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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
December 21, 2013

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The Burden of Uterine Fibroids
Calcium and Vitamin D: Big Tablets, Little Yield?
Is Statin Use Associated with Cognitive Impairment
Statins, Diuretics Linked to Increased Diabetes Risk in Patients with Impaired
   Glucose Tolerance
Wider Role for HDL in Controlling Inflammation?
Acid Inhibition Associated with B12 Deficiency
Antibiotic Prophylaxis for Gynecologic Surgery: When More Isn't Better
Fewer Antibiotics in Your Burger, If the FDA Has Its Way
Prenatal Discussions about Breast-Feeding: Few and Far Between
Can Probiotics Prevent Late-Onset Neonatal Sepsis?
Colorectal Cancer Associated with Decreased Variety of Gut Microbiota
First Drug Approved for Peyronie's Disease

MM: It's impressive that D3 supplementation shows an enhanced clinical response when compared to D2 but it is also safer. That almost never happens! A product that is not only more effective but safer too? On top of that, D3 does not inhibit endogenous vitamin D production to the same degree that D2 does. That means that the consumer definitively gets more bang for their buck with Vitamin D3 when compared to D2.
J Clin Endocrinol Metab 2013 Nov; 98:4339
Another Comparison of Vitamin D2 and Vitamin D3 Supplementation
D3 was somewhat more effective in raising serum levels of total 25-hydroxyvitamin
Vitamin D that is produced naturally from sunlight exposure is vitamin D3. However, both D3 (cholecalciferol) and D2 (ergocalciferol) are available as supplements. In the U.S., supplemental vitamin D2 is usually a 50,000 IU prescription medication, whereas D3 is available over-the-counter in various doses. With D3 supplementation, essentially all measured serum 25-hydroxyvitamin D (25[OH]D) is hydroxylated D3. In contrast, with D2 supplementation, total serum 25(OH)D is the sum of supplemental D2 plus endogenous D3. Some, but not all, studies have suggested that supplemental D3 raises total serum 25(OH)D more than supplemental D2 does (NEJM JW Gen Med Apr 26 2011).
Researchers randomized 107 healthy volunteers in a northern German community to receive daily 2000 IU doses of vitamin D2, vitamin D3, or placebo during winter months. At 8 weeks, the mean increase in total 25(OH)D was significantly greater with D3 supplementation than with D2 supplementation (18 vs. 12 ng/mL). Interestingly, the D2 group's 12 ng/mL increase in total 25(OH)D reflected the net result of a 20 ng/mL increase in D2 but an 8 ng/mL decrease in D3.
Comment: In this study, vitamin D3 supplementation raised total serum 25-hydroxyvitamin D levels more effectively than did vitamin D2 supplementation. D2 supplementation appeared to suppress endogenous D3, thus offsetting some of the expected increment in total serum 25(OH)D. The authors conclude that D3 should be used for supplementation.
Citation(s): Lehmann U et al. Bioavailability of vitamin D2 and D3 in healthy volunteers, a randomized placebo-controlled trial. J Clin Endocrinol Metab 2013 Nov; 98:4339. (http://dx.doi.org/10.1210/jc.2012-4287)
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MM: It is unfortunate that many of these studies that are follow-ups to the Women's health Initiative (WHI) study are based on old and essentially faulty data. This study relates to recommended usage of 600IU of vitamin D daily and uses calcium carbonate (CaCO3)as the standard product when CaCO3 is a poorly absorbed form of calcium.
J Womens Health (Larchmt) 2013 Nov; 22:915
Calcium and Vitamin D: Big Tablets, Little Yield?
Mixed results provide limited guidance.
Many view calcium and vitamin D supplementation as a holistic strategy, but data on the effects of long term supplement use are lacking. Now, in post-intervention follow-up of almost 30,000 participants in the Women's Health Initiative (WHI) calcium plus vitamin D trial, researchers evaluated the effects of these supplements on risk for hip and vertebral fracture, as well as for colon and breast cancer (mean post-intervention follow up, 4.9 years). Personal use of either supplement at baseline was allowed. During the 7-year intervention phase, women were randomized to daily placebo or 1000 mg calcium carbonate plus 400 IU vitamin D3.
