Screening Mammography and Overdiagnosis of Breast Cancer

Andrew Kaunitz, MD

Nov 29, 2012

Hello. I'm Andrew Kaunitz, Professor and Associate Chair of the Department of Obstetrics and Gynecology at the University of Florida College of Medicine in Jacksonville, Florida. 

Today I'd like to discuss screening mammography and overdiagnosis of breast cancer.

Screening intended to reduce cancer mortality should meet 2 criteria:

• First, screening should facilitate earlier detection of cancers destined to cause death;

• Second, treatment of cancers diagnosed by screening should be associated with better outcomes.

In a recent issue of the New England Journal of Medicine, investigators used 3 decades of federal data to evaluate the long-term effect of screening mammography.^[1] The analysis began in the mid-1970s, when mammography screening was uncommon, and continued until 2008.

During these 3 decades, the incidence of early-stage breast cancer increased by more than twofold, reflecting more diagnosis of localized invasive lesions as well as ductal carcinoma in situ, a preinvasive condition that was rarely diagnosed prior to widespread mammographic screening.

During the same interval, the incidence of late-stage disease declined by less than 10%.

The authors estimate that overdiagnosis, defined as identification of tumors destined not to progress to advanced disease that are attributable to screening mammography, has affected 1.3 million women over the past 3 decades. This includes the overdiagnosis of 70,000 women in 2008, a number that accounts for almost one third of tumors diagnosed in women 40 years of age and older.

During the 3 decades encompassed by this study, mortality from breast cancer among women aged 40 years and older has decreased by 28% while decreasing by 42% in women younger than 40 years of age, a group in which screening was not prevalent. During this same time period, however, the incidence of late-stage disease has decreased only minimally among screened women.

By promoting early diagnosis of breast cancer, screening mammography saves lives. However, and consistent with other recent reports,^[2,3] this study suggests that screening's contribution to the decline in breast cancer mortality is surpassed by that of better treatment. The study also suggests that the benefits of screening mammograms are smaller and the harms associated with overdiagnosis from screening are greater than we have recognized.^[1]

This viewpoint supports the 2009 US Preventive Services Task Force (USPSTF) guidelines, which recommend that women begin biennial mammograms at age 50 years.^[4] In the future, comprehensive genetic analysis of breast tumors may allow cancers to be distinguished according to their potential to cause advanced disease.^[5] Until then, the pros and cons of mammography should be incorporated into the counseling that women receive prior to making decisions regarding screening.^[6]

Cervical Screening Guidelines Updated

Laurie Barclay, MD

Mar 21, 2013

New cervical screening guidelines posted online March 21 by the American Society for Colposcopy and Cervical Pathology (ASCCP) now address management of discordant co-tests, in which results of either Papanicolaou (Pap) smear or human papillomavirus (HPV) testing are positive, but not both. The new algorithms update the 2006 recommendations, based on risk analysis of new data from nearly 1.4 million women in a National Cancer Institute–Kaiser Permanente Northern California cohort.

"The primary focus of the revised recommendations [is] the obsolescence of the 2006 guidelines and the fact that guidelines on management of women with Pap tests read as unsatisfactory or missing endocervical cells were never ratified by a consensus conference," lead author L. Stewart Massad Jr, MD, professor of obstetrics and gynecology at Washington University in St. Louis, Missouri, and ASCCP board of directors member, told Medscape Medical News by email.

According to the 2012 consensus guidelines from the American Cancer Society, ASCCP, and the American Society of Clinical Pathologists, women aged 21 to 65 years should have Pap tests every 3 years. Further screening is not recommended for women with test results negative for precancerous lesions.

"Women ages 21-24 have a very low risk of cancer," Dr. Massad said. "Many lesions identified by Pap testing in this group are HPV-related changes that will resolve without treatment as the body's immune system recognizes and reacts to the HPV; they are not precancer. Treatment of these lesions with usual destructive therapies for precancer can predispose to preterm delivery if these young women later conceive."

For women aged 30 to 64 years, the Pap test and HPV test are preferred for screening. Although previous guidelines had recommended return to "routine screening" after evaluation, it was unknown whether that was still acceptable given the longer screening intervals.

