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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
July 30, 2011

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Vitamin D Lack Hurts Pro Athletes … Literally
Use of NSAIDs and COX-2 Inhibitors Raises Risk for AF
Risk for Diabetes Increases with Statin Dose
Risk for Sudden Cardiac Death in Women
Commonly Used Antidepressants No More Effective Than Placebo in Patients with
   Alzheimer Disease
Influenza Vaccine Components Unchanged from Last Season
Long-Acting Reversible Contraceptives Are Suitable for Adolescents
Media's Effect on Obesity in Kids
First-Trimester SSRI Exposure and Congenital Anomalies
Kids Can Get a Workout Playing Exergames
Sleeping Easy: Evening Media Use and Violent Content Affect Children's Sleep
Children: Stay Asleep and Stay Lean
ADT plus Radiation for Early, Localized Prostate Cancer
Therapeutic Massage Helps Alleviate Chronic Low Back Pain
A Second Big Step Toward a Universal Flu Vaccine
Fatty Foods Boost Mood
What Is the Yield of Serologic Screening for Celiac Disease in the U.S.?
Parenteral Nutrition in ICU Patients: What's the Rush?

Vitamin D Lack Hurts Pro Athletes … Literally  
Study in NFL players suggests that a shortage of the “sunshine-and-seafood” nutrient raises the risk of injuries to athletes’ muscles
by Craig Weatherby
     Vitamin D deficiency has been linked to a panoply of health problems, ranging from osteoporosis and flu to auto-immune disorders and common cancers.Now, a study in NFL football players suggests that lack of vitamin D may also raise the risk of muscle injuries in athletes.The authors tested the vitamin D blood levels of 89 players from the NFL’s New York Giants during the spring of 2010. Their average age was 25, and the group included 31 white and 58 black (African American) players.Vitamin D deficiency has been linked to a panoply of health problems, ranging from osteoporosis and flu to auto-immune disorders and common cancers.
     Now, a study in NFL football players suggests that lack of vitamin D may also raise the risk of muscle injuries in athletes. 
The authors tested the vitamin D blood levels of 89 players from the NFL’s New York Giants during the spring of 2010.  
Their average age was 25, and the group included 31 white and 58 black (African American) players. Likewise, the team’s average vitamin D levels might have been higher if the players had been tested later in the season, after a summer of sun exposure. However, a summertime test would probably have presented a less accurate picture of the players’ average annual vitamin D levels.
     Based on the growing evidence that 20 ng/mL is too low to ensure adequate health, many vitamin D testing laboratories have raised their definition of a “normal” blood level to 30 ng/ml or more. Yet, some of the players had less than 10 ng/mL, which falls very far short of the levels recommended by many vitamin D researchers. For example, Boston University’s Michael Holick, Ph.D., M.D. – a leading researcher and author of The Vitamin D Solution – says the optimal level is 40 to 60 ng/mL and that it takes 3,000 IU per day of dietary vitamin D to achieve and maintain that range.
     Co-author Scott Rodeo, M.D., urged team physicians to heed the implications of their findings: “Screening and treatment of vitamin D insufficiency in professional athletes may be a simple way to help prevent injuries.” (AAOSM 2011)
     Sources: American Orthopaedic Society for Sports Medicine (AOSSM). Vitamin D Lower in NFL Football Players Who Suffered Muscle Injuries, Study Reports. June 10, 2011. Accessed at http://www.sportsmed.org/tabs/newsroom/AOSSMPressReleaseDetails.aspx?DID=810, Shindle MK et al. Vitamin D Status in a Professional American Football Team. ID 46 – 9849. AOSSM 2011 Annual Meeting, San Diego. Accessed at http://www.sportsmed.org/secure/reveal/admin/

Ethnic divide seen in NFL players’ vitamin D levels

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BMJ 2011 Jul 4; 343:d3450
Use of NSAIDs and COX-2 Inhibitors Raises Risk for AF
Risk for atrial fibrillation was especially elevated among new users of nonsteroidal anti-inflammatory drugs and cyclooxygenase-2 inhibitors.
      Use of nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase (COX)-2 inhibitors has been associated with elevated risk for chronic atrial fibrillation (Arch Intern Med 2010; 170:1450). In this population-based case-control study from Denmark, investigators assessed risk for atrial fibrillation (AF) or flutter associated with these drugs.
     Nearly 33,000 patients (median age, 75) with first diagnoses of AF were matched with 326,000 age- and sex-matched controls. After adjustments for multiple variables including AF risk factors, NSAID or COX-2 inhibitor use was associated with significantly elevated risk for AF (incident rate ratios, 1.2 and 1.3 for current use of NSAIDs and COX-2 inhibitors, respectively, and 1.5 and 1.7 for new use of NSAIDs and COX-2 inhibitors, respectively). Results were similar for individual NSAIDs and COX-2 inhibitors.
