USPSTF updates recommendations on vitamin and mineral supplements

 The U.S. Preventive Services Task Force found inadequate evidence to make recommendations about most vitamins and minerals for primary disease prevention.

Sponsoring Organization: U.S. Preventive Services Task Force (USPSTF)

Background

Because more than half of U.S. adults use at least one multivitamin, mineral, or other nutrient supplement, the USPSTF updated its 2014 recommendation regarding vitamin and mineral supplementation, based on a review of more than 50 studies that have been published since 2014 (NEJM JW Gen Med Jun 1 2014 and Ann Intern Med 2014; 160:558). The recommendations apply to community-dwelling, nonpregnant adults and do not apply to children, pregnant women, or people who are chronically ill or have known nutritional deficiencies.

Recommendations

• The Task Force found no benefit and likely harm from use of β-carotene and lack of either benefit or harm from use of vitamin E, leading to a recommendation against use of either one for preventing cardiovascular disease or cancer (D recommendation).

• They found insufficient evidence to make a recommendation for or against use of multivitamins or other nutrients (except β-carotene or vitamin E) for preventing cardiovascular disease or cancer (I statement).

COMMENT

These recommendations by the USPSTF are identical to the 2014 version, despite the large number of new studies published since then. Many patients ask about multivitamins and other nutrient supplements, and many clinicians recommend supplements, based on the assumption that they can’t hurt and might help (except for the known excess risk for lung cancer with β-carotene use). In these clinical encounters, I would focus mainly on counseling against use of supplements that are proven to be harmful and then transition to a more general discussion of a healthy lifestyle.

Thomas L. Schwenk, MD, reviewing U.S. Preventive Services Task Force. JAMA 2022 Jun 21 O’Connor EA et al. JAMA 2022 Jun 21 Jia J et al. JAMA 2022 Jun 21

CITATIONS

U.S. Preventive Services Task Force. Vitamin, mineral, and multivitamin supplementation to prevent cardiovascular disease and cancer: U.S. Preventive Services Task Force recommendation statement. JAMA 2022 Jun 21; 327:2326.
[Full-text JAMA article]

Proton Pump Inhibitor Therapy in Eosinophilic Esophagitis: Predictors of Nonresponse

Ryan Alexander, Jeffrey A Alexander et al.

Dig Dis Sci. 2020 Sep 29 [Epub ahead of print]

BACKGROUND Identification of clinical predictors of response to first-line therapies for EoE is needed to guide initial medical management.

STUDY DESIGN A retrospective analysis of patients diagnosed with EoE from 2011 to 2018 was conducted. Clinical and diagnostic variables including demographics, endoscopic, and esophagram findings were compared between PPI responders and PPI nonresponders. All patients underwent a standard 8-week twice-daily PPI trial, with PPI responsiveness defined as < 15 eos/hpf on repeat EGD. Univariate and multivariable analyses were conducted to identify risk factors for nonresponse, and ROC curves were created to identify cutoff values.

RESULTS A total of 223 EoE patients (135 male, median age 39 (29-51)) were identified, with PPI nonresponse (PPI-NR) in 71% of patients. PPI-NR was seen in all 10 patients with failure of scope passage, with an OR of 9.06 by univariate analysis (P = 0.1485). In a multivariable model, age per 10 years (OR 0.71; P = 0.007), BMI per 1 kg/m 2 (OR 0.94; P = 0.03), and peripheral eosinophil count per 100 per mm 3 (OR 1.37; P = 0.003) were independent risk factors. Dichotomization to maximize sensitivity and specificity identified age ≤ 36 years old, BMI ≤ 25.2 kg/m 2 , and peripheral eos > 460 per mm 3 as predictive thresholds for PPI-NR. The probability of PPI-NR was 72.4-84.5% with 1 risk factor, 87.9-93.8% with 2 risk factors, and 97.2% with all 3 risk factors.

CONCLUSIONS Young age, reduced BMI, elevated peripheral eosinophil count, and likely inability to pass an endoscope predict lack of response to PPIs in patients with EoE.

Gastric bypass induces diabetes remission in obese patients

WASHINGTON (IMNG) – Gastric bypass surgery resulted in significantly more weight loss and also improved measures of glycemic control significantly more than did other forms of bariatric surgery, Dr. John Morton reported at the annual clinical congress of the American College of Surgeons.

