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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
March 1, 2014

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Might Estrogen Prevent Glaucoma?
Response to Oral Vitamin D Supplementation in Obese Adults
U.K Geriatrician: Statins, Antihypertensives "Greatly" Overprescribed for Adults 80 & Older
Rethinking Screening Mammography
Are Dietary FODMAPs a Cause of Irritable Bowel Syndrome
Do Bleach Baths Prevent Recurrent Staph (MRSA) Infections?
Trends in Breast Reconstruction After Mastectomy
Do Mediterranean Diets Prevent Type 2 Diabetes?
Not All Football Helmets Are Equal
Irreproducible Results? Stem-Cell Advance Found hard to Duplicate
Stem Cells Now Seem Easier to Make
Leukemia Succumbs to Patients' Own T-Cells
Endocrine Society Offers Statement on Testosterone After Recent Reports
Adult Tonsillectomy Shown to be Safe

MM: Compounding pharmacies and pharmacists are uniquely positioned to work with patients who may benefit from compounded sterile estrogen eye drops. An advantage of this approach would be limiting possible adverse systemic reactions and possibly eliminating the need to otherwise spend time, energy and money to balance hormones systemically. This would simplify treatment plans and limit consumer expense.
JAMA Ophthalmol 2014 Jan 30
Might Estrogen Prevent Glaucoma?
A large observational study suggests estrogen may lower risk for open-angle glaucoma.
Sex steroids may play a preventive role in the genesis of primary open-angle glaucoma (POAG) by lowering intraocular pressure or protecting retinal ganglion cells. Using data from a nationwide managed-care claims database, investigators assessed the incidence of POAG in >150,000 women (mean age, 65; 81% white, 4% black, 4% Latina, 2% Asian-American) who used estrogen-alone therapy (ET) or estrogen-progestin therapy (EPT), or who never used menopausal hormone therapy (HT). Eligible enrollees had ≥2 visits to an eye care provider from 2001 through 2009.
Incidence of POAG was 2.1% in nonusers of HT, 1.9% in EPT users, and 1.7% in ET users. In adjusted multivariable analysis, the reduced incidence of POAG with ET use remained statistically significant; no such association with EPT persisted. For each additional month of ET use, risk for POAG was reduced by 0.4% (P=0.02).
Comment: In addition to use of estrogen therapy, both white race and high socioeconomic status were associated with lower incidence of POAG, raising the possibility of confounding not fully addressed by the multivariable analysis in this observational study. My sense is that the authors see these findings as more intriguing from a therapeutic rather than a preventive standpoint. Given that these findings are congruent with those from animal studies as well as other large cohort studies, more research (with systemic ET as well as estrogen-containing eye drops) seems warranted.  
Citation(s): Newman-Casey PA et al. The potential association between postmenopausal hormone use and primary open-angle glaucoma. JAMA Ophthalmol 2014 Jan 30; [e-pub ahead of print].
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MM: These clinical results mimic what we have seen in our clinical practice. We have also seen that when people lose a significant amount of weight/fat their vitamin D levels tend to go up and are easier to maintain at a higher level.
J Clin Endocrinol Metab 2013 Dec; 98:484
Response to Oral Vitamin D Supplementation in Obese Adults
Despite a dose-response effect on average, individual responses vary widely.
On average, obese people have lower serum vitamin D levels and require higher doses of supplemental vitamin D to correct deficiency than do nonobese people. To examine dose-response effects, researchers randomized 62 adults with high body-mass index (BMI; (30–58 kg/m2) to receive 1000, 5000, or 10,000 IU of oral vitamin D3 daily for 5 months. The study was conducted during winter months in Nebraska (when skin synthesis of vitamin D is minimal). At baseline, mean serum hydroxyvitamin D (25[OH]D) level was 23 ng/mL.
A dose-response effect was noted. Mean serum 25(OH)D levels increased by 12 ng/mL, 28 ng/mL, and 48 ng/mL in the 1000, 5000, and 10,000 IU groups, respectively. However, participants varied widely in individual responses: The ranges of increase in serum 25(OH)D in the three dosing groups were 2 to 39 ng/mL, 13 to 46 ng/mL, and 16 to 83 ng/mL, respectively. The incremental response to a given vitamin D dose varied inversely with BMI, but vitamin D dose was more important than BMI in predicting response to supplementation.
