Cesarone 2002.

Study characteristics
Methods	Study design: double‐blind, randomised Country: Italy Setting: 7 centres Intention‐to‐treat: yes
Participants	Number of participants randomly assigned: 200 Number of participants analysed: 178 (88 pentoxifylline, 90 placebo) Exclusions postrandomisation: 0 Losses to follow‐up: 22 Age (mean): pentoxifylline: 61 (SD 9) years, placebo: 61 (SD 10) years Sex: pentoxifylline: 55 males, 45 females, placebo: 56 males, 44 females Inclusion criteria: severe IC with TWD 50–200 m; IC > 4 months; resting Doppler ABI < 0.8; decrease in ankle pressure > 15 mmHg after standard exercise rest on treadmill (12% inclination, 3 km/h, 10 minutes of exercise); aged 45–75 years; documentation of arterial stenoses, plaques and flow reduction due to arteriosclerosis by colour‐duplex imaging Exclusion criteria: indication for revascularisation or angioplasty; no angina or myocardial ischaemia on effort tested by bicycle ergometry, cardiac risk factors; previous coronary or vascular surgery or angioplasty; aneurysms; congestive heart failure NYHA III/IV; renal failure (creatinine > 2 mg/100 mL); IDDM; change of > ± 25% during 2‐week run‐in period; arthritis; pulmonary, cardiac or neoplastic disease; inflammatory or immunological disease
Interventions	Treatment: oral pentoxifylline, 400 mg 4 times daily Control: placebo Duration: 40 weeks
Outcomes	Primary: geometric mean TWD and PFWD Secondary: side effects
Notes	Treadmill protocol: 3 km/h at 12% inclination Geometric 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 into two treatment plans." Comment: no further information provided.
Allocation concealment (selection bias)	Unclear risk	Not mentioned.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "double blind;" and "pentoxifylline and equivalent placebo were administered." Comment: no other information provided.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not mentioned.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No information provided on dropouts.
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.