Medicine cases

Increased Coffee Consumption Linked to Lower Depression Risk in Women

2011-09-27T09:18:00.000-04:00

The more caffeinated coffee women drink, the less likely they are to develop depression, according to a prospective study in the Archives of Internal Medicine.

Some 50,000 Nurses' Health Study participants without depressive symptoms at baseline were followed for roughly 10 years. During that time, about 5% reported physician-diagnosed depression.

Overall, as self-reported caffeinated coffee consumption increased, the risk for depression decreased. In particular, compared with women who drank 1 cup or less a week, those drinking 2 to 3 cups a day had a 15% lower relative risk for depression, and those drinking 4 or more cups a day had a 20% lower risk. No link was seen between other sources of caffeine and depression, or between decaffeinated coffee and depression.

An editorialist says that the while these and other data may provide reassurance that coffee drinking has "no glaringly deleterious health consequences ... it seems premature to recommend coffee consumption."

Archives of Internal Medicine article (Free abstract)

ICAAC: Maggots Make Happy Meal of Diabetic Wounds

2011-09-22T09:33:00.002-04:00

By Michael Smith, North American Correspondent, MedPage Today
Published: September 21, 2011
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

CHICAGO -- Diabetic patients facing lower limb amputation because of non-healing lesions may get a leg up from the insect world, a researcher said here.
Biosurgery using the sterile larvae of the green blow-fly (Lucilia sericata) may be an alternative to amputation in many cases, according to Lawrence Eron, MD, of the University of Hawaii in Honolulu.
In a series of 37 patients with complicated limb wounds, the approach, which used the larvae to debride the lesion, yielded a successful outcome in 27, Eron reported at the Interscience Conference on Anti-Microbial Agents and Chemotherapy.
The larvae, commonly referred to as maggots, only eat "devitalized" tissue, leaving living tissue alone, Eron said. This makes them ideal to clean up diabetic lesions that have not responded to standard therapy with antibiotics.
But the process might someday be useful in patients earlier in the disease course, he told MedPage Today after his oral presentation.
The use of maggots to clean wounds goes back centuries particularly during wartime, but it had fallen out of favor. Now, Eron said, several groups are trying to see if the larvae have a clinical role in modern medicine, and especially in patients with diabetic limb wounds.
For the analysis, the researchers defined success as complete debridement of devitalized tissue, formation of robust granulation tissue, and at least 50% closure of the wound.
The 37 patients had lesions that had been present in some cases for up to five years and were resistant to all attempts at cure. The lesions included 18 abscesses, six infected ulcers, nine cases of osteomyelitis, and four cases of gangrene.
Eron said the researchers applied 50 to 100 maggots, left them in place for two days, and then removed them, repeating the process an average of five times per wound.
In 73% of the patients, the maggot debridement therapy was successful, although Eron noted that complete closure of the wound was not part of the definition of success. Other methods were used to finish the job.
"There's no question that these little critters are able to debride tissue very efficiently," Eron said.
The 10 failures were linked to excessive inflammation surrounding the wound, bleeding from the wound, fistulae from infected bones that closed after single treatment, and severe peripheral vascular disease.
One patient stopped because of pain, but most patients either couldn't feel the maggots working or found the "creepy-crawly" sensation reassuring, Eron said.
One reason to use the approach, he noted, is cost: a simple uninfected diabetic foot ulcer can cost up to $10,000 to treat, while amputation if treatment fails costs up to $65,000.
In contrast, the medical grade maggots sell for about $100 for about 200, so that an average five-cycle treatment would cost around $500, he said.
"This biosurgery is a different approach that gets us around the problem of antibiotic resistance," Catherine Bennett, PhD, of Deakin University in Melbourne, Australia, who moderated the session at which the research was presented.
"It's a very targeted, selective approach to tissue removal," she told MedPage Today.
She noted that the patients in the study had serious wounds, and it's not clear that the process would be acceptable in patients earlier in the disease course, even if it might be medically advisable.
She said formal trials are needed and "if the evidence is good, it will convince patients as well as physicians."

NSAID Use Linked to Increased Risk for Spontaneous Abortion

2011-09-07T08:08:00.000-04:00

Use of any nonaspirin nonsteroidal anti-inflammatory drug during pregnancy increases the risk for spontaneous abortion more than twofold, according to a case-control study in the Canadian Medical Association Journal.Researchers used the Quebec Pregnancy Registry to identify some 4700 women who had a spontaneous abortion by 20 weeks' gestation. Each case was matched to 10 controls who did not have spontaneous abortions. Exposure to a nonaspirin NSAID during pregnancy was noted in some 7.5% of cases, but in only 2.6% of controls. After adjustment for potential confounders such as history of rheumatoid arthritis or systemic lupus, all nonaspirin NSAIDs were associated with a significantly increased risk for spontaneous abortion, the highest being with diclofenac (odds ratio, 3.09). No dose-response effect was found.

Paralyzed Man Stands, Moves With Epidural Stimulation

2011-05-19T22:38:00.000-04:00

By Nancy Walsh, Staff Writer, MedPage Today
Published: May 19, 2011

Rob Summers was 20 in the summer before his junior year at Oregon State University in the summer of 2006. A pitcher on the school's baseball team, he went out around midnight to get his gym bag out of his car when a hit-and-run driver jumped the curb, striking him and leaving him paralyzed with an injury to the spinal cord from C7-T1.
Today Summers can stand for several minutes and move his legs, feet, and toes. He has regained some bladder control and sexual functioning, as well as the ability to regulate his body temperature through mechanisms such as perspiration.

These gains are the result of unprecedented treatment -- begun in December 2009 -- using electrical stimulation of the spinal cord.

After 80 sessions of task-specific training, epidural stimulation from an implanted unit allowed Summers to stand, bearing all his weight, for up to 4.25 minutes, Susan Harkema, PhD, of the University of Louisville in Kentucky, V. Reggie Edgerton, PhD, of the University of California Los Angeles, and colleagues reported online in The Lancet.

Summers had previously undergone 26 months of locomotor training with assistance on a treadmill that had failed to produce any changes in electromyographic activity in the legs, the researchers explained.

"This unexpected recovery of supraspinally mediated movement suggests that activity-dependent mechanisms promoted plasticity of anxonal projections that presumably were spared by the injury," observed Grégoire Courtine, PhD, of the University of Zurich in Switzerland, and colleagues in a commentary accompanying the case report.

Animal studies had shown that the spinal cord is capable of generating motor commands without signals from the brain by means of neural networks known as central pattern generators.

In paralyzed humans, epidural stimulation has been shown to induce rhythmic movements of the legs while the patient lies supine.

Most [spinal cord injuries] involve a contusion or compressive injury of the cord that causes a great deal of damage, but leaves a certain number of nerve fibers that connect the brain with the spinal cord," Edward D. Hall, PhD, of the University of Kentucky and the Spinal Cord and Brain Injury Research Center in Lexington, observed in an email to ABC News and MedPage Today.

Harkema's team in Louisville had been doing research to see if spinal cord stimulation could activate neural circuits in the spine and, coupled with sensory input from the legs, permit standing and locomotion. Summers went to Louisville to see if they could help him.

In December of 2009, the team implanted a 16-electrode array over the young man's spinal segments L1-S1.

They also implanted a pulse generator connected to an electrode lead in the abdomen.

The researchers explained that, although Summers was paralyzed below the chest, he was classified as grade B on the American Spinal Injury Association's neurologic impairment scale since he had light touch sensation below the area of the spinal injury. But he had no voluntary control over the muscles of legs and trunk and no ability to contract the bladder.

The investigators tested various amplitudes ranging from 0.5 to 10 V and frequencies of 5 Hz to 40 Hz, in stimulation sessions ranging from 40 minutes to two hours.

Summers has reported tingling sensations at the site of the implanted electrode and in the muscles being activated, but did not experience pain during the stimulation sessions.

Initially, he was able to stand only with 65% body weight support, but over time he progressed to full weight bearing.

In addition to learning to stand unaided, Summers eventually progressed to the extent that he could stand up from a sitting position, which resulted in a marked increase in electromyographic activity.

He then learned task-specific sensory cues such as positioning of the legs, hips, and knees to accomplish step-like movements during 30 Hz to 40 Hz epidural stimulation.

But without the epidural stimulation, no electromyographic activity could be detected when his trainers assisted him in performing these stepping movements.

Hall cautioned that if this approach is shown to help in other patients, it may allow them to walk with the aid of a walker.

"While this will have value, it is important to note that it will not reproduce normal walking," Hall said.

If Summers isn't running around any baseball diamonds, he has a renewed sense of well being and self-esteem. Now 25, he lives in Los Angeles. And last summer, he spent 10 days helping at a baseball camp in Florida.

"One possible explanation for this recovery is that residual supraspinal connections that existed but could not be detected clinically were reactivated or that new supraspinal connections to the spinal networks were formed," Edgarton's group noted in their paper.

"Challenges lie ahead," stated Courtine and colleagues in their commentary and the findings need to be replicated in a clinical trial with sufficient numbers of patients.

Nonetheless, they wrote, "The exceptional results bring new hope in a field that has remained unsatisfying -- with limited progress despite decades of research throughout the world."

Naomi Kleitman, PhD, of the National Institutes of Health in Bethesda, Md., also found Summers' story hopeful. Most people are unaware of the complex circuits in their spine that transmit commands to the body from the brain, she told MedPage Today and ABC News in an email.

"Spinal cord injuries break this vital connection but the sophisticated circuitry of the spinal cord remains, ready to coordinate stepping if it receives the right commands. Harnessing that potential has been the goal of decades of research to understand spinal cord function and to find effective ways to restore function after injury," Kleitman explained.

Scientists find "master switch" gene for obesity

2011-05-15T22:18:00.000-04:00

LONDON (Reuters) – Scientists have found that a gene linked to diabetes and cholesterol is a "master switch" that controls other genes found in fat in the body, and say it should help in the search for treatments for obesity-related diseases.
In a study published in the journal Nature Genetics, the British researchers said that since fat plays an important role in peoples' susceptibility to metabolic diseases like obesity, heart disease and diabetes, the regulating gene could be target for drugs to treat such illnesses.
"This is the first major study that shows how small changes in one master regulator gene can cause a cascade of other metabolic effects in other genes," said Tim Spector of King's College London, who led the study.
More than half a billion people, or one in 10 adults worldwide, are obese and the numbers have doubled since the 1980s as the obesity epidemic has spilled over from wealthy into poorer nations.
In the United States, obesity-related diseases already account for nearly 10 percent of medical spending -- an estimated $147 billion a year.
Type 2 diabetes, which is often linked to poor diet and lack of exercise, is also reaching epidemic levels worldwide as rates of obesity rise.
Scientists have already identified a gene called KLF14 as being linked to type 2 diabetes and cholesterol levels, but until now they did know what role it played.
Spector's team analyzed more than 20,000 genes in fat samples taken from under the skin of 800 British female twin volunteers. They found a link between the KLF14 gene and the levels of many other distant genes found in fat tissue, showing that KLF14 acts as a master switch to control these genes.
They then confirmed their findings in 600 fat samples from a separate group of people from Iceland.
In a report of their study, the researchers explained that other genes found to be controlled by KLF14 are linked to a range of metabolic traits, including body mass index, obesity, cholesterol, insulin and glucose levels.
"KLF14 seems to act as a master switch controlling processes that connect changes in the behavior of subcutaneous fat to disturbances in muscle and liver that contribute to diabetes and other conditions," said Mark McCarthy from Britain's Oxford University, who also worked on the study.
"We are working hard...to understand these processes and how we can use this information to improve treatment of these conditions."
(Reporting by Kate Kelland, editing by Mark Heinrich)

Heavy Coffee Intake Linked to Lower Breast Ca Risk

2011-05-14T09:54:00.002-04:00

y Charles Bankhead, Staff Writer, MedPage Today
Published: May 13, 2011
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner
Activate MedPage Today's CME feature and receive free CME credit on medical stories like this oneAction Points
Point out that this study in Sweden found a statistically significant decrease in ER-negative breast cancer among postmenopausal women who had a high daily intake of coffee.

