• FDA to Consider Moving Vicodin from Schedule III to Schedule II
• Painful Diabetic Neuropathy: A Three-Drug Comparison
• No Benefit of Vitamin D Supplementation for Knee Osteoarthritis
• The Effect of Milk Intake on Vitamin D and Iron Levels in Children
• Fructose and Glucose Ingestion Affect Appetite Pathways in the Brain Differently
• Hospitals Fire Employees Refusing Flu Shots
• Flu Activity Is High in Most of the Country
• Flu Vaccine Moderately Effective; Flu Season Possibly Peaking
• Trivalent Flu Vaccine — with Protein Grown in Insect Cells — Approved
• In Select Few, Autism Symptoms May Resolve
• Only Substantial Obesity Is Associated with All-Cause Mortality
• Why Do Fully Vaccinated Kids Get Pertussis?
• HBV Treatment Reverses Cirrhosis
• Smartphone Apps for Melanoma Detection Not So Smart
• Fecal Transplantation Effective for Recurrent C. difficile Infection
• Patients Would Accept Stool Transplant if Recommended by Their Physicians
• Defining Wheat Sensitivity Without Celiac Disease
• Double-Digit Rise in Insurance Premiums Causing Alarm in Several States
• Bisphosphonate-Associated Atypical Femur Fractures: A Case Series
• Grappling with Racial Disparities in Breast Cancer
MM: Since the propoxyphene analogs (Darvocet & Darvon) were removed from the shelves a couple of years ago, there are very few remaining narcotic analgesics (pain-killers) that are on the market today that are available with a simple prescription (only Tylenol® with Codeine and Vicodin®). There is no question in my mind that Vicodin®/Hydrocodone products are frequently abused but there are already significant barriers to patients who legitimately require pain medications. Changing the class of this family of products, in my opinion, is un-necessary and inappropriate. This however, does not mean that it will not occur. Unfortunately, converting a product to C2 status tends to place a stigma on its use and strikes fear into the hearts of practitioners who would otherwise order these medications. I do not think that this is an appropriate use of power or authority and that furthermore, it cripples legitimate treatment of pain for both the acute and chronic variety.
FDA to Consider Moving Vicodin from Schedule III to Schedule II
The FDA will consider whether to move Vicodin (hydrocodone and acetaminophen) from a schedule III to a schedule II drug, USA Today reports.
The reevaluation follows a 2009 request by the Drug Enforcement Agency. At the time, the DEA noted a substantial increase in hydrocodone-related emergency department visits, which have continued since then.
However, an analysis by Health and Human Services identified no evidence that a change in schedule would reduce abuse of drugs that contain hydrocodone.
As a schedule III drug, physicians can allow up to five refills on a 30-day prescription. This can give patients a 6-month supply. As a schedule II drug, patients would have to visit their physician every 30 days to renew their prescriptions.
http://www.usatoday.com/story/news/nation/2013/01/09/fda-might-tighten-reins-on-vicodin/1822211/
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MM: Mark Drugs has been working successfully with patients suffering from diabetic neuropathy for more than a decade. Many of the combination transdermal prescription cream and gel products that we compound relieve this life tormenting condition without drowsiness or other side effects that are commonly experienced from these medications. Please contact the staff at Mark Drugs for more information for you, your loved ones or your health care provider.
Diabetes Care 2012 Dec; 35:2451
Painful Diabetic Neuropathy: A Three-Drug Comparison
Amitriptyline, duloxetine, and pregabalin reduced pain to a similar extent.
Head-to-head comparisons of drugs commonly prescribed for painful diabetic neuropathy are scarce. In this double-blind trial, funded by a maker of pregabalin (an anticonvulsant; Lyrica), 83 patients (mean age, 65) with painful diabetic neuropathy were randomized to receive amitriptyline (a tricyclic antidepressant), duloxetine (a serotonin-norepinephrine reuptake inhibitor; Cymbalta), or pregabalin. Patients were treated for 4 weeks; total daily doses were titrated to a maximum of 75 mg of amitriptyline, 120 mg of duloxetine, and 600 mg of pregabalin.
At 4 weeks, mean pain scores had improved in all three groups, with no significant differences among groups. Duloxetine lessened sleep efficiency compared with the other two drugs, whereas pregabalin was associated with slightly worse cognitive function than the other two drugs. Adverse effects (particularly fatigue, dizziness, and somnolence) were most common with pregabalin. Premature withdrawal from the study due to adverse events occurred in six pregabalin recipients, three duloxetine recipients, and one amitriptyline recipient.
