| Methods |
Single‐blind, placebo‐controlled randomised trial with blinded outcome assessment.
Four treatment arms: sintrom, placebo, pentoxifylline, pentoxifylline + sintrom.
Run‐in period: none.
Drop‐outs and study withdrawals: 28.
Intention‐to‐treat: no.
Characteristics of study sample: no significant difference between groups at baseline. |
| Participants |
Country: Italy: 146 participants:
Age: range of mean 58 to 62 years; males: 134; females: 12; diabetes mellitus: 21.
Inclusion criteria: 12‐month history of IC with ABI < 0.90.
Exclusion criteria: age > 75, effort angina or other diseases interfering with walking capacity, rest pain, ischaemic ulcers, gangrene, indication for surgery, previous vascular surgery, diseases necessitating oral anticoagulation or contra‐indication to oral anticoagulation, non‐atherosclerotic causes of IC, any clinical condition limiting exercise. |
| Interventions |
Treatment group (A): 36 patients:
acenocoumarol (Sintrom) + placebo, target INR range 2.0 to 4.5.
Treatment group (B): 36 patients:
Sintrom + pentoxifylline 400 mg t.i.d.
Control group (A): 37 patients:
placebo (indistinguishable from Control group (B) tablets).
Control group (B): 37 patients:
pentoxifylline 400 mg t.i.d.
Duration: one year.
Compliance: evaluated (90%). |
| Outcomes |
PFWD, ABI, cardiovascular events (TIA, stroke, UA, AMI), overall mortality, bleeding events. |
| Notes |
PFWD expressed as geometric mean and range.
No data provided by authors on pain‐free walking distance due to length of time since publication.
Improvement > 25% of baseline significant in pentoxifylline and sintrom group.
Reasons for withdrawal:
11 participants for negative end‐points of trial; 8 participants for medical problems unrelated to study medication; 4 participants for intolerance to pentoxifylline; 5 participants for refusal to attend regularly.
Intensity of walking test: 3 km/h elevation 10%. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
