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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
August 1, 2015

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Chemotherapy Associated with Worse Quality of Life Near Death
High doses of biotin in chronic progressive multiple sclerosis: a pilot study.
Two Common Drugs Promote Remyelination in Demyelinating Disease of Mice
Can a Carbohydrate Found in Many Fruits Lower Risk for Gestational Diabetes?
FDA Approves Stomach Balloon for Weight Loss
Obese People Unlikely to Achieve Normal Body Weight
Physical Activity Protects Bullied Youth Against Adverse Mental Health Outcomes
Obesity Independently Increases the Risk for AF
Nasal Balloon Autoinflation Provides a Low-Cost, Nonsurgical Treatment Option for Kids
   with Middle Ear Effusion
Metformin: A New Approach to Acne Therapy?
Fetal Ultrasounds on the Rise — Often Without Medical Indication

MM: My grandmother worked as a hospice volunteer for the last 20+ years of her life. She got tremendous gratification by working closely by the side of other caregivers. She saw what the patients and their families experienced as loved ones drew near to the end of their lives. She also saw what many of us never experience, that is, the way people face death. She found that those who realized that "quality" trumped limited changes of" quantity of life" and as she drew near to her own end she opted not to have surgery or chemotherapy as those options would have drastically changed her quality of life.
She lived to within weeks of her 92nd birthday but she lived every single one of those days with pleasure and dignity and a very high quality of life up to the final week or so and then she chose to accept enough medication to make her comfortable but cognizant. I spoke to her a couple of days before she passed away and she was still the exciting and vibrant woman who I had known all of my life. I have to wonder if she would have been that person had she accepted the option of chemotherapy.

Chemotherapy Associated with Worse Quality of Life Near Death
By Kelly Young
Chemotherapy given near the end of life doesn't appear to improve patients' quality of life — and might even worsen it in some patients — according to a prospective study in JAMA Oncology.
Researchers studied some 300 adults with end-stage cancer and a life expectancy of 6 months or less. At baseline, half of patients were receiving chemotherapy.
In adjusted analyses, chemotherapy use was not associated with reduced mortality. For patients with higher performance scores at baseline (e.g., symptomatic but ambulatory), chemotherapy use was associated with lower caregiver-rated quality of life in the last week of life, compared with no palliative chemotherapy. Chemotherapy use wasn't associated with quality of life in patients who had moderate or poor performance scores at baseline.
Commentators conclude that there is not yet enough data to prohibit chemotherapy near end of life, but "if an oncologist suspects the death of a patient in the next 6 months, the default should be no active treatment."
Why We Chose This as Our Top Story:
William E. Chavey, MD, MS: This story underscores the need for discussions with patients about the risks and limitations of chemotherapy near the end of life with a shared medical decision-making model.
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MM:This is one of the most exciting studies that I have come across in the past 5 years relative to MS. It merges the allopathic and the nutritional worlds and we can only hope that Big Pharma does not thump its very heavy fist (the FDA)on the patients, practitioners and all who are affected by the possible benefits of this nutritional product. Why would Big Pharma flex its' muscles to stop the use of this product? Because MS is a mulit-billion drug industry that has no proven products to treat this portion of the condition. Those patients who have chronic progressive MS have nowhere to go. They are debilitated physically and many of them financially. This product offers hope and an alternative that has demonstrated benefits beyond the incredibly expensive drugs that Big Pharma would have patients use irrespective of their clinical value, benefit or lack thereof.
Mult Scler Relat Disord. 2015 Mar;4(2):159-69. doi: 10.1016/j.msard.2015.01.005.
Epub 2015 Jan 24.
High doses of biotin in chronic progressive multiple sclerosis: a pilot study.
Sedel F1, Papeix C2, Bellanger A3, Touitou V4, Lebrun-Frenay C5, Galanaud D6, Gout O7, Lyon-Caen O2, Tourbah A8.
No drug has been found to have any impact on progressive multiple sclerosis (MS). Biotin is a vitamin acting as a coenzyme for carboxylases involved in key steps of energy metabolism and fatty acids synthesis. Among others, biotin activates acetylCoA carboxylase, a potentially rate-limiting enzyme in myelin synthesis.
The aim of this pilot study is to assess the clinical efficacy and safety of high doses of biotin in patients suffering from progressiveMS.
Uncontrolled, non-blinded proof of concept study
23 consecutive patients with primary and secondary progressive MS originated from three different French MS reference centers were treated with high doses of biotin (100-300mg/day) from 2 to 36 months (mean=9.2 months). Judgement criteria varied according to clinical presentations and included quantitative and qualitative measures.
In four patients with prominent visual impairment related to optic nerve injury, visual acuity improved significantly. Visual evoked potentials in two patients exhibited progressive reappearance of P100 waves, with normalization of latencies in one case. Proton magnetic resonance spectroscopy (H-MRS) in one case showed a progressive normalization of the Choline/Creatine ratio. One patient with left homonymous hemianopia kept on improving from 2 to 16 months following treatment׳s onset. Sixteen patients out of 18 (89%) with prominent spinal cord involvement were considered as improved as confirmed by blinded review of videotaped clinical examination in 9 cases. In all cases improvement was delayed from 2 to 8 months following treatment׳s onset.
These preliminary data suggest that high doses of biotin might have an impact on disability and progression in progressive MS. Two double-blind placebo-controlled trials are on going.
Copyright © 2015 The Authors. Published by Elsevier B.V. All rights reserved.
KEYWORDS: Biotin; Multiple sclerosis; Optic neuritis; Progressive; Visual evoked potentials
PMID: 25787192
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Nature 2015 Jun 11; 522:216
Two Common Drugs Promote Remyelination in Demyelinating Disease of Mice
Might miconazole and clobetasol have a role in managing multiple sclerosis?

