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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
October 12, 2013

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Vitamin D for Bone Mineral Density? Little Evidence of Benefit
Government Furloughs and Food Safety
Herbal Therapies for Inflammatory Bowel Disease
More Evidence Links One Bacterial Species to Colorectal Cancer
Nutrition Guidelines Issued for Patients with Diabetes
AHA: TreatUnhealthy Habits as Aggressively as High Cholesterol, Blood Pressure
Consuming Specific Whole Fruits Is Associated with Lower Risk for Type 2 Diabetes
Neither antibiotics nor Ibuprofen Shortens Cough Duration in Acute Bronchitis
People Increasingly Prescribed Levothyroxine for subclinical Hypothyroidism
Breast Cancer, Hormone Exposure, and Cognitive Function
'Death Knell' for Venous Blockage Hypothesis in MS
Methylprednisolone was more effective than placebo at 10 weeks, but most
   patients still underwent surgery by 1 year
Adolescent Scoliosis: Is Bracing Effective?

MM: It's quite a conundrum when you see conflicting literature to other clinical evidence or known experiential data. Vitamin D deficiency has been correlated to diminished bone density yet in this study where levels were brought up to barely above an insufficient level there was no definitive increase in bone density at two traditionally measured sites. The question remains, 'What blood level is sufficient to show a marked increase in bone density?'. Also, what other benefits of higher vitamin D levels are being ignored and what is an appropriate blood level of vitamin D? I contend that levels in the 60-80ng/ml or 140-200nmol/L are optimal levels of 25-(OH)D for wellness and overall health.
Vitamin D for Bone Mineral Density? Little Evidence of Benefit
By Amy Orciari Herman
Vitamin D supplementation does not appear to improve bone mineral density (BMD) in generally healthy adults, according to a Lancet meta-analysis.
Researchers examined 23 randomized trials of vitamin D supplementation that included over 4000 adults (average age, 59; 92% women). Most of the studies were placebo-controlled; in over half, the daily dose was 800 IU or more. BMD was measured at the lumbar spine, femoral neck, total hip, trochanter, total body, or forearm.
Participants' average 25-hydroxyvitamin D level increased from 53 nmol/L at baseline to 92 nmol/L at follow-up. However, the effects on BMD were minimal: a small increase was seen at the femoral neck, with no effect elsewhere. The researchers say, "such a localized effect could be artifactual, or could be a chance finding."
They conclude, "Continuing widespread use of vitamin D for osteoporosis prevention in community-dwelling adults without specific risk factors for vitamin D deficiency seems to be inappropriate."
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MM: In our litigious society, I have to wonder if someone gets sick and dies, will the congress be sued for wrongful death? Just a thought.
Government Furloughs and Food Safety
By Kelly Young
The recent salmonella outbreak that has sickened hundreds of people who reportedly ate contaminated chicken is complicated by the partial U.S. government shutdown, the New York Times reports.
The CDC recalled 30 furloughed workers to investigate the outbreak but is still operating on a skeleton crew. Over two thirds of the agency's employees were furloughed during the shutdown, including dozens who run a database that identifies clusters of foodborne illnesses.
The FDA's domestic food inspections have stopped during the shutdown, while less than 2% of imported food is being inspected. Domestic meat and poultry are inspected by the Agriculture Department, and those inspections have continued during the shutdown because federal law requires it.
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MM: This is fantastic data and should serve to provide practitioners with information that they may feel confident passing along to patients who are asking for 'natural' remedies and alternatives. Although many of these studies are limited in size, the dramatic differences between placebo and similar efficacy to prescription only products is quite reassuring. An imporrtant thing to remember is that not all herbal companies are created equal and it is important that if someone is going to rely on one of these herbal products then they must use a company that practices "cGMP" production practices or you may not be getting what you are paying for. Mark Drugs reviews all of the products and manufacturers that we carry to assure our patients and clients that they are truly receiving what they are paying for.
Aliment Pharmacol Ther 2013 Oct; 38:854
Herbal Therapies for Inflammatory Bowel Disease
Some herbs have shown efficacy, but larger and more-robust trials are needed.
Patients with inflammatory bowel disease (IBD) often ask about alternative therapies or report using them. To assess the current evidence on the efficacy of herbal therapies in treating ulcerative colitis (UC) and Crohn disease (CD), investigators conducted a systematic review.
Of 1094 abstracts identified, researchers selected 21 randomized, controlled trials for review (14 in UC and 7 in CD) involving a total of 1484 patients.
Studies showing positive findings for herbal therapies compared with placebo in UC included:
A 4-week comparison of active treatment with wheat grass juice (Triticum aestivum) in 23 patients with active distal UC (response, 91% vs. 42%)
An 8-week trial of Andrographis paniculata extract(HMPL-004; 1800 mg daily) in 224 patients with mild-to-moderate UC (clinical response, 60% vs. 40% [P=0.018]; remission rate similar at 8 weeks)
A 4-week trial of aloe vera gel in 44 patients with moderately active UC (remission rate, 30% vs. 7%)
A 2-week trial of Xilei-san suppositories in 30 patients with distal UC (remission rate, 46% vs. 0%)
In studies comparing herbal therapies with active agents in UC, Boswellia serrata gum resin and Plantago ovata seeds showed similar efficacy to 5-aminosalicylates for induction and maintenance of remission, respectively, and Oenothera biennis (evening primrose oil) had similar efficacy to omega-3 fatty acids in maintenance of remission. Curcumin, however, was superior to placebo in maintaining remission (P=0.04).In CD, wormwood and Tripterygium wilfordii beat placebo in inducing remission and preventing postoperative recurrence.
Comment: This is a useful summary of the limited evidence on herbal therapies in inflammatory bowel disease and would likely be considered valuable by interested patients.
Citation(s): Ng SC et al. Systematic review: The efficacy of herbal therapy in inflammatory bowel disease. Aliment Pharmacol Ther 2013 Oct; 38:854.

