Analysis reveals long-term impact of calcium and vitamin D supplements on health in postmenopausal women

Embargoed for release until 5:00 p.m. ET on Monday 11 March 2024   
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Below please find summaries of new articles that will be published in the next issue of Annals of Internal Medicine. The summaries are not intended to substitute for the full articles as a source of information. This information is under strict embargo and by taking it into possession, media representatives are committing to the terms of the embargo not only on their own behalf, but also on behalf of the organization they represent.   
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1. Analysis reveals long-term impact of calcium and vitamin D supplements on health in postmenopausal women

After more than 20 years, supplementation associated with lower cancer mortality and higher CVD mortality

Abstract: https://www.acpjournals.org/doi/10.7326/M23-2598  

URL goes live when the embargo lifts    

A follow-up analysis of a randomized clinical trial found that the use of calcium and vitamin D supplements among postmenopausal women was associated with decreased risk for cancer mortality, but increased risk for cardiovascular disease (CVD) mortality. The analysis is published in Annals of Internal Medicine.

The largest randomized trial of CaD supplementation, completed by the Women’s Health Initiative (WHI), examined the effects of daily CaD supplementation on health outcomes in postmenopausal women. The results were largely null. However, the 20-year adjudication of health events and mortality in the WHI CaD trial, complemented with National Death Index data, provided an opportunity to update the original findings and evaluate longer-term health risks.

Researchers from the University of Arizona conducted a post-hoc analysis long-term postintervention follow-up of the 7-year randomized intervention WHI trial of CaD versus placebo to evaluate long-term health outcomes among postmenopausal women. The researchers looked for incidence of cancer, disease-specific and all-cause mortality, CVD, and hip fracture by randomization assignment. Analyses also were stratified on personal supplement use. They found that for women who were randomly assigned to take CaD supplements had a 7% lower risk of dying from cancer over a period of about 22 years compared to those taking placebo. However, there was also a 6% higher risk of dying from CVD among those who took the supplements. The study didn't find any significant overall effect on other measures, including all-cause mortality. The authors noted that cancer incidence seemed to depend on whether the women were already taking supplements before the study began and CVD mortality was higher among those taking the supplements.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with the corresponding author, Cynthia A. Thomson, PhD, RD, please contact cthomson@arizona.edu.

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2. New FDA food label initiatives aim to combat diet-related chronic disease by improving nutritional decision making

Abstract: https://www.acpjournals.org/doi/10.7326/M23-3266   

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New initiatives by the U.S. Food and Drug Administration (FDA) aim to combat preventable death and disability caused by poor nutrition by making food nutrition labels easier to understand for consumers. A commentary describing recent and proposed upcoming changes to food labeling is published in Annals of Internal Medicine. 

Authors from the FDA describe three important changes to nutrition labels – one already implemented and two proposed – designed to help consumers more easily understand the nutritional contents of the food they consume. The first change, implemented by food manufacturers by 2021, requires the addition of added sugar, vitamin D, and potassium to the Nutrition Facts label. The second change being considered by the FDA is the inclusion of standardized, science-based, front-of-package scheme to complement information on the Nutrition Facts label. The third proposed change is the inclusion of a “healthy” symbol that manufacturers could voluntarily use on product labels to visually communicate that a food meets the “healthy” definition. The authors encourage clinicians to engage with the FDA’s proposed labeling changes, including providing comment on changes that would be most beneficial to their patients. 

The authors say clinicians have conversations about dietary choices with their patients and can play a key role in communicating the changes to nutrition labeling. Free continuing medical education programs have been designed to help health care professionals better understand and utilize food labels when counseling their patients.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with the corresponding author, Haider J. Warraich, MD, please contact FDA’s Office of Media Affairs at FDAOMA@fda.hhs.gov

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3. Review offers strategies for mitigating racial and ethnic disparities in health care algorithms

Abstract: https://www.acpjournals.org/doi/10.7326/M23-2960  

URL goes live when the embargo lifts    

A review of 63 studies related to health care algorithms found that use of these algorithms can mitigate, exacerbate, or not impact racial and ethnic disparities at all. The authors offer several strategies for health care systems to implement to mitigate these effects. The review is published in Annals of Internal Medicine.

Health care algorithms are frequently used to guide clinical decision making, resource allocation, and health care management. Although algorithms are developed to optimize specific processes of care, they may introduce or perpetuate racial and ethnic biases, leading to unequal treatment and contributing to or exacerbating unequal health outcomes.

Researchers from the University of Pennsylvania conducted a systematic review of 51 modeling, 4 retrospective, 2 prospective, 5 pre-post studies, and 1 randomized controlled trial. The authors found varying results, with some research indicating that health care algorithms mitigate racial and ethnic disparities, and other research indicating that these algorithms exacerbate these disparities or have no effect at all. After review, the authors identified seven strategies for potentially mitigating disparities in health care algorithms: removing an input variable, replacing a variable, adding race, adding a non–race-based variable, changing the racial and ethnic composition of the population used in model development, creating separate thresholds for subpopulations, and modifying algorithmic analytic techniques. According to the authors, these results highlight the need for more high-quality research, transparency, and monitoring of algorithms to detect and address biases in their application that may develop over time.

The author of an accompanying editorial from Priscilla Chan and Mark Zuckerberg San Francisco General Hospital and the University of California San Francisco expressed disappointment in the quality of available evidence included in the systematic review. The author suggests that clinical algorithms should be based on good research and need to consider important factors like socioeconomic factors and discrimination instead of just race. Factors that influence equity care go beyond race and include how society is structured, access to health care for some racial and ethnic groups, environmental factors affecting health, and the way some people of color may feel they are treated in the physician-patient relationship, especially considering the lack of representation in medicine.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with the corresponding author Shazia Mehmood Siddique, MD, MSHP, please contact Shazia.Siddique@pennmedicine.upenn.edu.

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Also in this issue:

Where Are All the Specialists? Current Challenges of Integrating Specialty Care Into Population-Based Total Cost of Care Payment Models

Jennifer L. Wiler, MD, MBA; Lawrence R. Kosinski, MD, MBA; Terry L. Mills, MD, MMM, CPE; and James Walton, DO, MBA

Medicine and Public Issues

Abstract: https://www.acpjournals.org/doi/10.7326/M23-2991  

Editorial: https://www.acpjournals.org/doi/10.7326/M24-0198