Algorithms in the updated guidelines include the following:

• Management of discordant co-tests, in which results of either Pap smear or HPV testing are positive, but not both, with integration of co-testing into follow-up. Colposcopy and/or HPV DNA typing may be indicated.
• Return to "routine" screening in women treated for cervical cancer.
• Extension of management guidelines for adolescents under 21 years of age to women under 25 years of age. Workup varies according to findings of atypical squamous cells of undetermined significance, or low-grade or high-grade squamous intraepithelial lesion, and may include colposcopy.
• Consideration of whether cervical intraepithelial neoplasia grade 1 (CIN1) on endocervical canal curettage (ECC) should be treated as positive ECC or CIN1.
• Management of women with unsatisfactory cytologic findings and specimens that are missing endocervical or transformation zone components. Colposcopy may be required for women with positive HPV results or with repeated unsatisfactory cytologic findings.

The ASCCP funded development of these guidelines. The guidelines authors have disclosed no relevant financial relationships
.

Ten Foods Provide Half of Sodium Eaten in US

Lisa Nainggolan

Feb 10, 2012

 February 9, 2012 (Atlanta, Georgia) — New figures from a US food survey will hardly surprise readers of heartwire , detailing, as they do, that nine out of 10 adults in the US consume more sodium than is recommended. The findings are laid out in the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report on February 7, 2012.

The estimates of salt intake from 7227 participants in theNational Health and Nutrition Survey 2007–2008 show that the mean daily intake of sodium is 3266 mg. 

Daily guidelines for maximum sodium consumption are 2300 mg among the general population and 1500 mg for specific, high-risk populations, such as African Americans and those with hypertension, diabetes, and chronic kidney disease.

The survey shows that 44% of sodium consumed came from 10 food categories: bread, cold cuts and cured meats, pizza, poultry, soups, sandwiches, cheese, pasta mixed dishes, meat mixed dishes, and savory snacks. More than 70% of the sodium eaten came from goods obtained at a store.

The findings "reinforce the importance of implementing strategies to reduce US sodium intake," states the report.

"Nationwide, food manufacturers and restaurants can strive to reduce excess sodium added to foods before purchase. States and localities can implement policies to reduce sodium in foods served in institutional settings."

And clinicians can counsel most patients to check food labels and select foods lower in sodium, the report urges.

It adds that reducing the sodium content of the 10 leading sources by one-quarter would reduce total dietary sodium by more than 10%, preventing an estimated 28 000 deaths and $7 billion in healthcare expenditures annually.

Federal agencies in the US are currently considering whether they should implement stricter standards for the amount of salt that food manufacturers, restaurants, and food-service companies can add to their products, as recommended by the Institute of Medicine in 2010, along the lines of similar policies that have been successfully implemented in other countries, such as the UK.

Sixty Years of Diabetes Management in Primary Care

Mike G Kirby

Disclosures

British Journal of Diabetes and Vascular Disease. 2012;12(6):315-320. 

 

• Abstract and Introduction
• Therapeutic Advances
• Insulin Therapy
• Intensive Therapy
• Advances in Monitoring and Insulin Delivery Devices
• Insulin Delivery Systems
• Health Service Strategies
• Preventing Diabetes and Minimising the Complications
• What Have We Learnt Over the Last 60 Years?

• References

Abstract and Introduction

Abstract

The incidence of diabetes has increased exponentially over the last 60 years, meaning that the management of diabetes solely by specialist healthcare professionals is no longer feasible. Since the 1970s, primary and community healthcare professionals have increasingly treated patients with diabetes. Advances in diabetes equipment and new treatments have further enabled patients to be treated more conveniently in the community and this has enhanced their quality of life. There has also been an evolution in health service strategies for diabetes – notably growing acknowledgement of the benefits of intensive glycaemic treatment for patients with type 2, as well as type 1 diabetes, and the now well-recognised importance of effective shared care programmes between primary and secondary healthcare professionals. Thus, the organisation and delivery of care for patients with diabetes has improved dramatically since 1952.

Introduction

Sixty years ago people with diabetes would have been managed mainly by specialists in hospital. The remorseless increase in numbers of patients with type 2 diabetes has made this no longer practical. Since the 1970s increasing numbers of primary and community healthcare professionals in the UK have assumed responsibility for the routine review, monitoring and management of patients with diabetes.

