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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
February 13, 2016

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Menopause is associated with Excess Risk for New-Onset Asthma
Can simply providing water to Students affect their Weight?
A Cannabis Derivative for Treatment-Resistant Epilepsy?
Only a quarter of adults with Memory Complaints tell their Providers
Preventing Sexual Transmission of Zika Virus
New Bacteria Species that causes Lyme Disease Discovered
High-Dose Vitamin D Supplementation does not improve Leg Function
   in Frail Elders
Does Vitamin D reduce risk for Colorectal Cancer?
Does Vitamin D Supplementation during Pregnancy prevent Childhood Asthma?
Outrage over Unaffordable Hepatitis C Treatment
Compounder to make cheaper alternative to Retrophin's Thiola
Clarithromycin (Biaxin) is associated with excess Cardiovascular Risk
Shorter Course of Oral Antibiotics after hospitalization for Uncomplicated Cellulitis
No Effect of Marijuana use on IQ in Adolescents
A Small Step, not a Giant Leap, in Stem Cell Therapy for ALS
Physical Activity can improve Attention in Adolescents

J Allergy Clin Immunol 2016 Jan; 137:50
Menopause is associated with Excess Risk for New-Onset Asthma
Asthma development is twice as common among women after menopausal transition.
Asthma is more prevalent in boys than girls, but this tendency reverses in adulthood. Menopause is a systemic inflammatory state that predisposes women to cardiovascular disease and might have similar effects on pulmonary disease. However, epidemiological studies of the association between menopause and new-onset asthma have yielded inconsistent results.
Researchers followed a cohort of 2322 premenopausal Northern European women (age, >44) who were free from asthma at baseline. After 12 years, 19% of women were still premenopausal, 13% were transitional, 58% were early postmenopausal, and 11% were late postmenopausal. In analyses adjusted for age and other potentially confounding variables, women who were in transition, early postmenopause, and late postmenopause were significantly more likely to have developed asthma (odds ratios, 2.1, 2.4, and 3.4, respectively) than were women who remained premenopausal. The proportion of women with new diagnoses of asthma ranged from 2.8% in women who remained premenopausal to 6.9% in those who were late menopausal.
COMMENT: New-onset asthma in older adults is more common in women and usually is nonatopic and more resistant to treatment than earlier-onset asthma. As women enter menopause, we should ask routinely about respiratory symptoms and obtain spirometry in patients with cough, wheezing, and dyspnea.
CITATION(S): Triebner K et al. Menopause as a predictor of new-onset asthma: A longitudinal Northern European population study. J Allergy Clin Immunol 2016 Jan; 137:50. (http://dx.doi.org/10.1016/j.jaci.2015.08.019)
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JAMA Pediatr 2016 Jan 19
Can simply providing water to Students affect their Weight?
Providing easily accessible water in school cafeterias was linked to reduced weight.
The removal of sugar-sweetened beverages, such as soda, juice, and energy drinks, from schools has become a popular way to combat the child obesity epidemic in the U.S. A complementary strategy — making water more easily available and attractive as a school lunch drink option — was evaluated in a quasi-experimental study of roughly 1.1 million elementary and middle school students in New York City.
The study involved 483 public schools that installed “water jets” (large, fast-dispensing, electrically-cooled, water jugs costing about $1000 each) in cafeterias from 2008 to 2013 and 744 schools that did not. Standardized body-mass index (zBMI), overweight, and obesity were compared before and after installation of water jets between students at schools with and without water jets.
Water jet availability was associated with small, but significant, reductions in zBMI and rate of overweight in boys (–0.025 and –0.9 percentage points, respectively) and in girls (–0.022 and –0.6 percentage points, respectively), as well as rate of obesity in boys (–0.5 percentage points). In exploring possible mechanisms for this reduction, the authors found that students in schools with water jets bought about 14 fewer half-pints of fat-free chocolate milk per student per year.
COMMENT: Although the childhood obesity epidemic has complex causes, there are simple, school-based solutions that can have a significant effect on children's nutrition. Pairing removal of sweet drinks with addition of easily accessible water holds promise at the public health policy level and can inform conversations with families in the clinical setting, as well.
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Lancet Neurol 2015 Dec 23
A Cannabis Derivative for Treatment-Resistant Epilepsy?
A multicenter, open-label U.S. trial suggests that cannabidiol is relatively safe and has promising antiseizure properties in patients with childhood-onset epilepsy.
Cannabinoids, especially tetrahydrocannabinol (THC) and cannabidiol (CBD), are receiving increasing interest for their anticonvulsant effect. Some U.S. states permit marijuana use for epilepsy, despite the lack of robust evidence. CBD has shown interesting results in animals and in small clinical studies on epilepsy, and also has myorelaxant properties. To test CBD as an add-on drug, 214 patients aged 1 to 30 years who had intractable, childhood-onset epilepsy and ≥4 motor seizures monthly received a 99% pure sesame-oil CBD extract (titrated from 2–5 mg/kg to 25 mg/kg daily [50 mg/kg for 23 participants]). About 40% had Lennox-Gastaut or Dravet syndrome. The study was partially manufacturer-funded.