Comment: These three drugs had similar effects on painful diabetic neuropathy. Pregabalin was the least well tolerated, perhaps because of the high dose (note that target doses for duloxetine and pregabalin in this study were twice that of the FDA-approved maximal doses for diabetic neuropathy). Amitriptyline — by far the least expensive alternative — seems to be the winner here; however, many patients can't tolerate its anticholinergic side effects, and tricyclics are contraindicated in some patients with cardiac disease.
— Allan S. Brett, MD Published in Journal Watch General Medicine December 20, 2012
Citation(s): Boyle J et al. Randomized, placebo-controlled comparison of amitriptyline, duloxetine, and pregabalin in patients with chronic diabetic peripheral neuropathic pain: Impact on pain, polysomnographic sleep, daytime functioning, and quality of life. Diabetes Care 2012 Dec; 35:2451.
(http://dx.doi.org/10.2337/dc12-0656)
http://www.ncbi.nlm.nih.gov/pubmed/22991449?dopt=Abstract
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MM: I have to agree with the comments of Dr Schwenk. The duration of the study and the actual vitamin D goal level were too low. We have seen benefits to patients relative to OA and other pain conditions when 25 (OH) D levels reach the 60-80ng/ml level.
JAMA 2013 Jan 9; 309:155
No Benefit of Vitamin D Supplementation for Knee Osteoarthritis
A 2-year study might have been too short, but results still are discouraging.
Disruption of normal bone architecture in knee osteoarthritis (OA), combined with certain epidemiologic observations, led investigators to study the potential benefit of vitamin D supplementation in 146 adults with knee OA (mean age, 63; mean baseline 25-hydroxyvitamin D [25(OH)D] level, 22 ng/mL; most with knee malalignment and moderate-to-severe joint space narrowing and sclerosis). Participants were randomized to cholecalciferol (vitamin D3; 2000 IU daily) or placebo. Dosages in the intervention group were adjusted to achieve 25(OH)D levels >36 ng/mL; doses as high as 6000–8000 IU daily were required in several participants.
More than 80% of each group completed the 2-year trial, at which time knee pain was diminished slightly in both groups. No difference was found between the groups in pain, function, or loss of cartilage volume.
Comment: Perhaps 2 years was too little time, or the participants' baseline vitamin D levels were not low enough, or their osteoarthritis was too severe to permit detection of benefit — still, epidemiologic studies published during this study were less positive than those that inspired it in the first place. Although bone metabolism was the biological basis for exploring the benefit of vitamin D on knee OA, an alternative explanation that merits further study is the effect of vitamin D on neuromuscular fitness (which might help protect the knee before or during the onset of OA).
— Thomas L. Schwenk, MD Published in Journal Watch General Medicine January 15, 2013
Citation(s): McAlindon T et al. Effect of vitamin D supplementation on progression of knee pain and cartilage volume loss in patients with symptomatic osteoarthritis: A randomized controlled trial. JAMA 2013 Jan 9; 309:155.
(http://jama.jamanetwork.com/article.aspx?articleid=1556148)
http://www.ncbi.nlm.nih.gov/pubmed/23299607?dopt=Abstract
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MM: One of the confusing things about studies is the lack of a consistent use of units of measure. In the States we typically use ng/ml. In Europe and Canada nmol/L is used. The ratio of these units is roughly 2.5 to 1. That being said, the blood level of 25 (OH) D referenced in this study comes in at about 30ng/ml which is a bare minimum level to not exhibit disease and is distinctly insufficient and therefore the levels fail to achieve a sufficient concentration. The bottom line is that 2 glasses of milk a day is not adequate to reach acceptable levels of vitamin D.
Pediatrics 2013 Jan; 131:e144
The Effect of Milk Intake on Vitamin D and Iron Levels in Children
Consuming 2 cups of milk per day is sufficient to maintain healthy vitamin D levels without depleting iron levels for most children at northern latitudes.
Cow's milk consumption increases vitamin D levels; however, cow's milk can deplete iron stores in young children. The amount of intake required for sufficient stores of vitamin D and iron is poorly understood. Investigators recruited healthy children aged 2 to 5 years through a primary care practice research network in Toronto, Canada, over a 2-year period. They performed a cross-sectional analysis of the relationship between cow's milk and stores of vitamin D and iron. Cow's milk intake was assessed based on parental report. Serum 25-hydroxyvitamin D and ferritin levels were measured, and skin pigmentation, vitamin D supplementation, and season were noted.