There are of course, other reasons for the increased role of primary healthcare professionals in the care of contemporary diabetes management. New treatments and advances in monitoring and delivery devices have allowed more effective and flexible management strategies.

Healthcare professionals are also increasingly aware of the importance of quality of life and attention has become focused on disease management that is more suited to patients' lifestyles and provision of services closer to home. Additionally, many patients today expect to be actively involved in their treatment. They are better informed and less likely to accept advice unquestioningly from healthcare professionals.

Hence diabetes care has evolved and new concepts have been introduced. These include intensive therapy for patients with type 2 diabetes as well as those with type 1 diabetes. It is also appreciated now that diabetes is a cardiovascular disease and that a holistic approach to treatment (incorporating: education, lifestyle advice (including exercise), attention to blood pressure and dyslipidaemia), is essential to improve patients' outcome and well being. For patients with complications, a multidisciplinary team approach is essential. However the majority of uncomplicated patients are now managed exclusively in primary care by well trained practice nurses supported by a GP with an interest in diabetes. We have also seen the development of GPs with a special interest (GPSIs) who are fully accredited in the management of this condition, and they often provide support to neighbouring practices, as do community physicians.

Attempts in patients with type 2 diabetes mellitus to lower their blood glucose levels near to normal by intensive blood glucose control undoubtedly benefits some patients, but it also has the potential to do harm. An National Prescribing Centre (NPC) Rapid Review summed it up well in their headline, 'Blood glucose lowering and mortality in type 2 diabetes: not too little, not too much.^[1] The management of complex cases has become the realm of the hospital diabetes specialist.

When Should Bacteria in the Urine Be Treated?

Medscape Pharmacists 

Michael J. Postelnick, BSPharm

Mar 18, 2013

• Pediatric Urinary Tract Infection

Question

How do you know when a positive urine culture for bacteria is indicative of infection? When and how should asymptomatic bacteriuria be managed?

Response from Michael J. Postelnick, BSPharm, Lecturer, Department of Family and Community Medicine, Northwestern University School of Medicine

A common dilemma faced by the clinician, primarily in institutional settings, is whether to treat bacteria that grow on a urine culture with antimicrobial therapy. Many different laboratory and clinical factors -- bacterial colony count, presence or absence of white blood cells in the urine, presence of a Foley catheter, abnormal urinary anatomy, sex, and type of organism isolated -- should be considered when determining whether antimicrobial therapy is warranted. The Infectious Diseases Society of America has published guidelines that examine many of these issues.

This discussion will highlight some of the most common issues encountered in these situations and attempt to help clinicians steward the use and choice of antimicrobial agents toward situations where they are indicated and likely to be active against commonly isolated urinary pathogens.

The prime driver of whether a urine culture should be sent off to the laboratory should be patient signs and symptoms indicative of a urinary tract infection. There are only 2 clear indications for urine cultures in asymptomatic patients: pregnancy and presurgical evaluation for transurethral resection of the prostate. Among patients undergoing solid-organ transplant, the utility of culture in those without urinary tract symptoms is unclear.

Other patients who in the past may have been considered high risk with possible benefit from routine culturing of urine include nonpregnant premenopausal women, elderly persons, diabetic patients, spinal cord patients, and patients with indwelling catheters. However, available evidence discourages such practice.^[1]

Pyuria as an indicator for treatment of asymptomatic patients who may have positive urine cultures is also not supported.^[1] A colony count of bacteria is a way to determine the reliability of the culture: 10⁵colonies in a noncatheterized specimen in both women and men and 10² colonies in a catheterized specimen, when a single bacterial species is isolated, provides evidence of true bacteriuria.

The specific populations of patients with asymptomatic bacteriuria for whom treatment is indicated require special consideration when antimicrobial therapy is chosen. For the pregnant patient, the usual agents, such as trimethoprim/sulfamethoxazole and fluoroquinolones, are not indicated owing to concerns about adverse fetal affects. Nitrofurantoin and beta-lactam antimicrobials, such as amoxicillin/clavulanate and first- and second-generation cephalosporins, usually provide safe and effective therapy.

