Feng 2004.
| Study characteristics | ||
| Methods | Aim: to study the influence of Jieyu Huoxue decoction on rehabilitation of patients with depression after cerebral infarction | |
| Participants | Country: China 4 groups: fluoxetine plus usual care, Jieyu Huoxue decoction plus usual care, usual care in people with depression, usual care in people with no depression We are using data from 'fluoxetine plus usual care' versus 'usual care in people with depression' Setting: mixed inpatient and outpatient Stroke criteria: ischaemic stroke within 1 month of stroke onset, clinical diagnosis plus confirmation by imaging. Did not state whether a visible lesion was needed to make a diagnosis Depression: psychiatric interview using DSM IV, Zung SDS ≥ 41 Included those with no previous psychiatric history 54 participants with post‐stroke depression were randomised 18 received fluoxetine plus usual care, 18 received usual care only and 18 received Jieyu Huoxue decoction Of the 54 participants with depression randomised, mean age: 71.5 ± 6.7 years, 24 men Excluded: previous stroke, previous depression, and severe cardiac, pulmonary, hepatic and renal diseases |
|
| Interventions | Treatment: fluoxetine 20 mg daily plus usual stroke care Control: usual stroke care Duration of treatment: 60 days Duration of follow‐up (post‐treatment to study end): 0 weeks |
|
| Outcomes | Zung SDS ADL: although score not referenced, so not used in analysis MESSS Reported side effects in fluoxetine group but not in the control group Unclear how side effects were collected |
|
| Funding source | Funding source not stated | |
| Notes | − | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method not stated |
| Allocation concealment (selection bias) | Unclear risk | No description |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No placebo |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 8 participants dropped out (2 in fluoxetine group, 2 in the depression control group, 1 in the Jieyu Huoxue decoction, 3 in no‐depression control) |
| Selective reporting (reporting bias) | Unclear risk | No protocol |
| Other bias | Unclear risk | Baseline balanced |