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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
August 8, 2015

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Express Scripts Posted Modest Revenue Increase to $25.45 Billion
Express Scripts Complains About Costly New Cholesterol Drugs
No Benefit from Vitamin D Supplementation for Postmenopausal Musculoskeletal Health
Probiotics, Prebiotics, and Synbiotics for Irritable Bowel Syndrome
Feeling Threatened? Get Some Rest
Anxiety Increases the Risk for Infectious Gastroenteritis and Postinfectious IBS
The Myths and Emotional Burden of Miscarriage
First 3D-Printed Drug Product Approved
Midazolam Nasal Spray and Seizures
Breast-Feeding Delays Maternal Vascular Aging
Laparoscopic Sleeve Gastrectomy: Initial Benefits Drop Off with Longer Follow-Up
Tenofovir Gel for Preventing HSV-2 Infection?
Don't Bother with Lactose-Free Formula
More Chili Peppers, Please: Spicy Food Consumption Linked to Lower Mortality

MM: Have you ever walked into a pharmacy with a prescription in hand expecting to be able to get the medicine that your doctor ordered for you? The doctor's intent was to have a beneficial effect on your heath. Only, then you were told by the pharmacist that your insurance company wouldn't pay for the medication?
I have this happen to my patients almost every day. Either the insurance company doesn't like compounds (since I am a compounding pharmacist), or they want a less expensive dosage form such as a SR (sustained release) rather than an ER (Extended Release) tablet or they want a different generic because that company gives them a greater rebate (aka kickback). All of these can happen to a patient. This doesn't necessarily improve patient care or decrease costs of premiums or decrease healthcare costs to us as a nation. This invariably increases the profit to the PBM (Prescription Benefit Managers) like Express Scripts, Blue Cross or CVS-Caremark. This ends up frustrating a patient. It costs the consumer and the pharmacy time and money. And, the net effect is to decrease both the patient and the pharmacist while lining the PBM pockets.

Express Scripts Posted Modest Revenue Increase to $25.45 Billion
Overall, the company reported a profit of $600.1 million, or 88 cents a share, up from $515.2 million, or 67 cents a share, a year earlier. The number of adjusted claims filled in retail pharmacies and 90-day fills through the company's mail-order business fell 1% to 321.2 million. Revenue increased to $25.45 billion from $25.11 billion.
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Express Scripts Complains About Costly New Cholesterol Drugs
Express Scripts said the cost of potent, newly approved cholesterol drugs could "wreak financial havoc" among its clients. U.S. regulators approved the first of the new medicines, Praluent, from Regeneron Pharmaceuticals Inc. and Sanofi SA. Given every other week by injection, Regeneron said that Praluent will have a wholesale price of $1,120 for a 28-day supply. That comes to almost $15,000 a year.
Standard older cholesterol fighters such as statins, including generic forms of Pfizer Inc.'s Lipitor and Merck & Co.'s Zocor, can cost less than $50 a month.
Glen Stettin, a senior Express Scripts executive, said an estimated 70 million Americans have high cholesterol, but he estimates fewer than 10% of them should qualify for Praluent. Before getting their prescriptions filled, patients in Express Scripts plans will be asked for documentation of their diagnosis, their cholesterol levels, diet, and maximum tolerated statin therapy, Stettin said.
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MM: My first thought is that the authors and I have a very different definition of adequate blood levels of vitamin D and also of what "high doses" are. I firmly believe that an "optimal" blood level of vitamin D is 60-80ng/ml and a minimal level is 50ng/ml. General opinion is that the level of 30ng/ml is "adequate". Current recommendations also hold that 800IU of vitamin D3 daily is "sufficient" for adults. I disagree with this position. I feel that most people are deficient in D3 and that a beneficial way to get a "sufficient" level in the body is a combination of direct sunlight and oral supplementation on a regular, if not daily schedule. Oral daily dosing for most adults in the Chicago, New York, San Francisco latitude should be 2000-5000IU daily. Blood target levels during summer months should be closer to 80 than 60ng/ml and in winter months should not fall below 50-60ng/ml. Multiple studies have demonstrated that when D levels drop, disease. falls and injuries follow. Several professional sports teams that advise their athletes to take higher dose vitamin D3 supplementation have fewer reported injuries and report shorter recovery times needed after performance resulting in improved win-loss results. Practical information that comes from society should not be ignored here.
