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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
August 6, 2011

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Maximum Daily Dose of Tylenol Lowered by Manufacturer
Physical Activity and Cognitive Health, Revisited
Get Out! Nature Boosts Brains and Spirits
Cranberries vs. TMP-SMX to Prevent Urinary Tract Infections
Using Fish Bones to Eliminate Lead from Soil
Declining Kidney Function Linked to Higher AF Risk
ESBL-Producing Bacteria — From Chicken
Cholera in the U.S.
Sowing the Seeds of Unethical Research: The Story of the STEPS Trial
Kids Might Be Able to Forgo Fasting Before Lipid Screening
Moms’ Omega-3s Cut Babies’ Colds
Restricted Supplements May Help to Prevent Skin Cancer
Diflucan (Fluconazole): Long-term, High-dose Use During Pregnancy May Be
   Associated With Birth Defects
Daily Bisacodyl Effective for Chronic Constipation
Focused Ultrasound for Body Sculpting
TNF Inhibitors Double Infection Risk

Maximum Daily Dose of Tylenol Lowered by Manufacturer
     Johnson & Johnson is reducing the maximum daily dose of Extra-Strength Tylenol from 4000 mg to 3000 mg (eight to six pills) to help lower the risk for overdose. The change will appear on the drug's label beginning in the fall.
     The manufacturer says that it will also lower the maximum daily dose for regular-strength Tylenol and other drugs containing acetaminophen in 2012.
     The change is in line with the advice of an FDA working group that in 2009 recommended limiting the maximum adult daily dose to about 3000 mg in an attempt to decrease liver damage from the drug.
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Arch Intern Med 2011 Jul 25; 171:1244
Physical Activity and Cognitive Health, Revisited
Rx: 30 minutes of brisk walking daily to maintain cognition despite vascular risk factors
     Cerebrovascular disease risk factors are known to be associated with cognitive decline. Recent epidemiologic, cohort, and clinical-trial data support a role for physical activity in maintaining cognitive health. To assess the effect of physical activity on cognition in the setting of cerebrovascular disease, researchers conducted a retrospective subgroup analysis of more than 2800 female health professionals (age ≥65) with at least three vascular risk factors (e.g., diabetes mellitus, hypertension, hyperlipidemia, body-mass index ≥30, family history of premature myocardial infarction). Participants reported mean one-year physical activity levels a mean of 3.5 years before an initial global cognitive evaluation. The cognitive evaluation was conducted via telephone; 81% of the respondents completed at least three assessments at 2-year intervals. All instruments were previously validated.
     Women in the two highest quintiles of physical activity level — equivalent to brisk walking ≥30 minutes daily — had significantly slower rates of cognitive decline than those in the lowest quintile. When the data were compared to an analysis of age-associated cognitive decline, participants in the two highest quintiles of physical activity were cognitively 5 to 7 years "younger" than those in the lowest quintile. A secondary analysis specific to walking showed a possible threshold effect, with at least 30 minutes of brisk daily walking required for significant cognitive benefit.
     Comment: This analysis adds to a growing body of literature emphasizing the role of physical exercise throughout the life span as an important modifiable risk factor in maintaining cognitive health, even in the context of cerebrovascular risk factors. Although the self-report of physical activity is a potential confounder in this study, another study published in the same journal issue used an objective measure of energy expenditure and showed similar results in a mixed-sex cohort (Arch Intern Med 2011; 171:1251). On the basis of the accumulating evidence correlating physical exercise with cognitive health, a prescription for a daily walk should quite literally be "just what the doctor ordered."
Brandy R. Matthews, MD Published in Journal Watch Neurology August 2, 2011
Citation(s): Vercambre M-N et al. Physical activity and cognition in women with vascular conditions. Arch Intern Med 2011 Jul 25; 171:1244.
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Get Out! Nature Boosts Brains and Spirits
Studies show that time spent in natural settings is good for thinking and mood … and the wilder the better
by Craig Weatherby
     Can wilderness and waterside walks lift mood, relieve stress … and allow the aimless reflection that helps balance and focus our minds and spirits?  As John Muir wrote, “Everybody needs beauty as well as bread, places to play in and pray in, where nature may heal and give strength to body and soul.” But, to quote a certain 1980's hair band from Boston, is this “more than a feeling”?  It turns out that in fact, conventional wisdom about the restorative power of nature enjoys an increasing amount of scientific evidence.
     We saw John Muir’s quote in an article by former Los Angeles Times hiking columnist John McKinney titled, “Thoreau Was Right: Nature Hones the Mind” … which made us aware of a relatively new field of research. McKinney’s essay explores two decades of university studies showing that people report the strongest restorative experiences in the least-civilized places. He cites research suggesting that nature offers serious medical benefits:
“… post-surgery patients resting in rooms overlooking trees recovered better and faster than those in rooms with a view only of a brick wall … [and] women with breast cancer who walked in a park, watched birds or tended gardens recovered more quickly and were in better spirits than those with little or no contact with the natural world.” (McKinney J 2011).
