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. 2020 Oct 16;2020(10):CD005262. doi: 10.1002/14651858.CD005262.pub4

Lindgarde 1989.

Study characteristics
Methods Study design: double‐blind, randomised
Country: Scandinavia
Setting: multi‐centre
Intention‐to‐treat: yes
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
Interventions Treatment: oral pentoxifylline, 400 mg tid
Control: placebo
Duration: 6 months
Outcomes Primary: geometric means of % change in TWD and PFWD from baseline to follow‐up
Secondary: ABI, side effects
Notes Treadmill protocol: 3.2 km/h at 12.5% inclination
PFWD and TWD expressed as geometric mean of % change
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.