Jeff Evans

WASHINGTON — Physical activity during the pregnancy of previously inactive women is associated with a lower risk for gestational diabetes, according to a review of women in the National Maternal and Infant Health Survey.

In the study of 3,770 women without diabetes who reported being physically inactive before their singleton pregnancy, Jihong Liu, Sc.D., and her associates at the University of South Carolina, Columbia, found that a significantly lower percentage of women who were physically active during pregnancy had gestational diabetes mellitus (GDM) than did those who remained inactive (1.5% vs. 4.2%).

About 14% of the women who were previously inactive began physical activity after they learned of their pregnancy.

The women who were classified as physically active during pregnancy were 72% less likely to develop GDM than were those who were inactive, Dr. Liu reported in a poster at the annual scientific sessions of the American Diabetes Association.

The comparison was statistically adjusted for age, race/ethnicity, education, parity, smoking status, bed rest, and prepregnancy body mass index. The study results were weighted to achieve a nationally representative sample.

WASHINGTON — Physical activity during the pregnancy of previously inactive women is associated with a lower risk for gestational diabetes, according to a review of women in the National Maternal and Infant Health Survey.

In the study of 3,770 women without diabetes who reported being physically inactive before their singleton pregnancy, Jihong Liu, Sc.D., and her associates at the University of South Carolina, Columbia, found that a significantly lower percentage of women who were physically active during pregnancy had gestational diabetes mellitus (GDM) than did those who remained inactive (1.5% vs. 4.2%).

About 14% of the women who were previously inactive began physical activity after they learned of their pregnancy.

The women who were classified as physically active during pregnancy were 72% less likely to develop GDM than were those who were inactive, Dr. Liu reported in a poster at the annual scientific sessions of the American Diabetes Association.

The comparison was statistically adjusted for age, race/ethnicity, education, parity, smoking status, bed rest, and prepregnancy body mass index. The study results were weighted to achieve a nationally representative sample.

WASHINGTON — Physical activity during the pregnancy of previously inactive women is associated with a lower risk for gestational diabetes, according to a review of women in the National Maternal and Infant Health Survey.

In the study of 3,770 women without diabetes who reported being physically inactive before their singleton pregnancy, Jihong Liu, Sc.D., and her associates at the University of South Carolina, Columbia, found that a significantly lower percentage of women who were physically active during pregnancy had gestational diabetes mellitus (GDM) than did those who remained inactive (1.5% vs. 4.2%).

About 14% of the women who were previously inactive began physical activity after they learned of their pregnancy.

The women who were classified as physically active during pregnancy were 72% less likely to develop GDM than were those who were inactive, Dr. Liu reported in a poster at the annual scientific sessions of the American Diabetes Association.

The comparison was statistically adjusted for age, race/ethnicity, education, parity, smoking status, bed rest, and prepregnancy body mass index. The study results were weighted to achieve a nationally representative sample.

BOSTON — Long-term outcomes of hand transplant patients show that recipients can have good graft functionality and quality of life if they comply with immunosuppressive regimens, according to speakers at the 2006 World Transplant Congress.

Worldwide experience with hand transplants now includes 24 hands in 18 patients with “excellent results,” said Dr. Suzanne T. Ildstad, director of the Institute for Cellular Therapeutics at the University of Louisville (Ky.).

Patients are reluctant to undertake a hand transplant “until we modify or reduce the intensity of immunosuppression,” said Dr. Ildstad. “There are discussions right now with our group and other groups of using steroid-sparing protocols as well as attempts to induce tolerance,” she noted.

Dr. Ildstad presented the 7-year results of a 37-year-old, left-hand-dominant man (patient No. 1, currently the recipient of the longest-surviving hand transplant in the world) and the 4-year results of a 36-year-old, right-hand-dominant man (patient No. 2). Both men lost their left hands in fireworks accidents.

On measurements with the United Kingdom Medical Research Council strength scale, patient No. 1 had an excellent return of function of intrinsic muscles whereas patient No. 2 had an improved, but somewhat delayed, return of function because of a period of noncompliance with his immunosuppressive regimen.

Sensation gradually improved in patient No. 1 to the point where it has become “essentially normal” after 7 years of follow-up, Dr. Ildstad said. Patient No. 2 also experienced gradual improvement in sensation, but it was slightly delayed in comparison with patient No. 1.

In skin biopsy specimens from both patients, low-grade cellular infiltrates have been detected. The patients did not have rejections treated unless they were severe, she said.

When patient No. 2 decided to stop taking his immunosuppressive medications, he subsequently had a grade 3 rejection episode that was “relatively readily reversed” with antithymocyte globulins (Thymoglobulin), increased doses of tacrolimus (Prograf), and corticosteroid boluses, which is contrary to what Dr. Ildstad and many transplant immunologists would have predicted because of the presumed antigenicity of the skin.

In a study of two men who received bilateral hand transplants, improvement in function was accompanied by changes in brain function and good quality of life, reported Dr. Palmina Petruzzo of the department of transplantation at Hôpital Edouard Herriot, Lyon, France.

Functional MRI shows that the patients' representation of their hands in their brains progressively shifted from lateral to medial regions of the motor cortex.

By 2 years following transplantation, hand motor coordination had improved in both patients to the point where they could perform complex movements involving intersegmental coordination, which were assessed while the patients wore a CyberGlove containing 22 sensors that monitor hand movement, according to Dr. Ildstad.

A recipient of a transplant of a left hand demonstrated his manual dexterity and control by tying his shoe at his 4-year checkup. Courtesy Jewish Hospital/Kleinert, Kutz and Associates Hand Care Center/University of Louisville

BOSTON — Long-term outcomes of hand transplant patients show that recipients can have good graft functionality and quality of life if they comply with immunosuppressive regimens, according to speakers at the 2006 World Transplant Congress.

Worldwide experience with hand transplants now includes 24 hands in 18 patients with “excellent results,” said Dr. Suzanne T. Ildstad, director of the Institute for Cellular Therapeutics at the University of Louisville (Ky.).

Patients are reluctant to undertake a hand transplant “until we modify or reduce the intensity of immunosuppression,” said Dr. Ildstad. “There are discussions right now with our group and other groups of using steroid-sparing protocols as well as attempts to induce tolerance,” she noted.

Dr. Ildstad presented the 7-year results of a 37-year-old, left-hand-dominant man (patient No. 1, currently the recipient of the longest-surviving hand transplant in the world) and the 4-year results of a 36-year-old, right-hand-dominant man (patient No. 2). Both men lost their left hands in fireworks accidents.

On measurements with the United Kingdom Medical Research Council strength scale, patient No. 1 had an excellent return of function of intrinsic muscles whereas patient No. 2 had an improved, but somewhat delayed, return of function because of a period of noncompliance with his immunosuppressive regimen.

Sensation gradually improved in patient No. 1 to the point where it has become “essentially normal” after 7 years of follow-up, Dr. Ildstad said. Patient No. 2 also experienced gradual improvement in sensation, but it was slightly delayed in comparison with patient No. 1.

In skin biopsy specimens from both patients, low-grade cellular infiltrates have been detected. The patients did not have rejections treated unless they were severe, she said.

When patient No. 2 decided to stop taking his immunosuppressive medications, he subsequently had a grade 3 rejection episode that was “relatively readily reversed” with antithymocyte globulins (Thymoglobulin), increased doses of tacrolimus (Prograf), and corticosteroid boluses, which is contrary to what Dr. Ildstad and many transplant immunologists would have predicted because of the presumed antigenicity of the skin.

In a study of two men who received bilateral hand transplants, improvement in function was accompanied by changes in brain function and good quality of life, reported Dr. Palmina Petruzzo of the department of transplantation at Hôpital Edouard Herriot, Lyon, France.

Functional MRI shows that the patients' representation of their hands in their brains progressively shifted from lateral to medial regions of the motor cortex.

By 2 years following transplantation, hand motor coordination had improved in both patients to the point where they could perform complex movements involving intersegmental coordination, which were assessed while the patients wore a CyberGlove containing 22 sensors that monitor hand movement, according to Dr. Ildstad.

A recipient of a transplant of a left hand demonstrated his manual dexterity and control by tying his shoe at his 4-year checkup. Courtesy Jewish Hospital/Kleinert, Kutz and Associates Hand Care Center/University of Louisville

BOSTON — Long-term outcomes of hand transplant patients show that recipients can have good graft functionality and quality of life if they comply with immunosuppressive regimens, according to speakers at the 2006 World Transplant Congress.

Worldwide experience with hand transplants now includes 24 hands in 18 patients with “excellent results,” said Dr. Suzanne T. Ildstad, director of the Institute for Cellular Therapeutics at the University of Louisville (Ky.).

Patients are reluctant to undertake a hand transplant “until we modify or reduce the intensity of immunosuppression,” said Dr. Ildstad. “There are discussions right now with our group and other groups of using steroid-sparing protocols as well as attempts to induce tolerance,” she noted.

Dr. Ildstad presented the 7-year results of a 37-year-old, left-hand-dominant man (patient No. 1, currently the recipient of the longest-surviving hand transplant in the world) and the 4-year results of a 36-year-old, right-hand-dominant man (patient No. 2). Both men lost their left hands in fireworks accidents.

