Tesi 1989.
Methods | Double‐blind, placebo‐controlled randomised trial, allocation concealment unclear, method of random sequence generation not stated. Run‐in period: none. Drop‐outs and study withdrawals: no. Intention‐to‐treat: yes. Baseline characteristics comparable between two groups. | |
Participants | Country: Italy, 20 participants: Age: range 44 to 70 years; males: 11; females: 9; co‐morbidity not stated. Inclusion criteria: PAOD and IC diagnosed by clinical examination and ABI. Exclusion criteria: obesity, smoking, previous arterial surgery, AMI, angina pectoris. | |
Interventions | Treatment group: 10 participants: LMWH 8,000 U s.c. o.d. Control group: 10 participants: placebo sc od (indistinguishable from treatment). Duration: six months. Compliance: evaluated. | |
Outcomes | MWD, ABI, thrombotic complications, major and minor bleeding events. | |
Notes | Bar graphs only provided for MWD. No data provided by primary author. Intensity of walking test not stated. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
Abbreviations: ABI: ankle/brachial index AMI: acute myocardial infarction ASA: acetylsalicylic acid IC: intermittent claudication INR: international normalised ratio LMWH: low molecular weight heparin MWD: maximum walking distance o.d.: once daily PAOD: peripheral arterial obstructive disease PFWD: pain free walking distance s.c.: subcutaneously SD: standard deviation SEM: standard error of the mean TIA: transient ischaemic attack t.i.d.: tris in diem (three times daily) UA: unstable angina