     Comment: In this study, NSAIDs and COX-2 inhibitors were associated with elevated risk for AF, especially among new users. As an editorialist noted, these findings have important public health implications because these drugs are used widely and because AF prevalence increases with age. Although the results could be influenced by confounding (e.g., the investigators lacked body-mass index data; obesity is strongly associated with arthritis — a common indication for these drugs — and a risk factor for AF), the findings are plausible: These drugs can exacerbate hypertension and heart failure and, therefore, might precipitate AF or flutter.
Paul S. Mueller, MD, MPH, FACP Published in Journal Watch General Medicine July 26, 2011
     Citation(s):Schmidt M et al. Non-steroidal anti-inflammatory drug use and risk of atrial fibrillation or flutter: Population based case-control study. BMJ 2011 Jul 4; 343:d3450.
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JAMA 2011 Jun 22/29; 305:2556
Risk for Diabetes Increases with Statin Dose
Risk was highest with intensive-dose therapy.
     Small trials and a meta-analysis have suggested that intensive- versus moderate-dose statin therapy is associated with elevated risk for developing insulin resistance and type 2 diabetes (JW Gen Med Mar 4 2010). Researchers explored this association in a meta-analysis of five randomized statin trials with nearly 33,000 participants who did not have diabetes at baseline.
     During a mean follow-up of 4.9 years, 8.4% of participants developed diabetes, and 20.4% experienced major adverse cardiovascular (CV) events. Intensive-dose therapy (daily atorvastatin [Lipitor; 80 mg] or simvastatin [80 mg]) was compared with moderate-dose therapy (daily atorvastatin [10 mg], simvastatin [20 mg], or pravastatin [40 mg]). Risk for diabetes was higher by 12% in the intensive-dose group, with a number needed to treat [NNT] of 498 patients treated for 1 year for 1 patient to develop diabetes. Risk for CV events was lowered by 16% with an NNT of 155 for 1 patient to benefit.
     Comment: These somewhat counterintuitive results have no obvious biological explanation. The excess risk for developing type 2 diabetes is less than the lower risk for a CV event. Closer-than-usual monitoring might be appropriate for these patients, but they likely are monitored closely already because they are usually at elevated risk.
Thomas L. Schwenk, MD Published in Journal Watch General Medicine July 19, 2011
      Citation(s):Preiss D et al. Risk of incident diabetes with intensive-dose compared with moderate-dose statin therapy: A meta-analysis. JAMA 2011 Jun 22/29; 305:2556. (http://dx.doi.org/10.1001/jama.2011.860)
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JAMA 2011 Jul 6; 306:62
Risk for Sudden Cardiac Death in Women
Most risk was attributed to four lifestyle factors.
     Sudden cardiac death (SCD) can be the first manifestation of coronary artery disease (CAD); thus, lifestyle factors that influence CAD risk might also affect risk for SCD. Investigators used data from the Nurses' Health Study to assess how SCD risk was affected by four modifiable lifestyle factors — smoking, weight, exercise, and diet — among nearly 82,000 women (age range at baseline, 30–55) without known CAD. The women, whose lifestyle factors were updated every 2 to 4 years, were considered to have one or more low-risk factors if they were not current smokers, had body-mass indexes <25 kg/m2, exercised ≥30 minutes daily, or scored in the top 40% of the cohort for adherence to a Mediterranean diet.
      During 26 years of follow-up, 321 SCDs occurred. Compared with women with no low-risk factors, SCD was significantly less likely to occur in women with one or more low-risk factors (relative risks, 0.54, 0.41, 0.33, and 0.08 for 1, 2, 3, and 4 factors, respectively). The total population-attributable risk for SCD was 81% for all four risk factors.
Comment: The magnitude of reduced risk for SCD in women with one or more low-risk lifestyle factors is striking. Only 8% of the study population possessed all four low-risk factors, but their risk for SCD was lower by 92%. The population-attributable risk of 81% for all four factors emphasizes the relative importance of lifestyle over heredity as the primary risk factor for SCD in women.
Thomas L. Schwenk, MD Published in Journal Watch General Medicine July 26, 2011
     Citation(s):Chiuve SE et al. Adherence to a low-risk, healthy lifestyle and risk of sudden cardiac death among women. JAMA 2011 Jul 6; 306:62. (http://dx.doi.org/10.1001/jama.2011.907) http://www.ncbi.nlm.nih.gov/pubmed/21730242?dopt=Abstract
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Commonly Used Antidepressants No More Effective Than Placebo in Patients with Alzheimer Disease
     Sertraline (Zoloft®)  and mirtazapine (Remeron®) , commonly used in depressed patients with Alzheimer disease, are no more effective than placebo, according to a Lancet study.