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MM: This study indicates that bacterial inflammation and causation of secondary cancer may be concentration as well as agent sensitive. All the more reason that regular and consistent use of probiotics may be a good idea for those who may be predisposed to any type of colorectal problem risk.
Cell Host Microbe 2013 Aug 14; 14:207
More Evidence Links One Bacterial Species to Colorectal Cancer
Researchers have identified a bacterial protein that stimulates tumor proliferation.
In late 2011, two groups reported finding one particular bacterial species, Fusobacterium nucleatum, in human colorectal cancer (CRC; NEJM JW Gen Med Nov 3 2011). However, any mechanism by which it might cause cancer was unknown; these bacteria simply might have an affinity for colonizing tumors.
One of the original groups now reports that F. nucleatum stimulates growth of CRC cells. In addition, F. nucleatum contains a unique adhesion antigen (FadA) on its surface that binds to a particular receptor on CRC cells and stimulates both inflammation and carcinogenesis. FadA levels in CRC tissue were 10 to 100 times higher than those in normal colon tissue. A synthetic peptide that blocked the binding of FadA to CRC cells also blocked its ability to stimulate proliferation of those cells.
The second group studied mice that were genetically engineered to develop CRC at a high rate. When F. nucleatum was placed in the gut of these mice, the number of tumors increased greatly.
Comment: These reports provide a molecular explanation of how F. nucleatum might cause colorectal cancer. FadA could serve both as a diagnostic marker for CRC and as a target for treating patients with CRC. The role of Helicobacter pylori in causing stomach cancer, and the growing evidence that other bacterial species cause inflammatory bowel disease and its associated malignancies, suggest that a role for F. nucleatum in CRC is plausible.
Citation(s): Rubinstein MR et al. Fusobacterium nucleatum promotes colorectal carcinogenesis by modulating E-cadherin/β-catenin signaling via its FadA adhesin. Cell Host Microbe 2013 Aug 14; 14:195. (http://dx.doi.org/10.1016/j.chom.2013.07.012) PubMed abstract (Free) Kostic AD et al. Fusobacterium nucleatum potentiates intestinal tumorigenesis and modulates the tumor-immune microenvironment. Cell Host Microbe 2013 Aug 14; 14:207.

