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. 2016 Mar 11;2016(3):CD011033. doi: 10.1002/14651858.CD011033.pub3

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
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
Outcomes Primary: ulcer size, ulcer improvement
Secondary: improvement of rest pain
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