Lindgarde 1989.
Study characteristics | ||
Methods | Study design: double‐blind, randomised Country: Scandinavia Setting: multi‐centre Intention‐to‐treat: yes |
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Participants | Number of participants randomly assigned: 150 (76 pentoxifylline, 74 placebo) Number of participants analysed: 150 Exclusions postrandomisation: 0 Losses to follow‐up: 0 Age (mean): pentoxifylline: 65 (SD 7) years, placebo: 64 (SD 8) years Sex: pentoxifylline: 79% males, placebo: 80% males Inclusion criteria: aged ≥ 40 years; moderate‐to‐severe COAD; initial claudication distance 50–200 m; claudication history > 6 months; variance of walking distance < 35% in the last 2 treadmill tests with baseline walking distance < 100 m; variance of walking distance < 25% in the last 2 treadmill tests with baseline walking distance 101–200 m Exclusion criteria: complete occlusion of the aortoiliac segment, the femoral bifurcation or the popliteal artery without angiographically confirmed distal refilling of the respective segment; vascular reconstruction of sympathectomy within the past 12 months; peripheral neuropathy; Buerger's disease; marked postphlebotic syndrome; diabetes; cardiac failure or severe rhythm disorders; major infections; abnormal values for platelets; history of xanthine hypersensitivity; addiction to analgesics; malignant disease |
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Interventions | Treatment: oral pentoxifylline, 400 mg tid Control: placebo Duration: 6 months |
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Outcomes | Primary: geometric means of % change in TWD and PFWD from baseline to follow‐up Secondary: ABI, side effects |
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Notes | Treadmill protocol: 3.2 km/h at 12.5% inclination PFWD and TWD expressed as geometric mean of % change |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomisation stratified by centres." 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: "During the double‐blind period and according to a randomization plan, pentoxifylline or matching placebo was administered t.i.d. [tid]" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | ABI data not provided for the main analysis. |
Selective reporting (reporting bias) | Unclear risk | ABI data not provided for the main analysis. |
Other bias | Low risk | Study appeared free of other bias. |