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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
September 21, 2013

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Confronting Growing Resistance in Helicobacter pylori
Might Gut Bacteria Help Treat Autoimmune and Allergic Diseases?
Psoriasis and Co-Morbid Disease: A Dose Response in Relation to Psoriasis Severity
Candy Improves Bowel Preparation
Statins Associated with Increased Risk for Cataracts
Health Spending Growth Projected to Hold Steady This Year
All Combined Oral Contraceptives Increase Risk for Venous Thrombosis,
  Meta-Analysis Concludes
Most Unnecessary Thyroid Biopsies Could be Averted, Researchers Say
Researchers Call for Changes to Limit Overtreatment of Thyroid Cancer
Imported Spices a Surprising Source of Salmonella Poisonings
Fluoroquinolones and Risk for Peripheral Neuropathy
Clopidogrel's (Plavix) Benefits Seen Mainly in Smokers
Lower Overall Dose of Radiation in Fewer Treatments Effective for Breast Cancer,
  10-Year Data Shows
Does Ginseng Root Relieve Cancer-Related Fatigue?
Women Who Elect Contralateral Prophylactic Mastectomy May Overestimate Risk
Gluten Sensitivity Without Celiac Disease — A New Twist
Most Medications Okay During Breast-Feeding
Clawing Your Way Back: Why Nails Are So Important
Safety of Fluconazole During Pregnancy )
Kidney Injury and Androgen Deprivation Therapy
Johnson & Johnson Recalls Mold-contaminated Vials

MM: In spite of the significance that H. pylori is becoming resistant to antibiotic therapy, both the authors and the commentators fail to comment that dysbiosis and the correction of such with probiotics and digestive enzymes could mitigate the problem. The real problem is the dysbiosis. Rather, the recommended approach is to use more aggressive antibiotic combination treatments. Unfortunately this article misses the forest for the trees.
BMJ 2013 Aug 7; 347:f4587
Confronting Growing Resistance in Helicobacter pylori
Sequential therapy is superior to short courses of triple therapy.
Triple therapy, consisting of a proton-pump inhibitor (PPI), clarithromycin, and amoxicillin or metronidazole (all given twice daily), is standard treatment for patients with Helicobacter pylori infections. However, rising antibiotic resistance has made triple therapy less effective. Investigators conducted a meta-analysis of 46 randomized trials in which sequential therapy (twice-daily PPI plus amoxicillin for 5 days, followed by 5 days of triple therapy with PPI plus clarithromycin plus metronidazole) was compared with various other treatment regimens. Participants were treatment-naive, H. pylori–positive adults.
In 22 trials (with 5000 patients), sequential therapy was significantly better than 7-day courses of triple therapy (eradication rates, 87% vs. 72%). In 14 trials (2750 patients), sequential therapy performed significantly better than 10 days of triple therapy (eradication rates, 84% vs. 75%). Eradication rates were similar for sequential therapy compared with 14-day triple therapy in 7 trials, compared with bismuth-containing quadruple therapy in 5 trials, and compared with non–bismuth-containing quadruple therapy (PPI plus clarithromycin, amoxicillin, and metronidazole) in 6 trials. Among patients who harbored clarithromycin- or metronidazole-resistant H. pylori strains, sequential therapy remained superior to 7 or 10 days of triple therapy.
Comment: In this meta-analysis, sequential therapy was superior to either 7- or 10-day courses of triple therapy for eradication of H. pylori. These results suggest that clinicians should prescribe sequential therapy, at least 14 days of triple therapy, or quadruple therapy to eradicate H. pylori infections. Local resistance patterns should be made available to clinicians: Evidence (reported by the authors but not included in their meta-analysis) suggests that, for strains resistant to both clarithromycin and metronidazole, substitution of levofloxacin for clarithromycin in sequential therapy increases efficacy.
Citation(s): Gatta L et al. Global eradication rates for Helicobacter pylori infection: Systematic review and meta-analysis of sequential therapy. BMJ 2013 Aug 7; 347:f4587.
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Nature 2013 Aug 8; 500:232
Might Gut Bacteria Help Treat Autoimmune and Allergic Diseases?
Multiple nonpathogenic Clostridia species attenuated disease severity in mice.
