Belcaro 2002.
| Methods | Study design: double‐blinded, randomised Country: Italy/USA/UK Setting: 3 centres Intention‐to‐treat: no |
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| Participants | Number of participants randomly assigned: 60 Number of participants analysed: 53 (27 pentoxifylline, 26 placebo) Exclusions post randomisation: 7 Losses to follow‐up: none Age: pentoxifylline: 55 ± 7 years, placebo: 56 ± 11 years Sex: M:F: pentoxifylline: 16:11, placebo: 18:8 Inclusion criteria: severe intermittent claudication with total walking distance < 100 m; intermittent claudication > 3 months; resting Doppler ankle brachial index < 0.8; decrease in ankle pressure > 15 mmHg after standard exercise test on treadmill; age between 45 and 75 years; arterial stenoses, plaques and blood flow reduction due to arteriosclerosis (colour duplex); graded cardiac stress test showing no angina/MI; stable control of diabetes mellitus ≥ 5 years Exclusion criteria: presence of indication for vascular angioplasty or revascularisation; angina or cardiac ischaemia on effort; previous coronary or vascular surgery or angioplasty, aneurysm, congestive heart failure, renal failure (creatinine > 2 mg/dL) and diabetes requiring insulin; arthritis, pulmonary, cardiac, neoplastic inflammatory or immunologic disease Exclusion criteria after run‐in phase: variance of maximal walking distance > 25% during 2‐week run‐in phase |
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| Interventions | Treatment: oral pentoxifylline, 400 mg 4 times daily Control: placebo Duration: 6 months |
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| Outcomes | Primary: mean TWD Secondary: side effects |
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| Notes | Treadmill protocol: 3 km/h at 12% inclination Mean 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 'randomized'; no other information available |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Treatment allocation blinded for participants and personnel |
| 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 appears free of other bias |