Tu 2012.
Methods | RCT | |
Participants | 67 participants with acute ischaemic stroke (age and sex unknown) Time of randomisation after stroke onset: unknown Treatment: 34 participants at randomisation and all completed the trial Control: 33 participants at randomisation and all completed the trial |
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Interventions | Treatment: phosphopyridoxal buflomedil (20 mg, twice per day, ivgtt, 14 days) + control intervention Control: edaravone (ivgtt) + gangliosides (ivgtt) + aspirin (po) 14 days |
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Outcomes | Time of outcome assessment: by the end of 14‐day treatment SSS Haemorheological indices (platelet aggregation rate, whole blood viscosity, plasma viscosity, red blood cell deformation, fibrinogen) Adverse events (including renal and hepatic function tests) |
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Notes | Combination of buflomedil with edaravone and gangliosides and aspirin 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 |