Comment: This study provides information on the response to vitamin D supplementation in obese patients. The wide range of individual responses might reflect genetic variability in binding proteins and in vitamin D hydroxylation. In comparing these results to previous findings in nonobese cohorts, the authors estimate that the response to a given vitamin D dose is roughly 30% lower in obese than in nonobese people — presumably because vitamin D is diluted in body tissue mass.
Citation(s): Drincic A et al. 25-hydroxyvitamin D response to graded vitamin D3 supplementation among obese adults. J Clin Endocrinol Metab 2013 Dec; 98:4845.

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MM: I have long held the opinion that aggressive treatment of high blood pressure and elevated cholesterol levels in older patients is not warranted. This data supports that position. Aggressive lowering of BP leads to an increase in the risk of dizziness and falling leading to broken hips and other bones. The use of statins increases muscle pain and diminishes Quality of Life without showing a significant improvement in mortality in this patient group.
U.K Geriatrician: Statins, Antihypertensives "Greatly" Overprescribed for Adults 80 & Older
By Amy Orciari Herman
"The data strongly suggest that we are over-treating many healthy patients aged 80+ regarding stroke prevention," concludes U.K. geriatrician Kit Byatt in a perspective published in Evidence-Based Medicine.
Byatt offers a brief review of the evidence, noting that the large HYVET study in China and Europe showed only modest stroke-prevention benefits with antihypertensive therapy in those aged 80 and older. Similarly, the PROSPER trial, a large study of pravastatin in patients aged 70 to 82 in Europe, failed to find a significant stroke-prevention benefit with treatment. Byatt also notes that morbidity associated with statins may be underestimated
He writes: "We need actively to rethink our priorities and beliefs about stroke prevention, actively informing and involving the views of the key person, the patient. Most of the patients will probably eschew the modest potential benefit, preferring the reduced burden of polypharmacy and side effects judged as 'minor' by the prescriber."
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MM: Mammography leads to over-diagnosis and mis-diagnosis in more than 20% of women. Unfortunately, we still lack a viable test or screening that does a better job. The data indicates that the difference between those who were screened compared to those who were not was a mere 1% who died from breast cancer. These are paltry results from a procedure that has had so much support, use and applause from the lay and medical communities and does not support its' continued frequent use or recommendation for patients who are not at high risk or have multiple risk factors for breast cancer.
BMJ 2014 Feb 11; 348:g366
Rethinking Screening Mammography
Long-term Canadian study confirms overdiagnosis and lack of mortality benefit — where should we go from here
Randomized trials conducted from the 1960s to the 1980s indicated that screening mammography reduced breast cancer mortality (Cochrane Database Syst Rev 2013; 6:CD001877), but these studies were conducted in an era when breast cancer treatments were less effective and women's awareness of breast cancer less keen.
Now, Canadian investigators report findings from 25 years of follow-up in a screening mammography trial that was initiated in 1980 and involved some 90,000 women aged 40 to 59. All participants underwent baseline clinical breast examinations by trained clinicians. Women aged 40 to 49 were randomized to 5 annual mammograms (plus annual breast examinations) or to usual care. Women aged 50 to 59 were randomized to 5 annual mammograms (plus annual breast examinations) or to annual breast examinations only. Outcomes were tracked during the 5-year screening period and subsequent follow-up through 2005.
During the screening period, 484 of 666 cancers in the mammography group were screen detected. During the entire study period, breast cancer was diagnosed in 3250 and 3133 women in the mammography and no-mammography groups, respectively; 500 and 505 women died from breast cancer. The 25-year cumulative mortality from breast cancer was similar among women in the mammography and no-mammography groups, and these findings did not vary with age. Within 15 years of baseline, an excess of 106 cases of breast cancer were identified with screening mammography; thus, 22% of screen-detected cancers (106/484) represented overdiagnosed breast tumors.
