Donaldson 1984.
Study characteristics | ||
Methods | Study design: double‐blind, randomised Country: UK Setting: single centre Intention‐to‐treat: not mentioned |
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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 |
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Interventions | Treatment: oral pentoxifylline, 200 mg tid Control: placebo Duration: 8 weeks |
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Outcomes | Primary: mean PFWD, TWD Secondary: ABI, side effects |
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Notes | Treadmill protocol: 4 km/h at 0% inclination 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 | 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. |