Niu 2008.
Methods | RCT | |
Participants | 64 participants with acute ischaemic stroke Time of randomisation after stroke onset: between 6 hours and 7 days Treatment: 32 participants at randomisation (56% male, mean age 76 years) Control: 32 participants at randomisation (53% male, mean age 75 years) |
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Interventions | Treatment: buflomedil hydrochloride (200 mg, ivgtt, daily, 14 days) + control intervention Control: danshen (20 ml, ivgtt, daily, 14 days) + usual medical care |
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Outcomes | Time of outcome assessment: by the end of 14‐day treatment Death by the end of treatment CSS Haemorheological indices (whole blood viscosity, plasma viscosity, red blood cell aggregation, red blood cell deformation) |
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Notes | Combination of buflomedil with danshen Funding: not reported |
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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 | Unclear risk | The trial did not address this outcome |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
Selective reporting (reporting bias) | Unclear risk | The protocol was not available. Insufficient information to permit judgement |