However, he noted, while remission did correlate with weight loss in patients who had gastric banding or sleeving, it appeared to be independent of weight loss in those who had the bypass surgery. While he didn’t speculate on the reasons for this finding, he did affirm his belief that gastric bypass is the best option for most obese patients with comorbid diabetes.

“I feel very comfortable recommending it” for these patients, said Dr. Morton of the Stanford (Calif.) University. “There are, of course, other clinical conditions to consider when deciding [among] bypass, banding, and sleeve, but if the only consideration is around diabetes, I’m 100% comfortable in recommending it for obese diabetics.”

He presented the 1-year follow-up data on 1,792 obese patients who underwent bariatric surgery. Of these, 1,364 had a Roux-en-Y bypass; 264 had a sleeve gastrectomy; and 164 had adjustable gastric banding.

The patients were a mean of about 46 years old. Body mass index was statistically, but not clinically, different between the groups (bypass 47 kg/m2; band 44 kg/m2; sleeve 44 kg/m2). Waist circumference ranged from 51 to 53 inches. About 75% of the group was female and more than half, white.

Overall, about one-third of each group had type 2 diabetes. Most were taking only oral medications. About 5% took only insulin, and about a quarter took both oral agents and insulin. At baseline, the mean HbA_1c was more than 7% in each group. The mean fasting insulin was 36 microU/mL in the bypass group, 28 microU/mL in the band group, and 32 microU/mL in the sleeve group.

By 12 months after surgery, patients with diabetes who had bypass had lost the most weight – a mean of 71% of their excess body weight, compared with 38% in the banding group and 50% in the sleeve group.

Those who had the bypass surgery also experienced the biggest change in their HbA_1c – dropping almost 16% to a mean of 5.8%. Patients in the other two groups experienced a mean drop of 10%, resulting in HbA_1c levels of right around 6%.

Fasting insulin levels also improved significantly more in the bypass group, falling from a baseline mean of 56 microU/mL to 7.8 microU/mL – a decrease of 68%. In the band group, the level fell from 28 microU/mL to 12 microU/mL – a 52% decrease. In the sleeve group, levels fell from 32 microU/mL to 10 microU/mL – a 61% decrease.

“Fasting insulin is also considered an independent marker of cardiac risk,” Dr. Morton added, indicating that the risk of cardiovascular problems would fall along with insulin levels.

Blood glucose improved significantly more in the bypass group, falling from a baseline mean of 149 mg/dL to 101 mg/dL – a 22% change. In the band group, the level fell from 140 mg/dL to 125 mg/dL (8%) and in the sleeve group, from 130 mg/dL to 118 mg/dL (5.6%).

A multivariate analysis controlled for surgery type, sex, body mass index, race, age, and insurance status. Of these factors, surgery type was the strongest predictor, with bypass patients three times more likely to achieve that goal than those undergoing banding or sleeve placement.

Dr. Morton did not present his complication data. However, during the discussion period, he said the three procedures were similarly safe. The gastric sleeve group had a higher leak rate than did the other groups, but that remained less than 1%. Readmission rates were comparable, he said, but he did not provide that number.

“Any time you consider this, it has to be a risk/benefit analysis,” he said. “It’s our philosophy that for obese patients with severe diabetes, we approach them first with the bypass because it has the most proven track record over time.”

Dr. Morton has up to 7 years of data on some of the patients, and said he is now analyzing that. But when questioned about durability, he agreed that diabetes can recur in the rather common scenario of a patient regaining weight. “At the end of the day, though, what’s important is that the obese patient with diabetes gets treatment. All three surgeries demonstrated some improvement, and I believe that any surgery is better than no surgery at all.”

Dr. Morton has received research support from Covidien.

Can the Experience of Discrimination Increase Hypertension Risk?

New insights from the Jackson Heart Study link lifetime discrimination and risk for hypertension in African-Americans.

In the U.S., Black people bear a greater burden of hypertension than any other racial or ethnic group. Investigators hypothesized that beyond traditional risk factors, the experience of discrimination contributes to higher hypertension prevalence and tested the hypothesis by analyzing data on 1845 African-American participants without baseline hypertension from the Jackson Heart Study, the longitudinal investigation of genetic and environmental risk factors associated with the disproportionate burden of cardiovascular disease in African-Americans.