Comment: These findings echo those of other recent studies of breast cancer screening (NEJM JW Womens Health Sep 22 2010 and NEJM JW Womens Health Aug 11 2011). Mammograms are expensive (NEJM JW Womens Health Feb 10 2014) and have high rates of false-positive findings (NEJM JW Womens Health Jan 17 2014). For decades, we have marched to the drumbeat “Mammograms Save Lives.” Annual screens have become an easy recommendation to make — and for our patients, the reassurance that accompanies a normal mammogram is comforting. Many women will be perplexed by this new information; others may view it with suspicion. While we await updated guidance from professional societies, my approach is to encourage patients to follow the 2009 U.S. Preventive Services Task Force guidelines: In average-risk women, screen every 2 years beginning at age 50.
Citation(s): Miller AB et al. Twenty five year follow-up for breast cancer incidence and mortality of the Canadian National Breast Screening Study: Randomised screening trial. BMJ 2014 Feb 11; 348:g366.

Kalager M et al. Too much mammography. BMJ 2014 Feb 11; 348:g1403.

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MM: Many people have adopted a gluten free or low gluten diet. The question then arises whether the reason that they are feeling so much better is truly due to gluten sensitivity or due to the reduction of FODMAPs It becomes a valid thought that people who continue to have some degree of GI distress with a gluten free or reduced gluten diet should consider a low FODMAP diet rather than simply eliminating gluten.
Gastroenterology 2014 Jan; 146:67
Are Dietary FODMAPs a Cause of Irritable Bowel Syndrome
In a randomized trial, IBS symptoms improved with a diet low in these short-chain carbohydrates.
The idea that dietary constituents called FODMAPs (Fermentable, Oligo-, Di-, Monosaccharides, And Polyols) might be responsible for some cases of irritable bowel syndrome (IBS) is gaining traction. FODMAPs are poorly absorbed, short-chain carbohydrates that include fructose, lactose, fructans (found in wheat), galactans, and polyol sweeteners.
In this randomized, crossover trial from Australia, 30 patients who met IBS criteria and 8 healthy controls consumed either a low-FODMAP diet (prepared by the researchers) or a “typical Australian diet” for 3 weeks, followed by the opposite diet for another 3 weeks; the two diet periods were separated by a 3-week washout. Patients were blinded to diet constituents.
At baseline, the mean symptom score for IBS patients was 36 (on a 100-point scale); mean scores declined to 23 during the low-FODMAP period and increased to 45 during the typical-diet period — a highly significant difference (P<0.001). Regardless of IBS subtype, patients were more satisfied with stool consistency during the low FODMAP diet. In controls, symptom scores were low at baseline and did not change during either diet period.
Comment: This is the first randomized trial to provide high-quality evidence that FODMAPs contribute to irritable bowel symptoms. One potential confounding dietary constituent is gluten, because a low-FODMAP diet (which eliminates wheat, rye, and barley because of their fructan content) is also low in gluten; however, in a recent study by the same research group, FODMAPs — and not gluten — likely were responsible for gastrointestinal symptoms in nonceliac patients with perceived gluten sensitivity (NEJM JW Gen Med Sep 19 2013). Information on low-FODMAP diets is available from this research team's institution and from other sources (e.g., Stanford University). Clinicians should consider recommending a low-FODMAP diet to IBS patients with abdominal bloating, flatus, and diarrhea.  
Citation(s): Halmos EP et al. A diet low in FODMAPs reduces symptoms of irritable bowel syndrome. Gastroenterology 2014 Jan; 146:67.

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MM: This is an interesting study in the sense that it is inexpensive and easy to perform in the home. The only danger that I perceive would be using too much bleach in the tub and causing local skin or eye irritation. The other potential concern would be ingestion of bath water that could have an effect on intestinal dysbiosis (an imbalance in the bacteria and microorganisms inside the gut).
Clin Infect Dis 2014 Mar 1; 58:679
Do Bleach Baths Prevent Recurrent Staph (MRSA) Infections?
A large study says “maybe.”
One of the big frustrations of managing community-acquired methicillin-resistant Staphylococcus aureus (MRSA) infections is the recurrence rate, which studies put at about 50%. To interrupt the cycle, clinicians have tried a variety of preventive measures, usually some combination of antiseptics (e.g., chlorhexidine, dilute bleach) and topical antibiotics (e.g., mupirocin).
