Science Skepticism

 

“You can’t tell whether I’m lying, delusional, ignorant, or simply incompetent. Sometimes even I don’t know!”

I ran across a 2016 article by Callie Joubert that summarizes skeptical ideas I’ve read about for years, but most people and physicians don’t know about. Bottom line: scientific research and medical studies aren’t nearly as reliable as you think.

Read the whole thing, but here are some excerpts:

We tend to think of science as a dispassionate (impartial, neutral) search for truth and certainty. But is it possible that we are facing a situation in which there is a massive production of wrong information or distortion of information? Is it possible that certain scientific disciplines are facing a crisis of credibility? Mounting evidence suggests this is indeed the case, which raises two questions: How serious is the problem? And what could explain this?

***

The title of an editorial in the prestigious medical journal The Lancet, dated April 6, 2002, asks the question, “Just How Tainted Has Medicine Become?”4 The article states, “Heavily, and damagingly so, is the answer.” Among other things, in 2001, researchers completed experiments with biotechnology products in which they had a direct financial interest and doctors did not tell their patients that others had died using these products when safer alternatives were available. In the same journal, dated April 11, 2015, Dr. Richard Horton stated the gravity of the problem as follows: “The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue . . . science has taken a turn towards darkness.”

In 2004, under the heading of “Depressing Research,” the editor of The Lancet had this to say about antidepressants for children: “The story of research into selective serotonin reuptake inhibitor (SSRI) use in childhood depression is one of confusion, manipulation, and institutional failure. . . . In a global medical culture where evidence-based practice is seen as the gold standard for care, these failings [i.e., of the USA Food and Drug Administration to act on information provided to them about the harmful effects of these drugs on children] are a disaster.”6 After being editor of the New England Journal of Medicine for 20 years, Dr. Marcia Angell stated that “physicians can no longer rely on the medical literature for valid and reliable information.”7 She referred to a study of 74 clinical trials of antidepressants that indicates that 37 of 38 positive studies were published. In contrast, 33 of the 36 negative studies were either not published or published in a form that conveyed a positive outcome. She also mentions the fact that drug companies are financing “most clinical research on the prescription drugs, and there is mounting evidence that they often skew the research they sponsor to make their drugs look better and safer.”

In 2011, researchers at Bayer decided to test 67 recent drug discoveries on preclinical cancer biology research. In more than 75 percent of cases, the published data did not match their attempts to replicate them.8 In 2012, a study published in Nature announced that only 11 percent of the sampled preclinical cancer studies coming out of the academic pipeline were replicable.9

In the prestigious Science journal, in 2015, the Open Science Collaboration10 presented a study of 100 psychological research studies that 270 contributing authors tried to replicate. An astonishing 65 percent failed to show any statistical significance on replication, and many of the remainder showed greatly reduced effect sizes. In plain terms, evidence for original findings is weak.

***

A discovery in physics, the hardest of all hard sciences, is usually thought of as the most reliable in the world of science. However, two of the most vaunted physics results of the past few years—“cosmic inflation and gravitational waves at the BICEP2 experiment in Antarctica, and the supposed discovery of superluminal neutrinos at the Swiss-Italian border—have now been retracted, with far less fanfare than when they were first published.”

***

Parker here again….

The science skeptic best known to physicians is John P.A. Ioannidis:

Empirical evidence from diverse fields suggests that when efforts are made to repeat or reproduce published research, the repeatability and reproducibility is dismal.

Another quote form Ioannidis:

There is increasing concern that most current published research findings are false. The probability that a research claim is true may depend on study power and bias, the number of other studies on the same question, and, importantly, the ratio of true to no relationships among the relationships probed in each scientific field. In this framework, a research finding is less likely to be true when the studies conducted in a field are smaller; when effect sizes are smaller; when there is a greater number and lesser preselection of tested relationships; where there is greater flexibility in designs, definitions, outcomes, and analytical modes; when there is greater financial and other interest and prejudice; and when more teams are involved in a scientific field in chase of statistical significance. Simulations show that for most study designs and settings, it is more likely for a research claim to be false than true. Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias.

