Mary Ann Moon

A high intake of staples in the typical Chinese diet, particularly rice, moderately increased the risk for type 2 diabetes in a population-based study of Chinese women.

“Given that a large part of the world's population consumes rice and carbohydrates as the mainstay of their diets [this finding] may have substantial implications for public health,” study investigators wrote in Archives of Internal Medicine.

Little is known about diabetes risk in populations that traditionally subsist on diets high in carbohydrates. “In our [study] population, the amount of carbohydrates consumed by participants is much higher than in previous studies of primarily white participants,” Dr. Raquel Villegas of Vanderbilt University Medical Center, Nashville, Tenn., and her associates noted.

The researchers analyzed data from the Shanghai Women's Health Study, a prospective cohort study of nearly 75,000 women who were aged 40–70 years at baseline in 1996–2000. The women were followed every 2 years for an average of 5 years. A total of 1,608 women developed new cases of type 2 diabetes.

A high intake of carbohydrates in the form of rice, noodles, steamed bread, and bread moderately raised the risk of developing diabetes. Compared with those in the lowest quintile of carbohydrate consumption (263 g/day), those in the highest quintile (338 g/day) were at greater risk of developing diabetes. This association persisted across all categories of body mass index and waist-to-height ratio. It was somewhat stronger in overweight women (Arch. Intern. Med. 2007;167:2310–6).

The median intake of raw rice was 250 g/day. After adjustment for factors such as age and body mass index, those who ate at least 300 g/day of rice had a 78% increase in risk for diabetes, compared with those who ate less than 200 g/day.

In addition, women whose diets included a high percentage of energy contributed by carbohydrates also were at higher risk of developing diabetes.

A high intake of staples in the typical Chinese diet, particularly rice, moderately increased the risk for type 2 diabetes in a population-based study of Chinese women.

“Given that a large part of the world's population consumes rice and carbohydrates as the mainstay of their diets [this finding] may have substantial implications for public health,” study investigators wrote in Archives of Internal Medicine.

Little is known about diabetes risk in populations that traditionally subsist on diets high in carbohydrates. “In our [study] population, the amount of carbohydrates consumed by participants is much higher than in previous studies of primarily white participants,” Dr. Raquel Villegas of Vanderbilt University Medical Center, Nashville, Tenn., and her associates noted.

The researchers analyzed data from the Shanghai Women's Health Study, a prospective cohort study of nearly 75,000 women who were aged 40–70 years at baseline in 1996–2000. The women were followed every 2 years for an average of 5 years. A total of 1,608 women developed new cases of type 2 diabetes.

A high intake of carbohydrates in the form of rice, noodles, steamed bread, and bread moderately raised the risk of developing diabetes. Compared with those in the lowest quintile of carbohydrate consumption (263 g/day), those in the highest quintile (338 g/day) were at greater risk of developing diabetes. This association persisted across all categories of body mass index and waist-to-height ratio. It was somewhat stronger in overweight women (Arch. Intern. Med. 2007;167:2310–6).

The median intake of raw rice was 250 g/day. After adjustment for factors such as age and body mass index, those who ate at least 300 g/day of rice had a 78% increase in risk for diabetes, compared with those who ate less than 200 g/day.

In addition, women whose diets included a high percentage of energy contributed by carbohydrates also were at higher risk of developing diabetes.

A high intake of staples in the typical Chinese diet, particularly rice, moderately increased the risk for type 2 diabetes in a population-based study of Chinese women.

“Given that a large part of the world's population consumes rice and carbohydrates as the mainstay of their diets [this finding] may have substantial implications for public health,” study investigators wrote in Archives of Internal Medicine.

Little is known about diabetes risk in populations that traditionally subsist on diets high in carbohydrates. “In our [study] population, the amount of carbohydrates consumed by participants is much higher than in previous studies of primarily white participants,” Dr. Raquel Villegas of Vanderbilt University Medical Center, Nashville, Tenn., and her associates noted.

The researchers analyzed data from the Shanghai Women's Health Study, a prospective cohort study of nearly 75,000 women who were aged 40–70 years at baseline in 1996–2000. The women were followed every 2 years for an average of 5 years. A total of 1,608 women developed new cases of type 2 diabetes.

A high intake of carbohydrates in the form of rice, noodles, steamed bread, and bread moderately raised the risk of developing diabetes. Compared with those in the lowest quintile of carbohydrate consumption (263 g/day), those in the highest quintile (338 g/day) were at greater risk of developing diabetes. This association persisted across all categories of body mass index and waist-to-height ratio. It was somewhat stronger in overweight women (Arch. Intern. Med. 2007;167:2310–6).

The median intake of raw rice was 250 g/day. After adjustment for factors such as age and body mass index, those who ate at least 300 g/day of rice had a 78% increase in risk for diabetes, compared with those who ate less than 200 g/day.

In addition, women whose diets included a high percentage of energy contributed by carbohydrates also were at higher risk of developing diabetes.

Thiazolidinediones, primarily rosiglitazone, were associated with a significant increase in the risk of congestive heart failure, myocardial infarction, and mortality in a large study of older patients with diabetes.

“The magnitude of harm observed in our study may be sufficient to outweigh any potential benefits associated with TZDs in an older, higher-risk population,” study investigators reported in JAMA.

Most of the evidence implicating thiazolidinediones in cardiovascular problems has been collected in clinical trials, which usually exclude patients older than 65. Dr. Lorraine L. Lipscombe of the University of Toronto and her associates conducted a retrospective study of 159,026 diabetes patients aged 66 and older who resided in Ontario and received oral hypoglycemic drugs between 2002 and 2005.

The mean subject age was 75, and median follow-up was just under 4 years. During that time, approximately 8% (nearly 12,500) of the study subjects were hospitalized for congestive heart failure (CHF) and 8% for acute myocardial infarction (MI), while 19% (more than 30,000) died.

Compared with other oral diabetes therapies, thiazolidinediones, either alone or in combination regimens, were associated with significantly higher risks for CHF, MI, and all-cause mortality.

Further analysis showed that most of the association was limited to rosiglitazone. However, the study may have been underpowered to detect adverse effects linked to pioglitazone because of the relatively few subjects who received that agent.

The association between thiazolidinediones and adverse cardiac effects remained robust after the data were adjusted to account for various prognostic factors, and was independent of subjects' baseline cardiovascular risk and duration of diabetes. The results suggest that the drawbacks of TZD treatment may outweigh the benefits, even in patients who don't have evidence of cardiovascular disease, the investigators said.

“Our findings argue against current labeling of TZDs that warns against use only in persons at high risk of CHF, as we did not identify any subgroup of older diabetes patients who may be protected from the adverse effects of TZDs,” Dr. Lipscombe and her associates said (JAMA 2007;298:2634–43).

(Since this study was conducted, a warning has been added to rosiglitazone sold in the United States advising patients that a meta-analysis of 42 clinical studies “showed [rosiglitazone] to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction.” It also notes that three other studies “have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive.”)

This is the first study to assess TZD-related outcomes in an entire population of older people with diabetes. “While there have been previous attempts to evaluate the association between TZDs and CHF in real-world settings, prior studies were either small in sample size, composed of lower-risk diabetes populations, or insufficiently adjusted for case-mix,” the authors noted.

Dr. David Alter, one of the study's coauthors, disclosed that he is a consultant to INTERxVENT Canada and a limited partner in PrevCan. No other disclosures were reported. The study was funded by the Ontario Ministry of Health and Long-Term Care.

Thiazolidinediones, primarily rosiglitazone, were associated with a significant increase in the risk of congestive heart failure, myocardial infarction, and mortality in a large study of older patients with diabetes.

“The magnitude of harm observed in our study may be sufficient to outweigh any potential benefits associated with TZDs in an older, higher-risk population,” study investigators reported in JAMA.

Most of the evidence implicating thiazolidinediones in cardiovascular problems has been collected in clinical trials, which usually exclude patients older than 65. Dr. Lorraine L. Lipscombe of the University of Toronto and her associates conducted a retrospective study of 159,026 diabetes patients aged 66 and older who resided in Ontario and received oral hypoglycemic drugs between 2002 and 2005.