Among 1311 children, higher cow's milk consumption was associated with higher 25-hydroxyvitamin D (P
0.0001) levels and lower serum ferritin (P<0.0001) levels in a dose-dependent fashion. Two cups (500 mL) of cow's milk per day maintained 25-hydroxyvitamin D levels >75 nmol/L with minimal negative effect on serum ferritin for most children. However, during the winter, children with darker skin types were vitamin D deficient at 2 cups of milk per day.
Comment: Consuming 2 cups of milk per day (500 mL) is sufficient to maintain healthy vitamin D levels without depleting iron levels for most children at latitudes similar to Toronto. Wintertime vitamin D supplementation is important for children with darker skin. Milk is only a good source of vitamin D because it is added to milk to fortify it. Salmon, shiitake mushrooms, and almond or soy milk are good vitamin D sources. Vitamin D can also be easily and safely taken as a supplement. In addition to promoting iron deficiency, cow's milk can aggravate acne and other inflammatory conditions in many people. Even though I grew up in America's dairy land, I ask parents to think twice about the amount of milk their children consume.
— Mary Wu Chang, MD Published in Journal Watch Dermatology January 18, 2013
Citation(s): Maguire JL et al. The relationship between cow's milk and stores of vitamin D and iron in early childhood. Pediatrics 2013 Jan; 131:e144.
(http://dx.doi.org/10.1542/peds.2012-1793)
http://www.ncbi.nlm.nih.gov/pubmed/23248224?dopt=Abstract
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MM: The chronic consumption of fructose (High Fructose Corn Syrup – HFCS) leads to increased obesity, insulin resistance, type 2 diabetes and a host of related conditions. This study nicely demonstrates the differences between the 2 chemicals and how they affect the brain.
JAMA 2013 Jan 2; 309:63
Fructose and Glucose Ingestion Affect Appetite Pathways in the Brain Differently
Fructose also resulted in lower peak levels of satiety hormones.
Fructose (usually in the form of high-fructose corn syrup) is added to processed foods and beverages because it is more intensely sweet than glucose — and its consumption has risen dramatically in parallel with obesity. Fructose ingestion has been linked to excessive caloric consumption and weight gain, but biological mechanisms for this association are unclear. Investigators recruited 20 normal-weight, healthy young adults to assess the effects of fructose versus glucose ingestion on cerebral blood flow as a proxy for neuronal activity (measured with functional magnetic resonance imaging [fMRI]) in areas associated with appetite control; levels of satiety hormones also were measured. In two blinded sessions, participants consumed 75 g of either glucose or fructose (equivalent to two 12-oz beverages) after overnight fasts, then underwent fMRI and blood sampling.
Changes in blood flow in brain areas associated with hunger and reward (i.e., hypothalamus, thalamus, insula, cingulate cortex, fusiform gyrus, and striatum) differed significantly, depending on whether glucose or fructose had been ingested. Complex fMRI analyses suggested that these differences in blood flow delineated areas that preferentially promote glucose-induced satiety. Compared with glucose, fructose was associated with lower peak levels of hormones associated with satiety (e.g., insulin, glucagon-like polypeptide 1).
Comment: These results have no immediate clinical value but might help clinicians in discussions with patients (or their parents) about the potential risks associated with fructose consumption. This sweet habit might result in weight gain by not effectively promoting satiety.
— Thomas L. Schwenk, MD Published in Journal Watch General Medicine January 15, 2013
Citation(s):Page KA et al. Effects of fructose vs glucose on regional cerebral blood flow in brain regions involved with appetite and reward pathways. JAMA 2013 Jan 2; 309:63.
(http://dx.doi.org/10.1001/jama.2012.116975)
http://www.ncbi.nlm.nih.gov/pubmed/23280226?dopt=Abstract
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Hospitals Fire Employees Refusing Flu Shots
Hospitals' stringent measures coincide with an earlier-than-usual and very serious flu season, where at least 20 children have died. Most doctors and nurses get flu shots, however, in the past two months, at least 15 nurses and other hospital staffers in four states have been fired for refusing, and several others have resigned, according to affected workers, hospital authorities, and published reports.
http://www.journalnow.com/news/local/article_88c69c40-5f90-11e2-84a8-001a4bcf6878.html
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MM:The CDC can’t possibly be so out of touch that they ignore all the legitimate clinical follow-up data that is available that unequivocally states that Tamiflu® is virtually worthless. What is the problem here?
