Fiessinger 1990.

Methods	Study design: multicentre RCT
Participants	Country: Multicentre in Europe: (9 countries, 26 centres) Setting: in hospital and community Nº patients: 152 (19 did not fulfil criteria; 133: 68 in iloprost group and 65 in aspirin group) Mean age: not stated Gender: 116 M; 36 F Inclusion criteria: patients with Buerger's disease with rest pain, ischaemic ulcers or gangrene Exclusion criteria: patients with diabetes mellitus, other inflammatory vascular diseases, and amputation or lumbar sympathectomy in the preceding 3 months Gravity of illness: ulcers or gangrene ‐ 99 patients (65%)
Interventions	Treatment: Iloprost group: Placebo tablet identical to aspirin and a 6‐hour infusion of iloprost (intravenous): in first 3 days, titration to a maximum tolerated dose or 2.0 ng/kg/min. The maximum dose at day 3 was repeated on days 4 to 28. Aspirin group: 100 mg Aspirin tablet and a 6‐hour daily intravenous placebo infusion. Duration of treatment: 28 days Follow‐up: 6 months
Outcomes	Primary: total relief of rest pain, complete healing of all trophic changes Secondary: amputation
Notes	Conflict of Interest: not stated
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Method not described
Allocation concealment (selection bias)	Low risk	Randomisation centre was utilized
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double blind
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Outcomes assessed by a physician not involved in the patient's management, or with the study
Incomplete outcome data (attrition bias) All outcomes	Low risk	Post randomisation excluded patients were described and justified. Performed an 'intention‐to‐treat' analyses
Selective reporting (reporting bias)	Low risk	All outcomes assessed as described in methods. Relevants outcomes described.
Other bias	Low risk	Proportion of smokers to non‐smokers in the study arms at the beginning and after treatment were described