The mean subject age was 75, and median follow-up was just under 4 years. During that time, approximately 8% (nearly 12,500) of the study subjects were hospitalized for congestive heart failure (CHF) and 8% for acute myocardial infarction (MI), while 19% (more than 30,000) died.

Compared with other oral diabetes therapies, thiazolidinediones, either alone or in combination regimens, were associated with significantly higher risks for CHF, MI, and all-cause mortality.

Further analysis showed that most of the association was limited to rosiglitazone. However, the study may have been underpowered to detect adverse effects linked to pioglitazone because of the relatively few subjects who received that agent.

The association between thiazolidinediones and adverse cardiac effects remained robust after the data were adjusted to account for various prognostic factors, and was independent of subjects' baseline cardiovascular risk and duration of diabetes. The results suggest that the drawbacks of TZD treatment may outweigh the benefits, even in patients who don't have evidence of cardiovascular disease, the investigators said.

“Our findings argue against current labeling of TZDs that warns against use only in persons at high risk of CHF, as we did not identify any subgroup of older diabetes patients who may be protected from the adverse effects of TZDs,” Dr. Lipscombe and her associates said (JAMA 2007;298:2634–43).

(Since this study was conducted, a warning has been added to rosiglitazone sold in the United States advising patients that a meta-analysis of 42 clinical studies “showed [rosiglitazone] to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction.” It also notes that three other studies “have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive.”)

This is the first study to assess TZD-related outcomes in an entire population of older people with diabetes. “While there have been previous attempts to evaluate the association between TZDs and CHF in real-world settings, prior studies were either small in sample size, composed of lower-risk diabetes populations, or insufficiently adjusted for case-mix,” the authors noted.

Dr. David Alter, one of the study's coauthors, disclosed that he is a consultant to INTERxVENT Canada and a limited partner in PrevCan. No other disclosures were reported. The study was funded by the Ontario Ministry of Health and Long-Term Care.

Thiazolidinediones, primarily rosiglitazone, were associated with a significant increase in the risk of congestive heart failure, myocardial infarction, and mortality in a large study of older patients with diabetes.

“The magnitude of harm observed in our study may be sufficient to outweigh any potential benefits associated with TZDs in an older, higher-risk population,” study investigators reported in JAMA.

Most of the evidence implicating thiazolidinediones in cardiovascular problems has been collected in clinical trials, which usually exclude patients older than 65. Dr. Lorraine L. Lipscombe of the University of Toronto and her associates conducted a retrospective study of 159,026 diabetes patients aged 66 and older who resided in Ontario and received oral hypoglycemic drugs between 2002 and 2005.

The mean subject age was 75, and median follow-up was just under 4 years. During that time, approximately 8% (nearly 12,500) of the study subjects were hospitalized for congestive heart failure (CHF) and 8% for acute myocardial infarction (MI), while 19% (more than 30,000) died.

Compared with other oral diabetes therapies, thiazolidinediones, either alone or in combination regimens, were associated with significantly higher risks for CHF, MI, and all-cause mortality.

Further analysis showed that most of the association was limited to rosiglitazone. However, the study may have been underpowered to detect adverse effects linked to pioglitazone because of the relatively few subjects who received that agent.

The association between thiazolidinediones and adverse cardiac effects remained robust after the data were adjusted to account for various prognostic factors, and was independent of subjects' baseline cardiovascular risk and duration of diabetes. The results suggest that the drawbacks of TZD treatment may outweigh the benefits, even in patients who don't have evidence of cardiovascular disease, the investigators said.

“Our findings argue against current labeling of TZDs that warns against use only in persons at high risk of CHF, as we did not identify any subgroup of older diabetes patients who may be protected from the adverse effects of TZDs,” Dr. Lipscombe and her associates said (JAMA 2007;298:2634–43).

(Since this study was conducted, a warning has been added to rosiglitazone sold in the United States advising patients that a meta-analysis of 42 clinical studies “showed [rosiglitazone] to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction.” It also notes that three other studies “have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive.”)

This is the first study to assess TZD-related outcomes in an entire population of older people with diabetes. “While there have been previous attempts to evaluate the association between TZDs and CHF in real-world settings, prior studies were either small in sample size, composed of lower-risk diabetes populations, or insufficiently adjusted for case-mix,” the authors noted.

Dr. David Alter, one of the study's coauthors, disclosed that he is a consultant to INTERxVENT Canada and a limited partner in PrevCan. No other disclosures were reported. The study was funded by the Ontario Ministry of Health and Long-Term Care.

A pay-for-performance program designed to improve quality of care for underserved patients succeeded in getting physicians to order more hemoglobin A_1c testing in their diabetic patients, as is recommended.

However, improving physicians' compliance with testing recommendations did not in turn improve their patients' control of the disease or affect outcomes, researchers wrote in the Journal of Health Care for the Poor and Underserved.

These findings indicate that earning a bonus for every HbA_1c test that is ordered according to guidelines does improve physicians' performance. But patient behavior and other factors are beyond the scope of the physician and contribute heavily to patient outcomes, said Katie Coleman, a research associate at the MacColl Institute for Healthcare Innovation at the Group Health Cooperative, Seattle, and her associates.

“While most pay-for-performance programs have been implemented by managed care companies and other large payers like Medicaid and Medicare, academic medical centers, hospitals, and clinics are starting to look at realigning incentives for their staff physicians as a way to enhance productivity and performance,” the investigators noted.

Yet only a few randomized controlled trials have examined the impact of financial incentives on health outcomes, and none have assessed that impact in medically underserved communities. In addition, the results of these few studies have been mixed, Ms. Coleman and her associates said.

They analyzed data from a large Chicago network of health care organizations to assess how implementing a pay-for-performance program affected outcomes in patients with diabetes. The study involved 1,166 patients treated by 46 primary care physicians.

Almost all of the patients were low-income members of minority groups.

After the physicians were able to earn bonuses for ordering HbA_1c tests according to American Diabetes Association recommendations, the proportion of patients who were correctly referred for testing increased from 29% to 46%, a significant improvement.

However, the number of patients with controlled diabetes actually declined slightly during that time, and there was no change in average HbA_1c scores after the incentive program was introduced (J. Health Care Poor Underserved 2007;18:966–83).

“Patients spend less than 1% of their time with their doctors, managing their own health care the rest of the time. If you do a purely medical intervention, it really isn't surprising that we don't see major improvements in people's health.

“Pay-for-performance fills in half of the equation. Now we need to find ways to work on the other half—involving patients,” Ms. Coleman said in a statement.

A pay-for-performance program designed to improve quality of care for underserved patients succeeded in getting physicians to order more hemoglobin A_1c testing in their diabetic patients, as is recommended.

However, improving physicians' compliance with testing recommendations did not in turn improve their patients' control of the disease or affect outcomes, researchers wrote in the Journal of Health Care for the Poor and Underserved.

These findings indicate that earning a bonus for every HbA_1c test that is ordered according to guidelines does improve physicians' performance. But patient behavior and other factors are beyond the scope of the physician and contribute heavily to patient outcomes, said Katie Coleman, a research associate at the MacColl Institute for Healthcare Innovation at the Group Health Cooperative, Seattle, and her associates.

“While most pay-for-performance programs have been implemented by managed care companies and other large payers like Medicaid and Medicare, academic medical centers, hospitals, and clinics are starting to look at realigning incentives for their staff physicians as a way to enhance productivity and performance,” the investigators noted.

Yet only a few randomized controlled trials have examined the impact of financial incentives on health outcomes, and none have assessed that impact in medically underserved communities. In addition, the results of these few studies have been mixed, Ms. Coleman and her associates said.

They analyzed data from a large Chicago network of health care organizations to assess how implementing a pay-for-performance program affected outcomes in patients with diabetes. The study involved 1,166 patients treated by 46 primary care physicians.

Almost all of the patients were low-income members of minority groups.

After the physicians were able to earn bonuses for ordering HbA_1c tests according to American Diabetes Association recommendations, the proportion of patients who were correctly referred for testing increased from 29% to 46%, a significant improvement.

However, the number of patients with controlled diabetes actually declined slightly during that time, and there was no change in average HbA_1c scores after the incentive program was introduced (J. Health Care Poor Underserved 2007;18:966–83).