JAMA Intern Med 2015 Aug 3
No Benefit from Vitamin D Supplementation for Postmenopausal Musculoskeletal Health
Neither high-dose nor low-dose supplementation increased bone-mineral density, improved muscle outcomes, or lowered fall rates.
Low vitamin D levels are associated with lower bone-mineral density and possibly greater risk for muscle weakness and falls. However, the definition of “low” is unclear, with vitamin D insufficiency often defined as 25-hydroxyvitamin D (25[OH]D) levels of either <20 ng/mL or <30 ng/mL. In this study, 230 postmenopausal women (age, <75) with 25(OH)D levels between 14 ng/mL and 27 ng/mL (mean level, 21 ng/mL) and no diseases that could affect vitamin D or calcium absorption or musculoskeletal health were randomized to low-dose cholecalciferol (800 IU daily), high-dose cholecalciferol (50,000 IU twice monthly, after a 15-day loading dose), or placebo. High-dose participants were monitored to maintain 25(OH)D levels ≥30 ng/mL. All participants were counseled to consume 600 to 1400 mg daily of calcium through diet or supplementation.
During 1 year of follow-up, mean 25(OH)D level declined to 19 ng/mL in the placebo group and increased to 28 ng/mL and 56 ng/mL in the low-dose and high-dose supplementation groups, respectively. After adjustment for baseline calcium absorption, total calcium absorption was 1% higher in the high-dose group, 2% lower in the low-dose group, and 1.3% lower in the placebo group. The three groups did not differ significantly in changes in bone-mineral density or muscle outcomes (function, mass, strength) or in number of falls.
Comment: These results do not support recommendations for high-dose cholecalciferol supplementation to maintain 25(OH)D levels at ≥30 ng/mL. In fact, the findings do not support even low-dose supplementation in this population, whose mean 25(OH)D level at the start of the study was 21 ng/mL. However, a caveat is that this study's duration was only 1 year; in the ongoing placebo-controlled VITAL study, researchers will examine the health effects of 5 years of vitamin D supplementation.
Citation(s):Hansen KE et al. Treatment of vitamin D insufficiency in postmenopausal women: A randomized clinical trial. JAMA Intern Med 2015 Aug 3; [e-pub]. (http://dx.doi.org/10.1001/jamainternmed.2015.3874)
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MM: Old premise, no new data. Doses of probiotics as well as strains certainly have effects on the well-being of ill patients as well as the beneficial effect of stabilizing patients who are borderline. These studies failed to look sufficiently at co-morbid conditions (more than one problem) such as joint inflammation. psoriasis, acne and other life tormenting conditions that frequently require several months to see significant changes. The bottom line is that probiotics, prebiotics and synbiotics are safe and when given in adequate amounts quite effective for a wide variety of problems. The problem still exists that many probiotic preparations available at a variety of stores and online lack any significant presence of the active and living organisms.
Am J Gastroenterol 2014 Oct; 109:1547
Probiotics, Prebiotics, and Synbiotics for Irritable Bowel Syndrome
In a meta-analysis, probiotics conferred some benefit, but the number needed to treat
was 7.
Some patients with irritable bowel syndrome (IBS) use probiotic therapy — ingestion of live or attenuated microorganisms — either on their own or as recommended by clinicians. Alternatives to probiotics include prebiotics (nondigestible food ingredients that stimulate growth or activity of intestinal bacteria) and synbiotics (combinations of prebiotics and probiotics). In this meta-analysis, researchers examined the efficacy of these substances in patients with IBS or chronic idiopathic constipation.
