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Prepregnancy Obesity Linked to Birth Defects
Maternal obesity before pregnancy significantly increased the risk for offspring with anorectal atresia, hypospadias, limb reduction defects, diaphragmatic hernia, and omphalocele in a large study.
D. Kim Waller, Ph.D., of the University of Texas School of Public Health, Houston, and her associates used data from the National Birth Defects Prevention Study to assess whether maternal weight affected risk for several categories of structural birth defects. This is the first study to report a link between maternal obesity and these five types of defects using sufficient sample sizes of 150 or more cases.
More than half of American women aged 20–39 years are estimated to be overweight (with a body mass index [kg/m
The investigators analyzed data on 10,249 babies born with structural birth defects in eight states between 1997 and 2002, as well as 4,065 control subjects representative of the general population.
Maternal obesity was found to raise the risk for spina bifida and heart defects, confirming the findings of previous studies. It also significantly increased the risk for anorectal atresia, hypospadias, limb reduction defects, diaphragmatic hernia, and omphalocele, with odds ratios ranging from 1.3 to 1.6. Maternal obesity also carried a borderline increase in risk for cleft palate, the researchers said (Arch. Pediatr. Adolesc. Med. 2007;161:745-50).
Maternal overweight significantly increased the risk for heart defects, hypospadias, and omphalocele, and slightly raised the risk for craniosynostosis.
Unlike previous studies, this analysis failed to demonstrate an association between maternal obesity and anencephaly, hydrocephaly, or cleft lip. However, this finding may have been the result of chance, because the number of cases of these three birth defects was relatively low.
Maternal obesity before pregnancy significantly increased the risk for offspring with anorectal atresia, hypospadias, limb reduction defects, diaphragmatic hernia, and omphalocele in a large study.
D. Kim Waller, Ph.D., of the University of Texas School of Public Health, Houston, and her associates used data from the National Birth Defects Prevention Study to assess whether maternal weight affected risk for several categories of structural birth defects. This is the first study to report a link between maternal obesity and these five types of defects using sufficient sample sizes of 150 or more cases.
More than half of American women aged 20–39 years are estimated to be overweight (with a body mass index [kg/m
The investigators analyzed data on 10,249 babies born with structural birth defects in eight states between 1997 and 2002, as well as 4,065 control subjects representative of the general population.
Maternal obesity was found to raise the risk for spina bifida and heart defects, confirming the findings of previous studies. It also significantly increased the risk for anorectal atresia, hypospadias, limb reduction defects, diaphragmatic hernia, and omphalocele, with odds ratios ranging from 1.3 to 1.6. Maternal obesity also carried a borderline increase in risk for cleft palate, the researchers said (Arch. Pediatr. Adolesc. Med. 2007;161:745-50).
Maternal overweight significantly increased the risk for heart defects, hypospadias, and omphalocele, and slightly raised the risk for craniosynostosis.
Unlike previous studies, this analysis failed to demonstrate an association between maternal obesity and anencephaly, hydrocephaly, or cleft lip. However, this finding may have been the result of chance, because the number of cases of these three birth defects was relatively low.
Maternal obesity before pregnancy significantly increased the risk for offspring with anorectal atresia, hypospadias, limb reduction defects, diaphragmatic hernia, and omphalocele in a large study.
D. Kim Waller, Ph.D., of the University of Texas School of Public Health, Houston, and her associates used data from the National Birth Defects Prevention Study to assess whether maternal weight affected risk for several categories of structural birth defects. This is the first study to report a link between maternal obesity and these five types of defects using sufficient sample sizes of 150 or more cases.
More than half of American women aged 20–39 years are estimated to be overweight (with a body mass index [kg/m
The investigators analyzed data on 10,249 babies born with structural birth defects in eight states between 1997 and 2002, as well as 4,065 control subjects representative of the general population.
Maternal obesity was found to raise the risk for spina bifida and heart defects, confirming the findings of previous studies. It also significantly increased the risk for anorectal atresia, hypospadias, limb reduction defects, diaphragmatic hernia, and omphalocele, with odds ratios ranging from 1.3 to 1.6. Maternal obesity also carried a borderline increase in risk for cleft palate, the researchers said (Arch. Pediatr. Adolesc. Med. 2007;161:745-50).
Maternal overweight significantly increased the risk for heart defects, hypospadias, and omphalocele, and slightly raised the risk for craniosynostosis.
Unlike previous studies, this analysis failed to demonstrate an association between maternal obesity and anencephaly, hydrocephaly, or cleft lip. However, this finding may have been the result of chance, because the number of cases of these three birth defects was relatively low.
Depression Derails Recovery Following ACS
Depression severely impairs the recovery of heart rate variability after acute coronary syndrome, reported Dr. Alexander H. Glassman of Columbia University, New York, and his associates.
In addition, heart rate variability (HRV) continues to decline in patients whose depression does not respond to sertraline (Zoloft), while it ceases to decline in those whose depression does respond to sertraline. It is not yet known whether this cardiac benefit is attributable to a pharmacologic effect of the antidepressant, to improvement of the depressive illness, or to a combination of both, the researchers said in the September issue of the Archives of General Psychiatry.
“What is clear is that depression is associated with biological changes involving increased heart rate, inflammatory response, plasma norepinephrine, platelet reactivity, decreased heart rate variability, and now, absent post-ACS-HRV recovery, all of which [are] associated with life-threatening consequences,” said Dr. Glassman, a professor of psychiatry at the university.
“Patients with depression after myocardial infarction … should be both carefully watched and aggressively treated, because they are at an elevated cardiac risk and less likely to get better spontaneously,” the investigators noted (Arch. Gen. Psychiatry 2007;64:1025–31).
The researchers used data from 258 subjects who participated in the SADHART study to examine the effects of depression and of antidepressant therapy on heart rate variability. SADHART (Sertraline Antidepressant Heart Attack Randomized Trial), which took place in 1997–2001, compared sertraline with placebo in patients with major depressive disorder who were hospitalized after ACS.
In the general population, HRV falls abruptly during acute coronary episodes and recovers gradually but incompletely in the following weeks. However, Dr. Glassman and his associates found that HRV failed to recover in ACS patients with major depression.
The decline in HRV leveled off or improved slightly in those who responded to sertraline and in those whose mood improved spontaneously, but continued to decline in patients who received placebo or who failed to respond to sertraline.
Even patients who responded to sertraline showed only one-third as much HRV recovery as is reported in the literature among ACS patients who do not have depression. Thus, even successful therapy “may not fully eliminate the autonomic risk associated with major depressive disorder,” the investigators added.
Dr. Glassman served as a member of the steering committee for SADHART. He also has been a consultant for and has received honoraria from Pfizer Inc., which markets sertraline and provided partial support for the study.
Depression severely impairs the recovery of heart rate variability after acute coronary syndrome, reported Dr. Alexander H. Glassman of Columbia University, New York, and his associates.
In addition, heart rate variability (HRV) continues to decline in patients whose depression does not respond to sertraline (Zoloft), while it ceases to decline in those whose depression does respond to sertraline. It is not yet known whether this cardiac benefit is attributable to a pharmacologic effect of the antidepressant, to improvement of the depressive illness, or to a combination of both, the researchers said in the September issue of the Archives of General Psychiatry.
“What is clear is that depression is associated with biological changes involving increased heart rate, inflammatory response, plasma norepinephrine, platelet reactivity, decreased heart rate variability, and now, absent post-ACS-HRV recovery, all of which [are] associated with life-threatening consequences,” said Dr. Glassman, a professor of psychiatry at the university.
“Patients with depression after myocardial infarction … should be both carefully watched and aggressively treated, because they are at an elevated cardiac risk and less likely to get better spontaneously,” the investigators noted (Arch. Gen. Psychiatry 2007;64:1025–31).
The researchers used data from 258 subjects who participated in the SADHART study to examine the effects of depression and of antidepressant therapy on heart rate variability. SADHART (Sertraline Antidepressant Heart Attack Randomized Trial), which took place in 1997–2001, compared sertraline with placebo in patients with major depressive disorder who were hospitalized after ACS.
In the general population, HRV falls abruptly during acute coronary episodes and recovers gradually but incompletely in the following weeks. However, Dr. Glassman and his associates found that HRV failed to recover in ACS patients with major depression.
The decline in HRV leveled off or improved slightly in those who responded to sertraline and in those whose mood improved spontaneously, but continued to decline in patients who received placebo or who failed to respond to sertraline.