On measurements with the United Kingdom Medical Research Council strength scale, patient No. 1 had an excellent return of function of intrinsic muscles whereas patient No. 2 had an improved, but somewhat delayed, return of function because of a period of noncompliance with his immunosuppressive regimen.

Sensation gradually improved in patient No. 1 to the point where it has become “essentially normal” after 7 years of follow-up, Dr. Ildstad said. Patient No. 2 also experienced gradual improvement in sensation, but it was slightly delayed in comparison with patient No. 1.

In skin biopsy specimens from both patients, low-grade cellular infiltrates have been detected. The patients did not have rejections treated unless they were severe, she said.

When patient No. 2 decided to stop taking his immunosuppressive medications, he subsequently had a grade 3 rejection episode that was “relatively readily reversed” with antithymocyte globulins (Thymoglobulin), increased doses of tacrolimus (Prograf), and corticosteroid boluses, which is contrary to what Dr. Ildstad and many transplant immunologists would have predicted because of the presumed antigenicity of the skin.

In a study of two men who received bilateral hand transplants, improvement in function was accompanied by changes in brain function and good quality of life, reported Dr. Palmina Petruzzo of the department of transplantation at Hôpital Edouard Herriot, Lyon, France.

Functional MRI shows that the patients' representation of their hands in their brains progressively shifted from lateral to medial regions of the motor cortex.

By 2 years following transplantation, hand motor coordination had improved in both patients to the point where they could perform complex movements involving intersegmental coordination, which were assessed while the patients wore a CyberGlove containing 22 sensors that monitor hand movement, according to Dr. Ildstad.

A recipient of a transplant of a left hand demonstrated his manual dexterity and control by tying his shoe at his 4-year checkup. Courtesy Jewish Hospital/Kleinert, Kutz and Associates Hand Care Center/University of Louisville

BETHESDA, MD. — A complex set of predisposing, precipitating, and perpetuating factors appears to play a major role in driving the behavioral and neurochemical changes of patients with anorexia or bulimia, Craig Johnson, Ph.D., said at the annual conference of the National Eating Disorders Association.

“A belief system develops, and from that belief system, behaviors emerge. When those behaviors emerge, that also starts to alter the psychology and physiology of the patient and can set up these perpetuating factors so that they feed back on the predisposing and precipitating factors,” said Dr. Johnson, founder and director of the eating disorders program at the Laureate Psychiatric Clinic and Hospital in Tulsa, Okla.

The factors that serve to perpetuate an eating disorder may have little to do with why the illness is continuing. The structural and functional changes to neurochemical pathways in the brain that occurred as a result of the eating disorder behavior will continue to reinforce whatever stimulation was gained from the behavior, he said.

“Without exception, patients that we're taking care of entered into these behaviors to try to fix something in themselves. It was a self-improvement strategy. They thought they were doing a good thing. They were doing the same things they saw encouraged throughout our culture,” Dr. Johnson said.

“Eating disorders are as heritable, have the same level of relative risk, and look to be as genetically mediated as the other major psychiatric illnesses,” Dr. Johnson said. If a relative has anorexia nervosa, other members of the family are 12 times as likely to develop the disorder than members of the general population; if one family member has bulimia nervosa, other members are four times as likely to have it.

About two-thirds of eating disorder patients have a comorbid diagnosis of anxiety or depression, which predates the onset of the eating disorder in about half of such patients, he said. Some patients also have an impaired ability to work with different sets of challenges on neuropsychological tests, although this measure is not correlated with intelligence. These test results “make sense, in terms of what we see happening to them when they move into increasing levels of complexity developmentally, starting with puberty.”

Although he and his colleagues are seeing gender, ethnic, and socioeconomic drift in the epidemiology of anorexia nervosa and bulimia, Dr. Johnson said they are still illnesses that primarily affect white females.

Girls who drop below about 17% body fat lose the secondary sexual characteristics associated with puberty and flatten out their hormone profiles so that they don't “feel” the effects of puberty, he said.

“One of the things we want to know as soon as we can is where the menstrual threshold is. At what point with our weight restoration are we going to be sending them clearly on the other side of puberty?” he said. If patients do not stay in treatment long enough to restore their weight past the menstrual threshold, they will not have dealt adequately with their phobic fear of menstruation, he said.

Patients with bulimia nervosa often report that bingeing on carbohydrate-rich food calms them down, which may be the result of increased blood levels of tryptophan, an amino acid that can pass the blood-brain barrier and is synthesized into serotonin; treatment with SSRIs may make this effect even more pronounced by increasing the amount of serotonin available at synapses, Dr. Johnson said.

Vomiting also causes a sedating effect in bulimic patients because of the release of vasopressin. An autoaddiction to the vasopressin release may explain why binges become smaller and vomiting becomes disproportionate to the volume of food.

Excessive exercise also seems to be a reinforcing and possibly anorexia-inducing behavior. “Running seems to have a unique interaction with restricting behavior that essentially stimulates something very, very toxic for patients that have the more severe forms of the illness. We've found that very few patients are able to successfully return to running in our treatment program.”

Functional MRI studies of the brains of anorexic patients and healthy controls have revealed striking differences in dopamine pathways, suggesting that patients with the disorder do not discriminate between positive and negative feedback and have a blunted response to pleasurable stimuli, noted Dr. Walter Kaye, in a separate presentation during the same session at the conference.

During a gambling task in which participants could win or lose money, trials in which patients with anorexia nervosa won money produced brain activity similar to that of control patients during winning trials, but anorexic patients who lost money also had brain activity similar to that of controls who won money, said Dr. Kaye, research director of the eating disorder program at the University of Pittsburgh.

In a separate fMRI study, the taste of sugar produced blunted responses in the insula (the primary taste cortex) of recovered anorexic patients, compared with healthy controls. Unlike in the healthy patients, however, there was no correlation between the taster's rating of pleasantness and the insula's response to sugar in recovered anorexic individuals, he noted.

Before these data can be used to develop new treatments, it would be useful for patients to understand that this temperament is wired into their brains and that they might be able to learn to modulate their feelings and thoughts and develop adaptive coping strategies, said Dr. Kaye, also of the University of California, San Diego.

BETHESDA, MD. — A complex set of predisposing, precipitating, and perpetuating factors appears to play a major role in driving the behavioral and neurochemical changes of patients with anorexia or bulimia, Craig Johnson, Ph.D., said at the annual conference of the National Eating Disorders Association.

“A belief system develops, and from that belief system, behaviors emerge. When those behaviors emerge, that also starts to alter the psychology and physiology of the patient and can set up these perpetuating factors so that they feed back on the predisposing and precipitating factors,” said Dr. Johnson, founder and director of the eating disorders program at the Laureate Psychiatric Clinic and Hospital in Tulsa, Okla.

The factors that serve to perpetuate an eating disorder may have little to do with why the illness is continuing. The structural and functional changes to neurochemical pathways in the brain that occurred as a result of the eating disorder behavior will continue to reinforce whatever stimulation was gained from the behavior, he said.

“Without exception, patients that we're taking care of entered into these behaviors to try to fix something in themselves. It was a self-improvement strategy. They thought they were doing a good thing. They were doing the same things they saw encouraged throughout our culture,” Dr. Johnson said.

“Eating disorders are as heritable, have the same level of relative risk, and look to be as genetically mediated as the other major psychiatric illnesses,” Dr. Johnson said. If a relative has anorexia nervosa, other members of the family are 12 times as likely to develop the disorder than members of the general population; if one family member has bulimia nervosa, other members are four times as likely to have it.

About two-thirds of eating disorder patients have a comorbid diagnosis of anxiety or depression, which predates the onset of the eating disorder in about half of such patients, he said. Some patients also have an impaired ability to work with different sets of challenges on neuropsychological tests, although this measure is not correlated with intelligence. These test results “make sense, in terms of what we see happening to them when they move into increasing levels of complexity developmentally, starting with puberty.”

Although he and his colleagues are seeing gender, ethnic, and socioeconomic drift in the epidemiology of anorexia nervosa and bulimia, Dr. Johnson said they are still illnesses that primarily affect white females.

Girls who drop below about 17% body fat lose the secondary sexual characteristics associated with puberty and flatten out their hormone profiles so that they don't “feel” the effects of puberty, he said.

“One of the things we want to know as soon as we can is where the menstrual threshold is. At what point with our weight restoration are we going to be sending them clearly on the other side of puberty?” he said. If patients do not stay in treatment long enough to restore their weight past the menstrual threshold, they will not have dealt adequately with their phobic fear of menstruation, he said.

Patients with bulimia nervosa often report that bingeing on carbohydrate-rich food calms them down, which may be the result of increased blood levels of tryptophan, an amino acid that can pass the blood-brain barrier and is synthesized into serotonin; treatment with SSRIs may make this effect even more pronounced by increasing the amount of serotonin available at synapses, Dr. Johnson said.

Vomiting also causes a sedating effect in bulimic patients because of the release of vasopressin. An autoaddiction to the vasopressin release may explain why binges become smaller and vomiting becomes disproportionate to the volume of food.

Excessive exercise also seems to be a reinforcing and possibly anorexia-inducing behavior. “Running seems to have a unique interaction with restricting behavior that essentially stimulates something very, very toxic for patients that have the more severe forms of the illness. We've found that very few patients are able to successfully return to running in our treatment program.”

