PMID- 34290045 OWN - NLM STAT- MEDLINE DCOM- 20211129 LR - 20211129 IS - 2053-3624 (Print) IS - 2053-3624 (Electronic) IS - 2053-3624 (Linking) VI - 8 IP - 2 DP - 2021 Jul TI - 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. LID - 10.1136/openhrt-2021-001680 [doi] LID - e001680 AB - 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. CI - (c) Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Noakes, Timothy David AU - Noakes TD AD - Applied Design, Cape Peninsula University of Technology, Bellville, South Africa timothy.noakes@uct.ac.za. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PT - Review PL - England TA - Open Heart JT - Open heart JID - 101631219 SB - IM MH - Coronary Disease/epidemiology/*prevention & control MH - *Diet, Fat-Restricted MH - Female MH - Humans MH - Morbidity/trends MH - Outcome Assessment, Health Care/*methods MH - *Postmenopause MH - Randomized Controlled Trials as Topic/*methods MH - Risk Assessment/*methods MH - Risk Factors MH - United States/epidemiology MH - *Women's Health PMC - PMC8296783 OTO - NOTNLM OT - coronary artery disease OT - diabetes mellitus OT - epidemiology OT - risk factors COIS- Competing interests: TDN is the author of a number of books on low-carbohydrate diet, including The Real Meal Revolution, Super Food for Superchildren, Lore of Nutrition, The Banting Pocket Guide, Real Food on Trial and The Eat Right Revolution. TDN derives no personal income from the sale of these books. Instead all royalties are donated to the NGO The Noakes Foundation, of which TDN is the chairman. The money is used to fund the work of The Noakes Foundation, including the Eat Better South Africa Campaign. EDAT- 2021/07/23 06:00 MHDA- 2021/11/30 06:00 PMCR- 2021/07/21 CRDT- 2021/07/22 05:43 PHST- 2021/06/14 00:00 [accepted] PHST- 2021/07/22 05:43 [entrez] PHST- 2021/07/23 06:00 [pubmed] PHST- 2021/11/30 06:00 [medline] PHST- 2021/07/21 00:00 [pmc-release] AID - openhrt-2021-001680 [pii] AID - 10.1136/openhrt-2021-001680 [doi] PST - ppublish SO - Open Heart. 2021 Jul;8(2):e001680. doi: 10.1136/openhrt-2021-001680.