In the 137 intention-to-treat participants, median motor-seizure frequency after 12 weeks decreased by 36.5% (interquartile range, 0–64.7%); 4% became seizure-free. Of patients taking clobazam, 51% experienced ≥50% seizure reduction, compared with 27% of those not taking clobazam. Adverse events were reported by 79% of 162 analyzed participants, mostly mild-to-moderate somnolence, decreased appetite, diarrhea, and fatigue. Serious adverse events — mainly status epilepticus — were observed in 12%.
COMMENT: This is the largest study assessing CBD in epilepsy to date. The findings suggest that this compound is a promising add-on treatment. The relatively high rate of adverse effects should be viewed in light of the severity of the participants' underlying diseases. Nevertheless, important study limitations include a lack of blinding and of a comparison group, which prevent assessing the placebo effect, a particularly important issue in this emotionally loaded context. Further, the effect in patients taking clobazam may reflect an increase in co-medication levels due to cytochrome enzyme inhibition by CBD. Also, far fewer patients were analyzed than were recruited.
The burden of intractable epilepsy, especially in patients with complex genetic syndromes, is enormous, and CBD may indeed represent a step in the right direction. Three ongoing randomized controlled trials of cannabidiol for the Dravet, Lennox-Gastaut, and tuberous sclerosis complex syndromes will help fill the information gap.
Dr. Rossetti is Senior Lecturer at the Department of Clinical Neurosciences, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
CITATION(S): Devinsky O et al. Cannabidiol in patients with treatment-resistant epilepsy: An open-label interventional trial. Lancet Neurol 2015 Dec 23; [e-pub].
(http://dx.doi.org/10.1016/S1474-4422(15)00379-8), Detyniecki K and Hirsch LJ.Cannabidiol for epilepsy: Trying to see through the haze. Lancet Neurol 2016 Jan 8; [e-pub].
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MM: Fear is a powerful thing. Sometimes it prevents us from taking foolish actions. Sometimes it stands in our way from getting appropriate treatment. When we add fear to a limited amount of information it can lead to problems. For example, if a person is getting forgetful or having trouble concentrating then they may simply assume that they are developing senile dementia or Alzheimer's Disease and are afraid of hearing a confirmation of this. However, what if the problem is actually sleep apnea and oxygen depletion combined with sleep deprivation that may be improved with nightly oxygen treatments.This is an exaggerated example of how fear can prevent a person from getting a proper diagnosis and treatment. The bottom line is don't be afraid of talking to your health care practitioner. They have training and experience with other patients that may be beneficial and may truly improve your Quality of Life.
Only a quarter of adults with Memory Complaints tell their Providers
By Amy Orciari Herman, Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
Adults with memory complaints rarely discuss them with their healthcare providers, according to a report in Preventing Chronic Disease.
Using data from the 2011 Behavioral Risk Factor Surveillance System survey, researchers identified some 10,000 adults aged 45 or older who reported subjective memory complaints (confusion or memory loss that occurred more often or worsened in the past year). Roughly one-fourth reported discussing their memory complaints with a healthcare professional — even in analyses limited to those who'd had a recent medical appointment. Participants whose memory complaints caused functional difficulties (i.e., interfered with household chores or work) were more likely to talk with a clinician.
Among those who did talk to a provider about their memory problems, 42% received treatment (e.g., therapy, medication).
The researchers note: "The Affordable Care Act requires a cognitive assessment for Medicare recipients during their annual wellness visit, but these results suggest that adults younger than 65 might also benefit from such an assessment."
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MMWR Morb Mortal Wkly Rep 2016 Jan 29; 65:55
Preventing Sexual Transmission of Zika Virus
Infection during pregnancy is of concern, particularly during the first trimester.
Zika virus infection is widespread in Latin America, with some cases also reported in the U.S. and elsewhere. Most cases of Zika are transmitted through the bite of an infected mosquito (Aedes aegypti, the same species that can transmit dengue). However, Zika can be transmitted by two other modes: Fetal infection via the placenta of infected pregnant women; and sexual transmission from men to women.
Although Zika infection is often asymptomatic, it can cause mild fever, joint pain, and rash. Maternal infection during pregnancy has been associated with microcephaly and other congenital defects in offspring. In addition, incidence of Guillain-Barré syndrome is increased following Zika virus infection.
Data about the specific timing of Zika virus infection and risk for fetal damage continue to accrue. Among characterized cases of fetal microcephaly, symptomatic maternal infection during the first trimester of pregnancy is of greatest concern. However, lack of understanding about the duration of viremia, persistence of Zika virus in immunoprivileged sites (such as semen or placenta), and other relevant risk factors limit the ability to make definitive recommendations. The CDC's interim recommendations are as follows:
For pregnant women:

For women and men considering travel to areas with known Zika virus transmission:

Whereas half of pregnancies in the U.S. are unintended, many countries in Central and South America lack readily accessible birth control (especially highly effective methods), further hampering contraception. Men returning from areas with Zika virus transmission — and whose partners are pregnant — should abstain from sexual intercourse or use condoms consistently throughout the pregnancy.
CITATION(S): Oster AM et al. Interim guidelines for prevention of sexual transmission of Zika virus — United States, 2016. MMWR Morb Mortal Wkly Rep 2016 Feb 12; 65:120. (http://dx.doi.org/10.15585/mmwr.mm6505e1er)

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New Bacteria Species that causes Lyme Disease Discovered
By Kelly Young, Edited by Jaye Elizabeth Hefner, MD
Scientists report the discovery of a new species of bacteria (Borrelia mayonii) in the upper Midwest of the U.S. that causes a unique presentation of Lyme disease. Their findings appear in the Lancet Infectious Diseases.
Researchers screened over 100,000 clinical samples for the presence of B. burgdorferi bacteria, which causes Lyme disease. Of these, six were flagged as a unique species, which they called B. mayonii. Roughly 20 ticks also tested positive for this bacterium.
The researchers examined medical records and found that patients infected with B. mayonii experienced nausea, vomiting, diffuse macular rashes, and elevated levels of bacteria in the blood, in addition to symptoms typically associated with B. burgdorferi infection (e.g., headache, neck pain). Three patients also experienced neurologic symptoms, including confused speech, profound somnolence, and visual difficulties. All lived in Minnesota, Wisconsin, or North Dakota.
Commentators conclude: "Interestingly, candidatus B. mayonii was only detected in specimens obtained during 2012–14, although the sample collection dates back to 2003. This suggests that candidatus B. mayonii is a newly-emerged genospecies."
The CDC says that patients infected with B. mayonii should test positive for Lyme disease with current tests.
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MM: There is no magic bullet that will make people healthy by simply taking it. This is true for vitamin D3 and any other supplement. What appropriate supplements do provide is the opportunity for people to be proactive and be in a better place to improve their health conditions with activities such as walking, weight resistance and other activities that increase strength and improve balance. These are the benefits if using supplements. It seems that many studies ignore the basic tenet that the human body thrives when it moves. The human brain thrives when it is challenged. Work is a GOOD THING! Our overall Quality of Life is improved when we engage our minds and our bodies. Supplements are tools, not complete answers.
JAMA Intern Med 2016 Jan 4
High-Dose Vitamin D Supplementation does not improve Leg Function
in Frail Elders

