Bollinger 1977.
Study characteristics | ||
Methods | Study design: double‐blind, randomised Country: Switzerland Setting: single centre Intention‐to‐treat: not mentioned |
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Participants | Number of participants randomly assigned: 26 Number of participants analysed: 19 Exclusions postrandomisation: 0 Losses to follow‐up: 7 Age (mean): pentoxifylline: 63.9 years, placebo: 59.6 years Sex: pentoxifylline: 9 male, 1 female, placebo: 8 male, 1 female Inclusion criteria: IC (Fontaine stage II) Exclusion criteria: malleolar arteries could not be compressed by a cuff (mediasclerosis) |
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Interventions | Treatment: oral pentoxifylline, 200 mg tid Control: placebo Duration: 8 weeks |
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Outcomes | Primary: mean TWD Secondary: ABI |
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Notes | Treadmill protocol: 3.2 km/h at 12.5% inclination Mean TWD expressed in metres only Participants were instructed to refrain from smoking during the study and to walk daily for ≥ 1 hour |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "allocated at random to receive treatments." Comment: no other information provided. |
Allocation concealment (selection bias) | Unclear risk | Not mentioned. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Both pentoxifylline and placebo were presented in identical tablet form and supplied in containers of 40 tablets, identified only by a code number." |
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 | High risk | Differences in clinical baseline data between treatment groups. |