But a walk in the park … better yet, in the woods or along the water … can help people who feel blue or frazzled.

Nature proves restorative … the wilder the better
     Many studies have now been conducted, all designed to test something called Attention Restoration Theory (ART). The goal has been to quantify the restorative powers of nature and discover how natural settings enhance people’s thinking and mood. Three years ago, University of Michigan scientists reported on two “experiments that show that walking in nature or viewing pictures of nature can improve directed-attention abilities … thus validating attention restoration theory.” (Berman MG et al. 2008). And addressing the reasons for nature’s brain benefits, they noted that “Nature, which is filled with intriguing stimuli, modestly grabs attention in a bottom-up fashion, allowing top-down directed-attention abilities a chance to replenish.” In contrast, they wrote, “… urban environments are filled with stimulation that captures attention dramatically and additionally requires directed attention (e.g., to avoid being hit by a car), making them less restorative.” (Berman MG et al. 2008) And indoor environments are ruled by straight lines and flat, smooth surfaces, with none of the random or “fractal” shapes and movements seen everywhere in nature.

Scandinavian and student research affirms nature’s relaxing power
     Finnish researchers reported last year that most of 1,273 study participants beleived that time spent in their favorite outdoor areas and woodlands were more relaxing and restorative than time spent in their favorite built-up urban settings or city parks (Korpela KM et al. 2010). Encouragingly, those who had the most stress reported the greatest relief from time in relatively untamed nature. However, those who needed nature the most were the least likely to seek it out:
“the more worries about money and work a person had, the more stressed a person had felt during the last year, the less energetic s/he had felt, the lower was the number of visits to the favorite place (during the last 6 months) and the lower the typical level of restorative experiences.”

The lesson, it seems, is that if you are feeling stressed, depressed, or frazzled, it’s harder but even more important to get yourself into the woods.
     In a simultaneous Danish study, those “… living more than 1 km [about two-thirds of a mile] away from the nearest green space report poorer health and health-related quality of life … than respondents living closer.” (Stigsdotter UK et al. 2010). Interestingly, an Indiana University study found that even murals with wilderness scenes were more restorative than looking out a window at relatively green but civilized outdoor scenes … such as a green-lawn college campus featuring scattered trees and buildings.

     Participating college students “… rated settings with views of dramatic nature murals, especially those with water, more restorative than settings with window views of real, but mundane nature with built structures present. Students rated settings that lacked views of real or simulated nature least restorative.” (Felsten G 2009). We find this field of research intriguing and full of hope for troubled humans … click here to read “Thoreau Was Right: Nature Hones the Mind http://www.miller-mccune.com/health/thoreau-was-right-nature-hones-the-mind-26763/”.

Then take a daily walk, ride, or paddle in the wildest places nearby … and fill your home with plants and animals!
     Sources: Berman MG, Jonides J, Kaplan S. The cognitive benefits of interacting with nature. Psychol Sci. 2008 Dec;19(12):1207-12. Accessed at http://www-personal.umich.edu/~jjonides/pdf/2008_2.pdf. Felsten G. Where to take a study break on the college campus: An attention restoration theory perspective. Journal of Environmental Psychology, Volume 29, Issue 1, March 2009, Pages 160-167. doi:10.1016/j.jenvp.2008.11.006. Accessed at http://www.sciencedirect.com/science/article/
. Korpela  KM et al. Favorite green, waterside and urban environments, restorative experiences and perceived health in Finland. Accessed at http://heapro.oxfordjournals.org/content/25/2/200.abstract.   McKinney J. Thoreau Was Right: Nature Hones the Mind. Miller-McCune.com. January 11, 2011. Accessed at http://www.miller-mccune.com/health/thoreau-was-right-nature-hones-the-mind-26763/. Korpela KM, Ylén M, Tyrväinen L, Silvennoinen H. Favorite green, waterside and urban environments, restorative experiences and perceived health in Finland. Health Promot Int. 2010 Jun;25(2):200-9. Epub 2010 Feb 22. Korpela KM, Ylén M, Tyrväinen L, Silvennoinen H. Determinants of restorative experiences in everyday favorite places. Health Place. 2008 Dec;14(4):636-52. Epub 2007 Oct 23. Korpela KM, Ylén MP. Effectiveness of favorite-place prescriptions: a field experiment. Am J Prev Med. 2009 May;36(5):435-8. Epub 2009 Mar 6. Stigsdotter UK, Ekholm O, Schipperijn J, Toftager M, Kamper-Jørgensen F, Randrup TB. Health promoting outdoor environments--associations between green space, and health, health-related quality of life and stress based on a Danish national representative survey. Scand J Public Health. 2010 Jun;38(4):411-7. Epub 2010 Apr 22.
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MM: Its great to compare natural to allopathic products but the natural products are bound to look inferior if they are tested inappropriately. The dose in this study was simply too low. The 500mg, twice daily dosing may be easy to use but to be effective, D-mannose, the active ingredient in the extract needs a much higher presence. We have this dosing information that has consistently worked, available at Mark Drugs.