Note that the study is subject to residual confounding by unmeasured variables.
Women who drank at least five cups of coffee daily had a significantly lower risk of postmenopausal breast cancer, an analysis of two large cohort studies suggested.

Overall, the magnitude of the benefit ranged from 20% to more than 50% in unadjusted and adjusted analyses. Analysis of the results by estrogen receptor (ER) status showed that the favorable association pertained only to ER-negative cancers, according to an article published online in Breast Cancer Research.

"Coffee consumption was associated with a strong reduction in breast cancer risk for the ER-negative tumor subtype," Jingmei Li, PhD, of the Karolinska Institute in Stockholm, and co-authors wrote. "This effect was independent of hormone replacement therapy (HRT), smoking, highest education level attained, and average daily alcohol consumption."

"We speculate that coffee might contain compounds that differentially affect breast cancer of different ER subtypes," they added.

Coffee has a paradoxical relationship with breast cancer risk. The beverage's complex mix of caffeine and polyphenols suggests a potential to confer both carcinogenic and chemopreventive characteristics, the authors noted in the introduction to their study.

In general, previous studies have indicated that high coffee consumption might modestly reduce breast cancer risk. However, a meta-analysis of more than 500 reports about coffee's relationship to several types of cancer showed no association with breast cancer (Nutr Cancer 2010; 62: 271-283).

In an effort to add information to the knowledge base, Li and colleagues performed a case-control study of the relationship between coffee consumption and postmenopausal breast cancer. They drew participants from a population-based study of women who were ages 50 to 74, born in Sweden, and residents of the country during 1993 to 1995.

The analysis comprised 2,818 postmenopausal breast cancer patients and 3,111 age-matched controls.

The authors also performed validation analyses based on postmenopausal women who participated in a German case-control study of breast cancer. The analysis included 3,464 patients with breast cancer and 6,657 age-matched controls.

Participants in both studies provided detailed information about breast cancer risk factors, lifestyle factors (such as smoking and diet), and socioeconomic variables.

The initial analysis identified strong associations between breast cancer risk and several variables previously identified in epidemiologic studies: family history of breast cancer, age at menopause, parity, age at first birth, recent body mass index, use of HRT, alcohol consumption, physical activity, and education. Smoking, on the other hand, did not have a significant association with breast cancer risk.

Using data only from the Swedish cohort, the authors performed an age-adjusted analysis, which showed a 20% reduction in the hazard for breast cancer among women who reported drinking more than five cups of coffee daily versus those who averaged less than one cup (P=0.028).

After adjustment for HRT, smoking, education, and alcohol consumption, the effect of coffee consumption on breast cancer risk was no longer significant.

Analyses stratified by tumors' hormone-receptor status resulted in statistically significant reductions in the risk of ER-negative or progesterone (PR)-negative tumors among women who reported drinking more than five cups of coffee daily.

The strongest association between coffee consumption and breast cancer risk was for ER-negative tumors. The combination of ER-negative tumors and heavy coffee consumption resulted in a 57% reduction in the odds for breast cancer (OR 0.43, P=0.0003). Coffee consumption also had a significant association with PR-negative tumors (OR 0.66, P=0.034).

A test for heterogeneity confirmed that the breast cancer benefits of heavy coffee consumption were significantly higher for ER-negative versus ER-positive tumors (P=0.004). The association with PR status no longer remained significant.

Results of the trend analysis in ER-negative cancers led the authors to perform a validation analysis, using data from the German study. The analysis produced a modest overall association between coffee consumption and breast cancer risk, but the association did not achieve statistical significance (OR 0.87, P=0.173).

Analysis of the German data set stratified by cancer subtype confirmed that coffee consumption had the largest protective effect for ER-negative tumors, although the effect was less robust than the one observed in the Swedish cohort and did not achieve statistical significance (OR 0.67, P=0.326).

ACC: CVD Risk Seen in Middle School Students

2011-04-04T23:10:00.000-04:00

By Todd Neale, Staff Writer, MedPage Today
Published: April 03, 2011
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco.
Action Points
Note that these studies were published as abstracts and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

Explain that in this study, children as young as 11 showed worrisome signs of future cardiovascular danger -- with 16% of them found to have low HDL cholesterol levels.

Note that low HDL cholesterol levels were also associated with a higher body mass index, worse lipid profiles, and higher blood pressures.
NEW ORLEANS -- Children as young as 11 show worrisome signs of future cardiovascular danger, two studies of Michigan sixth-graders showed.
The first study of 1,104 students, found that 16% of the adolescents had low HDL cholesterol levels -- 40 mg/dL or less -- Elizabeth Jackson, MD, MPH, of the University of Michigan in Ann Arbor, reported in a poster session at the American College of Cardiology meeting here.

"That in itself was surprising," she said at a press briefing. "That's a significant amount of kids."

And a second study by Jackson's group showed that there were children with poor cardiovascular fitness identified through their heart rate recovery after a three-minute step test.

Both low HDL cholesterol levels and worse heart rate recovery were associated with increased prevalence of traditional cardiovascular risk factors, such as increased body mass index, poorer lipid profiles, and decreased physical activity levels, the researchers found.

Although both variables can be identified relatively easily through screening, Jackson stopped short of urging that all children should be screened for their heart rate recovery and lipid levels.

"With any of these things you have to think about the implications in terms of the community, in terms of parents," she said. "I don't advocate that these measures should be just routinely performed in all children without any input from schools or parents."

According to practice guidelines from the American Academy of Pediatrics, certain children should be screened for dyslipidemia -- including those with a family history of either significant hyperlipidemia or premature heart disease, and overweight children regardless of family history or other cardiovascular risk factors.

Children who are overweight or obese are at risk for abnormal lipid levels, Jackson explained.

According to background from the ACC, the National Heart, Lung and Blood Institute recommends lipid screening in children as early as age 2 if they have a parental history of high cholesterol (total cholesterol >240 mg/dl) or a family history of early heart disease.

In children with low HDL cholesterol in particular, lifestyle modifications should be tried, because studies show -- at least in adults -- that exercise can raise HDL cholesterol levels, Jackson added.

The studies were conducted as part of Project Healthy Schools, a school-based intervention program in southeast Michigan that brings together the University of Michigan, cardiologists, school personnel, and community leaders to educate kids about diet, exercise, and healthy lifestyle choices.

The analyses focused on sixth graders (mean age 11) -- 1,104 students for the HDL cholesterol study and 1,276 for the heart rate recovery study.

Children and their parents completed a standardized questionnaire about dietary, exercise, and sedentary habits, and the children underwent various tests.

Low HDL cholesterol (≤40 mg/dL) was associated strongly with a higher BMI (P=0.001 for trend). In the group of children with low HDL levels, 60.3% were overweight, compared with 28.8% in the group with high levels.

There was a significantly higher percentage of girls in the low HDL cholesterol group than in the high HDL cholesterol group (58.9% versus 49.7%, P=0.027). There were no differences based on age or race.

Children of both sexes with low HDL had higher LDL cholesterol and triglyceride levels, as well as higher systolic and diastolic blood pressures and resting and recovery heart rates (P<0.05 for all).

In addition, students in the low HDL cholesterol group reported getting fewer days of moderate and strenuous physical activity per week (P<0.05 for both).

About half of the children with low HDL had at least two additional components of the metabolic syndrome -- which includes high LDL and triglycerides, elevated blood pressure, and abdominal obesity.

The analysis looking at heart rate recovery found similar relationships with cardiovascular risk factors.

Following a three-minute step test, the researchers measured heart rate recovery in the students and then divided the children into quartiles.

Similar to children with low HDL cholesterol levels, those with the poorest heart rate recovery tended to have a higher BMI (P<0.001 for trend).

Compared with children with the quickest heart rate recovery rates, those with the slowest recovery had higher LDL and triglyceride levels and lower HDL cholesterol levels (P≤0.02 for all).

The least fit children also reported fewer days of moderate and strenuous exercise per week (P≤0.001 for both).

Sporadic Exercise, Even Sex, May Boost MI, Death Risk

2011-03-23T07:46:00.002-04:00

By Michael Smith, North American Correspondent, MedPage Today
Published: March 22, 2011
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco.

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VIDEO SOURCE: JAMA

Couch potatoes beware: Episodic bouts of physical or sexual activity may carry a risk of heart attack or sudden cardiac death, researchers reported.

But the risk drops with regular physical activity, according to Issa Dahabreh, MD, and Jessica Paulus, ScD, both of Tufts Medical Center in Boston.

And because periodic physical and sexual activity tends to be transient and infrequent, the absolute risks involved are small, Dahabreh and Paulus reported in the March 23/30 issue of the Journal of the American Medical Association.

"There is a link between episodic physical activity and sexual activity with the risk of heart attack and death from sudden cardiac events" within one or two hours after the episode, Paulus said in a video prepared for the journal.

Action Points

Explain that episodic bouts of physical or sexual activity may carry a risk of heart attack or sudden cardiac death.
Note that the risk drops with regular physical activity.

"This risk was sharpest," she said, "for those individuals who were unaccustomed to regular exercise" but it was buffered by habitual exercise. While such events often appear in anecdotes, pinning them down is not easy, the researchers noted, and traditional epidemiological tools are not well suited to the task.
But studies using a case-crossover design, in which the patient acts as his or her own control, can eliminate many confounding factors, they noted.
A systematic review of the literature found 14 such studies investigating the cardiac effects of episodic physical activity, sexual activity, or both, Dahabreh and Paulus reported.
The primary outcomes were myocardial infarction in 10 studies, sudden cardiac death in three, and acute coronary syndrome in one.
The meta-analysis showed:

Episodic physical activity was associated with more than a threefold increase in the risk of heart attack. The relative risk was 3.45 with a 95% confidence interval from 2.33 to 5.13.
By the same token, episodic sexual activity was associated with a relative risk of heart attack 2.70 with a 95% confidence interval from 1.48 to 4.91.
Episodic physical activity was associated with nearly a five-fold increase in the risk of sudden cardiac death. The relative risk was 4.98 with a 95% confidence interval from 1.47 to 16.91.

The triggering effect of such episodes was muted for people who were more active on a regular basis, the researchers found.
In subgroups with the lowest level of habitual exercise, the relative risk for episodic physical activity to trigger an MI ranged from 4.47 to 107, they found, but the range for those in the highest activity groups was from 0.86 to 3.3, "indicating much smaller increases in risk."
They estimated that the relative risk for an MI triggered by episodic physical activity decreased by about 45% for each additional time per week a person was habitually active.
Similarly, in the two studies that looked at the issue with respect to sudden cardiac death, the relative risk fell approximately 30% for each additional time per week a person habitually exercised.
The researchers also estimated that the absolute risk increase for MI associated with an hour of additional physical or sexual activity every week was two to three per 10,000 person-years. For sudden cardiac death the corresponding figure was one per 10,000 person-years.
Dahabreh and Paulus cautioned that the studies in their analysis had significant differences in design and protocols.
They also cautioned that the findings should not be interpreted "as indicating a net harm of physical or sexual activity."
Instead, they concluded, the results suggest that such exposures are associated with a "temporary short-term increase in the risk of acute cardiac events."