Ioannidis again:

Most physicians and other healthcare professionals are unaware of the pervasiveness of poor quality clinical evidence that contributes considerably to overuse, underuse, avoidable adverse events, missed opportunities for right care and wasted healthcare resources. The Medical Misinformation Mess comprises four key problems. First, much published medical research is not reliable or is of uncertain reliability, offers no benefit to patients, or is not useful to decision makers. Second, most healthcare professionals are not aware of this problem. Third, they also lack the skills necessary to evaluate the reliability and usefulness of medical evidence. Finally, patients and families frequently lack relevant, accurate medical evidence and skilled guidance at the time of medical decision‐making.

If you like videos, here’s Ioannidis on YouTube.

Staying skeptical,

Steve Parker, M.D.

h/t Vox Day

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Prevent Cardiovascular Events By Taking Hypertension Meds at Bedtime

High blood pressure is linked to heart attacksVery

This may be the most important biomedical research of 2019. Very recently I have noticed hypertension patients taking their medications at bedtime. Now I know why.

From Medscape:

Taking antihypertensive medication at bedtime led to an almost halving of cardiovascular events in a new study.

The Hygia Chronotherapy Trial is the largest ever study to investigate the effect of the time of day when people take their antihypertensive medication on the risk of cardiovascular events.

The trial randomly assigned 19,084 patients to take their medication on waking or at bedtime and followed them for an average of 6 years.Results showed that patients who took their pills at bedtime had a 45% reduction in overall cardiovascular events. This included a 56% reduction in cardiovascular death, a 34% reduction in myocardial infarction (MI), a 40% reduction in coronary revascularization [bypass surgery and angioplasty/stenting], a 42% reduction in heart failure, and a 49% reduction in stroke, all of which were statistically significant.

***

“We showed that if blood pressure is elevated during sleep then patients have increased cardiovascular risk regardless of daytime pressure, and if blood pressure during sleep is normal then cardiovascular risk is low even if the [doctor’s] office pressure is elevated,” Hermida said.

***

Results showed that during the 6.3-year median patient follow-up, 1752 participants experienced the primary cardiovascular disease (CVD) outcome (a composite of CVD death, MI, coronary revascularization, heart failure, or stroke).

Drug classes as physicians’ disposal were ARBs (angiotensin receptor blockers, calcium channel blockers, ACE inhibitors, and diuretics. Preventative effects were most pronounced for ARBs and ACE inhibitors.

Don’t change your BP medication dosing until you check with your personal physician.

Source: Bedtime Dosing of Hypertension Meds Reduces CV Events

Did you know most heart attacks occur in the morning, and those tend to be the most serious?

Steve Parker, M.D.

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Particular Diabetes Drugs May Protect Your Heart and Kidneys

 

Blood pressure control is also extremely important for protection of heart and kidneys

I’ve been reticent to tout the putative heart-protective effects of diabetes drugs in the classes called SGLT2 inhibitors and GLP-1 receptor agonists. Frankly, their supposed kidney-protective effects haven’t even been on my radar. My hesitation to report on these matters stems from:

Maybe if Big Pharma sent me a nice check….

The GLP-1 receptor agonists seem to have beneficial effects on both heart and kidney. With SGLT2 inhibitors, renal benefits may be more prominent than cardiac. Also note that any beneficial heart or renal effects may be attributable only to certain drug within the class, and not a class effect.

For what it’s worth, the American Diabetes Association recently hosted a conference on these issues. I assume the ADA endorses the report written by three experts, two of whom have received some sort of compensation from pharmaceutical companies. This doesn’t necessarily mean they are biased. Some excerpts:

Since patients with diabetes are at increased risk for CV [cardiovascular] and renal events, reducing the risk of these events is of primary interest to improve outcomes in the long-term. [Cardiovascular events usually refers to heart attacks, strokes, and death from those. Renal events would be high loss of protein through the kidneys, impaired kidney function or chronic kidney disease, or the need for dialysis.]

SGLT2 inhibitors and GLP-1 RAs have dramatically changed the treatment landscape of type 2 diabetes due to their established CV benefits, and the observed improvements in renal function seen with these classes of agents are currently undergoing intense investigation.

***

It is now apparent that both SGLT2 inhibitors and GLP-1 RAs show consistent reductions in major adverse cardiovascular events for patients with established cardiovascular (CV) disease, and both appear to have renal benefits as well.

***

The nephron is the microscopic structural and functional unit of the kidney.