Arch Intern Med 2011 Jul 25; 171:1270
Cranberries vs. TMP-SMX to Prevent Urinary Tract Infections
Trimethoprim-sulfamethoxazole was better, at the expense of greater antibiotic resistance.
     Premenopausal women who experience recurrent urinary tract infections (UTIs) are sometimes prescribed low-dose antibiotic prophylaxis. Growing concern about antibiotic resistance, coupled with many patients' desire for nonpharmacologic remedies, has led to renewed interest in cranberry consumption for UTI prophylaxis. The presumed mechanism is prevention of bacterial adhesion to uroepithelial cells by proanthocyanidins, a constituent of cranberries.
     In a double-blind study, Dutch investigators randomized 221 women (median age, 35) who reported having a median of 6 to 7 UTIs in the previous year to receive either cranberry extract (500 mg twice daily) or trimethoprim-sulfamethoxazole (TMP-SMX; 480 mg nightly). During 12 months of treatment, cranberry-extract recipients had a mean of 4 symptomatic UTIs compared with a mean of 1.8 in the TMP-SMX group — a significant difference; the median time to first recurrence was 4 months in the cranberry group and 8 months in the antibiotic group. Adverse events did not differ between groups, but the dropout rate was about 50% in both.
     Comment: Whereas cranberry extract recipients had fewer UTIs than they did in the preceding year, TMP-SMX was more effective. However, antibiotic resistance to TMP-SMX developed in >85% of Escherichia coli strains in women taking the antibiotic, compared with <30% in those taking cranberry extract. Unfortunately, cranberry juice was no better than placebo for preventing UTIs in a recent study (JW Gen Med Jan 20 2011); whether cranberry or one of its constituents ultimately will prove to be clinically useful remains unclear.
Thomas L. Schwenk, MD Published in Journal Watch General Medicine August 4, 2011
     Citation(s):Beerepoot MAJ et al. Cranberries vs antibiotics to prevent urinary tract infections: A randomized double-blind noninferiority trial in premenopausal women. Arch Intern Med 2011 Jul 25; 171:1270. (http://dx.doi.org/10.1001/archinternmed.2011.306)
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New York Times. Jul 21, 2011; p. A12
Using Fish Bones to Eliminate Lead from Soil
Mixing fishbone meal into the soil changes lead into a form that cannot be absorbed by the human body.
     Although the frequency of severe encephalopathy caused by environmental exposure to lead has decreased, many young children, especially in urban areas, continue to have low levels of lead in their blood that can have adverse effects on cognitive function. Removing lead from gasoline was a huge step forward in decreasing the burden of lead exposure in children, but lead in soil from decades of car exhaust and lead-based paint residue continues to be a problem in some communities.
     The Environmental Protection Agency in Oakland, California, is about to undertake a novel approach to eliminating lead in soil by mixing fishbone meal into the soil to change lead into a form that cannot be absorbed by the human body. Fishbone meal contains calcium phosphate that degrades to phosphate and binds with lead to create pyromorphite, a crystalline mineral that is harmless even when consumed. This method of mixing fishbone meal into the soil to transform lead in the environment has been used successfully in mining and by the U.S. Army. The estimated cost of the fishbone method is considerably less than that of removing soil in contaminated areas.
     Comment: If the fishbone strategy is successful and used in other communities where the burden of lead exposure in children persists, monitoring lead levels in pediatric practices could someday be a historical practice.
Martin T. Stein, MD Published in Journal Watch Pediatrics and Adolescent Medicine
August 3, 2011

     Citation(s): Barringer F. To nullify lead, add a bunch of fish bones. New York Times. Jul 21 , 2011; p. A12. (http://www.nytimes.com/2011/07/21/science/earth/
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MM: What makes this article particularly interesting is the effects of HCG that we have seen on both of these conditions. We have seen dramatic improvement with patients having early stage renal failure and we have seen remission of atrial fib while using the HCG weight loss protocol. I think this warrants further investigation
Circulation 2011 Jun 28; 123:2946
Declining Kidney Function Linked to Higher AF Risk
In combination with albuminuria, chronic kidney disease predicted atrial fibrillation.
     Chronic kidney disease (CKD) predisposes patients to coronary heart disease, but its association with atrial fibrillation (AF) is unclear. To explore this relation, researchers used data from a large cohort study with 10,328 participants who were AF-free at baseline.
     During median follow-up of about 10 years, 788 cases of incident AF were identified; declining kidney function as measured by cystatin C and albuminuria were both associated with elevated risk for incident AF. Compared with people who had estimated glomerular filtration rates (eGFRs) of ≥" />90 mL/minute/1.73 m2, the hazard ratios for AF were 1.3, 1.6, and 3.2 for those with eGFRs of 60–89, 30–59, and 15–29 mL/minute/1.73 m2, respectively. Macroalbuminuria and even microalbuminuria also were associated with elevated risk for AF (HRs, 3.2 and 2.0, respectively). In people with both low eGFRs and albuminuria, the HR for AF was 13.1.