For IBS, the proportion of patients with overall improvement in symptoms was significantly higher with probiotics than with placebo (44% vs. 27%) in 23 trials; seven patients had to be treated to benefit one patient. Synbiotics (2 trials) were of no clear benefit, and no trials of prebiotics were eligible for inclusion. For chronic idiopathic constipation, stool frequency increased from baseline with probiotics (3 trials) and with synbiotics (2 trials) but not with prebiotics (1 trial).
Comment: Probiotic therapy appears to be worthwhile for a minority of IBS patients. However, we don't know whether responses persist long term, because most studies lasted only a few weeks or months. Moreover, the bacterial strains used in these studies were quite heterogeneous. For patients with chronic idiopathic constipation, probiotics and synbiotics might be beneficial, but they require further study. Although probiotics generally are considered to be safe, data are sparse on long-term use and use by immunocompromised patients.
Citation(s): Ford AC et al. Efficacy of prebiotics, probiotics, and synbiotics in irritable bowel syndrome and chronic idiopathic constipation: Systematic review and meta-analysis. Am J Gastroenterol 2014 Oct; 109:1547.

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MM: Early to bed, early to rise... isn't just a nursery rhyme. there are definitive benefits to getting a good night's sleep. If we are ill, we go to bed "to rest". If we are injured, we "go to bed" to give our bodies a chance to heal. The human brain is no different in that respect from the human body. Sleep and rest are part of the healing process. Our bodies make resting and healing endorphins that effect our NK (natural killer) cells and effect our immune systems. REM sleep and dreaming allow us to work out our problems in our subconscious rather than trying to obtain resolution only in our very cluttered and very busy waking mind. All these aspects of good restful sleep have an impact on our lives. This is why we get so many questions about sleeping aids and techniques to improve sleep at Mark Drugs. Call us if you are having trouble getting sleep and see if we can help you.
J Neurosci 2015 Jul 15; 35:10135
Feeling Threatened? Get Some Rest
In an imaging study, sleep deprivation was associated with excessive recognition of threat and increased activity in the anterior insula and cingulate cortex.
Sleep deprivation may affect the assessment of threat and alter the central and peripheral nervous system connections that underlie threat assessment. In this crossover study, 18 adults (mean age, 20) underwent functional magnetic resonance imaging twice while identifying threat levels in 70 computer-generated faces that were morphed from threatening to nonthreatening (7 displays of each face): once after a night of total sleep deprivation and once after polysomnography-monitored sleep (mean, 7.5 hours). Sessions were presented in random order 6 days apart.
Significantly more faces were identified as threatening and fewer as nonthreatening after sleep deprivation than after rest. In post-rest sessions, recognition of threat was associated with increased activity in regions of the anterior insula and anterior cingulate cortex (ACC). The left amygdala also showed greater response to threat, but only after rest. Sleep deprivation impaired cardiac acceleration that ordinarily occurs with recognition of threat, which was correlated with changes in the right amygdala and right anterior insula. Lower noradrenergic tone during rapid eye movement (REM) sleep but not slow-wave sleep activity predicted greater threat discrimination in the amygdala in post-rest sessions.
Comment: Sleep deprivation appears to impair the ability of the anterior insula and ACC to integrate interoceptive information and accurately recognize threat. The vagus nerve is activated by higher circuits involved in threat recognition. Presumably, with sleep deprivation, this circuit gets disrupted due to excess limbic input, resulting in a runaway cardiovascular response that the individual perceives as a sign of threat. REM sleep appears to be important in resetting the emotional component of threat recognition. In people who repeatedly get insufficient sleep — e.g., emergency personnel, soldiers, physicians, and teenagers — impaired recognition of complex social cues involving threat leads to excessive reactions in situations requiring accurate discrimination between safety and danger.
Citation(s):Goldstein-Piekarski AN et al. Sleep deprivation impairs the human central and peripheral nervous system discrimination of social threat. J Neurosci 2015 Jul 15; 35:10135. (http://dx.doi.org/10.1523/JNEUROSCI.5254-14.2015)

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Gut 2015 Jun 12
Anxiety Increases the Risk for Infectious Gastroenteritis and Postinfectious IBS
People with anxiety are more likely to develop the infection in the first place.