Even patients who responded to sertraline showed only one-third as much HRV recovery as is reported in the literature among ACS patients who do not have depression. Thus, even successful therapy “may not fully eliminate the autonomic risk associated with major depressive disorder,” the investigators added.
Dr. Glassman served as a member of the steering committee for SADHART. He also has been a consultant for and has received honoraria from Pfizer Inc., which markets sertraline and provided partial support for the study.
Depression severely impairs the recovery of heart rate variability after acute coronary syndrome, reported Dr. Alexander H. Glassman of Columbia University, New York, and his associates.
In addition, heart rate variability (HRV) continues to decline in patients whose depression does not respond to sertraline (Zoloft), while it ceases to decline in those whose depression does respond to sertraline. It is not yet known whether this cardiac benefit is attributable to a pharmacologic effect of the antidepressant, to improvement of the depressive illness, or to a combination of both, the researchers said in the September issue of the Archives of General Psychiatry.
“What is clear is that depression is associated with biological changes involving increased heart rate, inflammatory response, plasma norepinephrine, platelet reactivity, decreased heart rate variability, and now, absent post-ACS-HRV recovery, all of which [are] associated with life-threatening consequences,” said Dr. Glassman, a professor of psychiatry at the university.
“Patients with depression after myocardial infarction … should be both carefully watched and aggressively treated, because they are at an elevated cardiac risk and less likely to get better spontaneously,” the investigators noted (Arch. Gen. Psychiatry 2007;64:1025–31).
The researchers used data from 258 subjects who participated in the SADHART study to examine the effects of depression and of antidepressant therapy on heart rate variability. SADHART (Sertraline Antidepressant Heart Attack Randomized Trial), which took place in 1997–2001, compared sertraline with placebo in patients with major depressive disorder who were hospitalized after ACS.
In the general population, HRV falls abruptly during acute coronary episodes and recovers gradually but incompletely in the following weeks. However, Dr. Glassman and his associates found that HRV failed to recover in ACS patients with major depression.
The decline in HRV leveled off or improved slightly in those who responded to sertraline and in those whose mood improved spontaneously, but continued to decline in patients who received placebo or who failed to respond to sertraline.
Even patients who responded to sertraline showed only one-third as much HRV recovery as is reported in the literature among ACS patients who do not have depression. Thus, even successful therapy “may not fully eliminate the autonomic risk associated with major depressive disorder,” the investigators added.
Dr. Glassman served as a member of the steering committee for SADHART. He also has been a consultant for and has received honoraria from Pfizer Inc., which markets sertraline and provided partial support for the study.
Obesity Before Pregnancy Raises Risk of Birth Defects
Maternal obesity before pregnancy significantly increases the risk for offspring with anorectal atresia, hypospadias, limb reduction defects, diaphragmatic hernia, and omphalocele, researchers reported.
D. Kim Waller, Ph.D., of the University of Texas School of Public Health, Houston, and her associates used data from the National Birth Defects Prevention Study to assess whether maternal weight affected risk for several categories of structural birth defects. This is the first study to report a link between maternal obesity and these five types of defects using sufficient sample sizes of 150 or more cases.
More than half of American women aged 20–39 years are estimated to be overweight (with a body mass index [kg/m
However, “the potential relation between obesity and other birth defects remains less certain, as those studies that have examined a range of different birth defects did not have sufficient numbers of cases to generate precise odds ratios,” the researchers said.
The National Birth Defects Prevention Study not only has a very large sample size but also includes “well-defined, state-of-the-art procedures for case definition, clinical review, and classification of birth defects—which are often complex and difficult to classify…. [F]or many types of birth defects, it provides much greater statistical precision than has been previously possible,” they noted.
The investigators analyzed data on 10,249 babies born with structural birth defects in eight states between 1997 and 2002, as well as 4,065 control subjects representative of the general population.
Maternal obesity was found to raise the risk for spina bifida and heart defects, confirming the findings of previous studies. It also significantly increased the risk for anorectal atresia, hypospadias, limb reduction defects, diaphragmatic hernia, and omphalocele, with odds ratios ranging from 1.3 to 1.6.
Maternal obesity also carried a borderline increase in risk for cleft palate, the researchers said (Arch. Pediatr. Adolesc. Med. 2007;161:745–50).
Maternal overweight significantly increased the risk for heart defects, hypospadias, and omphalocele, and slightly raised the risk for craniosynostosis.
In contrast, “mothers who were underweight had no significant increase or decrease in risk for these birth defects, except for a modest increase in risk for cleft lip with or without cleft palate,” Dr. Waller and her associates said.
Unlike previous studies, this analysis failed to demonstrate an association between maternal obesity and anencephaly, hydrocephaly, or cleft lip. However, this result may have been to the result of chance, because the number of cases of these three birth defects was relatively low.
The reason that maternal obesity or overweight is associated with birth defects is unknown.
Because an excess of these same defects has been reported in women with diabetes who become pregnant, it is possible that alterations in glycemic control underlie the association, the investigators added.
Maternal obesity before pregnancy significantly increases the risk for offspring with anorectal atresia, hypospadias, limb reduction defects, diaphragmatic hernia, and omphalocele, researchers reported.
D. Kim Waller, Ph.D., of the University of Texas School of Public Health, Houston, and her associates used data from the National Birth Defects Prevention Study to assess whether maternal weight affected risk for several categories of structural birth defects. This is the first study to report a link between maternal obesity and these five types of defects using sufficient sample sizes of 150 or more cases.
More than half of American women aged 20–39 years are estimated to be overweight (with a body mass index [kg/m
However, “the potential relation between obesity and other birth defects remains less certain, as those studies that have examined a range of different birth defects did not have sufficient numbers of cases to generate precise odds ratios,” the researchers said.
The National Birth Defects Prevention Study not only has a very large sample size but also includes “well-defined, state-of-the-art procedures for case definition, clinical review, and classification of birth defects—which are often complex and difficult to classify…. [F]or many types of birth defects, it provides much greater statistical precision than has been previously possible,” they noted.
The investigators analyzed data on 10,249 babies born with structural birth defects in eight states between 1997 and 2002, as well as 4,065 control subjects representative of the general population.
Maternal obesity was found to raise the risk for spina bifida and heart defects, confirming the findings of previous studies. It also significantly increased the risk for anorectal atresia, hypospadias, limb reduction defects, diaphragmatic hernia, and omphalocele, with odds ratios ranging from 1.3 to 1.6.
Maternal obesity also carried a borderline increase in risk for cleft palate, the researchers said (Arch. Pediatr. Adolesc. Med. 2007;161:745–50).
Maternal overweight significantly increased the risk for heart defects, hypospadias, and omphalocele, and slightly raised the risk for craniosynostosis.
In contrast, “mothers who were underweight had no significant increase or decrease in risk for these birth defects, except for a modest increase in risk for cleft lip with or without cleft palate,” Dr. Waller and her associates said.
Unlike previous studies, this analysis failed to demonstrate an association between maternal obesity and anencephaly, hydrocephaly, or cleft lip. However, this result may have been to the result of chance, because the number of cases of these three birth defects was relatively low.
The reason that maternal obesity or overweight is associated with birth defects is unknown.
Because an excess of these same defects has been reported in women with diabetes who become pregnant, it is possible that alterations in glycemic control underlie the association, the investigators added.
Maternal obesity before pregnancy significantly increases the risk for offspring with anorectal atresia, hypospadias, limb reduction defects, diaphragmatic hernia, and omphalocele, researchers reported.
D. Kim Waller, Ph.D., of the University of Texas School of Public Health, Houston, and her associates used data from the National Birth Defects Prevention Study to assess whether maternal weight affected risk for several categories of structural birth defects. This is the first study to report a link between maternal obesity and these five types of defects using sufficient sample sizes of 150 or more cases.
More than half of American women aged 20–39 years are estimated to be overweight (with a body mass index [kg/m
However, “the potential relation between obesity and other birth defects remains less certain, as those studies that have examined a range of different birth defects did not have sufficient numbers of cases to generate precise odds ratios,” the researchers said.
The National Birth Defects Prevention Study not only has a very large sample size but also includes “well-defined, state-of-the-art procedures for case definition, clinical review, and classification of birth defects—which are often complex and difficult to classify…. [F]or many types of birth defects, it provides much greater statistical precision than has been previously possible,” they noted.
