Pilkington 1960.
| Methods | RCT | |
| Participants | Men with angina or who have had a MI (UK)
CVD risk: high
Reduced fat: randomised unclear, analysed 12
Modified fat: randomised unclear, analysed 23
Mean years in trial:reduced fat 1.1, modified fat 1.1
% male: reduced fat 100%, modified fat 100%
Age: not stated Baseline BMI: not reported |
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| Interventions | Reduced fat vs modified fat diet Reduced fat aims: total fat 20 g/d, advice to avoid dairy fats except skimmed milk plus 1 egg or 21 g cheese/d. Lean meat and fish each allowed once/d, other non‐fatty foods allowed in unlimited quantities Modified fat aims: fat aims not stated, dairy produce avoided except skimmed milk, 90 ml/d soya oil provided, lean meat originally prohibited but allowed after 6 months along with 113 g/wk of 'relatively unsaturated margarine'. Fish and vegetables allowed freely Reduced fat methods: unclear, "dietary histories taken before and during treatment" Modified fat methods: unclear, "dietary histories taken before and during treatment" Weight goals: non‐fatty foods not restricted, no weight goals mentioned Total fat intake (during treatment): low fat 15.8 (SD unclear) %E, mod fat 36 (SD unclear) %E Saturated fat intake: unclear Style: diet advice Setting: community |
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| Outcomes | Stated trial outcomes: lipids Available outcomes: weight, total and LDL cholesterol |
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| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "randomised" |
| Allocation concealment (selection bias) | Unclear risk | No details provided |
| Blinding (performance bias and detection bias) All outcomes | High risk | No for participants, unclear for outcome assessors |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear exactly how many were randomised, but paper suggests that all randomised participants were analysed |
| Selective reporting (reporting bias) | Unclear risk | No protocol found |
| Other bias | Low risk | |
| Free of systematic difference in care? | Low risk | Appear to be similar levels of assessment and support in both arms |
| Free of dietary differences other than fat? | Low risk | Dietary focus entirely on fat |