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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
December 5, 2015

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Bright-Light Therapy Alleviates Nonseasonal Depression
U.S. Health Spending Up — Hitting $3 Trillion Last Year
Diabetes Risk and the Early Microbiome
Relation between Central Obesity and Cardiovascular Mortality in people
   of Normal Weight
Lidocaine for Dyspareunia in Breast Cancer Survivors
Quantifying the benefits of Breast-Feeding after Gestational Diabetes
Too much TV in Young Adulthood, worse Cognitionlater?
Does quantity of Gluten intake during Infancy influence risk for Celiac Disease?
"On-Demand" Pre-exposure Prophylaxis can prevent HIV Infection in high-risk men
CDC: New Diabetes cases on the decline in the U.S.
Systematic Review of Rehabilitation in Multiple Sclerosis
Morbidity and Mortality are rising among Middle-Aged U.S. Whites
Use of Mobile Devices by Young Children in U.S. Is nearly Universal
Are Bleach Baths overreach Baths?
Acupuncture and Alexander Technique help alleviate Chronic Neck Pain
FTC asked to investigate Antitrust Violations-Saline Shortages
Walgreens acquiring Rite Aid in $17.2B Deal
Does skipping breakfast matter in Non–Insulin-Treated Diabetic Patients?
Certain Antibiotics could affect Gut Microbiome for 1 year
Vaginal Progesterone didn't improve live birth rates in women with Recurrent Miscarriage
Antioxidants — On the wrong side of the tracks?
Safety and durability of Magnetic Treatment of GERD: Five-year follow-up
Topical Pain Drugs rival Oral
Sleep Disruption and Mood Disruption

Bright-Light Therapy Alleviates Nonseasonal Depression
By Amy Orciari Herman
Bright-light therapy can improve depression symptoms that are not related to seasonal affective disorder, according to a randomized, double-blind trial in JAMA Psychiatry.
Some 120 adults in Canada with nonseasonal major depression were assigned to one of four treatments for 8 weeks: light monotherapy (use of a fluorescent light box for 30 minutes each morning, plus a placebo pill), fluoxetine monotherapy (20 mg/day, plus use of an inactive ion generator as sham light therapy), combination therapy, or sham plus placebo.
At the end of treatment, light therapy — alone or combined with fluoxetine — was associated with significant improvements in depression symptoms relative to sham-placebo. In particular, the mean change in a 60-point depression score was 16.9 with combination therapy, 13.4 with light monotherapy, 8.8 with fluoxetine monotherapy, and 6.5 with sham-placebo.
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U.S. Health Spending Up — Hitting $3 Trillion Last Year
The nation's health bill came to $3 trillion in 2014, an increase of 5.3% over 2013, according to a report in Health Affairs.
Federal economists report that the increase "was primarily due to the major coverage expansions under the Affordable Care Act" and a 12-percentage-point increase in prescription drug spending.

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JAMA Pediatr 2015 Nov 9
Diabetes Risk and the Early Microbiome
Neonatal probiotic use is associated with lower type 1 diabetes risk in genetically susceptible children.
The potential relationship between the intestinal microbiome and autoimmune disease is a novel area of study.
As part of an ongoing birth-cohort study, researchers examined the association between probiotic supplementation in infants and childhood risk for persistent pancreatic islet autoimmunity (IA) in approximately 7500 children with genetic susceptibility to type 1 diabetes mellitus (T1DM). Children were followed for up to 10 years, and based on serologic testing, about 8% developed IA. During the first year of life, 22% of participants were given probiotics either in formula, as dietary supplements, or both.
Exposure to probiotics during the first 28 days of life was significantly associated with a decreased risk for developing IA compared with exposure after day 27 or no exposure (hazard ratio, 0.66), adjusted for potential confounders including maternal probiotic use, exclusive breast-feeding duration, child antibiotic use, and diarrhea episodes. When stratified by genotype, only children with the DR3/4 HLA genotype had a significantly reduced risk (HR, 0.40). An analysis excluding children who developed IA as infants showed similar results, allaying concern that some unknown factor in infancy was related to both decreased IA and use of probiotics. Results were similar across countries.
COMMENT: Although this large study's finding of a possible association between probiotics and decreased risk for T1DM is fascinating, randomized, controlled trials using specific strains and doses are necessary before we go ahead and test newborns' HLA genotypes and give probiotics accordingly. Nevertheless, microbiome manipulation in the neonatal period, when it may be easier and more effective, is an exciting prospect. As an editorialist suggests, probiotics and fecal transplant might someday allow us to change the course of genetically determined autoimmune diseases, or even prevent them.