In multiple sclerosis (MS) and other demyelinating diseases, autoimmune attacks lead to demyelination. Approved therapies for MS target this immune attack and prevent further demyelination. An alternative approach to treating demyelination would be to encourage remyelination. Oligodendrocytes in the central nervous system have the ability to promote remyelination; however, in humans (and other mammals), remyelination by oligodendrocytes typically is insufficient.

A multi-institutional team screened a library of 727 small-molecule drugs to identify any that might cause mouse oligodendrocyte-progenitor stem cells to turn into myelin-producing oligodendrocytes. Surprisingly, two common topically applied drugs — the antifungal miconazole and the steroid clobetasol — potently induced this process. Although other steroids shared clobetasol's anti-inflammatory effects, none shared its potent induction of remyelination.

In several different mouse models of demyelination, including one that clinically and pathologically resembles chronic progressive MS in humans, these drugs dramatically enhanced remyelination. For example, in one mouse model, >70% of axons in treated mice were myelinated, compared with only 6% in untreated mice. In another model, nearly all treated mice regained function of their hind limbs, whereas no untreated mice did. Finally, the team showed that these two drugs also induced human oligodendrocyte progenitor cells to form myelin-producing oligodendrocytes.

Comment In mice, two drugs that already are FDA-approved for human use dramatically encouraged remyelination in various demyelinating conditions and appear to have similar effects in vitro with human cells. This study will encourage human trials of “remyelinating therapy,” including testing whether these two topical drugs are effective when administered systemically.

Citation(s):Najm FJ et al. Drug-based modulation of endogenous stem cells promotes functional remyelination in vivo. Nature 2015 Jun 11; 522:216. (http://dx.doi.org/10.1038/nature14335)