Flu Activity Is High in Most of the Country
By Cara Adler
Influenza activity is rising and much of the country is seeing high levels of influenza-like illness, the CDC reported Friday.
The CDC's latest weekly FluView report shows that the proportion of visits to a healthcare provider for influenza-like illness was elevated for 4 consecutive weeks and had reached 5.6% during the week ending December 29. For comparison, that proportion peaked at 2.2% during last year's relatively mild season and at 7.7% during the 2009 H1N1 pandemic. As of December 29, 41 states reported widespread flu activity and 29 states and New York City reported high levels of influenza-like illness.
The CDC continues to recommend influenza vaccination for people who have not yet been vaccinated and treatment with oseltamivir (Tamiflu) or zanamivir (Relenza) — regardless of vaccination status — as soon as possible for people with severe influenza illness and for those with flu symptoms who are at high risk for complications.
http://www.cdc.gov/flu/spotlights/flu-activity-picks-up.htm
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MM: From week to week the story seems to change. I wonder what next week will bring. Aren’t slow news days wonderful?
Flu Vaccine Moderately Effective; Flu Season Possibly Peaking
By Christine Sadlowski
The influenza vaccine appears to be about 62% effective, according to early CDC data released Friday.
The estimate was based on about 1200 patients presenting with acute respiratory infection, over 400 of whom tested positive for influenza. All of the subtyped influenza A strains were A(H3N2).
Also on Friday, the CDC said it's possible that influenza may have peaked in some regions. The number of states reporting high influenza-like activity declined (24 vs. 29 the week before) and fewer people were seeking medical care for influenza-like illness (4.3% vs. 6%).
In his blog Journal Watch HIV and ID Observations, Paul Sax writes that despite his "unequivocal" support for influenza vaccination, "in the court of public opinion, it just can't win."
Meanwhile, Journal Watch Cardiology editor Harlan Krumholz discusses in Forbes several flaws in the evidence supporting oseltamivir's effectiveness.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm62e0111a1.htm?s_cid=mm62e0111a1_x
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Trivalent Flu Vaccine — with Protein Grown in Insect Cells — Approved
By Kristin J. Kelley
The FDA has approved the first recombinant protein-based influenza vaccine. Flublok — indicated for adults aged 18 to 49 — is produced using insect (fall armyworm) cells instead of eggs. The vaccine protects against two strains of influenza A (H1N1 and H3N2) and one strain of influenza B.
In a randomized study encompassing nearly 5000 people, Flublok was 44.6% effective against all circulating strains of influenza — not just those matching the strains in the vaccine — compared with placebo. Side effects included fatigue, headache, and pain at the injection site.
The manufacturer expects to have 150,000 doses of the vaccine to be available for the current flu season, which according to the CDC, hasn't peaked yet in parts of the country.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm335891.htm
http://www.nytimes.com/2013/01/17/business/flublok-a-flu-vaccine-wins-fda-approval.html?_r=0
http://www.nytimes.com/2013/01/17/business/flublok-a-flu-vaccine-wins-fda-approval.html?_r=0
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In Select Few, Autism Symptoms May Resolve
By Kelly Young
Patients may be asking about a study summarized in the New York Times indicating that in a minority of cases, patients with autism spectrum disorders may recover.
Thirty-four people who were diagnosed with autism spectrum disorder before the age of 5 but who no longer met the criteria were compared with people with high-functioning autism and people with typical development. People with a history of autism scored as well on communication and social skills tests as people with typical development. Three of the 34 had difficulty on a facial recognition test.
The study's authors say it is still not clear how many children with current autism diagnoses will be able to recover or what intervention produces the highest rate of recovery.
"I want to stress to parents that it's a minority of kids who are able to do this, and no one should think they somehow missed the boat if they don't get this outcome," one of the authors told the Times.
http://onlinelibrary.wiley.com/doi/10.1111/jcpp.12037/full
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MM: A person does not have to be a skinny mini to be healthy and improve their quality of life along with the length of their life and the decrease of chronic disease. The use of the HCG weight loss protocol can help many people obtain a weight range that is beneficial. Contact the staff at Mark Drugs for more information.
JAMA 2013 Jan 2; 309:71
Only Substantial Obesity Is Associated with All-Cause Mortality
In a meta-analysis, being modestly overweight was somewhat protective.