Experience of discrimination was measured at visit 1 by two validated scales measuring lifetime and everyday discrimination. Of the [participants], 954 (52%) developed hypertension during follow-up. After adjustment for traditional cardiovascular risk and socioeconomic factors such as education, income, and occupation, individuals who reported medium-to-high levels of lifetime discrimination were more likely to develop hypertension than participants reporting low discrimination levels. No association was found between everyday discrimination and incident hypertension. In sex-stratified analyses, the association between lifetime discrimination and incident hypertension was observed only in women.

COMMENT

These study results suggest that discrimination might be an important contributor to the glaring disparities in hypertension experienced by African-American women. Discrimination was measured with validated survey instruments, but only at one point in time; however, it is likely that discrimination experiences are dynamic and thus incompletely captured cross-sectionally. More work is needed to see how interventions to combat discrimination affect cardiovascular risk in African-American communities.

Fatima Rodriguez, MD, MPH, FACC, FAHA reviewing Forde AT et al. Hypertension 2020 Jul 1

CITATION(S):

Forde AT et al. Discrimination and hypertension risk among African Americans in the Jackson Heart Study. Hypertension 2020 Jul 1; [e-pub].

[PubMed® abstract]

FDA MedWatch: Gabapentin and Pregabalin Linked to Respiratory Depression Risk

(FDA)—Serious respiratory depression may occur in pts using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors, including use of central nervous system depressants (ie, opioids) or presence of lung dz such as COPD. The elderly are also at risk. FDA is mandating that the drugs carry new warnings and that manufacturers conduct trials to further evaluate their abuse potential, especially when used in combination w/ opioids. Prescribe gabapentinoids at the lowest possible dose and monitor for sx such as confusion/disorientation, unusual dizziness/presyncope, extreme somnolence/lethargy, slowed/shallow breathing or dyspnea, unresponsiveness, and cyanosis.

Aspirin Use Linked to Reduced Mortality in Older Adults

PubMed)—Compared w/ nonusers, older adults who used aspirin ≥3x/wk had lower rates of mortality related to all causes (hazard ratio [HR], 0.81), any cancer (HR, 0.85), GI cancer (HR, 0.75), and colorectal cancer (HR, 0.71), in a cohort study involving >146,000 individuals from the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. Use of aspirin as little as 1-3x/mo was associated w/ lower all-cause mortality (HR, 0.84) and cancer mortality (HR, 0.87).

More info is available in the full-text JAMA Netw Open article.

Infection rates after colonoscopy, endoscopy at US specialty centers are far higher than expected