Renal effects of GLP-1 receptor agonists

These drugs may exert their beneficial actions on the kidneys through their effects on lowering blood glucose and blood pressure and by reducing the levels of insulin.

For GLP-1RAs, these [studies] include ELIXA with lixisenatide, LEADER with liraglutide, SUSTAIN-6 with semaglutide, EXCSEL with exenatide once-weekly, HARMONY with albiglutide, and REWIND with dulaglutide.

All these studies indicate that albuminuria [protein loss through urine] is reduced during treatment with GLP-1 RAs, and eGFR [estimated glomerular filtration rate, a measure of kidney function] appears to be stabilized.

These benefits are seen independently of HbA1c, weight, and blood pressure variations.

***

Heart attack is only one type of cardiovascular event

Cardiovascular effects of GLP-1 receptor agonists

Large CV outcomes trials with GLP-1 RAs have shown that these agents can reduce the risk of major adverse CV events, CV mortality, and all-cause mortality.

These CV benefits appear to be related to four distinct mechanisms:

    • Improve myocardial [heart muscle] performance in ischemic heart failure [caused by poor blood flow to heart]
    • Improve myocardial survival in ischemic heart disease
    • Ameliorate endothelial dysfunction [endothelium is the lining of arteries]
    • Decrease markers of CV risk.

***

Renal effects of SGLT2 inhibitors

  • However, many potential mechanisms have been linked to the renoprotective effects of SGLT2 inhibitors.
  • These include reduction of blood pressure, improved metabolic parameters, reduced volume overload, reduction in albuminuria, and glomerular pressure.
  • For the latter, SGLT2 inhibition appears to reduce hyperfiltration via a tubuloglomerular feedback mechanism.
  • Clinical data from CV outcomes trials have shown consistent variations in eGFR and reduction in death from renal causes with empagliflozin, canagliflozin, and dapagliflozin.
  • However, to gain more information about the renal effects of these agents, dedicated renal outcomes trials are needed to study reductions in albuminuria, changes in eGFR, number of patients reaching end-stage renal disease, need for dialysis, and deaths due to kidney failure.

***

Key Messages from the authors

Large CV outcomes trials have shown that both SGLT2 inhibitors and GLP-1 RAs are associated with significant reductions in CV events in patients with elevated CV risk.

From CV outcomes trials both classes of agents also appear to have renal benefits, although large dedicated studies are needed to establish the magnitude of this potential benefit

The mechanism of action at the basis of CV and renal benefits of SGLT2 inhibitors and GLP-1 RAs is complex, multifactorial, and still not completely understood.

I’m still skeptical but will keep an open mind.

Steve Parker, M.D.

PS: Bold emphasis above is mine.

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Is a Very Low-Carb Diet Reasonable for Type 1 Diabetes?

Exercise was natural when we were kids

Bottom line: A very low-carb diet worked well for children and adults with type 1 diabetes in this relatively small study.

Abstract

OBJECTIVES:

To evaluate glycemic control among children and adults with type 1 diabetes mellitus (T1DM) who consume a very low-carbohydrate diet (VLCD).

METHODS:

We conducted an online survey of an international social media group for people with T1DM who follow a VLCD. Respondents included adults and parents of children with T1DM. We assessed current hemoglobin A1c (HbA1c) (primary measure), change in HbA1c after the self-reported beginning of the VLCD, total daily insulin dose, and adverse events. We obtained confirmatory data from diabetes care providers and medical records.

RESULTS:

Of 316 respondents, 131 (42%) were parents of children with T1DM, and 57% were of female sex. Suggestive evidence of T1DM (based on a 3-tier scoring system in which researchers took into consideration age and weight at diagnosis, pancreatic autoimmunity, insulin requirement, and clinical presentation) was obtained for 273 (86%) respondents. The mean age at diagnosis was 16 ± 14 years, the duration of diabetes was 11 ± 13 years, and the time following a VLCD was 2.2 ± 3.9 years. Participants had a mean daily carbohydrate intake of 36 ± 15 g. Reported mean HbA1c was 5.67% ± 0.66%. Only 7 (2%) respondents reported diabetes-related hospitalizations in the past year, including 4 (1%) for ketoacidosis and 2 (1%) for hypoglycemia.