Although post-intervention rates of hip fracture and colorectal cancer were generally similar between groups, a 23% reduction in hip fracture was achieved during the combined study phases by women who were adherent to supplement use. Additionally, in the supplement group, postintervention vertebral fracture rates were reduced by 17% (and by 20% in women older than 60). Calcium supplementation did not affect risk for coronary heart disease, myocardial infarction, or stroke. Overall risk for in situ breast cancer was 18% lower in the supplement group; however, women who took higher doses of vitamin D at baseline (i.e., >600 IU daily) had increased risk for invasive breast cancer (hazard ratio, 1.3).
Comment: The authors suggest that enrolling more women older than 70 would have increased the number of hip fractures observed, thereby providing more statistical power to investigate effects of calcium and vitamin D supplementation on risk for such fractures. Although the results failed to show clear benefits in preventing hip fracture and colon cancer, valuable information emerged associating use of these supplements with decreases in risk for vertebral fracture — the most common (and often the first) skeletal site of fracture in women with low bone mass.
Citation(s): Cauley JA et al. Calcium plus vitamin D supplementation and health outcomes five years after active intervention ended the Women's Health Initiative. J Womens Health (Larchmt) 2013 Nov; 22:915.

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MM: I have never been on the "statin band wagon" although I think that there are some good things that statins can be used for, I don't believe that they should be used as much as they are in allopathic medicine. There still exists a number of people who's cognition can be diminished by the use of statins and we need to be aware of this potential adverse reaction. On the other hand, there are so many people worldwide who are using this class of drug, it is somewhat reassuring that only a small percentage of that population is likely to have this detrimental effect on them.
Ann Intern Med 2013 Nov 19; 159:688
Is Statin Use Associated with Cognitive Impairment
The largest systematic review to date to address this issue suggests no adverse effects of statins on cognition.
In 2012, the FDA issued a safety announcement, noting that statin use might be associated with cognitive impairment such as memory loss or confusion. To evaluate this association, researchers conducted a systematic review and meta-analysis of 57 studies, including 19 randomized controlled trials, in which assessments of cognition among statin users were reported; FDA postmarketing surveillance data also were analyzed.
Moderate-quality evidence suggested no excess risk for dementia or mild cognitive impairment, and low-quality evidence suggested no excess risk for Alzheimer disease. Analysis of postmarketing surveillance data revealed similar cognitive-related adverse-event reporting rates for statins (1.9 per million prescriptions) and two cardiovascular drugs not associated with cognitive impairment: losartan (1.6 per million prescriptions) and clopidogrel (1.9 per million prescriptions).
Comment: Although this systematic review was limited by the small number of randomized trials in which this outcome was evaluated, the data do not suggest excess risk for cognitive impairment with statin use. Nevertheless, a rare idiosyncratic effect of statins on cognition remains possible for individual patients, even if studies of large groups of people show no adverse effect on average. Indeed, in its safety announcement, the FDA acknowledged that it drew substantially from post-marketing case reports of adverse events.
Citation(s): Richardson K et al. Statins and cognitive function: A systematic review. Ann Intern Med 2013 Nov 19; 159:688.

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MM: This study makes a strong argument against "poly-pharmacy". It encourages the clinician to "pick his/her battle" and do it wisely. Determine the condition that is the greatest risk to the patient and develop a treatment plan that is appropriate to address the primary issue as it appears that the combination of treating all the problems may potentially do more harm than good.
Statins, Diuretics Linked to Increased Diabetes Risk in Patients with Impaired Glucose Tolerance
By Kelly Young
Diuretics and statins are both associated with significantly increased risks for new-onset diabetes in patients with impaired glucose tolerance at high cardiovascular risk, according to a BMJ study.
Researchers reanalyzed data from a trial of 9300 patients with impaired glucose tolerance who started various cardiovascular drug treatments. After a median follow-up of 5 years, patients who began taking diuretics were at higher risk for developing diabetes than those who did not (adjusted hazard ratio, 1.23). New statin users were also at increased risk (HR, 1.32). Beta-blockers and calcium-channel blockers did not pose a significantly higher risk for incident diabetes.