     Comment: In this population-based study, risk for incident AF was associated with both declining estimated GFR and albuminuria, even after adjustment for other risk factors. Previous studies of this issue have been mixed, and an association does not necessarily mean causality. However, the authors present several plausible mechanisms by which CKD might beget AF, such as worsened hypertension and fluid status and activation of the renin–angiotensin system.
Kirsten E. Fleischmann, MD, MPH Published in Journal Watch General Medicine July 28, 2011
     Citation(s): Alonso A et al. Chronic kidney disease is associated with the incidence of atrial fibrillation: The Atherosclerosis Risk in Communities (ARIC) study. Circulation 2011 Jun 28; 123:2946.
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Clin Microbiol Infect 2011 Jun; 17:873
ESBL-Producing Bacteria — From Chicken
Extended-spectrum β-lactamase–producing Escherichia coli, detected in 94% of retail chicken meat samples in the Netherlands, is probably transmitted through the food chain to humans.
     Recent years have seen an alarming worldwide rise in the incidence of infections caused by multidrug-resistant gram-negative bacteria that produce extended-spectrum β-lactamases (ESBLs). Now, researchers in the Netherlands have used molecular methods to examine the relation among ESBL-producing bacteria in retail chicken meat, in poultry isolates from a prevalence survey, and in human patients.
     Ninety-eight fresh, raw chicken breasts bought in 12 stores in Utrecht in 2010 were sampled. ESBL-producing Escherichia coli was isolated from 92 (94%) of the samples (total, 163 isolates). Further analysis of 81 isolates from 42 samples revealed genes from six ESBL groups. Taken together, blaCTX-M-1 and blaTEM-52 — both considered "poultry associated" — accounted for 75% of these genes.
     A similar distribution (but lower frequency) of ESBL-producing bacteria was seen in a prevalence survey of poultry in the Netherlands in 2006. Ten percent of E. coli and Salmonella enterica isolates from poultry harbored ESBL genes, with blaCTX-M-1 and blaTEM-52 together accounting for 78% of these genes.
     ESBL-producing E. coli isolates from humans, submitted by 31 Dutch laboratories between February and April 2009, were also analyzed. Of these 409 isolates, 35% contained poultry-associated ESBL genes and 19% contained poultry-associated ESBL genes located on plasmids; again, blaCTX-M-1 and blaTEM-52 were the most prevalent (taken together, 86%).
     Comment: These findings suggest transmission of ESBL-producing E. coli from poultry to humans through the food chain. The extremely high prevalence of ESBL-producing bacteria in retail chicken meat is alarming and is probably not restricted to the Netherlands. This situation calls for perfect hygiene when handling poultry meat — and also for a ban on antibiotic use in food animals.
Thomas Glück, MD Published in Journal Watch Infectious Diseases August 3, 2011
     Citation(s): Leverstein-van Hall MA et al. Dutch patients, retail chicken meat and poultry share the same ESBL genes, plasmids and strains. Clin Microbiol Infect 2011 Jun; 17:873. http://www.ncbi.nlm.nih.gov/pubmed/21463397?dopt=Abstract
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MM: What we must learn is that history will repeat itself and cholera has plagued the world for centuries. Remember that what kills from cholera is the dehydration aspect of the disease. We can typically combat the infection with a strong immune system but surviving the initial onslaught is critical. Saccharomyces Boulardii was first described in the medical literature when it was observed that locals were making a mixture for treating the diarrhea associated with a cholera epidemic. We now have this safe, effective and highly tested probiotic readily available for the same treatment. It is just as effective and very inexpensive. Contact Mark Drugs for more information.
Emerg Infect Dis 2011 Nov
Cholera in the U.S.
Twenty-three cases of cholera have been confirmed in the U.S. since the epidemic
began in Haiti in 2010.

     In October 2010, cases of cholera caused by toxigenic Vibrio cholerae O1 were confirmed in Haiti. Since then, more than 275,000 cases of cholera (and more than 4700 deaths) have been reported in Haiti and the Dominican Republic (DR), which together constitute the island of Hispaniola. Now, researchers describe 23 related cases of cholera that occurred in the U.S. between November 2010 and April 2011. All were CDC confirmed — 20 by culture and 3 by serologic testing.
     Case patients resided in eight states, with the largest numbers in Florida, Massachusetts, and New York. Their median age was 38 (range, 9–84). Most of the patients were hospitalized (39%) or seen in an emergency department (30%); none died. Twenty-two patients reported recent travel (Haiti, 13; DR, 9); the remaining patient ate seafood brought from Haiti by relatives. All DR-associated cases were linked to a January wedding. Cases associated with Haiti mainly involved visits to friends or relatives (7) or relief activities (4). Illness onset was on the day of return in 5 patients and 1–11 days after return in 12. No secondary transmission was seen in the U.S.