T regulatory (Treg) lymphocytes play a central role in quieting the immune response in autoimmune diseases. Because many Treg lymphocytes are produced by the gut immune system, researchers are exploring ways to boost the number of these Treg cells to treat patients with autoimmune diseases.
Some species of bacteria that are normal gut flora in mice increase the number of Treg cells. A Japanese team tested the ability of different human gut bacterial species to induce Treg cells in germ-free mice. They identified 17 Clostridia strains that produced the desired effect; inoculating the germ-free mice with all 17 strains simultaneously produced the largest boost. The function (anti-inflammatory cytokine production), as well as the number, of Treg cells rose. The 17 identified Clostridia strains did not produce toxins (as is the case with pathogenic human Clostridia strains). The investigators then demonstrated that adding these bacteria to the guts of mice with experimentally induced severe allergic diseases greatly attenuated their severity.
Comment: Nonpathogenic Clostridia strains that normally are found in the human gut can suppress immunologically mediated disease in mice. Whether such a probiotic cocktail would be effective in treating human disease remains to be determined. However, along with many other recent studies, this report suggests that the nonpathogenic bacteria that live in our guts might play an important role in human illness and, someday, in its treatment.
Citation(s): Atarashi K et al. Treg induction by a rationally selected mixture of Clostridia strains from the human microbiota. Nature 2013 Aug 8; 500:232.

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MM: I like the idea that additional assessments may be deduced or just recognized by observing existing conditions. Perhaps this may be taken one step further to determine causative factors and thereby prevent more serious or life threatening medical problems down the road that have not yet appeared. The old adage, "an ounce of prevention is worth a pound of cure" could be applied here.
JAMA Dermatol 2013 Aug 7
Psoriasis and Co-Morbid Disease: A Dose Response in Relation to Psoriasis Severity
Confirmation of an association between psoriasis and cardiovascular and peripheral vascular disease, validation of the link between psoriasis severity and risk for other disease, and reportage of some new associations.
Gelfand and his colleagues were among the first to report an association between psoriasis and atherosclerotic vascular disease of the heart, central nervous system, and peripheral vascular system (see JW Dermatol Oct 27 2006). The data suggested that the association was strongest in more severe disease (this research used the need for phototherapy or for systemic therapy as a surrogate for severity). Other investigators have linked chronic pulmonary disease, diabetes, and metabolic syndrome to psoriasis and its severity (JW Dermatol May 15 2009).
Odds Ratios for Associated Systemic Disease in Patients with Psoriasis
This most recent study relies on data collected from medical records and responses to patient surveys in the U.K. In 9035 psoriasis patients and 90,350 controls without psoriasis, investigators found significant associations between psoriasis and systemic disease (see Table). Higher psoriasis severity increased this risk. Cerebrovascular disease, moderate-to-severe liver disease, and cancer were not more prevalent in the psoriasis patients in this study. Smoking status, the presence of obesity, and the effects of therapy were not reported. The authors state that their results “should be considered hypothesis generating and require confirmation in prospective studies.”
COMMENT: These results confirm an association between psoriasis and cardiovascular and peripheral vascular disease and validate the link between psoriasis severity and risk for other disease. Some relatively new associations are demonstrated, including with peptic ulcer disease, renal disease, and rheumatologic disease other than psoriatic arthritis. The prevalence of liver disease may be weight-related rather than an independent association. If these associations hold up in prospective studies, early intervention, including initiation of systemic therapy and recommendations promoting a healthful lifestyle, will become part of the regular dermatologic care of psoriatic patients.
CITATION(S): Yeung H et al. Psoriasis severity and the prevalence of major medical comorbidity: A population-based study. JAMA Dermatol 2013 Aug 7; [e-pub ahead of print].
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MM: Mary Poppins would love this article! It makes me wonder why no-one has used this technique before this. Anyone who has ever had to have an upper or lower GI examination will likely attest that they would welcome an easy method to make the pre-test process less unpleasant. I know that I will recommend this approach to all my patients and colleagues.
Gastrointest Endosc 2013 Jun 14
Candy Improves Bowel Preparation
Patients who sucked on menthol drops while drinking the bowel-prep solution reported better palatability and achieved higher-quality cleansing than controls.