CITATION(S): Uusitalo U et al. Association of early exposure of probiotics and islet autoimmunity in the TEDDY study. JAMA Pediatr 2015 Nov 9; [e-pub]. (http://dx.doi.org/10.1001/jamapediatrics.2015.2757)
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Ann Intern Med 0 2015 Nov 10
Relation between Central Obesity and Cardiovascular Mortality
in people of Normal Weight

Waist-to-hip ratio might be more accurate than body-mass index for determining CV risk.
Are risks for cardiovascular-related and total mortality higher among people who have normal body-mass indexes (BMIs) but central obesity? Using data from the National Health and Nutrition Examination Survey (NHANES), researchers evaluated this association in >15,000 adults (age range, 18–90). Participants were categorized as normal weight (BMI, 18.5–27.4 kg/m2), overweight (BMI, 27.5–32.9 kg/m2), or obese (BMI, ≥33 kg/m2). Men with waist-to-hip ratio (WHR) ≥0.90 and women with WHR ≥0.85 were considered to be centrally obese.
Multivariate analyses demonstrated that normal-weight men and women with central obesity were more likely to die during a mean follow-up of 14 years than were other participants. For example, a man with a normal BMI and central obesity had a higher mortality risk than did an overweight or obese man with normal WHR (hazard ratios, 2.2 and 2.4, respectively). Similar patterns were seen in women.
COMMENT: These researchers found that central obesity is a risk factor for mortality even among individuals with normal BMIs. The results also suggest that WHR might be a better marker than BMI for mortality risk. As noted by the authors, BMI is a measure of both lean and fat mass, whereas WHR is associated with visceral fat accumulation, which has a stronger association with adverse metabolic profile than does BMI alone.
CITATION(S): Sahakyan KR et al. Normal-weight central obesity: Implications for total and cardiovascular mortality. Ann Intern Med 2015 Nov 10; [e-pub]. (http://dx.doi.org/10.7326/M14-2525)
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J Clin Oncol 2015 Oct 20; 33:3394
Lidocaine for Dyspareunia in Breast Cancer Survivor
Applying topical lidocaine prior to sexual intercourse significantly reduced penetration pain associated with dyspareunia.
One of the most common complaints from breast cancer survivors, if the subject is broached, relates to sexual dysfunction, of which there can be many manifestations, including lack of desire, body image, depression, and anxiety, as well as physical issues such as dyspareunia.
To explore whether aqueous lidocaine could prevent penetration pain associated with dyspareunia, investigators conducted a randomized, controlled, blinded study involving 46 breast cancer survivors with documented severe vulvovaginal atrophy, dyspareunia, increased sexual distress scores, or abnormal sexual dysfunction. Patients applied either saline or 4% aqueous lidocaine compresses 3 minutes prior to twice-weekly vaginal intercourse or tampon insertion. Thereafter, patients participated in a 2-month, open-label trial during which patients received lidocaine; the primary outcome was patient-reported penetration pain and secondary assessment of sexual function and distress.
Individuals receiving lidocaine in the blinded phase of the trial experienced significantly less pain during intercourse compared with those receiving saline. In the open-label phase of the trial, 90% of patients reported comfortable penetration. Scores of sexual function and distress also declined significantly with lidocaine use. Equally important, whereas almost 50% of patients abstained from intercourse before using lidocaine, 85% of them resumed sexual relations with intercourse after using lidocaine. None of the sexual partners of the participants experienced penile numbness.
COMMENT: A relatively simple maneuver of using topical lidocaine prior to intercourse can significantly improve the experience for many women who were previously unable or unwilling to participate in sexual intimacy. A larger trial will be needed to confirm these findings, but this approach could be used by many patients who are currently in distress.
CITATION: Goetsch MF et al. A practical solution for dyspareunia in breast cancer survivors: A randomized controlled trial. J Clin Oncol 2015 Oct 20; 33:3394. (http://dx.doi.org/10.1200/JCO.2014.60.7366)

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Ann Intern Med 2011 2015 Nov 24
Quantifying the Benefits of Breast-Feeding after Gestational Diabetes
Risk for type 2 diabetes was halved with exclusive breast-feeding versus formula-feeding.
