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. 2012 May 16;2012(5):CD002137. doi: 10.1002/14651858.CD002137.pub3

Rose 1965.

Methods RCT
Participants Men (?) with angina or following MI (UK)
 CVD risk: high
 Control: randomised 26, analysed 18
 Intervention ‐ olive: randomised 28, analysed 12
Intervention ‐ corn: randomised 26, analysed 13
 Mean years in trial: control 1.7, olive 1.5, corn 1.5
 % male: unclear (100%?)
 Age: mean control 58.8, olive 55.0, corn 52.6 (all <70)
Interventions Modified fat vs. usual diet
Control aims: usual diet
 Intervention aims ‐olive: restrict dietary fat, plus 80g/day olive oil provided
Intervention aims ‐ corn: restrict dietary fat, plus 80g/day corn oil provided
Control methods: usual physician care plus follow up clinic monthly, then every 2 months, no dietary fat advice or oil provided
Intervention methods: usual physician care plus follow up clinic monthly, then every 2 months, dietary fat advice plus oil provided
Total fat intake (at 18 months): corn 50.5 (sd unclear), olive 46.2 (sd unclear), cont 32.6 (sd unclear)%E
Saturated fat intake: unclear
Style: diet advice & supplement (oil)
Setting: community
Outcomes Stated trial outcomes: cardiac events
 Data available on total mortality? yes
 Cardiovascular mortality? yes
 Events available for combined cardiovascular events: cardiovascular deaths, non‐fatal MI, angina, stroke
Secondary outcomes: stroke (none), non‐fatal and total MI
Tertiary outcomes: total cholesterol
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "sealed envelopes"
Allocation concealment (selection bias) Unclear risk Unclear if envelopes were opaque
Blinding (performance bias and detection bias) 
 All outcomes High risk Physician blinding: inadequate
 Participant blinding: inadequate
Incomplete outcome data (attrition bias) 
 All outcomes High risk Some lost to follow up by 2 years
Selective reporting (reporting bias) Low risk Not relevant for primary and secondary outcomes as all trialists asked for data
Other bias Low risk  
Free of systematic difference in care? Low risk All received conventional treatments at the discretion of the physicians, all attended a special follow up clinic. See Control and Intervention Methods in Interventions section of the Table of Characteristics of Included Studies
Free of dietary differences other than fat? Low risk See Control and Intervention Aims in Interventions section of the Table of Characteristics of Included Studies