Summary of findings for the main comparison. Oral aspirin for venous leg ulcers.
| Oral aspirin for venous leg ulcers | ||||||
| Patient or population: patients with venous leg ulcers Settings: hospital outpatients in UK and Spain Intervention: oral aspirin | ||||||
| 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 | Oral aspirin | |||||
| Average time for ulcer healing | 22 weeks | 12 weeks | Not estimable | 51 (1 study) | ⊕⊕⊝⊝ low1,2 | P values and confidence intervals were not reported |
| Reduction of ulcer area (median) | 0 cm² | 6.5cm² | Not estimable | 20 (1 study) | ⊕⊕⊝⊝ low2,3 | P value < 0.002 Follow‐up: 4 months |
| Proportion of healed ulcers in the trial period | No healed ulcers | 38% of healed ulcers | Not estimable | 20 (1 study) | ⊕⊕⊝⊝ low2,3 | P value < 0.007 Follow‐up: 4 months |
| Major bleeding | See comment | See comment | Not estimable | 20 (1 study) | ⊕⊕⊝⊝ low2,3 | No events were observed in either group, follow‐up: 4 months Another study reported 2 hospitalisations for unknown reasons, intervention group not specified |
| Average time of ulcer recurrence |
16.33 days SD: 7.5 |
39 days SD: 6.0 |
Not estimable | 51 (1 study) | ⊕⊕⊝⊝ low1,2 | P value = 0.007 Post hoc assessment not pre‐specified in protocol |
| Mortality | See comment | See comment | Not estimable | See comment | See comment | Mortality not reported |
| Other adverse events | See comment | See comment | Not estimable | 71 (2 study) | See comment | No events were observed in either group. del Río Solá reported 2 hospitalisations for unknown reasons, the group of these patients were not specified and they were removed from the study |
| *The basis for the assumed risk (for example, 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; RR: risk ratio; SD: standard deviation | ||||||
| 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 | ||||||
1 Allocation concealment and blinding of outcome assessment were not described. Participants and personnel were not blinded. There was a high risk of bias from incomplete outcome data.There were some inconsistencies in the reporting of the data 2 The study results are based on one small study with insufficient data to estimate the effect precisely 3 Selection, performance and reporting biases were unclear