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MM: The best sources of Myo-Inositol are fruits, beans, grains, and nuts. Surprisingly fresh vegetables and fruits contain more Myo-Inositol than frozen, canned, or salt-free products. Cantaloupe and citrus fruit, other than lemons, are very rich in Myo-Inositol and oats and bran contain more than other grains. Milk and yogurt contain very little Myo-Inositol. Myo-inositol has been touted as an anti-cancer product and immuno-modulator. It isn't a surprise that it may show benefits for diabetes as well.
Obstet Gynecol 2015 Aug; 126:310
Can a Carbohydrate Found in Many Fruits Lower Risk for Gestational Diabetes?
In a controlled trial, obese pregnant women who received myo-inositol supplementation had lower incidence of GDM.
Many fruits are rich in myo-inositol, a stereoisomer of the carbohydrate inositol. Myo-inositol is an intracellular second messenger that may act as an insulin sensitizer. To test the hypothesis that myo-inositol consumption can lower risk for developing gestational diabetes mellitus (GDM), 220 pregnant obese women were randomized at 12 to 13 weeks' gestation to receive 4 g of myo-inositol plus a folic acid supplement daily or folic acid alone (control group). Significantly more women with family histories of type 2 diabetes mellitus (T2DM) were randomized to the control group, enriching this group for women at risk for developing GDM. All subjects underwent a 75-g oral glucose tolerance test (OGTT) at 24 to 28 weeks' gestation.
The OGTT revealed that, compared with women in the control group, those who received myo-inositol had significantly lower concentrations of fasting glucose (81 vs. 85 mg/dL), 1-h glucose (129 vs. 143 mg/dL), and 2-h glucose (105 vs. 123 mg/dL) as well as lower rates of GDM diagnosis (14% vs. 34%). Women receiving myo-inositol also had significantly lower rates of gestational hypertension (0% vs. 6%) and fewer babies who were admitted to the neonatal intensive care unit (0% vs. 5%). Mean birth weight and incidence of birth weight >4000 g, neonatal hypoglycemia, and shoulder dystocia did not differ significantly between groups.
Comment: Although this study reported that myo-inositol lowered risk for developing GDM in obese pregnant women, the randomization process resulted in a control group at excess risk for GDM, thereby weakening the reliability of the finding. Additional randomized trials are needed to fully assess the potential of myo-inositol, a low-cost, naturally occurring carbohydrate, to improve pregnancy outcomes.
Citation(s):D'Anna R et al. Myo-inositol supplementation for prevention of gestational diabetes in obese pregnant women: A randomized controlled trial. Obstet Gynecol 2015 Aug; 126:310.
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MM: We continue to look for the easy fix to obesity. Inserting a saline filled balloon is not much different than wiring a jaw shut. The end result is that a person is unable to eat as much or as quickly as they would without the impediment. The underlying problem remains. The patient fails to learn a preferred activity to guide him through his future eating life. This is a reason that lap-banding, crash diets, stomach stapling and a variety of other weight loss approaches fail over time. the person does not learn a new lifestyle. This learning process is one of the many reasons that the HCG diet is so successful with so many of our patients. They lose weight, get immediate gratification from that loss and when they discontinue the weight loss segment they learn new eating habits over a six week period of time and continue to get reinforcement for these new behaviors.
FDA Approves Stomach Balloon for Weight Loss
By Kristin J. Kelley, Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM
The FDA has approved a balloon that helps obese patients lose weight by filling part of the stomach and triggering feelings of fullness. The ReShape Integrated Dual Balloon System is indicated for adults who have at least one obesity-related condition (e.g., diabetes, hypertension, hyperlipidemia) and for whom diet and exercise hasn't worked.
The balloon — which is inserted into the stomach via the patient's mouth and then filled with saline — is only intended to be used for up to 6 months. Patients should still adhere to a supervised diet and exercise plan during and after use of the device.
In a randomized trial of over 300 obese patients, those who received the balloon lost an average of 6.8% of their total body weight (14 pounds) in 6 months versus 3.3% (7 pounds) among those who didn't receive it.
Side effects include gastric ulcers, indigestion, abdominal pain, and vomiting. Myocardial infarction, infection, and severe allergic reactions are rare. The device shouldn't be used in patients who've had bariatric or gastrointestinal surgery.
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Obese People Unlikely to Achieve Normal Body Weight
By Amy Orciari Herman, Edited by Susan Sadoughi, MD
Patients may ask about a widely reported study suggesting that few obese adults will achieve a normal weight. The findings appear in the American Journal of Public Health.
Using a U.K. general practice database, researchers studied over 175,000 obese adults who had at least three BMI measurements over a 10-year period. Those who underwent bariatric surgery were excluded.
For participants with simple obesity (BMI, 30.0–34.9) at baseline, the annual likelihood of attaining normal weight during follow-up was 1 in 210 for men and 1 in 124 for women. Among those who were initially morbidly obese (BMI, 40.0–44.9), the annual likelihood was just 1 in 1290 for men and 1 in 677 for women.