“Patients spend less than 1% of their time with their doctors, managing their own health care the rest of the time. If you do a purely medical intervention, it really isn't surprising that we don't see major improvements in people's health.

“Pay-for-performance fills in half of the equation. Now we need to find ways to work on the other half—involving patients,” Ms. Coleman said in a statement.

A pay-for-performance program designed to improve quality of care for underserved patients succeeded in getting physicians to order more hemoglobin A_1c testing in their diabetic patients, as is recommended.

However, improving physicians' compliance with testing recommendations did not in turn improve their patients' control of the disease or affect outcomes, researchers wrote in the Journal of Health Care for the Poor and Underserved.

These findings indicate that earning a bonus for every HbA_1c test that is ordered according to guidelines does improve physicians' performance. But patient behavior and other factors are beyond the scope of the physician and contribute heavily to patient outcomes, said Katie Coleman, a research associate at the MacColl Institute for Healthcare Innovation at the Group Health Cooperative, Seattle, and her associates.

“While most pay-for-performance programs have been implemented by managed care companies and other large payers like Medicaid and Medicare, academic medical centers, hospitals, and clinics are starting to look at realigning incentives for their staff physicians as a way to enhance productivity and performance,” the investigators noted.

Yet only a few randomized controlled trials have examined the impact of financial incentives on health outcomes, and none have assessed that impact in medically underserved communities. In addition, the results of these few studies have been mixed, Ms. Coleman and her associates said.

They analyzed data from a large Chicago network of health care organizations to assess how implementing a pay-for-performance program affected outcomes in patients with diabetes. The study involved 1,166 patients treated by 46 primary care physicians.

Almost all of the patients were low-income members of minority groups.

After the physicians were able to earn bonuses for ordering HbA_1c tests according to American Diabetes Association recommendations, the proportion of patients who were correctly referred for testing increased from 29% to 46%, a significant improvement.

However, the number of patients with controlled diabetes actually declined slightly during that time, and there was no change in average HbA_1c scores after the incentive program was introduced (J. Health Care Poor Underserved 2007;18:966–83).

“Patients spend less than 1% of their time with their doctors, managing their own health care the rest of the time. If you do a purely medical intervention, it really isn't surprising that we don't see major improvements in people's health.

“Pay-for-performance fills in half of the equation. Now we need to find ways to work on the other half—involving patients,” Ms. Coleman said in a statement.

Prenatal alcohol exposure appears to cause later conduct problems in childhood, reported Dr. Brian M. D'Onofrio of Indiana University, Bloomington, and his associates.

In contrast, the later attention and impulsivity problems seen in children who were exposed to alcohol in utero appear to be caused by other factors correlated with maternal drinking rather than to the alcohol exposure itself, the researchers said.

Dr. D'Onofrio and his associates used data from a large longitudinal study of adolescents and young adults to examine the relation between drinking in young women and behavior in their offspring. The survey, funded by the U. S. Bureau of Labor Statistics, covered a racially diverse sample of over 6,000 subjects assessed annually from 1979 through 1994 and then biannually since then (Arch. Gen. Psychiatry 2007;64:1296–304).

Dr. D'Onofrio and his associates analyzed data on a subsample of 4,912 young female subjects who had at least one child aged 4–11 years by the 2004 assessment. The women had furnished information on their substance use both before they had become pregnant and during their pregnancies. They then reported on their children's conduct problems and attention/impulsivity problems using the Behavior Problem Index.

Prenatal exposure strongly correlated with conduct problems, and children with exposure to higher levels of alcohol had more such problems than those exposed to less alcohol. Compared with children who were not exposed to alcohol in utero, those who were exposed to alcohol every day had an increase of 0.35 standard deviations in conduct problems.

This link persisted after the data were adjusted to account for potentially confounding factors such as prenatal exposure to nicotine and other drugs, maternal traits, and genetic and environmental factors. It also persisted in comparisons with siblings and cousins, and in a number of statistical models.

“The results of all models are consistent with a causal association between prenatal alcohol exposure and offspring conduct problems,” the authors said. In contrast, prenatal alcohol exposure did not appear to be causally related to attention/impulsivity problems, although these problems were highly prevalent in exposed children.

Prenatal alcohol exposure appears to cause later conduct problems in childhood, reported Dr. Brian M. D'Onofrio of Indiana University, Bloomington, and his associates.

In contrast, the later attention and impulsivity problems seen in children who were exposed to alcohol in utero appear to be caused by other factors correlated with maternal drinking rather than to the alcohol exposure itself, the researchers said.

Dr. D'Onofrio and his associates used data from a large longitudinal study of adolescents and young adults to examine the relation between drinking in young women and behavior in their offspring. The survey, funded by the U. S. Bureau of Labor Statistics, covered a racially diverse sample of over 6,000 subjects assessed annually from 1979 through 1994 and then biannually since then (Arch. Gen. Psychiatry 2007;64:1296–304).

Dr. D'Onofrio and his associates analyzed data on a subsample of 4,912 young female subjects who had at least one child aged 4–11 years by the 2004 assessment. The women had furnished information on their substance use both before they had become pregnant and during their pregnancies. They then reported on their children's conduct problems and attention/impulsivity problems using the Behavior Problem Index.

Prenatal exposure strongly correlated with conduct problems, and children with exposure to higher levels of alcohol had more such problems than those exposed to less alcohol. Compared with children who were not exposed to alcohol in utero, those who were exposed to alcohol every day had an increase of 0.35 standard deviations in conduct problems.

This link persisted after the data were adjusted to account for potentially confounding factors such as prenatal exposure to nicotine and other drugs, maternal traits, and genetic and environmental factors. It also persisted in comparisons with siblings and cousins, and in a number of statistical models.

“The results of all models are consistent with a causal association between prenatal alcohol exposure and offspring conduct problems,” the authors said. In contrast, prenatal alcohol exposure did not appear to be causally related to attention/impulsivity problems, although these problems were highly prevalent in exposed children.

Prenatal alcohol exposure appears to cause later conduct problems in childhood, reported Dr. Brian M. D'Onofrio of Indiana University, Bloomington, and his associates.

In contrast, the later attention and impulsivity problems seen in children who were exposed to alcohol in utero appear to be caused by other factors correlated with maternal drinking rather than to the alcohol exposure itself, the researchers said.

Dr. D'Onofrio and his associates used data from a large longitudinal study of adolescents and young adults to examine the relation between drinking in young women and behavior in their offspring. The survey, funded by the U. S. Bureau of Labor Statistics, covered a racially diverse sample of over 6,000 subjects assessed annually from 1979 through 1994 and then biannually since then (Arch. Gen. Psychiatry 2007;64:1296–304).

Dr. D'Onofrio and his associates analyzed data on a subsample of 4,912 young female subjects who had at least one child aged 4–11 years by the 2004 assessment. The women had furnished information on their substance use both before they had become pregnant and during their pregnancies. They then reported on their children's conduct problems and attention/impulsivity problems using the Behavior Problem Index.

Prenatal exposure strongly correlated with conduct problems, and children with exposure to higher levels of alcohol had more such problems than those exposed to less alcohol. Compared with children who were not exposed to alcohol in utero, those who were exposed to alcohol every day had an increase of 0.35 standard deviations in conduct problems.

This link persisted after the data were adjusted to account for potentially confounding factors such as prenatal exposure to nicotine and other drugs, maternal traits, and genetic and environmental factors. It also persisted in comparisons with siblings and cousins, and in a number of statistical models.

“The results of all models are consistent with a causal association between prenatal alcohol exposure and offspring conduct problems,” the authors said. In contrast, prenatal alcohol exposure did not appear to be causally related to attention/impulsivity problems, although these problems were highly prevalent in exposed children.

After 18 months, the functional and aesthetic outcomes of the first human face transplantation are satisfactory and “encouraging,” according to the physicians who performed the surgery.

It appears that face transplantation “can offer hope” to selected patients who have severe facial disfigurement, they reported in the New England Journal of Medicine.

Dr. Jean-Michel Dubernard of the University of Lyons, France, and his associates previously published the initial results of the partial face transplantation, which they performed in a 38-year-old woman in November 2005. They now report longer-term outcomes.