Women with gestational diabetes mellitus (GDM) subsequently face excess risk for type 2 diabetes; however, this risk is reduced among mothers who breast-feed their infants. In a prospective cohort study involving 1035 women with GDM who delivered term singletons at Kaiser Permanente Northern California, researchers assessed the relative importance of lactation intensity and duration following GDM.
Overall, 1010 participants were free of diabetes 6 to 9 weeks after delivery. At 2 years postpartum, diabetes risk was reduced with higher intensity and longer duration of lactation. Compared with mothers exclusively breast-feeding 6 to 9 weeks postpartum, those exclusively formula-feeding were more than twice as likely to develop diabetes in 2 years. Similarly, mothers who breastfed for <2 months had more than twice the risk for diabetes as those who breastfed for >10 months. Postpartum weight change attenuated these relations only slightly.
COMMENT: These data add to the growing evidence that lactation plays an important role in both recovery from pregnancy and long-term cardiovascular health, but the analyses do not answer the question, “How long must I breast-feed to get all these benefits?” Although I advise mothers to strive for at least 1 year of lactation, they are at highest risk for developing diabetes if they don't breast-feed at all — and even 1 month of lactation significantly lowers maternal risk for diabetes. Thus, the key message for pregnant women is, “the most important thing is to start breast-feeding and to get the help you need to learn how to do so.”
CITATION(S): Gunderson EP et al. Lactation and progression to type 2 diabetes mellitus after gestational diabetes mellitus: A prospective cohort study. Ann Intern Med 2015 Nov 24; [e-pub].
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Too much TV in Young Adulthood, worse Cognitionlater?
By Christine Sadlowski Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM
People who are both sedentary and watch a lot of television from young adulthood on have worse cognition in midlife, researchers report inJAMA Psychiatry.
More than 3000 U.S. adults described their activity levels and TV viewing habits starting at a mean age of 25 and periodically thereafter. At 25 years' follow-up, participants completed tests of cognitive speed, memory, and executive functioning.
In adjusted analyses, those who consistently had both high TV viewing (more than 3 hours a day) and low physical activity (the lowest quartile of sex-specific activity) were twice as likely to have poor cognition scores compared with participants with low TV viewing and high physical activity.
Each of the two behaviors was also independently associated with worse cognition. Processing speed and executive function, but not verbal memory, were affected by both behaviors.
The authors conclude that both behaviors may be modifiable risk factors for prevention of cognitive impairment.
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Clin Gastroenterol Hepatol d 2015 Oct 7
Does quantity of Gluten intake during Infancy influence risk for Celiac Disease?
A positive association was noted in prospectively studied infants with genetic susceptibility for celiac disease.
Whether changes in grain products (resulting from hybridization, etc.), timing of introduction of gluten, or the amount of gluten ingested by infants affects the risk for celiac disease are current subjects of research.
In Sweden, infants are commonly fed gluten-containing gruel and porridge after weaning from breast-feeding. To evaluate whether the quantity of gluten consumed before age 24 months is associated with risk for celiac disease, investigators conducted a nested case-control study among 3723 Swedish infants enrolled in a prospective cohort study who had at least one human leukocyte antigen (HLA) genotype associated with high risk for celiac disease. Newborns underwent HLA genotyping and were tested annually for tissue transglutaminase autoantibodies (tTGA) beginning at age 2 years. Parents submitted 3-day food intake diaries recorded at infant ages 9, 12, 18, and 24 months.
Of 2062 infants screened for tTGA, 330 were persistently antibody-positive and 147 received a diagnosis of celiac disease by biopsy. Increased gluten intake prior to tTGA seroconversion was associated with a significantly increased risk for celiac diagnosis. For each 1 gram increase of gluten consumed daily, the risk for celiac disease increased by 28%.
COMMENT: Although further data are needed, these findings suggest that reducing gluten exposure in infancy and perhaps childhood may lower risk for celiac disease in children with genetic susceptibility.
Note to readers: At the time NEJM Journal Watch reviewed this paper, its publisher noted that it was not in final form and that subsequent changes might be made.
CITATION(S): Aronsson CA et al. Effects of gluten intake on risk of celiac disease: A case-control study on a Swedish birth cohort. Clin Gastroenterol Hepatol 2015 Oct 7; [e-pub].
