bias) | Unclear risk | No protocol |
Other bias | Low risk | Balanced baseline, no obvious risks |