The researchers calculate that there is one case of new-onset diabetes for every 17 patients treated with diuretics over 5 years, and one case for every 12 treated with statins.
These results "suggest that glycemia should be better monitored when these drugs are initiated in high risk patients," the researchers conclude.
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MM: HDL is touted as the 'happy' or 'good' cholesterol. Although most people accept this simple statement as fact, it remains that studies fail to demonstrate that raising HDL serves any clinical purpose of improving rates of cardiovascular morbidity or mortality. The premise that all disease is a function of inflammation brings HDL into a new spotlight and begs the question, 'Can you improve inflammation and consequently improve overall health and have an effect on other disease states?'
Wider Role for HDL in Controlling Inflammation?
You may have wondered how HDL plays its "good cholesterol" role. According to a Nature Immunology study, HDL increases the activity of a transcriptional regulator, ATF3, which limits the inflammatory responses in macrophages.
The study authors think that this action of HDL "may be beneficial in other chronic inflammatory diseases."
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MM: It used to be that pernicious anemia was almost the exclusive the disease of the elderly. The common use of proton pump inhibitors (PPI's) may have brought this disease into the common presence of baby boomers and new born infants. The lack of intrinsic factor typically secreted by cells lining the stomach leads to the body's inability to absorb vitamin B12. Traditionally this was a problem that was rare in anyone other than the elderly. Unfortunately, the cavalier use of PPI's may have made this a disease that will be present in people of all ages.
Acid Inhibition Associated with B12 Deficiency
By Joe Elia
Use of acid-suppressing drugs for more than 2 years is associated with a greater risk for vitamin B12 deficiency, according to a JAMA study. Gastric acid plays a key role in extracting B12 from dietary proteins.
Using Kaiser Permanente health records, researchers identified 26,000 cases of incident B12 deficiency, comparing their medication histories with those of 185,000 controls without the condition.
Incident B12 deficiency was more likely among those who'd received 2 years or more of proton pump inhibitors than among nonusers (odds ratio, 1.65). The effect was more pronounced in those taking 1.5 PPI pills a day or more; similar dose-dependent effects occurred with histamine-2 receptor antagonists. The association weakened with time after discontinuation of drug use.
The authors write that their findings don't argue against acid suppression, but instead advise that "clinicians should exercise appropriate vigilance" when prescribing the drugs.
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MM: Although it is reassuring to know that 87% of the time that an antibiotic is being prescribed for female surgeries it is being done correctly, it is quite disturbing that 40% of the procedures where antibiotics are INAPPROPRIATE the patients are still receiving them. In the past couple of years, pediatricians have made giant strides in moving towards sensible use of antibiotics. Now, obstetricians and gynecologists must make that same transition. Who knows, maybe we will see a concomitant increase in the use of probiotics/prebiotics by these same professionals as they move into this new age of integrative enlightenment. We can only hope that this will be the case...
Obstet Gynecol 2013 Dec; 122:1145
Antibiotic Prophylaxis for Gynecologic Surgery: When More Isn't Better
Perioperative antibiotics are used in many instances in which benefit is questionable.
Numerous studies have documented the benefits of prophylactic antibiotics to limit infectious morbidity in women undergoing high-risk surgical procedures. But how often is prophylaxis used correctly? To answer this question, investigators analyzed a voluntary database of information from >500 U.S. hospitals encompassing gynecologic procedures in >1 million women from 2003 to 2010.
Antibiotics were used appropriately in 87% of 545,000 procedures for which these agents are recommended (e.g., hysterectomy by any route); however, 11% of such procedures involved no prophylaxis and 2% involved non-guideline-recommended antibiotics. Use of prophylactic antibiotics for hysterectomy rose significantly during the study period. Prophylactic antibiotics were used in 40% of 490,000 gynecologic surgeries for which antibiotics are not recommended (e.g., oophorectomy, laparoscopic tubal ligation, myomectomy). Antibiotic usage in these surgeries increased from 33% to 44%. High-volume surgeons were 41% less likely to omit indicated antibiotics and 13% less likely to use antibiotics in procedures in which they were not indicated.