CONCLUSIONS:

Exceptional glycemic control of T1DM with low rates of adverse events was reported by a community of children and adults who consume a VLCD. The generalizability of these findings requires further studies, including high-quality randomized controlled trials.

Source: Management of Type 1 Diabetes With a Very Low-Carbohydrate Diet. – PubMed – NCBI

Steve Parker, M.D.

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2019 ADA Conference Recommendations on Medical Nutrition Therapy (Diet)

Shrimp Salad

I’m astounded by how many people with diabetes I meet who pretty much eat whatever they want. Others, when I ask if they’re on a particular diet, say, “I watch what I eat.” Which usually just means avoiding obvious sugar bombs.

The American Diabetes Association in 2019 hosted a conference on nutrition therapy for diabetes. I assume the ADA endorses the panel’s recommendations. The big news is continued movement toward carb-restricted eating. Some excerpts:

Today, there is strong evidence to support both the efficacy and cost-effectiveness of nutrition therapy as a key component of integrated management of individuals with diabetes. This is increasingly relevant as it is evident that “one-size-fits-all” eating plan is not suitable for prevention or management of diabetes, also considering diverse cultural backgrounds, personal preferences, comorbidities, and socioeconomic settings. The American Diabetes Association (ADA) is now emphasizing that medical nutrition therapy (MNT) is fundamental for optimal diabetes management, and the new report also includes information on prediabetes.

***

One of the key recommendations is to refer adults living with type 1 or type 2 diabetes to individualized, diabetes-focused MNT [medical nutrition therapy] at diagnosis and as needed throughout the life span, particularly during times of changing health status to achieve treatment goals.

***

The new consensus recommendations consider that a variety of eating patterns are acceptable for the management of diabetes.

In the absence of additional strong evidence on the comparative benefits of different eating patterns in specific individuals, healthcare providers should focus on the key factors that are common among the patterns, including emphasizing non-starchy vegetables, minimizing added sugars and refined grains, and preferring whole foods over highly processed foods.

Reducing overall carbohydrate intake for individuals with diabetes is associated with the most evidence for improving glycemia and may be applied in a variety of eating patterns.

For selected adults with type 2 diabetes who are not meeting glycemic targets or where reducing anti-glycemic medications is a priority, reducing overall carbohydrate intake with low or very low carbohydrate eating plans is also a viable approach.

***

Regarding weight loss in overweight or obese folks with diabetes or prediabetes:

…a low carbohydrate diet is now recognized as a safe, viable, and important option for patients with diabetes, and the other is that greater emphasis is now placed on weight loss in patients who are overweight/obese for the prevention of diabetes and its treatment.

Indeed, in type 2 diabetes, 5% weight loss is recommended to achieve clinical benefits, with a goal of 15%, when feasible and safe, in order to achieve optimal outcomes.

In prediabetes, the goal is 7–10% for preventing progression to type 2 diabetes.

“Metabolic surgery,” better known as bariatric surgery, and medication-assisted weight loss (aka weight-loss drugs) should be considered in some cases.

***

Best approach for optimizing blood sugars:

For macronutrients, the available evidence suggests that there is not an ideal percentage of calories from carbohydrate, protein, and fat for all people with or at risk for diabetes; therefore, macronutrient distribution should be based on individualized assessment of current eating patterns, preferences, and metabolic goals.

[Self-monitoring of carbohydrate consumption is important.]

People with diabetes and those at risk for diabetes are encouraged to consume at least the amount of dietary fiber recommended for the general population; increasing fiber intake, preferably through food (vegetables, pulses (beans, peas, and lentils), fruits, and whole intact grains) or through dietary supplement, may help in modestly lowering HbA1C.

***

What about sugar-sweetened beverages?

Firstly, sugar-sweetened beverages should be replaced with water as often as possible.

Secondly, if sugar substitutes are used to reduce overall calorie and carbohydrate intake, people should be counseled to avoid compensating with intake of additional calories from other food sources.

***

Is alcohol forbidden? No.

…educating people with diabetes about the signs, symptoms, and self-management of delayed hypoglycemia after drinking alcohol, especially when using insulin or insulin secretagogues, is recommended.

To reduce hypoglycemia risk, the importance of glucose monitoring after drinking alcohol beverages should be emphasized.

