Verstraete 1998.
| Study characteristics | ||
| Methods | Study design: multicentre, parallel RCT | |
| Participants | Country: six countries: Bulgaria, Poland, Portugal, Greece, France, and Israel Setting: hospitalised during the first week of treatment; after first week, participants continued the study as out‐patients Nº patients: 319 (103 in placebo group, 106 in low‐dose iloprost group, and 110 in high‐dose iloprost group) Mean age: 40 years Gender: 292 M; 27 F Inclusion criteria: age under 50 years, current smoker or history of smoking, angiographic criteria compatible with Buerger's disease with typical arteriographic findings, e.g. skip lesions below the popliteal artery, corkscrew collaterals, or both (Martorell's sign), or direct collaterals below the knee in the absence of atherosclerotic lesions, and history of or current superficial thrombophlebitis or vasospastic symptoms Exclusion criteria: patients with diabetes mellitus, treated or untreated hypertension (systolic BP > 160 mmHg/diastolic BP > 95 mmHg), hypercholesterolaemia (> 260 mg/dL), atrial fibrillation (or other known causes of arterial embolism), and sympathectomy within the last 3 weeks of entering the study |
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| Interventions | Treatment: 3 groups Iloprost group 1: day 1: 100 mcg (1 capsule with 50 mcg, twice daily, orally). From day 2 until the end of the study: 200 mcg (2 capsules with 50 mcg, twice daily, orally) Iloprost group 2: day 1: 200 mcg (1 capsule with 100 mcg, twice daily, orally). From day 2 until the end of the study: 400 mcg (2 capsules with 100 mcg, twice daily, orally) Placebo group: day 1: one capsule with iloprost placebo, twice daily, orally. From day 2 until the end of the study: two capsules with iloprost placebo, twice daily, orally. Duration of treatment: 8 weeks Follow‐up: 6 months after treatment |
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| Outcomes | Primary: total healing of most important trophic lesion Secondary: total relief of rest pain without analgesics Combined endpoint: alive without major amputation, no lesion, no rest pain, no analgesics |
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| Notes | Conflict of Interest was not described | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method not described |
| Allocation concealment (selection bias) | Unclear risk | Method not stated |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double blind |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Does not describe whether the outcome assessments were done by the same person responsible for recruitment |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Losses were justified. Performed 'intention‐to‐treat' analyses |
| Selective reporting (reporting bias) | Low risk | All outcomes were described |
| Other bias | Unclear risk | Conflict of Interest was not described |
BP: blood pressure dL: decilitre F: female Kg: kilogram Lipo PGE1: lipid emulsion of prostaglandin E1 M: male mcg: microgram mg: milligram min: minute ng: nanogram PGE1: prostaglandin analogue E1 RCT: randomised controlled trial TTC‐909: prostacyclin analogue clinprost (isocarbacyclin methylester; methyl 5‐[(1S,5S,6R,7R)‐7‐hydroxy‐6‐[(E)‐(S)‐3‐hydroxy‐1‐octenyl] bicyclo[3.3.0]oct‐2‐en‐3‐yl] pentanoate)