The investigators analyzed data on 10,249 babies born with structural birth defects in eight states between 1997 and 2002, as well as 4,065 control subjects representative of the general population.
Maternal obesity was found to raise the risk for spina bifida and heart defects, confirming the findings of previous studies. It also significantly increased the risk for anorectal atresia, hypospadias, limb reduction defects, diaphragmatic hernia, and omphalocele, with odds ratios ranging from 1.3 to 1.6.
Maternal obesity also carried a borderline increase in risk for cleft palate, the researchers said (Arch. Pediatr. Adolesc. Med. 2007;161:745–50).
Maternal overweight significantly increased the risk for heart defects, hypospadias, and omphalocele, and slightly raised the risk for craniosynostosis.
In contrast, “mothers who were underweight had no significant increase or decrease in risk for these birth defects, except for a modest increase in risk for cleft lip with or without cleft palate,” Dr. Waller and her associates said.
Unlike previous studies, this analysis failed to demonstrate an association between maternal obesity and anencephaly, hydrocephaly, or cleft lip. However, this result may have been to the result of chance, because the number of cases of these three birth defects was relatively low.
The reason that maternal obesity or overweight is associated with birth defects is unknown.
Because an excess of these same defects has been reported in women with diabetes who become pregnant, it is possible that alterations in glycemic control underlie the association, the investigators added.
Dexamethasone Fails to Benefit in Bronchiolitis
Dexamethasone neither prevented hospital admission nor improved the respiratory status of babies aged 2–12 months who presented to the emergency department with moderate to severe bronchiolitis, reported Dr. Howard M. Corneli of the University of Utah, Salt Lake City, and his associates.
The corticosteroid also did nothing to reduce the patients' visits to the hospital or to physicians during the week following the emergency department visit, the researchers said.
Treatment for bronchiolitis is controversial. An estimated 25% of babies hospitalized with the disorder are given corticosteroids, even though the agents' efficacy has never been established definitively.
Dr. Corneli and his associates assessed outcomes in 600 babies treated for a first episode of moderate to severe bronchiolitis at 20 emergency departments throughout the United States during flu seasons in 2004–2006. The patients were randomly assigned to receive oral dexa-methasone or placebo, as well as any bronchodilators or other therapies that their treating physicians deemed necessary.
Four hours after treatment, the proportion of patients admitted to the hospital for observation and further treatment was 40% in the dexamethasone group and 41% in the placebo group, a difference that was not statistically significant.
Similarly, there was no significant difference between the two groups in mean scores on a measure of respiratory distress 4 hours after treatment. For patients who were admitted to the hospital, there was no significant difference in length of stay between those who received dexamethasone and those who received placebo.
The two study groups also showed no significant differences in the rates of hospitalization, physician visits, or adverse drug reactions in the week following their emergency department visits, the investigators said (N. Engl. J. Med. 2007;357:331–9).
These results held true regardless of whether or not the babies had eczema or a family history of asthma, which indicates that the response to corticosteroids was no different whether or not they had atopy.
Because respiratory syncytial virus can cause bronchiolitis, the researchers assessed outcomes according to whether or not patients tested positive for the virus. Again, they found no significant difference in response to dexamethasone between babies who had the virus and those who did not.
Given these findings, “we recommend evaluation of other treatments and preventive strategies for bronchiolitis,” Dr. Corneli and his associates said.
Dexamethasone neither prevented hospital admission nor improved the respiratory status of babies aged 2–12 months who presented to the emergency department with moderate to severe bronchiolitis, reported Dr. Howard M. Corneli of the University of Utah, Salt Lake City, and his associates.
The corticosteroid also did nothing to reduce the patients' visits to the hospital or to physicians during the week following the emergency department visit, the researchers said.
Treatment for bronchiolitis is controversial. An estimated 25% of babies hospitalized with the disorder are given corticosteroids, even though the agents' efficacy has never been established definitively.
Dr. Corneli and his associates assessed outcomes in 600 babies treated for a first episode of moderate to severe bronchiolitis at 20 emergency departments throughout the United States during flu seasons in 2004–2006. The patients were randomly assigned to receive oral dexa-methasone or placebo, as well as any bronchodilators or other therapies that their treating physicians deemed necessary.
Four hours after treatment, the proportion of patients admitted to the hospital for observation and further treatment was 40% in the dexamethasone group and 41% in the placebo group, a difference that was not statistically significant.
Similarly, there was no significant difference between the two groups in mean scores on a measure of respiratory distress 4 hours after treatment. For patients who were admitted to the hospital, there was no significant difference in length of stay between those who received dexamethasone and those who received placebo.
The two study groups also showed no significant differences in the rates of hospitalization, physician visits, or adverse drug reactions in the week following their emergency department visits, the investigators said (N. Engl. J. Med. 2007;357:331–9).
These results held true regardless of whether or not the babies had eczema or a family history of asthma, which indicates that the response to corticosteroids was no different whether or not they had atopy.
Because respiratory syncytial virus can cause bronchiolitis, the researchers assessed outcomes according to whether or not patients tested positive for the virus. Again, they found no significant difference in response to dexamethasone between babies who had the virus and those who did not.
Given these findings, “we recommend evaluation of other treatments and preventive strategies for bronchiolitis,” Dr. Corneli and his associates said.
Dexamethasone neither prevented hospital admission nor improved the respiratory status of babies aged 2–12 months who presented to the emergency department with moderate to severe bronchiolitis, reported Dr. Howard M. Corneli of the University of Utah, Salt Lake City, and his associates.
The corticosteroid also did nothing to reduce the patients' visits to the hospital or to physicians during the week following the emergency department visit, the researchers said.
Treatment for bronchiolitis is controversial. An estimated 25% of babies hospitalized with the disorder are given corticosteroids, even though the agents' efficacy has never been established definitively.
Dr. Corneli and his associates assessed outcomes in 600 babies treated for a first episode of moderate to severe bronchiolitis at 20 emergency departments throughout the United States during flu seasons in 2004–2006. The patients were randomly assigned to receive oral dexa-methasone or placebo, as well as any bronchodilators or other therapies that their treating physicians deemed necessary.
Four hours after treatment, the proportion of patients admitted to the hospital for observation and further treatment was 40% in the dexamethasone group and 41% in the placebo group, a difference that was not statistically significant.
Similarly, there was no significant difference between the two groups in mean scores on a measure of respiratory distress 4 hours after treatment. For patients who were admitted to the hospital, there was no significant difference in length of stay between those who received dexamethasone and those who received placebo.
The two study groups also showed no significant differences in the rates of hospitalization, physician visits, or adverse drug reactions in the week following their emergency department visits, the investigators said (N. Engl. J. Med. 2007;357:331–9).
These results held true regardless of whether or not the babies had eczema or a family history of asthma, which indicates that the response to corticosteroids was no different whether or not they had atopy.
Because respiratory syncytial virus can cause bronchiolitis, the researchers assessed outcomes according to whether or not patients tested positive for the virus. Again, they found no significant difference in response to dexamethasone between babies who had the virus and those who did not.
Given these findings, “we recommend evaluation of other treatments and preventive strategies for bronchiolitis,” Dr. Corneli and his associates said.
Western Diet Tied to Colon Cancer Return
Colon cancer patients who eat a typical Western diet seem to have triple the risk of recurrence, compared with those who don't follow a Western diet.
After a potentially curative resection of stage III colon cancer and adjuvant chemotherapy, a diet replete with sweets, french fries, refined grains, and red and processed meats “may facilitate a milieu that allows residual microscopic disease to proliferate and spread,” Dr. Jeffrey A. Meyerhardt of the Dana-Farber Cancer Institute, Boston, and his associates said.
Some studies have examined the influence of diet and other lifestyle factors on the development of colon cancer, but few have addressed diet's influence in patients with established colon cancer. The investigators assessed the effect of two distinct dietary patterns—a typical Western diet versus what the investigators termed a “prudent” diet that included greater intakes of fruits, vegetables, legumes, fish, poultry, and whole grains—in 1,009 adult subjects who were already participating in a National Cancer Institute trial comparing different chemotherapy regimens.
The subjects had undergone complete surgical resection of the primary tumor in 1999–2001, and had regional lymph node metastases but no distant metastases. Their diets were assessed midway through the adjuvant chemotherapy. They were followed for a median of 5 years; a total of 324 developed a recurrence during follow-up.