     The 20 V. cholerae isolates all matched the Hispaniolan outbreak-isolate pattern by pulsed-field gel electrophoresis. All 20 were resistant to sulfamethoxazole/trimethoprim; 18 showed intermediate resistance to ampicillin and amoxicillin/clavulanic acid.
     Comment: Travel between the U.S. and Haiti is easy, with four airports offering daily direct flights from Florida or New York to Port-au-Prince. Most cases were reported by states with large Haitian or Dominican populations. Clinicians should be prepared for the continued importation of cases as long as the cholera epidemic continues in Hispaniola. There is no licensed cholera vaccine available in the U.S. Secondary transmission can be avoided with good hygiene and access to safe water.
Mary E. Wilson, MD Published in Journal Watch Infectious Diseases August 3, 2011
     Citation(s): Newton AE et al. Cholera in the United States associated with epidemic in Hispaniola. Emerg Infect Dis 2011 Nov; [e-pub ahead of print]. (http://www.cdc.gov/eid/content/17/11/pdfs/11-0808.pdf)
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Arch Intern Med 2011 Jun 27; 171:1100
Sowing the Seeds of Unethical Research: The Story of the STEPS Trial
According to a review of documents revealed in litigation, a large phase IV clinical trial of gabapentin was merely a ploy to sell more of the drug.
     "Seeding trials" — industry-funded, phase IV clinical trials that typically use trifling hypotheses about already-approved drugs or devices — aim to sell more of a product, not to advance science. Those who agree to participate, as investigators or subjects, are often unaware of the marketing intent. Institutional review boards (IRBs) rarely identify the false intent or provide critical feedback. Quality control is often lax. So it was with STEPS (Study of Neurontin: Titrate to Effect, Profile of Safety), conducted in the 1990s.
    These authors, who had consulted to plaintiffs in a suit involving gabapentin (Neurontin), have now analyzed documents on marketing, sales practices, and product liability litigation. STEPS recruited 772 physician-investigators and enrolled 2759 subjects. The informed consent document stated that STEPS was designed to study the efficacy and tolerability of gabapentin (titrated from 900 to 3600 mg/day) in patients whose partial seizures were not controlled by other drugs. The study was uncontrolled and unblinded.
     Documents revealed that study sites were not audited before the trial began. Sales representatives assisted in collecting and recording data from trial subjects. Promotional rewards were offered to achieve enrollment goals. After physician-investigators attended an introductory briefing about the trial, their prescription rates and average prescribed doses increased substantially. An internal company report, produced before any trial results were disseminated, touted the increase in these prescribing habits. Overall, the narrative evidence demonstrated the intent of STEPS to promote gabapentin and to increase prescribing among investigators.
     Comment: How can neurologists, patients, academics, independent reviewers, and editors alike be deceived by such "trials"? Among the many reasons for this blind spot, one has to consider whether the presence of Big Pharma's money creates a lax ethicality that affects judgments about social value, scientific standards, and fairness. Because the FDA has no authority over most phase IV postmarketing studies, other oversight mechanisms are needed.
     An extreme solution would be a moratorium on all postmarketing studies without clear purposes, such as to elucidate long-term drug effects or expand labeling indications. Certified surveillance programs for studies with such purposes could minimize bias and ensure quality. Absent extreme solutions, neurologists, clinical researchers, and instititutional review boards must, at a minimum, increase their awareness of seeding trials and learn to probe the ethical intent of postmarketing studies. A posture of "unethical until proven otherwise" might allow us to better detect shoddy research practices, focus biomedical research on more socially valuable activities, and enable us to recognize when we fall short of our own standards.
— Robert Holloway, MD, MPH Dr. Holloway is Professor of Neurology and Community and Preventive Medicine at the University of Rochester Medical Center.
Published in Journal Watch Neurology August 2, 2011
     Citation(s): Krumholz SD et al. Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) Trial: A narrative account of a gabapentin seeding trial. Arch Intern Med 2011 Jun 27; 171:1100.
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Kids Might Be Able to Forgo Fasting Before Lipid Screening
     Fasting appears to have little effect on cholesterol values among children, according to a cross-sectional study in Pediatrics. (In 2008, the American Academy of Pediatrics recommended fasting lipid panels for high-risk children.)
Researchers examined data on nearly 13,000 children aged 3 to 17 years who underwent lipid screening as part of the National Health and Nutrition Examination Survey. Fasting before screening varied across the sample.
     After adjustment for weight and other confounders, lipid measurements changed little according to fasting status. For example, the researchers calculate that LDL cholesterol in an average child would be about 5 mg/dL lower postprandially versus after a 12-hour fast.
     The authors say such changes in lipid values are "likely not clinically important." They conclude that "physicians might be able to decrease the burden of childhood cholesterol screening by not requiring prescreening fasting."