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MM: It is great to see that lifestyle recommendations are taking a more prominent role in the treatment of chrinic disease states such as Diabetes. Mark Drugs supports this approach and had Nutritionists or Dietitians at all of our locations who are available for patient consultation. Please call us today for more information.
Nutrition Guidelines Issued for Patients with Diabetes
By Kelly Young
People with diabetes should receive individualized medical nutrition therapy to achieve their treatment goals, ideally from a registered dietitian soon after diagnosis, according to a position statement on nutrition from the American Diabetes Association.
The evidence-based recommendations, published in Diabetes Care and updated from 2008, note that only about half of patients with diabetes receive nutrition education and fewer see a registered dietitian.
For patients with type 1 diabetes, carbohydrate-counting meal planning can improve glycemic control.
The authors note that no one dietary pattern will work for all people. That said, dietary carbohydrates should come from vegetables, whole grains, fruits, legumes, and dairy. Patients with diabetes should try to avoid drinking sugar-sweetened beverages and restrict their sodium consumption to less than 2300 mg per day, the same as the general population.
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AHA: TreatUnhealthy Habits as Aggressively as High Cholesterol, Blood Pressure
By Amy Orciari Herman
Healthcare providers should treat unhealthy behaviors such as smoking, poor diet, and lack of exercise as aggressively as they treat high cholesterol, hypertension, and other markers of heart disease, according to a science advisory from the American Heart Association.
The advisory, published in Circulation, urges clinicians to provide the "5 A's" intervention to patients at low-to-moderate cardiovascular risk:

For patients at moderate-to-high risk, an interprofessional healthcare team (including the primary care provider and specialists such as dietitians and psychologists) must work together to provide intensive lifestyle intervention.

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BMJ 2013 Aug 29; 347:f5001
Consuming Specific Whole Fruits Is Associated with Lower Risk for
Type 2 Diabetes

