Li 2008.
Methods | RCT | |
Participants | 85 participants with ischaemic stroke (age and sex unknown, but were comparable between 2 groups) Time of randomisation after stroke onset: within 48 hours Treatment: 44 participants at randomisation and all completed the trial Control: 41 participants at randomisation and all completed the trial |
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Interventions | Treatment: buflomedil hydrocholoride (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 European Stroke Scale Acute Physiology and Chronic Health Evaluation II (APACHE II) Barthel Index (dependence) Serum C‐reaction protein Hepatic and renal function tests Coagulation function Adverse events |
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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 | High risk | Some safety measures, e.g. hepatic and renal functions, were listed in the Methods section but were not reported in the Results section |
Selective reporting (reporting bias) | Unclear risk | The protocol was not available. Insufficient information to permit judgement |