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"On-Demand" Pre-exposure Prophylaxis can Prevent HIV Infection in
High-Risk Men

By Amy Orciari Herman, Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD
Among high-risk men who have sex with men (MSM), "on-demand" pre-exposure prophylaxis (PrEP) — that is, antiretroviral therapy before and after sexual activity — significantly lowers the risk for HIV acquisition, according to a New England Journal of Medicine study. Previous research focused instead on daily use.
Some 400 HIV-negative MSM in France and Canada who'd had unprotected anal sex in the past 6 months were randomized to take either tenofovir disoproxil fumarate (TDF) plus emtricitabine (FTC) or a placebo both before and after sexual activity (two pills 2 to 24 hours before sex, a third pill 24 hours later, and a fourth 24 hours after that).
During a median 9 months' follow-up, HIV was diagnosed in significantly fewer TDF-FTC than placebo recipients (2 vs. 14). The two men in the TDF-FTC group who developed HIV were nonadherent to the medication. Serious adverse events didn't differ between the groups, although gastrointestinal events were more common with active treatment (14% vs. 5% of participants).
In NEJM Journal Watch Infectious Diseases, Dr. Carlos del Rio writes: "This approach is cheaper compared to daily PrEP and may be an option for MSM at extremely high risk, who are highly adherent and who know precisely when they will have sex.

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CDC: New Diabetes Cases on the Decline in the U.S.
For the first time in decades, the annual number of new diabetes cases among U.S. adults appears to be declining, according to new data from the CDC.
After rising steadily from the mid-1990s onward, the annual number exceeded 1.7 million in 2009 — but then began to drop, reaching roughly 1.4 million in 2014. In addition, the age-adjusted incidence decreased significantly from 2008 to 2014, from 8.5 to 6.6 per 1000.
While these data are encouraging, it's worth noting that in 1980 the annual number of new cases was just 493,000, and the age-adjusted incidence was 3.5 per 1000.
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Neurology 2015 Nov 24; 85:1896z
Systematic Review of Rehabilitation in Multiple Sclerosis
Comprehensive rehabilitation is effective for those with progressive MS and moderate-to-severe disability.
To examine the data on the use of comprehensive multidisciplinary rehabilitation to improve function, minimize disability, or improve quality of life, researchers conducted a systematic review. In addition, supervised physical therapy or physical training programs were evaluated to determine their benefit and to identify the most effective techniques. Energy-conservation techniques, specialty devices, and educational programs were also assessed. The authors' main conclusions were as follows:
• For patients with moderate-to-severe disability and progressive multiple sclerosis (MS), 6 weeks of comprehensive outpatient rehabilitative therapy may be effective for disability reduction and functional improvement according to functional independence measures. Studies are inadequate to determine whether comprehensive rehabilitation is beneficial for self-efficacy, fatigue, depression, or quality of life.
• Weekly home or outpatient physical therapy for 8 weeks can be effective for improving balance and gait, and reducing disability in those able to ambulate ≥5 meters. Three weeks of inpatient training followed by home exercise for 15 weeks may be effective for reducing disability. Three weeks of sensory and/or motor balance training may be effective for improving static and dynamic balance.
• Data are inadequate to comment on cooling garments and specific physical therapy techniques to improve balance, respiratory muscles, or fatigue.
• Questions remain surrounding frequency, duration, and intensity of specific rehabilitation techniques and therapies. Sham interventions and objective measures are required for high-level evidence. Most studies evaluate neither the long-term impact of such interventions nor how to encourage patients to continue their rehabilitation program after discharge.
Comment: Comprehensive rehabilitation is beneficial for patients with moderate-to-severe disability, however, it remains unclear how individual physical and occupational therapy techniques affect specific MS symptoms. Although clinicians and patients believe in the importance of comprehensive, individualized rehabilitation for maintaining quality of life, many insurance plans do not cover rehabilitation or require a high co-payment. The present analysis can justify rehabilitation for many with moderate-to-severe disability, although the number of unanswerable questions about common practices is a sobering reminder of the need for additional high-quality research.
Citation(s): Haselkorn JK et al. Summary of comprehensive systematic review: Rehabilitation in multiple sclerosis: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology 2015 Nov 24; 85:1896.
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Proc Natl Acad Sci U S A 2015 Nov 2
Morbidity and Mortality are rising among Middle-Aged U.S. Whites
Among men with no more than high school degrees, suicide and chronic liver disease are taking a toll.