Functional MRI studies of the brains of anorexic patients and healthy controls have revealed striking differences in dopamine pathways, suggesting that patients with the disorder do not discriminate between positive and negative feedback and have a blunted response to pleasurable stimuli, noted Dr. Walter Kaye, in a separate presentation during the same session at the conference.

During a gambling task in which participants could win or lose money, trials in which patients with anorexia nervosa won money produced brain activity similar to that of control patients during winning trials, but anorexic patients who lost money also had brain activity similar to that of controls who won money, said Dr. Kaye, research director of the eating disorder program at the University of Pittsburgh.

In a separate fMRI study, the taste of sugar produced blunted responses in the insula (the primary taste cortex) of recovered anorexic patients, compared with healthy controls. Unlike in the healthy patients, however, there was no correlation between the taster's rating of pleasantness and the insula's response to sugar in recovered anorexic individuals, he noted.

Before these data can be used to develop new treatments, it would be useful for patients to understand that this temperament is wired into their brains and that they might be able to learn to modulate their feelings and thoughts and develop adaptive coping strategies, said Dr. Kaye, also of the University of California, San Diego.

BETHESDA, MD. — A complex set of predisposing, precipitating, and perpetuating factors appears to play a major role in driving the behavioral and neurochemical changes of patients with anorexia or bulimia, Craig Johnson, Ph.D., said at the annual conference of the National Eating Disorders Association.

“A belief system develops, and from that belief system, behaviors emerge. When those behaviors emerge, that also starts to alter the psychology and physiology of the patient and can set up these perpetuating factors so that they feed back on the predisposing and precipitating factors,” said Dr. Johnson, founder and director of the eating disorders program at the Laureate Psychiatric Clinic and Hospital in Tulsa, Okla.

The factors that serve to perpetuate an eating disorder may have little to do with why the illness is continuing. The structural and functional changes to neurochemical pathways in the brain that occurred as a result of the eating disorder behavior will continue to reinforce whatever stimulation was gained from the behavior, he said.

“Without exception, patients that we're taking care of entered into these behaviors to try to fix something in themselves. It was a self-improvement strategy. They thought they were doing a good thing. They were doing the same things they saw encouraged throughout our culture,” Dr. Johnson said.

“Eating disorders are as heritable, have the same level of relative risk, and look to be as genetically mediated as the other major psychiatric illnesses,” Dr. Johnson said. If a relative has anorexia nervosa, other members of the family are 12 times as likely to develop the disorder than members of the general population; if one family member has bulimia nervosa, other members are four times as likely to have it.

About two-thirds of eating disorder patients have a comorbid diagnosis of anxiety or depression, which predates the onset of the eating disorder in about half of such patients, he said. Some patients also have an impaired ability to work with different sets of challenges on neuropsychological tests, although this measure is not correlated with intelligence. These test results “make sense, in terms of what we see happening to them when they move into increasing levels of complexity developmentally, starting with puberty.”

Although he and his colleagues are seeing gender, ethnic, and socioeconomic drift in the epidemiology of anorexia nervosa and bulimia, Dr. Johnson said they are still illnesses that primarily affect white females.

Girls who drop below about 17% body fat lose the secondary sexual characteristics associated with puberty and flatten out their hormone profiles so that they don't “feel” the effects of puberty, he said.

“One of the things we want to know as soon as we can is where the menstrual threshold is. At what point with our weight restoration are we going to be sending them clearly on the other side of puberty?” he said. If patients do not stay in treatment long enough to restore their weight past the menstrual threshold, they will not have dealt adequately with their phobic fear of menstruation, he said.

Patients with bulimia nervosa often report that bingeing on carbohydrate-rich food calms them down, which may be the result of increased blood levels of tryptophan, an amino acid that can pass the blood-brain barrier and is synthesized into serotonin; treatment with SSRIs may make this effect even more pronounced by increasing the amount of serotonin available at synapses, Dr. Johnson said.

Vomiting also causes a sedating effect in bulimic patients because of the release of vasopressin. An autoaddiction to the vasopressin release may explain why binges become smaller and vomiting becomes disproportionate to the volume of food.

Excessive exercise also seems to be a reinforcing and possibly anorexia-inducing behavior. “Running seems to have a unique interaction with restricting behavior that essentially stimulates something very, very toxic for patients that have the more severe forms of the illness. We've found that very few patients are able to successfully return to running in our treatment program.”

Functional MRI studies of the brains of anorexic patients and healthy controls have revealed striking differences in dopamine pathways, suggesting that patients with the disorder do not discriminate between positive and negative feedback and have a blunted response to pleasurable stimuli, noted Dr. Walter Kaye, in a separate presentation during the same session at the conference.

During a gambling task in which participants could win or lose money, trials in which patients with anorexia nervosa won money produced brain activity similar to that of control patients during winning trials, but anorexic patients who lost money also had brain activity similar to that of controls who won money, said Dr. Kaye, research director of the eating disorder program at the University of Pittsburgh.

In a separate fMRI study, the taste of sugar produced blunted responses in the insula (the primary taste cortex) of recovered anorexic patients, compared with healthy controls. Unlike in the healthy patients, however, there was no correlation between the taster's rating of pleasantness and the insula's response to sugar in recovered anorexic individuals, he noted.

Before these data can be used to develop new treatments, it would be useful for patients to understand that this temperament is wired into their brains and that they might be able to learn to modulate their feelings and thoughts and develop adaptive coping strategies, said Dr. Kaye, also of the University of California, San Diego.

BETHESDA, MD. — A multidisciplinary approach to treating eating disorder patients can help to prevent relapse when the treatment team works closely with family members and other concerned individuals, speakers from Johns Hopkins University said at the annual conference of the National Eating Disorders Association.

It's important to use the approach even when a multidisciplinary professional team is not available because of geographic isolation or because a patient has limited resources and insurance coverage, said Dr. Angela S. Guarda, director of the eating disorders program at Johns Hopkins Hospital in Baltimore.

To prevent relapse in patients with anorexia nervosa or bulimia after they return home, clinicians should incorporate strategies that address patient and family behaviors around shopping, eating, and food preparation, Dr. Guarda said. They also need to replace the time spent on eating disordered activities with more age-appropriate and functional behaviors.

The Hopkins program requires new patients to bring a close relative to the first appointment. After the end of the evaluation, the family member is invited to join the session, and the treatment plan is discussed with both the patient and family.

“We initially meet separately with the patient and the family to take a history and to address the issues that relate to the patient's eating disorder,” said Josie Bodenstein, a social worker at Johns Hopkins. “The goal is to educate the family, to diffuse feelings of blame or responsibility for the eating disorder, to listen to their respective viewpoints, and to help parents become part of a unified team in assisting their child to change her behavior.”

“Patients and families must understand that unless you change your behavior, you won't be able to correct your eating disordered thoughts and feelings,” Dr. Guarda said. “Treatment is a process of conversion—from seeing dieting as the answer to recognizing it as the problem.”

Discussions with patients include making patients realize that it is normal to have ambivalent feelings toward change, to relapse on the road to recovery, and to be initially dissatisfied with the changes to their bodies. Body dissatisfaction typically lags behind behavioral change by several months, Dr. Guarda said.

Despite the reluctance of some therapists to weigh patients for fear of encouraging focus on weight, it is critical to weigh patients at weekly office visits. “We are very explicit with patients that we require [weigh-ins] in order to treat them. You don't treat hypertension without checking a patient's blood pressure; why would we treat anorexia nervosa without checking weight?”

Many patients with eating disorders have problems with preparing meals and eating in social settings, which can be isolating and result in occupational and educational limitations. Eating disorders can “freeze” a person's developmental progress, resulting in impaired formation of identity and intimate relationships, and difficulty in separating from parents, according to Dr. Guarda.

“It's important to educate parents about grocery shopping,” because eating disorder patients often want to be involved in planning family meals, the grocery shopping list, and anything related to food, said Sandra Kirckhoff, a nurse on the inpatient unit in the eating disorders program. Adolescent patients can request some nondiet foods, but they should not be in charge of doing the shopping or making menus or lists.

Families should try to eat balanced meals together at a table, with no one eating diet food. After-meal activities can help to prevent purging, strenuous exercise, or guilt from feeling full.

At various points during a patient's treatment, clinicians may have to assess the family's mealtime behavior, parenting skills, and assist them in setting firm but supportive limits on disordered behavior and to carry out the roles assigned to them by the treatment team. This may involve having the family practice designing menus, going to the grocery store, and eating at a restaurant together. Family members must show a united front in setting limits on the patient's behavior and in following through with consequences, Ms. Bodenstein said.

“When lines get blurred, roles become unclear, and progress stalls or regresses; it can be helpful to use a behavior contract … to make explicit what everybody's role is,” said Dr. Graham Redgrave, assistant director of the eating disorder program at Johns Hopkins.

During hospitalization, Hopkins clinicians do not allow any arguments over whether something should be eaten or not, Ms. Kirckhoff said. Nurses supervise meals and encourages patients to eat all of their food. Each patient is expected to eat like a normal weight, nondieter, to consume a range of foods, and to stop all exercise if on weight gain. Team sports and weight training are introduced after patients reach their target weight. The staff also teaches patients to determine appropriate portions for weight maintenance by eyeballing portions, not measuring them.