Comment: This retrospective analysis documents that gynecologic surgeons generally use prophylactic antibiotics for hysterectomy when indicated, but a considerable number also use prophylactic antibiotics in low-risk surgical procedures for which evidence of efficacy is lacking. The additional cost of the antibiotics (along with risk for antibiotic resistance and antibiotic-related complications) does not justify this use. Clearly, more-frequent antibiotic use is not necessarily better — and, evidently, surgeons who operate more frequently are more familiar with published guidelines.
Citation(s): Wright JD et al. Use of guideline-based antibiotic prophylaxis in women undergoing gynecologic surgery. Obstet Gynecol 2013 Dec; 122:1145.
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MM: It's about time that the agency whose job it is to protect the American consumer does its job when it comes to antibiotics and livestock. This is only a VOLUNTARY reduction/removal of non-therapeutic uses of antibiotics in food producing animals at the present time. Unfortunately, this will be a very slow process and could be only marginally enforced through the transition. Animals that receive non-therapeutic drugs get bigger faster while consuming less food and thereby are more profitable to producers.
Fewer Antibiotics in Your Burger, If the FDA Has Its Way
By Joe Elia
To do its part against the threat of antibiotic resistance, the FDA is embarking on a 3-year plan to encourage judicious use of antimicrobials in livestock.
Part of the plan is to phase out routine/OTC use of "medically important antimicrobials" that are currently used for non-therapeutic reasons, such as enhancing animal growth or lowering feeding costs.
Companies producing drugs for the food industry will be asked to voluntarily revise their labels to require veterinarian oversight for therapeutic use, and to remove all non-therapeutic production purposes. Extra-label use of drugs is not allowed with livestock. The drug companies have been asked to offer their plans within 90 days and would have 3 years to make the transition.
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MM: It is surprising and distressing that only 2% of clinicians made an explicit recommendation to breast feed and that a mere 42% of midwives and only 10% of obstetric residents in this study assessed a patient's prior experience with breast feeding. One would think that these latter clinicians would be some of the greatest advocates and most recently educated on the benefits of nursing the child.
Obstet Gynecol 2013 Dec; 122:1263
Prenatal Discussions about Breast-Feeding: Few and Far Between
At initial prenatal visits, breast-feeding is rarely brought up.
Clinicians who provide prenatal care play a critical role in promoting breast-feeding. To assess the nature of breast-feeding discussions between patients and their clinicians at a large academic medical center, researchers audio-recorded 172 first prenatal visits with 6 certified nurse midwives, 5 certified nurse practitioners, and 36 obstetric residents.
Overall, fewer than one third of visits included any discussion of breast-feeding and only 2% included an explicit recommendation that breast-feeding is superior to formula-feeding.
Midwives were more likely than other clinicians to discuss breast-feeding, but only 42% (vs. 10% of obstetric residents) assessed the patient's prior experience with breast-feeding.
Comment: Given the substantial costs of the low prevalence of optimal breast-feeding on maternal and infant health (NEJM JW Womens Health Aug 9, 2013), clinicians have an ethical obligation to inform mothers — long before their milk supplies have come and gone — of the long-term health effects of not breast-feeding.
Citation(s): Demirci JR et al. Characteristics of breastfeeding discussions at the initial prenatal visit. Obstet Gynecol 2013 Dec; 122:1263.
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MM: The question of whether this trial was a success is a silly one. Yes! It was a success. Only a very small number of patients were needed to demonstrate benefit and there are virtually no down sides to this treatment approach. As far as an appropriate dose of probiotics, it may have been postulated that since these infants had essentially naive guts and being quite small, would not need a large number of probiotics to effectively colonize the gut, the use of a mere 1 billion organisms was likely not an optimal number. I would postulate that a daily dose of 3-5 billion organisms would be more beneficial. Unfortunately, the only way to definitively determine this would be additional studies.