     In a double-blind trial, researchers randomly assigned patients with Alzheimer disease and coexisting depression to one of three treatments: placebo, sertraline (target dose: 150 mg per day), or mirtazapine (45 mg per day). Each group comprised roughly 100 patients.
     At 13 weeks, depression-in-dementia scores did not differ significantly among the groups — all showed improvement in scores. Adverse events, however, were more common among those on the antidepressants.
     The authors conclude that "the drugs from the two classes of antidepressants most likely to be prescribed for depression in Alzheimer's disease seem to be no more effective than placebo." They suggest that the drugs might be better reserved for patients whose depression has not resolved 3 months after referral to specialist services.
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Influenza Vaccine Components Unchanged from Last Season
     The components of influenza vaccine for the 2011-2012 season will be the same as those in the previous season's vaccine, the FDA announced on Monday. The vaccine will include:

     In addition, a new vaccine formulation will be available this year. In May, the FDA approved Fluzone Intradermal for patients aged 18 to 64 years. This vaccine will be administered under the skin with a smaller needle.
     Patients may ask whether, having been vaccinated with these same strains last year, another round of shots is necessary. The answer is yes. The FDA's Dr. Karen Midthun explains: "It is important to get vaccinated every year, even if the strains in the vaccine do not change, because the protection received the previous year will diminish over time and may be too low to provide protection into the next year."
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MM: It bothers me when studies or accepted medical practice are myopic. The autthors endorse chemical birth or ovulation control and state that the most effective form of birth control for adolescents is the one that is used regularly and covered by insurance. They fail to look at ALL the long term problems associated with chemical birth control. In my practice I regularly see female patients with little or no libido. Many of these women are not suffering from age-related diminished libido but rather from chronic elevated sex hormone binding globulin (SHBG). This is frequently associated with past use of birth control drugs. Unfortuinately, theyhave never been warned of this persistent side effect of these drugs that last for years, even decades following discontinuation. A disservice is being done to the women who are prescribed these drugs because they are NOT getting proper information. Leave alone the debate of danger of Cancer and other maladies. What about long term Quality of Life?
Obstet Gynecol. 2011 Jul;118(1):184-96
Long-Acting Reversible Contraceptives Are Suitable for Adolescents
IUDs and the subdermal implant can be offered to most women, including nulliparous women and adolescents.
     The American College of Obstetricians and Gynecologists has updated its practice bulletin on the use and clinical management of long-acting reversible contraceptives. Based primarily on consensus and expert opinion, it concludes that intrauterine devices (IUDs) and contraceptive implants have few contraindications and can be considered for most women. Highlights of the bulletin are as follows:
     Long-acting reversible contraceptives are extremely effective; first-year failure rates for typical use and perfect use are the same (<0.8%). Two IUDs (1 containing copper and the other levonorgestrel) and one subdermal implant (containing etonogestrel, the metabolite of the progestin desogestrel) are approved for use in the U.S. The copper and levonorgestrel IUDs can be left in place for 10 and 5 years, respectively. The subdermal implant is effective for 3 years.
     Concerns about IUD placement in adolescents have focused on a possible increased risk for pelvic inflammatory disease (PID) and expulsion. However, current research does not support a link between IUD use and PID. A recent systematic review reported expulsion rates in adolescents of 5% to 22%, with two of the studies suggesting an inverse relation between age and expulsion rate. For women at high risk for sexually transmitted infections (including adolescents and adults aged ≥25), screening for such infections, especially chlamydia, can be performed on the same day as IUD placement.
     Between 6% and 12% of implant users report weight gain, but only 3% to 7% of all users have the implant removed for this reason. Extrapolation of data from pharmacokinetic studies in etonogestrel implant users and data from bone mineral density (BMD) assessments in women aged 18 and older suggest that the subdermal implant should not affect estrogen production or BMD in adolescents.
     Comment: The best contraceptive for an adolescent is the one she will use consistently and that her insurance plan will cover. The IUD and implant are safe and may be ideal methods for adolescents who might have trouble taking pills daily, cannot use estrogen-containing products, or might not be able to adhere to the 3-month schedule for injectable contraceptives (or might fear the associated weight gain). Long-acting reversible contraceptives may be particularly suitable for teenage mothers after the birth of their first child.
Alain Joffe, MD, MPH, FAAP Published in Journal Watch Pediatrics and Adolescent Medicine July 13, 2011
     Citation(s): Practice bulletin no. 121: Long-acting reversible contraception: Implants and intrauterine devices. Obstet Gynecol 2011 Jul; 118:184.
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Pediatrics 2011 Jul; 128:201
Media's Effect on Obesity in Kids
The AAP recommends that pediatricians ask parents of children and adolescents about media use at every well-child visit.