The woman had been mauled by a dog in May of that year, with her distal nose, upper and lower lips, her entire chin, and the adjacent areas of both cheeks amputated. She received a graft of the lower face from a 46-year-old donor who had the same blood type and all but one of the same HLA antigens.

The recipient's sensory discrimination recovered quickly in the entire skin surface and the oral mucosa, although it remains subnormal. Heat and cold sensation was nearly normal at 4 months and normal at 6 months over the entire graft.

Motor recovery was slower. The patient was unable to close her mouth completely until 6 months post transplant, when that milestone greatly improved pronunciation and mastication. The smile was asymmetrical until 10 months, but became normal by 18 months.

The patient experienced two episodes of acute graft rejection, one 18 days after transplantation and the other 7 months later.

Initial treatment with a standard regimen of oral prednisone, tacrolimus, and mycophenolate mofetil were ineffective, but intravenous boluses of methylprednisolone reversed both of the episodes of rejection.

Extracorporeal photochemotherapy was started to reduce the risk of further graft rejection, and the treatment has been well tolerated.

The woman also developed two infectious complications: type 1 herpes simplex virus of the lips responded to oral valacyclovir and topical acyclovir, and molluscum contagiosum on the cheeks—affecting both the patient's own skin and the allograft skin—was treated by curettage.

The patient's initial immunosuppressive regimen impaired her renal function. This dysfunction was attributed to tacrolimus, which was replaced by sirolimus. Renal function has improved since the switch.

Although the patient has not undergone formal psychological testing, she has gradually resumed a normal social life.

“The progressive return of [facial] expressiveness correlated well with psychological acceptance of the foreign graft,” Dr. Dubernard and his associates said (N. Engl. J. Med. 2007;357:2451–60).

“She is not afraid of walking in the street or meeting people at a party, and she is very satisfied with the aesthetic and functional results,” they noted.

After 18 months, the functional and aesthetic outcomes of the first human face transplantation are satisfactory and “encouraging,” according to the physicians who performed the surgery.

It appears that face transplantation “can offer hope” to selected patients who have severe facial disfigurement, they reported in the New England Journal of Medicine.

Dr. Jean-Michel Dubernard of the University of Lyons, France, and his associates previously published the initial results of the partial face transplantation, which they performed in a 38-year-old woman in November 2005. They now report longer-term outcomes.

The woman had been mauled by a dog in May of that year, with her distal nose, upper and lower lips, her entire chin, and the adjacent areas of both cheeks amputated. She received a graft of the lower face from a 46-year-old donor who had the same blood type and all but one of the same HLA antigens.

The recipient's sensory discrimination recovered quickly in the entire skin surface and the oral mucosa, although it remains subnormal. Heat and cold sensation was nearly normal at 4 months and normal at 6 months over the entire graft.

Motor recovery was slower. The patient was unable to close her mouth completely until 6 months post transplant, when that milestone greatly improved pronunciation and mastication. The smile was asymmetrical until 10 months, but became normal by 18 months.

The patient experienced two episodes of acute graft rejection, one 18 days after transplantation and the other 7 months later.

Initial treatment with a standard regimen of oral prednisone, tacrolimus, and mycophenolate mofetil were ineffective, but intravenous boluses of methylprednisolone reversed both of the episodes of rejection.

Extracorporeal photochemotherapy was started to reduce the risk of further graft rejection, and the treatment has been well tolerated.

The woman also developed two infectious complications: type 1 herpes simplex virus of the lips responded to oral valacyclovir and topical acyclovir, and molluscum contagiosum on the cheeks—affecting both the patient's own skin and the allograft skin—was treated by curettage.

The patient's initial immunosuppressive regimen impaired her renal function. This dysfunction was attributed to tacrolimus, which was replaced by sirolimus. Renal function has improved since the switch.

Although the patient has not undergone formal psychological testing, she has gradually resumed a normal social life.

“The progressive return of [facial] expressiveness correlated well with psychological acceptance of the foreign graft,” Dr. Dubernard and his associates said (N. Engl. J. Med. 2007;357:2451–60).

“She is not afraid of walking in the street or meeting people at a party, and she is very satisfied with the aesthetic and functional results,” they noted.

After 18 months, the functional and aesthetic outcomes of the first human face transplantation are satisfactory and “encouraging,” according to the physicians who performed the surgery.

It appears that face transplantation “can offer hope” to selected patients who have severe facial disfigurement, they reported in the New England Journal of Medicine.

Dr. Jean-Michel Dubernard of the University of Lyons, France, and his associates previously published the initial results of the partial face transplantation, which they performed in a 38-year-old woman in November 2005. They now report longer-term outcomes.

The woman had been mauled by a dog in May of that year, with her distal nose, upper and lower lips, her entire chin, and the adjacent areas of both cheeks amputated. She received a graft of the lower face from a 46-year-old donor who had the same blood type and all but one of the same HLA antigens.

The recipient's sensory discrimination recovered quickly in the entire skin surface and the oral mucosa, although it remains subnormal. Heat and cold sensation was nearly normal at 4 months and normal at 6 months over the entire graft.

Motor recovery was slower. The patient was unable to close her mouth completely until 6 months post transplant, when that milestone greatly improved pronunciation and mastication. The smile was asymmetrical until 10 months, but became normal by 18 months.

The patient experienced two episodes of acute graft rejection, one 18 days after transplantation and the other 7 months later.

Initial treatment with a standard regimen of oral prednisone, tacrolimus, and mycophenolate mofetil were ineffective, but intravenous boluses of methylprednisolone reversed both of the episodes of rejection.

Extracorporeal photochemotherapy was started to reduce the risk of further graft rejection, and the treatment has been well tolerated.

The woman also developed two infectious complications: type 1 herpes simplex virus of the lips responded to oral valacyclovir and topical acyclovir, and molluscum contagiosum on the cheeks—affecting both the patient's own skin and the allograft skin—was treated by curettage.

The patient's initial immunosuppressive regimen impaired her renal function. This dysfunction was attributed to tacrolimus, which was replaced by sirolimus. Renal function has improved since the switch.

Although the patient has not undergone formal psychological testing, she has gradually resumed a normal social life.

“The progressive return of [facial] expressiveness correlated well with psychological acceptance of the foreign graft,” Dr. Dubernard and his associates said (N. Engl. J. Med. 2007;357:2451–60).

“She is not afraid of walking in the street or meeting people at a party, and she is very satisfied with the aesthetic and functional results,” they noted.

Infusion of glucose, insulin, and potassium yielded no benefit for patients with ST-segment elevation myocardial infarction in two large clinical trials, and the treatment may even cause harm, suggests an analysis of data on almost 23,000 patients.

Twenty-four-hour glucose-insulin-potassium (GIK) infusion exerted no favorable effect on any important clinical end point, and it appeared to raise mortality in the early postinfarction period, researchers wrote in the JAMA.

Several small studies have supported the use of GIK infusion to treat STEMI, but the Clinical Trial of Reviparin and Metabolic Modulation in Acute Myocardial Infarction Treatment and Evaluation—Estudios Clinicos Latino America (CREATE-ECLA), which enrolled more than 20,000 subjects, showed only a neutral effect.

A second large-scale clinical study assessing the treatment—the Organization for the Assessment of Strategies for Ischemic Syndromes-6 (OASIS-6) trial—was halted early when the CREATE-ECLA results were announced. The data from the first 2,748 subjects in the OASIS-6 trial have just been analyzed and combined with the CREATE-ECLA findings.

Dr. Rafael Diaz of Estudios Cardiologica Latin America, Rosario, Argentina, and his associates have reported the 30-day outcomes for 22,943 subjects in both studies.

There were no differences between STEMI patients who received GIK infusions and control subjects who received standard care in 30-day rates of death (9.7% vs. 9.3%), heart failure (16.5% vs. 16.7%), or the combined end point of death or heart failure (20.3% vs. 20.4%) in the combined analysis. Similarly, in subgroup analyses comparing patients who were treated immediately (within 2 hours) after symptom onset, those treated soon (within 4 hours), and those treated later (after 4 hours), GIK infusion did not reduce mortality in any group.