Polyethylene glycol electrolyte lavage solution (PEG-ELS), the active ingredient in many FDA-approved colonoscopy bowel preparations, is often considered to be the worst tasting of available prep options. In fact, about 15% of patients are unable to finish 4 liters of PEG-ELS. Nevertheless, recent meta-analyses suggest that 4-liter PEG-ELS given in split doses is still the most effective bowel preparation.
To test whether the use of menthol candy drops can improve the palatability of PEG-ELS preparations, investigators evaluated 100 patients who received 4 liters of PEG-ELS in split doses, half of whom also received a packet of 15 sugar-free, colorless, (Halls) menthol drops and were instructed to suck on the drops while drinking the PEG-ELS preparation.
Patients in the menthol group reported higher palatability scores than controls (3.9 vs. 2.8, on a scale of 1–5; P<0.001), were more willing to repeat the same preparation (92% vs. 80%; P=0.091), and achieved a higher rate of excellent bowel preparations (63.3% vs. 34.0%; P=0.004). The unconsumed volume of PEG-ELS on the day of colonoscopy was non-significantly lower in the menthol group (67 mL vs. 128 mL; P=0.32). However, patients with excellent preparations had significantly lower unconsumed volumes (31 mL vs. 162 mL; P=0.024).
Comment: I am still a believer that 4 liters of polyethylene glycol electrolyte lavage solution should be the preparation of choice for patients with a history of previously poor preparation as well as for patients with known constipation or those taking constipating agents such as opioids. These patients account for about one third of the population in our practice. The use of menthol candy drops seems to be an inexpensive and safe method of improving tolerability that can be used now and deserves additional study.
Citation(s): Shahara AI et al. Sugar-free menthol candy drops improve the palatability and bowel cleansing effect of polyethylene glycol electrolyte solution. Gastrointest Endosc 2013 Jun 14; [e-pub ahead of print].
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MM: Increased risk of cataracts may now be added to the lengthening list of adverse effects associated with statin drugs. As the risks mount, the benefits of these drugs must be further assessed and the recommendation of their use must also be assessed. We must determine on an individual basis, who is the best candidate for these drugs and when they should be avoided. The time that they are universally recommended or prescribed for patients entering the hospital should come to an end.
Statins Associated with Increased Risk for Cataracts
By Amy Orciari Herman
Statin use may be associated with increased risk for cataracts, according to a retrospective study in JAMA Ophthalmology.
Using data from a military healthcare system, researchers matched some 7000 statin users with 7000 nonusers according to 44 variables, including age, obesity, and diabetes status. Statin use was defined as filling a statin prescription for at least 90 days between October 2004 and September 2005. Outcomes were assessed until March 2010.
Overall, statin use was associated with a significant, 9% increase in cataract incidence. In an analysis limited to patients without comorbidities, the increase in risk was higher, at 20%.
Asked to comment, NEJM Journal Watch's JoAnne Foody said: "Data on whether statins increase risk for cataracts remain inconclusive and conflicting. For now clinicians should continue to weigh individual patient ... benefits and potential harms in determining whether statins are the right choice for a given patient
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MM: Estimates are that healthcare spending will increase by 50% in the next year and will increase by an additional 400% relative to the GDP over the next decade! That is an abominable statistic! It frightens me that we are further mortgaging our children's future. Years ago I heard people talking about how the Reagan administration was overspending on the military budget and how that would mortgage the future of America. Healthcare spending is no different. We are overspending and not improving health or care. This is another example of how our government lacks fiscal responsibility. Unfortunately, we the people who are working and who are paying taxes will continue to shoulder the burden of government's rampant excesses.
Health Spending Growth Projected to Hold Steady This Year
By Joe Elia
Growth in U.S. health spending will stay around 4% this year, according to estimates from the Centers for Medicare and Medicaid Services published in Health Affairs.
Coverage expansions available through the Affordable Care Act will increase growth to near 6% for 2014 and 2015, after which growth is expected to stabilize at 5%, according to the estimates.
Total national health expenditures, estimated at close to $3 trillion for 2013, are expected to reach $5 trillion by 2022, or 20% of GDP. Half of those expenditures will have been paid for by local, state, and national government agencies.
Per-capita expenditure, at about $9200 for 2013, is projected to reach $14,600 by 2022.
