A panel of FDA advisers voted unanimously in favor of recommending 
approval of the Cologuard device for colorectal cancer screening. It 
is designed to test patients’ stool for hemoglobin, DNA methylation 
and mutation markers, and total amount of DNA, according to Reuters.

In addition, the group narrowly recommended approval of Epi proColon 
— a blood test for colorectal cancer — the Associated Press 
reports. The panel voted 5 to 4 that the benefits of the test 
outweighed the risks in people of average cancer risk. Epi proColon 
measures plasma levels of methylated Septin 9 DNA, which has been 
associated with colorectal cancer.

Patients who screen positive for either test would be referred for 
colonoscopy.

At 3 years, glycemic control and quality of life were better with 
surgery than with medical management.

In a previously published report from a randomized Cleveland Clinic 
trial, Roux-en-Y gastric bypass and sleeve gastrectomy were more 
likely than medical therapy (42% and 37% vs. 12%) to lower 
glycosylated hemoglobin (HbA1c) levels to ≤6% in 150 obese diabetic 
patients (mean age at baseline, 48; mean body-mass index at baseline, 
36 kg/m2) at 1 year (NEJM JW Gen Med Mar 26 2012). Now, the 
researchers present longer-term outcomes.

At 3 years, the proportions of patients whose HbA1c levels were ≤6% 
and who no longer were taking diabetes medications remained 
significantly higher in the gastric-bypass and sleeve-gastrectomy 
groups than in the medical-treatment group (35% and 20% vs. 0%). On 
standardized questionnaires that reflected eight quality-of-life 
domains, scores improved significantly in five domains in the bypass 
group, two domains in the gastrectomy group, and no domains in the 
medical-treatment group. Four surgically treated patients required 
additional surgical interventions to address complications within the 
first year, but no patients required additional surgery thereafter.

Schauer PR et al., N Engl J Med 2014 Mar 31;

The FDA has approved the first sublingual allergen extract to treat 
rhinitis — with or without conjunctivitis — caused by grass 
pollens. The once-daily tablet (Oralair) is indicated for patients 
aged 10 to 65 years.

The drug contains a mix of five grass pollens: Kentucky Blue Grass, 
Orchard, Perennial Rye, Sweet Vernal, and Timothy. In studies among 
some 2500 patients, those taking Oralair had a 16% to 30% reduction in 
symptoms compared with those on placebo.

The first dose should be administered in a clinician’s office (before 
the start of the grass pollen season) so that the patient can be 
observed for adverse reactions. The prescribing information includes a 
boxed warning about potentially life-threatening allergic reactions 
(e.g., anaphylaxis). The most common side effects include itching and 
swelling in the mouth, and throat irritation.

FDA news release

The risk for stroke increases significantly in the weeks after the 
onset of herpes zoster, especially cases of zoster affecting the 
distribution of the trigeminal nerve, according to a Clinical 
Infectious Diseases study.

Using a U.K. general practice database, researchers studied some 6500 
patients who had zoster and subsequent stroke. The observations began 
in the baseline period before the onset of zoster and extended for at 
least a year.

Patients were at greatest risk in the first 4 weeks after zoster 
onset, having an incidence ratio of 1.63 relative to baseline. The 
ratio in weeks 13 through 26 declined to 1.23, becoming nonsignificant 
thereafter. Stroke risks were especially strong after zoster 
ophthalmicus.

Roughly half the patients received oral antiviral treatment, and among 
those, there was a protective effect. The authors, suspecting a role 
for vasculopathy, encourage improvement in what they see as a 
relatively low rate of treatment with antivirals.

Clinical Infectious Diseases article

Two new studies demonstrate the shaky underpinnings of guidelines that 
encourage the intake of omega-3 fatty acids.

The first, a large meta-analysis in the Annals of Internal Medicine, 
examined dietary fatty acid consumption, fatty acid biomarkers, and 
fatty acid supplements. Among the chief findings:

Omega-3 and omega-6 fatty acids: There were trends for modest benefits 
associated with dietary intake or supplements, but these did not 
achieve statistical significance.

Saturated fatty acids: There was no discernible effect of total 
saturated fat as measured by either dietary intake or circulating 
biomarkers.

Monounsaturated fatty acids: No effect was found.

Trans dietary fats: A harmful effect was confirmed.

In the second study, published in JAMA Internal Medicine, 4200 
patients with age-related macular degeneration were randomized to 
omega-3 fatty acids; lutein/zeaxanthin (carotenoids found in the eye); 
both; or placebo. After roughly 5 years, there was no significant 
reduction in cardiovascular outcomes in the treatment groups.

Commentators say it’s now clear that omega-3 supplements “with daily 
doses close to 1 g in patients with or without established CVD shows 
no clear, considerable benefit.” They conclude that for now, omega-3s 
should be prescribed only for patients with severe 
hypertriglyceridemia, “an extreme minority of the general population.”

Plasma concentrations of phenylephrine spike to potentially risky 
levels when the drug is used in combination with acetaminophen, 
according to a letter in the New England Journal of Medicine. Drugs 
that combine phenylephrine and acetaminophen include over-the-counter 
cold medicines such as DayQuil and Tylenol Cold and Flu.