The reported relation of overweight or obesity to mortality for any given follow-up has been inconsistent, because studies have used varying definitions and categories of normal weight and obesity. In this meta-analysis, researchers identified 97 studies, mostly from the U.S., Europe, and Australia (2.88 million participants and >270,000 deaths), in which weight categories were standardized. Participants were categorized by body-mass index (BMI) as normal weight (18.5 to <25 kg/m2), overweight (25 to <30), grade 1 obese (30 to <35), grade 2 obese (35 to <40) and grade 3 obese (
40).
Compared with normal-weight participants, all-cause mortality was significantly lower for overweight participants (hazard ratio, 0.94), was similar for grade 1 obesity (HR, 0.95), and was significantly higher for grade 2 and grade 3 obesity (HR, 1.29). Results were similar when analysis was limited to studies that were considered to be appropriately adjusted (neither overadjusted for possible causal pathways between obesity and mortality, nor underadjusted for age, sex, and smoking status).
Comment: These results call into question, as have prior data, the assumption that mild overweight or low-grade obesity are associated with early all-cause mortality. Editorialists note that BMI does not account for demographic, racial, and other differences in how fat is stored or for the independent association of cardiorespiratory fitness with mortality, regardless of weight. Healthcare advances might have traded mortality for substantial morbidity and lower quality of life in patients with mild obesity, which would not be captured by this study. Weight and BMI provide useful, but imperfect, data for counseling patients.
— Thomas L. Schwenk, MD Published in Journal Watch General Medicine January 17, 2013
Citation(s): Flegal KM et al. Association of all-cause mortality with overweight and obesity using standard body mass index categories: A systematic review and meta-analysis. JAMA 2013 Jan 2; 309:71. (http://dx.doi.org/10.1001/jama.2012.113905)
http://www.ncbi.nlm.nih.gov/pubmed/23280227?dopt=Abstract
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JAMA 2012 Nov 28; 308:2126
Why Do Fully Vaccinated Kids Get Pertussis?
Immunity wanes after the full series, but completing five doses is still our best option for prevention.
In 2010, California suffered a large pertussis outbreak; in addition to significant infant mortality, a high disease burden was seen in 7- to 10-year-olds. Investigators used 2010 data from 15 California counties to examine the association between pertussis and time since completion of the five-dose diphtheria, tetanus, and acellular pertussis (DTaP) series.
Among 682 pertussis cases in children aged 4 to 10 years and 2016 controls, cases were significantly more likely than controls to be unvaccinated (7.8% vs. 0.9%) and to be older (median age, 9 vs. 7 years). Unvaccinated children were 8.9 times more likely to contract pertussis than fully vaccinated children. Among children who completed the five-dose series, the odds for pertussis increased with time since administration of the fifth dose (odds ratios ranged from 0.02 in the 12 months since last dose to 0.29 at 60 months or longer). Vaccine efficacy decreased during this period from 98.1% within the first year to 71.2% after 60 months.
Comment: This decline in vaccine efficacy is disappointing, but it does explain the phenomenon, noted by many practitioners, of many fully vaccinated children acquiring pertussis. The results also confirm that lack of vaccination continues to be a major risk factor for pertussis. Some concern exists that the waning immunity might be partially due to the switch from whole-cell to acellular vaccine, but until more research is available, completion of the initial full five-dose series remains our best option for prevention.
— Peggy Sue Weintrub, MD Published in Journal Watch Pediatrics and Adolescent Medicine January 16, 2013
Citation(s): Misegades LK et al. Association of childhood pertussis with receipt of 5 doses of pertussis vaccine by time since last vaccine dose, California, 2010. JAMA 2012 Nov 28; 308:2126.
http://www.ncbi.nlm.nih.gov/pubmed/23188029?dopt=Abstract
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MM: This is very exciting data at first glance. The appropriate follow-up question is “For how long?” Viruses, like bacteria are extremely adaptive and tend to survive most treatments over the long haul. The bottom line is that an ounce of prevention is worth a pound of cure. We need to focus on means of disease prevention as well as disease treatment. I would hate to think that people would become less vigilant just because they think that there is a “cure” for Hepatitis B.
Lancet 2012 Dec 10
HBV Treatment Reverses Cirrhosis
Nearly three quarters of hepatitis B virus–infected patients with cirrhosis at baseline were no longer cirrhotic after 5 years of tenofovir therapy.
Hepatitis B virus (HBV) is a common cause of cirrhosis, end-stage liver disease, and hepatocellular carcinoma, particularly in areas of the world where infection rates are high. Although short-term studies have shown that tenofovir and other antiviral drugs lead to improvement in liver histology, the effect of extended treatment on severe hepatic fibrosis or cirrhosis is less certain. Now, investigators have evaluated the effect of long-term tenofovir use on liver histology in a large number of HBV-infected patients.
