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. 2018 Jul 18;2018(7):CD003177. doi: 10.1002/14651858.CD003177.pub3
Methods RCT, parallel (n‐3 EPA + DHA vs MUFA), 12 months
Summary risk of bias: moderate to high
Participants Adults with documented coronary heart disease
N: 15 intervention, 15 control
Level of risk for CVD: high
Men: unclear
Mean age in years (SD): 52 (9) intervention, 54 (7) control
Age range: not reported
Smokers: 87% intervention, 100% control
Hypertension: not reported
Medications taken by at least 50% of those in the control group: aspirin, beta‐blockers
Medications taken by 20%‐49% of those in the control group: not reported
Medications taken by some, but less than 20% of the control group: not reported
Lipid lowering medications were not allowed
Location: Germany
Ethnicity: not reported
Interventions Type: fish oil capsules
Comparison: EPA + DHA vs MUFA
Intervention: 9 × 1 g capsules/day of fish oils (20% EPA, 15% DHA, 3.15 g/day total omega 3). Dose: 3.15 g/d EPA + DHA
Control: 9 × 1 g capsules/day olive oil (which contains 6.3 g/day MUFA, 1.35 g/day SFA, 1.35 g/d total omega 6 fat)
Compliance: assessed by pill counts and FA in body tissue analysis
Length of intervention: 12 months
Outcomes Main study outcome: blood lipids and FA in body tissues
Dropouts: 0 intervention, 0 control
Available outcomes: mortality (nil death), CVD events (nil), lipids (only TC used as the others were different at baseline), adverse events, serum fatty acids
Response to contact: yes
Notes Study funding: unclear
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated list
Allocation concealment (selection bias) Unclear risk No details. They received their initial allocation in a sealed box in person; subsequent doses arrived in the post
Blinding of participants and personnel (performance bias) All outcomes Unclear risk No further details beyond stating "double blind"
Blinding of outcome assessment (detection bias) All outcomes Unclear risk No details
Incomplete outcome data (attrition bias) All outcomes Low risk No attrition
Selective reporting (reporting bias) Unclear risk No trial register or protocol found
Attention Low risk No difference between groups
Compliance Unclear risk Measured but no results
Other bias Low risk None noted