Infectious gastroenteritis (IGE) is followed by persistent functional gut syndromes including postinfectious irritable bowel syndrome (PI-IBS) in up to 30% of patients. Psychological morbidity increases susceptibility to PI-IBS, and psychological stress is known to affect the balance between T-helper 1 and T-helper 2 cells.
In two small towns in Belgium, 18,620 people were exposed to drinking water that was contaminated by stream water containing norovirus, Giardia lamblia, and Campylobacter jejuni. Among 968 eligible participants who completed questionnaires in a prospective investigation, 28% developed Infectious gastroenteritis (IGE). Risk factors for IGE included younger age, dyspepsia prior to exposure, and psychological comorbidities including anxiety and somatization, though not depression.
In univariate analyses, anxiety and somatization were also risk factors for developing PI-IBS, and patients with anxiety were found during the acute infection to have a reduction in IL-2–expressing, CD4-positive, CD8-negative T cells. Patients with an elevated number of T-helper 2 cells during the acute infection were predisposed to develop PI-IBS.
Comment: These results indicate that psychological factors not only predispose patients to postinfectious IBS but increase the risk for developing the acute infectious illness during initial exposure, possibly because of stress-induced alteration in immune cell function.
Citation(s):Wouters MM et al. Psychological comorbidity increases the risk for postinfectious IBS partly by enhanced susceptibility to develop infectious gastroenteritis. Gut 2015 Jun 12; [e-pub].
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MM: It's unfortunate that such a significant portion of respondents felt that they were inadequately supported by their healthcare practitioners. Any time that we experience a setback, tragedy or other problem in life we typically want reasons or explanations. In the info-ready age that we live in we now expect viable answers but sometimes there are simply no good ones. Medical practitioners go through their academic lives always having or expected to have the answers and when they are confronted by a situation that they either don't have the answer or can't get one it is very uncomfortable for them. They are likely to hide behind their professionalism or worse yet, they are advised to avoid patient contact for fear of perceived liability and fiduciary fear of their insurance carrier or that of their affiliated institution. This is a sad and inhuman commentary; not an excuse for the lack of humanism in a time of sadness. But, it is a possible explanation for a tragic response.
Obstet Gynecol 2015 Jun; 125:1313
The Myths and Emotional Burden of Miscarriage
Public perceptions of miscarriage need revamping.
To examine the U.S. public's views of miscarriage (defined as pregnancy loss before 20 weeks' gestation), investigators developed a national voluntary online survey that was completed by 1084 respondents (594 women, 485 men; 78% white). Fifteen percent of participants reported that they or their partner had experienced at least one miscarriage (in line with the national rate of 15%–20%).
Overall, 55% of respondents erroneously thought miscarriage occurred in ≤5% of pregnancies. Three quarters (74%) knew that pregnancy loss is usually caused by a genetic or medical problem, but 22% believed that lifestyle choices (e.g., tobacco use during pregnancy) were among the most common causes of miscarriage. Other misconceptions were that miscarriage could be caused by a stressful event (76%), lifting heavy objects (64%), or a history of sexually transmitted disease (41%). Among respondents who had experienced miscarriage, 47% felt guilty, 41% felt they had done something wrong, 41% felt alone, and 28% felt ashamed. More than half (57%) said they were not given a cause for the miscarriage, and only 45% believed they had received sufficient emotional support from the medical community.
Comment: Although this study's small size and predominance of white respondents limits its generalizability, the results point to the general knowledge gaps about miscarriage — as well as the search for causation and meaning among those who have experienced this often devastating event. Even in this age of hospital-based programs for pregnancy loss and bereavement, Internet apps, and multiple lay books on the subject, the need for continued education and support through counseling and the sharing of experiences should receive more attention.