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Moms’ Omega-3s Cut Babies’ Colds
Clinical trial finds that babies suffer fewer, milder cold symptoms when their mothers take supplemental omega-3 DHA
by Craig Weatherby
An Emory University study in Mexican mothers and infants suggests that taking omega-3 DHA from seafood during pregnancy helps protect babies against illness during early infancy. According to lead author Usha Ramakrishnan, Ph.D., “This is a large scale, robust study that underscores the importance of good nutrition during pregnancy. Our findings indicate that pregnant women taking 400 mg of DHA are more likely to deliver healthier infants.” The randomized, placebo-controlled trial followed approximately 1,094 pregnant women and 849 infants in Mexico. (Imhoff-Kunsch B et al. 2011).
     The women were assigned to take either algae capsules providing 400mg of omega-3 DHA, or placebo capsules, for the 30 days between the 18th and 20th weeks of their pregnancy. As the authors concluded, “DHA supplementation during pregnancy decreased the occurrence of colds in children at 1 month and influenced illness symptom duration at 1, 3, and 6 months.” (Imhoff-Kunsch B et al. 2011).

Results show reduced cold symptoms in the omega-3 DHA group
     First, the authors of the study – funded by the NIH and the March of Dimes Foundation – found higher omega-3 DHA levels in the breast milk of mothers in the omega-3 group. All of the infants in the study were breastfed. At one month of age, the infants in the DHA group enjoyed a 24 percent lower risk of cold symptoms, including a shorter duration of cough, phlegm, and wheezing.
     Compared with babies of mothers in the placebo group, the DHA babies showed these outcomes at one, three, and six months of age:

     Oddly, the DHA-group babies suffered slightly more rashes and significantly more vomiting. Dr. Ramakrishnan and her colleagues previously reported that the babies of women pregnant with their first child, who took 400mg of omega-3 DHA during pregnancy, were 100 grams (3.5 oz) heavier at birth and 3/4 cm longer at 18 months of age (Stein AD et al. 2011; Ramakrishnan U et al. 2010).

Sorting out omega-3s
     Of the two essential omega-3s – DHA and EPA, both found only in seafood and algae – DHA is the one considered most important to child development. Humans can make DHA and EPA from the scarce plant-source omega-3 called ALA – found in beans, dark leafy greens, walnuts, and flaxseed –  but this is a very inefficient conversion process. And this conversion is made even more inefficient by Americans’ (and Mexicans’) grossly excessive intake of competing omega-6 fat from cheap vegetable oils … soy, corn, cottonseed, safflower, sunflower … except hi-oleic sunflower oil, which is very low in omega-6 fats.
     Sources: Imhoff-Kunsch B et al. Prenatal Docosahexaenoic Acid Supplementation and Infant Morbidity: Randomized Controlled Trial. Pediatrics. Published online August 1, 2011. doi: 10.1542/peds.2010-1386. Imhoff-Kunsch B, Stein AD, Villalpando S, Martorell R, Ramakrishnan U. Docosahexaenoic acid supplementation from mid-pregnancy to parturition influenced breast milk fatty acid concentrations at 1 month postpartum in Mexican women. J Nutr. 2011 Feb;141(2):321-6. Epub 2010 Dec 22. Parra-Cabrera S, Stein AD, Wang M, Martorell R, Rivera J, Ramakrishnan U. Dietary intakes of polyunsaturated fatty acids among pregnant Mexican women. Matern Child Nutr. 2011 Apr;7(2):140-7. doi: 10.1111/j.1740-8709.2010.00254.x. Ramakrishnan U, Imhoff-Kunsch B, DiGirolamo AM. Role of docosahexaenoic acid in maternal and child mental health.Am J Clin Nutr. 2009 Mar;89(3):958S-962S. Epub 2009 Jan 28. Review. Ramakrishnan U, Stein AD, Parra-Cabrera S, Wang M, Imhoff-Kunsch B, Juárez-Márquez S, Rivera J, Martorell R. Effects of docosahexaenoic acid supplementation during pregnancy on gestational age and size at birth: randomized, double-blind, placebo-controlled trial in Mexico. Food Nutr Bull. 2010 Jun;31(2 Suppl):S108-16. Stein AD, Wang M, Martorell R, Neufeld LM, Flores-Ayala R, Rivera JA, Ramakrishnan U. Growth to age 18 months following prenatal supplementation with docosahexaenoic acid differs by maternal gravidity in Mexico. J Nutr. 2011 Feb;141(2):316-20. Epub 2010 Dec 22.
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J Clin Oncol 2011 Jun 27
Restricted Supplements May Help to Prevent Skin Cancer
Grape seed extract and vitamin D show some indications of possible protection, but these need to be borne out by prospective clinical trials.
     Despite billions spent on supplements, many claimed health benefits are unsubstantiated. Two recent studies evaluated supplements' protection against skin cancer.
     Tang and colleagues analyzed incidence of melanoma and nonmelanoma skin cancer (NMSC) in postmenopausal participants in the Women's Health Initiative Randomized Controlled Trial. Participants were randomized to receive 1000 mg of elemental calcium and 400 IU of vitamin D3 (18,716 women) or placebo (18,106 women); personal calcium and vitamin D supplementation was also allowed. Mean follow-up was 7.0 years. At 2 years, serum 25-hydroxyvitamin D levels were 28% higher in the intervention group than in the placebo group. No statistically significant between-group differences occurred in the numbers of NMSCs or melanomas. However, among participants with a history of NMSC, those in the calcium/vitamin D group were 57% less likely to develop melanoma.
