Chen 2001.
| Methods | Randomised trial Aim: to observe effects of integrative Chinese herb YuLeShu and fluoxetine on the depressive symptoms and rehabilitation of neurological impairment in patients with post‐stroke depression |
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| Participants | Country: China Setting: not described Participants: internal carotid system cerebral infarction or haemorrhage within previous 2 months Fluoxetine: 19 people, mean age 61.71 ± 8.13 years, 8 men Control: 18 people, mean age 62.85 ± 7.32 years, 7 men Depression: diagnosis of depression according to DSM‐IV Inclusion criteria: HDRS ≥ 20 but < 35 and/or Zung SDS ≥ 41 Exclusion criteria: HDRS > 35, previous depression, aphasia, severe cardiac, pulmonary, hepatic and renal diseases, previous stroke |
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| Interventions | 3 groups: fluoxetine plus usual care versus YuLeShu plus usual care versus usual care. We are using the fluoxetine plus usual care versus usual care alone in the comparison | |
| Outcomes | HDRS Zung SDS BI Scandinavian Neurological Stroke Scale (also known as CSS) Stated no side effects, but not clear which side effects were sought, or how they were sought. They were reported at 4, 8 and 12 weeks after treatment |
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| Funding source | Funded by a local scientific academic fund, drug company not involved | |
| Notes | − | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "using a computer", but method 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 | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Dropouts: 2 people dropped out of the fluoxetine group, 1 dropped out of the YuLeShu group and 2 dropped out of the control group |
| Selective reporting (reporting bias) | Unclear risk | Protocol not published |
| Other bias | Unclear risk | Reported that of the people who completed the tests, there were no differences in baseline No comment on whether there were differences in baseline for the entire group |