Diet Soda Tied to Vascular Risk, With Caveats

2011-02-09T17:32:00.000-05:00

By Todd Neale, Staff Writer, MedPage Today
Published: February 09, 2011
Reviewed by Michael Mullen, MD; Clinical Instructor of Vascular Neurology, University of Pennsylvania.

LOS ANGELES -- Drinking diet soda -- but not regular soda -- was associated with a greater risk of stroke, MI, or vascular death in an older, multiethnic cohort, researchers found. Individuals who reported drinking diet soda every day were 48% more likely to have a vascular event through more than nine years of follow-up (RR 1.48, 95% CI 1.3 to 2.12), according to Hannah Gardener, ScD, of the University of Miami in Florida.
There was no such association for less-frequent consumption of diet soda or for any level of regular soda consumption, she reported at the American Stroke Association's International Stroke Conference here.
In a separate study, Gardener and her research team also found that individuals who had the highest daily sodium consumption had a nearly threefold increased risk of stroke compared with those who met the American Heart Association target of 1,500 mg a day.
Gardener acknowledged some limitations of the diet soda study, including the use of self-reported dietary data at a single time point, and concluded that the findings are "too preliminary to suggest any dietary advice."
"If and only if the results are confirmed can we suggest that diet soda may not be an optimal substitute for sugar-sweetened beverages, which have been shown to have various health consequences," she said.
Doctors contacted by ABC News and MedPage Today were also hesitant to declare diet sodas the next great health risk, with many attributing the increased vascular risk to other dietary factors that were not measured in the study, such as the types of foods contributing to the total caloric intake.
"Unfortunately, it may be that individuals with poor dietary habits do resort [to] some kind of calorie balancing and continue to eat high-calorie sweet foods but reduce their 'guilt' by drinking diet soda," Howard Weintraub, MD, clinical director of the NYU Center for the Prevention of Cardiovascular Disease, wrote in an e-mail.
The study "adds to the growing evidence of an association between diet sodas and cardiovascular disease," according to Cam Patterson, MD, a cardiologist at the University of North Carolina at Chapel Hill. But, he added, that, although the association cannot be ignored, it is too early to interpret what it means.
"People need to know about this, but it is important for everyone to realize that no general guidelines should be derived from these types of observational studies," Patterson wrote in an e-mail.
"I'll continue to pack a diet soda with my lunch, but I'll look more carefully at what else is in my lunch box, and I'll pay more attention to what I'm doing while I'm drinking my diet soda."
Gardener and her colleagues analyzed data from the Northern Manhattan Study (NOMAS), which includes individuals older than 40 living in New York City.
The current analysis included 2,564 participants. Their mean age was 69; about half were Hispanic, one-fifth were white, and one-quarter were black.
Based on a food frequency questionnaire completed at baseline, 35% of the cohort did not drink either regular or diet soda. Only 24% reported drinking any amount of diet soda.
Diet soda consumption was associated with white race, diabetes, elevated blood sugar, low HDL cholesterol, elevated waist circumference and body mass index, peripheral vascular disease, and metabolic syndrome (P<0.05 for all).
Through an average follow-up of 9.3 years, there were 559 incident vascular events, including 212 strokes, 149 MIs, and 338 vascular deaths.
After adjustment for demographic and behavioral and vascular risk factors -- including BMI -- there was an increased risk of having a vascular event with daily diet soda consumption, but no other levels of consumption of diet or regular soda.
Commenting on the findings, Christopher Cannon, MD, of Brigham and Women's Hospital in Boston, pointed out, however, that the number of participants who drank diet soda daily was small -- 116 -- and that the lack of an association with regular soda consumption was at odds with previous studies.
"This suggests that the finding may be spurious, and needs confirmation in a much larger group of patients," he wrote in an e-mail.
Gardener agreed that confirmation was needed before drawing any definitive conclusions, with further studies that focus on a younger population with more diet soda consumption and that collect diet information at multiple time points.
She and her colleagues also examined the relationship between dietary sodium intake and stroke in the NOMAS cohort.
Although the American Heart Association recommends consuming less than 1,500 mg a day, only 12% of the participants met that goal.
The average daily consumption at baseline was 3,031 mg, with one-fifth of the cohort ingesting more than 4,000 mg a day.
Over a mean follow-up of 10 years, there were 227 strokes.
After adjustment for demographics and behavioral and vascular risk factors -- including hypertension -- every 500 mg/day increase in sodium intake was associated with an 18% relative increase in stroke risk (RR 1.18, 95% CI 1.08 to 1.27).
Those individuals who consumed the most -- more than 4,000 mg/day -- had a 2.67-fold (95% CI 1.31 to 5.41) increased risk compared with those who met the AHA target.
"The results of our study suggest that the new AHA strategic dietary goals will help promote ideal cardiovascular as well as brain health," Gardener said, "and this evidence can be used in campaigns aimed at reducing cardiovascular disease risk by targeting dietary behavior."

Early Introduction of Solid Foods Linked to Risk for Early Childhood Obesity

2011-02-08T11:31:00.002-05:00

February 7, 2011 — Early introduction of solid foods is linked to a risk for early childhood obesity, according to the results of a prospective prebirth cohort study reported online February 7 in Pediatrics.
"Parental feeding practices during early infancy, such as the timing of solid food introduction, may be 1 key modifiable determinant of childhood obesity," write Susanna Y. Huh, MD, MPH, from the Division of Gastroenterology and Nutrition, Children's Hospital Boston in Boston, Massachusetts, and colleagues. "Data suggest that the introduction of solid foods earlier than 4 months of age is associated with increased body fat or weight in childhood or with greater weight gain during infancy, which itself predicts later adiposity. Other studies have found no association between the timing of solid food introduction and body fat or an association between delayed introduction of solid foods after 6 months and greater adiposity."
The goal of the study was to evaluate the association between timing of introduction of solid foods during infancy and obesity at age 3 years, defined as a body mass index for age and sex at the 95th percentile or above, using a cohort of 847 children enrolled in Project Viva. Timing of introduction of solid foods was categorized as younger than 4 months, ages 4 to 5 months, and 6 months or older. Logistic regression models were applied separately for infants who were breast-fed for at least 4 months ("breast-fed"; n = 568; 67%) and for infants who were never breast-fed or in whom breast-feeding was stopped before age 4 months ("formula-fed"; n = 279; 32%). These models were adjusted for child and maternal factors, including change in weight-for-age z score from 0 to 4 months as a marker of early infant growth.
Obesity was present in 75 children (9%) at age 3 years. The timing of solid food introduction was not associated with odds of obesity in breast-fed infants, (odds ratio, 1.1; 95% confidence interval [CI], 0.3 - 4.4). However, introducing formula-fed infants to solid foods before age 4 months was associated with a 6-fold increase in odds of obesity at age 3 years, which was not explained by rapid early growth (odds ratio after adjustment, 6.3; 95% CI, 2.3 - 6.9).
"Among infants who were never breastfed or those who stopped breastfeeding before the age of 4 months, the introduction of solids before the age of 4 months was associated with a sixfold increase in the odds of obesity at the age of 3 years," the study authors write.
Limitations of this study include possible residual confounding; some loss of the cohort to follow-up; limited generalizability to more socioeconomically disadvantaged populations; and small numbers in some cells, leading to possible chance results.
"Among infants breastfed for 4 months or longer, the timing of the introduction of solid foods was not associated with the odds of obesity," the study authors conclude. "Increased adherence to guidelines regarding the timing of solid food introduction may reduce the risk of obesity in childhood."
The National Institutes of Health supported this study. The study authors have disclosed no relevant financial relationships.

Pediatrics. Published online February 7, 2011. Abstract

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Authors and Disclosures

Journalist

Laurie Barclay, MD

Freelance writer and reviewer, Medscape, LLC

Disclosure: Laurie Barclay, MD, has disclosed no relevant financial relationships.

Phone App Improves Metabolic Control in Type 1 Diabetes

2011-02-07T19:40:00.000-05:00

By Will Boggs MD

NEW YORK (Reuters Health) Feb 04 - Use of the Diabeo software on a mobile phone improves metabolic control in patients with chronic, poorly controlled type 1 diabetes, researchers from France report online in Diabetes Care.
An active electronic log book such the Diabeo system facilitates the management of complex insulin treatment of type 1 patients, improves blood glucose results and quality of life, and assists follow up by physicians "thanks to the transmission of whole data through GPRS (General Packet Radio System) and Internet," Dr. Guillaume Charpentier from Sud-Francilien Hospital, Corbeil-Essonnes, France told Reuters Health in an email.
Dr. Charpentier and colleagues evaluated the efficiency of the Diabeo system in improving metabolic control in a randomized, open-label, parallel-group study of 180 patients with chronic, poorly controlled type 1 diabetes. Voluntis, makers of Diabeo, provided the software, and sanofi-aventis partially funded the trial.
Diabeo software is uploaded onto smart phones with Internet connection that provides bolus calculators using validated algorithms; plasma glucose targets; automatic algorithms for adjusting carbohydrate ratio and basal insulin or pump basal rates; and data transmission to medical staff computers.
Mean HbA1c was 9.07% at baseline. At the end of the 6-month study, HbA1c was significantly lower in the 60 patients allocated to electronic logbook alone (8.63%) and in the 59 patients allocated to electronic logbook plus teleconsultation (8.41%) than in the 61 patients allocated to the usual paper logbook (9.10%).
Only the difference between the electronic logbook plus teleconsultation group and the usual paper logbook group remained statistically significant after adjustment for multiple comparisons.
Similarly, significantly more patients in the electronic logbook plus teleconsultation group (10/59, 17%) than in the paper logbook group (1/61, 1.6%) reached the target HbA1c of 7.5% or less, with patients in the electronic logbook only falling in-between (4/60, 6.7%).
The frequency of symptomatic, non-severe hypoglycemia didn't differ between groups and did not increase from baseline.
Also, quality of life at baseline and endpoint did not differ between the groups.
Total time spent on follow-up was the same among groups, but participants in the electronic logbook only and usual paper logbook groups spent additional time traveling to and from the hospital, waiting for consultations, and carrying out administrative procedures.
Researchers say the software didn't require more time for the patient to manage diabetes. The combined time of launching the software on the smart phone, inputting blood glucose values and meal carbohydrate intake, and reading the software dose recommendation was less than 10 seconds, and transmission of the data was automatic and instantaneous.
"The Diabeo system is now proposed routinely to any patients treated with a basal bolus insulin regimen with either multiple daily injections or pump (that is to say nearly all type 1 patients and some type 2 followed in our center and other co-investigator centers), owning a smart phone or willing to acquire one," Dr. Charpentier said. "There is no specific skill require to use the system except to be able to use a mobile phone in a current manner."
He says that a nationwide study should begin in 2011, enrolling 600 patients, at the request of the health authority in order to obtain reimbursement by national health care insurance.
"The system has been adapted to type 2 patients treated with long acting insulin titration algorithm and automatic coaching about blood glucose monitoring, diet and physical exercise, and hypoglycemic events." He added that it's currently being evaluated through a multicenter randomized trial.
Diabetes Care. Posted online January 25, 2011. Abstract

How health system reform affects patients

2010-03-29T20:19:00.002-04:00

The Patient Protection and Affordable Care Act (H.R. 3590)—health system reform legislation signed into law by President Obama on March 23—contains a number of key provisions for you and your patients. Some provisions may have an immediate impact on your practice and patients, while others will not take effect for some time.