Clothes shopping is very important, especially after a patient has attained normal weight, Ms. Scott said. She instructs patients to get rid of all of their old clothes, especially those associated with the illness. New clothes should be appropriate for their age and size and neither baggy nor tight-fitting.

BETHESDA, MD. — A multidisciplinary approach to treating eating disorder patients can help to prevent relapse when the treatment team works closely with family members and other concerned individuals, speakers from Johns Hopkins University said at the annual conference of the National Eating Disorders Association.

It's important to use the approach even when a multidisciplinary professional team is not available because of geographic isolation or because a patient has limited resources and insurance coverage, said Dr. Angela S. Guarda, director of the eating disorders program at Johns Hopkins Hospital in Baltimore.

To prevent relapse in patients with anorexia nervosa or bulimia after they return home, clinicians should incorporate strategies that address patient and family behaviors around shopping, eating, and food preparation, Dr. Guarda said. They also need to replace the time spent on eating disordered activities with more age-appropriate and functional behaviors.

The Hopkins program requires new patients to bring a close relative to the first appointment. After the end of the evaluation, the family member is invited to join the session, and the treatment plan is discussed with both the patient and family.

“We initially meet separately with the patient and the family to take a history and to address the issues that relate to the patient's eating disorder,” said Josie Bodenstein, a social worker at Johns Hopkins. “The goal is to educate the family, to diffuse feelings of blame or responsibility for the eating disorder, to listen to their respective viewpoints, and to help parents become part of a unified team in assisting their child to change her behavior.”

“Patients and families must understand that unless you change your behavior, you won't be able to correct your eating disordered thoughts and feelings,” Dr. Guarda said. “Treatment is a process of conversion—from seeing dieting as the answer to recognizing it as the problem.”

Discussions with patients include making patients realize that it is normal to have ambivalent feelings toward change, to relapse on the road to recovery, and to be initially dissatisfied with the changes to their bodies. Body dissatisfaction typically lags behind behavioral change by several months, Dr. Guarda said.

Despite the reluctance of some therapists to weigh patients for fear of encouraging focus on weight, it is critical to weigh patients at weekly office visits. “We are very explicit with patients that we require [weigh-ins] in order to treat them. You don't treat hypertension without checking a patient's blood pressure; why would we treat anorexia nervosa without checking weight?”

Many patients with eating disorders have problems with preparing meals and eating in social settings, which can be isolating and result in occupational and educational limitations. Eating disorders can “freeze” a person's developmental progress, resulting in impaired formation of identity and intimate relationships, and difficulty in separating from parents, according to Dr. Guarda.

“It's important to educate parents about grocery shopping,” because eating disorder patients often want to be involved in planning family meals, the grocery shopping list, and anything related to food, said Sandra Kirckhoff, a nurse on the inpatient unit in the eating disorders program. Adolescent patients can request some nondiet foods, but they should not be in charge of doing the shopping or making menus or lists.

Families should try to eat balanced meals together at a table, with no one eating diet food. After-meal activities can help to prevent purging, strenuous exercise, or guilt from feeling full.

At various points during a patient's treatment, clinicians may have to assess the family's mealtime behavior, parenting skills, and assist them in setting firm but supportive limits on disordered behavior and to carry out the roles assigned to them by the treatment team. This may involve having the family practice designing menus, going to the grocery store, and eating at a restaurant together. Family members must show a united front in setting limits on the patient's behavior and in following through with consequences, Ms. Bodenstein said.

“When lines get blurred, roles become unclear, and progress stalls or regresses; it can be helpful to use a behavior contract … to make explicit what everybody's role is,” said Dr. Graham Redgrave, assistant director of the eating disorder program at Johns Hopkins.

During hospitalization, Hopkins clinicians do not allow any arguments over whether something should be eaten or not, Ms. Kirckhoff said. Nurses supervise meals and encourages patients to eat all of their food. Each patient is expected to eat like a normal weight, nondieter, to consume a range of foods, and to stop all exercise if on weight gain. Team sports and weight training are introduced after patients reach their target weight. The staff also teaches patients to determine appropriate portions for weight maintenance by eyeballing portions, not measuring them.

Clothes shopping is very important, especially after a patient has attained normal weight, Ms. Scott said. She instructs patients to get rid of all of their old clothes, especially those associated with the illness. New clothes should be appropriate for their age and size and neither baggy nor tight-fitting.

BETHESDA, MD. — A multidisciplinary approach to treating eating disorder patients can help to prevent relapse when the treatment team works closely with family members and other concerned individuals, speakers from Johns Hopkins University said at the annual conference of the National Eating Disorders Association.

It's important to use the approach even when a multidisciplinary professional team is not available because of geographic isolation or because a patient has limited resources and insurance coverage, said Dr. Angela S. Guarda, director of the eating disorders program at Johns Hopkins Hospital in Baltimore.

To prevent relapse in patients with anorexia nervosa or bulimia after they return home, clinicians should incorporate strategies that address patient and family behaviors around shopping, eating, and food preparation, Dr. Guarda said. They also need to replace the time spent on eating disordered activities with more age-appropriate and functional behaviors.

The Hopkins program requires new patients to bring a close relative to the first appointment. After the end of the evaluation, the family member is invited to join the session, and the treatment plan is discussed with both the patient and family.

“We initially meet separately with the patient and the family to take a history and to address the issues that relate to the patient's eating disorder,” said Josie Bodenstein, a social worker at Johns Hopkins. “The goal is to educate the family, to diffuse feelings of blame or responsibility for the eating disorder, to listen to their respective viewpoints, and to help parents become part of a unified team in assisting their child to change her behavior.”

“Patients and families must understand that unless you change your behavior, you won't be able to correct your eating disordered thoughts and feelings,” Dr. Guarda said. “Treatment is a process of conversion—from seeing dieting as the answer to recognizing it as the problem.”

Discussions with patients include making patients realize that it is normal to have ambivalent feelings toward change, to relapse on the road to recovery, and to be initially dissatisfied with the changes to their bodies. Body dissatisfaction typically lags behind behavioral change by several months, Dr. Guarda said.

Despite the reluctance of some therapists to weigh patients for fear of encouraging focus on weight, it is critical to weigh patients at weekly office visits. “We are very explicit with patients that we require [weigh-ins] in order to treat them. You don't treat hypertension without checking a patient's blood pressure; why would we treat anorexia nervosa without checking weight?”

Many patients with eating disorders have problems with preparing meals and eating in social settings, which can be isolating and result in occupational and educational limitations. Eating disorders can “freeze” a person's developmental progress, resulting in impaired formation of identity and intimate relationships, and difficulty in separating from parents, according to Dr. Guarda.

“It's important to educate parents about grocery shopping,” because eating disorder patients often want to be involved in planning family meals, the grocery shopping list, and anything related to food, said Sandra Kirckhoff, a nurse on the inpatient unit in the eating disorders program. Adolescent patients can request some nondiet foods, but they should not be in charge of doing the shopping or making menus or lists.

Families should try to eat balanced meals together at a table, with no one eating diet food. After-meal activities can help to prevent purging, strenuous exercise, or guilt from feeling full.

At various points during a patient's treatment, clinicians may have to assess the family's mealtime behavior, parenting skills, and assist them in setting firm but supportive limits on disordered behavior and to carry out the roles assigned to them by the treatment team. This may involve having the family practice designing menus, going to the grocery store, and eating at a restaurant together. Family members must show a united front in setting limits on the patient's behavior and in following through with consequences, Ms. Bodenstein said.

“When lines get blurred, roles become unclear, and progress stalls or regresses; it can be helpful to use a behavior contract … to make explicit what everybody's role is,” said Dr. Graham Redgrave, assistant director of the eating disorder program at Johns Hopkins.

During hospitalization, Hopkins clinicians do not allow any arguments over whether something should be eaten or not, Ms. Kirckhoff said. Nurses supervise meals and encourages patients to eat all of their food. Each patient is expected to eat like a normal weight, nondieter, to consume a range of foods, and to stop all exercise if on weight gain. Team sports and weight training are introduced after patients reach their target weight. The staff also teaches patients to determine appropriate portions for weight maintenance by eyeballing portions, not measuring them.

Clothes shopping is very important, especially after a patient has attained normal weight, Ms. Scott said. She instructs patients to get rid of all of their old clothes, especially those associated with the illness. New clothes should be appropriate for their age and size and neither baggy nor tight-fitting.

BETHESDA, MD. – The release this year of American Psychiatric Association guidelines on treating eating disorders and two analyses of the available evidence to support such treatments have highlighted the dearth of effective, evidence-based interventions for the disorders.

The lack of such data and the funding to support eating disorders research show that much remains to be accomplished before the disorders get the recognition they deserve from the medical community and insurers, said speakers and attendees at the annual conference of the National Eating Disorders Association. At least 5 million Americans have the disorders, and anorexia nervosa has the highest premature mortality of any mental illness.

The National Institute of Mental Health is funding 10 extramural studies on eating disorders at outside locations (seven of which are in New York), but none of the institutes within the National Institutes of Health are conducting any intramural studies on the disorders. In comparison, the NIMH and other NIH institutes are funding 12 intramural studies on schizophrenia and 14 on bipolar disorder, in addition to many more extramural studies, said Dr. Pauline S. Powers of the department of psychiatry at the University of South Florida, Tampa. The total NIMH/NIH funding for schizophrenia, which affects 3 million Americans, is estimated to be $291 million, while about $30 million is spent on eating disorders research, Dr. Powers said.