Steve Parker, M.D.

PS: I note that William Yancy, M.D., was on the expert panel.

PPS: Bold emphasis above is mine.

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A Paleolithic Vegan Diet? News to Me

Not many vegan foods here

From European Endocrinology:

Abstract

INTRODUCTION:

The Palaeolithic diet is designed to resemble that of human hunter-gatherer ancestors thousands to millions of years ago. This review summarises the evidence and clinical application of this diet in various disorders. An empiric vegan variant of it has been provided, keeping in mind vegan food habits.

REVIEW OF THE LITERATURE:

Different types of Palaeolithic diets in vogue include the 80/20, the autoimmune, the lacto, the Palaeolithic vegan and the Palaeolithic ketogenic. We have developed an Indian variant of the Palaeolithic vegan diet, which excludes all animal-based foods. The Palaeolithic diet typically has low carbohydrate and lean protein of 30-35% daily caloric intake in addition to a fibre diet from non-cereal, plant-based sources, up to 45-100 g daily. In different observational studies, beneficial effects on metabolic syndrome, blood pressure, glucose tolerance, insulin secretion, lipid profiles and cardiovascular risk factors have been documented with the Palaeolithic diet. Short-term randomised controlled trials have documented weight loss, and improved glycaemia and adipo-cytokine profiles. Few concerns of micronutrient deficiency (e.g. calcium) have been raised.

CONCLUSION:

Initial data are encouraging with regard to the use of the Palaeolithic diet in managing diabesity. There is an urgent need for large randomised controlled trials to evaluate the role of the Palaeolithic diet with different anti-diabetes medications for glycaemic control and the reversal of type 2 diabetes.

Source: Palaeolithic Diet in Diabesity and Endocrinopathies – A Vegan’s Perspective. – PubMed – NCBI

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But I thought we originated in northeast Africa: Paleontologists trace origins of modern humans to southern Africa

Where am I?

I’m skeptical, and I’m not the only one.

Oct. 29 (UPI) — The earliest ancestors of anatomically modern humans, Homo sapiens sapiens, emerged in southern Africa, according to a new study published this week in the journal Nature.

“It has been clear for some time that anatomically modern humans appeared in Africa roughly 200 thousand years ago,” lead researcher Vanessa Hayes, a professor of human genomics at the Garvan Institute of Medical Research in Australia, said in a news release. “What has been long debated is the exact location of this emergence and subsequent dispersal of our earliest ancestors.”

Hayes and her colleagues used mitochondrial DNA samples from indigenous Africans to trace the human family tree back to its roots. According to the genetic analysis, the earliest modern humans emerged in an area south of the Zambezi River, in what’s now Botswana.

Source: Paleontologists trace orgins of modern humans to Botswana – UPI.com

Steve Parker, M.D.

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Paleolithic diet during pregnancy: A potential beneficial effect on metabolic indices and birth weight

Paleobetic diet

“Think of me”

A paleo diet lowered glucose levels during pregnancy. Hmmm…I wonder if that would prevent to treat gestational diabetes. From the European Journal of Obstetrics, Gynecology, and Reproductive Biology:

Abstract

BACKGROUND:

Paleolithic diet has recently gained popularity due to its presumed health benefits. The favorable metabolic effects of this diet were assessed in non-pregnant population but its impact during pregnancy remains to be evaluated.

STUDY DESIGN:

A retrospective cohort study comparing two groups. Group A comprised of women with singleton low-risk pregnancy adherent to paleolithic diet throughout gestation (n = 37). Group B comprised low risk pregnant women on a regular diet (n = 39). Women were excluded if they had low adherence to diet, started paleolithic diet during pregnancy, and had pre-gestational diabetes mellitus or other types of metabolic syndrome such as pre gestational hyperlipidemia, hypertension or BMI > 35. Blood indices such as Glucose challenge test scores, hemoglobin, ferritin, and TSH levels were compared. Other pregnancy factors such as maternal weight gain, rest days during gestation and pregnancy complications such as IUGR, GDM or preeclampsia were compared. Lastly, obstetrical outcomes such as mode of delivery and complications such as high-grade tears, as well as neonatal factors such as birth weight and pH were compared between the two groups.