     The American Academy of Pediatrics (AAP) recent policy statement on Children, Adolescents, Obesity, and the Media addresses the emerging evidence base linking increased media time with childhood obesity. Highlights of the statement include the following:
     Many longitudinal and correlational studies link excessive television viewing and obesity. Watching TV can contribute to obesity by promoting sedentary activity and decreasing physical activity, teaching unhealthy eating patterns, increasing snacking behavior, and interfering with normal sleep patterns. Further, increasing physical activity, reducing media time, and improving nutritional practices have been shown to prevent the onset of obesity and reduce the prevalence of existing obesity.
     Effects of advertising on unhealthy eating habits: Children and teens who watch more TV consume more calories, eat higher-fat diets, drink more soda, and eat fewer fruits and vegetables. In addition, advertisements for foods high in fat, salt, and sugar and low in nutritional content encourage children to choose unhealthy foods. More than 80% of advertisements during children's TV programming are for fast foods or snacks — that's at least 10 advertisements per hour. Currently, nearly 40% of children's caloric intake comes from solid fat and added sugars, and soda or fruit drinks provide nearly 10% of total calories.
    Effects of media on sleep habits: Among adolescents, TV viewing for ≥3 hours per day doubles the risk for having difficulty falling asleep compared with TV viewing for <1 hour per day (JW Pediatr Adolesc Med Jul 27 2011). Some evidence suggests that later bedtimes and less sleep increase risk for obesity. In addition, sleep deprivation leads to fatigue and increases sedentary behavior.
Recommendations for pediatricians:

     Comment: Excess TV viewing has proven adverse effects on sleep and eating habits of children. Pediatricians should actively discourage parents from allowing TVs in children's bedrooms. Like watching TV, playing video games is largely a sedentary activity, although some video games do involve physical activity (JW Pediatr Adolesc Med Jul 27 2011). Like incremental increases in calories (e.g., from butter and soda), incremental increases in screen time might lead to significant weight gain over time. Pediatricians can educate patients and parents about how increased media watching contributes to obesity.
Martin T. Stein, MD Published in Journal Watch Pediatrics and Adolescent Medicine
July 27, 2011
     Citation(s):American Academy of Pediatrics Council on Communications and Media. Policy Statement. Children, adolescents, obesity, and the media. Pediatrics 2011 Jul; 128:201. (http://dx.doi.org/10.1542/peds.2011-1066) http://www.ncbi.nlm.nih.gov/pubmed/21708800?dopt=Abstract
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Obstet Gynecol 2011 Jul; 118:111
First-Trimester SSRI Exposure and Congenital Anomalies
Specific antidepressants are associated with risk for cardiovascular or neural-tube defects in a population-based study.
     Studies have only inconsistently linked cardiovascular anomalies with first-trimester exposure to selective serotonin reuptake inhibitors (SSRIs). The very low base rates of these anomalies require researchers to use large samples to detect statistically significant differences. The current researchers examined the issue in a retrospective study using Finnish national registries.
     Data included pregnancies ending in live birth, stillbirth, or termination due to severe fetal anomaly between 1996 and 2006. SSRI exposure was defined as at least one purchase of an SSRI in the month before pregnancy or in the first trimester. SSRI-exposed women were less likely to be married than nonexposed women, twice as likely to smoke or to have a chronic medical condition, and 20 times more likely to have purchased other psychiatric medications.
     Overall, after adjustment for confounders such as maternal age, diabetes, and purchase of other psychiatric drugs, major anomalies were not more common among the 6976 offspring exposed to SSRIs than among the 628,607 nonexposed offspring. In adjusted analyses, significant associations existed between fluoxetine (Prozac®) and both overall cardiovascular anomalies (2.04% vs. 1.29% without SSRI exposure) and ventricular septal defects (1.43% vs. 0.87%); between paroxetine (Paxil®) and right ventricular outflow defects (0.31% vs. 0.07%); and between citalopram (Celexa®)  and neural tube defects (0.29% vs. 0.09%). Prevalence of fetal alcohol spectrum disorders was higher with SSRI exposure than with no exposure (0.12% vs. 0.012%).
     Comment: Even in this large, population-based study, anomalies were rare, making it difficult to reach definite conclusions. Still, the study gives further evidence of associations between SSRIs and at least cardiovascular anomalies, and clinicians must inform patients of these potential risks. Within the informed consent process, weighing these risks against those of untreated depression is essential. Clinicians should also address their patients' smoking and alcohol use and should avoid multiple psychiatric prescriptions during pregnancy.
Deborah Cowley, MD Published in Journal Watch Psychiatry July 18, 2011
     Citation(s):Malm H et al. Selective serotonin reuptake inhibitors and risk for major congenital anomalies. Obstet Gynecol 2011 Jul; 118:111. http://www.ncbi.nlm.nih.gov/pubmed/21646927?dopt=Abstract
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Arch Pediatr Adolesc Med 2011 Jul; 165:597
Kids Can Get a Workout Playing Exergames
Children playing active video games can exercise at moderate-to-vigorous intensity and
enjoy it too.

