Ciocon 1997.
Study characteristics | ||
Methods | Study design: randomised Country: USA Setting: 2 centres Intention‐to‐treat: not mentioned |
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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 |
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Interventions | Treatment: oral pentoxifylline, 400 mg tid Control: aspirin, 325 mg daily Duration: 6 weeks |
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Outcomes | Primary: TWD Secondary: ABI |
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Notes | Treadmill protocol: not specified 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 | 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. |