For patients about to undergo transurethral prostate resection, a history of fluoroquinolone use, which is widespread in this patient population, often selects out fluoroquinolone-resistant pathogens. This, along with the growing incidence of multidrug-resistant gram-negative pathogens, makes antimicrobial choice challenging. Local susceptibility patterns and individual culture and susceptibility results should always be used to guide antimicrobial choice in this patient population.

We have encountered situations where patients who received fluoroquinolone prophylaxis before undergoing prostate biopsy (a somewhat less invasive procedure) developed gram-negative sepsis due to fluoroquinolone resistant organisms. This has prompted us to develop a policy of routine culture-driven therapy in these procedures as opposed to exclusive use of fluoroquinolones.

In conclusion, routine treatment of asymptomatic bacteriuria in all but a few selected patient populations is not supported by evidence and is likely to contribute to the growing burden of antimicrobial resistance.

Excess Salt Blamed for 2.3 Million Deaths From CVD Worldwide in 2010

Heartwire > Conference News

Marlene Busko

Mar 22, 2013

 

New Orleans, Louisiana — Researchers estimate that in 2010, adults in most parts of the world consumed about twice as much salt as recommended, and millions of CVD deaths worldwide were linked to excess sodium [1,2].

These findings were presented at EPI-NPAM 2013, theEpidemiology and Prevention/Nutrition, Physical Activity and Metabolism 2013 Scientific Sessions.

In the first study, Dr Saman Fahimi (Harvard School of Public Health, Boston, MA) and colleagues reported that in 2010, adults in 187 countries consumed, on average, 3950 mg sodium a day--roughly twice the maximum intake recommended by the World Health Organization (WHO) (2000 mg/day) or the AHA (1500 mg/day).

In the second study, Dr Dariush Mozaffarian (Harvard School of Public Health) and colleagues reported that in the same year, they estimate that excess dietary salt led to 2.3 million deaths from CVD worldwide and about one in 10 deaths from CVD in the US.

The average salt consumption in the US was 3600 mg/day, and the US ranked 19th of the 30 largest countries, in estimated numbers of CVD deaths that were thought to be related to excess salt consumption.

The authors told heart wire that the findings, the first to provide detailed estimates of global salt intake and its impact on heart health, should help guide public policies and physician counseling.

"Sodium intake in only six countries of 187 countries met the WHO guidelines," Fahimi said. "Therefore, implementation of sodium-reduction programs in order to reduce sodium intake of men and women of all age groups, in both developing and the developed world, should be considered as a top priority."

When counseling patients about the impact of dietary salt on heart health, physicians need to be aware that salty snacks such as peanuts and chips are not the only culprits, Mozaffarian said. "In the US and in most highly developed countries, 90% of the salt in the diet comes from packaged foods," where salt is used as a preservative; perhaps surprisingly, bread is the number-one source of salt, and cheese is a major source, he noted.

High-salt diet, a universal finding

Using data from the Global Burden of Disease study, Fahimi and colleagues reviewed national surveys of sodium intake based on 24-hour urinary sodium excretion (143 surveys) or on estimated dietary sodium intake (104 surveys).

They developed a model to estimate national, regional, and global sodium intake, by age and sex, in 1990 and 2010, from 187 surveyed countries (99% of the world's population).

Excess sodium intake was universal--seen in men and women of all ages, living in low- to high-income countries. In 2010, the average daily sodium intake exceeded 2000 mg in 181 countries and exceeded 3000 mg in 119 countries.

Sodium intake varied widely between different parts of the world. Kazakhstan had the highest sodium intake (6.0 g/day), followed by Mauritius (5.6 g/day), and Uzbekistan (5.5 g/day), whereas Kenya (1.5 g/day), Malawi (1.5 g/day), and Rwanda (1.6 g/day) had the lowest daily intake of sodium.

Model linked CVD deaths to sodium intake

To estimate how sodium intake contributed to death from CVD, Mozzaffarian and colleagues analyzed data from 247 national surveys of sodium intake in 66 countries in 2010. They performed a meta-analysis of 107 randomized controlled trials to determine the effects of sodium on blood pressure and then analyzed large prospective cohorts to determine the effects of blood pressure on CVD. They obtained the number of deaths from CVD from the Global Burden of Disease study. In their model, they assumed that the optimal intake was 1000 mg/day sodium (or 2.5 g/day salt).