Given the new direction for the nation's health system, the AMA has developed Health System Reform Insight to help you understand the new law and how it will affect you, when certain provisions are scheduled to take effect, how you can be ready when the regulations go into effect and what your patients need to know. The first issue of the series explained how health system reform will affect physician practices. Today we focus on information for your patients. We encourage you to visit the AMA's health system reform Web site (PDF) and print copies to share with them.

How health system reform affects patients
H.R. 3590 has many significant benefits for patients—those who already have health insurance and those who don't. While some benefits take effect in 2010, many others will be phased in over several years to allow the health care system to absorb the changes ahead. Here's a snapshot of those benefits.

Patient benefits that take effect in 2010
For patients with private health insurance:

Your insurer can no longer drop you from your plan if you get sick.
Children ages 18 and younger can no longer be denied private insurance coverage if they have a pre-existing medical condition.
For adults with pre-existing medical conditions who cannot obtain private insurance coverage, a temporary national "high-risk pool" will be established to provide coverage, with financial subsidies to make premiums more affordable, until all insurers are required to cover people with pre-existing conditions in 2014.
Young adults up to age 26 can remain as a dependent on their parents' private health insurance plan.
Your health insurance benefits can no longer run out because of a long or expensive illness because insurers can no longer impose lifetime financial limits on benefits.
Preventive services for women, such as mammograms, and immunizations for children must be covered by insurers, with no co-payments or deductibles required.

In addition, Medicare patients who will hit the coverage gap known as the "doughnut hole" this year under the prescription drug benefit will receive a $250 rebate from Medicare.

Patient benefits that take effect during the next four years
In the private health insurance market:

U.S. citizens and legal residents cannot be denied private health insurance coverage for any reason, beginning in 2014. All U.S. citizens and legal residents must obtain health insurance coverage or pay a minor tax penalty (although there are some exemptions). This is to ensure that everyone is in the insurance pool so no one can get a "free ride" by not having affordable coverage and then going to an emergency room for care.
State-based health insurance exchanges will begin operating in 2014, where people who do not have access to employer-based insurance can shop and compare the benefits and costs of private health insurance plans. These exchanges will create insurance pools that will allow people to choose among affordable coverage options. All insurance companies in the exchange must provide at least a minimum benefit package, as well as additional coverage options beyond a basic plan.
Federal subsidies through tax credits or vouchers will be provided in 2014 to people who cannot afford the full cost to help them purchase coverage through the exchanges.
Beginning in 2011, states can require insurance companies to submit justification for premium increases and can impose penalties for excessive increases.

For patients enrolled in Medicare or Medicaid:

You no longer will pay any cost-sharing for a number of preventive services, effective Jan. 1, 2011.
If you are subject to the "doughnut hole" for your Medicare drug coverage, you will receive a 50 percent discount on those prescription drugs beginning Jan. 1, 2011.
A series of pilot programs will be implemented during the next four years to help find new ways to improve quality and lower the cost of the care you receive from your doctors, hospitals and nursing homes in the Medicare and Medicaid programs.
Medicaid coverage will be expanded in 2014 to all eligible children, pregnant women, parents and childless adults under age 65 who have incomes at or below 133 percent of the federal poverty level.

AAAAI: Test May Identify Asthma Patients Unresponsive to Steroids

2010-03-06T09:59:00.000-05:00

By John Gever, Senior Editor, MedPage Today
Published: March 05, 2010
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

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NEW ORLEANS -- Asthma patients who will be unlikely to gain control of symptoms with inhaled corticosteroids might be identified with a blood test, a researcher suggested here.

A plasma protein called uteroglobin appeared elevated enough in patients unresponsive to inhaled corticosteroids that a blood test might be feasible, reported Elena Goleva, PhD, of National Jewish Health in Denver.

By identifying such patients before starting on these drugs -- the standard of care for patients with persistent asthma -- they might instead be treated with alternative controller medications such as omalizumab (Xolair) or montelukast (Singulair), Goleva suggested in a featured poster presentation at the American Academy of Allergy, Asthma & Immunology meeting.

Goleva said about 15% to 20% of patients seen at her institution show poor responses to inhaled steroids. However, National Jewish Health is a national referral center, she pointed out, and the percentage would likely be smaller in an ordinary community practice.

Action Points

Explain to interested patients that inhaled corticosteroids are the standard of care for long-term control of asthma symptoms and that most patients respond to them when used as directed.
Explain that other medications are available for patients who fail to respond to these drugs after a fair trial.
Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered preliminary until published in a peer-reviewed journal.

She and her colleagues conducted a study in a total of 89 patients, 24 of whom were determined to be steroid-resistant.
These 24 patients continued to show asthma symptoms despite treatment with inhaled corticosteroids. They also showed essentially no improvement in lung function (as measured by FEV₁) following oral treatment with prednisone.
In contrast, symptomatic patients believed to be responsive to steroids had a mean 39% increase in FEV₁ with the prednisone burst.
Previous research had suggested that uteroglobin, which is produced by Clara cells in the lung, was increased in patients with steroid-resistant asthma, but with insufficient detail to confirm that the protein could be a useful biomarker.
Goleva and colleagues initially performed bronchoalveolar lavage in 20 patients, including 13 with steroid-resistant asthma and seven with asthma responding to the drugs.
Mean levels of uteroglobin expression, as measured by mRNA for the uteroglobin gene in BAL fluid, was elevated about six-fold in the resistant patients (P<0.05).
Actual levels of uteroglobin protein in the lavage fluid were roughly twice as high on average in the resistant patients (P<0.01), the researchers found.
Moreover, they discovered that mean uteroglobin levels in plasma were about 50% higher in the resistant patients, prompting the researchers to perform blood tests on an additional 25 patients, including 11 with steroid-resistant disease.
The findings were initially somewhat disappointing, Goleva explained.
The means were still significantly different -- about 65 ng per μg of plasma protein in the resistant patients, compared with about 45 in the steroid-sensitive group, but there was considerable overlap between the individual results.
For example, setting the cutoff at the lowest value in the steroid-resistant group would leave about three-quarters of the steroid-sensitive group above it as well.
But Goleva said her team hypothesized that airway disease might allow uteroglobin in the lungs to "leak" into circulation in the steroid-sensitive group, inflating their plasma levels of the protein.
If that were the case, they believed, lung proteins such as surfactant protein D and mucin-1 would also be elevated in the patients' plasma.
When they tested for those proteins, they found that four patients with elevated plasma levels of those lung proteins also had high plasma levels of uteroglobin.
With those four patients removed, there was clearer separation among the groups in their uteroglobin levels, although some overlap still remained, Goleva reported.
Finally, the researchers performed an in vitro experiment on peripheral blood mononuclear cells from 44 asthmatic patients, without regard to whether they were steroid-resistant, to correlate plasma uteroglobin with steroid responsiveness.
The latter was measured by the quantity of dexamethasone required to suppress lymphocyte proliferation and tumor necrosis factor production, both of which are associated with inflammatory activity.
The researchers found strong correlations -- r coefficients of 0.35 and 0.46, respectively, both with P<0.05 -- between uteroglobin and steroid responsiveness in these cells.
In sum, she said, it appears that uteroglobin could be a useful biomarker in guiding treatment selection.
Stanley Szefler, MD, also of National Jewish Health, although not involved with the study, said the research held some promise but cautioned that most cases of "steroid resistance" seen in routine practice have nonbiologic causes -- especially lack of treatment compliance or inadequate dosing.

ASA: Coffee Drinkers Have Lower Stroke Risk

2010-02-27T13:50:00.003-05:00

By Todd Neale, Staff Writer, MedPage Today
Published: February 26, 2010
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner
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SAN ANTONIO -- Drinking just one cup of coffee a day -- either regular or decaffeinated -- was associated with a 30% reduced risk of stroke, a large, prospective study showed.

Greater consumption did not heighten the apparent protective effect, according to Yangmei Li, MPhil, of the University of Cambridge in England.

The results, gathered over a mean 12-year follow-up, were not affected by adjusting for several known stroke risk factors, Li reported at the American Stroke Association meeting here.

Coffee drinking has been linked to lower risks of several other conditions, including type 2 diabetes and impaired cognition. (See Tea, Coffee Seem to Protect Against Diabetes and Caffeine May Slow Cognitive Decline in Women)Action Points
Explain to interested patients that this study could not establish a causal relationship between coffee drinking and stroke risk.

Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered preliminary until published in a peer-reviewed journal.
Studies examining the association with stroke, however, have been mixed, with some showing no relationship and others echoing the lower risk in the current analysis. (See High Coffee Consumption Linked to Lower Stroke Risk for Women)

Li and her colleagues explored the issue using data on 9,978 men and 12,254 women from the U.K. general population who were taking part in the European Prospective Investigation into Cancer (EPIC)-Norfolk.

The participants' mean age was 59 (range 39 to 79).

All were free of known heart disease, stroke, and cancer at the baseline period from 1993 to 1997.

Overall, 17,807 reported drinking some amount of coffee -- 3.1 cups a day on average -- and 4,425 said they never drank any coffee.

Through March 2008, 855 strokes occurred, with a lower risk among those who reported drinking any amount of coffee.

Adjusting for smoking, social class, educational level, body mass index, alcohol intake, physical activity, tea drinking, urinary sodium:creatinine, urinary potassium:creatinine, plasma vitamin C, systolic blood pressure, diabetes, and serum cholesterol did not affect the results.

Although men appeared to derive more of a benefit from drinking coffee than women -- HR 0.62 versus 0.84 -- the confidence intervals overlapped, and it was not clear that they were actually different.

Among current smokers, coffee drinkers had a 61% reduced risk of stroke (HR 0.59, 95% 0.38 to 0.94).

Li noted that the subgroup analyses may have lacked statistical power.

Commenting on the study, Daniel Lackland, DrPH, of the Medical University of South Carolina in Charleston, said the main weakness of the study was the use of self-reported data, which makes it difficult to determine the actual quantity of coffee consumed.

He said that even if the association is confirmed, it would be hard to identify the mechanism underlying it, which would be the next challenge.

Compounds in the coffee itself, something linked to the act of coffee drinking, or social behaviors surrounding coffee drinking could all be involved, he said.

Li could not identify a mechanism either, but suggested that compounds in coffee might benefit by improving insulin sensitivity, inhibiting platelet aggregation, and decreasing endothelial dysfunction. Coffee has also been shown to have some antioxidant properties.

Until a mechanism is established, probably in a large clinical trial, Lackland said, it is unlikely the medical community will be telling patients to drink more coffee to prevent stroke.

"Are you going to see this in the recommendations? I don't think right now," Lackland said.

Blocking Enzyme in Mice Reduces Fat

2010-02-03T18:34:00.000-05:00

By Michael Smith, North American Correspondent, MedPage Today
Published: February 02, 2010
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

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Action Points

Note that this study, in animals, suggests that interfering with a single enzyme might lead to substantial changes in energy expenditure and body fat.
Caution that more research is needed to find a compound that can block the enzyme safely in humans.

