Rose corn oil 1965.

Study characteristics
Methods	RCT Summary risk of bias: moderate to high
Participants	Men (?) with angina or following MI (UK) CVD risk: high Control: randomised 26, analysed 18 Intervention ‐ corn: randomised 26, analysed 13 Mean years in trial: control 1.7, corn 1.5 % male: unclear (100%?) Age: mean control 58.8, corn 52.6 (all < 70) Ethnicity: not stated Statins use allowed? Unclear (anti‐coagulants not allowed, but all participants received conventional treatments at the discretion of their physicians) % taking statins: Not reported (probably none as too early, pre‐1980)
Interventions	Modified fat vs usual diet Control aims: usual diet Intervention aims ‐ corn: restrict dietary fat, plus 80 g/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 Unclear how the advice was delivered or by whom Total fat intake, %E (at 18 months): corn 50.5 (SD unclear), cont 32.6 (SD unclear) (mean difference 17.90, 95% CI 10.77 to 25.03 assuming SDs of 10) significant increase Saturated fat intake: unclear (mean difference unclear) PUFA intake: unclear PUFA n‐3 intake: not reported PUFA n‐6 intake: not reported MUFA intake: unclear CHO intake, %E (at 18 months): corn 36.5 (SD unclear), cont 51.5 (|SD unclear) (mean difference ‐15.00, 95% CI ‐29.27 to ‐0.73 assuming SDs of 20) significant reduction Protein intake, %E (at 18 months): corn 11.0 (SD unclear), cont 13.2 (SD unclear) (mean difference ‐2.20, 95% CI ‐5.77 to 1.37 assuming SDs of 5) no significant difference Trans fat intake: unclear Replacement for saturated fat: mainly PUFA (based on aims and achievements) Style: diet advice and 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, CHD mortality (fatal MI and sudden death), CHD events (all MI and sudden death) Tertiary outcomes: total cholesterol
Notes	Study duration 2 years Study aim was to reduce total fat (by restricting fatty meat, sausages, pastry, ice cream, cheese, cake, milk, eggs and butter) and prescribe vegetable oil (so reducing saturates), but saturated fat intakes during intervention were not reported. SFA reduction aimed (but unclear whether achieved as SFA intake not reported) Total serum cholesterol, difference between intervention and control, mmol/L: ‐0.58 (95% CI ‐1.42 to 0.26), NO statistically significant reduction but > 0.20 Trial dates: unclear, published in 1965 Funding: probably unfunded (they thank the Paddington General Hospital for clinic facilities, and St Mary's and Paddington General Hospital physicians for referral of patients, but no funding acknowledged) Declarations of Interest of primary researchers: none stated, all authors worked for academic or health institutions.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Trial was stated as "randomised" but without further detail, apart from use of a sealed envelope as below.
Allocation concealment (selection bias)	Unclear 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.
Blinding of participants and personnel (performance bias) All outcomes	High 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) CVD outcomes	Low risk	The electrocardiograms were assessed without the knowledge of the participant's treatment group.
Blinding of outcome assessment (detection bias) All‐cause mortality	Low risk	Blinding is not relevant in assessment of mortality.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Some lost to follow‐up by 2 years, so some events may have been missed
Selective reporting (reporting bias)	Low risk	Not relevant for primary and secondary outcomes as all trialists were asked for data.
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 the Interventions section of the table of Characteristics of included studies
Stated aim to reduce SFA	Low risk	Aim to reduce SFA stated
Achieved SFA reduction	Unclear risk	SFA intake not reported
Achieved TC reduction	High risk	Although the TC in the intervention group was 0.58 mmol/L lower than in the control group, this was not statistically significant in this small study.
Other bias	Low risk	None noted