DART 1989.
| Methods | Diet And Reinfarction Trial (DART) – oily fish advice (or capsule) arm RCT – parallel, 2 × 2 × 2 factorial (n‐3 EPA + DHA vs nil or fat advice vs not, oily fish advice (or capsule) vs not, dietary fibre advice vs not)), 2 years Summary risk of bias: moderate or high |
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| Participants | Men recovering from myocardial infarction N: 1015 intervention, 1018 Level of risk for CVD: high (post‐MI) Men: 100% Mean age, SD: 56.7 intervention, 56.4 control (SDs not stated) Age range: unclear Smokers: 61.7% intervention, 62.2% control Hypertension: 22.7% intervention, 24.6% control Medications taken by at least 50% of those in the control group: none reported Medications taken by 20%‐49%: beta‐blockers, other antihypertensives, antianginals Medications taken by some, but < 20%: anticoagulant, aspirin/antiplatelet, digoxin/antiarrhythmic Location: UK Ethnicity: not stated |
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| Interventions | Type: dietary advice (to eat more oily fish) Comparison: EPA + DHA vs SFA + MUFA (by dietary achievement below) Intervention: advised to eat at least 2 weekly portions of 200‐400 g fatty fish (mackerel, herring, kipper, pilchard, sardine, salmon, trout). If this was not possible, given MaxEPA capsules, 3/d (0.5 g EPA/d). 191/883 participants were taking MaxEPA at 2 years. Advice was reinforced 3‐monthly. Dose: aimed for 0.5 g/d EPA Control: No such dietary advice or capsules Compliance: 7 day weighed food diary of a random sub‐sample indicated intake of 2.5 g/week EPA intervention, 0.8 g/week EPA control Dietary achievements Total fat intake, %E (through study): control 35 (SD 6), intervention 31 (SD 7) (MD −4.00, 95% CI −4.57 to −3.43); significant reduction Saturated fat intake, %E (through study): control 15 (SD 3), intervention 11 (SD 3), (MD −4.00, 95% CI −4.26 to −3.74); significant reduction PUFA intake (through study), %E⁑: control 7 (SD unclear), intervention 9 (SD unclear), (MD 2.00, 95% CI 1.57 to 2.43 assuming SDs of 5) significant increase PUFA n‐3 intake: EPA, control 0.6 (SD 0.7) g/week, intervention 2.4 (SD 1.4) g/week PUFA n‐6 intake: not reported MUFA intake (through study), %E⁑: control 13 (SD unclear), intervention 11 (SD unclear) (MD −2.00, 95% CI −2.43 to −1.57 assuming SDs of 5); significant reduction CHO intake (through study), %E: control 44 (SD 6),intervention 46 (SD 7) (MD 2.00, 95% CI 1.43 to 2.57); significant increase Protein intake (through study), %E: control 17(SD 4), intervention 18 (SD 4) (MD 1.00, 95% CI 0.65 to 1.35); significant increase Trans fat intake: not reported Length of intervention: 24 months |
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| Outcomes | Main study outcome: total mortality, reinfarction, CHD death Dropouts: none for mortality Available outcomes: total and CV deaths, MI, CHD events, lipids, blood pressure, cancer deaths Response to contact: yes (data provided) |
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| Notes | Some of each group were also advised on low fat and high PUFA and/or high fibre diets, all participants who smoked were advised to stop and all with a BMI > 30 kg/m2 were given weight reduction advice, regardless of randomisation arm. The low fat high PUFA comparison was included in the omega‐6 review. Study funding: by the Welsh Scheme for the Development of Health and Social Research, the Welsh Heart Foundation and the Health Promotion, Research Trust. Seven Seas Health Care and Duncan Flockhart provided Maxepa capsules |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "randomised" confirmed by author |
| Allocation concealment (selection bias) | Unclear risk | Pre‐prepared sequentially numbered enveloped opened by dietitian (unclear if envelopes were opaque) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of dietary advice (or lack of it) is not possible |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors were not aware of study allocation (Prof Burr stated he did not know assignments) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Hospital notes and death registers were flagged to catch all outcome data |
| Selective reporting (reporting bias) | Unclear risk | No study protocol or trials register entry was found |
| Attention | High risk | More attention was paid to those given dietary advice |
| Compliance | Unclear risk | 7 day weighed food diary of a random sub‐sample indicated intake of 2.5 g/week EPA intervention, 0.8 g/week EPA control |
| Other bias | Low risk | None noted |