Greater intake of a Western diet was associated with recurrence and cancer mortality. Patients in the highest quintile of the Western dietary pattern were three times more likely to develop recurrence and die from cancer than those in the lowest quintile of the pattern, the authors said (JAMA 2007;298:754-64). There was no association between the prudent diet and risk of cancer recurrence or mortality.
The deleterious effect of the typical Western diet was not significantly modified by patient age, gender, body mass index, or level of physical activity.
ELSEVIER GLOBAL MEDICAL NEWS
Colon cancer patients who eat a typical Western diet seem to have triple the risk of recurrence, compared with those who don't follow a Western diet.
After a potentially curative resection of stage III colon cancer and adjuvant chemotherapy, a diet replete with sweets, french fries, refined grains, and red and processed meats “may facilitate a milieu that allows residual microscopic disease to proliferate and spread,” Dr. Jeffrey A. Meyerhardt of the Dana-Farber Cancer Institute, Boston, and his associates said.
Some studies have examined the influence of diet and other lifestyle factors on the development of colon cancer, but few have addressed diet's influence in patients with established colon cancer. The investigators assessed the effect of two distinct dietary patterns—a typical Western diet versus what the investigators termed a “prudent” diet that included greater intakes of fruits, vegetables, legumes, fish, poultry, and whole grains—in 1,009 adult subjects who were already participating in a National Cancer Institute trial comparing different chemotherapy regimens.
The subjects had undergone complete surgical resection of the primary tumor in 1999–2001, and had regional lymph node metastases but no distant metastases. Their diets were assessed midway through the adjuvant chemotherapy. They were followed for a median of 5 years; a total of 324 developed a recurrence during follow-up.
Greater intake of a Western diet was associated with recurrence and cancer mortality. Patients in the highest quintile of the Western dietary pattern were three times more likely to develop recurrence and die from cancer than those in the lowest quintile of the pattern, the authors said (JAMA 2007;298:754-64). There was no association between the prudent diet and risk of cancer recurrence or mortality.
The deleterious effect of the typical Western diet was not significantly modified by patient age, gender, body mass index, or level of physical activity.
ELSEVIER GLOBAL MEDICAL NEWS
Colon cancer patients who eat a typical Western diet seem to have triple the risk of recurrence, compared with those who don't follow a Western diet.
After a potentially curative resection of stage III colon cancer and adjuvant chemotherapy, a diet replete with sweets, french fries, refined grains, and red and processed meats “may facilitate a milieu that allows residual microscopic disease to proliferate and spread,” Dr. Jeffrey A. Meyerhardt of the Dana-Farber Cancer Institute, Boston, and his associates said.
Some studies have examined the influence of diet and other lifestyle factors on the development of colon cancer, but few have addressed diet's influence in patients with established colon cancer. The investigators assessed the effect of two distinct dietary patterns—a typical Western diet versus what the investigators termed a “prudent” diet that included greater intakes of fruits, vegetables, legumes, fish, poultry, and whole grains—in 1,009 adult subjects who were already participating in a National Cancer Institute trial comparing different chemotherapy regimens.
The subjects had undergone complete surgical resection of the primary tumor in 1999–2001, and had regional lymph node metastases but no distant metastases. Their diets were assessed midway through the adjuvant chemotherapy. They were followed for a median of 5 years; a total of 324 developed a recurrence during follow-up.
Greater intake of a Western diet was associated with recurrence and cancer mortality. Patients in the highest quintile of the Western dietary pattern were three times more likely to develop recurrence and die from cancer than those in the lowest quintile of the pattern, the authors said (JAMA 2007;298:754-64). There was no association between the prudent diet and risk of cancer recurrence or mortality.
The deleterious effect of the typical Western diet was not significantly modified by patient age, gender, body mass index, or level of physical activity.
ELSEVIER GLOBAL MEDICAL NEWS
Depressive Symptoms Could Lead to Diabetes in Elderly
Older adults who report a high degree of depressive symptoms are more likely to develop type 2 diabetes than are those without depressive symptoms, according to Mercedes R. Carnethon, Ph.D., of Northwestern University, Chicago, and her associates in the Cardiovascular Health Study.
Several studies have found an association between depressive symptoms or clinical depression and diabetes, but this is the first to examine the issue in a population of people over age 65, who have a high prevalence of both disorders, Dr. Carnethon and her associates said (Arch. Intern. Med. 2007;167:802–7).
The researchers assessed data on 4,681 participants in the Cardiovascular Health Study, which took place from 1989 to 1999. Depressive symptoms had been evaluated annually using the 10-item Center for Epidemiological Studies Depression Scale.
A minimum score of 0 for each item would indicate that the subject experienced that depressive symptom never or rarely, and a maximum score of 3 for each item would indicate that the subject experienced that symptom most of the time or always. Total scores of 8 or more points, out of a possible maximum of 30 points, were considered high.
Twenty percent of the participants had high depressive symptom scores on at least one occasion. The proportion of subjects who were overweight or obese–a factor that could potentially confound the association with diabetes–was similar across those who had low, intermediate, or high depressive symptom scores.
New-onset diabetes was determined by the subjects' use of insulin or oral diabetes medications and by fasting glucose levels that were measured on two occasions during follow-up. A total of 234 subjects developed diabetes.
A high number of depressive symptoms on a single occasion, a significant increase in such symptoms over time, and persistently high symptoms over time all were associated with an excess incidence of diabetes, the investigators said.
The strongest link with diabetes was found when depressive symptom scores rose by at least 5 points over time.
“These findings were present across demographic strata and persisted with statistical adjustment for known correlates of depression and diabetes, such as BMI [body mass index], physical activity, cigarette smoking, alcohol intake, and C-reactive protein level,” Dr. Carnethon and her associates said.
In summary, high depressive symptoms might be connected to the development of diabetes in older adults, and this association might not be attributable solely to adverse health behaviors or weight gain. “The pathophysiologic mechanism for this association remains unclear,” they said.
Inflammation is often proposed as a likely mechanism, because inflammatory markers are associated with both diabetes and depression. However, the findings of this study showed no attenuation of the link between the two disorders when the data were adjusted for C-reactive protein levels.
This suggests that “other biological mechanisms previously proposed, such as hypothalamic-pituitary-adrenal axis dysregulation and sympathetic nervous system stimulation, may be more salient,” they added.
Older adults who report a high degree of depressive symptoms are more likely to develop type 2 diabetes than are those without depressive symptoms, according to Mercedes R. Carnethon, Ph.D., of Northwestern University, Chicago, and her associates in the Cardiovascular Health Study.
Several studies have found an association between depressive symptoms or clinical depression and diabetes, but this is the first to examine the issue in a population of people over age 65, who have a high prevalence of both disorders, Dr. Carnethon and her associates said (Arch. Intern. Med. 2007;167:802–7).
The researchers assessed data on 4,681 participants in the Cardiovascular Health Study, which took place from 1989 to 1999. Depressive symptoms had been evaluated annually using the 10-item Center for Epidemiological Studies Depression Scale.
A minimum score of 0 for each item would indicate that the subject experienced that depressive symptom never or rarely, and a maximum score of 3 for each item would indicate that the subject experienced that symptom most of the time or always. Total scores of 8 or more points, out of a possible maximum of 30 points, were considered high.
Twenty percent of the participants had high depressive symptom scores on at least one occasion. The proportion of subjects who were overweight or obese–a factor that could potentially confound the association with diabetes–was similar across those who had low, intermediate, or high depressive symptom scores.
New-onset diabetes was determined by the subjects' use of insulin or oral diabetes medications and by fasting glucose levels that were measured on two occasions during follow-up. A total of 234 subjects developed diabetes.
A high number of depressive symptoms on a single occasion, a significant increase in such symptoms over time, and persistently high symptoms over time all were associated with an excess incidence of diabetes, the investigators said.
The strongest link with diabetes was found when depressive symptom scores rose by at least 5 points over time.
“These findings were present across demographic strata and persisted with statistical adjustment for known correlates of depression and diabetes, such as BMI [body mass index], physical activity, cigarette smoking, alcohol intake, and C-reactive protein level,” Dr. Carnethon and her associates said.
In summary, high depressive symptoms might be connected to the development of diabetes in older adults, and this association might not be attributable solely to adverse health behaviors or weight gain. “The pathophysiologic mechanism for this association remains unclear,” they said.