Blocking a single enzyme leads to increased energy expenditure and loss of body fat -- at least in mice, researchers said. Mice treated with a compound that blocks the so-called Fyn kinase expended 14% more energy than animals treated with an inert compound, according to Claire Bastie, PhD, and colleagues at Albert Einstein College of Medicine in New York City.
They also displayed a significant weight loss within 12 hours of receiving the compound, compared with animals given the inert substance, Bastie and colleagues reported in the Feb. 3 issue of Cell Metabolism.
"This is a new mechanism to help the body to burn extra energy," Bastie said in a statement.
The Fyn kinase has previously been linked to energy use: animals with the enzyme blocked burn more fatty acids and are leaner than their normal littermates, Bastie and colleagues noted.
Those animals also had increased insulin sensitivity, the researchers said, but the absence of the enzyme did not block the normal anabolic processes of protein synthesis and muscle growth during the feeding cycle.
The findings suggested that drugs blocking the enzyme might have a significant effect on energy balance and weight, they theorized.
To test the idea, they turned to wild-type mice and a compound called SU6656, a known inhibitor of the Src family of tyrosine kinases, of which Fyn is a member.
The mice spent spent 48 hours getting used to a so-called metabolic chamber, which allows researchers to monitor energy intake and expenditure. Then the compound was administered via intraperitoneal injection.
Control animals got injections of an inert substance, the researchers said. The shots were given at the beginning of the light cycle, when the animals are least active.
Both groups showed identical carbohydrate use during the dark cycle (when they are most active) that preceded the injection.
After the injection, the control animals reduced energy use as their bodies switched to the normal lipid production seen during the light cycle.
The treated animals, on the other hand, continued to expend energy at a rate that was significantly greater (P<0.0098) than the controls, although there was no significant difference in physical activity.
Because mice eat 80% of their calories during the dark cycle, they have a daily pattern of weight loss and gain, Bastie and colleagues noted, so that 12 hours after the start of the light cycle -- when they had been given the shots -- their weight was lowest.
But the SU6656-treated mice had a 40% greater weight loss than the control group, a difference that was significant at P<0.003.
Lean mass was slightly reduced in all the animals, Bastie and colleagues said, but without significant differences between groups. On the other hand, fat mass was significantly reduced (P<0.05) in the SU6656-treated mice, they found.
The metabolic effect of the inhibitor appears to be specific to Fyn, because it had no effect on mice lacking the enzyme, the researchers noted.
Unfortunately, SU6656 itself isn't a good choice for clinical trials of the idea in humans, Bastie said, because the Fyn kinase affects the brain, as well as muscle and fat tissue.
"Our next goal," she said, "is to design something extremely specific to muscle and adipose."

Metformin Cuts Obese Teens' Weight

2010-02-02T20:28:00.000-05:00

By Michael Smith, North American Correspondent, MedPage Today
Published: February 01, 2010
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

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The diabetes drug metformin can help obese teenagers lose weight even if they don't have the disease, researchers said.

In a randomized, placebo-controlled study that combined nearly two years of treatment and follow-up, the drug was associated with a statistically significant drop in body mass index, according to Darrell Wilson, MD, of Stanford University, and colleagues.

But the drug appeared to have no effect on many other aspects of obesity, including fat distribution and insulin resistance, Wilson and colleagues reported in the February Archives of Pediatrics & Adolescent Medicine.

The study is the longest and largest to test the effect of the drug, Wilson told MedPage Today. Treatment lasted 48 weeks, with another 48 weeks of follow-up, for 77 randomized volunteers.

The researchers enrolled the teens (ages 13 to 17) at six pediatric centers in the U.S. After a one-month run-in, they were randomized to 2,000 milligrams of extended-release metformin or to a placebo.

Action Points

Explain to interested patients that this study found that, for obese teens without diabetes, the diabetes drug metformin can help them lose weight.

All participants also took part in a lifestyle modification program that included diet and exercise.
To be eligible, the participants had to be in the 95th percentile or higher for their age and sex and could not have diabetes, Wilson said.
The primary goal was to see if the drug had any effect on body mass index, but Wilson and colleagues also measured body fat using dual-emission X-ray absorptiometry and computer tomography (CT) scanning, and measured insulin resistance using an oral glucose tolerance test.
After 48 weeks, they found, those in the metformin group had experienced on average a 0.9-point drop in body mass index, compared with a 0.2-point gain in the control group. The difference was significant at P=0.03.
The weight loss is roughly equivalent to three kilograms (6.6 pounds) for a 5' 5" adolescent, Wilson and colleagues said.
"It's not a 20-pound weight loss, it's not what the world is looking for in a weight-loss drug," he said. "It was a meaningful weight loss, just not a spectacular one."
On the other hand, the researcher reported significant differences in body composition, abdominal fat, or insulin indices.
The loss of weight lasted between 12 and 24 weeks after stopping the drug, the researchers reported. After that, the BMI of participants in the active group trended back toward levels of the placebo group.
There were no significant differences between the groups in adverse events, which were mostly mild or moderate. Two cases of nausea in metformin-treated volunteers were considered probably related to the study drug. One participant stopped the drug because of the nausea.
For clinicians, the study suggests that the drug might be useful in treating some obese adolescents, Wilson said.
"We've certainly started some of our patients on it, but it has not unleashed us on a campaign of getting everybody on it," he said.

Fish Oils May Slow Genetic Aging

2010-01-20T09:40:00.000-05:00

By Kristina Fiore, Staff Writer, MedPage Today
Published: January 19, 2010
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner
Earn CME/CE credit
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For heart disease patients, omega-3 fatty acids may protect against morbidity and mortality by slowing biological aging, researchers say.

Patients who had the highest omega-3 fatty acid blood levels also had telomeres that shortened at a significantly slower rate than patients with lower intake, Ramin Farzaneh-Far, MD, of the University of California San Francisco, and colleagues reported in the Jan. 20 JAMA.

Patients in the lowest quartile of omega-3 fatty acid blood levels had the fastest rate of telomere shortening over five years: 0.13 telomere-to-single-copy gene ratio (95% CI 0.09 to 0.17).

Those who had the highest omega-3 fatty acid blood levels had the slowest rate of telomere shortening: 0.05 telomere-to-single copy ratio (95% CI 0.02 to 0.08, P<0.001).
Action Points
Explain that patients who had the highest intake of omega-3 fatty acids had the slowest decrease in telomere length. On the other hand, patients with the lowest levels of omega-3s in their blood had the fastest rate of telomere shortening.
Telomeres are the protective caps at the end of chromosomes that reveal how biological stress ages a person.
"Patients with the highest levels of omega-3 fish oils were found to display the slowest decrease in telomere length, whereas those with the lowest levels of omega-3 fish oils in the blood had the fastest rate of telomere shortening," Farzaneh-Far said. "This suggests that these patients were aging faster than those with higher fish oil levels."

They said omega-3s may protect against oxidative stress, or increase the activity of the telomerase enzyme, which would decrease telomere shortening by creating more accurate telomere copies.

But some cardiologists were quick to point out that the results are preliminary and need to be replicated before physicians can use them in practice.

Since the study was observational and couldn't prove cause-and-effect, "we don't really know whether ingestion of omega-3 fatty acids resulted in this 'benefit,'" Steven E. Nissen, MD, of the Cleveland Clinic, noted in an e-mail. "It remains entirely possible that individuals who consume more fish also have other favorable healthy habits."

Nissen also pointed out that the study was not randomized to compare fish oil directly with a placebo treatment, and cautioned that "the relationship between telomere shortening and cardiovascular health is not well established."

Studies have shown that omega-3s appear to be effective for patients with coronary artery disease. Yet the underlying mechanisms are not well understood. Some researchers think it may have something to do with anti-inflammatory, triglyceride-lowering, antihypertensive, antiplatelet, or antiarrhythimic effects.

Research has shown that the length of telomeres -- chromosome caps that have long been compared to the plastic ends of shoelaces -- may be a marker of biological age. Biological age is independent of chronological age, and takes into account genetic and environmental stressors that may wreak havoc on cells.

Since there's been increasing evidence that omega-3s exert direct effects on aging and age-related diseases, the researchers decided to investigate them as a potential mechanism for protective effects in heart patients.

So they conducted a prospective cohort study of 608 patients in California with stable coronary artery disease. Patients were recruited from the Heart and Soul Study between September 2000 and December 2002.

They were followed for five years, and the researchers assessed telomere length of their leukocytes at baseline and again at the end of follow-up.

"By measuring telomere length at two different times," Farzaneh-Far said, "we were able to see the speed at which the telomers are shortening and that gives us some indication of how rapidly the biological aging process is taking place in these patients."

The researchers found that baseline omega-3 fatty acid levels were positively correlated with changes in telomere length over five years (P=0.001).

The relationships remained after controlling for potential confounders including demographics, blood pressure, serum lipids, and inflammatory biomarkers.

The researchers noted that each standard-deviation increase in fatty acid levels was associated with a 32% reduction in the odds of telomere shortening (95% CI 0.47 to 0.98).

So how do omega-3s stop telomeres from getting smaller?

They may protect against oxidative stress, which is a major driver of telomere shortening and aging. Or, fatty acids may increase the activity of the enzyme telomerase, which can result in more accurate copying and hence, longer telomeres, the researchers suggested.

The researchers agreed that the study was limited by its observational nature, which leaves no room for definitive conclusions about causality. Also, they only measured telomere length in leukocytes, which means the findings may not translate to other cell types, including myocardial or endothelial cells.

Researchers who were not involved in the study noted that omega-3s have been shown to have effects on other factors that contribute to heart disease risk.

"Omega-3 fatty acids have a potent positive impact on lipids that circulate in the blood stream and damage the heart," said Cam Patterson, MD, of the University of North Carolina Chapel Hill McAllister Heart Institute. "The effects of omega-3 fatty acids on lipids are still the best advertisement for their use to prevent heart disease."

Merle Myerson, MD, of Columbia University, agreed. "[The researchers] don't mention that omega-3 fatty acids lower triglycerides and non-HDL cholesterol, and stabilize cell membranes -- all of which may reduce risk for coronary artery disease and sudden cardiac death."

Myerson said the findings need to be replicated in future studies.

While their study may not have implications for intake of omega-3s among the general population, the researchers said it upholds recommendations for patients with heart disease.

"The results of our study underscore the recommendations of the American Heart Association, that patients with known coronary artery disease should be getting at least one gram a day of omega-3 fish oil," Farzaneh-Far said.