Since the end of World War II, annual morbidity and mortality have been decreasing among U.S. residents in all age and socioeconomic strata. Two Princeton economists, one of whom won the 2015 Nobel Prize, analyzed multiple datasets collected during the past several decades in the U.S. and other developed nations.
These investigators report a remarkable and worrisome finding: Between 1999 and 2013, morbidity and mortality increased among middle-aged (age range, 45–54) white non-Hispanic U.S. residents. Rates did not increase in other age strata of white non-Hispanic U.S. residents, in black non-Hispanic or Hispanic U.S. residents, or in residents of other developed nations. The reported increase was driven exclusively by rates in residents who had no more than high school degrees. Mortality in this group increased largely due to dramatically rising rates of drug and alcohol poisoning (accidental or intentional), suicide, and chronic liver disease and cirrhosis. Morbidity increases were reflected in rising rates of excessive drinking, with elevated levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT), and more pain, disability, and unemployment.
COMMENT: The authors speculate that the rising morbidity and mortality they found in middle-aged white non-Hispanics might reflect a “lost generation” — people trapped in mid-life by an economy that provides fewer jobs for less well-educated people and by rising income inequality. Why the same trend was not seen in poorly educated black and Hispanic residents is puzzling, but absolute mortality rates remain higher among black than among white U.S. residents.
CITATION(S): Case A and Deaton A.Rising morbidity and mortality in midlife among white non-Hispanic Americans in the 21st century. Proc Natl Acad Sci U S A 2015 Nov 2; [e-pub]. (http://dx.doi.org/10.1073/pnas.1518393112)
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Use of Mobile Devices by Young Children in U.S. Is nearly Universal
By Kelly Young, Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH
Nearly all children aged 4 and under in a low-income community used an electronic mobile device, according to a cross-sectional study inPediatrics.
Roughly 350 parents of children ages 6 months to 4 years in an urban, minority community completed surveys about their children's media habits in 2014.
Overall, 97% of children had ever used a mobile device (e.g., cell phone, tablet). Nearly half of children under age 1 year used a mobile device daily; by age 2, three-quarters of kids did. By age 4, three-fourths of children owned their own device.
Based on a 2013 national survey, it appears that the percentage of households that owned a tablet doubled in 1 year (40% to 83%), indicating "a rapid decline of the digital divide," the authors write.
They conclude: "Studies are urgently needed to update recommendations for families and providers on the use of mobile media by young children."
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J Dermatolog Treat 2015 Aug 13
Are Bleach Baths Overreach Baths?
Bleach baths may be preferred when heavy S. aureus colonization is suspected.
Staphylococcus aureus can be isolated from lesional skin in at least 80% of patients with atopic dermatitis whether or not the skin looks “infected.” Crusting hints at high levels of colonization. At some point, heavy colonization contributes to disease severity and persistence. Although antistaphylococcal antibiotics are often prescribed, bathing the skin in tap water may wash off crusts and bacteria to reduce the density of S. aureus. Recently, sodium hypochlorite (NaOCl) bleach baths have become fashionable, added to bathwater. Do bleach baths really work better than regular baths?
In a double-blind, placebo-controlled, crossover trial, 40 children aged 4 to 18 years with moderate-to-severe atopic dermatitis were randomized to bleach baths or tap-water baths twice weekly for 4 weeks and then crossed over to the other bath treatment. Bleach baths were not significantly superior to tap-water baths per the Children Dermatology Life Quality Index, skin hydration, transepidermal water-loss measurement, blood eosinophil count, total IgE level, or levels of IgE to staphylococcal enterotoxins A and B. Water baths better reduced the affected area in the SCORing Atopic Dermatitis index (SCORAD) measurements. Bleach baths did significantly reduce topical corticosteroid use.
COMMENT: This was a small study with some nonadherent subjects. Baths were twice weekly, so daily or twice-daily baths may have worked better. Some subjects may have detected NaOCl by smell, unblinding them to treatment.
These findings reaffirm that children with moderate-to-severe crusted eczema improve after soaking baths. In my view, water is the most important ingredient in bath therapy. Adding something to the water (NaOCl, vinegar, Epsom salts, sodium chloride, aluminum acetate, oatmeal, etc.) increases compliance and maybe efficacy. Bleach baths at least have merit in safely reducing the need for systemic antibiotics and may be preferred when heavy S. aureus colonization is suspected. It also seems safe and reasonable to recommend their routine use in “soak and slather” bath and emollients regimens, at least in older children.