     Most video games promote obesity by encouraging sedentary activity, but some video games incorporate physical activity. Can children playing these so-called "exergames" exercise at moderate (3–6 metabolic equivalent tasks [METs]) or vigorous (≥6 METs) intensity? To find out, researchers in Massachusetts evaluated the effects of playing exergames in 19 boys and 20 girls (age range, 9–13 years; 54% overweight or obese).
     Physical activity intensity, measured during 10 minutes of exergaming by indirect calorimetry, ranged from moderate to vigorous (mean, 4.2–7.2 METs) for the six video games (Dance Dance Revolution, Nintendo Wii Boxing, Xavix J-Mat, LightSpace, Cybex Trazer, and Sportwall). Mean energy expenditure at rest and while walking on a treadmill at 3 miles per hour were 1.1 and 4.9 METs, respectively. Overweight and obese children used the same amount of energy during exergaming activities as normal-weight children. Enjoyment of the games was high (averaging 6–8 on a 10-point scale), and overweight and obese children enjoyed the games as much as or more than normal-weight children. Girls enjoyed dance and boys enjoyed boxing significantly more than the opposite sex.
     Comment: The exergaming examined in this study might not mimic real-life play because the researchers chose games and levels that were quite aerobically challenging, and children played for only 10 minutes. However, these kids exercised at proven moderate-to-vigorous intensity and enjoyed it. Other studies have shown that this degree of enthusiasm can be short-lived. An editorialist emphasizes that although exergaming has the potential to help with energy balance in adolescents, it's only one of many physical activity options that adolescents should consider.
Cornelius W. Van Niel, MD Published in Journal Watch Pediatrics and Adolescent Medicine July 27, 2011
     Citation(s):Bailey BW and McInnis K. Energy cost of exergaming: A comparison of the energy cost of 6 forms of exergaming. Arch Pediatr Adolesc Med 2011 Jul; 165:597.
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Pediatrics 2011 Jul; 128:29.
Sleeping Easy: Evening Media Use and Violent Content Affect Children's Sleep
Watching scary or violent content anytime, exposure to media in the evening, and having a TV in a child's bedroom were associated with sleep problems in preschoolers.
     To understand the effects of media content and timing of use on sleep patterns in children, researchers analyzed baseline parent-reported survey data on media use and 1-week media diaries from a randomized trial of 612 children aged 3 to 5 years enrolled in community pediatric practices in Seattle, Washington. Children with English-speaking parents and reported exposure to television, video games, and computers during the week were eligible. Researchers used validated tools to assess sleep habits and violent media content.
     Average daily viewing time was 73 minutes; 14 minutes (19%) occurred after 7:00 PM. Eighteen percent of parents reported that their child experienced at least one sleep problem 5 to 7 days per week. The most common problems were delayed sleep onset (≥20 minutes), nightmares, and daytime tiredness. The 10% of children with bedroom TVs had more screen time than children without bedroom TVs and were significantly more likely to have parent-reported daytime tiredness. Watching violent content at any time of day and exposure to any media after 7:00 PM were associated with increased sleep disturbances.
     Comment: Although these results might be limited by selection bias and parental recall, it seems prudent to suggest no TV after dinner, no TV in bedrooms, and no scary or violent media at any time for preschoolers. Parents should be encouraged to develop other bedtime rituals for their children (e.g., listen or dance to music, read a book, or make up a story together). Everyone might sleep better for it.
Louis M. Bell, MD Published in Journal Watch Pediatrics and Adolescent Medicine July 27, 2011
     Citation(s):Garrison MM et al. Media use and child sleep: The impact of content, timing, and environment. Pediatrics 2011 Jul; 128:29.
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BMJ 2011 May 26; 342:d2712
Children: Stay Asleep and Stay Lean
In the first longitudinal study to measure sleep objectively, reduced sleep duration during early childhood increased risk for becoming overweight.
     Short sleep duration has been linked with increased risk for obesity in children. In a longitudinal study, researchers in New Zealand used objective measures of sleep and body composition to examine this association in 244 children (83% white) recruited from a birth cohort and followed from age 3 to 7 years.
     Sleep duration and physical activity were determined by accelerometer at ages 3, 4, and 5 years. Body-mass index (BMI), anthropometry, and body composition (fat mass and free fat mass measured by bioelectrical impedance and dual energy x-ray absorptiometry) were assessed annually. Children's dietary intake and maternal BMI, education, and smoking during pregnancy were assessed by questionnaire.
     In analysis adjusted for multiple confounders, each additional hour of sleep per night between ages 3 and 5 years was associated with a reduction in BMI of 0.48 and a 61% reduced risk for being overweight (BMI ≥85th percentile) at age 7 years. Weight gain resulted from increased fat deposition rather than accumulation of fat-free mass. Maternal factors and gestational smoking did not affect the results.