Gastric Bypass Extends Life for Most Patients

2010-01-19T09:24:00.000-05:00

By John Gever, Senior Editor, MedPage Today
Published: January 18, 2010
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

Earn CME/CE credit
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For most patients in most categories, bariatric surgery increases life expectancy, according to a new mathematical model. Only when short-term mortality following bariatric surgery is expected to be high or the likelihood of success is low will the procedure fail to improve life expectancy, researchers reported in the January Archives of Surgery.
Computer modeling predicted that a hypothetical "base case" patient -- a 42-year-old woman with a body mass index of 45 -- would gain 2.95 years of additional survival following bariatric surgery, according to Daniel P. Schauer, MD, of the University of Cincinnati, and colleagues.
Surgery failed to be beneficial in the model only when 30-day mortality reached 9.5% or the likelihood that surgery would not add life-years was 2% or less, they found.
Baseline 30-day mortality in the model was 0.2%, and the baseline efficacy of surgery in extending life expectancy was 53%.
"While not all patients are guaranteed a good outcome, our model indicates that gastric bypass increases life expectancy for most patient subgroups," they concluded.
Their analysis was based on a Markov decision model using published data to estimate 30-day mortality following bariatric surgery and the efficacy of surgery in reducing long-term death rates.
The latter had two components: reduction in excess mortality associated with obesity, and research data on long-term mortality following bariatric surgery.
Excess mortality estimates came from National Health Interview Survey data on some 400,000 participants from 1991 to 1996 linked to the National Death Index. Inputs on surgery efficacy were derived from a 2007 study of nearly 8,000 patients who had undergone gastric bypass and the same number of medically treated or untreated obese controls.
That study found that the procedure cut death rates by half during about seven years of follow-up. (See Missing Link Found: Bariatric Surgery Reduces Mortality)
Schauer and colleagues obtained rates of inhospital mortality following bariatric surgery from the 2005 National Inpatient Survey, then multiplied them by three to estimate 30-day mortality.
The researchers explained that according to earlier research, inhospital death rates typically underestimate 30-day mortality by a factor of two to three.
Their threefold correction factor represents "a conservative estimate that biases the model against gastric bypass surgery," they wrote.
Schauer and colleagues tested this correction factor and other aspects of the model in sensitivity analyses.
The biggest gains in life expectancy occurred in younger women with relatively high BMI values, the model showed.
The age effect was less important than BMI at the time of surgery. A 35-year-old woman with BMI of 45 would gain about 3.2 years of extra life, whereas at 55, a similarly obese woman would gain about 2.5 extra years.
But a 35-year-old woman with BMI of 55 could expect to live five more years with surgery, the model indicated.
Men in general derived less survival benefit from bariatric surgery, particularly with advancing age at the time of the procedure.
At 35, the difference in life expectancy gained was roughly 10%, but by age 75 it had grown to about 50%.
The sensitivity analyses found that relatively large changes in most parameters used in the model did not affect the overall results substantially.
The effect of 30-day mortality on whether or not surgery was beneficial for long-term survival was related to BMI and gender.
For women with a BMI of 40, 30-day mortality of more than 5% would mean surgery was not helpful, but short-term mortality had to exceed 15% for surgery not to be preferable for those with BMI of 55 or more. These thresholds were about 10% higher for men.
The efficacy of surgery in reducing mortality was less important for older men, the analysis also showed. A 75-year-man with a BMI of 35 could expect only a very slight gain in life span -- perhaps one or two months.
"Younger patients have lower surgical risk and more time over which to realize the benefits of surgery. For older patients, the gain is smaller, and for some, gastric bypass surgery will decrease life expectancy," Schauer and colleagues wrote.
However, they identified several potentially serious limitations to the analysis.
The study of long-term mortality following bariatric surgery was conducted at a single center and was not randomized. Additionally, long-term complications, such as need for repeat surgery, were not addressed in the model. Certain other risks that might be heightened after bariatric surgery were excluded as well, and quality of life was not modeled.
"The decision analysis presented here is a step forward in understanding optimal patient selection but also highlights some of the areas for which better data are needed," the researchers wrote.

Exercise May Aid Cognitive Function

2010-01-13T10:45:00.000-05:00

By Charles Bankhead, Staff Writer, MedPage Today
Published: January 12, 2010
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

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Action Points

Explain to patients that two different studies showed that physical activity in midlife or late in life may improve certain aspects of cognitive function.
The studies differed in that one showed benefits only in women and with vigorous activity whereas the other study demonstrated benefits in men and women but was limited to moderately intense exercise.

Almost any amount of moderate physical activity in mid- or late life reduced the odds of mild cognitive impairment by 30% to 40% in an ongoing cohort study, researchers reported. Men and women derived similar benefit, which was limited to moderate exercise -- not light or vigorous physical activity, investigators wrote in the January Archives of Neurology.
"Our findings contribute to the growing body of literature that indicates the potentially beneficial relationship between physical exercise and cognition," Yonas E. Geda, MD, of the Mayo Clinic in Rochester, Minn., and colleagues concluded. "A future population-based cohort study is needed to confirm whether physical exercise is associated with decreased risk of incident mild cognitive impairment."
Meanwhile, a small, separate interventional study described in the same journal showed that six months of high-intensity aerobic exercise was associated with significant improvement in executive function in older women at increased risk of cognitive decline, but not in older men.
Mild cognitive impairment confers a five- to 10-fold increased risk of dementia compared with normal cognition. Observational studies have shown that physical activity may protect against dementia and Alzheimer's disease, and some evidence suggests that exercise for individuals with mild cognitive impairment offers some protection, too, the authors wrote.
Geda and colleagues continued exploration of the association between physical activity and cognitive impairment with an evaluation of the effect of physical activity in midlife, approximately the age of onset for mild cognitive impairment. Data for the study came from the Mayo Clinic Study of Aging.
The study included 1,324 participants who completed a standardized questionnaire about physical activity. Their median age was about 80, and none of the participants exhibited signs of dementia at baseline.
Investigators assessed the frequency and intensity of physical activity as reported by each participant.

Light exercise: bowling, leisurely walking, stretching, slow dancing, and golfing using a cart.
Moderate exercise: brisk walking, hiking, aerobics, strength training, swimming, tennis doubles, yoga, martial arts, weight lifting, moderate use of exercise machines, and golfing without use of a cart.
Vigorous exercise: jogging, backpacking, bicycling uphill, tennis singles, racquetball, skiing, and intense or extended use of exercise machines.

The neuropsychologic evaluation consisted of nine tests that assessed memory, executive function, language, and visuospatial skills.
A consensus panel classified each participant as having normal cognition (N=1,126) or mild cognitive impairment (N=198). The two groups differed significantly in several respects. Participants with mild cognitive impairment were more likely to be men, older, less educated, more likely to be depressed, and had more comorbidity (P<0.001 to P=0.02).
Any frequency of moderately intense activity in midlife (ages 50 to 65) was associated with an odds ratio of 0.61 for mild cognitive impairment (95% CI 0.43 to 0.88, P=0.008). Moderate activity in later life was associated with an odds ratio of 0.68 (95% CI 0.49 to 0.93, P=0.02).
More or less intense activity of any frequency or duration did not significantly affect the odds ratio for mild cognitive impairment.
The authors noted several limitations of the study, including a cross-sectional design than could not assess causality, self-reported physical exercise data and relatively few subjects engaged in vigorous exercise in late life, which limited statistical power for that analysis.
A prospective evaluation of high-intensity aerobic exercise for patients with existing mild cognitive impairment showed that women had improved executive function, but men did not.
The study involved 17 women and 16 men ages 55 to 85. All had mild cognitive impairment by standardized assessment criteria, and all reported sedentary lifestyles at enrollment, Laura D. Baker, PhD, of the Veterans Affairs Puget Sound Health Care System in Seattle, and colleagues reported.
Participants were randomized 2:1 to aerobic exercise or stretching activity (control) and followed for six months. Both groups engaged in their assigned, supervised activities four times a week for 45 to 60 minutes at each session.
After two weeks, activity was supervised once a week. Participants assigned to aerobic exercise increased the duration and intensity of exercise over the first six weeks until they reached 75% to 85% of heart rate reserve, a level maintained for the remainder of the study.
Cognitive function was assessed at baseline and after three and six months of follow-up, as were physical status and laboratory values.
The results showed overall improvement in executive function among aerobic exercisers (P=0.04). Including gender as a predictive variable in the statistical model revealed significant interaction, reflecting a difference in response to the intervention for men and women (P=0.04).
Aerobic exercise increased glucose disposal, and reduced fasting plasma levels of insulin, cortisol, and brain-derived neurotrophic factor in women, the researchers reported. Among men, aerobic exercise increased plasma levels of insulin-like growth factor I.
Women on aerobic exercise demonstrated improvement in all four assessments of executive function, while men showed improvement in only one test.
"Aerobic exercise is a cost-effective practice that is associated with numerous physical benefits," the authors concluded. "The results of this study suggest that exercise also provides a cognitive benefit from some adults with mild cognitive impairment."
They also noted several limitations, including small sample size, exclusion of a number of subjects for medical reasons, and the fact that "the demands of the aerobic intervention are suited for a controlled trial, but may not be well-tolerated in less structured, less supervised population-based studies."

Nursing Homes Overuse Antipsychotics

2010-01-12T09:34:00.000-05:00

By Nancy Walsh, Contributing Writer, MedPage Today
Published: January 11, 2010
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

In 2006, a year after the FDA issued mortality warnings about prescribing antipsychotic drugs for the elderly, nearly 30% of nursing home residents received the medication -- despite the fact that a third of them had no indication for the drugs, a study revealed. In nursing homes where rates of antipsychotic drug use were highest, residents had a risk ratio of 1.37 (95% CI 1.24 to 1.51) for receiving at least one of them, compared with facilities where rates of prescribing were low, according to Yong Chen, MD, of the University of Massachusetts Medical School in Worcester, and colleagues.
This elevated risk associated with facility-level prescribing was seen for patients with dementia but no psychosis (RR 1.40, 95% CI 1.23 to 1.59), and in residents with neither psychosis nor dementia (RR 1.54, 95% CI 1.24 to 1.91), the researchers reported in the Jan. 11 Archives of Internal Medicine.
An unrelated study, also released today, indicated that office-based physicians were in fact cutting back on prescription of antipsychotics for dementia as a result of FDA warnings.
Recent research suggest that there's wide variation in use of antipsychotics among facilities, reflecting what the authors of the current study called "an institutional prescribing culture."
Previous work had suggested that facility-level factors contributed to this effect in Canada, but the extent to which these factors exist in the U.S. has been unclear.
So Chen and colleagues assessed a nationwide, cross-sectional sample of 16,586 U.S. residents newly admitted to 1,257 nursing homes.
The nursing homes were categorized into quintiles according to their rates of antipsychotic use, with prescribing rates in the previous year ranging from zero to 24.4% in quintile one to 43.8% to 100% in quintile five.
The sample included 972 patients with psychosis, 6,188 patients with dementia but no psychosis, and 9,426 with neither dementia nor psychosis.
Among residents with psychosis, 74.8% received at least one antipsychotic, as did 41.1% of those with dementia but no psychosis, and 16.4% of those with neither condition.
Compared with residents in quintile five facilities, those in quintile one were more likely to be:

Older (>75 years, 75% versus 59%, P<0.001)
Women (69.4% versus 60.9%, P<0.001)
White (85% versus 71.9%, P<0.001)

Residents in quintile one also were more likely to be frail, as determined by the Changes in Health, End-stage disease and Symptoms and Signs (CHESS) score of 3 or higher (24.7% versus 14%, P<0.001), than those in quintile five.
They also had better Cognitive Performance Scale scores of 0 or 1 (39.2% versus 31.4%, P<0.001).
Conversely, compared with patients in quintile one nursing homes, those in quintile five facilities were more likely to have:

Moderate or severe behavioral problems (23.5% versus 12.6%, P<0.001)
Dementia (52.3% versus 41.4%, P<0.001)
Psychosis (10.3% versus 4%, P<0.001)