Efforts aimed at spreading the word about the high prevalence, morbidity, and mortality of eating disorders to legislators may be the best bet for greater funding of eating disorders, which in turn may attract greater interest from researchers to submit research grant proposals, said Dr. Thomas R. Insel, director of the NIMH.

While the lack of research funding has made it difficult to discern which treatments are best for particular eating disorders, the APA's new guidelines will still be helpful for clinicians who “are not real familiar with the kinds of things that you see as complications in patients with eating disorders,” said Dr. Powers, who was a member of the APA work group on eating disorders that wrote the guidelines.

For providers to make the best judgment of the level of care and specific type of treatment that a patient needs, the APA guidelines stress the assessment of physical complications and laboratory tests that may be relevant in patients with anorexia nervosa or bulimia nervosa (Am. J. Psychiatry 2006;163[suppl.]:1–54). For different organ systems, the guidelines list symptoms and signs to look for and particular laboratory tests that may help to diagnose the problem.

“Almost everyone seeing patients with eating disorders should at least know the symptoms and then be able to choose how they're going to work with those particular problems–either by themselves, or [by] consult with a primary care doctor or a specialist,” Dr. Powers advised.

Bulimia nervosa patients may have many of the same symptoms as anorexia nervosa patients because they have a past history of anorexia.

According to the guidelines, basic laboratory tests for bulimia and anorexia patients should include urinalysis for ketones and blood tests for electrolytes, urea nitrogen, creatinine, thyroid-stimulating hormone, a complete blood count, liver enzymes, and erythrocyte sedimentation rate.

Other tests may be necessary in certain circumstances, such as dual-energy x-ray absorptiometry in anorexic patients who haven't had a menstrual period for more than 6 months, Dr. Powers said. At her center, clinicians also routinely order an electrocardiogram, a 24-hour urine creatinine clearance test, and a test for level of complement 3, which is an immune system protein that often drops to low levels early in anorexic patients.

It also may be easier to make a case for insurance coverage with reviewers if you have baseline values for laboratory tests, she noted.

The guidelines recommend placing patients at different levels of care (outpatient, intensive outpatient, partial hospitalization, residential treatment center, inpatient hospitalization) according to categories that are used to assess the severity of their illness, even though there is little evidence to substantiate such placements.

The independent, nonprofit health services research agency ECRI (formerly the Emergency Care Research Institute) conducted a meta-analysis of 48 unique randomized clinical trials on bulimia nervosa.

The report found weak to moderate evidence supporting the effectiveness of medications in reducing bingeing and purging behaviors, as well as anxiety and depression. Except for moderate evidence suggesting some benefit of cognitive-behavioral therapy (CBT) on purging, little data were available to support its effectiveness on bingeing and anxiety or depression.

Weak evidence suggests that CBT may be more effective than medications for purging behaviors, but no other distinction between the two interventions could be made.

Virtually no evidence exists to suggest that CBT is better than other forms of psychotherapy. There was no evidence on whether the interventions improved quality of life.

Fluoxetine is already Food and Drug Administration-approved at 60 mg per day for the treatment of bulimia nervosa, based on 6- to 18-week trials showing that it reduced binge eating, purging, and associated psychological features, even though the results were “pretty weak because of the high dropout rates,” said Dr. Russell Marx, medical director of the eating disorders program at the University Medical Center at Princeton (N.J.).

Dialectical behavior therapy has shown preliminary evidence of being effective for bulimia.

In binge eating disorder, short-term trials of selective serotonin reuptake inhibitors have reduced the severity of illness as well as eating, psychiatric, and weight symptoms, compared with placebo.

BETHESDA, MD. – The release this year of American Psychiatric Association guidelines on treating eating disorders and two analyses of the available evidence to support such treatments have highlighted the dearth of effective, evidence-based interventions for the disorders.

The lack of such data and the funding to support eating disorders research show that much remains to be accomplished before the disorders get the recognition they deserve from the medical community and insurers, said speakers and attendees at the annual conference of the National Eating Disorders Association. At least 5 million Americans have the disorders, and anorexia nervosa has the highest premature mortality of any mental illness.

The National Institute of Mental Health is funding 10 extramural studies on eating disorders at outside locations (seven of which are in New York), but none of the institutes within the National Institutes of Health are conducting any intramural studies on the disorders. In comparison, the NIMH and other NIH institutes are funding 12 intramural studies on schizophrenia and 14 on bipolar disorder, in addition to many more extramural studies, said Dr. Pauline S. Powers of the department of psychiatry at the University of South Florida, Tampa. The total NIMH/NIH funding for schizophrenia, which affects 3 million Americans, is estimated to be $291 million, while about $30 million is spent on eating disorders research, Dr. Powers said.

Efforts aimed at spreading the word about the high prevalence, morbidity, and mortality of eating disorders to legislators may be the best bet for greater funding of eating disorders, which in turn may attract greater interest from researchers to submit research grant proposals, said Dr. Thomas R. Insel, director of the NIMH.

While the lack of research funding has made it difficult to discern which treatments are best for particular eating disorders, the APA's new guidelines will still be helpful for clinicians who “are not real familiar with the kinds of things that you see as complications in patients with eating disorders,” said Dr. Powers, who was a member of the APA work group on eating disorders that wrote the guidelines.

For providers to make the best judgment of the level of care and specific type of treatment that a patient needs, the APA guidelines stress the assessment of physical complications and laboratory tests that may be relevant in patients with anorexia nervosa or bulimia nervosa (Am. J. Psychiatry 2006;163[suppl.]:1–54). For different organ systems, the guidelines list symptoms and signs to look for and particular laboratory tests that may help to diagnose the problem.

“Almost everyone seeing patients with eating disorders should at least know the symptoms and then be able to choose how they're going to work with those particular problems–either by themselves, or [by] consult with a primary care doctor or a specialist,” Dr. Powers advised.

Bulimia nervosa patients may have many of the same symptoms as anorexia nervosa patients because they have a past history of anorexia.

According to the guidelines, basic laboratory tests for bulimia and anorexia patients should include urinalysis for ketones and blood tests for electrolytes, urea nitrogen, creatinine, thyroid-stimulating hormone, a complete blood count, liver enzymes, and erythrocyte sedimentation rate.

Other tests may be necessary in certain circumstances, such as dual-energy x-ray absorptiometry in anorexic patients who haven't had a menstrual period for more than 6 months, Dr. Powers said. At her center, clinicians also routinely order an electrocardiogram, a 24-hour urine creatinine clearance test, and a test for level of complement 3, which is an immune system protein that often drops to low levels early in anorexic patients.

It also may be easier to make a case for insurance coverage with reviewers if you have baseline values for laboratory tests, she noted.

The guidelines recommend placing patients at different levels of care (outpatient, intensive outpatient, partial hospitalization, residential treatment center, inpatient hospitalization) according to categories that are used to assess the severity of their illness, even though there is little evidence to substantiate such placements.

The independent, nonprofit health services research agency ECRI (formerly the Emergency Care Research Institute) conducted a meta-analysis of 48 unique randomized clinical trials on bulimia nervosa.

The report found weak to moderate evidence supporting the effectiveness of medications in reducing bingeing and purging behaviors, as well as anxiety and depression. Except for moderate evidence suggesting some benefit of cognitive-behavioral therapy (CBT) on purging, little data were available to support its effectiveness on bingeing and anxiety or depression.

Weak evidence suggests that CBT may be more effective than medications for purging behaviors, but no other distinction between the two interventions could be made.

Virtually no evidence exists to suggest that CBT is better than other forms of psychotherapy. There was no evidence on whether the interventions improved quality of life.

Fluoxetine is already Food and Drug Administration-approved at 60 mg per day for the treatment of bulimia nervosa, based on 6- to 18-week trials showing that it reduced binge eating, purging, and associated psychological features, even though the results were “pretty weak because of the high dropout rates,” said Dr. Russell Marx, medical director of the eating disorders program at the University Medical Center at Princeton (N.J.).

Dialectical behavior therapy has shown preliminary evidence of being effective for bulimia.

In binge eating disorder, short-term trials of selective serotonin reuptake inhibitors have reduced the severity of illness as well as eating, psychiatric, and weight symptoms, compared with placebo.

BETHESDA, MD. – The release this year of American Psychiatric Association guidelines on treating eating disorders and two analyses of the available evidence to support such treatments have highlighted the dearth of effective, evidence-based interventions for the disorders.

The lack of such data and the funding to support eating disorders research show that much remains to be accomplished before the disorders get the recognition they deserve from the medical community and insurers, said speakers and attendees at the annual conference of the National Eating Disorders Association. At least 5 million Americans have the disorders, and anorexia nervosa has the highest premature mortality of any mental illness.

The National Institute of Mental Health is funding 10 extramural studies on eating disorders at outside locations (seven of which are in New York), but none of the institutes within the National Institutes of Health are conducting any intramural studies on the disorders. In comparison, the NIMH and other NIH institutes are funding 12 intramural studies on schizophrenia and 14 on bipolar disorder, in addition to many more extramural studies, said Dr. Pauline S. Powers of the department of psychiatry at the University of South Florida, Tampa. The total NIMH/NIH funding for schizophrenia, which affects 3 million Americans, is estimated to be $291 million, while about $30 million is spent on eating disorders research, Dr. Powers said.

