Summary of findings for the main comparison. Prostanoids versus lumbar sympathectomy for critical limb ischaemia due to non‐reconstructable peripheral arterial disease.
| Prostanoids versus lumbar sympathectomy for critical limb ischaemia due to non‐reconstructable peripheral arterial disease | ||||||
| Participants or population: people with critical limb ischaemia due to non‐reconstructable peripheral arterial disease Settings: 12 centres in Turkey Intervention: prostanoids versus lumbar sympathectomy | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Lumbar sympathectomy | Prostanoids | |||||
| Complete ulcer healing without rest pain or major amputation (per protocol) Clinical assessment follow‐up: 24 weeks | 526 per 1000 | 331 per 1000 (158 to 552) | RR 1.63 (1.30 to 2.05) | 162 (1 study) | ⊕⊕⊝⊝ low1 | The outcomes 'relief of rest pain', 'complete ulcer healing' and 'avoidance of amputation' were all derived from a single outcome reported by Bozkurt 2006 as "complete healing without pain or major amputation". We chose to deviate from the review protocol and combine the outcomes, reflecting the single included study in order to limit potential bias. |
| Intermittent and absolute claudication distances | See comment | See comment | Not estimable | Not reported in included study. | ||
| Quality of life and functional status | See comment | See comment | Not estimable | Not reported in included study. | ||
| Adverse effects Clinical assessment follow‐up: 24 weeks | See comment | See comment | Not estimable | 162 (1 study) | ⊕⊕⊝⊝ low1 | Adverse effects were not reported in a way that we could include in an analysis. Authors of the one included study reported more adverse effects in participants that received prostaglandin, but only one participant withdrew due to adverse effects. |
| Mortality Clinical assessment follow‐up: 24 weeks | See comment | See comment | Not estimable | 162 (1 study) | ⊕⊕⊝⊝ low1 | No mortality reported in this trial. |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is that the risk in the control group. 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. | ||||||
| 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 Downgraded by two levels due to serious imprecision: study sample size was small with significant dropouts, and the data were only from a single trial.