And it might increase risk for falls.
Evidence suggests a positive relation between vitamin D levels and lower-extremity strength and function, but whether vitamin D supplementation benefits leg function in older, noninstitutionalized patients is unclear. Researchers randomized 200 older home-dwelling adults (mean age, 78; 67% women) who had experienced falls during the previous 12 months to monthly oral supplementation with 24,000 IU vitamin D3 (control group); 60,000 IU vitamin D3; or 24,000 IU vitamin D3 plus 300 μg calcifediol (a hepatic metabolite of vitamin D). Patients were excluded if they had major impairments or chronic diseases or were taking medications that affect vitamin D levels or calcium metabolism. At baseline, 58% of patients had serum 25-hydroxyvitamin D (25[OH]D) levels <20 ng/mL.
At 1 year, patients who received 60,000 IU vitamin D3 and those who received 24,000 IU vitamin D3 plus calcifediol were more likely than controls to achieve the researchers' specified target of 25(OH)D level ≥30 ng/mL (81%, 83%, and 55%, respectively). Improvement in lower-extremity function did not differ significantly among groups; risk for falls was marginally but significantly higher in the two high-dose groups than in controls.
COMMENT: This study adds to the confusion about the musculoskeletal benefits of vitamin D supplementation in older adults. Despite raising vitamin D levels substantially, intermittent high-dose supplementation was associated with excess risk for falls; this adverse outcome has been observed in a previous study of intermittent high-dose supplements (NEJM JW Gen Med Jun 1 2010 and JAMA 2010; 303:1815). At this point, the current recommendation from the Institute of Medicine still holds for elders (age, >70): Recommend a total daily intake of 800 IU of vitamin D without routine monitoring of vitamin D levels.
CITATION(S): Bischoff-Ferrari HA et al. Monthly high-dose vitamin D treatment for the prevention of functional decline: A randomized clinical trial. JAMA Intern Med 2016 Jan 4; [e-pub].
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Gut 2016 Feb; 65:296
Does Vitamin D Reduce Risk for Colorectal Cancer?
High vitamin D levels were associated with lower risk for CRC, but only for tumors with high-level immune response.
High vitamin D levels have been associated with reduced risk for colorectal cancer (CRC), although recent trials have shown that vitamin D supplementation does not prevent development of colorectal neoplasia.
Given that vitamin D regulates immune function, investigators conducted a nested, case–control trial within the two large cohort studies (the Nurses' Health Study and the Health Professionals Follow-up Study) to determine whether vitamin D plays a greater protective role in tumors with a prominent immune response. The researchers measured plasma 25-hydroxyvitamin D levels in 318 CRC patients and 624 healthy matched controls.
High vitamin D levels were associated with a lower risk for tumors with high-level immune responses, but not for tumors with low-level immune responses.
COMMENT: The vitamin D story continues unresolved despite the recent negative randomized controlled trials. This study suggests a specific mechanism and a specific subtype of colorectal tumor for which vitamin D might be protective.
CITATION(S):Song M et al. Plasma 25-hydroxyvitamin D and colorectal cancer risk according to tumor immunity status. Gut 2016 Feb; 65:296.