Globally, of the CVD deaths attributed to high dietary sodium, 42.1% were from CHD, 41.0% were from stroke, and 16.9% were from other types of CVD.

Deaths from CVD that were related to dietary salt did not occur only in older men in wealthier countries:

• Four in five deaths were in low- and middle-income countries.
• 40% of the deaths were in women,
• One in three deaths occurred in people younger than 69.
  
  

Energy Drinks May Prolong QT Interval, Raise BP Marlene Busko

Heartwire > Conference News

Marlene Busko

Mar 22, 2013

 New Orleans, Louisiana — Tossing back one to three energy drinks may result in more than just a buzz. A small-meta analysis found that immediately afterward, subjects had increased systolic blood pressure and, more troubling, they also had, on average, a 10-msec prolongation in their QT interval.

The study, by Dr Sachin Shah (University of the Pacific, Stockton, CA) and colleagues, was presented at EPI-NPAM 2013, the Epidemiology and Prevention/Nutrition, Physical Activity and Metabolism 2013 Scientific Sessions.

"The blood-pressure finding falls in line with what we would suspect because of the caffeine content," Shah told heartwire . "The QT prolongation that we are seeing--I was very surprised with that. It's a bit of a wake-up call for us investigators to start studying it a bit more thoroughly, and it needs to happen sooner rather than later."

The group aimed to see how energy drinks affect heart health, given that these drinks, along with dietary supplements, are not regulated as stringently as new drugs that must meet Food and Drug Administration (FDA) safety requirements, Shah said.

In a literature search, they identified seven observational and interventional trials that evaluated the impact of energy drinks on QT interval, blood pressure, and heart rate.

Three studies with a pooled sample of 93 subjects had QT/QTc data. Six studies with a pooled sample of 132 subjects had blood-pressure data, and seven studies investigated heart rate.

The patients, who were all young (aged 18 to 45) and healthy, underwent ECG and blood-pressure testing before and just after drinking one to three cans of energy drink--most commonly Red Bull, but also others such as Full Throttle and Meltdown RTD. An 8.4-oz can of Red Bull contains 80 mg of caffeine, compared with 35 mg of caffeine in a 12-oz Coke or about 100 mg of caffeine in an average cup of coffee, Shah said.

Shortly after drinking the energy drinks, the pooled subjects had a systolic blood pressure increase of an average 3.5 mm Hg. "If people are drinking energy drinks every day, that change in blood pressure could be very significant," Shah noted, adding that, as reported by heartwire , research on torcetrapibwas terminated because of a similar 3-mm-Hg increase in blood pressure.

People who don't normally drink coffee might have a heightened blood-pressure response to an energy drink, he added.

In a clinical setting, physicians are usually concerned if a patient has a QT-interval increase of about 30 msec from baseline, Shah noted. He acknowledges that this was a small study, but it did uncover a disturbing signal that needs to be further investigated.

Diastolic BP and heart rate increased nonsignificantly.

Although the 10-msec prolongation in the QT interval is a "small number, if it were consistently produced by a drug being considered by the FDA, the FDA would require more testing to make sure that there was not a liability for producing further, more serious, and life-threatening prolongation of the QT interval and associated arrhythmias," AHA spokesperson and past president Dr Gordon F Tomaselli (Johns Hopkins University, Baltimore, MD) commented.

Both Shah and Tomaselli pointed out that people who are older or who have underlying CVD might have even more heart-related side effects from energy drinks than the young, healthy people in this meta-analysis.

The authors had no conflict of interest related to this study.

Azithromycin Poses Fatal Cardiac Risk, FDA Warns

Robert Lowe

Mar 12, 2013

 

The popular antibiotic azithromycin (Zithromax and Zmax, Pfizer) poses the risk for a potentially fatal irregular heart rhythm, which therefore warrants careful screening of patients for this drug, the US Food and Drug Administration (FDA) announced today.

The macrolide-class antibiotic can cause abnormal changes in the electrical activity of the heart that may prolong the QT interval and trigger a rare, associated arrhythmia calledtorsades de pointes.