Of 641 patients participating in double-blind, phase III trials comparing tenofovir with adefovir therapy for 48 weeks, 585 entered a manufacturer-sponsored, open-label study in which they were to receive 7 additional years of tenofovir therapy; 348 of these patients had liver biopsies performed at baseline and again after 240 weeks of treatment. Liver histology was improved in 87% of these patients at year 5; individuals with the most pretherapy liver injury showed the greatest improvement. Strikingly, of 96 patients with cirrhosis prior to treatment, 74% were no longer cirrhotic at year 5 of therapy. Patients with lower body-mass indexes were more likely to have fibrosis regression. Only 12 patients developed hepatocellular carcinoma, and only 2 developed decompensated liver disease. Virologic breakthrough was uncommon, and no resistance to tenofovir was detected.
Comment: This large trial demonstrates that long-term suppression of HBV replication results in improved liver histology, even in patients who have previously developed cirrhosis. The low rates of hepatocellular carcinoma and end-stage liver disease in patients receiving tenofovir suggest that effective antiviral therapy will lead to improved survival — as has recently been demonstrated in patients treated successfully for hepatitis C virus infection (JAMA 2012; 308:2584).
— Rajesh T. Gandhi, MD Published in Journal Watch Infectious Diseases January 9, 2013
Citation(s): Marcellin P et al. Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: A 5-year open-label follow-up study. Lancet 2012 Dec 10; [e-pub ahead of print].
(http://dx.doi.org/10.1016/S0140-6736(12)61425-1)
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Smartphone Apps for Melanoma Detection Not So Smart
By Cara Adler
Smartphone apps for helping nonclinicians determine whether their skin lesions might be benign or malignant are not accurate, according to a study published in JAMA Dermatology.
Researchers tested the performance of four apps that evaluate photographs of skin lesions to assess risk for melanoma. Three apps missed more than 30% of histology-confrmed melanomas. Sensitivity of the apps varied from 7% to 98%.
The authors caution that "reliance on these applications, which are not subject to regulatory oversight, in lieu of medical consultation can delay the diagnosis of melanoma and harm users."
http://archderm.jamanetwork.com/article.aspx?articleid=1557488#qundefined
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Fecal Transplantation Effective for Recurrent C. difficile Infection
By Kelly Young
Donor feces infusion effectively treated recurrent Clostridium difficile infection in an open-label trial in the New England Journal of Medicine.
Forty-three patients with relapsing C. difficile infection were randomized to a standard vancomycin regimen, or vancomycin with bowel lavage, or an abbreviated vancomycin treatment followed by bowel lavage and a duodenal infusion of donor feces.
The trial was terminated early because of high rates of recurrence in the control groups. After the first infusion, 81% of patients in the fecal infusion group were cured, defined as the absence of diarrhea without relapse within 10 weeks. An additional 13% were cured with a second infusion from another donor. The cure rates in the vancomycin and the vancomycin–bowel lavage groups were 31% and 23%.
An editorialist concludes that these results "represent a clear precedent in which planned therapeutic manipulation of the human intestinal microbiota can lead to demonstrable, clinically important benefits, thereby bringing [fecal microbiota transplantation] to the mainstream of modern, evidence-based medical practice."
http://www.nejm.org/doi/full/10.1056/NEJMoa1205037
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Clostridium difficile infection. Clin Infect Dis 2012 Dec 15; 55:1652
Patients Would Accept Stool Transplant if Recommended by Their Physicians
On a survey, only a small percentage found it too gross to consider.
Stool transplantation (now, sometimes known by the more elegant name of fecal microbiota transplantation [FMT]) is the safest and most effective treatment for recurrent Clostridium difficile infection (CDI). FMT involves recolonizing the gastrointestinal tract with microbes from stool provided by a healthy volunteer; the stool suspension is infused via a nasogastric tube or rectally. Despite its efficacy, implementation has been slow, partially because of logistic difficulties and partially because of aesthetic considerations.
But, how unappealing do patients actually find FMT? Investigators surveyed 400 patients who attended a single clinic; the survey described recurrent CDI and elicited treatment preferences. Response rate was about 50%; most respondents were women (70%), white (94%), and age 50 or older (59%).