Citation(s):Bardos J et al. A national survey on public perceptions of miscarriage. Obstet Gynecol 2015 Jun; 125:1313. (http://dx.doi.org/10.1097/AOG.0000000000000859)

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MM: I love these articles that promote my geek side. Imagine, creating a drug chemical product. not in a laboratory with test tubes or big vats of E. coli or algae, but with a 3D printer! How cool is that !!
First 3D-Printed Drug Product Approved
By Amy Orciari Herman, Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
The FDA has approved an oral anti-seizure medication — Spritam (levetiracetam) — made by three-dimensional printing, the manufacturer announced on Tuesday. Part of the company's ZipDose Technology, the 3D printer connects several layers of powdered medication with a fluid to make a water-soluble matrix.
Because Spritam dissolves in seconds with a sip of liquid, it may help ease drug delivery for children and those with swallowing disorders, the company says. Spritam allows up to 1000 mg of levetiracetam in a single dose. It is recommended for those who weigh at least 44 pounds (20 kg).
Like other formulations of levetiracetam, Spritam is indicated to treat partial-onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures in those with epilepsy. It is expected to be available in early 2016.
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MM: This is an example of where a compounded product, that is not initially patient specific can have a significant beneficial effect on patient care. The product mentioned in this article is only available if it is compounded. The current position of the FDA is that compounded medications must either be products that cover a shortage of commercially available products or must be prepared in advance for a specific patient pursuant to a pre-written prescription. This approach by the FDA prevents a hospital or emergency clinic from having a product on hand that is new and yet to be approved. The argument could be that the product may not be safe and that is why it is not approved but Midazolam is a chemical that has been around for decades and is given IV for surgery. A nasal spray is less invasive than intravenous administration and likely shorter acting yet may have a completely different effect on the body therapeutically. The patient is the loser here and Big Pharma keeps their playing field clear of competition.
Midazolam Nasal Spray and Seizures
A nasal spray formulation of midazolam may diminish repeated seizures and lower the risk of generalized tonic-clonic seizures in hospitalized epilepsy patients, researchers found. They stated that only four of 75 patients had an adverse event; there were no serious adverse events and the treatment was generally well-tolerated.
The nasal spray was prepared at the hospital's pharmacy and delivered a dose of 2.5 mg midazolam per puff. The average dose per patient was 5 mg, or two sprays. Those given intranasal midazolam during or right after a seizure remained free of seizures longer than those not given the drug (5.83 hours versus 2.37 hours).
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MM: There are many reasons that moms are encouraged to breast feed. Getting closer emotionally and physically with your child; providing immune support to the infant by passing on the mom's antibodies through breast milk are just a few. Mom's tend to lose "baby fat" more readily if they are nursing their child and that is a frequently given incentive to nurse but the prevention of vascular aging is a much longer term benefit for moms that is infrequently discussed, This is not just for the here and now but for the long run. A couple of days, weeks or months of nursing may enable a mom to enjoy more time at the back end as a grand-mom or great grand-mom. These are pretty good reasons to try to nurse just a little longer or to try to get past those very challenging first couple of weeks if you are having difficulties with latching or milk production. Mark Drugs can help new moms with their nursing challenges. We carry electric breast pumps that are covered by Blue Cross PPO insurance. Call us for more information.
Obstet Gynecol 2015 Aug; 126:381
Breast-Feeding Delays Maternal Vascular Aging
Mothers who don't breast-feed are more likely to have midlife carotid disease.
Multiple studies have indicated that, as they age, mothers who didn't breast-feed are more likely to develop heart disease than mothers who did breast-feed. To assess the relation between lactation duration and subclinical vascular disease, researchers followed 846 women, recording lactation duration for all incident pregnancies and measuring common carotid intima media thickness (CCIMT) at year 20 (ages 38–50).
As in prior studies, lactation duration was favorably associated with maternal body-mass index (BMI), lipids, blood pressure, and type 2 diabetes mellitus at year 20. In addition, lactation duration was significantly and inversely associated with CCIMT, even after adjusting for prepregnancy BMI, parity, smoking, and sociodemographic and cardiometabolic risk factors. The authors estimate that the higher CCIMT seen with suboptimal lactation corresponds to 3 to 5 years of vascular aging. Adjustment for pregnancy complications had minimal effect on these results.