“We observed a higher rate of death and the composite of death or heart failure at 3 days in patients allocated to GIK therapy, compared with controls. Between 4 and 30 days, there were lower rates of death and the composite of death or heart failure in the GIK infusion group than in the control group, and the overall effect of GIK therapy on 30-day outcomes was neutral.

“It is possible that despite its early harmful effects, GIK therapy may have delayed benefits that neutralize its early hazard, but a more likely explanation for the observed 'late benefit' is postrandomization (survivor) bias,” the investigators said (JAMA 2007;298:2399–405).

It appears that rather than simply ensuring normalized glucose levels, potassium levels, and fluid balance after STEMI, GIK infusion may actually induce hyperglycemia, hyperkalemia, and net fluid gain, they said.

The OASIS-6 trial was funded by Sanofi Aventis, Organon, and GlaxoSmithKline.

Infusion of glucose, insulin, and potassium yielded no benefit for patients with ST-segment elevation myocardial infarction in two large clinical trials, and the treatment may even cause harm, suggests an analysis of data on almost 23,000 patients.

Twenty-four-hour glucose-insulin-potassium (GIK) infusion exerted no favorable effect on any important clinical end point, and it appeared to raise mortality in the early postinfarction period, researchers wrote in the JAMA.

Several small studies have supported the use of GIK infusion to treat STEMI, but the Clinical Trial of Reviparin and Metabolic Modulation in Acute Myocardial Infarction Treatment and Evaluation—Estudios Clinicos Latino America (CREATE-ECLA), which enrolled more than 20,000 subjects, showed only a neutral effect.

A second large-scale clinical study assessing the treatment—the Organization for the Assessment of Strategies for Ischemic Syndromes-6 (OASIS-6) trial—was halted early when the CREATE-ECLA results were announced. The data from the first 2,748 subjects in the OASIS-6 trial have just been analyzed and combined with the CREATE-ECLA findings.

Dr. Rafael Diaz of Estudios Cardiologica Latin America, Rosario, Argentina, and his associates have reported the 30-day outcomes for 22,943 subjects in both studies.

There were no differences between STEMI patients who received GIK infusions and control subjects who received standard care in 30-day rates of death (9.7% vs. 9.3%), heart failure (16.5% vs. 16.7%), or the combined end point of death or heart failure (20.3% vs. 20.4%) in the combined analysis. Similarly, in subgroup analyses comparing patients who were treated immediately (within 2 hours) after symptom onset, those treated soon (within 4 hours), and those treated later (after 4 hours), GIK infusion did not reduce mortality in any group.

“We observed a higher rate of death and the composite of death or heart failure at 3 days in patients allocated to GIK therapy, compared with controls. Between 4 and 30 days, there were lower rates of death and the composite of death or heart failure in the GIK infusion group than in the control group, and the overall effect of GIK therapy on 30-day outcomes was neutral.

“It is possible that despite its early harmful effects, GIK therapy may have delayed benefits that neutralize its early hazard, but a more likely explanation for the observed 'late benefit' is postrandomization (survivor) bias,” the investigators said (JAMA 2007;298:2399–405).

It appears that rather than simply ensuring normalized glucose levels, potassium levels, and fluid balance after STEMI, GIK infusion may actually induce hyperglycemia, hyperkalemia, and net fluid gain, they said.

The OASIS-6 trial was funded by Sanofi Aventis, Organon, and GlaxoSmithKline.

Infusion of glucose, insulin, and potassium yielded no benefit for patients with ST-segment elevation myocardial infarction in two large clinical trials, and the treatment may even cause harm, suggests an analysis of data on almost 23,000 patients.

Twenty-four-hour glucose-insulin-potassium (GIK) infusion exerted no favorable effect on any important clinical end point, and it appeared to raise mortality in the early postinfarction period, researchers wrote in the JAMA.

Several small studies have supported the use of GIK infusion to treat STEMI, but the Clinical Trial of Reviparin and Metabolic Modulation in Acute Myocardial Infarction Treatment and Evaluation—Estudios Clinicos Latino America (CREATE-ECLA), which enrolled more than 20,000 subjects, showed only a neutral effect.

A second large-scale clinical study assessing the treatment—the Organization for the Assessment of Strategies for Ischemic Syndromes-6 (OASIS-6) trial—was halted early when the CREATE-ECLA results were announced. The data from the first 2,748 subjects in the OASIS-6 trial have just been analyzed and combined with the CREATE-ECLA findings.

Dr. Rafael Diaz of Estudios Cardiologica Latin America, Rosario, Argentina, and his associates have reported the 30-day outcomes for 22,943 subjects in both studies.

There were no differences between STEMI patients who received GIK infusions and control subjects who received standard care in 30-day rates of death (9.7% vs. 9.3%), heart failure (16.5% vs. 16.7%), or the combined end point of death or heart failure (20.3% vs. 20.4%) in the combined analysis. Similarly, in subgroup analyses comparing patients who were treated immediately (within 2 hours) after symptom onset, those treated soon (within 4 hours), and those treated later (after 4 hours), GIK infusion did not reduce mortality in any group.

“We observed a higher rate of death and the composite of death or heart failure at 3 days in patients allocated to GIK therapy, compared with controls. Between 4 and 30 days, there were lower rates of death and the composite of death or heart failure in the GIK infusion group than in the control group, and the overall effect of GIK therapy on 30-day outcomes was neutral.

“It is possible that despite its early harmful effects, GIK therapy may have delayed benefits that neutralize its early hazard, but a more likely explanation for the observed 'late benefit' is postrandomization (survivor) bias,” the investigators said (JAMA 2007;298:2399–405).

It appears that rather than simply ensuring normalized glucose levels, potassium levels, and fluid balance after STEMI, GIK infusion may actually induce hyperglycemia, hyperkalemia, and net fluid gain, they said.

The OASIS-6 trial was funded by Sanofi Aventis, Organon, and GlaxoSmithKline.

Infants born at term with congenital heart disease show widespread brain abnormalities similar to those in preterm neonates, an imaging study of 57 newborns has shown.

These anomalies, are present well before the infants undergo cardiac surgery, reported Dr. Steven P. Miller of the University of California, San Francisco, and his associates. “Although most forms of congenital heart disease [CHD] are now amenable to early surgical repair, deficits that impair widespread neurodevelopmental domains are identified in up to half of childhood survivors: fine motor skills, visuospatial skills, and cognition, including memory, attention, and higher-order language skills,” they noted.

Most studies on the issue have focused on acute brain injury related to delivery or to the surgery and its support procedures, such as cardiopulmonary bypass and hypothermic circulatory arrest. The investigators hypothesized that instead, much of this brain injury predates the surgery. They used MRI, three-dimensional magnetic resonance spectroscopic (MRS) techniques, and spectroscopic and diffusion tensor imaging to prospectively examine the brains of 29 term infants with transposition of the great arteries, 12 with single-ventricle physiology, and 16 normal term infants.

The newborns with CHD showed altered brain metabolism and microstructure shortly after birth, before they underwent surgery. These abnormalities were present even in areas that showed no visible injury on regular MRI. In some cases where the infants appeared to have discrete lesions, the abnormalities in metabolism and microstructure were evident even in areas that appeared to be uninvolved. For example, MRS showed that the ratio of N-acetylaspartate to choline, which increases with maturation, was significantly lower in the newborns with CHD than in the controls.

This impairment was widespread “and did not conform to the pattern of brain injury that is typical of hypoxia-ischemia in term newborns,” so it was more likely due to longstanding abnormal brain development rather than to an acute injury, the investigators said (N. Engl. J. Med. 2007;357:1928–38).

Infants born at term with congenital heart disease show widespread brain abnormalities similar to those in preterm neonates, an imaging study of 57 newborns has shown.

These anomalies, are present well before the infants undergo cardiac surgery, reported Dr. Steven P. Miller of the University of California, San Francisco, and his associates. “Although most forms of congenital heart disease [CHD] are now amenable to early surgical repair, deficits that impair widespread neurodevelopmental domains are identified in up to half of childhood survivors: fine motor skills, visuospatial skills, and cognition, including memory, attention, and higher-order language skills,” they noted.

