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. 2018 Nov 27;2018(11):CD012345. doi: 10.1002/14651858.CD012345.pub3

Rose 1965.

Methods RCT, 2 arms, parallel (n6 LA vs MUFA), 24 months
Summary risk of bias: moderate to high
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
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
  • Energy intake: intervention 2070 kcal/d control 2045 kcal/d

  • Total fat intake: intervention 50 g/d + 595 kcal from oil or 1045 kcal/d or 52% E, control 45 g/d + 540 kcal from oil or 945 kcal/d or 47.3% E

  • SFA intake: not reported

  • PUFA intake: not reported

  • PUFA n‐3 intake: not reported

  • PUFA n‐6 intake: +20.6% E (higher in intervention than control)

  • Trans fat intake: not reported (oils provided so not likely to be a problem)

  • MUFA intake: ‐18.6% E (lower in intervention than control)

  • CHO intake: intervention 189 g/d or 756 kcal/d or 37.8% E, control 216 g/d or 864 kcal/d or 43.2% E

  • Sugars intake: not reported

  • Protein intake: intervention 57 g/d or 228 kcal/d or 11.4% E, control 49 g/d or 196 kcal/d or 9.8% E

  • Alcohol intake: not reported


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
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
Notes Trial funding: no details
The trial had a 3rd control arm (no intervention), which has not been used here.
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