The letter’s authors, including drug company employees, report 
findings from three crossover trials: when healthy volunteers took 
phenylephrine (10 mg) in combination with acetaminophen (1000 mg), the 
maximal plasma concentration of phenylephrine was four times higher 
than when they took phenylephrine alone.

Combining the drugs increased phenylephrine exposure “beyond levels 
that were previously deemed to be safe and effective,” the authors 
write, thereby “increasing the potential risk of adverse events.” 
Among those potential events are “higher blood pressure, elevated 
heart rate and nervousness,” the New York Times reports.

Dietary constituents called “FODMAPs” complicate the idea of 
nonceliac gluten sensitivity.

Some people without celiac disease report gastrointestinal intolerance 
to gluten-containing foods. In 2011, Australian researchers conducted 
a controlled-diet study that boosted the case for “nonceliac gluten 
sensitivity” (NEJM JW Gen Med Apr 5 2011). Now, the same group has 
explored whether “FODMAPs” (Fermentable, Oligo-, Di-, 
Monosaccharides, And Polyols) might confound the perceived response to 
a gluten-free diet. FODMAPs are fermentable, poorly absorbed, short-
chain carbohydrates that include fructose, lactose, fructans (found in 
wheat), galactans, and polyol sweeteners.

The trial included 37 patients with irritable bowel syndrome who 
reported gluten sensitivity, and whose evaluations for celiac disease 
were negative. During a 2-week run-in period, all patients followed a 
gluten-free, low-FODMAP diet. Then, in a randomized, double-blind, 
crossover format, each patient received high-gluten, low-gluten, and 
no-gluten diets (1 week for each diet, separated by 2-week washout 
periods).

During the low-FODMAP run-in period, mean symptom scores improved 
significantly. However, symptoms worsened during each of the three 
double-blind treatments — with no differences between the high-
gluten, low-gluten, and no-gluten periods. Twenty-two patients 
repeated the whole study with 3-day (rather than 7-day) food 
challenges, and with dairy products and chemical food additives also 
eliminated from their diets. Again, symptoms worsened just as much 
with the no-gluten diet as with the gluten-containing diets.

COMMENT

In this study of nonceliac patients who reported previous gluten 
sensitivity, a gluten-containing diet was no more likely than a no-
gluten diet to worsen symptoms in the presence of a low-FODMAP diet. 
Because many gluten-containing foods also are high in FODMAPs, the 
authors speculate that improved symptoms with a gluten-free diet 
actually might reflect simultaneous reduction in FODMAP intake. 
However, our understanding of nonceliac gluten sensitivity remains 
incomplete.

Biesiekierski JR et al. No effects of gluten in patients with self-
reported non-celiac gluten sensitivity after dietary reduction of 
fermentable, poorly absorbed, short-chain carbohydrates. 
Gastroenterology 2013 Aug; 145:320. (http://dx.doi.org/10.1053/j.gastro.2013.04.051
) PubMed abstract (Free)Web of Science

Allan S. Brett, MD reviewing Biesiekierski JR et al. Gastroenterology 
2013 Aug.

Job insecurity is associated with psychological distress, adverse 
physical symptoms, and poor self-rated health. But, whether job 
insecurity is associated with coronary heart disease (CHD) is unclear. 
Researchers analyzed data from 174,000 working adults who were 
participating in 17 prospective studies in the U.S. and Europe. 
Participants were free of CHD at baseline. Job insecurity was assessed 
using a global question regarding level of insecurity in the current 
job or with questions regarding fear of layoff or unemployment; 
answers were dichotomized as high versus low job insecurity. Incident 
CHD was ascertained from hospital records or death registries.

During mean follow-up of nearly 10 years, 1900 incident CHD-related 
events (e.g., myocardial infarction, coronary death) occurred. 
Adjusted for multiple variables (i.e., age, sex, socioeconomic status, 
smoking, alcohol use, physical activity, and CHD risk factors), high 
job insecurity was associated with significant 20% higher risk for CHD 
compared with low job insecurity.

COMMENT

In this meta-analysis, high self-reported job insecurity was 
associated with excess risk for incident CHD. However, the study has 
important limitations. First, as the authors note, job insecurity 
measured at a single point does not distinguish short-term from long-
term job insecurity, which might have different health effects. 
Second, the findings do not prove causality; residual confounders 
(e.g., psychiatric disorders) might account for some of the association.

Virtanen M et al. Perceived job insecurity as a risk factor for 
incident coronary heart disease: Systematic review and meta-analysis. 
BMJ 2013 Aug 8; 347:f4746. (http://dx.doi.org/10.1136/bmj.f4746) 
Abstract/FREE Full Text

Paul S. Mueller, MD, MPH, FACP reviewing Virtanen M et al. BMJ 2013 
Aug 8.

The World Health Organization has proposed lowering the recommended 
upper limit for dietary sugars to less than 5% of total energy intake 
to reduce the risk for excess weight gain and dental cavities.

In draft guidelines, the WHO maintains that sugars should comprise 
less than 10% of a person’s caloric intake, as it noted in its 2002 
guidelines, but further benefits would be seen if less than 5% of 
calories were from sugar. This is equivalent to about six teaspoons of 
sugar a day. One can of soda may contain around 10 teaspoons.

The group is seeking public input until the end of March before 
releasing its final guidelines.