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

Donaldson 1984.

Study characteristics
Methods Study design: double‐blind, randomised
Country: UK
Setting: single centre
Intention‐to‐treat: not mentioned
Participants Number of participants randomly assigned: 80 (40 each group)
Number of participants analysed: not mentioned
Exclusions postrandomisation: 0
Losses to follow‐up: 7
Age (mean): pentoxifylline: 58.2 (SD 11.7) years, placebo: 58.9 (SD 9.1) years
Sex: 31 males, 9 females in each group
Inclusion criteria: typical IC pain
Exclusion criteria: rest pain (or incipient gangrene); severe ischaemic heart disease; postural hypotension; receiving any drugs likely to alter claudication distance within 4 weeks before inclusion in study
Interventions Treatment: oral pentoxifylline, 200 mg tid
Control: placebo
Duration: 8 weeks
Outcomes Primary: mean PFWD, TWD
Secondary: ABI, side effects
Notes Treadmill protocol: 4 km/h at 0% inclination
Mean PFWD and TWD expressed in metres only
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomised."
Comment: no other information provided.
Allocation concealment (selection bias) Unclear risk Not mentioned.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Insufficient information provided to permit judgement.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not mentioned.
Incomplete outcome data (attrition bias)
All outcomes Low risk No incomplete 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.