The authors write: "These findings raise questions concerning whether current obesity treatment frameworks, grounded in weight management programs accessed through primary care, may be expected to achieve clinically relevant and sustained reductions in BMI" for most obese patients.
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J Am Acad Child Adolesc Psychiatry 2015 Jul 17
Physical Activity Protects Bullied Youth Against Adverse Mental Health Outcomes
Exercise was associated with lower likelihood of sadness, suicidal ideation, and suicide attempts in bullied adolescents.
Chronic bullying is associated with adverse effects on social behavior, educational achievement, and risk for depression. Protective factors have not been studied extensively.
In a 2013 nationally representative survey, 13,633 students from 148 U.S. public and private high schools (grades 9–12) answered questions about suicidal ideation and suicide attempts during the past year, physical activity during the past 7 days (lasting at least 60 minutes and causing increased heart rate and some hard breathing), feeling sad for ≥2 weeks during the past year, and being bullied during the past year, either in person (defined as when 1 or more students tease, threaten, spread rumors about, hit, shove, or hurt another student repeatedly) or electronically (via e-mail, chat rooms, instant messaging, websites, or texting).
Among all respondents, 30% reported feeling sadness for ≥2 weeks, 22% reported suicidal ideation, and 8% reported suicide attempt. Being bullied was associated with a twofold increased likelihood of sadness and a threefold increased likelihood of suicidal ideation or suicide attempt. Overall, increased frequency of exercise was associated with decreased frequencies of sadness, suicidal ideation, or suicide attempt. These protective effects of exercise were similar though slightly weaker among bullied students; those who reported exercising ≥4 days/week had a 23% lower likelihood of suicidal ideation and attempt.
Comment: The observation that physical activity may protect against adverse psychological outcomes of being bullied is good news and gives pediatric clinicians another reason to actively encourage exercise in all children and adolescents. The challenge is to find an effective method to achieve exercise adoption in youth. I suspect that well-organized exercise programs in schools and communities will have the greatest impact. Pediatricians can help lay the groundwork for success by providing anticipatory guidance in early childhood and supporting adequate time for physical activity in the school curriculum.
Citation(s):Sibold J et al. Physical activity, sadness, and suicidality in bullied US adolescents. J Am Acad Child Adolesc Psychiatry 2015 Jul 17; [e-pub]. (http://dx.doi.org/10.1016/j.jaac.2015.06.019)
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J Am Coll Cardiol 2015 Jul 7; 66:1
Obesity Independently Increases the Risk for AF
In epidemiologic studies, obesity is associated with atrial fibrillation (AF). However, this association is confounded by the frequent coexistence of sleep apnea, diabetes, hypertension, and coronary disease, all of which are also associated with the risk for AF.
In a sheep model from Australia, researchers have now focused on the effects of weight alone on the risk for AF and on the risk factors associated with AF. The investigators followed 10 sheep fattened to obesity (110 ± 9 kg) from birth until 36 weeks and then followed them for 36 more weeks and compared them with 10 lean sheep (60 ± 7 kg).
Multiple biological factors associated with AF were observed more frequently in the obese sheep. These factors included but were not limited to left atrial volume (86 ± 15 mL in obese vs. 74 ± 13 ml in lean), left atrial pressure (8.1 ± 1.6 mm Hg vs. 3.7 ± 1.4 mm Hg); systolic BP (86 ± 13 mm Hg vs. 71 ± 12 mm Hg); and infiltration of epicardial fat into the posterior left atrial wall (grade 2.5 ± 0.7 vs. 1.0 ± 0). Also increased in the obese sheep were electrophysiologic predictors of AF such as greater conduction heterogeneity, greater fractionated potentials, and decreased conduction velocity. Finally, induction of AF at electrophysiologic study was more common in the obese than lean sheep (median 4.5 vs. 1), as was the cumulative time in AF (46 s vs. 4.1 s).
Comment; I am impressed by the thoroughness of the current evaluation and by the marked biological changes observed in a relatively short time period. The growing obesity epidemic will contribute to the growing AF epidemic. On both the individual patient level and the epidemiologic level, we as a physician community must combat this epidemic.
Citation(s):  Mahajan R et al. Electrophysiological, electroanatomical, and structural remodeling of the atria as consequences of sustained obesity. J Am Coll Cardiol 2015 Jul 7; 66:1. (http://dx.doi.org/10.1016/j.jacc.2015.04.058)
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MM: In my more than 35 years of pharmacy experience I think about all the children that I dispensed antibiotics to for ear infections or in fear of those infections. I also recall an old treatment of using warm compresses or putting cups on the ears during airplane flights to alter the back pressure that these children were experiencing and the associated discomfort. Those antibiotics certainly contributed to today's superbugs and their antibiotic resistance but those funny looking compresses or cups on the ears may have been a much better solution. This study demonstrates than an action such as physical manipulation by a pediatric chiropractor or massage therapist may be a valid option to surgery, balloons or antibiotics. This in both an eye and an ear opener.
