Methods | RCT, parallel (n‐3 EPA + DHA vs MUFA), 12 months Summary risk of bias: moderate to high |
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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 |
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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 |
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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 |
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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 |