Comment: These findings add to the literature by considering data collected on multiple occasions, including before most women became pregnant. Thus, it provides evidence against reverse causation (i.e., that mothers at risk for midlife vascular disease have lactation problems). However, given the hypothesis that longer lactation duration protects against subclinical vascular disease, it's odd that the authors neglected baseline lactation when adjusting for baseline parity.
Citation(s):Gunderson EP et al. Lactation duration and midlife atherosclerosis. Obstet Gynecol 2015 Aug; 126:381.

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MM: One of the problems with gastrectomy is that patients are not adequately taught new approaches to living and eating. As time progresses the volume consumption limitations of the gastrectomy diminish and old habits tend to return with subsequent weight gain and health deterioration associated with the poor habits of old. It's not just the weight that is effected but this is the most obvious and easiest sign to measure. Dietary strategies like the HCG Metabolic Syndrome Protocol help to train and re-train the patient to better eating and lifestyle habits. An occasional repeat of the program every couple of years is not a failure but a supportive renewal. Unfortunately, once you've had a portion of your stomach removed from a gastrectomy, there is no tune-up or repeat available.
Laparoscopic Sleeve Gastrectomy: Initial Benefits Drop Off with Longer Follow-Up
By Amy Orciari Herman, Edited by Susan Sadoughi, MD
Most patients who undergo laparoscopic sleeve gastrectomy experience weight loss and remission of obesity-related comorbidities in the short term, but the benefits decline with longer follow-up, according to an analysis in JAMA Surgery.
Researchers in Israel retrospectively studied some 440 adults who were operated on by the same surgical team. Outcomes were assessed up to 5 years after gastrectomy, with complete data available for only 39 patients at the 5-year mark.
Among the findings:

Improvement in comorbidities was not correlated with the amount of excess weight loss. The authors conclude that the findings should be taken into account when deciding on the most appropriate procedure for a particular patient.
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MM: The data that a viral infection or outbreak may be avoided by the prophylactic use of an anti-viral is generally heralded as good news but the fact that only 50% of those who saw success means something much more ominous. It means that there are likely to be numerous viruses that are resistant and not susceptible to the anti-viral medication. It also means that we are ignoring our lessons of the past in that we presently have "super bacterial infections" from at least partially the overuse and abuse of antibiotics. Now we are taking the risk that we will repeat this trend with viruses, Are we stupid, ignorant, arrogant or all three??
N Engl J Med 2015 Aug 6; 373:530
Tenofovir Gel for Preventing HSV-2 Infection?
In a study involving women in South Africa, pericoital application of tenofovir gel halved the risk for acquiring herpes simplex virus type 2.
Herpes simplex virus type 2 (HSV-2) infection is among the most common sexually transmitted diseases worldwide. Tenofovir, a nucleotide reverse-transcriptase inhibitor used in tablet form for treating HIV infection, also has activity against HSV-2. In the VOICE trial (results recently reported but not yet published), tenofovir gel reduced the risk for acquiring HSV-2 by 46%.
To further evaluate its efficacy in preventing HSV-2 infection, investigators conducted a subgroup analysis involving 422 HSV-2–negative women enrolled in CAPRISA 004, a double-blind, placebo-controlled, randomized trial conducted in South Africa to assess whether tenofovir gel prevents HIV transmission to women.
Tenofovir and placebo gels were dispensed in prefilled vaginal applicators with instructions to use one dose within 12 hours before sex and a second dose as soon as possible within 12 hours after sex, with a maximum of two doses per 24-hour period. Mean follow-up duration was 18 months, and study retention was 94.8%. HSV-2 seroconversion was detected by enzyme-linked immunosorbent assay, with Western blot testing performed for verification.