Pediatrics 2013 Dec; 132:1055
Can Probiotics Prevent Late-Onset Neonatal Sepsis?
In very preterm infants, a combination of three species of probiotics slightly reduced the incidence of moderately severe necrotizing enterocolitis, but not late-onset sepsis.
In preterm infants, gastrointestinal colonization with normal bacterial flora is delayed and lacks biodiversity, thereby allowing potentially pathogenic bacteria to colonize. Alterations in intestinal flora may predispose preterm infants to late-onset sepsis (i.e., occurring >48 hours after birth) and necrotizing enterocolitis (NEC). Administering probiotic bacteria to preterm infants has been shown, in meta-analyses, to significantly reduce the incidence of NEC and all-cause mortality, but not late-onset sepsis. Now, researchers in Australia and New Zealand have randomized 1099 infants born before 32 weeks' gestation and weighing <1500 g to receive either a combination of Bifidobacterium infantis, Streptococcus thermophilus, or Bifidobacterium lactis (containing 1 billion total organisms) or placebo.
The two groups did not differ significantly in the incidence of definite late-onset sepsis (diagnosed when a pathogen was isolated from blood or other normally sterile fluids) or clinical late-onset sepsis (diagnosed when signs and laboratory tests indicated infection but blood culture was sterile). The incidence of NEC Bell stage 2 (mild to moderate systemic illness, absent bowel sounds, abdominal tenderness, pneumatosis intestinalis or portal venous gas, metabolic acidosis, and decreased platelets) or greater was significantly lower in the probiotic group than in the placebo group (2.0% vs. 4.4%).
Comment: Was this trial a success or a failure? The number of infants that would need to be treated with this probiotic combination to prevent one NEC of Bell stage 2 or greater was 43 (95% confidence interval, 23 to 333). No one has yet determined the most effective probiotic or combination of probiotics, or the optimal dose or duration of a probiotic regimen.
Citation(s): Jacobs SE et al. Probiotic effects on late-onset sepsis in very preterm Infants: A randomized controlled trial. Pediatrics 2013 Dec; 132:1055.
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MM: Although not directly related, this information could support the premise that a variety of friendly bacteria in the form of probiotics may be more helpful than introducing a single or pair of probiotic organisms into an environment. The entire Synergy Blends line of nutritional support and Functional Medicine products uses a variety of probiotic organisms to complement the activity of the "actives".
Colorectal Cancer Associated with Decreased Variety of Gut Microbiota
By Joe Elia
Patients with colorectal cancer have a narrower range of fecal bacteria, according to a study in the Journal of the National Cancer Institute. Editorialists express enthusiasm for the results, but caution that "a lot more research" is needed before the findings can be used clinically.
Researchers analyzed bacterial DNA from fecal samples that were collected roughly 25 years ago in a case-control study of patients with colorectal cancer; the controls were patients undergoing elective surgery. Fecal samples were collected after confirmation of the diagnosis, but before therapy.
Patients with cancer had decreased overall diversity of bacteria in their gut relative to the controls. For example, they had a lower relative abundance of Clostridia species, but an increased presence of Fusobacterium.
The editorialists write that the "exciting" findings echo similar observations that have suggested a role for the microbiota in colorectal cancer.
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First Drug Approved for Peyronie's Disease
By Kristin J. Kelley
The FDA has approved collagenase clostridium histolyticum (CCH, marketed as Xiaflex) as the first nonsurgical method for treating Peyronie's disease, a condition in which scar tissue develops under the skin of the penis and causes a curvature during erection, making sexual intercourse difficult.
Approval for the injectable, which works by breaking down collagen, was based on two randomized trials of some 830 men with penile curvature deformity of at least 30 degrees. Participants treated with CCH (four treatment cycles) experienced significantly reduced deformity and side effects compared with those on placebo.
The FDA is requiring a risk evaluation and mitigation strategy for those prescribing CCH for Peyronie's disease because of the risk for penile fracture and other serious adverse reactions. Penile hematoma, pain, and swelling were the most common side effects.

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