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Hiding unhealthy heart outcomes in a low-fat diet trial: the Women's Health Initiative Randomized Controlled Dietary Modification Trial finds that postmenopausal women with established coronary heart disease were at increased risk of an adverse outcome if they consumed a low-fat 'heart-healthy' diet.

Open heart
July 1, 2021
Timothy David Noakes
Journal ArticleResearch Support, Non-U.S. Gov'tReviewHuman Study
Study Details

Study Goal

The study aimed to test whether the US Department of Agriculture's 1977 Dietary Guidelines for Americans, specifically a low-fat 'heart-healthy' diet, protects against coronary heart disease (CHD) and other chronic diseases in postmenopausal women.

Results Summary

The study found that postmenopausal women with CHD randomized to a low-fat high-carbohydrate diet had a 26% greater risk of additional CHD events initially, which increased to 47%-61% after extended follow-up. The authors suggest this adverse outcome may be due to insulin resistance exacerbated by the diet, challenging the evidence base for such dietary guidelines in this population.

Population

Postmenopausal women with coronary heart disease (CHD) and features of insulin resistance, including type 2 diabetes mellitus (T2DM).

Effective Dosage

Not specified

Duration

13 years

Interactions

None mentioned

Extracted Claims (6)
InterventionDirectionEndpointPopulationDosageImpactClaim #
low-fat 'heart-healthy' diet
increase
additional CHD events
postmenopausal women with CHD
26%
were at 26% greater risk of developing
#1
low-fat 'heart-healthy' diet
increase
CHD risk
postmenopausal women with CHD
47%-61%
had increased further to
#2
high-fat low-carbohydrate diet
decrease
All the worst clinical features of IR, including type 2 diabetes mellitus (T2DM)
postmenopausal women with features of insulin resistance (IR)
-
can be 'reversed'
#3
-
increase
future CHD development
women
10.71-fold
10.71-fold increased risk
#4
-
increase
future CHD development
women
6.09-fold
6.09-fold increased risk
#5
-
increase
future CHD development
women
1.38-fold
1.38-fold increased risk
#6
Abstract

The Women's Health Initiative Randomized Controlled Dietary Modification Trial (WHIRCDMT) was designed to test whether the US Department of Agriculture's 1977 Dietary Guidelines for Americans protects against coronary heart disease (CHD) and other chronic diseases. The only significant finding in the original 2006 WHIRCDMT publication was that postmenopausal women with CHD randomised to a low-fat 'heart-healthy' diet in 1993 were at 26% greater risk of developing additional CHD events compared with women with CHD eating the control diet. A 2017 WHIRCDMT publication includes data for an additional 5 years of follow-up. It finds that CHD risk in this subgroup of postmenopausal women had increased further to 47%-61%. The authors present three post-hoc rationalisations to explain why this finding is 'inadmissible': (1) only women in this subgroup were less likely to adhere to the prescribed dietary intervention; (2) their failure to follow the intervention diet increased their CHD risk; and (3) only these women were more likely to not have received cholesterol-lowering drugs. These rationalisations appear spurious. Rather these findings are better explained as a direct consequence of postmenopausal women with features of insulin resistance (IR) eating a low-fat high-carbohydrate diet for 13 years. All the worst clinical features of IR, including type 2 diabetes mellitus (T2DM) in some, can be 'reversed' by the prescription of a high-fat low-carbohydrate diet. The Women's Health Study has recently reported that T2DM (10.71-fold increased risk) and other markers of IR including metabolic syndrome (6.09-fold increased risk) were the most powerful predictors of future CHD development in women; blood low-density lipoprotein-cholesterol concentration was a poor predictor (1.38-fold increased risk). These studies challenge the prescription of the low-fat high-carbohydrate heart-healthy diet, at least in postmenopausal women with IR, especially T2DM. According to the medical principle of 'first do no harm', this practice is now shown to be not evidence-based, making it scientifically unjustifiable, perhaps unethical.

Medical Subject Headings (MeSH)
Coronary DiseaseDiet, Fat-RestrictedFemaleHumansMorbidityOutcome Assessment, Health CarePostmenopauseRandomized Controlled Trials as TopicRisk AssessmentRisk FactorsUnited StatesWomen's Health
Study Links
Quality Scores
Safety30
Efficacy20/10
Quality85/10
Citation Metrics
Total Citations9
Citations/Year2.3
Relative Citation Ratio0.83
NIH Percentile43.3%
Research Impact Scores
APT Score0.75
Weight Score2.54
Normalized Score0.37
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