Inflammation is often proposed as a likely mechanism, because inflammatory markers are associated with both diabetes and depression. However, the findings of this study showed no attenuation of the link between the two disorders when the data were adjusted for C-reactive protein levels.
This suggests that “other biological mechanisms previously proposed, such as hypothalamic-pituitary-adrenal axis dysregulation and sympathetic nervous system stimulation, may be more salient,” they added.
Older adults who report a high degree of depressive symptoms are more likely to develop type 2 diabetes than are those without depressive symptoms, according to Mercedes R. Carnethon, Ph.D., of Northwestern University, Chicago, and her associates in the Cardiovascular Health Study.
Several studies have found an association between depressive symptoms or clinical depression and diabetes, but this is the first to examine the issue in a population of people over age 65, who have a high prevalence of both disorders, Dr. Carnethon and her associates said (Arch. Intern. Med. 2007;167:802–7).
The researchers assessed data on 4,681 participants in the Cardiovascular Health Study, which took place from 1989 to 1999. Depressive symptoms had been evaluated annually using the 10-item Center for Epidemiological Studies Depression Scale.
A minimum score of 0 for each item would indicate that the subject experienced that depressive symptom never or rarely, and a maximum score of 3 for each item would indicate that the subject experienced that symptom most of the time or always. Total scores of 8 or more points, out of a possible maximum of 30 points, were considered high.
Twenty percent of the participants had high depressive symptom scores on at least one occasion. The proportion of subjects who were overweight or obese–a factor that could potentially confound the association with diabetes–was similar across those who had low, intermediate, or high depressive symptom scores.
New-onset diabetes was determined by the subjects' use of insulin or oral diabetes medications and by fasting glucose levels that were measured on two occasions during follow-up. A total of 234 subjects developed diabetes.
A high number of depressive symptoms on a single occasion, a significant increase in such symptoms over time, and persistently high symptoms over time all were associated with an excess incidence of diabetes, the investigators said.
The strongest link with diabetes was found when depressive symptom scores rose by at least 5 points over time.
“These findings were present across demographic strata and persisted with statistical adjustment for known correlates of depression and diabetes, such as BMI [body mass index], physical activity, cigarette smoking, alcohol intake, and C-reactive protein level,” Dr. Carnethon and her associates said.
In summary, high depressive symptoms might be connected to the development of diabetes in older adults, and this association might not be attributable solely to adverse health behaviors or weight gain. “The pathophysiologic mechanism for this association remains unclear,” they said.
Inflammation is often proposed as a likely mechanism, because inflammatory markers are associated with both diabetes and depression. However, the findings of this study showed no attenuation of the link between the two disorders when the data were adjusted for C-reactive protein levels.
This suggests that “other biological mechanisms previously proposed, such as hypothalamic-pituitary-adrenal axis dysregulation and sympathetic nervous system stimulation, may be more salient,” they added.
Child Abuse Rate Rises With Fathers' Combat Deployment
The rate of child abuse in U.S. Army families who are prone to such maltreatment rises significantly when the soldiers are deployed for combat, researchers reported.
Most of this increase is attributable to civilian wives of the Army enlisted personnel.
Their rates of inflicting moderate to severe child abuse and neglect are nearly four times higher when their husbands are deployed on combat-related duties than when their husbands are not deployed, reported Deborah A. Gibbs of RTI International, an independent research institute in Research Triangle Park, N.C., and her associates.
Clinicians in communities with military populations should be aware of this added stressor, and of the need for enhanced support for these families, the investigators noted.
Ms. Gibbs and her associates linked information from two confidential U.S. Army databases to study substantiated incidents of child maltreatment among 1,771 families of enlisted soldiers worldwide from 2001 through 2004. Maltreatment included incidents of neglect, physical abuse, emotional abuse, and sexual abuse.
The researchers emphasized that they restricted their study to army families known to have at least one substantiated report of child abuse, and did not assess army families in general. There were 3,334 separate incidents of abuse against 2,968 children during the 40-month study period. Boys and girls were abused in approximately equal numbers.
The rate of maltreatment was 42% higher during periods of deployment than during times when the soldiers were not deployed. The severity of abuse also increased during deployment, and the rate of incidents involving multiple types of abuse was “quite elevated” during deployment, the investigators said (JAMA 2007;298:528-35).
Rates of child abuse were much higher for civilian mothers than for civilian fathers married to soldiers, “suggesting that these two groups may be different in terms of the stress that they experience during their spouses' deployment, how they cope with such stress, or how they mobilize resources such as assistance with child care,” Ms. Gibbs and her associates said.
Child abuse rates also were markedly higher in white families than in black or Hispanic families. “This difference may reflect racial-ethnic patterns in factors that are potentially related to the stress associated with soldier deployments, such as civilian parent employment or use of formal and informal support services,” they noted.
The study findings indicate that supportive and preventive services for army families are particularly important during times of deployment, they said.
The rate of child abuse in U.S. Army families who are prone to such maltreatment rises significantly when the soldiers are deployed for combat, researchers reported.
Most of this increase is attributable to civilian wives of the Army enlisted personnel.
Their rates of inflicting moderate to severe child abuse and neglect are nearly four times higher when their husbands are deployed on combat-related duties than when their husbands are not deployed, reported Deborah A. Gibbs of RTI International, an independent research institute in Research Triangle Park, N.C., and her associates.
Clinicians in communities with military populations should be aware of this added stressor, and of the need for enhanced support for these families, the investigators noted.
Ms. Gibbs and her associates linked information from two confidential U.S. Army databases to study substantiated incidents of child maltreatment among 1,771 families of enlisted soldiers worldwide from 2001 through 2004. Maltreatment included incidents of neglect, physical abuse, emotional abuse, and sexual abuse.
The researchers emphasized that they restricted their study to army families known to have at least one substantiated report of child abuse, and did not assess army families in general. There were 3,334 separate incidents of abuse against 2,968 children during the 40-month study period. Boys and girls were abused in approximately equal numbers.
The rate of maltreatment was 42% higher during periods of deployment than during times when the soldiers were not deployed. The severity of abuse also increased during deployment, and the rate of incidents involving multiple types of abuse was “quite elevated” during deployment, the investigators said (JAMA 2007;298:528-35).
Rates of child abuse were much higher for civilian mothers than for civilian fathers married to soldiers, “suggesting that these two groups may be different in terms of the stress that they experience during their spouses' deployment, how they cope with such stress, or how they mobilize resources such as assistance with child care,” Ms. Gibbs and her associates said.
Child abuse rates also were markedly higher in white families than in black or Hispanic families. “This difference may reflect racial-ethnic patterns in factors that are potentially related to the stress associated with soldier deployments, such as civilian parent employment or use of formal and informal support services,” they noted.
The study findings indicate that supportive and preventive services for army families are particularly important during times of deployment, they said.
The rate of child abuse in U.S. Army families who are prone to such maltreatment rises significantly when the soldiers are deployed for combat, researchers reported.
Most of this increase is attributable to civilian wives of the Army enlisted personnel.
Their rates of inflicting moderate to severe child abuse and neglect are nearly four times higher when their husbands are deployed on combat-related duties than when their husbands are not deployed, reported Deborah A. Gibbs of RTI International, an independent research institute in Research Triangle Park, N.C., and her associates.
Clinicians in communities with military populations should be aware of this added stressor, and of the need for enhanced support for these families, the investigators noted.
Ms. Gibbs and her associates linked information from two confidential U.S. Army databases to study substantiated incidents of child maltreatment among 1,771 families of enlisted soldiers worldwide from 2001 through 2004. Maltreatment included incidents of neglect, physical abuse, emotional abuse, and sexual abuse.
The researchers emphasized that they restricted their study to army families known to have at least one substantiated report of child abuse, and did not assess army families in general. There were 3,334 separate incidents of abuse against 2,968 children during the 40-month study period. Boys and girls were abused in approximately equal numbers.
The rate of maltreatment was 42% higher during periods of deployment than during times when the soldiers were not deployed. The severity of abuse also increased during deployment, and the rate of incidents involving multiple types of abuse was “quite elevated” during deployment, the investigators said (JAMA 2007;298:528-35).
Rates of child abuse were much higher for civilian mothers than for civilian fathers married to soldiers, “suggesting that these two groups may be different in terms of the stress that they experience during their spouses' deployment, how they cope with such stress, or how they mobilize resources such as assistance with child care,” Ms. Gibbs and her associates said.
