| Methods |
Study design: double blind, randomised controlled trial.
Method of randomisation: not stated.
Allocation concealment: numbered, sealed envelopes.
Exclusions post randomisation: 3 (2 in treatment group and 1 in placebo group)
Losses to follow up: 2 (1 in each group).
Intention to treat: no. |
| Participants |
Country: Netherlands.
Setting: hospital.
No: 37 randomised, 32 completed the trial.
Age: range 18 to 80 years.
Sex: male 22, females 10.
Inclusion criteria: intermittent claudication due to PAD, stable for 1 year according to treadmill and ABPI.
Exclusion criteria: MI < 3 months; unstable angina; poorly controlled DM; CLI; hypertension; fish allergy; other lipid‐lowering treatment; antiplatelet treatment; and other medical disorders. |
| Interventions |
Treatments: six capsules fish oil daily (1.8 g eicosapentaenoic acod + 1.2 g docosahexaenoic acid).
Control: six capsules corn oil (3 g linoleic acid) daily.
Duration: 4 months. |
| Outcomes |
ABPI; walking distance (pain‐free and total). |
| Notes |
Biochemical and haematologcial outcomes measured pre, during, and post study. Active treatment associated with reduced TG and increased HDL. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
