for the main comparison.
| Buflomedil for patients with acute ischaemic stroke | ||||||
|
Patient or population: patients with acute ischaemic stroke Settings: inpatients Intervention: buflomedil + usual care/another intervention Comparison: usual care or another intervention | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Control | Buflomedil + control intervention | |||||
|
Long‐term death or disability (follow‐up: 3 months) |
580 per 1000 | 410 per 1000 | Participants in the buflomedil group had a lower risk of death or disability by 3 months after stroke than participants in the control group RR 0.71 (0.53 to 0.94) | 200 (1) | ⊕⊕⊝⊝ low1 | Disability was defined by a total score on the Barthel Index of 60 or less; a higher score on the Barthel Index indicates better outcome |
|
Short‐term death (follow‐up: immediately after treatment) |
22 per 1000 | 9 per 1000 | Participants in the buflomedil group had a lower risk of death by the end of treatment than participants in the control group RR 0.45 (0.14 to 1.46) | 731 (4) | ⊕⊕⊝⊝ low2 |
NA |
|
Short‐term disability assessed by the Barthel Index (follow‐up: immediately after treatment) |
The mean score for independence in daily living was 45 (39 to 51) in the control group | The mean score for independence in daily living was 60 (52 to 67) in the buflomedil group | The independence score in the buflomedil group was 15 points higher (6 to 24 higher) than in the control group | 85 (1) | ⊕⊕⊝⊝ low3 | A higher score on the Barthel Index indicates better outcome |
|
Severity of neurological deficits assessed by stroke scales for neurological deficits (follow‐up: immediately after treatment) |
NA | NA | The severity of neurological deficits was lower in the buflomedil group than in the control group SMD ‐0.98 (‐1.21 to ‐0.75) | 745 (7) | ⊕⊕⊝⊝ low4 | We converted scores from all scales to the same direction, i.e. higher scores indicate more severe deficits |
|
Clinical improvement assessed by the China Stroke Scale (follow‐up: immediately after treatment) |
734 per 1000 | 901 per 1000 | A higher proportion of participants in the buflomedil group had clinical improvement than in the control group RR 1.19 (1.14 to 1.25) | 2374 (20) | ⊕⊕⊝⊝ low5 | Higher risk (or proportion) of clinical improvement indicates better outcome |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; NA: not applicable; RR: risk ratio; SMD: standardised mean difference | ||||||
| GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||
1This trial was at risk of bias as it did not use adequate allocation concealment, nor blinding of participants or researchers (risk of bias). Also, the sample size was small and the 95% CI for the effect size was wide (imprecision).
2Trials for this outcome were at risk of bias as none of them used adequate allocation concealment, nor blinding of participants or researchers (risk of bias). Also, the total number of participants for this outcome was far less than the expected optimal information size and the 95% CI for the effect size was wide (imprecision).
3This trial was at risk of bias as it did not use adequate allocation concealment, nor blinding of participants or researchers. Also, it was at risk of attrition bias (risk of bias). In addition, the sample size was small and the 95% CI for the effect size was wide (imprecision).
4Trials for this outcome were at risk of bias as none of them used adequate allocation concealment, nor blinding of participants or researchers (risk of bias). In addition, there was moderate heterogeneity (53%) between trials (inconsistency).
5Trials for this outcome were at risk of bias as none of them used adequate allocation concealment, nor blinding of participants or researchers (risk of bias). Also, there was significant publication bias for this outcome (publication bias).