Residents in quintile five had twice the unadjusted risk ratio of receiving antipsychotics compared with those in quintile one (RR 2, 95% CI 1.78 to 2.24), although this was reduced to 1.37 after adjusting for demographics, health status, and potential indication for antipsychotics.
When the investigators looked at individual patient characteristics, they found that antipsychotic medication users were:

Younger (≤65, 13.7% versus 10.2%, P<0.001)
Male (37.6% versus 34.1%, P<0.001)
Less frail (CHESS score 0, 24.9% versus 17.6%, P<0.001)

Antipsychotic users also tended to have:

Moderate and severe behavioral problems (32.3% versus 8.9%, P<0.001)
Dementia (68.8% versus 36.9%, P<0.001)
Psychosis (15.1% versus 2.1%, P<0.001)

The study confirms the existence of facility-level variation in prescribing, with the likelihood of a new resident being given an antipsychotic medication being "strongly and independently related to the facility-level antipsychotic prescribing rate, even after adjustment for clinical and sociodemographic characteristics," the investigators wrote.
Only a small proportion of residents receiving the drugs had diagnoses of schizophrenia, bipolar disorder, or aggressive behavioral symptoms of dementia, which suggests that managing behavioral problems is an important component of facility-level decisions regarding antipsychotic medication use.
The study also suggests that organizational culture plays an important role in medication prescribing in nursing homes, because in these settings, prescribing decisions often are made without direct contact between the prescriber and the patient.
Among the limitations of the study were its cross-sectional design, which precludes conclusions about causality, and the use of a sole data source: a single long-term-care pharmacy provider. They also pointed out that "we have excluded NHs with fewer than five residents. . . . and we further excluded short-stay residents because of their distinct characteristics from long-stay residents. Limiting our study sample therefore prevents us from extending the interpretation of our findings to smaller facilities."
They further pointed out that the "prevalence of psychoses in our sample was lower compared with that found in another study using medical records. Thus, we may have underestimated the prevalence of psychoses in this sample."
The investigators concluded that "safety concerns continue to persist in the use of antipsychotic medications in [nursing home] residents whose benefits from these agents are unclear."
They called for further research to clarify why this prescribing culture exists and to determine whether there are adverse health consequences for patients.

H1N1 Influenza May Increase Maternal Deaths

2009-12-27T17:19:00.000-05:00

Fran Lowry

December 23, 2009 — Women with suspected or confirmed H1N1 influenza who are pregnant or who have delivered within the previous 2 weeks should receive prompt and aggressive antiviral treatment and be closely monitored, according to new research published online December 23 in the New England Journal of Medicine.

"As in previous influenza epidemics and pandemics, pregnant women with 2009 pandemic influenza A (H1N1) appear to have an increase risk of severe disease," write Janice K. Louie, MD, MPH, from the California Department of Public Health, Richmond, and colleagues.

"From April 23 to August 11, 2009, a total of 10% of the 1088 patients who were hospitalized or died from 2009 H1N1 influenza, as reported to the California Department of Public Health...were pregnant. A recent report from the first month of the outbreak noted that the rate of hospitalization among pregnant women was approximately four times the rate in the general population."

In this report, Dr. Louie and colleagues reviewed the clinical course of the disease and the characteristics of all hospitalized pregnant, nonpregnant, and postpartum women (those who had delivered less than 2 weeks previously) of childbearing age from data reported to the California Department of Public Health in the first 4 months of the pandemic.

During this time period, data were reported for 94 pregnant women, 8 postpartum women, and 137 nonpregnant women, for a total of 239 women.

The researchers found that most pregnant patients (89/94, 95%) were in the second or third trimester when they were hospitalized. Five women (5%) were in the first trimester. Thirty-two women (34%) had underlying conditions for influenza complications other than pregnancy. The most common condition was asthma.

Rapid antigen tests were falsely negative in 38% (58/153) of the patients tested. Of these 58 patients, 28 were pregnant. Only 7 pregnant women with false-negative results received early (≤2 days after the onset of symptoms) antiviral treatment.

Overall, only half of pregnant women received early antiviral treatment throughout the surveillance period, the authors report. Six pregnant patients and one postpartum patient received oseltamivir 150 mg every 12 hours — a dose that was twice the current recommended dose. Forty-five percent of pregnant women and 58% of nonpregnant women were treated with antibiotics.

Starting antiviral treatment more than 2 days after the onset of symptoms in pregnant women was associated with admission to an intensive care unit or death (relative risk, 4.3; 95% confidence interval [CI], 1.4 - 13.7).

In all, 18 pregnant and 4 postpartum women — almost one fifth — required intensive care, and 8 died: 6 during pregnancy and 2 after delivery (on day 1 and on day 8). The 2 deaths in the immediate postpartum period highlight the continued high risk immediately after delivery, the authors note.

Six of the patients who died had underlying medical conditions in addition to pregnancy, including hypothyroidism in 2 patients, asthma in 2 patients, gestational diabetes in 1 patient, and a history of Hodgkin's lymphoma in 1 patient.

None of these patients had received prompt antiviral treatment. In these patients, the median time from symptom onset to receipt of antiviral agents was 6.5 days (range, 3 - 36 days).

Six deliveries occurred in the intensive care unit. Four of these were emergency cesarean deliveries.

During the surveillance period, there were an estimated 188,383 births in the state of California. The 8 deaths from H1N1 influenza resulted in a cause-specific maternal mortality ratio of 4.3 (95% CI, 1.8 - 8.4), the authors report.

"More than two thirds of maternal deaths in the United States each year are directly related to obstetrical factors, and maternal deaths due to influenza have been rare," they write. "The high 2009 H1N1 influenza-specific maternal mortality suggests that this pandemic has the potential to notably increase overall maternal mortality in the United States in 2009."

The authors note limitations of their study. Despite enhanced surveillance, cases relied on passive reporting by clinicians, and this probably resulted in underreporting of cases. Also, recommendations for testing were based on the severity of illness, clinicians may have been more inclined to test pregnant women than nonpregnant women, and pregnant women may have been hospitalized more readily.

Finally, the records of nonpregnant women requiring intensive care were not reviewed as carefully as those of pregnant women because of time and resource constraints.

The authors conclude that pregnant and postpartum women should be counseled about the importance of vaccination against H1N1 influenza. The vaccine is expected to have the same safety profile among pregnant women as the seasonal influenza vaccine, and preliminary results from a trial of the 2009 H1N1 monovalent vaccine have shown a strong immune response in pregnant women — similar to that seen in nonpregnant adults — with no identifiable safety concerns, the authors note.

They also advise that critically ill pregnant and postpartum women who are hospitalized in non–tertiary care centers be transferred to facilities that provide "a higher level of care, including neonatal intensive care for premature infants."

N Engl J Med. Published online December 23, 2009.

Psychotherapy May Prevent Obesity in At-Risk Teens

2009-12-21T09:39:00.000-05:00

By Kristina Fiore, Staff Writer, MedPage Today
Published: December 18, 2009
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine.

Psychotherapy may help prevent excessive weight gain in teen girls considered at risk for obesity, researchers say.

In a pilot trial, girls who participated in interpersonal psychotherapy saw their body mass index (BMI) stabilize over one year, while those who took traditional health education classes did not, Marian Tanofsky-Kraff, PhD, of the National Institutes of Health, and colleagues reported online in the International Journal of Eating Disorders.

The treatment also curbed binge-eating episodes, the researchers said.

Action Points

Explain that a small pilot study found girls who participated in interpersonal psychotherapy saw their body mass index (BMI) stabilize over one year, while those who took traditional health education classes did not. Their binge-eating habits were also curbed.

"We found very preliminary support that the therapy may reduce loss-of-control eating and prevent excess BMI gain," they wrote. All 38 girls enrolled in the trial were above average in weight, and some had previously reported episodes of loss-of-control of eating, or binge eating.
In loss-of-control eating, patients cannot control their food intake. This, of course, has been tied to risk of weight gain.
Interpersonal psychotherapy focuses on improving interpersonal relationships by targeting the underlying social difficulties that influence patients to engage in loss-of-control of eating, the researchers wrote.
The treatment has demonstrated effectiveness in reducing binge eating in obese adults.
It's "based on the assumption that binge eating occurs in response to poor social functioning and the consequent negative moods," Tanofsky-Kraff said in a statement.
Yet there is a dearth of intervention research in adolescents with binge eating, the researchers said.
So the researchers conducted the pilot program among 38 girls, ages 12 to 17, who were at risk for excess weight gain, and some of whom had reported episodes of loss-of-control of eating.
The girls were randomly assigned to therapy or to standard health education classes.
The researchers acknowledged that their team "made a concerted effort to maintain positive rapport and regular contact with study families, and girls were offered modest financial compensation."
Every participant completed a 12-week program, with 80% attendance required, and had follow-up visits through six months. A total of 35 returned for a complete assessment visit at one year. Two completed survey questionnaires instead, and one was lost to follow-up.
The researchers found that girls who had psychotherapy were more likely to stabilize or reduce their BMI than those who had health education classes (P=0.028).
Also, girls who had problems with binge eating at baseline experienced greater reductions in control-loss episodes if they had psychotherapy than those who had health education classes (P=0.036).
"This may provide a mechanism for the findings that more girls in the therapy group than the health education group experienced less-than-expected BMI growth at follow-up," the researchers wrote.
Even though the participants were compensated, the researchers speculated that the high level of attendance "may speak to an overarching desire on the part of the public to prevent obesity and find approaches that may bolster standard weight loss programs."
They acknowledged that the study was limited by a lack of statistical power due to its small size.
Still, Tanofsky-Kraff said that if psychotherapy "proves to be effective, we may be able to prevent not only excessive weight gain, but the development of related adverse health conditions in a subset of susceptible youth."

Soy may benefit breast cancer survivors

2009-12-09T18:28:00.000-05:00

By Denise Mann, Health.com

Soy components such as folate, protein, calcium, and fiber may be responsible for health benefits reported in the study.

STORY HIGHLIGHTS

Soy foods such as milk, tofu, and edamame are rich in naturally occurring estrogens
But study says soy may actually reduce the amount of estrogen that's available to the body
More studies are needed to confirm these findings, experts say

(Health.com) -- Women with breast cancer who eat more soy are less likely to die or have a recurrence of cancer than women who eat few or no soy products, according to a new study.

In the past, physicians have often warned breast cancer patients not to eat soy. The new research represents "a complete turnaround" from the previous understanding about the link between soy consumption and breast cancer, says Sally Scroggs, a registered dietician and senior health education specialist at M.D. Anderson's Cancer Prevention Center in Houston, Texas.

"We have gone from saying, 'No soy for breast cancer survivors' to, 'It's not going to hurt,'" Scroggs says. "Now it looks like we can say, 'It may help.'"

The study looked at more than 5,000 women in China who had undergone a mastectomy; they were followed for about four years. The women who consumed the most soy protein (about 15 grams or more a day) had a 29 percent lower risk of dying and a 32 percent decreased risk of breast cancer recurrence compared to the women who consumed less than about 5 grams of soy protein a day, according to the study, which appears in the December 9 issue of the Journal of the American Medical Association. The National Cancer Institute and the U.S. Department of Defense's Breast Cancer Research Program funded the study.

Health.com: How to take care of yourself after breast cancer surgery

We have gone from saying, 'No soy for breast cancer survivors' to, 'It's not going to hurt.' Now it looks like we can say, 'It may help.'
--Sally Scroggs, R.D.