     Comment: This was the first longitudinal study to use objective measurements and demonstrate that young children who sleep less are at increased risk for becoming overweight. An editorialist cites sleep deprivation experiments suggesting that short sleep duration causes increased energy intake and reduced energy expenditure by activating leptin and ghrelin — leading to increased appetite, glucose intolerance, and insulin resistance. We should actively encourage parents to develop healthy sleep patterns in young children by educating them about factors associated with sleep latency (JW Pediatr Adolesc Med Aug 19 2009 and JW Pediatr Adolesc Med Apr 6 2011) and nighttime behaviors that promote sustained sleep (e.g., avoiding caffeine, creating a quiet home environment 1 hour before sleep, eliminating the television in a child's bedroom, taking a lukewarm bath, reading to the child in bed with only a reading light).
Martin T. Stein, MD Published in Journal Watch Pediatrics and Adolescent Medicine
July 6, 2011
     Citation(s): Carter PJ et al. Longitudinal analysis of sleep in relation to BMI and body fat in children: The FLAME study. BMJ 2011 May 26; 342:d2712.
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N Engl J Med 2011 Jul 14; 365:107.
ADT plus Radiation for Early, Localized Prostate Cancer
Combined short-course androgen-deprivation therapy and external beam radiotherapy conferred a survival benefit to men with intermediate-risk disease.
     The use of androgen-deprivation therapy (ADT) as an adjunct to radiotherapy (RT) has been shown to improve disease-free and overall survival in men with high-risk localized prostate cancer or locally advanced disease. To determine whether this therapy also has survival benefits in patients with earlier-stage disease, researchers conducted a phase III trial, involving 1979 men with stage T1b, T1c, T2a, or T2b prostate adenocarcinoma and prostate-specific antigen (PSA) levels ≤20. The median age of participants was 71; 35% had low-risk disease, 54% had intermediate-risk disease, and 11% had high-risk disease.
     Patients were randomized to undergo external beam RT (total dose, 66.6 Gy) with or without 4 months of ADT. During a median follow-up of approximately 9 years, the combined-therapy group had significantly better 10-year outcomes than the RT-alone group, including a higher rate of overall survival (62% vs. 57%; P=0.03), a lower rate of prostate cancer–specific mortality (4% vs. 8%; P=0.001), and a lower rate of biochemical failure (26% vs. 41%; P<0.001).
     In an unplanned subgroup analysis, the mortality benefits of combined therapy were limited to men with intermediate-risk disease. Overall, radiation-induced adverse effects, both acute and late, were similar between the treatment groups.
     Comment: Although the subgroup analysis was not prespecified, it provides good evidence that adding ADT to external beam RT is not beneficial in men with low-risk disease. An editorialist states that, on the basis of these data and emerging evidence of potentially significant toxicity with ADT, one can reasonably conclude that hormonal therapy is not indicated for low-risk patients. The editorialist and the study authors note that, for high-risk patients, the duration of ADT used was probably not sufficient to see the expected benefit. For intermediate-risk patients, adding ADT to RT improved survival, but is the hormonal therapy necessary now that patients can safely receive higher doses of radiation? This question is currently being addressed in the RTOG 0815 trial, which compares dose-escalated RT alone to dose-escalated RT plus 6 months of ADT in intermediate-risk patients.
Robert Dreicer, MD, MS, FACP Published in Journal Watch Oncology and Hematology
July 26, 2011
     Citation(s):Jones CU et al. Radiotherapy and short-term androgen deprivation for localized prostate cancer. N Engl J Med 2011 Jul 14; 365:107.
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Ann Intern Med 2011 Jul 5; 155:1
Therapeutic Massage Helps Alleviate Chronic Low Back Pain
Relaxation massage and structural massage were both effective in the short term.
     Back problems are widespread in the U.S., where they constitute one of the most common reasons for seeking complementary and alternative medical therapies. Total national healthcare costs associated with back and neck problems increased 65% from 1997 to 2005 (JAMA 2008; 299:656). Few studies have evaluated the effectiveness of massage for back pain. In a trial funded by the National Center for Complementary and Alternative Medicine, 401 patients with chronic low back pain were randomized to receive either usual care or 10 weekly sessions of relaxation massage or structural massage. Dysfunction was evaluated with the Roland Disability Questionnaire (RDQ) at baseline and at 10, 26, and 52 weeks. The RDQ scale ranges from 0 to 23 points; between-group differences in mean improvement of ≥2 points were clinically meaningful. Pain was assessed on a scale of 0 ("not at all bothersome") to 10 ("extremely bothersome"); between-group differences in mean improvement of ≥1.5 points were clinically meaningful.
