H1N1 Influenza May Increase Maternal Deaths

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

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

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.

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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

• Breast Cancer
• M.D. Anderson Cancer Center
• Cancer

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

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

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
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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.