CITATION(S): Hon KL et al. Efficacy of sodium hypochlorite (bleach) baths to reduce Staphylococcus aureus colonization in childhood onset moderate-to-severe eczema: A randomized, placebo-controlled cross-over trial. J Dermatolog Treat 2015 Aug 13: [e-pub]. (http://www.tandfonline.com/doi/full/10.3109/09546634.2015.1067669)
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Acupuncture and Alexander Technique help alleviate Chronic Neck Pain
By Jenni Whalen, Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD
Both acupuncture and the Alexander Technique can improve chronic neck pain, according to a study in the Annals of Internal Medicine.
Over 500 U.K. patients with nonspecific neck pain of at least 3 months' duration were randomized to one of three strategies: 12 acupuncture sessions plus usual care, 20 one-to-one Alexander Technique lessons plus usual care, or usual care alone. The Alexander Technique is a method of changing how one carries out daily activities, with a focus on reducing tension through coordination, balance, posture, and spatial awareness.
At 12 months, both the acupuncture and Alexander Technique groups had significantly greater reductions in a score measuring neck pain and disability (about a 30% reduction from baseline), compared with usual care alone (23%). The pain/disability reductions with acupuncture and the Alexander Technique were considered clinically significant.
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FTC asked to investigate Antitrust Violations-Saline Shortages
A bipartisan group of U.S. Senators urged the Federal Trade Commission (FTC) to investigate possible illegal collusion by saline solution manufacturers. This results from the nation's shortage of saline solution since 2013, and the failure of the three companies that provide all of the saline solution in the U.S. to end the shortage. "Since the saline shortage began in late 2013, suppliers are reported to have increased their prices by 200-300 percent," the senators wrote. "This equates to increased annual costs to individual hospitals in the range of hundreds of thousands to millions of dollars." 
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Walgreens acquiring Rite Aid in $17.2B Deal
Walgreens is buying rival Rite Aid in a $17.2 billion deal that would whittle the nation's one-time mom-and-pop drug-store industry into two massive chains, combining the second and third largest drug-store operators. The market is shifting as pharmacies are adjusting with the rapidly changing healthcare industry. Currently, CVS has a 58% market share, Walgreens controls 31% and Rite Aid has 10%, according to research firm IBISWorld. The industry has $263 billion in annual revenue and $10.3 billion in profit. 
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Diabetes Care 2015 Oct; 38:1820
Does skipping breakfast matter in Non–Insulin-Treated Diabetic Patients?
In this study, having no breakfast was associated with higher blood glucose after lunch and dinner.
Skipped meals complicate management of insulin-treated diabetic patients. A new study suggests that skipping breakfast might affect glycemic control even in patients who are not taking insulin.
Researchers enrolled 22 patients (mean age, 57; mean glycosylated hemoglobin level, 7.7%) whose type 2 diabetes was controlled by diet or metformin only. All patients were studied on one day when they ate three meals and again on one day when they skipped breakfast and ate only two meals. Meals were standardized (prepared by the researchers), so the only difference between the two study days was the presence or absence of breakfast.
On no-breakfast days, mean peak glucose excursions after lunch and after dinner were significantly higher (by 40% and 25%, respectively) — and post-lunch and post-dinner insulin levels were lower — than on breakfast days. Other observations on no-breakfast days were higher levels of free fatty acids (FFAs) and lower levels of glucagon-like peptide-1 (GLP-1); both higher FFA and lower GLP-1 levels have downstream metabolic effects that potentially raise plasma glucose levels.
COMMENT: Skipping breakfast appears to affect glucose homeostasis adversely later in the day in patients with diet-controlled or metformin-treated type 2 diabetes. One explanation discussed by the authors is a “second-meal phenomenon,” in which the first meal (breakfast) induces enhanced β cell responsiveness later in the day. Whether this phenomenon has important long-term clinical implications is unknown.
CITATION(S): Jakubowicz D et al. Fasting until noon triggers increased postprandial hyperglycemia and impaired insulin response after lunch and dinner in individuals with type 2 diabetes: A randomized clinical trial. Diabetes Care 2015 Oct; 38:1820. (http://dx.doi.org/10.2337/dc15-0761)

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Certain Antibiotics could affect Gut Microbiome for 1 year
By Kelly Young
Gut microbial diversity may be diminished for up to a year following oral antibiotic use, suggests a small, industry-conducted study published inmBio.