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MM: The risk of oral contraceptives is nothing new. It is simply being noted. I recall over a decade ago when Dr Eisenstein stated that it was his belief the oral contraceptives contributed to the increased prevalence of a variety of cancers. Big PHARMA and the American College of Obstetrics and Gynecology (ACOG) have long maintained that birth control pills were not dangerous and were in fact beneficial to women's health. The American public is being sold a bill of goods and consumers need to be made more aware of the serious potential adverse effects of these drugs.
All Combined Oral Contraceptives Increase Risk for Venous Thrombosis, Meta-Analysis Concludes
By Cara Adler
Taking any generation of combined oral contraceptives more than doubles the risk for venous thromboembolism, according to a BMJ meta-analysis.
The analysis included 26 observational studies of healthy women taking different combined oral contraceptives.
The VTE incidence in non-users was approximately 0.02% to 0.04% (2 to 4 per 10,000). Overall, women taking a combined oral contraceptive were nearly four times more likely to develop a first VTE than non-users. Risk increased with higher doses of ethinyl estradiol and varied with type and dose of progestogen. All generations of progestogens conferred increased risk. Risk was highest with 50 micrograms ethinyl estradiol plus levonorgestrel (relative risk, 5.2) and lowest with 20 micrograms ethinyl estradiol plus either levonorgestrel or gestodene (RR, 2.2). (Gestodene formulations are not available in the U.S.)
The authors note that the levonorgestrel intrauterine device is a birth control option that does not increase risk for VTE. For women who prefer oral contraceptives, the authors recommend those with low risk and good compliance, such as 30 micrograms ethinyl estradiol plus levonorgestrel.
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MM: Anytime we hear the words nodule, fibroid, tumor, growth or atypical cells we become fearful. Cancer is what we tend to associate these words with and that simply terrifies us. Unfortunately, our caregivers (health professionals) tend to want to err on the side of caution - and who could blame them?- but are we doing a greater disservice to our patients if we are too careful? What exactly is too careful? When do we pay attention to the statistics and decide not to proceed with additional testing because the treatment may not be warranted or may be more deleterious that the risk of disease?
Most Unnecessary Thyroid Biopsies Could be Averted, Researchers Say
By Kelly Young
Researchers have identified several characteristics of thyroid nodules that appear to predict cancer risk in a retrospective case-control study in JAMA Internal Medicine.
Roughly 100 people with thyroid cancer were matched with 370 people without cancer who underwent thyroid ultrasound. Nodules were found in nearly all of cases and over half of controls.
Three nodule characteristics were predictive of thyroid cancer: microcalcifications, size greater than 2 cm, and a completely solid make-up. Here are the rates of thyroid cancer according to the number of suspect characteristics:

The authors conclude: "Adoption of [a] rule requiring two abnormal nodule characteristics to prompt biopsy would reduce unnecessary biopsies by 90% while maintaining a low risk of cancer."
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Researchers Call for Changes to Limit Overtreatment of Thyroid Cancer
By Amy Orciari Herman
Increased use of imaging (e.g., CT, MRI) has led to sharp increases in the incidental diagnosis of low-risk thyroid cancers that often are treated unnecessarily, according to a BMJ analysis.
The authors say the "most compelling evidence" that such cancers are being overtreated is that death rates from thyroid cancer have remained stable, even though diagnosis of low-risk lesions has tripled over the past three decades. They note that thyroidectomy is being performed more and more often, rising by 60% between 1996 and 2006.
To help avoid overtreatment, the authors suggest renaming low-risk cancers (<20 mm in the absence of family history, radiation exposure, and ultrasound evidence of extraglandular invasion) as micropapillary lesions of indolent course "to convey their favorable prognosis." They stress the importance of shared decision-making with patients, noting that active surveillance should be offered to those with low-risk findings.
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MM: As an avid cook who loves spices and a variety of flavors, this is a very disturbing article. Much of the media focuses on Chinese sources of food and spices in our food chain but apparently we must become more vigilant of other international sources well. Unfortunately domestic sources of foods are not immune from contamination and may become tainted as was evidenced last year with lettuce and spinach. Proper washing and preparation of fruits, vegetables, meat, poultry and fish is necessary in addition to eating a well balanced diet in order to maintain optimal health.
Imported Spices a Surprising Source of Salmonella Poisonings
By Kelly Young
Imported spices are frequently contaminated with salmonella, the New York Times reports.