Child abuse rates also were markedly higher in white families than in black or Hispanic families. “This difference may reflect racial-ethnic patterns in factors that are potentially related to the stress associated with soldier deployments, such as civilian parent employment or use of formal and informal support services,” they noted.
The study findings indicate that supportive and preventive services for army families are particularly important during times of deployment, they said.
Progesterone Stems Preterm Delivery in Short-Cervix Cases
Progesterone appears to reduce the rate of preterm delivery in asymptomatic women found to have a short cervix on transvaginal ultrasound performed midway through gestation.
However, progesterone does not reduce the rate of preterm delivery in another group of high-risk women–those carrying twins, researchers in two separate randomized clinical trials reported
Since the 2003 publication of a report that weekly injections of 17 α-hydroxyprogesterone (17P) decreased the rate of recurrent preterm birth, numerous studies have been undertaken to assess the hormone's potential benefit in different high-risk populations. Now, Dr. Eduardo B. Fonseca of King's College Hospital, London, and his associates have evaluated the effect of 200-mg vaginal capsules of micronized progesterone in women who were found at routine midtrimester ultrasound screening to have a short cervix (15 mm or less).
The researchers tested the vaginal formulation of progesterone because of its enhanced bioavailability and reduced incidence of adverse effects, compared with the oral formulation. They chose a high dose rather than the 100-mg dose used in previous studies, because they considered women with a short cervix to be at very high risk for preterm delivery.
The study subjects were 250 women treated at maternity hospitals in London, Santiago (Chile), and São Paulo (Brazil). The rate of spontaneous preterm delivery was 19% in those who had been randomly assigned to use progesterone capsules from 24 weeks' gestation until delivery, compared with 34% in those who had used placebo capsules.
This finding demonstrates that daily vaginal administration of progesterone significantly decreases the rate of preterm delivery in women with a short cervix, Dr. Fonseca and his associates said (N. Engl. J. Med. 2007;357:462-9).
Similar results were seen across most subgroups of subjects, including those who had previously delivered prematurely. However, in the small number of twin pregnancies (24) included in this study, the progesterone treatment was associated with only a nonsignificant reduction in preterm delivery.
In the second study, Dr. Dwight J. Rouse of the University of Alabama, Birmingham, and his associates assessed weekly 250-mg IM injections of 17P in 661 women pregnant with twins. The study population was drawn from a broad geographic area and was racially and ethnically diverse. Two-thirds of the women had conceived spontaneously.
The subjects were randomly assigned to receive either active injections or placebo beginning at 20 weeks' gestation and were followed at 14 sites across the United States.
The rates of preterm delivery or fetal death did not differ significantly between the group receiving 17P (42%) and those receiving placebo (37%). The mean gestational age at delivery also did not differ significantly, nor did the proportion of deliveries that occurred at 28 weeks, 32 weeks, or 36 weeks.
The rates of obstetric interventions such as tocolysis, cervical cerclage, and cesarean section also were similar between the two groups, as were the rates of adverse neonatal outcomes such as major congenital malformations. The composite outcome of serious adverse events including respiratory distress syndrome, severe intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, bronchopulmonary dysplasia, severe retinopathy of prematurity, and sepsis also was similar between the two groups.
Side effects from the injections were frequent in both groups, and three women discontinued injections because of intense local reactions.
The findings, which “are generalizable to most women in the United States who are pregnant with twins,” demonstrate that 17P doesn't lower the rate of preterm birth, prolong gestation, or improve fetal or neonatal outcomes in twin pregnancies, Dr. Rouse and his associates said (N. Engl. J. Med. 2007:357:454-61).
In an editorial comment accompanying these reports, Dr. Jim G. Thornton of the University of Nottingham (England) said that much more information is needed if progesterone is to be used widely to curtail preterm delivery in women found to have a short cervix. In particular, the possible risks associated with daily vaginal administration of medication must be rigorously evaluated in women who are already susceptible to preterm delivery.
“Even if progesterone therapy is effective for some women who are at risk of preterm labor, reliable evidence is needed about long-term effects on the children before it could be widely recommended,” he noted (N. Engl. J. Med. 2007;357:499-501).
“There are at least 14 ongoing trials involving women with high-risk pregnancies (both singleton and twin) that aim to recruit a total of more than 5,000 women, and I am aware of at least 2 more currently awaiting funding decisions. These should have ample power to test the effect of progesterone on important fetal outcomes as well as any differential effect in twin gestations, and long-term follow-up of the surviving children will provide important additional information,” Dr. Thornton added.
Progesterone appears to reduce the rate of preterm delivery in asymptomatic women found to have a short cervix on transvaginal ultrasound performed midway through gestation.
However, progesterone does not reduce the rate of preterm delivery in another group of high-risk women–those carrying twins, researchers in two separate randomized clinical trials reported
Since the 2003 publication of a report that weekly injections of 17 α-hydroxyprogesterone (17P) decreased the rate of recurrent preterm birth, numerous studies have been undertaken to assess the hormone's potential benefit in different high-risk populations. Now, Dr. Eduardo B. Fonseca of King's College Hospital, London, and his associates have evaluated the effect of 200-mg vaginal capsules of micronized progesterone in women who were found at routine midtrimester ultrasound screening to have a short cervix (15 mm or less).
The researchers tested the vaginal formulation of progesterone because of its enhanced bioavailability and reduced incidence of adverse effects, compared with the oral formulation. They chose a high dose rather than the 100-mg dose used in previous studies, because they considered women with a short cervix to be at very high risk for preterm delivery.
The study subjects were 250 women treated at maternity hospitals in London, Santiago (Chile), and São Paulo (Brazil). The rate of spontaneous preterm delivery was 19% in those who had been randomly assigned to use progesterone capsules from 24 weeks' gestation until delivery, compared with 34% in those who had used placebo capsules.
This finding demonstrates that daily vaginal administration of progesterone significantly decreases the rate of preterm delivery in women with a short cervix, Dr. Fonseca and his associates said (N. Engl. J. Med. 2007;357:462-9).
Similar results were seen across most subgroups of subjects, including those who had previously delivered prematurely. However, in the small number of twin pregnancies (24) included in this study, the progesterone treatment was associated with only a nonsignificant reduction in preterm delivery.
In the second study, Dr. Dwight J. Rouse of the University of Alabama, Birmingham, and his associates assessed weekly 250-mg IM injections of 17P in 661 women pregnant with twins. The study population was drawn from a broad geographic area and was racially and ethnically diverse. Two-thirds of the women had conceived spontaneously.
The subjects were randomly assigned to receive either active injections or placebo beginning at 20 weeks' gestation and were followed at 14 sites across the United States.
The rates of preterm delivery or fetal death did not differ significantly between the group receiving 17P (42%) and those receiving placebo (37%). The mean gestational age at delivery also did not differ significantly, nor did the proportion of deliveries that occurred at 28 weeks, 32 weeks, or 36 weeks.
The rates of obstetric interventions such as tocolysis, cervical cerclage, and cesarean section also were similar between the two groups, as were the rates of adverse neonatal outcomes such as major congenital malformations. The composite outcome of serious adverse events including respiratory distress syndrome, severe intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, bronchopulmonary dysplasia, severe retinopathy of prematurity, and sepsis also was similar between the two groups.
Side effects from the injections were frequent in both groups, and three women discontinued injections because of intense local reactions.
The findings, which “are generalizable to most women in the United States who are pregnant with twins,” demonstrate that 17P doesn't lower the rate of preterm birth, prolong gestation, or improve fetal or neonatal outcomes in twin pregnancies, Dr. Rouse and his associates said (N. Engl. J. Med. 2007:357:454-61).
In an editorial comment accompanying these reports, Dr. Jim G. Thornton of the University of Nottingham (England) said that much more information is needed if progesterone is to be used widely to curtail preterm delivery in women found to have a short cervix. In particular, the possible risks associated with daily vaginal administration of medication must be rigorously evaluated in women who are already susceptible to preterm delivery.
“Even if progesterone therapy is effective for some women who are at risk of preterm labor, reliable evidence is needed about long-term effects on the children before it could be widely recommended,” he noted (N. Engl. J. Med. 2007;357:499-501).