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JAMA 2016 Jan 26; 315:353
Does Vitamin D Supplementation during Pregnancy prevent Childhood Asthma?
In two trials, reduction in asthma incidence in the first 3 years was not significant but trended toward benefit.
Observational studies have yielded mixed results concerning the association of umbilical cord blood levels of 25-hydroxyvitamin D and reduced risk for asthma or recurrent wheezing in early childhood. In pregnant women, low circulating levels of 25-hydroxyvitamin D are common. Based on such epidemiologic observations, two research groups explored the effects on early childhood asthma and wheezing of high-dose vitamin D administration to pregnant women.
In the first study, 806 pregnant U.S. women at high risk for having a child with asthma (based on histories of asthma, allergic rhinitis, or eczema in either parent) were randomized to receive 4400 IU or 400 IU of vitamin D daily starting at 10 to 18 weeks' gestation. Incidence of asthma or recurrent wheeze in 3-year-old children of mothers in the 4400-IU group was 24.3%, compared with 30.4% in the 400-IU group (P=0.051).
In the second trial, 623 pregnant women in Denmark were randomized to receive 2800 IU or 400 IU of vitamin D3 starting at 22 to 26 weeks' gestation. In the first 3 years of their children's lives, rates of persistent wheeze were 16% in the high-dose group and 20% in the 400-IU group (P=0.16), while asthma rates were 12% and 14%, respectively (P=0.45).
COMMENT: Taken together, these results indicate a trend toward reduced wheezing and asthma among children whose mothers received high-dose vitamin D supplements during pregnancy. However, in neither case was statistical significance reached, possibly because smaller-than-anticipated effect sizes lowered statistical power. Editorialists suggest that, pending results of larger trials and given the lack of untoward effects, clinicians may want to offer higher-than-recommended daily vitamin D supplementation to pregnant women at high risk for having children with asthma. Such dosing would be higher than 400 IU but substantially below 4000 IU.
CITATION(S): Chawes BL et al. Effect of vitamin D3 supplementation during pregnancy on risk of persistent wheeze in the offspring: A randomized clinical trial. JAMA 2016 Jan 26; 315:353.

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Outrage over Unaffordable Hepatitis C Treatment
Congress is looking into reasons why veterans are being denied a cure for hepatitis, the cure of which was developed by a doctor working for the Veterans Administration (VA). The doctor got rich, but at $1,000 a dose, the VA can't afford it. The target is Dr. Raymond Schinazi, who played a leading role developing a drug that cures hepatitis C; when he sold his company to pharmaceutical giant Gilead in 2012, he made over $400 million, and he did it all while working seven-eighths of his time for the VA. Schinazi said "So, I'm not full time -- what I do with my remaining time is up to me." Congress wants to know why Schinazi got rich, but the VA got nothing for a drug that one of its own doctors helped develop. "Is it bureaucratic incompetence or is it corruption, or is it a combination of the two?" Congress asked. Schinazi wasn't there to be questioned as he retired just two days ago; it was stated that "The person that's responsible always seems to retire before the investigation starts." 
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Compounder to make cheaper alternative to Retrophin's Thiola
Compounding pharmacy Imprimis Pharmaceuticals Inc. plans to make a cheaper alternative to Retrophin Inc.'s drug, Thiola. Retrophin raised the price of the drug from $1.50 to $30 per tablet after buying the rights from Mission Pharmacal Co. in 2014, Imprimis said. Imprimis' compounded alternative may reduce the cost of the drug by more than 70% and will be available to patients in April. 
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BMJ 2016 Jan 13; 352:h6926
Clarithromycin (Biaxin) is associated with excess Cardiovascular Risk
But excess risk disappears after the antibiotic course is completed.
Evidence suggests clarithromycin use is associated with excess cardiovascular (CV) risk, but whether such risk is short-term or long-term is unclear. In this population-based study, investigators in Hong Kong compared CV outcomes among 109,000 adults who received oral clarithromycin with outcomes among 218,000 adults who received oral amoxicillin (which is not associated with CV risk). Patients were matched by age, sex, and calendar year of antibiotic use.
Propensity-adjusted analyses showed that, with current use, risk for myocardial infarction (MI) was 3.7 times higher and risk for arrhythmia was 2.2 times higher among clarithromycin users than among amoxicillin users. All-cause and cardiac-related mortality was roughly doubled among current clarithromycin users versus current amoxicillin users. These excess risks disappeared after 14 days of clarithromycin use (i.e., after completing the antibiotic course). Stroke risk was not elevated in clarithromycin users at any time. Subgroup analyses showed that risk with clarithromycin use was highest among people older than 75 and for those with hypertension-associated disease or diabetes.
COMMENT: In this study, only current clarithromycin use was associated with excess risk for MI, cardiac arrhythmia, and death. Case reports have linked clarithromycin with QT prolongation and arrhythmia — a possible mechanism for the noted excess CV risk. Overall, caution is necessary when considering clarithromycin, especially in patients with, or at high risk for, CV disease.
CITATION(S): Wong AYS et al. Cardiovascular outcomes associated with use of clarithromycin: Population based study. BMJ 2016 Jan 13; 352:h6926. (http://www.bmj.com/content/352/bmj.h6926)