The Times references a soon-to-be-released FDA analysis of 20,000 food shipments. The FDA found nearly 7% of spice lots had salmonella contamination. Other imported foods have about half that rate.
High contamination levels were found in shipments of coriander, oregano, basil, sesame seeds, curry powder, and cumin. Spices from Mexico and India had the highest rates of contamination, 14% and 9%, respectively. While bacteria living on spices can be killed by the high heat of cooking, contamination of table spices, like black pepper, is more problematic.
DNA sequencing of salmonella types has led the FDA to trace recent outbreaks to imported spices.
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Fluoroquinolones and Risk for Peripheral Neuropathy
The FDA now requires stronger safety warnings for disabling, potentially permanent nerve damage related to systemic fluoroquinolones.
Although a warning about peripheral neuropathy was added to the labels of injectable and orally administered fluoroquinolones in 2004, the FDA has received numerous additional reports of this potentially disabling adverse reaction. Symptoms can develop rapidly or at any time after starting therapy; they can last for months to years after stopping the offending drug. The FDA has not identified any specific risk factors.
The FDA is now requiring manufacturers to update fluoroquinolone drug labels and medication guides to better describe the potential for serious and possibly permanent nerve damage. Healthcare providers should educate patients about this adverse reaction when prescribing these drugs and urge them to contact the prescriber promptly if symptoms develop. For patients who experience symptoms of peripheral neuropathy, the fluoroquinolone should be stopped and replaced by an antibacterial of another class, unless the benefit of continuing the fluoroquinolone outweighs the risk.
Citation(s): U.S. Food and Drug Administration (FDA). FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection. Aug 15, 2013.
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Clopidogrel's (Plavix) Benefits Seen Mainly in Smokers
By Amy Orciari Herman
Clopidogrel appears to offer more protection against cardiovascular events among smokers than nonsmokers, according to a systematic review in BMJ.
Researchers examined data from six randomized trials comparing clopidogrel (alone or with aspirin) with control treatments (namely, aspirin alone or lower-dose clopidogrel plus aspirin). Nearly 75,000 patients with established cardiovascular disease, 30% of whom were smokers, were included.
Among smokers, clopidogrel was associated with a 25% reduction in the composite outcome of cardiovascular death, MI, or stroke; however, among nonsmokers, it conferred only an 8% reduction. (In a separate analysis, they also found that prasugrel or ticagrelor "seemed to be more efficacious" than clopidogrel in smokers and "marginally more efficacious" in nonsmokers.)
The researchers conclude: "Different risk-benefit considerations might be required for smokers and nonsmokers."

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Lower Overall Dose of Radiation in Fewer Treatments Effective for Breast Cancer, 10-Year Data Shows
By Kelly Young
Using a lower total dose of radiation in fewer, larger fractions for early breast cancer treatment is as effective as a longer, higher-dose course of radiotherapy, potentially with fewer side effects, according to a follow-up study in the Lancet Oncology.
In the START trials, some 4400 women underwent surgery for invasive breast cancer, followed by chemotherapy and endocrine treatment. They then received various doses of radiation: a total of 50 Gy in 25 fractions over 5 weeks (control group), 41.6 or 39 Gy in 13 fractions over 5 weeks, or 40 Gy in 15 fractions over 3 weeks.
The 10-year rate of local-regional relapse did not differ significantly among the groups. The 39- and 40-Gy treatment groups had fewer cases of telangiectasia and breast edema than the control group.
"I think treating patients in this fashion is both efficacious and cosmetically acceptable, and there may be some cost benefit," said NEJM Journal Watch's William Gradishar. "It would not be unreasonable to consider this for patients with early-stage disease."
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MM: This is another excellent use of a long standing supplement that has shown benefits for nausea and vomiting, has demonstrated safety and effectiveness in general and during pregnancy. Further assessment must be made to determine when this and other products are most effective so that consumers may benefit and not receive sub-therapeutic or inferior products. This is an instance where standardization should be implemented to support, protect and benefit the consumer.
J Natl Cancer Inst 2013 Aug 21; 105:1230
Does Ginseng Root Relieve Cancer-Related Fatigue?
In a double-blind trial, a carefully standardized preparation helped many patients.