Efforts aimed at spreading the word about the high prevalence, morbidity, and mortality of eating disorders to legislators may be the best bet for greater funding of eating disorders, which in turn may attract greater interest from researchers to submit research grant proposals, said Dr. Thomas R. Insel, director of the NIMH.

While the lack of research funding has made it difficult to discern which treatments are best for particular eating disorders, the APA's new guidelines will still be helpful for clinicians who “are not real familiar with the kinds of things that you see as complications in patients with eating disorders,” said Dr. Powers, who was a member of the APA work group on eating disorders that wrote the guidelines.

For providers to make the best judgment of the level of care and specific type of treatment that a patient needs, the APA guidelines stress the assessment of physical complications and laboratory tests that may be relevant in patients with anorexia nervosa or bulimia nervosa (Am. J. Psychiatry 2006;163[suppl.]:1–54). For different organ systems, the guidelines list symptoms and signs to look for and particular laboratory tests that may help to diagnose the problem.

“Almost everyone seeing patients with eating disorders should at least know the symptoms and then be able to choose how they're going to work with those particular problems–either by themselves, or [by] consult with a primary care doctor or a specialist,” Dr. Powers advised.

Bulimia nervosa patients may have many of the same symptoms as anorexia nervosa patients because they have a past history of anorexia.

According to the guidelines, basic laboratory tests for bulimia and anorexia patients should include urinalysis for ketones and blood tests for electrolytes, urea nitrogen, creatinine, thyroid-stimulating hormone, a complete blood count, liver enzymes, and erythrocyte sedimentation rate.

Other tests may be necessary in certain circumstances, such as dual-energy x-ray absorptiometry in anorexic patients who haven't had a menstrual period for more than 6 months, Dr. Powers said. At her center, clinicians also routinely order an electrocardiogram, a 24-hour urine creatinine clearance test, and a test for level of complement 3, which is an immune system protein that often drops to low levels early in anorexic patients.

It also may be easier to make a case for insurance coverage with reviewers if you have baseline values for laboratory tests, she noted.

The guidelines recommend placing patients at different levels of care (outpatient, intensive outpatient, partial hospitalization, residential treatment center, inpatient hospitalization) according to categories that are used to assess the severity of their illness, even though there is little evidence to substantiate such placements.

The independent, nonprofit health services research agency ECRI (formerly the Emergency Care Research Institute) conducted a meta-analysis of 48 unique randomized clinical trials on bulimia nervosa.

The report found weak to moderate evidence supporting the effectiveness of medications in reducing bingeing and purging behaviors, as well as anxiety and depression. Except for moderate evidence suggesting some benefit of cognitive-behavioral therapy (CBT) on purging, little data were available to support its effectiveness on bingeing and anxiety or depression.

Weak evidence suggests that CBT may be more effective than medications for purging behaviors, but no other distinction between the two interventions could be made.

Virtually no evidence exists to suggest that CBT is better than other forms of psychotherapy. There was no evidence on whether the interventions improved quality of life.

Fluoxetine is already Food and Drug Administration-approved at 60 mg per day for the treatment of bulimia nervosa, based on 6- to 18-week trials showing that it reduced binge eating, purging, and associated psychological features, even though the results were “pretty weak because of the high dropout rates,” said Dr. Russell Marx, medical director of the eating disorders program at the University Medical Center at Princeton (N.J.).

Dialectical behavior therapy has shown preliminary evidence of being effective for bulimia.

In binge eating disorder, short-term trials of selective serotonin reuptake inhibitors have reduced the severity of illness as well as eating, psychiatric, and weight symptoms, compared with placebo.

SAN FRANCISCO — African American patients, especially women, appear to lose a smaller percentage of excess weight after laparoscopic adjustable gastric banding than their white counterparts, despite similar resolution of comorbidities, Dr. Manish S. Parikh reported at the annual meeting of the American Society for Bariatric Surgery.

“It's unclear what impact race has on outcomes after bariatric surgery. There have been conflicting reports of decreased mean excess weight loss among African Americans after bariatric surgery, most of which involved gastric bypasses,” said Dr. Parikh, of the department of surgery at New York University, New York.

In a previously published review of 630 white and 61 African American patients, Dr. Parikh and his colleagues found a significant difference in mean excess weight loss between white and African Americans at 3 years of follow-up (54% and 38%, respectively) after laparoscopic adjustable gastric banding (LABG). But that study did not examine any differences in age, body mass index, or prevalence of comorbidities (Surg. Endosc. 2005;19:1631–5).

To study more thoroughly any racial differences in LABG outcomes, Dr. Parikh and his colleagues used prospectively collected data on 959 patients who underwent the procedure during 2001–2004. They retrospectively matched 65 white patients with 58 African American patients based on age (mean 37 years), sex (104 females), and preoperative BMI (47 kg/m

Compared with African American patients, white patients on average lost a significantly higher percentage of excess weight at 1 year (49% vs. 39%), 2 years (55% vs. 44%), and 3 years of follow-up (52% vs. 41%). But obesity-related comorbidities (type 2 diabetes, hypertension, obstructive sleep apnea, and hyperlipidemia) resolved in a similar percentage of patients in both groups at each time point.

At baseline, 64% of African Americans and 55% of whites had obesity-related comorbidities. A decrease in the dose or number of medications was seen in 77% of African Americans and 61% of whites while obesity-related comorbidities completely resolved (medications were discontinued) in 32% of African Americans and in 29% of whites.

The follow-up rates at 3 years were 60% for African Americans and 74% for whites.

“This is a very small study with preliminary data. Larger studies are needed to delineate ethnic differences in outcomes after bariatric surgery,” Dr. Parikh said.

Physicians should look at such data “with a little bit of caution, especially the types of studies that may foster far-reaching implications,” said Dr. Titus D. Duncan, a scheduled discussant. “Insurance companies and other entities get these papers as well, and they can—and have—historically denied access to patients” based on studies that have not reached final conclusions.

It's important to consider “difficult-to-study” variables, such as social support issues, social negotiation skills, personal life experiences, conditioned preferences and avoidances, role models, and body image, which influence the overall outcomes in African American patients, said Dr. Duncan, director of minimally invasive and bariatric surgery at the Atlanta Medical Center.

Taking those variables into consideration in postoperative care plans, Dr. Duncan said that his group has found no significant racial differences in weight loss parameters or resolution of comorbidities in 3,500 bariatric procedures performed at their institution (including more than 800 African American patients).

ELSEVIER GLOBAL MEDICAL NEWS

SAN FRANCISCO — African American patients, especially women, appear to lose a smaller percentage of excess weight after laparoscopic adjustable gastric banding than their white counterparts, despite similar resolution of comorbidities, Dr. Manish S. Parikh reported at the annual meeting of the American Society for Bariatric Surgery.

“It's unclear what impact race has on outcomes after bariatric surgery. There have been conflicting reports of decreased mean excess weight loss among African Americans after bariatric surgery, most of which involved gastric bypasses,” said Dr. Parikh, of the department of surgery at New York University, New York.

In a previously published review of 630 white and 61 African American patients, Dr. Parikh and his colleagues found a significant difference in mean excess weight loss between white and African Americans at 3 years of follow-up (54% and 38%, respectively) after laparoscopic adjustable gastric banding (LABG). But that study did not examine any differences in age, body mass index, or prevalence of comorbidities (Surg. Endosc. 2005;19:1631–5).

To study more thoroughly any racial differences in LABG outcomes, Dr. Parikh and his colleagues used prospectively collected data on 959 patients who underwent the procedure during 2001–2004. They retrospectively matched 65 white patients with 58 African American patients based on age (mean 37 years), sex (104 females), and preoperative BMI (47 kg/m

Compared with African American patients, white patients on average lost a significantly higher percentage of excess weight at 1 year (49% vs. 39%), 2 years (55% vs. 44%), and 3 years of follow-up (52% vs. 41%). But obesity-related comorbidities (type 2 diabetes, hypertension, obstructive sleep apnea, and hyperlipidemia) resolved in a similar percentage of patients in both groups at each time point.

At baseline, 64% of African Americans and 55% of whites had obesity-related comorbidities. A decrease in the dose or number of medications was seen in 77% of African Americans and 61% of whites while obesity-related comorbidities completely resolved (medications were discontinued) in 32% of African Americans and in 29% of whites.

The follow-up rates at 3 years were 60% for African Americans and 74% for whites.

“This is a very small study with preliminary data. Larger studies are needed to delineate ethnic differences in outcomes after bariatric surgery,” Dr. Parikh said.

Physicians should look at such data “with a little bit of caution, especially the types of studies that may foster far-reaching implications,” said Dr. Titus D. Duncan, a scheduled discussant. “Insurance companies and other entities get these papers as well, and they can—and have—historically denied access to patients” based on studies that have not reached final conclusions.

It's important to consider “difficult-to-study” variables, such as social support issues, social negotiation skills, personal life experiences, conditioned preferences and avoidances, role models, and body image, which influence the overall outcomes in African American patients, said Dr. Duncan, director of minimally invasive and bariatric surgery at the Atlanta Medical Center.

