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. 2020 Oct 16;2020(10):CD005262. doi: 10.1002/14651858.CD005262.pub4

Ciocon 1997.

Study characteristics
Methods Study design: randomised
Country: USA
Setting: 2 centres
Intention‐to‐treat: not mentioned
Participants Number of participants randomly assigned: 90
Number of participants analysed: 90 (45 in each group)
Exclusions postrandomisation: not mentioned
Losses to follow‐up: not mentioned
Age (mean): 79 (SD 3.5) years
Sex: male:female: pentoxifylline: 10:34, aspirin: 12:34
Inclusion criteria: aged ≥ 65 years; ankle‐to‐arm pressure < 0.8; not taken aspirin/pentoxifylline over previous 6 months; experienced leg claudication
Exclusion criteria: took aspirin or pentoxifylline in previous 6 months; leg rest pain; vascular surgery; coexisting stable angina, severe osteoarthritis, peripheral neuropathy, leg surgery within previous 6 months; ankle‐to‐arm pressure ratio > 0.8
Interventions Treatment: oral pentoxifylline, 400 mg tid
Control: aspirin, 325 mg daily
Duration: 6 weeks
Outcomes Primary: TWD
Secondary: ABI
Notes Treadmill protocol: not specified
TWD expressed in metres only
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "were randomly assigned to."
Comment: no further information provided.
Allocation concealment (selection bias) Unclear risk Not mentioned.
Blinding of participants and personnel (performance bias)
All outcomes High risk Different treatments: pentoxifylline bid, aspirin once daily.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not mentioned.
Incomplete outcome data (attrition bias)
All outcomes Low risk No missing outcome data.
Selective reporting (reporting bias) Unclear risk Protocol not available; insufficient information available to permit judgement.
Other bias Low risk Study appeared free of other bias.