Ishitobi 1991.
| Methods | Study design: RCT | |
| Participants | Country: Japan Setting: hospitalised and community Nº patients: 134 (55 with Buerger's disease; 25 in iloprost group and 30 in alprostadil group) Mean age: not specified. Gender: the proportion and numbers of participants with Buerger's disease were not specified Inclusion criteria: patients diagnosed with Buerger's disease Exclusion criteria: a) patients who had previous surgical treatment for chronic arterial obstructive disease; b) patients with necrosis, where the judgement of varicose ulcer is unclear; c) patients with haemorraghic events; d) patients with serious liver, kidney, or heart disease; e) hypersensitivity to medication or drugs; e) pregnancy |
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| Interventions | Treatment: Iloprost group: iloprost 6 mcg in a liquid injection. One dose plus 3 doses PGE1 placebo/day; Alprostadil group (PGE1): liquid injection containing 20 mcg of alprostadil. Three doses plus 1 dose iloprost placebo/day Duration of treatment: 28 days No follow‐up |
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| Outcomes | Primary: ulcer size, ulcer improvement Secondary: improvement of rest pain |
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| 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) | 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 if the outcome assessments were done by the same person responsible for recruitment |
| Incomplete outcome data (attrition bias) All outcomes | High risk | More drop‐out patients in the iloprost group than in the alprostadil group, actual numbers and possible reasons for drop‐out not provided |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |
| Other bias | High risk | Does not described the proportion of smokers to non‐smokers in the groups |