Sixty-six healthy participants in the U.K. and Sweden were randomized to receive placebo or an antibiotic (clindamycin, amoxicillin, ciprofloxacin, or minocycline). They provided saliva and fecal samples before and after receiving antibiotics.
Over the long term, the salivary microbiome was largely undisturbed by antibiotic administration. Meanwhile, microbiome diversity in fecal samples was reduced for up to 4 months in patients receiving clindamycin and up to 12 months in those receiving ciprofloxacin. Specifically, bacteria that produce the short-chain fatty acid butyrate — which is linked to lower inflammation, carcinogenesis, and oxidative stress in the gut — were significantly reduced.
In addition, genetic testing found more genes associated with antibiotic resistance in the fecal samples.
The authors conclude: "Clearly, even a single antibiotic treatment in healthy individuals contributes to the risk of resistance development and leads to long-lasting detrimental shifts in the gut microbiome."
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Vaginal Progesterone didn't improve live birth rates in women with Recurrent Miscarriage
By Robert W. Rebar, MD, Dr. Rebar is associate editor of NEJM Journal Watch Women's Health, from which this story was adapted. See full coverage at the link below.
Vaginal progesterone was not associated with higher live birth rates in women who'd had multiple miscarriages, according to a New England Journal of Medicine study.
Over 800 women with unexplained recurrent miscarriage (loss of three or more pregnancies) were randomized to receive vaginal progesterone suppositories (400 mg twice daily) or placebo beginning no later than 6 weeks' gestation through 12 weeks' gestation.
The rate of live birth after 24 weeks' gestation was not significantly different between groups (66% for progesterone and 63% for placebo).
Although this well-conducted study is at odds with a recent Cochrane report suggesting that progesterone lowers rates of subsequent miscarriage, the results should not be surprising. Until the causes of unexplained recurrent miscarriage are determined, any single therapeutic modality is unlikely to be uniformly effective. Still, couples and their clinicians should be buoyed by knowing that the chances of subsequent live birth have remained at 65% to 70% in virtually all trials, regardless of therapy.

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Nature 2015 Oct 14
Antioxidants — On the wrong side of the tracks?
Two animal studies indicate that antioxidant exposure may have significant unintended consequences for the progression of melanoma.
Antioxidants, available in many over-the-counter forms (vitamins C, E), are commonly regarded as safe and possibly cancer-protective. However, regulation of reactive oxygen species in cancers is quite complex, and though cells have evolved multiple mechanisms to control potentially mutagenic and damaging reactive oxygen species (ROS), increasing evidence suggests that cancers tune ROS levels to a sweet spot that avoids catastrophic toxicity while preserving generation of new mutations and inhibiting immune control.
Two recent studies in mouse models directly addressed how antioxidants might affect melanoma progression. Le Gal and colleagues showed that antioxidants increased melanoma invasiveness and metastasis. Both N-acetylcysteine (NAC) and Trolox (a vitamin E analogue) affected RHOA kinase pathways that regulate invasiveness and migration. NAC administration in a Braf/Pten mouse model of melanoma doubled the number of lymph node metastases. Piskounova and colleagues made similar observations but took things further, determining that melanoma cells experience oxidative stress in circulation. They showed that melanomas passaged through subcutaneous tissue had a substantially different redox status than did melanomas moving through the circulation or implanted in the spleen. In their assays, NAC also increased the metastatic efficiency of melanoma cells by 10-fold. Having detected greater levels of reduced glutathione in efficiently metastatic cells, the authors reasoned that NADPH-generating enzymes allow these cells to withstand oxidative stress. Since folate metabolism is critical for this process, they tested whether methotrexate would suppress metastases, which it did.
COMMENT: These important papers show that oxidative stress is a major barrier to successful intravascular transit of metastatic melanoma. Modulation of oxidative stress through antioxidant exposure may have significant — if not dangerous — unintended consequences, though it is unknown whether dietary supplements produce the same pharmacologic effects. Careful manipulation of redox status in these cells may potentially be therapeutically useful.
CITATION(S): Piskounova E et al. Oxidative stress inhibits distant metastasis by human melanoma cells. Nature 2015 Oct 14; [e-pub].
Le Gal K et al. Antioxidants can increase melanoma metastasis in mice. Sci Transl Med 2015 Oct 7; [e-pub].
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Clin Gastroenterol Hepatol 2015 Jun 2
Safety and durability of Magnetic Treatment of GERD: Five-year follow-up
Final follow-up of patients who received this surgical intervention revealed continued efficacy and no safety concerns.
