| Methods |
Study design: double blind, randomised, controlled, pilot trial.
Method of randomisation: computer generated using balanced blocks without stratification (randomisation ratio 1:1).
Concealment of allocation: details of medication sealed in sequentially numbered identical containers according to progressive inclusion order.
Exclusions post randomisation: none.
Losses to follow up: policosanol 0; lovostatin 1.
Intention to treat: yes. |
| Participants |
Country: Cuba.
Setting: hospital outpatients.
No: 28.
Age:(mean) policosanol 60 ± 9; lovostatin 65 ± 9.
Sex: policosanol, males 10, females 4; lovastatin, males 11, females 3.
Inclusion criteria: ICD 50 to 300 metres; ACD < 500 metres.
Exclusion criteria: > 80 years MI; vascular surgery unstable angina or stroke 3 months before the study; severe hypertension; occlusive thromboangiitis; congenital or acquired haemorrhagic diseases; pregnant or nursing women. |
| Interventions |
Treatment: policosanol 10 mg tablets once daily.
Control: lovostatin 20 mg tablets once daily.
Duration: 20 weeks. |
| Outcomes |
Primary: initial claudication distance; absolute claudication distance; ABPI.
Secondary: lipid profile and fibrinogen levels.
Side effects: tolerability. |
| Notes |
Some patients had hypercholesterolemia.
Biochemical and haematological outcomes measured and recorded pre, during, and post study.
ABPI recorded as ankle/arm pressure ratio of the worst lower limb.
Authors used terms initial (ICD) and absolute claudication distance (ACD). For comparison we used pain‐free and total walking distance.
Authors contacted for additional information on trial. Response received. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