The overall incidence rate of HSV-2 infection was 10.2 cases per 100 person-years (95% confidence interval, 6.8–14.7) for the tenofovir gel group versus 21.0 cases per 100 person-years (95% CI, 16.0–27.2) for the placebo group (incidence rate ratio, 0.49; 95% CI, 0.30–0.77). HSV-2 infection was confirmed by Western blot testing in 51 (59%) of the 87 women with seroconversion; the incidence rate ratio in this group was 0.45 (95% CI, 0.23–0.82).
Comment: The efficacy of tenofovir gel in preventing HSV-2 infection in the CAPRISA trial is striking and supports further evaluation of this strategy. More work is needed both to assess efficacy and to better define the vaginal tenofovir concentrations necessary for protection.
Citation(s):Abdool Karim SS et al. Tenofovir gel for the prevention of herpes simplex virus type 2 infection. N Engl J Med 2015 Aug 6; 373:530. (http://dx.doi.org/10.1056/NEJMoa1410649)
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J Pediatr Gastroenterol Nutr 2015 Jul; 61:119
Don't Bother with Lactose-Free Formula
Look elsewhere for solutions to infant feeding problems and related parental distress.
Medical reasons for infants to avoid lactose are very rare, but parents often blame cow's-milk formula or the lactose it contains for their babies' feeding problems, fussiness, and other subjective symptoms. As a result, parents and also clinicians change formulas in an effort to treat these problems.
In an industry-supported, double-blind study, 300 babies (mean age, 5 weeks) fed with cow's-milk formula who presented with parent-reported fussiness/crying/cramping, gas, or diarrhea at one of 19 general pediatric clinics were randomized to receive lactose-free cow's-milk formula, soy-based formula, or regular lactose-containing cow's-milk formula.
After 2 weeks, no significant differences were observed between the three groups with respect to mothers' reports of infants' difficult behaviors or measures of parenting efficacy, psychological well-being, or psychological distress among mothers. Statistically significant improvements in these measures occurred similarly in all three groups. Mothers in all three groups were similarly satisfied with the study formula itself and with their babies' spit-up and stool.
Comment: Parents often change formulas for purely subjective reasons, and because the results of these changes are often hard to assess, many babies end up on a merry-go-round of multiple formula changes. In this study, researchers quantified subjective outcomes and found no differences among formulas with or without lactose. The placebo effect of a possible formula change for infants probably contributed to improvements seen in all groups; however, I think these findings strongly support continuing babies with difficulties on their usual lactose-containing formula while working on other ways to improve feeding, reduce fussiness, and reassure distressed parents. I will cite this study when I try to dissuade parents who suspect formula intolerance and feel that a trial of lactose-free formula might be beneficial for their babies.
Citation(s):Sherman AL et al. Lactose-free milk or soy-based formulas do not improve caregivers' distress or perceptions of difficult infant behavior. J Pediatr Gastroenterol Nutr 2015 Jul; 61:119.

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More Chili Peppers, Please: Spicy Food Consumption Linked to Lower Mortality
By Amy Orciari Herman, Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
The more often you eat spicy foods, the longer you might live, according to an observational study in the BMJ.
Nearly 500,000 adults in China reported how frequently they consumed spicy foods. Those with cancer, stroke, or heart disease at baseline were excluded.
During 7 years' follow-up, 20,000 participants died. After multivariable adjustment, the risk for all-cause mortality was 10% lower among those who ate spicy foods 1–2 days/week — and 14% lower among those who ate spicy foods 3–7 days/week — relative to those who ate them less than once/week. Significant reductions were seen in deaths attributable to cancer, ischemic heart disease, and respiratory diseases.
Chili pepper was the most commonly used spice. The authors note that capsaicin, the main active component of chilis, has long-reported anti-obesity, antioxidant, anti-inflammatory, anticancer, and antihypertensive benefits.
Dr. Paul Mueller of NEJM Journal Watch General Medicine commented, "As noted by the authors, causality cannot be established because of the study's design. Nonetheless, these results should be gratifying for people who enjoy spicy foods."

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