“There are at least 14 ongoing trials involving women with high-risk pregnancies (both singleton and twin) that aim to recruit a total of more than 5,000 women, and I am aware of at least 2 more currently awaiting funding decisions. These should have ample power to test the effect of progesterone on important fetal outcomes as well as any differential effect in twin gestations, and long-term follow-up of the surviving children will provide important additional information,” Dr. Thornton added.
Progesterone appears to reduce the rate of preterm delivery in asymptomatic women found to have a short cervix on transvaginal ultrasound performed midway through gestation.
However, progesterone does not reduce the rate of preterm delivery in another group of high-risk women–those carrying twins, researchers in two separate randomized clinical trials reported
Since the 2003 publication of a report that weekly injections of 17 α-hydroxyprogesterone (17P) decreased the rate of recurrent preterm birth, numerous studies have been undertaken to assess the hormone's potential benefit in different high-risk populations. Now, Dr. Eduardo B. Fonseca of King's College Hospital, London, and his associates have evaluated the effect of 200-mg vaginal capsules of micronized progesterone in women who were found at routine midtrimester ultrasound screening to have a short cervix (15 mm or less).
The researchers tested the vaginal formulation of progesterone because of its enhanced bioavailability and reduced incidence of adverse effects, compared with the oral formulation. They chose a high dose rather than the 100-mg dose used in previous studies, because they considered women with a short cervix to be at very high risk for preterm delivery.
The study subjects were 250 women treated at maternity hospitals in London, Santiago (Chile), and São Paulo (Brazil). The rate of spontaneous preterm delivery was 19% in those who had been randomly assigned to use progesterone capsules from 24 weeks' gestation until delivery, compared with 34% in those who had used placebo capsules.
This finding demonstrates that daily vaginal administration of progesterone significantly decreases the rate of preterm delivery in women with a short cervix, Dr. Fonseca and his associates said (N. Engl. J. Med. 2007;357:462-9).
Similar results were seen across most subgroups of subjects, including those who had previously delivered prematurely. However, in the small number of twin pregnancies (24) included in this study, the progesterone treatment was associated with only a nonsignificant reduction in preterm delivery.
In the second study, Dr. Dwight J. Rouse of the University of Alabama, Birmingham, and his associates assessed weekly 250-mg IM injections of 17P in 661 women pregnant with twins. The study population was drawn from a broad geographic area and was racially and ethnically diverse. Two-thirds of the women had conceived spontaneously.
The subjects were randomly assigned to receive either active injections or placebo beginning at 20 weeks' gestation and were followed at 14 sites across the United States.
The rates of preterm delivery or fetal death did not differ significantly between the group receiving 17P (42%) and those receiving placebo (37%). The mean gestational age at delivery also did not differ significantly, nor did the proportion of deliveries that occurred at 28 weeks, 32 weeks, or 36 weeks.
The rates of obstetric interventions such as tocolysis, cervical cerclage, and cesarean section also were similar between the two groups, as were the rates of adverse neonatal outcomes such as major congenital malformations. The composite outcome of serious adverse events including respiratory distress syndrome, severe intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, bronchopulmonary dysplasia, severe retinopathy of prematurity, and sepsis also was similar between the two groups.
Side effects from the injections were frequent in both groups, and three women discontinued injections because of intense local reactions.
The findings, which “are generalizable to most women in the United States who are pregnant with twins,” demonstrate that 17P doesn't lower the rate of preterm birth, prolong gestation, or improve fetal or neonatal outcomes in twin pregnancies, Dr. Rouse and his associates said (N. Engl. J. Med. 2007:357:454-61).
In an editorial comment accompanying these reports, Dr. Jim G. Thornton of the University of Nottingham (England) said that much more information is needed if progesterone is to be used widely to curtail preterm delivery in women found to have a short cervix. In particular, the possible risks associated with daily vaginal administration of medication must be rigorously evaluated in women who are already susceptible to preterm delivery.
“Even if progesterone therapy is effective for some women who are at risk of preterm labor, reliable evidence is needed about long-term effects on the children before it could be widely recommended,” he noted (N. Engl. J. Med. 2007;357:499-501).
“There are at least 14 ongoing trials involving women with high-risk pregnancies (both singleton and twin) that aim to recruit a total of more than 5,000 women, and I am aware of at least 2 more currently awaiting funding decisions. These should have ample power to test the effect of progesterone on important fetal outcomes as well as any differential effect in twin gestations, and long-term follow-up of the surviving children will provide important additional information,” Dr. Thornton added.
Nonfasting Triglycerides Shown More Revealing
Nonfasting triglyceride levels may be superior indicators of cardiovascular risk than fasting levels, researchers in two separate studies found.
In the first study, Dr. Sandeep Bansal and associates at Brigham and Women's Hospital, Boston, used data from the Women's Health Study to examine the predictive ability of fasting and nonfasting blood testing for triglyceride levels.
The subjects were 20,118 healthy women aged 45 and older whose triglyceride levels were determined in blood samples drawn during fasting and 6,391 whose samples were drawn within 8 hours of a meal. Incident cardiovascular disease (CVD) events were tracked during a median of 11 years of follow-up. There were 276 nonfatal MIs, 265 ischemic strokes, 628 coronary revascularizations, and 163 cardiovascular deaths.
The robust association between nonfasting triglyceride levels and CVD events remained strong after adjusting the data to account for total cholesterol levels, HDL cholesterol levels, the presence of diabetes, a high body mass index, and elevated C-reactive protein levels. Nonfasting triglyceride levels were strong risk predictors independent of baseline CVD risk factors, levels of other lipids, and markers of insulin resistance, Dr. Bansal and his associates said (JAMA 2007;298:309–16).
In the second study, Dr. Børge G. Nordestgaard of Herlev (Denmark) University Hospital and associates compared the predictive ability of fasting and nonfasting triglyceride testing in 7,587 women and 6,394 men who participated in a cardiovascular study of the general Danish population from 1976 until the present.
High nonfasting triglyceride levels were found to be better independent predictors of the risk of MI, ischemic heart disease, and death than were fasting triglyceride levels, they said (JAMA 2007;298:299–308).
Nonfasting triglyceride levels may be superior indicators of cardiovascular risk than fasting levels, researchers in two separate studies found.
In the first study, Dr. Sandeep Bansal and associates at Brigham and Women's Hospital, Boston, used data from the Women's Health Study to examine the predictive ability of fasting and nonfasting blood testing for triglyceride levels.
The subjects were 20,118 healthy women aged 45 and older whose triglyceride levels were determined in blood samples drawn during fasting and 6,391 whose samples were drawn within 8 hours of a meal. Incident cardiovascular disease (CVD) events were tracked during a median of 11 years of follow-up. There were 276 nonfatal MIs, 265 ischemic strokes, 628 coronary revascularizations, and 163 cardiovascular deaths.
The robust association between nonfasting triglyceride levels and CVD events remained strong after adjusting the data to account for total cholesterol levels, HDL cholesterol levels, the presence of diabetes, a high body mass index, and elevated C-reactive protein levels. Nonfasting triglyceride levels were strong risk predictors independent of baseline CVD risk factors, levels of other lipids, and markers of insulin resistance, Dr. Bansal and his associates said (JAMA 2007;298:309–16).
In the second study, Dr. Børge G. Nordestgaard of Herlev (Denmark) University Hospital and associates compared the predictive ability of fasting and nonfasting triglyceride testing in 7,587 women and 6,394 men who participated in a cardiovascular study of the general Danish population from 1976 until the present.
High nonfasting triglyceride levels were found to be better independent predictors of the risk of MI, ischemic heart disease, and death than were fasting triglyceride levels, they said (JAMA 2007;298:299–308).
Nonfasting triglyceride levels may be superior indicators of cardiovascular risk than fasting levels, researchers in two separate studies found.
In the first study, Dr. Sandeep Bansal and associates at Brigham and Women's Hospital, Boston, used data from the Women's Health Study to examine the predictive ability of fasting and nonfasting blood testing for triglyceride levels.
The subjects were 20,118 healthy women aged 45 and older whose triglyceride levels were determined in blood samples drawn during fasting and 6,391 whose samples were drawn within 8 hours of a meal. Incident cardiovascular disease (CVD) events were tracked during a median of 11 years of follow-up. There were 276 nonfatal MIs, 265 ischemic strokes, 628 coronary revascularizations, and 163 cardiovascular deaths.
