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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 using prepared envelopes
Allocation concealment: Unclear
Participants masked: No
Providers masked: No Outcome assessors masked: Yes
Summary risk of bias: medium or high
Participants N: 1571 int., 1543
Control Level of risk for CVD: High (men being treated for angina)
Male: 100%
Mean age, sd: 61.1 int., 61.1 control
Age range: Unclear
Smokers: 25% int., 23% control
Hypertension: 49% int., 47% control
Location: UK
Interventions Type: dietary advice (to eat more oily fish)
Intervention: Most (1109) advised to eat at least 2 weekly portions of fatty fish OR take MaxEPA capsules, 3/d (0.5g EPA/d). But 462 participants were sub-randomised to receive only fish oil capsules, not dietary fish advice.
Control: No such dietary advice or capsules.
Compliance: Postal dietary questionnaire suggested dietary EPA intake increased by 2.4g /week int., 0.2g /week control
Length of intervention: 36 to 108 mo
Outcomes Main study outcome: total mortality
Dropouts: none for mortality
Available outcomes: total and CV deaths, sudden death
Response to contact: Yes
Notes Some of each group were also advised on high fruit, veg and oat diets, and those who received neither fish nor fruit advice received ‘non-specific’ dietary advice. All those whose BMI >30 in both groups received weight reduction advice
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Unclear B - Unclear