Respondents were informed that chances of cure were 65% with antibiotics and 90% with a technique called "floral reconstitution" (initially, floral reconstitution was not described further). Eight-five percent said they would opt for floral reconstitution; after they were apprised of floral reconstitution's full nature, 81% still opted for it. If floral reconstitution could be packaged in an odorless, colorless pill, 90% would accept it; if the patient's physician recommended floral reconstitution (in any form), 94% would accept it. Reasons for declining floral reconstitution included concerns about safety or efficacy, and, for about 40% of those who declined (a small percentage), that it was just "too gross." Older age predicted higher likelihood of accepting floral reconstitution.
Comment: This survey suggests most patients can deal with the prospect of FMT just fine. One suspects that a survey of patients actually in the throes of recurrent CDI would uncover even more enthusiasm for a likely cure.
— Abigail Zuger, MD Published in Journal Watch General Medicine January 15, 2013
Citation(s): Zipursky JS et al. Patient attitudes toward the use of fecal microbiota transplantation in the treatment of recurrent Clostridium difficile infection. Clin Infect Dis 2012 Dec 15; 55:1652.
(http://dx.doi.org/10.1093/cid/cis809)
http://www.ncbi.nlm.nih.gov/pubmed/22990849?dopt=Abstract
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Am J Gastroenterol 2012 Dec; 107:1898
Defining Wheat Sensitivity Without Celiac Disease
Clinical characteristics included higher rates of anemia and weight loss than seen with irritable bowel syndrome.
Wheat sensitivity in the absence of celiac disease is increasingly considered a distinct clinical condition. To describe clinical, serological, and histological markers of the condition, researchers retrospectively examined data from a group of 920 patients with irritable bowel syndrome (IBS)–like symptoms who were diagnosed with nonceliac wheat sensitivity using a double-blind, placebo-controlled wheat challenge.
Two hundred and seventy-six patients (30%) were identified with wheat sensitivity — 70 with wheat sensitivity alone and 206 with multiple food hypersensitivity including wheat sensitivity. Clinical characteristics of these 276 patients in comparison with 2 control groups (50 patients with IBS and 100 patients with celiac disease) included anemia (24% vs. 8% of the IBS group and 78% of the celiac group), intermediate weight loss (35% vs. 4% and 52%, respectively), self-reported wheat intolerance (50% vs. 14% and 22%), history of food allergy in infancy (18% vs. 4% and 6%), concomitant atopy (29% vs. 6% and 8%), and median number of endoscopies (3.5 vs. 0.5 and 1).
Serologic findings in all 276 patients with wheat sensitivity showed 40% with positive IgA antigliadin antibodies and 55% with positive IgG antigliadin antibodies. Histologic findings showed 90% with intraepithelial lymphocytosis in the duodenum (compared with 0% in the IBS group), a higher eosinophil count than those in the IBS or celiac groups (63 per 10 high-power fields vs. 31 and 38, respectively), and histologic abnormalities of the colon, including 60% with eosinophilic infiltration in the lamina propria and 63% with intraepithelial eosinophils (vs. 3% and 0%, respectively, in the IBS group). Compared with the 206 patients with multiple food hypersensitivity, the 70 patients with wheat sensitivity alone were more likely to be anemic or experience weight loss but less likely to self report wheat intolerance, have coexistent atopy, or have IgG antigliadin antibodies. The two groups also differed in several histologic markers, including fewer eosinophils per 10 high-power fields in the duodenum among patients with wheat sensitivity alone (43 vs. 70).
Comment: This study provides a useful, detailed characterization of wheat sensitivity, which for many of us is a new clinical entity, albeit one that is fairly common among patients with irritable bowel syndrome.
— Douglas K. Rex, MD Published in Journal Watch Gastroenterology January 11, 2013
Citation(s): Carroccio A et al. Non-celiac wheat sensitivity diagnosed by double-blind placebo-controlled challenge: Exploring a new clinical entity. Am J Gastroenterol 2012 Dec; 107:1898.
http://www.ncbi.nlm.nih.gov/pubmed/22825366?dopt=Abstract
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Double-Digit Rise in Insurance Premiums Causing Alarm in Several States
Small businesses and people without employer-provided health insurance are vulnerable to big hikes in insurance premiums — over 20% in some cases — because some state insurance regulators don't have the authority to deny excessive increases, the New York Times reports.
The California insurance commissioner said that without the authority to deny increases, insurance companies can raise rates like they did before the Affordable Care Act was passed. The commissioner, Dave Jones, is quoted in the Times as saying, "This is business as usual. It's a huge loophole in the Affordable Care Act."