The FDA stated that patients at risk for this azithromycin-induced arrhythmia include those who already have a prolonged QT interval, low blood levels of potassium or magnesium, and an abnormally slow heart rate, or who take drugs to treat arrhythmias. Elderly patients and patients with cardiac disease also may be more susceptible to the arrhythmogenic effects of the antibiotic.

The agency advised clinicians to put the cardiac risk for azithromycin in an "appropriate context," because other antibiotics in the macrolide class as well as nonmacrolides such as fluoroquinolones can prolong the heart's QT interval.

The FDA safety announcement about azithromycin follows a review of a study conducted by Pfizer on the antibiotic's effect on cardiac electrical activity and another study published in the New England Journal of Medicine in May 2012. The study reported that patients receiving a 5-day course of azithromycin had a small, increased risk for sudden cardiac death compared with those who received amoxicillin or no antibiotics. The FDA said at the time that it wouldreview these findings.

The agency has updated the label of azithromycin to warn of the risk for QT interval prolongation and torsades de pointes.

More information about today's drug safety communication is available on the FDA Web site.

To report problems with azithromycin, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online athttps://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787
.

Diabetics Need Not Restrict Fruit Intake, RCT Suggests Marlene Busko

Marlene Busko

Mar 08, 2013

 

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Drug & Reference Information

• Diabetes Mellitus and Pregnancy
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• Type 2 Diabetes Mellitus

Contrary to popular belief, advising patients who are newly diagnosed with type 2 diabetes to limit their fruit intake does not improve glycemic control, according to a new studypublished online March 5 in Nutrition Journal.

Researchers in Denmark randomized 63 patients to high fruit or low fruit intake, and after 12 weeks, the 2 groups had similar drops in glycated hemoglobin (HbA_1c) levels, weight, and girth.

"We conclude that advice to restrict fruit intake as part of standard [medical nutrition therapy] in overweight adults with newly diagnosed type 2 diabetes mellitus [TDM2] does not improve glycemic control, body weight, or waist circumference," the group, with lead author Allan S. Christensen, from the Department of Nutrition, Regional Hospital West Jutland, Denmark, writes.

"Considering the many possible beneficial effects of fruit, we recommend that fruit intake should not be restricted in T2DM subjects," they add.

Patients with diabetes are usually advised to eat more, varied, fiber-rich fruits and vegetables; high fruit intake, however, has been linked to lower risk of cardiovascular disease and some cancers.

Some health professionals remain concerned about fruit's high sugar content and tell diabetic patients to avoid eating too many fruits, despite a lack of any trial evidence.

Christensen and colleagues conducted what they believe is the first randomized intervention study to examine this.

They enrolled patients with newly diagnosed type 2 diabetes who had been referred for nutritional counseling. The patients were an even mix of men and women, with a mean age of 58 years and a mean body mass index (BMI) of 32. They met with a dietitian and filled in a 3-day food diary at the beginning and end of the study.

All received standard medical nutrition therapy. However, the 32 subjects in the low-fruit-intake group were advised eat no more than 2 pieces of fruit a day, whereas the 31 subjects in the high-fruit-intake group were told to indulge in 2 or more pieces of fruit a day.

A piece of fruit was defined as the amount that contained about 10 g of carbohydrate — for example, an apple (100 g), half a banana (50 g), or an orange (125 g). The subjects were also instructed to eat whole fruit, skip dried fruit, and not drink fruit juice.

The patients were compliant. Over the 12 weeks, on average, fruit consumption rose from 194 g/day to 319 g/day in the high-intake group and decreased from 186 g/day to 135 g/day in the low-intake group.

Patients in the high-fruit-intake group had a significant drop in HbA_IC levels, from 6.74% to 6.26%. They also lost about 2 kg (from 92 kg to 90 kg) and trimmed their waist by about 4 cm (from 103 to 99 cm). However, similar results were obtained by patients in the low-fruit-intake group, and there were no significant between-group differences in these 3 outcomes.

"When changing the fruit intake, other changes in the diet most likely occur, and this would explain [the reason for] no difference in [these outcomes]," Christensen and colleagues speculate.

The authors have reported no relevant financial relationships.

Nutr J. Published online March 5, 2013. Full article