     Asgari and colleagues compared supplement use in 415 patients with at least one histologically confirmed squamous cell carcinoma (SCC) and 415 with no prior SCC (mean age, 72.5). Individuals taking vitamins A, C, D, or E had no statistically significant difference in SCC incidence. But people who regularly took grape seed extract at least once a week for 3 months during the past 10 years had 69% fewer SCCs than people who did not take the extract; the protective effect endured after adjustment for known risk factors.
     Comment: Study design of the Women's Health Initiative trial may have interfered with assessment of vitamin D's chemopreventive activities against melanoma. Both study groups were allowed vitamin D supplements, and the recommended supplementation level was low. Moreover, the study population was older, and melanoma occurs more commonly in younger individuals. The grape seed extract findings corroborate findings in animal models. Grape seed extract is a potent antioxidant, which may explain its protection against SCCs. Other antioxidants are under evaluation for UV protection; finding of some photoprotective effect is encouraging. Both studies were observational; interventional clinical trials are needed. Prospective studies to determine protective effects of grape seed extract and vitamin D against other cancers are under way. Little evidence shows that vitamin D protects against melanoma or NMSC, and more evidence is needed to conclude that grape seed extract or other antioxidants prevent skin cancer. Therefore, patients must be warned that claims for supplements must be evaluated carefully and that their use should not preclude use of sunscreens and other photoprotective measures.
Craig A. Elmets, MD Published in Journal Watch Dermatology July 29, 2011      
     Citation(s):Tang JY et al. Calcium plus vitamin D supplementation and the risk of nonmelanoma and melanoma skin cancer: Post hoc analyses of the Women's Health Initiative randomized controlled trial. J Clin Oncol 2011 Jun 27; [e-pub ahead of print]. (http://dx.doi.org/10.1200/JCO.2011.34.5967)
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Diflucan (Fluconazole): Long-term, High-dose Use During Pregnancy May Be Associated With Birth Defects
     The FDA has announced that treatment with chronic, high doses (400 to 800 mg/day) of Diflucan (fluconazole) during the first trimester of pregnancy may be associated with a rare and distinct set of birth defects in infants. These defects do not appear to be associated with a single, low dose of fluconazole 150 mg to treat vaginal yeast infection (candidiasis). Due to this, the pregnancy category for fluconazole indications (other than vaginal candidiasis) has been changed from category C to category D. The pregnancy category for a single, low dose of fluconazole has not changed and remains category C.
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MM: Yes. Laxatives are effective but they also promote possible malabsorbtion and fail to address the cause of the problem. The use of Probiotics with Prebiotics such as FOS (fructooligosaccharides) is a much better approach. It restores the normal flora of the gut and causes no griping or other insults to the system. For short term or drug induced constipation I have no big problem with the use of a laxative such as bisacodyl but for maintenance I will continue to recommend more natural approaches. The most common adverse effect of probiotics is secondary to micro-organism die-off and balancing with the result being a restoration of normal gut flora. This leads to long term benefits not just “taking care” of constipation for the short run.
Clin Gastroenterol Hepatol 2011 Jul; 9:577
Daily Bisacodyl Effective for Chronic Constipation
Whether tolerance will develop after more-prolonged therapy — and whether intermittent treatment might produce better results for some patients — remains to be determined.
     The over-the-counter laxative bisacodyl has been available for decades. Intestinal enzymes convert this agent into an active metabolite, bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM). BHPM stimulates fluid secretion and also has a direct prokinetic effect. Gastroenterologists often recommend bisacodyl — but primarily for short-term use, out of concern that patients will develop tolerance and then require either higher doses or a different laxative. Whether it should be used in chronic constipation remains uncertain: Few data are available from controlled trials.
     Investigators recently addressed this issue in a manufacturer-sponsored, multicenter, double-blind trial conducted in the U.K. among adults who fulfilled Rome III criteria for chronic constipation. During a 2-week baseline period, all had fewer than three complete spontaneous bowel movements (CSBMs) per week on average and at least one additional symptom — straining, incomplete evacuation, or lumpy or hard stools — more than 25% of the time. A total of 368 participants (75% women; mean age, 55) were randomized in a 2:1 ratio to receive oral bisacodyl (10 mg daily) or placebo for 4 weeks.
     The mean number of CSBMs per week during treatment increased from a baseline of 1.1 in both groups to 5.2 in the bisacodyl group and 1.9 in the placebo group. In each group, the mean number of CSBMs per week exceeded baseline levels throughout treatment, peaking during week 1, and then declining slightly and remaining fairly stable for the next 3 weeks. Constipation-related quality-of-life scores improved significantly more in the bisacodyl group than in the placebo group. Adverse events (generally diarrhea and abdominal pain, and during the first treatment week) were nearly twice as common in the bisacodyl group. Discontinuation was also more common in the bisacodyl group (17.8% vs. 5.0%).
