Accetto 1982.
Methods | Study design: double‐blinded, randomised Country: Yugoslavia Setting: single centre Intention‐to‐treat: no |
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Participants | Number of participants randomly assigned: 60 Number of participants analysed: 47 (23 pentoxifylline, 24 nylidrin HCL) Exclusions post randomisation: 13 Losses to follow‐up: none Age: mean 61 years (range 30 to 80 years) Sex: 36 male, 14 female Inclusion criteria: Fontaine stage II or III; initial claudication distance > 50 m and < 500 m at 3 km/h at 0 degrees of inclination; severity of disorder unchanged for 6 months Exclusion criteria: advanced limb arterial occlusion; peripheral venous disorders; systemic haematological disorders; severely impaired renal function; GI disorders; hypersensitivities to methylxanthines; women of childbearing age; taking cardiac medication, glycosides and antihypertensives or antibiotics < 4 weeks before the study |
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Interventions | Treatment: oral pentoxifylline, 400 mg 3 times daily Control: nylidrin HCl, 3 mg 3 times daily Duration: 8 weeks |
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Outcomes | Primary: mean TWD Secondary: side effects |
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Notes | Treadmill protocol: 3 km/h without inclination Mean TWD stated in metres and seconds |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not mentioned |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Reports 'double blinded'; no other information available |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Reasons for withdrawals not provided |
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 |