Fatigue that is related to cancer and its treatment is notoriously difficult to manage. Ginseng root has a grass-roots reputation for efficacy in “balancing” body energy, and in vitro and animal data — supported by pilot studies in humans — have suggested that it might be useful for cancer-related fatigue. Mayo Clinic researchers conducted a multicenter, double-blind, placebo-controlled trial that involved 341 patients who received cancer diagnoses within 2 years of study entry and who complained of moderate fatigue as assessed by a standard scale. Powdered American ginseng root, prepared from a single production lot and standardized for quality and potency, was administered as two 500-mg capsules taken twice daily.
After 4 weeks, ginseng patients reported somewhat less fatigue than placebo patients; after 8 weeks, this difference reached both statistical and clinical significance on a variety of standard scales. Results were somewhat more dramatic for the 83 ginseng patients who were receiving radiation or chemotherapy while enrolled in the study, with significant improvements in fatigue at both 4 and 8 weeks. Toxicities attributable to ginseng were negligible.
Comment: Ginseng is believed to have anti-inflammatory effects and to downregulate the hypothalamic-pituitary-adrenal axis. Certainly, it seems safe enough for clinical use, and it has no known interactions with common chemotherapeutic agents. The big caveat is that the careful standardization measures taken in this study are unlikely to be available elsewhere, leaving patients at the mercy of the variability often seen in unregulated supplements. Editorial boards Journal Watch AIDS Clinical Care; Clinical Infectious Diseases Other New York Times medical writer
Citation(s): Barton DL et al. Wisconsin ginseng (Panax quinquefolius) to improve cancer-related fatigue: A randomized, double-blind trial, N07C2. J Natl Cancer Inst 2013 Aug 21; 105:1230.
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MM: Unfortunately people fall subject to misinformation, lack of information or blatant disinformation. When this happens they can make the wrong decisions. This may be the case when it comes to buying a car, an appliance or buying in to a surgery or medical procedure. Unfortunately, surgical removal of an organ or appendage is not generally reversible. That being said, women are entitled to receive accurate information of the risks of conditions and it is the responsibility of the health care practitioner (HCP) to provide that information. If we fail to be informative, then we have failed at that part of our job.
Women Who Elect Contralateral Prophylactic Mastectomy May Overestimate Risk
By Kelly Young
Many young women with unilateral breast cancer who choose to undergo prophylactic bilateral mastectomy overestimate their risk for cancer in the other breast, according to an Annals of Internal Medicine study.
Roughly 125 women aged 40 years and younger who had contralateral prophylactic mastectomy after a diagnosis of unilateral breast cancer completed surveys 2 years post-surgery. Most women (94%) said that improving their survival odds was an important factor in their decision, but only 18% thought that women who undergo contralateral prophylactic mastectomy live longer than those who don't.
Women who did not carry BRCA mutations estimated that 10% of women would develop contralateral breast cancer without prophylactic mastectomy within 5 years. The actual risk is 2%–4%. Mutation carriers had a more accurate risk perception.
Only 51% said their physicians provided reasons not to undergo surgery.
Editorialists write: "The apparent discordance between patient perceptions and realistic expectations provides a teachable opportunity for physicians treating newly diagnosed patients with breast cancer." They recommend that physicians communicate the actual risk, potential mastectomy complications, the odds of distant metastases, and mastectomy alternatives.
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Gastroenterology 2013 Aug; 145:320
Gluten Sensitivity Without Celiac Disease — A New Twist
Dietary constituents called “FODMAPs” complicate the idea of non-celiac gluten sensitivity.
Some people without celiac disease report gastrointestinal intolerance to gluten-containing foods. In 2011, Australian researchers conducted a controlled-diet study that boosted the case for “non-celiac gluten sensitivity” (NEJM JW Gen Med Apr 5 2011). Now, the same group has explored whether “FODMAPs” (Fermentable, Oligo-, Di-, Monosaccharides, And Polyols) might confound the perceived response to a gluten-free diet. FODMAPs are fermentable, poorly absorbed, short-chain carbohydrates that include fructose, lactose, fructans (found in wheat), galactans, and polyol sweeteners.
The trial included 37 patients with irritable bowel syndrome who reported gluten sensitivity, and whose evaluations for celiac disease were negative. During a 2-week run-in period, all patients followed a gluten-free, low-FODMAP diet. Then, in a randomized, double-blind, crossover format, each patient received high-gluten, low-gluten, and no-gluten diets (1 week for each diet, separated by 2-week washout periods).