Most studies on the issue have focused on acute brain injury related to delivery or to the surgery and its support procedures, such as cardiopulmonary bypass and hypothermic circulatory arrest. The investigators hypothesized that instead, much of this brain injury predates the surgery. They used MRI, three-dimensional magnetic resonance spectroscopic (MRS) techniques, and spectroscopic and diffusion tensor imaging to prospectively examine the brains of 29 term infants with transposition of the great arteries, 12 with single-ventricle physiology, and 16 normal term infants.

The newborns with CHD showed altered brain metabolism and microstructure shortly after birth, before they underwent surgery. These abnormalities were present even in areas that showed no visible injury on regular MRI. In some cases where the infants appeared to have discrete lesions, the abnormalities in metabolism and microstructure were evident even in areas that appeared to be uninvolved. For example, MRS showed that the ratio of N-acetylaspartate to choline, which increases with maturation, was significantly lower in the newborns with CHD than in the controls.

This impairment was widespread “and did not conform to the pattern of brain injury that is typical of hypoxia-ischemia in term newborns,” so it was more likely due to longstanding abnormal brain development rather than to an acute injury, the investigators said (N. Engl. J. Med. 2007;357:1928–38).

Infants born at term with congenital heart disease show widespread brain abnormalities similar to those in preterm neonates, an imaging study of 57 newborns has shown.

These anomalies, are present well before the infants undergo cardiac surgery, reported Dr. Steven P. Miller of the University of California, San Francisco, and his associates. “Although most forms of congenital heart disease [CHD] are now amenable to early surgical repair, deficits that impair widespread neurodevelopmental domains are identified in up to half of childhood survivors: fine motor skills, visuospatial skills, and cognition, including memory, attention, and higher-order language skills,” they noted.

Most studies on the issue have focused on acute brain injury related to delivery or to the surgery and its support procedures, such as cardiopulmonary bypass and hypothermic circulatory arrest. The investigators hypothesized that instead, much of this brain injury predates the surgery. They used MRI, three-dimensional magnetic resonance spectroscopic (MRS) techniques, and spectroscopic and diffusion tensor imaging to prospectively examine the brains of 29 term infants with transposition of the great arteries, 12 with single-ventricle physiology, and 16 normal term infants.

The newborns with CHD showed altered brain metabolism and microstructure shortly after birth, before they underwent surgery. These abnormalities were present even in areas that showed no visible injury on regular MRI. In some cases where the infants appeared to have discrete lesions, the abnormalities in metabolism and microstructure were evident even in areas that appeared to be uninvolved. For example, MRS showed that the ratio of N-acetylaspartate to choline, which increases with maturation, was significantly lower in the newborns with CHD than in the controls.

This impairment was widespread “and did not conform to the pattern of brain injury that is typical of hypoxia-ischemia in term newborns,” so it was more likely due to longstanding abnormal brain development rather than to an acute injury, the investigators said (N. Engl. J. Med. 2007;357:1928–38).

Patent foramen ovale is significantly associated with cryptogenic stroke in people aged 55 years and older, as well as in younger stroke patients.

Findings from previous studies have suggested such an association, but few earlier investigations have included older patients as subjects. “Proof of a significant relationship” in older patients will have “significant implications for diagnostic and therapeutic management,” Dr. Michael Handke and his associates wrote.

Routine diagnostic testing fails to identify the cause of stroke in approximately 40% of patients. One potential cause is patent foramen ovale (PFO), which can predispose to embolism because it allows right-to-left intracardiac shunting. However, “it has long been debated whether the presence of patent foramen ovale actually does play a causal role in stroke or whether there is only a noncausal statistical relationship,” they noted.

The foramen ovale remains open in approximately 25% of the general population.

To clarify whether the presence of PFO is associated with cryptogenic stroke in older adults, Dr. Handke and his associates at University Hospital Freiburg (Germany) assessed 503 consecutive stroke patients treated at their institution during a 16-month period.

Stroke was classified as cryptogenic in 227 patients.

The prevalence of PFO, with or without a concomitant atrial septal aneurysm, was significantly higher in patients with cryptogenic stroke (34%) than in those whose stroke had a known etiology (12%), judging from findings from transesophageal echocardiography performed within 2 days of stroke onset.

The higher prevalence of PFO in patients with cryptogenic stroke held true both for patients aged 55 years and older and for younger patients. In patients aged 55 and older, PFO was present in 28% of those with cryptogenic stroke, compared with only 12% of those who had stroke of known etiology. In younger patients, the respective prevalences were 44% and 14%, the investigators said (N. Engl. J. Med. 2007;357:2262–8).

At present, “there are no clear guidelines based on randomized trials for therapy if patent foramen ovale is present.” But three ongoing randomized trials are examining the issue and “may clarify the effectiveness of percutaneous closure, as compared with medical therapy,” Dr. Handke and his associates said.

However, as with previous studies of stroke in patients with PFO, all three of these trials enrolled only subjects aged 60 or younger. “Studies that include older patients are needed to develop diagnostic and therapeutic management strategies for this large group of patients,” they noted.

Patent foramen ovale is significantly associated with cryptogenic stroke in people aged 55 years and older, as well as in younger stroke patients.

Findings from previous studies have suggested such an association, but few earlier investigations have included older patients as subjects. “Proof of a significant relationship” in older patients will have “significant implications for diagnostic and therapeutic management,” Dr. Michael Handke and his associates wrote.

Routine diagnostic testing fails to identify the cause of stroke in approximately 40% of patients. One potential cause is patent foramen ovale (PFO), which can predispose to embolism because it allows right-to-left intracardiac shunting. However, “it has long been debated whether the presence of patent foramen ovale actually does play a causal role in stroke or whether there is only a noncausal statistical relationship,” they noted.

The foramen ovale remains open in approximately 25% of the general population.

To clarify whether the presence of PFO is associated with cryptogenic stroke in older adults, Dr. Handke and his associates at University Hospital Freiburg (Germany) assessed 503 consecutive stroke patients treated at their institution during a 16-month period.

Stroke was classified as cryptogenic in 227 patients.

The prevalence of PFO, with or without a concomitant atrial septal aneurysm, was significantly higher in patients with cryptogenic stroke (34%) than in those whose stroke had a known etiology (12%), judging from findings from transesophageal echocardiography performed within 2 days of stroke onset.

The higher prevalence of PFO in patients with cryptogenic stroke held true both for patients aged 55 years and older and for younger patients. In patients aged 55 and older, PFO was present in 28% of those with cryptogenic stroke, compared with only 12% of those who had stroke of known etiology. In younger patients, the respective prevalences were 44% and 14%, the investigators said (N. Engl. J. Med. 2007;357:2262–8).

At present, “there are no clear guidelines based on randomized trials for therapy if patent foramen ovale is present.” But three ongoing randomized trials are examining the issue and “may clarify the effectiveness of percutaneous closure, as compared with medical therapy,” Dr. Handke and his associates said.

However, as with previous studies of stroke in patients with PFO, all three of these trials enrolled only subjects aged 60 or younger. “Studies that include older patients are needed to develop diagnostic and therapeutic management strategies for this large group of patients,” they noted.

Patent foramen ovale is significantly associated with cryptogenic stroke in people aged 55 years and older, as well as in younger stroke patients.

Findings from previous studies have suggested such an association, but few earlier investigations have included older patients as subjects. “Proof of a significant relationship” in older patients will have “significant implications for diagnostic and therapeutic management,” Dr. Michael Handke and his associates wrote.

Routine diagnostic testing fails to identify the cause of stroke in approximately 40% of patients. One potential cause is patent foramen ovale (PFO), which can predispose to embolism because it allows right-to-left intracardiac shunting. However, “it has long been debated whether the presence of patent foramen ovale actually does play a causal role in stroke or whether there is only a noncausal statistical relationship,” they noted.

The foramen ovale remains open in approximately 25% of the general population.

To clarify whether the presence of PFO is associated with cryptogenic stroke in older adults, Dr. Handke and his associates at University Hospital Freiburg (Germany) assessed 503 consecutive stroke patients treated at their institution during a 16-month period.

Stroke was classified as cryptogenic in 227 patients.

The prevalence of PFO, with or without a concomitant atrial septal aneurysm, was significantly higher in patients with cryptogenic stroke (34%) than in those whose stroke had a known etiology (12%), judging from findings from transesophageal echocardiography performed within 2 days of stroke onset.