In 2012, the U.S. Food and Drug Administration approved the use of a magnetic device that augments the lower esophageal sphincter function as an intervention option for patients with symptomatic gastroesophageal reflux disease (GERD). The current study provides final 5-year data on safety and efficacy of the device, updating a prior report of 3-year follow-up data (NEJM JW Gastroenterol May 2013).
The industry-funded, multicenter study initially comprised 100 patients with partial response to daily proton-pump inhibitors (PPIs) and evidence of pathologic reflux on 24-hour pH monitoring who underwent implantation of the magnetic device. Five-year follow-up data, available for 85 patients, showed that postapproval efficacy endpoints of ≥50% improvement in GERD-related quality-of-life score and ≥50% reduction in daily PPI dose were achieved by 83% and 89% of patients, respectively. Between baseline and 5 years, no device erosions, migrations, or other malfunctions occurred, and notable reductions were seen in use of PPIs (100% vs. 15%), moderate or severe regurgitation without use of PPIs (57% vs. 1%), and gas bloat (52% vs 8%). All patients reported the ability to belch or vomit if needed.
COMMENT: Despite the recognized 15% loss of patient data and lack of an intention-to-treat analysis of efficacy, these 5-year data support the conclusion that this device provides a safe, effective, and sustained control of reflux. Particularly notable is the improvement in regurgitation, for which PPIs do not offer effective control. It should be noted that in addition to implanting the magnetic device, surgeons performed a cruroplasty in 34% of patients at their discretion. Curiously, no mention of this was made in the initial report. This disclosure suggests that surgical expertise required for this procedure may extend beyond placement of the device.
CITATION(S): Ganz RA et al. Long-term outcomes of patients receiving a magnetic sphincter augmentation device for gastroesophageal reflux. Clin Gastroenterol Hepatol 2015 Jun 2; [e-pub]. (http://dx.doi.org/10.1016/j.cgh.2015.05.028)
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Topical Pain Drugs rival Ora
Topical NSAIDs effectiveness is similar to oral NSAIDs, and they can decrease the risk for ulcers, heart attacks, and strokes. Data is showing that topical products "can work as effectively" for pain relief as oral medications. Clinical trials are backing gels and patches. Studies show comparatively small amounts of the medication gets into the bloodstream and some scientists say it is logical that a lower exposure will result in lower risk, but so far a safety benefit hasn't been proven. The NSAIDS appear to be best used on superficial joints. 
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Sleep 2015 Nov; 38:1735
Sleep Disruption and Mood Disruption
Sleep loss from frequent awakening is more detrimental to mood than sleep loss from restricted sleep.
Insomnia, affecting 10% of the population, is associated with increased risk for depression. Investigators examined possible mechanisms for this association in 62 healthy men and women (39 women; mean age, 26) who demonstrated good sleep and did not have psychiatric or substance use disorders. Participants were randomized to one of three conditions for 3 nights: forced awakenings for 20 minutes each hour and one 60-minute period per night (21 participants; maximum sleep time, 280 minutes); restricted sleep by delaying bedtime so that sleep equaled the total sleep time of a matched participant in the forced awakening condition (17 participants); or usual uninterrupted sleep (24 participants). Sleep architecture was measured by polysomnography.
Uninterrupted-sleep participants showed no change in positive or negative mood during the 3 days. In contrast, the forced-awakenings and restricted-sleep groups had similar and significant mean increases in self-reported negative mood. However, the forced-awakenings group had significantly less slow-wave sleep after the first night and significantly reduced positive mood after the second night. Changes in slow-wave sleep mediated the changes in positive mood.
COMMENT: Despite comparable reductions in total sleep time, disrupted sleep was more detrimental to positive mood than restricted sleep. This study suggests that reductions in slow-wave sleep drive decreased positive mood in healthy individuals and could be a risk factor for depression. The authors note that the forced awakenings in this study are especially pertinent to experiences in early parenthood, combat, and on-call work in healthcare. Measures to help patients in such situations consolidate sleep and avoid frequent awakenings may help prevent lowered positive mood and subsequent depression.
CITATION(S):Finan PH et al. The effects of sleep continuity disruption on positive mood and sleep architecture in healthy adults. Sleep 2015 Nov; 38:1735. (http://dx.doi.org/10.5665/sleep.5154)
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