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Pediatrics 2016 Jan 18
Shorter Course of Oral Antibiotics after hospitalization for
Uncomplicated Cellulitis

The duration of antibiotics prescribed at discharge for nonpurulent cellulitis was shortened from 14 days to ≤7 days at a children's hospital, without an increase in readmissions for treatment failure.
There is evidence that shorter courses of antibiotics (≤7 days) adequately treat uncomplicated skin and soft tissue infections (SSTIs). Using quality improvement methods, investigators at a children's hospital sought to shorten the duration of prescribed antibiotics at discharge for patients with these infections.
Interventions included an educational program for providers, changing the electronic order defaults to 7 days from 14 days, and defining complicated SSTIs (those in children with immunodeficiency, fasciitis, osteomyelitis, animal or human bites, or burns; surgical site infections; and head or neck infections).
Over a 23-month period, 641 children aged 91 days to 18 years were admitted for uncomplicated SSTIs. The median hospital stay was 1.2 days. The median proportion of children discharged with a short course of antibiotics (≤7 days) increased from 23% at baseline to 74% after the intervention began, and the increase was sustained for 6 months after the project ended. Importantly, the proportion of children readmitted for treatment failure (readmission within 14 days) remained unchanged.
COMMENT: This well-done quality improvement project improved care of children hospitalized with uncomplicated SSTIs by shortening the duration of antibiotics prescribed at discharge without an increase in readmission rates. Although the authors do not mention blood culture results, I assume none of the children with these infections had a positive blood culture, as this would certainly complicate their management.
CITATION(S):Schuler CL et al. Decreasing duration of antibiotic prescribing for uncomplicated skin and soft tissue infections. Pediatrics 2016 Jan 18; [e-pub].


Proc Natl Acad Sci U S A 2016 Feb 2; 113:E500
No Effect of Marijuana use on IQ in Adolescents
In two longitudinal twin studies, marijuana users had significant declines in intelligence quotient but not greater than their non–marijuana-using twin siblings.
Whether marijuana use during adolescence affects cognitive function over time is controversial. To investigate this issue, researchers analyzed data from two separate longitudinal studies of twins. One study followed 614 ethnically diverse families from California with 1241 twins or triplets. Siblings were assessed at ages 9–10, 11–13, 14–15, 16–18, and 19–20 years. The other study included two population-based samples, enriched for twins with externalizing behaviors, comprising 2527 twins from Minnesota recruited at age 11 and evaluated every 3 years until age 18.
Mean intelligence quotient (IQ) decreased significantly more in marijuana users compared with nonusers — by about 3 to 4 points — from baseline to follow-up in both studies; however, these results were no longer significant after adjustment for other drug use in one study. In both studies, heavy (>30 times) or daily marijuana use was not associated with the degree of IQ change. Furthermore, in one study, IQ trajectory did not significantly differ between twin pairs in which one twin used marijuana and the other did not.
COMMENT: In contrast with findings of a larger study with longer-term follow-up, overall, these results do not support an effect of marijuana use on IQ. One explanation may be that through use of twins discordant for marijuana use, this study could control for familial factors. The results do suggest that familial factors exist that predispose adolescents both to marijuana initiation and to diminished intellectual achievement. I suspect that we will never have a definitive answer to the marijuana and IQ question, but there are still many reasons to dissuade adolescents — especially those under age 16 — from using this drug.
CITATION(S):Jackson NJ et al. Impact of adolescent marijuana use on intelligence: Results from two longitudinal twin studies. Proc Natl Acad Sci U S A 2016 Feb 2; 113:E500. (http://dx.doi.org/10.1073/pnas.1516648113)