According to the Times report, Anthem Blue Cross in California has proposed 26% increases for some policy holders. Florida and Ohio have seen similar increases, which can amount to several hundred dollars a month.
http://www.nytimes.com/2013/01/06/business/despite-new-health-law-some-see-sharp-rise-in-premiums.html?_r=0
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J Clin Endocrinol Metab 2012 Dec; 97:4324
Bisphosphonate-Associated Atypical Femur Fractures: A Case Series
Index fractures occurred after a mean 9 years of bisphosphonate therapy.
The prescribing information for bisphosphonates now includes a warning about the potential complication of atypical low-energy femur fractures (AFFs) involving the shaft below the trochanteric region. This case series of 81 patients (78 women) with AFFs has an unusual genesis: The lead author (a physician) began an online support group for patients with AFFs, collected detailed information from them, and verified reported cases by reviewing radiographs.
Seventy-one patients had complete fractures, and 10 had stress fractures. Mean duration of previous bisphosphonate therapy was 9 years. Two thirds of patients who received the drug had osteopenia, not osteoporosis. An astonishing 40% of patients suffered contralateral AFFs a mean 10 months after index fractures. Among the 71 patients with complete fractures, 77% had prodromal thigh or hip pain for several months, and 38% reported delayed healing after treatment. One third of patients reported having metatarsal fractures during or after bisphosphonate treatment.
Comment: Critical take-home points emerge from this report. First, clinicians should take seriously new complaints of hip or thigh pain in long-term recipients of bisphosphonate therapy. Second, clinicians should order bone-density testing only when indicated and not rush to prescribe bisphosphonates for osteopenic patients whose fracture risk is otherwise low (based on clinical and demographic risk factors); among such patients, the potential harms of these agents could outweigh the benefits.
— Allan S. Brett, MD Published in Journal Watch General Medicine January 3, 2013
Citation(s): Schneider JP et al. Atypical femur fractures: 81 individual personal histories. J Clin Endocrinol Metab 2012 Dec; 97:4324.
(http://dx.doi.org/10.1210/jc.2012-2590)
http://www.ncbi.nlm.nih.gov/pubmed/23076349?dopt=Abstract
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MMWR Morb Mortal Wkly Rep 2012 Nov 16; 61:922
Grappling with Racial Disparities in Breast Cancer
For multiple reasons, black women in the U.S. have lower incidence but substantially higher breast cancer mortality than white women.
Declining breast cancer incidence and improved outcomes in the U.S. and other developed countries represent progress that, hopefully, will continue. Nonetheless, a recent CDC report indicates that these favorable outcomes do not reach all black women. Breast cancer incidence, stage at diagnosis, and mortality were calculated using U.S. Cancer Statistics data for black women and white women from 2005 through 2009. Mortality ratios and mortality-to-incidence ratios (an indication of prognosis after diagnosis) were calculated by race.
Despite having lower incidence, black women had 41% higher breast cancer mortality than white women. Fewer black women were diagnosed with localized disease — and for every 100 breast cancers diagnosed, black women had 9 more deaths than white women (27 versus 18 deaths per 100 breast cancers diagnosed).
Comment: These data confirm previous U.S. reports suggesting racial disparities in breast cancer outcomes. The numbers are not simple to explain, but probably result from multiple factors related to socioeconomic issues, access to care, and biological differences between breast cancer in whites and blacks. Among women older than 40, utilization of screening mammography is declining in patients with less education and no health insurance. Black women are less likely than their white counterparts to undergo sentinel lymph node biopsy (now a standard procedure) and axillary dissection. Although black patients frequently present with later-stage disease than do whites, analyses adjusted for age and disease stage show that black patients have worse outcomes, suggesting that breast cancer in blacks and whites is biologically distinct. Indeed, breast cancer in blacks is more often negative for estrogen receptors, progesterone receptors, and human epidermal growth factor receptor 2 ("triple-negative" breast cancer; JW Womens Health Apr 30 2009) or of the basal subtype. Triple-negative breast cancer has a more aggressive phenotype and worse prognosis. In addition, obesity (which has been attributed to worse outcomes) is more prevalent in black women than in white women. All of these factors must be addressed in order to diminish the racial differences in breast cancer outcomes.
— William J. Gradishar, MD Published in Journal Watch Oncology and Hematology January 8, 2013
Citation(s): Centers for Disease Control and Prevention (CDC). Vital signs: Racial disparities in breast cancer severity — United States, 2005–2009. MMWR Morb Mortal Wkly Rep 2012 Nov 16; 61:922.
http://www.ncbi.nlm.nih.gov/pubmed/23151952?dopt=Abstract
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