In a randomized, single-blind trial, Houston researchers evaluated the preventive efficacy of bleach baths alone in 987 healthy immunocompetent children (age range, 3 months–18 years) who had sustained one to three skin or soft tissue infections ascribed to S. aureus. The 3-month recurrence rate was 21% in children who were treated only with “standard hygienic measures” (i.e., frequent soap-and-water handwashing, nail grooming, and daily bathing), and 17% in children who also were advised to bathe twice weekly in a tub of dilute bleach — a difference that did not reach statistical significance (P=0.15). Results were similar when methicillin-sensitive and methicillin-resistant infections were considered separately. Severity of recurrence, as indicated by need for incision and drainage, was not affected by bleach bathing.
Recurrence rate was affected significantly by age, with children younger than 22 months experiencing about twice as many recurrences as older children did. Number of sites colonized with staph at study entry also influenced recurrence rate (16% for those not colonized in nose, throat, or groin vs. 30% for those colonized at all three sites).
Comment: This study did not have sufficient power to deliver a conclusive finding that bleach helps prevent recurrence of pediatric staph infections, although the authors suspected that it did. A larger study might bolster the statistics behind that conclusion, but assessing how bleach performs with concomitant use of chlorhexidine (prohibited in this study), mupirocin, or both also will require additional evaluation.
Citation(s): Kaplan SL et al. Randomized trial of “bleach baths” plus routine hygienic measures vs routine hygienic measures alone for prevention of recurrent infections. Clin Infect Dis 2014 Mar 1; 58:679.

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MM: I find this data interesting. Note that this 10 year review is before Angelina Julie, one of the most beautiful and visible women in the world elected to have a double mastectomy followed by reconstructive surgery. It will be interesting to see how these trends will change over the next 10 year review. Also, I have to wonder if the geographic distribution of patients will show a significant change.
J Clin Oncol 2014 Feb 18
Trends in Breast Reconstruction After Mastectomy
A significant rise in reconstructions was driven largely by increased use of implant-based techniques.
The quality-of-life and psychosocial benefits of breast reconstruction following mastectomy are well known. But recent trends data regarding the use of the procedure are lacking.
Investigators have now analyzed an employment-based, medical-claims database to evaluate breast reconstruction in 20,560 women undergoing mastectomy for breast cancer in the U.S. from 1998 to 2007.
Results were as follows:

Comment: It is not surprising that breast-reconstruction rates increased among employed women given that the safety of the approach and the more aesthetically pleasing techniques of skin-sparing mastectomy grew and flourished during this same period. The data highlight the clinicians' subjective impression regarding increasing requests for bilateral mastectomy with immediate reconstruction. A marked and substantial decline was noted in the use of autologous-based reconstruction in favor of implant-based reconstruction. Why this is occurring may be multifactorial and possibly related to patients' desires for less involved surgery with shorter recovery times or to financial disincentives associated with reimbursements to plastic surgeons for more complex, labor-intensive procedures. Geographical disparities in breast reconstruction are clear opportunities for improvements.
Citation(s): Jagsi R et al. Trends and variation in use of breast reconstruction in patients with breast cancer undergoing mastectomy in the United States. J Clin Oncol 2014 Feb 18; [e-pub ahead of print].
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MM: It is impressive that supplementation with EVOO demonstrated a 40% improvement compared to the control group. Since this is a simple approach and these are real numbers they are even more meaningful. It's pretty easy to add olive oil to one's diet. Adding 45-60ml daily may be more of a chllenge. Some easy ways to accomplish this would be to use EVOO on salads and cooked vegetables in lieu of other dressings and sauces. add a small amount to soup or stew. Use EVOO instead of butter/margarine on baked potatoes.
Ann Intern Med 2014 Jan 7; 160:1
Do Mediterranean Diets Prevent Type 2 Diabetes?
A Mediterranean diet supplemented with extra-virgin olive oil was associated with 40% reduction in risk for diabetes.
