Rose 1965.
Methods | RCT, 2 arms, parallel (n6 LA vs MUFA), 24 months Summary risk of bias: moderate to high |
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Participants | People with ischaemic heart disease
CVD risk: high
N: 28 intervention, 26 control (analysed 15 intervention, 12 control)
% male: not reported
Mean age: 52.6 intervention, 55 control (no SDs) Age range: not reported Smokers: not reported Hypertension: not reported Medications taken by ≥ 50% of those in the control group: not reported Medications taken by 20%‐49% of those in the control group: not reported Medications taken by some, but < 20% of the control group: not reported Location: UK Ethnicty: not reported |
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Interventions | Type: test oil provided (equivalent advice to both arms) Comparison: n‐6 vs MUFA Intervention: 80 g/day corn oil to be taken in 3 equal doses at meal‐times plus participants were instructed to avoid fried foods. Fatty meat, sausages, pastry, ice‐cream, cheese, cakes, milk, eggs, butter were restricted: assuming 80% LA in corn oil, 64 g/d LA or 576 kcal/d or 28.8% E from LA Control: 80 g/day olive oil plus participants were instructed to avoid fried foods, fatty meat, sausages, pastry, ice‐cream, cheese, cakes, milk, eggs, butter were restricted. assuming 12% LA and 69% MUFA in olive oil, 9.6 g/d LA or 4.3% E LA and 55.2 g/d MUFA or 24.8% E Dose aim: +24.5% E from LA, ‐24.8% E MUFA Baseline PUFA: unclear Compliance using biomarkers: serum TC reduced, but not statistically significantly reduced in intervention compared to control (‐0.49 mmol/L, 95% CI ‐1.34 to 0.36). No fatty acid biomarkers reported. Compliance using dietary assessment: poor. Measured using questionnaire. Mean intake of oil in intervention was 595 kcal/d or 476 kcal/d LA or 23.8% E, in control 540 kcal/d or 3.2% E LA and 18.6% E MUFA, achieved: +20.6% E from LA, ‐18.6% E MUFA within the oils, unclear how diet altered
Compliance by other methods: no others reported Inclusion basis: aim was to increase omega‐6 fats, not total PUFA. Total PUFA not reported but LA dose so big that total PUFA must have been increased in intervention compared to control. Best estimate 20.6% E total PUFA dose, > 10% increase from baseline PUFA dose: according to questionnaire 20.6% E from LA, assume equivalent to 20.6% E from total PUFA Duration of intervention: 2 years |
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Outcomes | Main trial outcome: occurrence of infraction
Dropouts: 6 intervention, 11 control?, details provided in table but unclear how many dropped out.
Available outcomes: major CVD events, MI (fatal and non‐fatal), sudden death, serum cholesterol Response to contact: not attempted as published in the 1960s |
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Notes | Trial funding: no details The trial had a 3rd control arm (no intervention), which has not been used here. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | When a new participant was accepted for the trial a sealed envelope was opened containing the allocation instructions. In the case of participants allocated to an oil group the instructions referred only to a code number. |
Allocation concealment (selection bias) | Unclear risk | Unclear |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | The physicians in charge knew which participants were receiving oil, but they did not know until the end of the trial the kind of oil that they were receiving. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The electrocardiograms were assessed without the knowledge of the participant's treatment group |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 52% intervention, and 57% control remained in the trial after 24 months. However, the list of reasons and complications is provided. |
Selective reporting (reporting bias) | Unclear risk | No trial registry record or protocol found |
Attention bias | Low risk | Oil provided to both groups, appeared similar |
Compliance | Low risk | TC somewhat reduced in intervention compared to control (‐0.49 mmol/L, 95% CI ‐1.34 to 0.36). No fatty acid biomarkers reported |
Other bias | Low risk | None noted |