The rates of infection following colonoscopies and upper-GI endoscopies performed at U.S. outpatient specialty centers are far higher than previously believed, according to a Johns Hopkins study published online this month in the journal Gut. Johns Hopkins researcher Susan Hutfless led a team that plumbed medical data from the year 2014 and determined that patients who underwent one of the common procedures at facilities known as ambulatory surgery centers (ASCs) were at greater-than-expected risk of bacterial infections, including E. coli and Klebsiella. "Though patients are routinely told that common endoscopic procedures are safe," says Hutfless, "we found that post-endoscopic infections are more common than we thought, and that they vary widely from one ASC facility to another." Each year in the United States, there are more than 15 million colonoscopies and 7 million upper-GI endoscopies, known as esophagogastroduodenoscopies, or EGDs. Both colonoscopies and EGDs are performed with an endoscope, a reusable optical instrument that allows an endoscopist access to a patient's gastrointestinal tract. They can be used to screen for disease or to perform a number of procedures, such as polyp removal, without the need for invasive surgery. Using an all-payer claims database, Hutfless and her team examined data from six states—California, Florida, Georgia, Nebraska, New York and Vermont—to track infection-related emergency room visits and unplanned inpatient admissions within seven and 30 days after a colonoscopy or EGD. Hutfless says that post-endoscopic infection rates were previously believed to be in the neighborhood of one in a million. This research, the first to explore data on ASCs and postprocedure infection, revealed that the rate of infection seven or fewer days after the procedure was slightly higher than 1 in 1,000 for screening colonoscopies and about 1.6 per 1,000 for nonscreening colonoscopies. Rates for EGDs within that time were more than 3 per 1,000. Patients who'd been hospitalized before undergoing one of the procedures were at even greater risk of infection. Almost 45 in 1,000 patients who'd been hospitalized within 30 days prior to a screening colonoscopy visited a hospital with an infection within a month. Within those same parameters, the rate of infection-related hospitalization for EGDs was more than 59 patients per 1,000. Though the nation's first ASC was established more than 40 years ago, the facilities gained popularity over the last 20 years as more convenient, less expensive alternatives to hospital care for outpatient surgeries and other procedures. The team found evidence that, among the ASC postprocedure infections, the rates were slightly higher for diagnostic procedures, as opposed to screening procedures. ASCs with the highest volume of procedures had the lowest rates of post-endoscopic infections. According to the Ambulatory Surgery Center Association, in 2017, 64 percent of ASCs were owned by physicians, while 28 percent were affiliated with hospitals or health systems. Hutfless points out that, since many ASCs lack an electronic medical record system connected to hospital emergency departments, those ASCs are unlikely to learn of their patients' infections. "If they don't know their patients are developing these serious infections, they're not motivated to improve their infection control," she says. While the overwhelming majority of ASCs follow strict infection-control guidelines, says Hutfless, she and her team found infection rates at some ASCs more than 100 times higher than expected. Advances in endoscopy and colonoscopy have revolutionized gastroenterology and the treatment and prevention of gastric diseases, says Hutfless. But she and her co-authors agree that patients should be aware of infection risk associated with all endoscopic procedures.

Head Games: VR Measures Link Between Endoscopy Performance and Physician Stress

When we use the words “tense up” or “freeze” to describe physical reactions to stress, we may be on the right track in describing how physicians respond to stress while performing complex procedures.

For doctors dealing with life-threatening emergencies during endoscopy, the management of stress is crucial, but poorly understood. Using virtual reality, my team studied how stress affects how trainees perform during gastrointestinal procedures, as well as the relationship between specific body movements and procedure performance. We’re pleased to be presenting our results during the 2018 Digestive Disease Week. 

In the first study, we placed motion sensors on the hands, forearms and foreheads of trainees performing endoscopy on a virtual reality simulator and examined how performance related to reported levels of stress (“Use of Wearable Sensors to Assess Stress Response in Endoscopy Training,” abstract 765). As trainees experienced more stress, they decreased the velocity and acceleration of their arm and hand movements, suggesting less motion and decreased range of movement. Understanding the changes caused by stress is an important first step to help trainees better cope with emergency situations, both early and late in their careers. 

This new field of inquiry is part of a growing emphasis on physician self-awareness. Currently, little data exist on how individual factors, such as stress response, impact quality of care and patient outcomes. We hope future research may identify how to better manage and reduce stress during endoscopy—potentially improving doctor education and patient outcomes.

More investigations are needed to determine if there is a definitive connection between stress and negative or positive outcomes. Experienced physicians may respond differently to stress compared to inexperienced trainees. 

In a separate analysis of data from the trainees’ time on the simulators, we examined how body motion impacts procedure performance, and we determined that head motion could be used to assess trainees’ motor skills ("Use of Wearable Sensors to Assess Biomechanical Learning Patterns in Endoscopy Training," abstract 764).

We found that head motion correlated with performance outcomes and provided a valid measure of procedural competence. Head motion decreased as doctors advanced in their training and completed more procedures. Excess head motion in trainees suggested they may be looking away from the video monitor to check hand or endoscope position too frequently. This loss of visual focus on the monitor may contribute to prolonged task-completion times and may be related to diminished competence with the equipment.

Additional studies may help us identify an objective set of motion variables to define trainee competence in endoscopy allowing us to create personalized training curricula using this technology. Our current training model relies upon expert mentorship and lacks standardized biomechanical assessment and feedback. Motion sensors could help us develop a driver’s test for endoscopy during which trainees complete a set of tasks with defined motion performance thresholds. In the future, such an educational program could help identify individuals best suited for training in advanced procedures or provide specific feedback to individuals in need of remedial education.