Nasal Balloon Autoinflation Provides a Low-Cost, Nonsurgical Treatment Option for Kids with Middle Ear Effusion
By Jenni Whalen, Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD
Children who have otitis media with effusion may benefit from autoinflation with a nasal balloon device, according a study in the Canadian Medical Association Journal.
Approximately 300 U.K. children aged 4 to 11 years with recent ear symptoms and current otitis media with effusion in one or both ears were randomized to usual care alone or with nasal balloon autoinflation (3 times daily for up to 3 months). With autoinflation, the child blows through each nostril to inflate a purpose-manufactured balloon; this increases pressure in the nasopharynx and opens the Eustachian tubes, leading to drainage of middle ear effusions (see brief video linked below).
Compared with children receiving usual care alone, those treated with autoinflation were significantly more likely to achieve normal middle ear pressure at 1 and 3 months (number needed to treat, 9). Autoinflation was also associated with better ear-related quality of life.
The authors conclude: "Autoinflation is a simple, low-cost procedure that can be taught to young children in a primary care setting with a reasonable expectation of compliance."
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Clin Exp Dermatol 2015 Jun 6
Metformin: A New Approach to Acne Therapy?
The use of metformin and a hypocaloric diet significantly improved stubborn acne in young men with an altered metabolic profile.
Women with polycystic ovaries and insulin resistance frequently develop acne. Insulin-like growth factor stimulates production of androgens and the growth of sebaceous glands. Does insulin resistance predispose to acne in men? Would treatment with a hypoglycemic diet and metformin reduce acne in men with an altered metabolic profile?
Investigators studied a group of 20 young men (mean age, 19.5) with acne resistant to common therapies and an altered metabolic profile as defined by elevated fasting glucose level, raised levels of total low-density lipoprotein, low levels of high-density lipoprotein, and waist circumference and body-mass index at the upper limit of normal. Half the group was randomly assigned to receive metformin (500 mg twice daily; group A) and consume a hypocaloric diet low in carbohydrates and rich in fruits, vegetables, and fish. The other half continued their regular diets without metformin (group B). All subjects used a bland detergent to wash and applied an anti-acne cream containing azelaic acid and nicotinamide.
After 6 months, mean Global Acne Grading System (GAGS) scores were reduced significantly in the metformin group (from 25.1 to 14.1; P<0.03) and non-significantly in the non-metformin group (from 24.9 to 19.4; P=0.06). Oral glucose serum levels were also reduced significantly in the metformin group (P<0.04). No metformin-related adverse effects were reported.
Comment: This small study showed a trend for better outcomes with metformin and a hypocaloric diet for group A. A larger study may show significance. Both groups were treated with standard anti-acne therapies that may obscure the true response to metformin and low-caloric diet alone. The hypothesis does make sense. Metabolic syndrome and insulin resistance may well be associated with stubborn acne in men. Metformin decreases hepatic glucose output and increases utilization of glucose by muscle cells and adipocytes, thereby reducing serum insulin levels and effects. A low-caloric, low-carbohydrate diet may also help.
Citation(s):Fabbrocini G et al. Low glycaemic diet and metformin therapy: A new approach in male subjects with acne resistant to common treatments. Clin Exp Dermatol 2015 Jun 6; [e-pub]. (http://dx.doi.org/10.1111/ced.12673)
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MM: Sure. It's fun and exciting to see your baby as its growing inside you or your partner but is it safe? We are constantly assured that it is safe but this article brings to light the possible hidden dangers. I am not saying that we should abandon ultrasounds but it certainly makes sense that fewer might be better.
Fetal Ultrasounds on the Rise — Often Without Medical Indication
By Amy Orciari Herman
U.S. women underwent an average of 5 fetal ultrasounds per delivery in 2014 — up 92% since 2004 — according to a Wall Street Journal report. Medical groups recommend just one to two ultrasounds in low-risk pregnancies.
Among the reasons cited for the increase: clinicians' fear that they will miss something, patients' desire to see and bond with their growing baby, and possible financial motives.
While many clinicians believe that ultrasounds are safe because there's no cancer-causing radiation, most safety studies were performed on equipment made before 1992. Today's equipment emits much stronger acoustic waves than older versions. In addition, animal studies have suggested ill effects from ultrasound exposure, such as neurologic abnormalities and hyperactive behavior. And there's always the concern that too many ultrasounds can lead to false-positives.
One ultrasound scientist told the Journal: "The public needs to be made aware that if you're pregnant ... you don't need to have an ultrasound at every doctor's visit."

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