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) |
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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 |
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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 |
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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 |