Blueberries, grapes or raisins, apples, and pears conferred the most benefit.
Some, but not all, epidemiological studies have shown that higher consumption of whole fruits is associated with lower risk for type 2 diabetes. These mixed results could be caused by different effects of different fruits. In this review of data from three prospective longitudinal cohort studies, investigators determined whether consuming specific whole fruits was associated differentially with risk for type 2 diabetes. Participants were 150,000 women and 36,000 men without chronic disease at baseline; during 3.5 million person-years of follow-up, 12,000 participants developed type 2 diabetes.
Adjusted for personal, lifestyle, and dietary factors, the pooled hazard ratios for developing type 2 diabetes for every 3 servings of fruit consumed weekly were:
Blueberries, 0.74
Grapes and raisins, 0.88
Apples and pears, 0.93
Bananas, 0.95
Grapefruit, 0.95
Total whole fruits, 0.98
All HRs were significant. Consuming prunes, peaches, plums, apricots, or cantaloupe was not associated with altered risk for type 2 diabetes. In contrast, the pooled HR for every 3 servings of fruit juice consumed weekly was 1.08 — also significant.
Comment: If these findings are causal, all fruits do not confer the same benefit. Consuming specific whole fruits — especially blueberries, grapes, apples, and pears — is associated with lower risk for developing type 2 diabetes. These results are biologically plausible, given the heterogeneous components and glycemic loads of different fruits. The risk for type 2 diabetes associated with fruit juice consumption likely is due to the high calorie content of juices; fruit juice is not the same as its whole fruit counterpart.
Citation(s): Muraki I et al. Fruit consumption and risk of type 2 diabetes: Results from three prospective longitudinal cohort studies. BMJ 2013 Aug 29; 347:f5001.
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MM: The bottom line is that if the bronchitis and cough are un-complicated by other severe problems, the best approach is just to wait it out and put up with the discomfort. Cough suppressants may help with sleep as decongestants may ease chest tightness along with plenty of fluids. In more severe conditions the use of oral steroids may reduce some congestion and inflammation but these are merely temporary fixes and carry their own risk factors so it comes back to the best treatment is probably no treatment if possible. That being said, I have had success with simple hydration using a room humidifier and water.
Neither antibiotics nor Ibuprofen Shortens Cough Duration in Acute Bronchitis
By Kelly Young
Neither amoxicillin-clavulanic acid nor ibuprofen improve cough symptoms in patients with acute bronchitis, according to a BMJ study.
Researchers randomized over 400 patients presenting with acute bronchitis and discolored sputum to 10 days of amoxicillin-clavulanic acid, ibuprofen, or placebo
Between 11 and 13 days after initial presentation, patient-reported duration of frequent cough did not differ significantly across the three groups. However, adverse events were more common in the antibiotic group (12%) than in the ibuprofen (5%) or placebo (3%) groups.
The authors conclude that this is the "first study to show that an oral anti-inflammatory treatment or an antibiotic are not more effective than placebo for shortening the duration of cough in patients with otherwise non-complicated acute bronchitis with discolored sputum."
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MM: I think it's great that clinicians are recognizing subclinical hypothyroidism but a problem still remains that only Levothyroxine (T4) is being prescribed in most cases. This is the wrong approach. If a patient is not converting the storage T4 into the active T3, then the use of T4 is only a temporary stopgap and the patient will start feeling lousy again in a relatively short time period. A mixed combination of balanced T3 and T4 is more appropriate and even of greater use would be the discovery and treatment of the underlying reason that the thyroid problem is occurring. This may be a lack of iodine, selenium, B-complex, Vitamin C, Estrogen/progesterone imbalance and/or adrenal fatigue. Unless these underlying problems are addressed the problem is likely to reappear and be even more daunting to correct or treat.
People Increasingly Prescribed Levothyroxine for subclinical Hypothyroidism
By Kelly Young
Prescriptions for levothyroxine have increased markedly since 2002, and many people are potentially being overtreated for subclinical hypothyroidism, according to a JAMA Internal Medicine study.
U.K. researchers retrospectively assessed thyrotropin levels among some 52,000 people who began taking levothyroxine between 2001 and 2009. During that time, new prescriptions increased 1.74-fold. The median thyrotropin level at treatment initiation fell from 8.7 to 7.9 mIU/L, partly reflecting an increase in patients treated at 4.0 to 10.0 mIU/L. (Guidelines recommend considering treatment at 10.0 mIU/L or lower in those with hypothyroidism symptoms, cardiovascular disease, or other factors.)
Five years after levothyroxine initiation, 5.8% of patients had suppressed thyrotropin levels and 10.2% had low levels.
The authors conclude: "While thyroidologists are still debating whether subclinical hypothyroidism should be more widely treated, it is increasingly apparent that this is already happening in primary care. Randomized controlled trials … are urgently needed to refine current levothyroxine prescribing and to indicate the balance of risks and benefits of current practice."
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Menopause 2013 Sep; 20:905
Breast Cancer, Hormone Exposure, and Cognitive Function
Alterations in pretreatment cognitive function in women with breast cancer may be related to history of estrogen exposure.
Although published findings conflict, estrogen seems to have a beneficial effect on cognitive function. In contrast, breast cancer diagnosis has been associated with diminished cognitive function that has been attributed to the effects of adjuvant therapy. Investigators at a single U.S. institution compared medical histories, verbal intelligence, depressive symptoms, and cognitive function in 264 menopausal breast cancer patients before receiving adjuvant therapy (mean age, 61) with 95 healthy age- and education-matched control women (mean age, 59). Women in the control group had a higher mean estimated verbal intelligence than those with breast cancer. Mean cumulative duration of oral contraceptive (OC) use was 5.0 years in the control group and 3.6 years in the cancer group (P=0.03).Before initiating systemic adjuvant therapy, women with breast cancer performed worse than controls in verbal learning, memory, and attention domains (P≤0.05). In both groups, prior OC use was associated with better cognitive performance and longer time since last use of OC was associated with worse cognitive function.
Comment: Importantly, neither depression nor anxiety appears to explain the mild cognitive impairment seen in these women with cancer. However, the authors appropriately speculate that women recently diagnosed with and treated for breast cancer may suffer from sleep problems and effects of surgery and anesthesia, all of which could impair cognitive performance. The correlation between oral contraceptive use and higher cognitive function might be based on the biological impact of exogenous sex steroids. Alternatively, women who have used OC have higher socioeconomic status (SES) than women who have not (Matern Child Health J 2012; 16:213), and controlling for years of education might not have adequately reflected SES discrepancies. Perhaps the most important message here is for clinicians to be vigilant for and sensitive to cognitive changes in women with recently diagnosed breast cancer.
Citation(s): Bender CM et al. Does lifetime exposure to hormones predict pretreatment cognitive function in women before adjuvant therapy for breast cancer? Menopause 2013 Sep; 20:905.
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'Death Knell' for Venous Blockage Hypothesis in MS
By Amy Orciari Herman
Findings from a new Lancet study provide the "definitive conclusion" to the debate surrounding chronic cerebrospinal venous insufficiency (CCSVI) as the purported cause of multiple sclerosis, editorialists write. The CCSVI hypothesis has led to much hype over venoplasty as a potential cure for MS in recent years, despite the FDA warning against its use.
In the new study, researchers in Canada used catheter venography, the gold standard for assessing venous stenosis, to examine the internal jugular and azygous veins in 79 people with MS, 55 of their unaffected siblings, and 43 unrelated controls. The prevalence of CCSVI did not differ significantly across the groups (roughly 2%).
The editorialists, who disclose ties to MS drug makers, say the study "sounds a death knell for the hypothesis of chronic cerebrospinal venous insufficiency as a disease entity. Chronic cerebrospinal venous insufficiency is not highly prevalent in multiple sclerosis. The disorder is neither specific to the disease nor does it have a causative role."
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Ann Intern Med 2013 Sep 3; 159:309
Methylprednisolone was more effective than placebo at 10 weeks, but most patients still underwent surgery by 1 year.
Interventions for carpal tunnel syndrome include wrist splints, surgery, or steroid injections, although data to support steroid injections are sparse.
To evaluate the efficacy of steroid injections for alleviating carpal tunnel pain, a group from Sweden randomized 111 patients to single injections of methylprednisolone (80 mg or 40 mg) or placebo. Patients were included if a 2-month trial of wrist splinting failed and if they had never received steroid injections; they could elect to undergo surgery 3 months after study enrollment if their symptoms didn't improve.
At 10 weeks, mean carpal tunnel symptom scores (range, 1–5) had improved significantly more in the methylprednisolone groups than in the placebo group (change from baseline vs. placebo: 80-mg methylprednisolone, –0.64; 40-mg methylprednisolone, –0.88). However, by the end of year 1, most patients had undergone surgery (73%, 81%, and 92% of the 80-mg, 40-mg, and control groups, respectively); the difference between surgery rates for the 80-mg methylprednisolone group and the control group was significant. At 1 year, symptom scores were similar in all three groups. No serious adverse events occurred in any group. Comment Steroid injections for alleviating carpal tunnel symptoms were only modestly effective; pain was lessened at 10 weeks but not at 1 year. Although surgery was performed less often in the 80-mg methylprednisolone group, three quarters of these patients still underwent surgery.
Citation(s): Atroshi I et al. Methylprednisolone injections for the carpal tunnel syndrome: A randomized, placebo-controlled trial. Ann Intern Med 2013 Sep 3; 159:309.

