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. Author manuscript; available in PMC: 2014 Sep 22.
Published in final edited form as: Cochrane Database Syst Rev. 2004 Oct 18;(4):CD003177. doi: 10.1002/14651858.CD003177.pub2
Methods Randomisation: dietitian allocated by opening a sealed envelope containing a card which indicated a diet to be advised (following the taking of a diet history by that dietitian)
Allocation concealment: Unclear
Participants masked: No
Providers masked: No Outcome assessors masked: Yes
Summary risk of bias: medium or high
Participants N: 1015 int., 1018
Control Level of risk for CVD: High (post-MI)
Male: 100%
Mean age, sd: 56.7 int., 56.4 control
Age range: Unclear
Smokers: 61.7% int., 62.2% control
Hypertension: 22.7% int., 24.6% control
Location: UK
Interventions Type: dietary advice (to eat more oily fish)
Intervention: Advised to eat at least 2 weekly portions of 200-400g fatty fish (mackerel, herring, kipper, pilchard, sardine, salmon, trout). If this was not possible, given MaxEPA capsules, 3/d (0.5g EPA/d). 191 of 883 participants were taking MaxEPA at 2 years. Advice was reinforced 3-monthly.
Control: No such dietary advice or capsules.
Compliance: 7 day weighed food diary of a random sub-sample indicated intake of 2.5g/week EPA int., 0.8g/week EPA control.
Length of intervention: 24 mo
Outcomes Main study outcome: total mortality, reinfarction, CV death
Dropouts: none for mortality
Available outcomes: total and CV deaths, MI, combined CV events
Response to contact: Yes
Notes Some of each group were also advised on low fat and/or high fibre diets, all participants who smoked were advised to stop and all with a BMI >30 were given weight reduction advice, regardless of randomisation arm
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Unclear B - Unclear