RESULTS:

General maternal characteristics such as age, BMI and parity were comparable between the two groups. Women who maintained a paleolithic diet had a significant decrease in glucose challenge test scores (95.8 mg/dL vs. 123.1 mg/dL, p < 0.01) and increase in hemoglobin levels (12.1 g/dL vs. 11.05 g/dL p < 0.01) and Ferritin (32.1 vs 21.3 mg/mL, p = 0.03) compared to women maintaining regular diet. Maternal pregnancy weight gain was also slightly decreased in group A (9.3Kg vs. 10.8 kg, p = 0.03). Birthweights were lower in group A (3098 g Vs.3275 g, p = 0.046) with no difference in adverse neonatal outcomes. We found no differences in other pregnancy complications or labor outcomes such as mode of delivery, shoulder dystocia or high grade perineal tears.

CONCLUSION:

Paleolithic diet maintained during pregnancy may have a beneficial effect on the glucose tolerance. It also may increase iron stores and hemoglobin levels. Neonates of women maintaining paleolithic diet are slightly lighter but appropriate for gestational age with no difference in neonatal outcomes.

Source: Paleolithic diet during pregnancy-A potential beneficial effect on metabolic indices and birth weight. – PubMed – NCBI

Steve Parker, M.D.

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Marriage Linked to Longer Lifespan

dementia, memory loss, Mediterranean diet, low-carb diet, glycemic index, dementia memory loss

“Sweat Pea, let’s schedule you a check-up with Dr. Gupta.”

From UPI:

Married men in 2017 had an age-adjusted death rate of 943 per 100,000, compared to 2,239 for widowers. The death rate was 1,735 per 100,000 for lifelong bachelors and 1,773 for divorced men.

Married women had a death rate of 569 per 100,000, two-and-a-half times lower than the 1,482 rate for widows. The death rate was 1,096 for divorcees and 1,166 for never-married women.

*  *  *

While the death rate for married men and women declined by the same 7 percent, women’s overall death rate was much lower.

But the death rates among men in all other marital categories remained essentially the same between 2010 and 2017, researchers found.

On the other hand, the death rate for widowed women rose 5 percent, while the rate for never-married women declined by 3 percent and remained stable for divorced women.

Source: Marriage linked to longer lifespan, new data shows – UPI.com

Steve Parker, M.D.

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Diet Quality Affects Risk of Cardiovascular Disease in Post-Menopausal Diabetic Women

Not your average cave-woman

Regarding the mention of paleo diet below, I rather doubt the study at hand hand significant numbers of paleo diet followers. From the Journal of the American Heart Association:

ABSTRACT

Background Dietary patterns are associated with cardiovascular disease (CVD) risk in the general population, but diet-CVD association in populations with diabetes mellitus is limited. Our objective was to examine the association between diet quality and CVD risk in a population with type 2 diabetes mellitus.

Methods and Results

We analyzed prospective data from 5809 women with prevalent type 2 diabetes mellitus at baseline from the Women’s Health Initiative. Diet quality was defined using alternate Mediterranean, Dietary Approach to Stop Hypertension, Paleolithic, and American Diabetes Association dietary pattern scores calculated from a validated food frequency questionnaire. Multivariable Cox’s proportional hazard regression was used to analyze the risk of incident CVD. During mean 12.4 years of follow-up, 1454 (25%) incident CVD cases were documented. Women with higher alternate Mediterranean, Dietary Approach to Stop Hypertension, and American Diabetes Association dietary pattern scores had a lower risk of CVD compared with women with lower scores (Q5 v Q1) (hazard ratio [HR]aMed 0.77, 95% CI 0.65-0.93; HRDASH 0.69, 95% CI 0.58-0.83; HRADA 0.71, 95% CI 0.59-0.86). No association was observed between the Paleolithic score and CVD risk.

Conclusions

Dietary patterns that emphasize higher intake of fruits, vegetables, whole grains, nuts/seeds, legumes, a high unsaturated:saturated fat ratio, and lower intake of red and processed meats, added sugars, and sodium are associated with lower CVD risk in postmenopausal women with type 2 diabetes mellitus.

Source: Diet Quality and Cardiovascular Disease Risk in Postmenopausal Women With Type 2 Diabetes Mellitus: The Women’s Health Initiative. – PubMed – NCBI

Steve Parker, M.D.

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