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N Engl J Med 2013 Sep 19
Adolescent Scoliosis: Is Bracing Effective?
The amount of time spent wearing a brace was positively associated with treatment success.
Idiopathic adolescent scoliosis develops in 3% of youth younger than 16 years, but only 0.3%–0.5% of cases progress to spine curves that require treatment. Curve progression <40 degrees typically stabilizes without long-term effects, and progression >50 degrees increases risk for progressive deformity, disc and joint degeneration, and neurological complications. Rigid thoracic-lumbar bracing is the most common nonoperative treatment to prevent progression >40 degrees, but studies of the effects of bracing are inconsistent.
In a multicenter study of 242 patients (age range, 10–15 years) with idiopathic adolescent scoliosis (Cobb angle for largest curve, 20–40 degrees), 116 agreed to be randomized to bracing or observation. The remaining 126 patients chose between bracing (71%) and observation. Treatment success rates (skeletal maturity without progression >50 degrees) were 72% in 146 patients treated with bracing and 48% in the 96 patients who were observed (odds ratio, 1.93). Daily duration of wearing a brace (determined by a temperature logger embedded in the brace) was positively related to treatment success: Success rates were >90% in patients who wore the brace for a mean of at least 12.9 hours daily and 41% in those who wore the brace for a mean of 0–6 hours daily.
Comment: Bracing led to spine curve progression <50 degrees significantly more often than no bracing. However, the results are limited because many eligible patients chose not to be randomized. Remarkably, 48% of patients in the observation group achieved treatment success status. Editorialists note that patients with idiopathic adolescent scoliosis are a heterogeneous group and suggest that future research focus on identifying those most likely to do well without treatment and those who might benefit most from bracing.
Citation(s): Weinstein SL et al. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med 2013 Sep 19; [e-pub ahead of print].

Carragee EJ and Lehman RA. Spinal bracing in adolescent idiopathic scoliosis. N Engl J Med 2013 Sep 19; [e-pub ahead of print].

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