Taking those variables into consideration in postoperative care plans, Dr. Duncan said that his group has found no significant racial differences in weight loss parameters or resolution of comorbidities in 3,500 bariatric procedures performed at their institution (including more than 800 African American patients).

ELSEVIER GLOBAL MEDICAL NEWS

SAN FRANCISCO — African American patients, especially women, appear to lose a smaller percentage of excess weight after laparoscopic adjustable gastric banding than their white counterparts, despite similar resolution of comorbidities, Dr. Manish S. Parikh reported at the annual meeting of the American Society for Bariatric Surgery.

“It's unclear what impact race has on outcomes after bariatric surgery. There have been conflicting reports of decreased mean excess weight loss among African Americans after bariatric surgery, most of which involved gastric bypasses,” said Dr. Parikh, of the department of surgery at New York University, New York.

In a previously published review of 630 white and 61 African American patients, Dr. Parikh and his colleagues found a significant difference in mean excess weight loss between white and African Americans at 3 years of follow-up (54% and 38%, respectively) after laparoscopic adjustable gastric banding (LABG). But that study did not examine any differences in age, body mass index, or prevalence of comorbidities (Surg. Endosc. 2005;19:1631–5).

To study more thoroughly any racial differences in LABG outcomes, Dr. Parikh and his colleagues used prospectively collected data on 959 patients who underwent the procedure during 2001–2004. They retrospectively matched 65 white patients with 58 African American patients based on age (mean 37 years), sex (104 females), and preoperative BMI (47 kg/m

Compared with African American patients, white patients on average lost a significantly higher percentage of excess weight at 1 year (49% vs. 39%), 2 years (55% vs. 44%), and 3 years of follow-up (52% vs. 41%). But obesity-related comorbidities (type 2 diabetes, hypertension, obstructive sleep apnea, and hyperlipidemia) resolved in a similar percentage of patients in both groups at each time point.

At baseline, 64% of African Americans and 55% of whites had obesity-related comorbidities. A decrease in the dose or number of medications was seen in 77% of African Americans and 61% of whites while obesity-related comorbidities completely resolved (medications were discontinued) in 32% of African Americans and in 29% of whites.

The follow-up rates at 3 years were 60% for African Americans and 74% for whites.

“This is a very small study with preliminary data. Larger studies are needed to delineate ethnic differences in outcomes after bariatric surgery,” Dr. Parikh said.

Physicians should look at such data “with a little bit of caution, especially the types of studies that may foster far-reaching implications,” said Dr. Titus D. Duncan, a scheduled discussant. “Insurance companies and other entities get these papers as well, and they can—and have—historically denied access to patients” based on studies that have not reached final conclusions.

It's important to consider “difficult-to-study” variables, such as social support issues, social negotiation skills, personal life experiences, conditioned preferences and avoidances, role models, and body image, which influence the overall outcomes in African American patients, said Dr. Duncan, director of minimally invasive and bariatric surgery at the Atlanta Medical Center.

Taking those variables into consideration in postoperative care plans, Dr. Duncan said that his group has found no significant racial differences in weight loss parameters or resolution of comorbidities in 3,500 bariatric procedures performed at their institution (including more than 800 African American patients).

ELSEVIER GLOBAL MEDICAL NEWS

SAN FRANCISCO — Patients who shed pounds before undergoing Roux-en-Y gastric bypass surgery lose excess weight and resolve comorbidities at rates comparable with those who do not lose weight preoperatively, according to short-term results from one of the first randomized trials to examine the effect of early weight loss.

The role of weight loss prior to bariatric surgery, particularly with Roux-en-Y gastric bypass (RYGB), is not well established, said Dr. Ramzi S. Alami, who presented results of the trial at the annual meeting of the American Society for Bariatric Surgery.

“There is significant concern that preoperative weight loss requirements may deter potential patients from seeking” surgery, he said. But the trial showed that the time to surgery was nearly the same among the 26 patients who participated in the weight-loss intervention and the 35 who were not randomized to lose weight.

Proponents of preoperative weight loss see it as a marker of patient compliance and commitment to lifestyle changes. Some surgeons think that because heavier patients tend to lose less weight postoperatively than lighter patients, the preoperative weight loss will help produce better results.

“Convincing data” also suggest that rapid weight loss shrinks the liver, which may lead to easier operations with fewer complications, said Dr. Alami, of the department of surgery at Stanford (Calif.) University.

Opponents of preoperative weight loss argue that efforts to lose weight before surgery may only delay the procedure and that many bariatric surgery candidates have tried unsuccessfully to lose weight in the past.

Dr. Alami and his associates randomized 100 patients to lose either 10% of their initial weight or to lose no weight, but only 61 patients actually underwent RYGB. The investigators encouraged patients in the weight-loss group to “lose weight by any means that had worked for them in the past.” A nutritionist was available to the patients for consultation.

Patients in the weight-loss group lost a mean of 8% of their initial body weight (mean of 23.5 pounds), ranging from 1.3% to 16%. This led to a significant difference in the preoperative body mass index of patients in the weight-loss group (44.5 kg/m

Both groups waited a similar amount of time on average to have their surgery (5.4 months in the weight-loss group vs. 5.2 months in the other). Patients who did not lose weight before surgery spent a significant 30 minutes longer in the operating room than those who did, but most of that was attributed to anesthesia management rather than the actual procedure, Dr. Alami said.

At 3 months, patients in the weight-loss group had lost a total of 44% of their weight, compared with 33% in their counterparts, but at 6 months, the differences were 54% vs. 51%, respectively. With such weight-loss results, it “was not surprising” that a similar percentage of patients in each group resolved their comorbidities, he said.

The study had a high dropout rate because patients were randomized “very early”—at their first point of contact with the clinic when they were still deciding on whether or not to have surgery; the high rate was not secondary to the weight-loss requirement, Dr. Alami said.

In a prior retrospective study of 90 patients who were instructed to lose weight before undergoing laparoscopic RYGB, Dr. Alami and his associates found that a preoperative weight loss of 1% translated into an increase of 1.8% of excess weight loss after 1 year.

In that study, operative times were 36 minutes shorter on average in patients who lost weight before surgery (Obes. Surg. 2005;15:1282–6).

SAN FRANCISCO — Patients who shed pounds before undergoing Roux-en-Y gastric bypass surgery lose excess weight and resolve comorbidities at rates comparable with those who do not lose weight preoperatively, according to short-term results from one of the first randomized trials to examine the effect of early weight loss.

The role of weight loss prior to bariatric surgery, particularly with Roux-en-Y gastric bypass (RYGB), is not well established, said Dr. Ramzi S. Alami, who presented results of the trial at the annual meeting of the American Society for Bariatric Surgery.

“There is significant concern that preoperative weight loss requirements may deter potential patients from seeking” surgery, he said. But the trial showed that the time to surgery was nearly the same among the 26 patients who participated in the weight-loss intervention and the 35 who were not randomized to lose weight.

Proponents of preoperative weight loss see it as a marker of patient compliance and commitment to lifestyle changes. Some surgeons think that because heavier patients tend to lose less weight postoperatively than lighter patients, the preoperative weight loss will help produce better results.

“Convincing data” also suggest that rapid weight loss shrinks the liver, which may lead to easier operations with fewer complications, said Dr. Alami, of the department of surgery at Stanford (Calif.) University.

Opponents of preoperative weight loss argue that efforts to lose weight before surgery may only delay the procedure and that many bariatric surgery candidates have tried unsuccessfully to lose weight in the past.

Dr. Alami and his associates randomized 100 patients to lose either 10% of their initial weight or to lose no weight, but only 61 patients actually underwent RYGB. The investigators encouraged patients in the weight-loss group to “lose weight by any means that had worked for them in the past.” A nutritionist was available to the patients for consultation.

Patients in the weight-loss group lost a mean of 8% of their initial body weight (mean of 23.5 pounds), ranging from 1.3% to 16%. This led to a significant difference in the preoperative body mass index of patients in the weight-loss group (44.5 kg/m

Both groups waited a similar amount of time on average to have their surgery (5.4 months in the weight-loss group vs. 5.2 months in the other). Patients who did not lose weight before surgery spent a significant 30 minutes longer in the operating room than those who did, but most of that was attributed to anesthesia management rather than the actual procedure, Dr. Alami said.

At 3 months, patients in the weight-loss group had lost a total of 44% of their weight, compared with 33% in their counterparts, but at 6 months, the differences were 54% vs. 51%, respectively. With such weight-loss results, it “was not surprising” that a similar percentage of patients in each group resolved their comorbidities, he said.

The study had a high dropout rate because patients were randomized “very early”—at their first point of contact with the clinic when they were still deciding on whether or not to have surgery; the high rate was not secondary to the weight-loss requirement, Dr. Alami said.

In a prior retrospective study of 90 patients who were instructed to lose weight before undergoing laparoscopic RYGB, Dr. Alami and his associates found that a preoperative weight loss of 1% translated into an increase of 1.8% of excess weight loss after 1 year.

In that study, operative times were 36 minutes shorter on average in patients who lost weight before surgery (Obes. Surg. 2005;15:1282–6).

SAN FRANCISCO — Patients who shed pounds before undergoing Roux-en-Y gastric bypass surgery lose excess weight and resolve comorbidities at rates comparable with those who do not lose weight preoperatively, according to short-term results from one of the first randomized trials to examine the effect of early weight loss.

