Cesarone 2002b.
| Methods | Study design: double‐blinded, randomised Country: Italy Setting: multi‐centre ‐ 7 centres Intention‐to‐treat: yes |
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| Participants | Number of participants randomly assigned: 200 Number of participants analysed: 178 (88 pentoxifylline, 90 placebo) Exclusions post randomisation: none Losses to follow‐up: 22 Age: pentoxifylline: 61 ± 9 years, placebo: 61 ± 10 years Sex: pentoxifylline: 55 males, 45 females, placebo: 56 males, 44 females Inclusion criteria: severe intermittent claudication with total walking distance between 50 and 200 m; intermittent claudication > 4 months; resting Doppler ankle‐brachial index < 0.8; decrease in ankle pressure > 15 mmHg after standard exercise rest on treadmill (12% inclination, 3 km/h, 10 minutes of exercise); age between 45 and 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); insulin‐dependent diabetes mellitus; change of > ± 25% during 2‐week run‐in period; arthritis; pulmonary, cardiac or neoplastic disease; inflammatory or immunologic disease |
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| Interventions | Treatment: oral pentoxifylline, 400 mg 4 times daily Control: placebo Duration: 40 weeks |
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| Outcomes | Primary: geometric mean TWD and PFWD Secondary: side effects |
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| Notes | Treadmill protocol: 3 km/h at 12% inclination Geometric mean PFWD and TWD expressed in metres only |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | States 'randomised into two treatment plans'; no further information provided |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | States 'double blind' and 'pentoxifylline and equivalent placebo were administered'; 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 appears free of other bias |