The higher prevalence of PFO in patients with cryptogenic stroke held true both for patients aged 55 years and older and for younger patients. In patients aged 55 and older, PFO was present in 28% of those with cryptogenic stroke, compared with only 12% of those who had stroke of known etiology. In younger patients, the respective prevalences were 44% and 14%, the investigators said (N. Engl. J. Med. 2007;357:2262–8).

At present, “there are no clear guidelines based on randomized trials for therapy if patent foramen ovale is present.” But three ongoing randomized trials are examining the issue and “may clarify the effectiveness of percutaneous closure, as compared with medical therapy,” Dr. Handke and his associates said.

However, as with previous studies of stroke in patients with PFO, all three of these trials enrolled only subjects aged 60 or younger. “Studies that include older patients are needed to develop diagnostic and therapeutic management strategies for this large group of patients,” they noted.

The pneumococcal vaccine appears to have markedly reduced the overall burden of pediatric pneumonia, results of a large retrospective study suggest.

Rates of hospitalization and ambulatory medical visits for all-cause and pneumococcal pneumonia fell dramatically by 2004, 4 years after the 7-valent pneumococcal conjugate vaccine (PCV7) was introduced into the routine childhood immunization schedule in the United States. Associated medical expenditures also dropped considerably, the researchers reported.

Studies have found substantial decreases in the incidence of invasive pneumococcal disease such as meningitis and septicemia after the PCV7 vaccine was introduced, but few have examined its effect on all-cause pneumonia and pneumococcal pneumonia in the general population, and none to date have tallied the economic effects.

Fangjun Zhou, Ph.D., and associates at the Centers for Disease Control and Prevention, Atlanta, analyzed data from more than 100 large health insurance plans covering about 500 million claims between 1997 and 2004, including more than 40,000 each year for children younger than 2 years, the population targeted by the vaccine.

They found a 52% decline in hospitalizations for all-cause pneumonia and a 58% decline in hospitalizations for pneumococcal pneumonia after use of the PCV7 vaccine became widespread. The mean length of stay per all-cause pneumonia hospitalization also decreased significantly. During the same period, the number of ambulatory visits for all-cause pneumonia declined by 41%, and the number of visits for pneumococcal pneumonia declined by 47%.

“This suggests that [Streptococcus] pneumoniae was a major contributor to the burden of pneumonia hospitalizations and ambulatory visits in children younger than 2 years,” they noted (Arch. Pediatr. Adolesc. Med. 2007;161:1162–8).

They estimated annual national medical expenditures for all-cause pneumonia hospitalizations and ambulatory visits for children younger than age 2 dipped by 45%, from roughly $688 million to $377 million. Annual medical expenditures for pneumococcal pneumonia treatment declined 27%, from $122 million to $89 million.

“Total net savings from the vaccine would be much greater if indirect costs such as work loss by parents or productivity loss by disability or death due to the disease were included,” said the investigators, none of whom reported any financial conflicts of interest.

The pneumococcal vaccine appears to have markedly reduced the overall burden of pediatric pneumonia, results of a large retrospective study suggest.

Rates of hospitalization and ambulatory medical visits for all-cause and pneumococcal pneumonia fell dramatically by 2004, 4 years after the 7-valent pneumococcal conjugate vaccine (PCV7) was introduced into the routine childhood immunization schedule in the United States. Associated medical expenditures also dropped considerably, the researchers reported.

Studies have found substantial decreases in the incidence of invasive pneumococcal disease such as meningitis and septicemia after the PCV7 vaccine was introduced, but few have examined its effect on all-cause pneumonia and pneumococcal pneumonia in the general population, and none to date have tallied the economic effects.

Fangjun Zhou, Ph.D., and associates at the Centers for Disease Control and Prevention, Atlanta, analyzed data from more than 100 large health insurance plans covering about 500 million claims between 1997 and 2004, including more than 40,000 each year for children younger than 2 years, the population targeted by the vaccine.

They found a 52% decline in hospitalizations for all-cause pneumonia and a 58% decline in hospitalizations for pneumococcal pneumonia after use of the PCV7 vaccine became widespread. The mean length of stay per all-cause pneumonia hospitalization also decreased significantly. During the same period, the number of ambulatory visits for all-cause pneumonia declined by 41%, and the number of visits for pneumococcal pneumonia declined by 47%.

“This suggests that [Streptococcus] pneumoniae was a major contributor to the burden of pneumonia hospitalizations and ambulatory visits in children younger than 2 years,” they noted (Arch. Pediatr. Adolesc. Med. 2007;161:1162–8).

They estimated annual national medical expenditures for all-cause pneumonia hospitalizations and ambulatory visits for children younger than age 2 dipped by 45%, from roughly $688 million to $377 million. Annual medical expenditures for pneumococcal pneumonia treatment declined 27%, from $122 million to $89 million.

“Total net savings from the vaccine would be much greater if indirect costs such as work loss by parents or productivity loss by disability or death due to the disease were included,” said the investigators, none of whom reported any financial conflicts of interest.

The pneumococcal vaccine appears to have markedly reduced the overall burden of pediatric pneumonia, results of a large retrospective study suggest.

Rates of hospitalization and ambulatory medical visits for all-cause and pneumococcal pneumonia fell dramatically by 2004, 4 years after the 7-valent pneumococcal conjugate vaccine (PCV7) was introduced into the routine childhood immunization schedule in the United States. Associated medical expenditures also dropped considerably, the researchers reported.

Studies have found substantial decreases in the incidence of invasive pneumococcal disease such as meningitis and septicemia after the PCV7 vaccine was introduced, but few have examined its effect on all-cause pneumonia and pneumococcal pneumonia in the general population, and none to date have tallied the economic effects.

Fangjun Zhou, Ph.D., and associates at the Centers for Disease Control and Prevention, Atlanta, analyzed data from more than 100 large health insurance plans covering about 500 million claims between 1997 and 2004, including more than 40,000 each year for children younger than 2 years, the population targeted by the vaccine.

They found a 52% decline in hospitalizations for all-cause pneumonia and a 58% decline in hospitalizations for pneumococcal pneumonia after use of the PCV7 vaccine became widespread. The mean length of stay per all-cause pneumonia hospitalization also decreased significantly. During the same period, the number of ambulatory visits for all-cause pneumonia declined by 41%, and the number of visits for pneumococcal pneumonia declined by 47%.

“This suggests that [Streptococcus] pneumoniae was a major contributor to the burden of pneumonia hospitalizations and ambulatory visits in children younger than 2 years,” they noted (Arch. Pediatr. Adolesc. Med. 2007;161:1162–8).

They estimated annual national medical expenditures for all-cause pneumonia hospitalizations and ambulatory visits for children younger than age 2 dipped by 45%, from roughly $688 million to $377 million. Annual medical expenditures for pneumococcal pneumonia treatment declined 27%, from $122 million to $89 million.

“Total net savings from the vaccine would be much greater if indirect costs such as work loss by parents or productivity loss by disability or death due to the disease were included,” said the investigators, none of whom reported any financial conflicts of interest.

A bedtime dose of buckwheat honey was more effective than was dextromethorphan or no treatment at all for quieting cough and facilitating sleep in children aged 2–17 who had upper respiratory infection, reported Dr. Ian M. Paul and his associates at Pennsylvania State University, Hershey.

Honey decreased the frequency, severity, and “bothersome” nature of children's coughs associated with upper respiratory tract infections, thus improving both their sleep and their parents' sleep. Dextromethorphan wasn't any better than no treatment at all in a study comparing the three strategies.

The findings, combined with those of a previous study by the same researchers that found that neither dextromethorphan nor diphenhydramine was superior to placebo for cold symptoms, “now provide a generally safe and well-tolerated alternative for practitioners to recommend,” they wrote.

Dextromethorphan is the most commonly used over-the-counter antitussive for childhood cough, even though its use is not supported by the American Academy of Pediatrics or the American College of Chest Physicians.

The agent has been linked to serious adverse events including dystonia, anaphylaxis, and bullous mastocytosis at standard doses, as well as psychosis, mania, hallucinations, ataxia, dependence, and death at higher doses.

In contrast, honey, an alternative remedy used by many cultures and endorsed by the World Health Organization, is generally considered safe—with the exception of a risk of infantile botulism in children aged under 1 year.