During the low-FODMAP run-in period, mean symptom scores improved significantly. However, symptoms worsened during each of the three double-blind treatments — with no differences between the high-gluten, low-gluten, and no-gluten periods. Twenty-two patients repeated the whole study with 3-day (rather than 7-day) food challenges, and with dairy products and chemical food additives also eliminated from their diets. Again, symptoms worsened just as much with the no-gluten diet as with the gluten-containing diets.
Comment: In this study of non-celiac patients who reported previous gluten sensitivity, a gluten-containing diet was no more likely than a no-gluten diet to worsen symptoms in the presence of a low-FODMAP diet. Because many gluten-containing foods also are high in FODMAPs, the authors speculate that improved symptoms with a gluten-free diet actually might reflect simultaneous reduction in FODMAP intake. However, our understanding of non-celiac gluten sensitivity remains incomplete.
Citation(s): Biesiekierski JR et al. No effects of gluten in patients with self-reported non-celiac gluten sensitivity after dietary reduction of fermentable, poorly absorbed, short-chain carbohydrates. Gastroenterology 2013 Aug; 145:320.

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Most Medications Okay During Breast-Feeding
By Kelly Young
Most drugs taken by nursing mothers do not pose a risk to their infants, according to the American Academy of Pediatrics. However, an analysis of potential risks versus benefits is necessary for some agents, particularly those that concentrate in human milk, have long half-lives, or could result in clinically significant exposures in the infant, the group writes in Pediatrics.
The AAP provides a brief overview on painkillers, antidepressants, substance abuse treatments, and common herbal remedies. For more complete and current drug data, it recommends that clinicians turn to LactMed, part of the National Library of Medicine's Toxicology Data Network.
Evidence for lactation-stimulating drugs known as galactagogues (e.g., domperidone, which is not approved in the U.S.) is lacking. Instead, nursing mothers should consult a lactation specialist and use other measures to increase milk supply.
Maternal vaccines, with the exception of smallpox and yellow fever, may be safely administered during lactation.
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Nature 2013 Jul 11; 499:228
Clawing Your Way Back: Why Nails Are So Important
This groundbreaking work might point to a molecular path for regenerating limbs.
The distal tips of mammalian digits can regenerate following amputation, but only when the nail apparatus is intact. Coordinated regrowth of nail and distal phalanx involves nail epithelial cells and undifferentiated mesenchymal cells that form the “blastema,” which subsequently differentiates to reform the distal digit.
Takeo and colleagues explored the role of nail epithelial cells in tip regeneration by first localizing nail epithelial stem cells (NSCs). They used a clever trick in mice allowing every progenitor cell of a given keratin-14 (K14+)–expressing basal cell to be labeled and followed in space and time. They discovered that K14+ cells from the proximal nail matrix persisted for over 5 months, giving rise to the proximal and distal nail plates and bed cells. Progeny of distal matrix K14+ basal cells, by contrast, persisted for less than 3 months. The investigators concluded that long-lived NSCs reside in the proximal fold.
Next, they proved that the highly conserved Wnt signaling pathway — involved in cell differentiation, proliferation, and axis patterning in animals from invertebrates to humans — is required for nail differentiation. Upon amputation of the distal digits, mice lacking Wnt signaling failed to reinnervate and regenerate bone. Conversely, the inability to regenerate the digit following proximal amputation could be partially overcome by forcing elevated Wnt expression in the nail epithelium.
Comment: This groundbreaking work shows that the proximal nail matrix is the privileged site where nail stem cells reside and that Wnt signaling directs nail differentiation and coordinated reinnervation and regeneration of bone. These findings offer a potential molecular path for regenerating limbs following traumatic or developmental defects.
Citation(s): Takeo M et al. Wnt activation in nail epithelium couples nail growth to digit regeneration. Nature 2013 Jul 11; 499:228.

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N Engl J Med 2013 Aug 29; 369:830
Safety of Fluconazole During Pregnancy
First-trimester use of typical therapeutic doses of oral fluconazole was not associated with excess risk for birth defects overall, but risk for tetralogy of Fallot was significantly increased.