     Compared with patients who received usual care, those who received either relaxation or structural massage had better RDQ and pain scores at 10 weeks. Adjusted mean RDQ scores were 2.9 points lower in the relaxation massage group and 2.5 points lower in the structural massage group than in the usual care group. Adjusted mean pain scores were 1.7 points lower with relaxation massage and 1.4 points lower with structural massage than with usual care. The beneficial effects of relaxation massage on function, but not pain, persisted at 52 weeks but were modest.
     Comment: These results suggest that either structural or relaxation massage is an effective short-term treatment for chronic low back pain, with benefits that can persist for 1 year. The distinct mechanisms underlying the efficacy of each type of massage will be interesting to determine.
Jaime Toro, MD Published in Journal Watch Neurology July 26, 2011
Citation(s):Cherkin DC et al. A comparison of the effects of 2 types of massage and usual care on chronic low back pain: A randomized, controlled trial. Ann Intern Med 2011 Jul 5; 155:1.
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Science 2011 July 7
A Second Big Step Toward a Universal Flu Vaccine
Researchers have identified monoclonal antibodies with neutralizing activity against nearly all group 2 influenza viruses.
     Most antibodies against influenza A viruses target surface structures of the hemagglutinin (HA) protein that can readily change to allow immune escape. In 2009, investigators (some of them employees of a biopharmaceutical company) described a human monoclonal antibody — CR6261 — that targets a conserved region on the HA stalk in group 1 influenza A viruses, including all H1 and H5 strains (JW Infect Dis Mar 18 2009).
     Now, the same research group has identified a human monoclonal antibody — CR8020 — with broad neutralizing activity against group 2 viruses. Like CR6261, this antibody binds to a conserved region at the base of the HA stalk and interferes with conformational changes in the molecule that are necessary for fusion with host cells.
     On in vitro testing, CR8020 bound to H3 virus strains from the last 50 years with high affinity. In a mouse model, it was active both prophylactically and therapeutically against infections caused by H3N2 and H7N7 viruses. Examination of HA sequences across group 2 influenza A viruses showed little variation in the target area, suggesting that CR8020 should neutralize most strains, including H3, H7, and H10.
     Comment: The identification of these two monoclonal antibodies, CR6261 and CR8020, offers the possibility of an essentially universal influenza A vaccine and of immunologic therapy for seasonal and pandemic influenza A.
Richard T. Ellison III, MD Published in Journal Watch Infectious Diseases July 27, 2011
Citation(s):Ekiert DC et al. A highly conserved neutralizing epitope on group 2 influenza A viruses. Science 2011 July 7; [e-pub ahead of print]. (http://dx.doi.org/10.1126/science.1204839)
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Fatty Foods Boost Mood
Finding helps explain the obesity epidemic and suggests that if people become aware of this, they might at least choose healthier mood-lifters 
by Craig Weatherby
     New findings support the idea that fatty foods can elevate your mood … with obvious implications for efforts to maintain a healthy weight.  But the news has a silver lining, in that it suggests that if people are made aware of this, they could make healthier choices among fatty foods. That is, they could pick fatty foods that satiate them faster than empty-calorie junk foods, while delivering nutrients (like omega-3s) that tend to improve metabolism and overall health. For example, if someone seeks a fatty food to boost their mood, it’s smarter to pick some nutrient-dense salmon, tuna, or sardines – rich in omega-3s, vitamin D, and filling protein – rather than a slice of sugary cheesecake.

Dutch study finds that fat acts like a mood drug
     Researchers from the Netherlands’ University of Leuven recruited 12 healthy, non-obese people for their novel experiment (Van Oudenhove L et al. 2011). The participants were placed in functional Magnetic Resonance Imaging (fMRI) scanning machines to monitor brain activity as they viewed images of people with sad expressions and listened to one-minute clips of somber classical music. To test the effects of dietary fat on mood, the participants were then hooked up to gastric feeding tubes that pass through the mouth into the stomach. (Feeding tubes were used so that participants could not use any senses to tell what they were being given.) Half of the group was tube-fed lauric acid – a rather healthful saturated fat found in human, cow, goat, and coconut milks – while the other half received a saline solution. During the 40 minute testing period, participants were asked to rate their levels of hunger, fullness, and mood at four different times. Those who received the fatty liquid reported feeling about half as sad as those who had received the saline solution (placebo), but there was no difference in hunger or fullness. And the fMRI scans showed that the participants who received the fatty liquid showed less activity in the areas of the brain associated with feelings of sadness.

Findings hold practical implications
     As the researchers noted, it’s been shown that emotions affect the hunger signals that the stomach sends to the brain, and influence our food choices … what we eat and how much. These findings shed light on the role that mood plays in influencing food choices … and may alert people to the hidden emotional enticements of fatty junk food. Prior research shows that unhelpful brain responses to food persist in obese people even after they lose substantial weight, making it hard to keep pounds off (DelParigi A et al. 2004). However, if an overweight person becomes aware that they use fatty foods to boost mood, they can at least make better choices! 