Honey is thought to soothe the throat and to have antioxidant and antimicrobial effects, although there is “no scientific evidence to support” its use, Dr. Paul and his associates noted (Arch. Pediatr. Adolesc. Med. 2007;161:1140–6).

The researchers assessed the two cough remedies against no treatment in 105 patients at a single university-affiliated pediatric practice. The patients were randomly assigned to receive no treatment (37 children), buckwheat honey (35 children), or a honey-flavored dextromethorphan liquid (33 children) packaged in identical 10-mL syringes. They were treated for a single night and assessed via parent interviews before and after the intervention. The children had a median age of 5 years and had cough or rhinorrhea for 7 days or fewer before receiving treatment.

Buckwheat honey provided the greatest relief from cough and was significantly superior to both dextromethorphan and no treatment, the researchers wrote.

There was no difference in illness duration among the three groups. Parents reported mild adverse events such as hyperactivity, nervousness, or insomnia in five children who received honey and two who received dextromethorphan, compared with none of the children in the no-treatment group. This could influence physicians' recommendations in some cases, Dr. Paul and his associates said.

Among the limitations of this study noted by the researchers was that much of the improvement in all groups “can also be attributed to the natural history of [upper respiratory tract infections], which generally improve with time and supportive care.

“While additional studies to confirm our findings should be encouraged, each clinician should consider the findings for honey, the absence of such published findings for dextromethorphan, and the potential for adverse effects and cumulative costs associated with dextromethorphan when recommending treatments for families,” they added. The researchers explained that compared with other types, darker honeys, such as buckwheat, tend to have more phenolic compounds. These compounds have been associated with the antioxidant properties of honey that may have contributed to its relieving effect.

Further, they wrote, honey's “topical demulcent effect may contribute to its benefits for cough as postulated by the World Health Organization review.”

Antioxidant properties of darker honey are believed to help relieve coughing. Elsevier Global Medical News

A bedtime dose of buckwheat honey was more effective than was dextromethorphan or no treatment at all for quieting cough and facilitating sleep in children aged 2–17 who had upper respiratory infection, reported Dr. Ian M. Paul and his associates at Pennsylvania State University, Hershey.

Honey decreased the frequency, severity, and “bothersome” nature of children's coughs associated with upper respiratory tract infections, thus improving both their sleep and their parents' sleep. Dextromethorphan wasn't any better than no treatment at all in a study comparing the three strategies.

The findings, combined with those of a previous study by the same researchers that found that neither dextromethorphan nor diphenhydramine was superior to placebo for cold symptoms, “now provide a generally safe and well-tolerated alternative for practitioners to recommend,” they wrote.

Dextromethorphan is the most commonly used over-the-counter antitussive for childhood cough, even though its use is not supported by the American Academy of Pediatrics or the American College of Chest Physicians.

The agent has been linked to serious adverse events including dystonia, anaphylaxis, and bullous mastocytosis at standard doses, as well as psychosis, mania, hallucinations, ataxia, dependence, and death at higher doses.

In contrast, honey, an alternative remedy used by many cultures and endorsed by the World Health Organization, is generally considered safe—with the exception of a risk of infantile botulism in children aged under 1 year.

Honey is thought to soothe the throat and to have antioxidant and antimicrobial effects, although there is “no scientific evidence to support” its use, Dr. Paul and his associates noted (Arch. Pediatr. Adolesc. Med. 2007;161:1140–6).

The researchers assessed the two cough remedies against no treatment in 105 patients at a single university-affiliated pediatric practice. The patients were randomly assigned to receive no treatment (37 children), buckwheat honey (35 children), or a honey-flavored dextromethorphan liquid (33 children) packaged in identical 10-mL syringes. They were treated for a single night and assessed via parent interviews before and after the intervention. The children had a median age of 5 years and had cough or rhinorrhea for 7 days or fewer before receiving treatment.

Buckwheat honey provided the greatest relief from cough and was significantly superior to both dextromethorphan and no treatment, the researchers wrote.

There was no difference in illness duration among the three groups. Parents reported mild adverse events such as hyperactivity, nervousness, or insomnia in five children who received honey and two who received dextromethorphan, compared with none of the children in the no-treatment group. This could influence physicians' recommendations in some cases, Dr. Paul and his associates said.

Among the limitations of this study noted by the researchers was that much of the improvement in all groups “can also be attributed to the natural history of [upper respiratory tract infections], which generally improve with time and supportive care.

“While additional studies to confirm our findings should be encouraged, each clinician should consider the findings for honey, the absence of such published findings for dextromethorphan, and the potential for adverse effects and cumulative costs associated with dextromethorphan when recommending treatments for families,” they added. The researchers explained that compared with other types, darker honeys, such as buckwheat, tend to have more phenolic compounds. These compounds have been associated with the antioxidant properties of honey that may have contributed to its relieving effect.

Further, they wrote, honey's “topical demulcent effect may contribute to its benefits for cough as postulated by the World Health Organization review.”

Antioxidant properties of darker honey are believed to help relieve coughing. Elsevier Global Medical News

A bedtime dose of buckwheat honey was more effective than was dextromethorphan or no treatment at all for quieting cough and facilitating sleep in children aged 2–17 who had upper respiratory infection, reported Dr. Ian M. Paul and his associates at Pennsylvania State University, Hershey.

Honey decreased the frequency, severity, and “bothersome” nature of children's coughs associated with upper respiratory tract infections, thus improving both their sleep and their parents' sleep. Dextromethorphan wasn't any better than no treatment at all in a study comparing the three strategies.

The findings, combined with those of a previous study by the same researchers that found that neither dextromethorphan nor diphenhydramine was superior to placebo for cold symptoms, “now provide a generally safe and well-tolerated alternative for practitioners to recommend,” they wrote.

Dextromethorphan is the most commonly used over-the-counter antitussive for childhood cough, even though its use is not supported by the American Academy of Pediatrics or the American College of Chest Physicians.

The agent has been linked to serious adverse events including dystonia, anaphylaxis, and bullous mastocytosis at standard doses, as well as psychosis, mania, hallucinations, ataxia, dependence, and death at higher doses.

In contrast, honey, an alternative remedy used by many cultures and endorsed by the World Health Organization, is generally considered safe—with the exception of a risk of infantile botulism in children aged under 1 year.

Honey is thought to soothe the throat and to have antioxidant and antimicrobial effects, although there is “no scientific evidence to support” its use, Dr. Paul and his associates noted (Arch. Pediatr. Adolesc. Med. 2007;161:1140–6).

The researchers assessed the two cough remedies against no treatment in 105 patients at a single university-affiliated pediatric practice. The patients were randomly assigned to receive no treatment (37 children), buckwheat honey (35 children), or a honey-flavored dextromethorphan liquid (33 children) packaged in identical 10-mL syringes. They were treated for a single night and assessed via parent interviews before and after the intervention. The children had a median age of 5 years and had cough or rhinorrhea for 7 days or fewer before receiving treatment.

Buckwheat honey provided the greatest relief from cough and was significantly superior to both dextromethorphan and no treatment, the researchers wrote.

There was no difference in illness duration among the three groups. Parents reported mild adverse events such as hyperactivity, nervousness, or insomnia in five children who received honey and two who received dextromethorphan, compared with none of the children in the no-treatment group. This could influence physicians' recommendations in some cases, Dr. Paul and his associates said.

Among the limitations of this study noted by the researchers was that much of the improvement in all groups “can also be attributed to the natural history of [upper respiratory tract infections], which generally improve with time and supportive care.

“While additional studies to confirm our findings should be encouraged, each clinician should consider the findings for honey, the absence of such published findings for dextromethorphan, and the potential for adverse effects and cumulative costs associated with dextromethorphan when recommending treatments for families,” they added. The researchers explained that compared with other types, darker honeys, such as buckwheat, tend to have more phenolic compounds. These compounds have been associated with the antioxidant properties of honey that may have contributed to its relieving effect.

Further, they wrote, honey's “topical demulcent effect may contribute to its benefits for cough as postulated by the World Health Organization review.”

Antioxidant properties of darker honey are believed to help relieve coughing. Elsevier Global Medical News