RELATED TOPICS

Women who ate between 9.5 and 15 grams of soy protein saw nearly the same decrease in risk as the women who ate more than 15 grams. In fact, the researchers found no additional benefits to eating more than 11 grams of soy protein a day. (An 8-ounce glass of soy milk and a cup of shelled edamame contain about 7 and 14 grams of soy protein, respectively.)

In all, 534 women had a breast cancer recurrence or died from breast cancer during the study period.

Soy foods--such as milk, tofu, and edamame--are rich in naturally occurring estrogens (especially isoflavones) that can mimic the effects of estrogen in the female body. Because the most common types of breast cancer depend on estrogen to grow, experts once feared that soy isoflavones could stimulate the estrogen receptors in breast-cancer cells, even though the estrogens in soy are much weaker than those produced by the body.

Health.com: 'I stayed in control of my breast cancer treatment'

The current study suggests the exact opposite: Soy may actually reduce the amount of estrogen that's available to the body.

"Soy isoflavones may compete with estrogens produced by the body. Soy isoflavones may also reduce the body's production of estrogen, and increase clearance of these hormones from the circulation--all of which together reduce the overall amount of estrogen in the body," says the lead author of the study, Dr. Xiao Ou Shu, M.D., Ph.D., a cancer epidemiologist at the Vanderbilt-Ingram Cancer Center of Vanderbilt University Medical Center in Nashville, Tennessee.

Shu says, however, that factors beyond estrogen may be at work. Other components of soy foods, such as folate, protein, calcium, or fiber (or some combination thereof) may also be responsible for the health benefits reported in the study, she says.

Health.com: New breasts to go with my cancer-free life

The new findings, which seem to contradict what many women have heard from their doctors over the years, could prove perplexing for women such as Andrea Mulrain, 44, a former music executive who was first diagnosed with breast cancer 10 years ago.

After her diagnosis, Mulrain's doctors told her to steer clear of all soy foods because these foods could encourage the growth of cancer cells. Mulrain had estrogen-sensitive breast cancer, which means that estrogen helps the cancer grow.

Her doctors eventually softened their stance a bit, and said she could consume soy in moderation. "I pretty much avoided soy for 10 years after diagnosis but recently was told it was OK to have soy in moderation as long as I read the labels and make sure it's not the main ingredient in any food," says Mulrain, who is currently being treated for a recurrence.

In the study, the association between soy consumption and lower risk of death and cancer recurrence was seen in women like Mulrain with estrogen-sensitive breast cancers, and in women taking tamoxifen, a drug designed to prevent cancer recurrence by blocking the effects of estrogen in the breast tissue.

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Despite the study's findings, the final verdict on soy and breast-cancer recurrence is not yet in, according to an accompanying editorial written by Dr. Rachel Ballard-Barbash, M.D., of the National Cancer Institute in Bethesda, Maryland, and Marian L. Neuhouser, Ph.D., of the Fred Hutchinson Cancer Research Center in Seattle, Washington.

The follow-up period in the new study was relatively short, they say, and breast-cancer diagnosis and treatment may be different in China compared to the United States. Similarly, there may be differences in the types of soy foods that Chinese and American women eat. (In general, Chinese women consume significantly more soy than American women.)

More studies are needed to confirm these findings, especially as they apply to women with estrogen-sensitive breast cancer or those who take drugs such as tamoxifen to keep breast cancer at bay, say Ballard-Barbash and Neuhouser. Still, they say, "Patients with breast cancer can be assured that enjoying a soy latte or indulging in pad thai with tofu causes no harm, and when consumed in plentiful amounts may reduce risk of disease recurrence."

The study should be reassuring to women who have been trained to steer clear of soy, says Scroggs. "Don't freak out if there is some tofu mixed in with your vegetables at an Asian restaurant," she says.

Health.com: Breast cancer -- What should I do if I'm high risk?

Her soy prescription for breast-cancer survivors? "Eat soy in moderation, and your soy proteins should come from foods, not concentrated supplements," she says. "Soy is a complete protein so it is high in fiber and has a place in a healthy, balanced diet."

Eating more soy is beneficial because it tends to replace less healthy foods in people's diets, Scroggs says. "When people are eating soy protein, they are likely eating less of something else, such as red meat," she says.

Weight Loss Eases Apnea Symptoms in Obese Men

2009-12-05T12:55:00.000-05:00

By Michael Smith, North American Correspondent, MedPage Today
Published: December 04, 2009
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

A low-calorie diet can reduce the symptoms of obstructive sleep apnea in obese patients and in some cases cure the condition, Swedish researchers said.

In a randomized controlled trial, obese men who spent seven weeks on a very low-calorie liquid diet saw their sleep apnea drop from severe or moderate to mild or normal, according to Kari Johansson, a PhD candidate at the Karolinska Institute in Stockholm, and colleagues.

At the same time, obese men in the control group -- who maintained their normal diet -- saw no change, Johansson and colleagues reported online in BMJ.
Action Points

    * Explain to interested patients that obesity is a major risk factor for obstructive sleep apnea.

    * Note that this randomized controlled trial showed that a low-energy diet can relieve the symptoms of the disease, at least over a short term.

Only one other randomized trial has looked at the effect of weight loss in sleep apnea, Johansson and colleagues wrote, and that study did not include men with moderate or severe disease.

To help fill the gap, the researchers enrolled 63 men with a body mass index between 30 and 40. They randomly assigned 30 men to follow a seven-week, 550-kcal liquid regimen (the Cambridge Diet), followed by a two-week period of gradual reintroduction of normal food.

The remaining 33 men formed a control group and continued their normal diet, although two dropped out when they found they were to be controls.

At the start of the study, the average apnea-hypopnea index (AHI) was 37 in both groups -- meaning they averaged 37 episodes of stopped or shallow breathing per hour of sleep.

An index of less than 5 is regarded as normal, while scores of 5 through 14, 15 through 29, and 30 or more indicate mild, moderate, or severe obstructive sleep apnea, respectively.

At the end of the nine weeks, the researchers reported:

    * Men on the diet lost an average of 41 pounds, while those in the control group gained an average of 2.4 pounds.
    * On average, the dieting men lost 5.7 points on their BMI, compared with a gain of 0.3 points in the control group.
    * Twenty-two of the 30 dieters were no longer obese, while all of the control participants remained obese.
    * The average AHI among the dieters was 12 (mild), compared with 35 (severe) in the control group.
    * Five of the dieters were disease-free, with an AHI of less than 5, and half had mild disease. Only one participant in the control group was below 15 on the AHI.
    * Researchers identified eight transient adverse effects that might have been caused by the diet, including three cases of constipation and two of elevated alanine aminotransferase concentrations. There were no adverse events in the control group.

The main limitation of the study, Johansson and colleagues wrote, is that its short length made the long-term effect difficult to determine.

Even so, the study fills a "major gap" in evidence-based treatment of sleep apnea, according to Nathaniel Marshall, PhD, of the University of Sydney, and Ronald Grunstein, MD, PhD, of the Royal Prince Alfred Hospital, both in Sydney, Australia.

Writing an accompanying editorial, Marshall and Grunstein noted that much sleep apnea research has focused on mechanical interventions, such as continuous positive airway pressure machines.

The Swedish study provides "the first high-quality evidence that moderate-severe obstructive sleep apnea can be treated with weight loss," they wrote in the journal.

But they also noted that the study was only nine weeks long, "which leaves open the question of the long-term sustainability of the weight loss."

Obesity Outweighs Smoking as Life Expectancy Threat

2009-12-03T18:34:00.000-05:00

By Crystal Phend, Senior Staff Writer, MedPage Today
Published: December 02, 2009
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner
Earn CME/CE credit
for reading medical news

Gains in life expectancy from lower smoking rates over the next decade will be offset, to some degree, by reductions in life expectancy based on the rise in obesity, researchers estimated.

If obesity and smoking rates had held steady, the average 18-year-old would have seen a 2.98-year increase in life expectancy over a 15-year period, according to Susan T. Stewart, PhD, of Harvard and the private nonprofit National Bureau of Economic Research in Cambridge, Mass., and colleagues.

But a 48% rise in obesity overrode the expected gain from a 20% reduction in smoking rates seen over the past 15 years, the researchers reported in the Dec. 3 New England Journal of Medicine.

Bottom line: a predicted net impact of 0.71 fewer life-years through 2020 -- one quarter of the anticipated increase.Action Points
Explain to interested patients that these population-level predictions show the importance of tackling obesity for the nation's health, but the life expectancy estimates would not apply on an individual basis for those who lose weight or quit smoking.
Overall, life expectancy isn't expected to fall over the next decade, the researchers cautioned. Instead, their estimates suggest that "life expectancy will continue to rise but less rapidly than it otherwise would."

Still, the findings should be a wake-up call for policymakers and physicians, Stewart said in an interview.

"We know that the effects of obesity are not quite as intense as the effects of smoking, but obesity is more widespread," she said. "It was a little discouraging to see that obesity was winning."

"But if we were to put the same kind of effort into addressing obesity as we have fairly successfully put into addressing smoking, then perhaps we could have the same kind of positive effects for the future," she added.

The researchers forecast life expectancy and quality-adjusted life expectancy for a representative 18-year-old for each year from 2005 through 2020.

Since both obesity and smoking impact quality of life, the researchers also estimated quality-adjusted life expectancy using 2003 Medical Expenditure Panel Survey data.

Four iterations of the National Health Interview Survey from 1978 through 2006 revealed an average 1.4% decrease in smoking rates per year in the 15 years prior to 2005.

But Body Mass Index (BMI) trends based on National Health and Nutrition Examination Surveys (NHANES) from 1971 through 2006 showed an average 0.5% increase per year over the 15 years before 2005.

Assuming a continuation of past trends for the next 15 years, 21% of current smokers would quit by 2020, the researchers estimated.

Based on this factor alone, life expectancy for the typical 18-year-old would increase 0.31 years, with an extra 0.41 years of quality-adjusted life expectancy.

But over the same time frame, the normal weight population would drop by 35% in the U.S. with an estimated 45% of Americans expected to be obese by 2020.

The impact of this change alone would reduce life expectancy by 1.02 years and quality-adjusted life expectancy by 1.32 years.

Thus the net effect of the two risk factors together would be a 0.71-year reduction in life expectancy and 0.91-year drop in quality-adjusted life expectancy relative to the trend.

This same pattern was forecast for every year from 2005 to 2020, with the disproportionate effects of obesity becoming even more pronounced over time.

Even in sensitivity analyses based on more rapid declines in smoking and slower rises in obesity, the effects of obesity exceeded those of smoking on life expectancy.

The trends could be expected to have less absolute impact for older adults, who have fewer years of remaining life expectancy, Stewart said.

However, the results might underestimate the impact of obesity on youth, considering that earlier onset leaves more time for risks such as diabetes to arise, she said.

"Though perhaps not achievable," completely eliminating both smoking and obesity would increase life expectancy by 3.76 years while quality-adjusted life expectancy would rise by 5.16, the researchers wrote.

They cautioned that these population-level forecasts do not apply at the individual level to smokers who quit or people who lose weight.

Nevertheless, "even modest weight loss and reductions in smoking at the individual level can have substantial effects on population health," they concluded.

The study was supported by grants from the National Institute on Aging, the Harvard Interfaculty Program for Health Systems Improvement, and the Lasker Foundation. The researchers reported no potential conflicts of interest.