     Sources:  Braconnier D. Fatty foods really are mood enhancers. Medicalxpress.com. July 27, 2011. Accessed at http://medicalxpress.com/news/2011-07-fatty-foods-mood.html. DelParigi A, Chen K, Salbe AD, Hill JO, Wing RR, Reiman EM, Tataranni PA. Persistence of abnormal neural responses to a meal in postobese individuals. Int J Obes Relat Metab Disord. 2004 Mar;28(3):370-7. Van Oudenhove L, McKie S, Lassman D, Uddin B, Paine P, Coen S, Gregory L, Tack J, Aziz Q. Fatty acid-induced gut-brain signaling attenuates neural and behavioral effects of sad emotion in humans. J Clin Invest. 2011 Jul 25. pii: 46380. doi: 10.1172/JCI46380. [Epub ahead of print]
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Am J Gastroenterol 2011 Jul; 106:1333
What Is the Yield of Serologic Screening for Celiac Disease in the U.S.?
In an unselected cohort of 4000 people, 0.8% were antibody-positive.
     Some authorities advocate routine screening for celiac disease. To determine the prevalence of celiac disease in an unselected U.S. cohort, researchers screened 3850 adults (mean age, 57; nearly all white) who attended a health screening fair in Wyoming.
     All people were tested initially for serum tissue transglutaminase IgA antibodies; in the 75 people with positive results, endomysial IgA antibodies were measured. Thirty-one people (0.8% of the cohort) had positive results on both tests (serologic evidence of celiac disease). Eighteen of the 31 seropositive people agreed to undergo endoscopic small bowel biopsy, and 17 had histologic evidence of celiac disease. All participants at the screening fair completed gastrointestinal-symptom questionnaires (including questions about bloating, heartburn, diarrhea, and constipation); notably, no symptom was more prevalent among the 31 screen-positive people than among the 3800 screen-negative people.
     Comment: The 0.8% prevalence of serologic celiac disease in this population-based study is identical to the prevalence found in another recent study from Minnesota (JW Gen Med Oct 7 2010). Although these findings suggest that undiagnosed celiac disease is relatively common, its correlation with nonspecific gastrointestinal symptoms is poor. Moreover, we still have no convincing evidence that routine screening in middle-aged adults results in better health or lower mortality.
Allan S. Brett, MD Published in Journal Watch General Medicine July 28, 2011
Citation(s):Katz KD et al. Screening for celiac disease in a North American population: Sequential serology and gastrointestinal symptoms. Am J Gastroenterol 2011 Jul; 106:1333. (http://dx.doi.org/10.1038/ajg.2011.21)
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N Engl J Med 2011 Jun 29
Parenteral Nutrition in ICU Patients: What's the Rush?
Delaying intravenous nutrition for 1 week led to fewer infectious complications, shorter length of stay, and lower hospital costs than did early initiation.
     Guidelines differ substantially in their recommendations about when to start parenteral nutrition in critically ill patients; these guidelines are based primarily on expert opinion. To evaluate prospectively the optimal timing of nutritional support, investigators in Belgium randomized 4640 nutritionally at-risk patients in the intensive care unit (ICU; ~85% surgical patients, including 60% who underwent cardiac surgery) to receive early initiation (ICU day 3) or late initiation (ICU day 8) of parenteral nutrition. The study was not blinded, but allocation was concealed.
     Although no differences were noted in mortality (ICU, in-hospital, or 90-day) between the groups, the late-initiation group had significantly shorter lengths of stay (LOS) in the ICU (3 vs. 4 days) and in the hospital (14 vs. 16 days); fewer infections, including fewer lung, bloodstream, and wound infections (22.8% vs. 26.2%, number needed to treat [NNT], 29); shorter mean duration of mechanical ventilation; and lower costs (~US$1600 less per patient). Surprisingly, surgical patients in the late-initiation group for whom early enteral nutrition was contraindicated benefited substantially in lower infection rate (30% vs. 40% for similar early-initiation patients; NNT, 10) and shorter ICU LOS.
     Comment: This well-designed study reveals that the early routine administration of parenteral nutrition in critically ill, nutritionally at-risk patients leads to worse outcomes. Delaying parenteral nutrition for at least 1 week should be standard practice for surgical ICU patients. Although this study included relatively few medical ICU patients (~500), this conclusion also can be reasonably applied to such patients, unless new evidence becomes available.
Daniel D. Dressler, MD, MSc, SFHM Published in Journal Watch Hospital Medicine July 18, 2011
     Citation(s):Casaer MP et al. Early versus late parenteral nutrition in critically ill adults. N Engl J Med 2011 Jun 29; [e-pub ahead of print]. (http://dx.doi.org/10.1056/NEJMoa1102662)

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