Vaginal candidiasis is common in pregnant women, who are often given 150-mg oral fluconazole (particularly for recurrent infections). Concern has been raised that higher doses of this medication during the first trimester confer excess risk for birth defects. Danish investigators linked national birth, prescription, and childhood health records to assess the effects of oral fluconazole on risk for birth defects when given at typical cumulative doses (mostly 150 or 300 mg) during the first trimester of pregnancy.
Nearly 1 million live born infants were studied, <1% of whom were exposed to fluconazole during the first trimester. Of these infants, 87% were exposed to <300 mg in total. First-trimester exposure was not associated with excess risk for birth defects overall (adjusted prevalence odds ratio, 1.1), nor with excess risk for 14 of 15 prespecified individual defects previously associated with azole agents. Risk for tetralogy of Fallot, however, was significantly increased (adjusted prevalence OR, 3.2).
Comment: This large, albeit retrospective, cohort study provides welcome safety data for common doses of fluconazole used during pregnancy. Overall risk for birth defects was not elevated, but prevalence of tetralogy of Fallot was higher among fetuses exposed even to low doses of fluconazole. Although absolute incidence of this defect was low among those exposed (an estimated 6.5 excess cases per 10,000 infants), and the possibility of a chance finding was increased given the number of specific defects examined, these data present some cause for restraint. Clinicians should keep in mind that topical preparations for yeast infections are first line, particularly during the first trimester — and these data should sway us away from fluconazole use merely for patients' convenience. On the other hand, for vaginitis refractory to topical therapies, women can be fairly well assured of the safety of this common medication.
Citation(s): Mølgaard-Nielsen D et al. Use of oral fluconazole during pregnancy and the risk of birth defects. N Engl J Med 2013 Aug 29; 369:830.
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JAMA 2013 Jul 17; 310:289
Kidney Injury and Androgen Deprivation Therapy
Among men with nonmetastatic prostate cancer, ADT was associated with excess risk for acute kidney injury.
Androgen deprivation therapy (ADT) for nonmetastatic prostate cancer, though somewhat common, remains controversial, given both the lack of level-1 evidence to support its routine use and the associated risks for adverse effects, including metabolic syndrome, osteoporosis, and impact on libido. Considering that ADT may also have a negative impact on renal function, as a result of treatment-induced testosterone suppression and its downstream consequences, investigators sought to determine the potential impact of ADT on the risk for acute kidney injury (AKI).
The researchers conducted a retrospective, nested, case-control analysis involving 10,250 men (age, ≥40) with nonmetastatic prostate cancer diagnosed from 1998 through 2008, with follow-up through 2009, and no history of metastatic disease or serious renal or liver disease. Patients were selected from the robust United Kingdom Clinical Practice Research Datalink in combination with the Hospital Episodes Statistics database. A total of 232 cases with first-ever AKI admission (incidence rate, 5.5 per 1000 person-years) were identified and matched with 2721 controls without AKI. ADTs were categorized as gonadotropin-releasing hormone agonists, oral antiandrogens, combined androgen blockade, bilateral orchiectomy, estrogens, or combinations of these treatments. ADT exposure was categorized as current use, past use, or never use.
Current use of any ADT significantly increased risk for AKI versus never use (OR, 2.48; 95% confidence interval, 1.61–3.82), generating a rate difference of 4.43 per 1000 persons per year (95% CI, 1.54–7.33). Past use did not significantly increase risk for AKI versus never use (OR, 1.25; 95% CI, 0.68–2.29).
Comment: Although provocative, these findings remain hypothesis-generating, and given that no prior study has addressed this issue, they must be replicated in other settings. Our current understanding of the risks associated with androgen deprivation therapy should preclude its routine use in patients with prostate-specific antigen (PSA)-only disease, especially in those with prolonged PSA doubling times.
Citation(s): Lapi F et al. Androgen deprivation therapy and risk of acute kidney injury in patients with prostate cancer. JAMA 2013 Jul 17; 310:289.
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Johnson & Johnson Recalls Mold-contaminated Vials
Johnson & Johnson recalled another product this week, pulling some vials of its antipsychotic treatment Risperdal Consta after discovering mold during routine quality testing. In recent years, J&J has issued dozens of recalls for a variety of products, costing it hundreds of millions of dollars in sales and prompting close government oversight of some manufacturing plants.

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