Summary of findings 3. (Oral or intravenous) prostanoid versus placebo for treatment of Buerger's disease.
| 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 | Anticipated absolute effects * (95% CI) | Relative effect (95% CI) | No of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with oral prostacyclin analogue (iloprost) | |||||
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Ulcer healing Follow‐up: 8 weeks |
Study population (200 mcg) | 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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| Study population (400 mcg) | 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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Complete relief of rest pain Follow‐up: 8 weeks |
Study population (200 mcg) | 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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| Study population (400 mcg) | 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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|
Rate of amputation Follow‐up: 6 months |
Study population (200 mcg) | 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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| Study population (400 mcg) | 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 risk in the intervention group (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 certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
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 certainty of evidence