Weight loss through calorie-restricted diets and exercise lowers risk for type 2 diabetes. To assess whether Mediterranean diets without caloric restriction also protect against diabetes, researchers in Spain analyzed data on the 3500 nondiabetic participants in the PREDIMED prevention trial (NEJM JW Gen Med Mar 12 2013http://www.jwatch.org/jw201303120000001), in which adults with ≥3 cardiovascular risk factors were randomized to one of three diets: a Mediterranean diet supplemented with extra-virgin olive oil (EVOO; 3–4 tablespoons daily), a Mediterranean diet supplemented with mixed nuts (1 ounce daily), or a control diet (consisting of advice to reduce intake of all fats). No participants were advised to restrict calories or to increase physical activity.
During median follow-up of 4 years, 273 participants developed diabetes. Incidence rates were 16, 19, and 24 cases per 1000 person-years, respectively, in the EVOO group, the nut-supplement group, and the control group. After adjustment for potential confounders, the hazard ratios for diabetes were significantly lower for the EVOO group (0.60) and slightly but not significantly lower for the nut group (0.82) relative to controls. No significant changes occurred in weight, waist circumference, or physical activity levels across groups.
Comment: In this study, a Mediterranean diet supplemented with extra-virgin olive oil lowered diabetes incidence without associated weight loss or increased physical activity. The mechanism by which a Mediterranean diet might lower diabetes risk is unknown, but, as the authors note, such diets might alleviate inflammation, oxidative stress, and insulin resistance.
Citation(s): Salas-Salvadó J et al. Prevention of diabetes with Mediterranean diets: A subgroup analysis of a randomized trial. Ann Intern Med 2014 Jan 7; 160:1.
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MM: This is a heads up that sometimes you get what you pay for. As parents and grandparents it is our responsibility to protect our children from injury when possible without being "helicopter caregivers". Here is a very good example of how we can have a large impact on child safety without over-shadowing our kids. This also lends itself to greater peace of mind knowing that we can reach out to our kids and take care of them without always being over-present.
J Neurosurg 2014 Jan 31
Not All Football Helmets Are Equal
Improved design can result in fewer concussions.
Although the Super Bowl is over, interest continues in football-related concussions, including whether they can be avoided or decreased. These researchers used retrospective data from helmet-mounted accelerometers (see also NEJM JW Psychiatry Jan 9 2014) on two models of Riddell helmets to analyze them for concussion risk and high-magnitude (>99th percentile) impacts. Some authors have proprietary interests in the accelerometers.
Data were obtained for 1,281,444 head impacts in eight collegiate football teams over five seasons (N=1833 players). Only 64 concussions were diagnosed in this time period. Even though players using the VSR4 helmet had fewer impacts overall, they experienced more-frequent high impacts compared with players using the Revolution helmet and had a 46.1% elevated relative risk for concussion. Laboratory testing of each helmet's capacity to attenuate linear acceleration confirmed the superiority of the Revolution helmet.
Comment:The relatively safer helmet has a greater offset and 40% thicker foam. These qualities appear to result in an improved safety profile, although it does not eliminate the need for other modifications in the sport (e.g., methods of tackling, penalties). Further research in improved helmet design is warranted — and the players should be using the safest ones, regardless of manufacturer.
Citation(s): Rowson S et al. Can helmet design reduce the risk of concussion in football? J Neurosurg 2014 Jan 31; [e-pub ahead of print].
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MM: How very disappointing this information is if it is true. I am very excited about the prospects of successful stem cell research and especially the prospect of stem cells from non-embryonic sources. We can only hope to see advances in this field that can be reproduced in other labs. It would be very unfortunate if this particular researcher falsified her data.
Irreproducible Results? Stem-Cell Advance Found hard to Duplicate
By Joe Elia
Temper the stem-cell celebrations. A finding from two recent Nature studies — that stressing mouse cells transformed them to a pluripotent state — has been hard to verify in other laboratories, according to media reports.
The Wall Street Journal notes that at least nine labs have failed to duplicate the results. And one of the coauthors of the Nature studies has been unable to reproduce the results since he left the lab where the original work was done.
