Summary of findings for the main comparison. Summary of findings: Oral prostacyclin analogue (iloprost) versus placebo.
| Oral prostacyclin analogue (iloprost) versus placebo for treatment of Buerger's disease | ||||||
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Patient or population: patients with Buerger's disease Settings: hospital and community Intervention: oral prostacyclin analogue (iloprost) in two doses: 200 mcg and 400 mcg Comparison: placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| placebo | oral prostacyclin analogue | |||||
|
Ulcer healing (200 mcg) Follow‐up: 8 weeks |
Study population | RR 1.11 (0.54 to 2.29) | 133 (1 RCT) |
⊕⊕⊕⊝1,2 moderate | ||
| 171 per 1000 |
190 per 1000 (93 to 393) |
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|
Ulcer healing (400 mcg) Follow‐up: 8 weeks |
Study population | RR 0.90 (0.42 to 1.93) | 135 (1 RCT) |
⊕⊕⊕⊝1,2 moderate | ||
| 171 per 1000 |
154 per 1000 (72 to 331) |
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|
Ulcer healing (200 mcg) Follow‐up: 6 months |
Study population | RR 1.19 (0.82 to 1.73) | 133 (1 RCT) |
⊕⊕⊕⊝1,2 moderate | ||
| 414 per 1000 |
493 per 1000 (340 to 717) |
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|
Ulcer healing (400 mcg) Follow‐up: 6 months |
Study population | RR 1.00 (0.67 to 1.50) | 135 (1 RCT) |
⊕⊕⊕⊝1,2 moderate | ||
| 414 per 1000 |
414 per 1000 (278 to 621) |
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|
Complete relief of rest pain (200 mcg) Follow‐up: 8 weeks |
Study population | RR 1.14 (0.79 to 1.63) | 207 (1 RCT) |
⊕⊕⊕⊝1,2 moderate | ||
| 343 per 1000 |
391 per 1000 (271 to 559) |
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|
Complete relief of rest pain (400 mcg) Follow‐up: 8 weeks |
Study population | RR 1.11 (0.77 to 1.59) | 210 (1 RCT) |
⊕⊕⊕⊝1,2 moderate | ||
| 343 per 1000 |
381 per 1000 (264 to 546) |
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|
Complete relief of rest pain (200 mcg) Follow‐up: 6 months |
Study population | RR 1.28 (1.00 to 1.64) | 207 (1 RCT) |
⊕⊕⊝⊝1,2,3 low | ||
| 490 per 1000 |
627 per 1000 (490 to 804) |
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|
Complete relief of rest pain (400 mcg) Follow‐up: 6 months |
Study population | RR 1.00 (0.76 to 1.32) | 210 (1 RCT) |
⊕⊕⊕⊝1,2 moderate | ||
| 490 per 1000 |
490 per 1000 (373 to 647) |
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|
Rate of amputation (200 mcg) Follow‐up: 6 months |
Study population | RR 0.54 (0.19 to 1.56) | 209 (1 RCT) |
⊕⊕⊕⊝1,2 moderate | ||
| 87 per 1000 |
47 per 1000 (17 to 136) |
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|
Rate of amputation (400 mcg) Follow‐up: 6 months |
Study population | RR 0.42 (0.13 to 1.31) | 213 (1 RCT) |
⊕⊕⊕⊝1,2 moderate | ||
| 87 per 1000 |
37 per 1000 (11 to 114) |
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| *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; 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 one single study (doubt about reproducibility of data), downgraded by one level 2 conflict of interest not stated but it was not considered sufficient to downgrade the quality of evidence 3 inconsistent with dose‐response effect, downgraded by one level