Abstract | OBJECTIVE: DESIGN: Evaluation of recovered data from the Sydney Diet Heart Study, a single blinded, parallel group, randomized controlled trial conducted in 1966-73; and an updated meta-analysis including these previously missing data. SETTING: Ambulatory, coronary care clinic in Sydney, Australia. PARTICIPANTS: 458 men aged 30-59 years with a recent coronary event. INTERVENTIONS: Replacement of dietary saturated fats (from animal fats, common margarines, and shortenings) with omega 6 linoleic acid (from safflower oil and safflower oil polyunsaturated margarine). Controls received no specific dietary instruction or study foods. All non-dietary aspects were designed to be equivalent in both groups. OUTCOME MEASURES: All cause mortality (primary outcome), cardiovascular mortality, and mortality from coronary heart disease (secondary outcomes). We used an intention to treat, survival analysis approach to compare mortality outcomes by group. RESULTS: The intervention group (n=221) had higher rates of death than controls (n=237) (all cause 17.6% v 11.8%, hazard ratio 1.62 (95% confidence interval 1.00 to 2.64), P=0.05; cardiovascular disease 17.2% v 11.0%, 1.70 (1.03 to 2.80), P=0.04; coronary heart disease 16.3% v 10.1%, 1.74 (1.04 to 2.92), P=0.04). Inclusion of these recovered data in an updated meta-analysis of linoleic acid intervention trials showed non-significant trends toward increased risks of death from coronary heart disease (hazard ratio 1.33 (0.99 to 1.79); P=0.06) and cardiovascular disease (1.27 (0.98 to 1.65); P=0.07). CONCLUSIONS: TRIAL REGISTRATION: Clinical trials NCT01621087.
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Authors | Christopher E Ramsden, Daisy Zamora, Boonseng Leelarthaepin, Sharon F Majchrzak-Hong, Keturah R Faurot, Chirayath M Suchindran, Amit Ringel, John M Davis, Joseph R Hibbeln |
Journal | BMJ (Clinical research ed.)
(BMJ)
Vol. 346
Pg. e8707
(Feb 04 2013)
ISSN: 1756-1833 [Electronic] England |
PMID | 23386268
(Publication Type: Journal Article, Meta-Analysis, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, N.I.H., Intramural, Research Support, Non-U.S. Gov't)
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Chemical References |
- Dietary Fats
- Plant Oils
- Linoleic Acid
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Topics |
- Adult
- Coronary Disease
(diet therapy, mortality, prevention & control)
- Diet, Fat-Restricted
(methods)
- Dietary Fats
(adverse effects)
- Epidemiologic Methods
- Humans
- Linoleic Acid
(administration & dosage)
- Male
- Middle Aged
- New South Wales
(epidemiology)
- Plant Oils
(administration & dosage)
- Secondary Prevention
(methods)
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