     Comment: These findings suggest that bisacodyl at 10 mg daily is an effective treatment for patients with chronic constipation. Clearly, some of the patients could have been managed adequately with a lower dose. Although this 4-week study provides valuable information, chronic constipation is a problem that can require years of treatment. It will be important to know whether tolerance develops with more-prolonged therapy and whether intermittent treatment might produce a more-sustained and better-tolerated effect for some patients.
Douglas K. Rex, MD Published in Journal Watch Gastroenterology August 5, 2011
     Citation(s):Kamm MA et al. Oral bisacodyl is effective and well-tolerated in patients with chronic constipation. Clin Gastroenterol Hepatol 2011 Jul; 9:577. http://www.ncbi.nlm.nih.gov/pubmed/21440672?dopt=Abstract
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Plast Reconstr Surg 2011 Jul; 128:253
Focused Ultrasound for Body Sculpting
One treatment produced subtle but statistically significant improvement in waist circumference.
     Noninvasive body sculpting with various devices has been promoted with precious little hard data to support efficacy. In this industry-funded, multicenter, randomized, sham-controlled, single-blind trial, 180 subjects with body-mass index less than 30 kg/m2 and with more than 2.5 cm of subcutaneous fat in the abdomen and flanks underwent one treatment with high-intensity focused ultrasound (LipoSonix). The subjects were randomized to receive three passes at 59 J/cm2 (177 total), 47 J/cm2 (141 total), or 0 J/cm2 (sham treatment) and were followed for 12 weeks. Waist circumference was measured with a tape measure at the top of the iliac crests. No changes in diet or exercise were allowed. No significant changes in weight were observed during the study.
     In all, 168 participants completed the study per protocol. The researchers found statistically significant mean waist circumference reductions of 2.5 cm in the 59 J/cm2 group and 2.1 cm in the 47 J/cm2 group, compared with a 1.2-cm reduction in the sham treatment group at 12 weeks after treatment. Significantly more patients in the active-treatment group than in the sham-treatment group rated themselves as improved or much improved (68% vs. 24%). However, the active-treatment and sham-treatment groups did not differ regarding the likelihood of undergoing additional treatments or in their satisfaction with the results. Most active-treatment patients experienced bruising (66%) and mild-to-moderate pain during treatment (90%) and for a few days afterward (57%). Several patients developed postprocedural edema (9%). All adverse effects resolved within 2 weeks. Lipid profiles and liver and renal function lab tests remained normal throughout the study.
     Comment: High-intensity focused ultrasound was able to achieve subtle but statistically significant waist circumference reductions with one treatment. However, most patients will find a half-inch reduction clinically insignificant. Multiple treatments may improve on these results. Because the sham-treatment group showed a significant placebo effect, using robust control groups will be imperative in future clinical studies of noninvasive fat reduction and skin tightening, where objective measures are very subtle.
George J. Hruza, MD Published in Journal Watch Dermatology July 29, 2011
     Citation(s): Jewell ML et al. Randomized sham-controlled trial to evaluate the safety and effectiveness of a high-intensity focused ultrasound device for noninvasive body sculpting. Plast Reconstr Surg 2011 Jul; 128:253.
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J Rheumatol 2011 Jul; 38:1258
TNF Inhibitors Double Infection Risk
At 1 year, tumor necrosis factor inhibitors were associated with excess risk for serious infections in rheumatoid arthritis patients.
     Tumor necrosis factor-α (TNF) inhibitors raise risk for infection in patients with rheumatoid arthritis. To quantitate this risk, Japanese investigators compared outcomes in 646 patients who were treated with TNF inhibitors (etanercept [Enbrel] or infliximab [Remicade]) and 498 patients who were treated with nonbiologic disease-modifying antirheumatic drugs. Median follow-up was about 1 year in both groups.
     Thirty-eight serious infections occurred in the TNF-inhibitor group (25 bacterial, 11 opportunistic, and 2 other), and 12 occurred in the unexposed group (6.4 vs. 2.6 infections per 100 person-years). In a multivariate analysis that was controlled for baseline differences between the two groups, TNF-inhibitor exposure doubled risk for serious infection. Within the TNF-inhibitor group, older age and corticosteroid use were independent predictors of serious infection.
     Comment: In this Japanese cohort, elevated risk for infection conferred by TNF inhibitors was similar to that observed in some European and American populations. Clinicians should be vigilant about infectious complications in patients with rheumatoid arthritis who are receiving TNF inhibitors.
Allan S. Brett, MD Published in Journal Watch General Medicine July 28, 2011
     Citation(s): Komano Y et al. Incidence and risk factors for serious infection in patients with rheumatoid arthritis treated with tumor necrosis factor inhibitors: A report from the Registry of Japanese Rheumatoid Arthritis Patients for Longterm Safety. J Rheumatol 2011 Jul; 38:1258. (http://dx.doi.org/10.3899/jrheum.101009)

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