The robust association between nonfasting triglyceride levels and CVD events remained strong after adjusting the data to account for total cholesterol levels, HDL cholesterol levels, the presence of diabetes, a high body mass index, and elevated C-reactive protein levels. Nonfasting triglyceride levels were strong risk predictors independent of baseline CVD risk factors, levels of other lipids, and markers of insulin resistance, Dr. Bansal and his associates said (JAMA 2007;298:309–16).
In the second study, Dr. Børge G. Nordestgaard of Herlev (Denmark) University Hospital and associates compared the predictive ability of fasting and nonfasting triglyceride testing in 7,587 women and 6,394 men who participated in a cardiovascular study of the general Danish population from 1976 until the present.
High nonfasting triglyceride levels were found to be better independent predictors of the risk of MI, ischemic heart disease, and death than were fasting triglyceride levels, they said (JAMA 2007;298:299–308).
Healthy Diet Fails to Reduce Breast Cancer Recurrences
A low-fat diet very high in vegetables, fruit, and fiber failed to decrease recurrences in women who had survived early-stage breast cancer, reported Dr. John P. Pierce and his associates in the Women's Healthy Eating and Living study.
Even though the women substantially increased their intake of vegetables, fruit, and fiber and cut down on fat consumption, their rates of breast cancer recurrence, new primary cancers, metastases, and mortality were no different from those of control subjects after a mean of 7 years of follow-up, the researchers said.
The WHEL study was a randomized trial “based on the recommendations of a national committee of experts called to respond to a 1993 challenge grant from a private philanthropist who believed that the role of diet in preventing cancer progression deserved scientific study,” said Dr. Pierce of the University of California, San Diego, and his associates.
Subjects were 3,088 women aged 18-70 years who had been treated with axillary dissection and total mastectomy or lumpectomy followed by radiation at seven medical centers between 1995 and 2000. A total of 1,537 women were randomly assigned to a dietary intervention involving frequent telephone consultation, cooking classes, and monthly newsletters.
The daily dietary target was intake of five vegetable servings plus 16 ounces of vegetable juice, three fruit servings, 30 g fiber, and 15%-20% of total energy intake from fat.
The remaining subjects, who constituted the control group, were given print materials encouraging them to follow the government's recommended daily intake of five servings of vegetables and fruit, 20 g or more of fiber, and less than 30% total energy intake from fat. They also were offered cooking classes and newsletters, but most did not participate.
The dietary patterns of the intervention group changed dramatically with the introduction of the diet, and most of the women maintained their healthy eating patterns throughout follow-up. For example, at 1-year follow-up the intervention group averaged approximately eight servings of vegetables each day. Total plasma carotenoid level, a biomarker of vegetable and fruit intake, was 73% higher in the intervention group than in the control group.
However, the same proportion of subjects in both groups–16%–developed a breast cancer recurrence, metastasis, or a new primary cancer, and “the disease-free survival curves were virtually identical across groups,” the investigators said (JAMA 2007;298:289-98).
All-cause mortality was 10% in both groups. More than 80% of the deaths in both groups were caused by breast cancer.
There were no differences between the intervention and control groups in depression, social support, or quality of life during the first year of treatment, when the intervention was most intense. “Therefore, we believe that our investigation provides an adequate test of whether the study dietary pattern provided an added benefit over the dietary pattern of the comparison group of women,” Dr. Pierce and his associates said.
The study diet included five vegetable servings, 16 oz vegetable juice, and three fruit servings. Lynda Banzi/Elsevier Global Medical News
A low-fat diet very high in vegetables, fruit, and fiber failed to decrease recurrences in women who had survived early-stage breast cancer, reported Dr. John P. Pierce and his associates in the Women's Healthy Eating and Living study.
Even though the women substantially increased their intake of vegetables, fruit, and fiber and cut down on fat consumption, their rates of breast cancer recurrence, new primary cancers, metastases, and mortality were no different from those of control subjects after a mean of 7 years of follow-up, the researchers said.
The WHEL study was a randomized trial “based on the recommendations of a national committee of experts called to respond to a 1993 challenge grant from a private philanthropist who believed that the role of diet in preventing cancer progression deserved scientific study,” said Dr. Pierce of the University of California, San Diego, and his associates.
Subjects were 3,088 women aged 18-70 years who had been treated with axillary dissection and total mastectomy or lumpectomy followed by radiation at seven medical centers between 1995 and 2000. A total of 1,537 women were randomly assigned to a dietary intervention involving frequent telephone consultation, cooking classes, and monthly newsletters.
The daily dietary target was intake of five vegetable servings plus 16 ounces of vegetable juice, three fruit servings, 30 g fiber, and 15%-20% of total energy intake from fat.
The remaining subjects, who constituted the control group, were given print materials encouraging them to follow the government's recommended daily intake of five servings of vegetables and fruit, 20 g or more of fiber, and less than 30% total energy intake from fat. They also were offered cooking classes and newsletters, but most did not participate.
The dietary patterns of the intervention group changed dramatically with the introduction of the diet, and most of the women maintained their healthy eating patterns throughout follow-up. For example, at 1-year follow-up the intervention group averaged approximately eight servings of vegetables each day. Total plasma carotenoid level, a biomarker of vegetable and fruit intake, was 73% higher in the intervention group than in the control group.
However, the same proportion of subjects in both groups–16%–developed a breast cancer recurrence, metastasis, or a new primary cancer, and “the disease-free survival curves were virtually identical across groups,” the investigators said (JAMA 2007;298:289-98).
All-cause mortality was 10% in both groups. More than 80% of the deaths in both groups were caused by breast cancer.
There were no differences between the intervention and control groups in depression, social support, or quality of life during the first year of treatment, when the intervention was most intense. “Therefore, we believe that our investigation provides an adequate test of whether the study dietary pattern provided an added benefit over the dietary pattern of the comparison group of women,” Dr. Pierce and his associates said.
The study diet included five vegetable servings, 16 oz vegetable juice, and three fruit servings. Lynda Banzi/Elsevier Global Medical News
A low-fat diet very high in vegetables, fruit, and fiber failed to decrease recurrences in women who had survived early-stage breast cancer, reported Dr. John P. Pierce and his associates in the Women's Healthy Eating and Living study.
Even though the women substantially increased their intake of vegetables, fruit, and fiber and cut down on fat consumption, their rates of breast cancer recurrence, new primary cancers, metastases, and mortality were no different from those of control subjects after a mean of 7 years of follow-up, the researchers said.
The WHEL study was a randomized trial “based on the recommendations of a national committee of experts called to respond to a 1993 challenge grant from a private philanthropist who believed that the role of diet in preventing cancer progression deserved scientific study,” said Dr. Pierce of the University of California, San Diego, and his associates.
Subjects were 3,088 women aged 18-70 years who had been treated with axillary dissection and total mastectomy or lumpectomy followed by radiation at seven medical centers between 1995 and 2000. A total of 1,537 women were randomly assigned to a dietary intervention involving frequent telephone consultation, cooking classes, and monthly newsletters.
The daily dietary target was intake of five vegetable servings plus 16 ounces of vegetable juice, three fruit servings, 30 g fiber, and 15%-20% of total energy intake from fat.
The remaining subjects, who constituted the control group, were given print materials encouraging them to follow the government's recommended daily intake of five servings of vegetables and fruit, 20 g or more of fiber, and less than 30% total energy intake from fat. They also were offered cooking classes and newsletters, but most did not participate.
The dietary patterns of the intervention group changed dramatically with the introduction of the diet, and most of the women maintained their healthy eating patterns throughout follow-up. For example, at 1-year follow-up the intervention group averaged approximately eight servings of vegetables each day. Total plasma carotenoid level, a biomarker of vegetable and fruit intake, was 73% higher in the intervention group than in the control group.
However, the same proportion of subjects in both groups–16%–developed a breast cancer recurrence, metastasis, or a new primary cancer, and “the disease-free survival curves were virtually identical across groups,” the investigators said (JAMA 2007;298:289-98).
All-cause mortality was 10% in both groups. More than 80% of the deaths in both groups were caused by breast cancer.
There were no differences between the intervention and control groups in depression, social support, or quality of life during the first year of treatment, when the intervention was most intense. “Therefore, we believe that our investigation provides an adequate test of whether the study dietary pattern provided an added benefit over the dietary pattern of the comparison group of women,” Dr. Pierce and his associates said.
The study diet included five vegetable servings, 16 oz vegetable juice, and three fruit servings. Lynda Banzi/Elsevier Global Medical News