Cui 2005.
Methods | RCT | |
Participants | 200 participants with ischaemic stroke Time of randomisation after stroke onset: within 7 days Treatment: 100 participants at randomisation (60% male, mean age 63 years) and 98 for analysis (2 lost to follow‐up) Control: 100 participants at randomisation (56% male, mean age 64 years) and 97 for analysis (3 lost to follow‐up) |
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Interventions | Treatment: buflomedil hydrochloride (200 mg, daily, 14 days) + control intervention Control: usual medical care or rehabilitation |
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Outcomes | Time of outcome assessment: by the end of 14‐day treatment and 3‐month follow‐up (after randomisation) Death at 3‐month follow‐up Disability (Barthel Index ≤ 60) at 3‐month follow‐up CSS by the end of treatment Adverse events during treatment |
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Notes | Funding: not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomised" but did not report the methods of randomisation |
Allocation concealment (selection bias) | Unclear risk | Insufficient information was reported to permit judgement |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Interventions used in the 2 groups were visibly different |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Blind assessment" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Reported that 2 participants in treatment group and 3 participants in control group lost to follow‐up |
Selective reporting (reporting bias) | Unclear risk | The protocol was not available. Insufficient information to permit judgement |