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JAMA Neurol 2016 Jan 11
A Small Step, not a Giant Leap, in Stem Cell Therapy for ALS
Intramuscular and intrathecal administration of mesenchymal stem cells appears safe and well tolerated in amyotrophic lateral sclerosis.
Advances in stem cell biology have fueled a growing interest in the use of stem cells as possible therapeutics for amyotrophic lateral sclerosis (ALS). Now, researchers describe the results of early-phase clinical trials of mesenchymal stem cells (MSCs) that were induced in vitro to secrete neurotrophic factors prior to transplantation (MSC-NTF cells).
In the first of these two manufacturer-funded, open-label studies, MSC-NTF cells were administered intramuscularly (IM) to 6 patients with relatively early disease and intrathecally (IT) to 6 patients with more-advanced disease. Following an interim safety analysis, the second study included an additional 14 patients with relatively early disease randomized to receive varying dosages of MSC-NTF cells both intramuscularly and intrathecally. All patients were followed for a 3-month run-in period before transplantation and for 6 months afterward.
MSC-NTF transplantation was generally safe and well tolerated. Secondary outcome measure analyses suggested a slowing of the rate of disease progression as measured by the revised-ALS functional rating scale (ALSFRS-R) and forced vital capacity (FVC) in the initial 6 treated with IT administration, the 14 treated with combined IM/IT dosing, and in post hoc analysis of the combined IT group. Post hoc analysis at 6 months reported 87% of patients to be “responders” (defined as a post-treatment improvement in slope of ALFRS-R or FVC of at least 25%). The investigators conclude that MSC-NTF transplantation is safe and has “possible clinical benefits.”
COMMENT: Although demonstration of the safety and tolerability of IM and IT administration of neurotrophic factor–releasing MSCs represents an important advance, regrettably, more has been made of the potential therapeutic benefits than is presently justified by the data. Limitations of study design (open-label, small sample size, absence of a contemporaneous control group), flooring effects of the ALSFRS-R in patients with more-advanced disease, and over-emphasis of post hoc analyses (while omitting presentation of some prespecified secondary endpoints) suggest great caution is needed in interpreting these data. Especially with a disease such as ALS for which the absence of effective therapeutics can cause understandable despair, over-optimism should not cloud our judgment and lead us to provide patients with false hope.
CITATION(S): Petrou P et al. Safety and clinical effects of mesenchymal stem cells secreting neurotrophic factor transplantation in patients with amyotrophic lateral sclerosis: Results of phase 1/2 and 2a clinical trials. JAMA Neurol 2016 Jan 11; [e-pub]. (http://dx.doi.org/10.1001/jamaneurol.2015.4321)
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J Pediatr 2016 Jan; 168:126
Physical Activity can improve Attention in Adolescents
Objective measurements of physical activity and attention capacity showed a significant association between the two.
Attention is a critical component of effective learning. Decreased time in school allotted to physical activity and less physical activity outside of school have been hypothesized to be related to the increase in attention disorders in children and adolescents. To evaluate the association between physical activity and attention capacity in adolescents, researchers analyzed data for 273 participants aged 12.5–17.5 years in a longitudinal European study of nutrition in youth.
Physical activity was monitored objectively throughout the day by an accelerometer that was worn for 7 days; at least 3 days of activity for at least 8 hours each day were required for inclusion in the analysis. Attention capacity was assessed with a standardized paper-and-pencil letter-cancellation test that measures speed and accuracy.
Attention capacity was significantly and positively correlated with longer time spent in moderate physical activity (≥41 minutes/day) and moderate-to-vigorous activity (≥58 minutes/day); attention capacity was not significantly improved with longer time in vigorous physical activity. The analysis was controlled for confounding variables including age, sex, body-mass index, parent education, fat mass, and aerobic fitness.
COMMENT: The cross-sectional design of the study limits an interpretation of causality. The authors note that youth with high attention capacity might apply that trait to sustained attention for moderate and moderate-to-vigorous physical activity. This study provides modest support for pediatricians to encourage the restoration of funding for physical education programs in schools. In addition, a recommendation for increased physical activity should be added to the current evidence-based treatments for attention-deficit/hyperactivity disorder (behavior modification and pharmacotherapy).
 (S): Vanhelst J et al. Physical activity is associated with attention capacity in adolescents. J Pediatr 2016 Jan; 168:126.

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