The Scientist says it's had no luck contacting Haruko Obokata, who is the first author on both papers. One researcher told the magazine, "If it's really real, people should be able to replicate it." He added, "Some labs, including ours, will continue to try. ... It's still early; we certainly need to give them the benefit of the doubt."
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MM: Let's hope that this approach will be more successful in reproducing results that the previous article.
Stem Cells Now Seem Easier to Make
By Joe Elia
Scientists report an approach to making stem cells that's much simpler than earlier attempts.
Reporting in two Nature papers, scientists describe stressing mouse cells with a low-pH environment and having some revert to the status of pluripotent stem cells. When these cells were injected into early mouse blastocysts, they formed tissues throughout the embryos, which matured to adult mice.
In a radio interview, one author says that experiments to test the idea with human cells are under way.
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MM: Although this study looked at only a small group of patients, the results were very positive and hopeful. If a process can use a patient's own cells, then the likelihood of rejection and other adverse effects may be reduced. Make no mistake, this is still a dangerous procedure but if it shows future success and reduction of adverse effects, then it could show great prospects for the future.
Leukemia Succumbs to Patients' Own T-Cells
By Joe Elia
Almost 90% of a small group of adults with relapsed or refractory acute lymphoblastic leukemia showed a complete response to treatment with autologous T cells. The cells had been given receptors for a protein on the surface of the leukemic cells.
As reported in Science Translational Medicine, most patients were well enough after treatment to be candidates for bone marrow transplantation. Some apparently suffered a side effect of the treatment — severe cytokine release syndrome — which the authors plan to curb in future patients with corticosteroids or interleukin-6 receptor blockade.
Regarding the durability of the response, the Wall Street Journal reports that of eight patients who did not undergo bone marrow transplantation, four died and four remain in remission. One patient has been in remission for more than 2 years since treatment.
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MM: It is important to note that the patients at greatest risk are those with pre-existing cardiovascular risk. The old adage, 'Don't throw out the baby with the bath water." certainly applies to this treatment choice and its' future. Many men who are at little to no CV risk have, and can benefit from testosterone supplementation. We have experienced this in our practice and expect to continue to see it in the future. The important take away from this is that all patients must be screened before initiating a therapy and a thorough history and health profile must be established for any longitudinal treatment or therapy.
Endocrine Society Offers Statement on Testosterone After Recent Reports
By the Editors
In the wake of recent studies pointing to increased risks for cardiovascular events after testosterone therapy, the Endocrine Society has issued a statement, dated February 7, that concludes: "Large scale, prospective, randomized controlled trials are needed to determine the risks and benefits of testosterone therapy in older men with age-related decline in testosterone levels."
Until that evidence is available, the Society says, "Patients should be made aware of the potential risk of cardiovascular events in middle-aged and older men who are taking or considering testosterone therapy. ... Physicians and patients should have a conversation about the risks and benefits ... especially in patients who have pre-existing heart disease."
The statement recommends that any prescriptions for testosterone be given in accordance with the Society's practice guidelines (see link below).

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MM: This study indicates that complication rates associated with tonsillectomies in adults are similar to those in pediatric patients. If this is the case, then adult patients must simply perceive that it is much worse. This may be due to busier work and life schedules that are not easily modified or adults may interpret pain differently than children. In either case, I can't think of any adults who have their tonsils out that complained less than a child with the same procedure. So, even if there is no difference in complications, children "seem" to fare better than adults do relative to this procedure.
Adult Tonsillectomy Shown to be Safe
By Amy Orciari Herman
Tonsillectomy in adults carries low risks for morbidity and mortality, according to a study in JAMA Otolaryngology–Head & Neck Surgery
Researchers examined outcomes among some 6000 adults (average age, 30) across the U.S. who underwent tonsillectomy from 2005 through 2011, most often for chronic tonsillitis. The 30-day mortality rate was low, at 0.03%. Just 1.2% of patients experienced complications; over half were infections, with pneumonia being the most frequent. Some 3.2% of patients required reoperation within 30 days; male patients, inpatients, or those who'd experienced complications were mostly likely to need reoperation.
The researchers say the observed morbidity and mortality rates are similar to those seen among pediatric patients.

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