The role of weight loss prior to bariatric surgery, particularly with Roux-en-Y gastric bypass (RYGB), is not well established, said Dr. Ramzi S. Alami, who presented results of the trial at the annual meeting of the American Society for Bariatric Surgery.

“There is significant concern that preoperative weight loss requirements may deter potential patients from seeking” surgery, he said. But the trial showed that the time to surgery was nearly the same among the 26 patients who participated in the weight-loss intervention and the 35 who were not randomized to lose weight.

Proponents of preoperative weight loss see it as a marker of patient compliance and commitment to lifestyle changes. Some surgeons think that because heavier patients tend to lose less weight postoperatively than lighter patients, the preoperative weight loss will help produce better results.

“Convincing data” also suggest that rapid weight loss shrinks the liver, which may lead to easier operations with fewer complications, said Dr. Alami, of the department of surgery at Stanford (Calif.) University.

Opponents of preoperative weight loss argue that efforts to lose weight before surgery may only delay the procedure and that many bariatric surgery candidates have tried unsuccessfully to lose weight in the past.

Dr. Alami and his associates randomized 100 patients to lose either 10% of their initial weight or to lose no weight, but only 61 patients actually underwent RYGB. The investigators encouraged patients in the weight-loss group to “lose weight by any means that had worked for them in the past.” A nutritionist was available to the patients for consultation.

Patients in the weight-loss group lost a mean of 8% of their initial body weight (mean of 23.5 pounds), ranging from 1.3% to 16%. This led to a significant difference in the preoperative body mass index of patients in the weight-loss group (44.5 kg/m

Both groups waited a similar amount of time on average to have their surgery (5.4 months in the weight-loss group vs. 5.2 months in the other). Patients who did not lose weight before surgery spent a significant 30 minutes longer in the operating room than those who did, but most of that was attributed to anesthesia management rather than the actual procedure, Dr. Alami said.

At 3 months, patients in the weight-loss group had lost a total of 44% of their weight, compared with 33% in their counterparts, but at 6 months, the differences were 54% vs. 51%, respectively. With such weight-loss results, it “was not surprising” that a similar percentage of patients in each group resolved their comorbidities, he said.

The study had a high dropout rate because patients were randomized “very early”—at their first point of contact with the clinic when they were still deciding on whether or not to have surgery; the high rate was not secondary to the weight-loss requirement, Dr. Alami said.

In a prior retrospective study of 90 patients who were instructed to lose weight before undergoing laparoscopic RYGB, Dr. Alami and his associates found that a preoperative weight loss of 1% translated into an increase of 1.8% of excess weight loss after 1 year.

In that study, operative times were 36 minutes shorter on average in patients who lost weight before surgery (Obes. Surg. 2005;15:1282–6).

BOSTON — Carefully selected liver transplant recipients older than 70 years can have survival rates similar to those of patients in their 50s, Dr. Gerald S. Lipshutz reported at the 2006 World Transplant Congress.

“As the older population continues to grow, more transplant centers will be forced to consider liver transplantation in the elderly,” said Dr. Lipshutz of the University of California, Los Angeles.

Previous single-center studies of liver transplant recipients aged 60 years and older have reported 5-year survival rates of 52%–69%. Kaplan-Meier curve estimates have predicted 10-year survival to be about 35% in that population. But no studies so far have looked at the outcomes of septuagenarians after liver transplant, Dr. Lipshutz said.

Dr. Lipshutz compared the outcome of liver transplants performed at his center during 1988–2005 in recipients aged 70–79 years with transplants in those aged 50–59 years. The 62 liver transplant recipients in the older group had a mean age of 72 years while the 864 younger patients had an average age of 54 years.

To be put on the liver transplant wait list, patients had to undergo “aggressive cardiac clearance.” If there was any evidence of significant cardiovascular disease, they had to undergo coronary artery catheterization.

Survival rates at 1, 3, 5, and 10 years were higher in the younger group than in the older group, but the difference was never statistically significant. At 1 year, survival rates were about 79% and 73%, respectively, followed by 72% and 66% at 3 years, 65% and 49% at 5 years, and 54% and 40% at 10 years.

A multivariate analysis combining both groups of patients showed that significant risk factors for death were preoperative hospitalization, longer cold ischemia times of the donor liver, a liver disease etiology of hepatitis C virus infection, and alcohol consumption. An age of 70 years or older was not a significant risk factor.

“With appropriate selection and screening, transplants in select septuagenarians may result in long-term survival,” Dr. Lipshutz said at the congress, which was sponsored by the American Society of Transplant Surgeons, the American Society of Transplantation, and the Transplantation Society.

BOSTON — Carefully selected liver transplant recipients older than 70 years can have survival rates similar to those of patients in their 50s, Dr. Gerald S. Lipshutz reported at the 2006 World Transplant Congress.

“As the older population continues to grow, more transplant centers will be forced to consider liver transplantation in the elderly,” said Dr. Lipshutz of the University of California, Los Angeles.

Previous single-center studies of liver transplant recipients aged 60 years and older have reported 5-year survival rates of 52%–69%. Kaplan-Meier curve estimates have predicted 10-year survival to be about 35% in that population. But no studies so far have looked at the outcomes of septuagenarians after liver transplant, Dr. Lipshutz said.

Dr. Lipshutz compared the outcome of liver transplants performed at his center during 1988–2005 in recipients aged 70–79 years with transplants in those aged 50–59 years. The 62 liver transplant recipients in the older group had a mean age of 72 years while the 864 younger patients had an average age of 54 years.

To be put on the liver transplant wait list, patients had to undergo “aggressive cardiac clearance.” If there was any evidence of significant cardiovascular disease, they had to undergo coronary artery catheterization.

Survival rates at 1, 3, 5, and 10 years were higher in the younger group than in the older group, but the difference was never statistically significant. At 1 year, survival rates were about 79% and 73%, respectively, followed by 72% and 66% at 3 years, 65% and 49% at 5 years, and 54% and 40% at 10 years.

A multivariate analysis combining both groups of patients showed that significant risk factors for death were preoperative hospitalization, longer cold ischemia times of the donor liver, a liver disease etiology of hepatitis C virus infection, and alcohol consumption. An age of 70 years or older was not a significant risk factor.

“With appropriate selection and screening, transplants in select septuagenarians may result in long-term survival,” Dr. Lipshutz said at the congress, which was sponsored by the American Society of Transplant Surgeons, the American Society of Transplantation, and the Transplantation Society.

BOSTON — Carefully selected liver transplant recipients older than 70 years can have survival rates similar to those of patients in their 50s, Dr. Gerald S. Lipshutz reported at the 2006 World Transplant Congress.

“As the older population continues to grow, more transplant centers will be forced to consider liver transplantation in the elderly,” said Dr. Lipshutz of the University of California, Los Angeles.

Previous single-center studies of liver transplant recipients aged 60 years and older have reported 5-year survival rates of 52%–69%. Kaplan-Meier curve estimates have predicted 10-year survival to be about 35% in that population. But no studies so far have looked at the outcomes of septuagenarians after liver transplant, Dr. Lipshutz said.

Dr. Lipshutz compared the outcome of liver transplants performed at his center during 1988–2005 in recipients aged 70–79 years with transplants in those aged 50–59 years. The 62 liver transplant recipients in the older group had a mean age of 72 years while the 864 younger patients had an average age of 54 years.

To be put on the liver transplant wait list, patients had to undergo “aggressive cardiac clearance.” If there was any evidence of significant cardiovascular disease, they had to undergo coronary artery catheterization.

Survival rates at 1, 3, 5, and 10 years were higher in the younger group than in the older group, but the difference was never statistically significant. At 1 year, survival rates were about 79% and 73%, respectively, followed by 72% and 66% at 3 years, 65% and 49% at 5 years, and 54% and 40% at 10 years.

A multivariate analysis combining both groups of patients showed that significant risk factors for death were preoperative hospitalization, longer cold ischemia times of the donor liver, a liver disease etiology of hepatitis C virus infection, and alcohol consumption. An age of 70 years or older was not a significant risk factor.

“With appropriate selection and screening, transplants in select septuagenarians may result in long-term survival,” Dr. Lipshutz said at the congress, which was sponsored by the American Society of Transplant Surgeons, the American Society of Transplantation, and the Transplantation Society.

The Food and Drug Administration has begun a new initiative aimed at improving the ability to identify and predict cardiac side effects of drugs and devices under development.

In partnership with the Duke Clinical Research Institute (DCRI), Durham, N.C., the FDA first will use an electronic database of 200,000–300,000 digital electrocardiogram recordings to understand the effects that some drugs and devices may have on heart function. The recordings have been submitted from about 30 clinical trials that were conducted as a part of new drug applications during the last 2 years, Dr. Norman Stockbridge, director of the division of cardiovascular and renal products at the Center for Drug Evaluation and Research, said in a teleconference.

The database standardizes recordings that have been pooled from different ECG waveforms into a single, digitized format for analysis.

For decades “we've received generally low-quality copies of ECGs on paper,” said Dr. Janet Woodcock, deputy commissioner for operations at the FDA. “We've been really limited in our ability to use this information to understand why some treatments affected a patient's heart or even to be able to predict whether treatment would affect someone's heart.”

The FDA and DCRI are developing a consortium to leverage the resources and expertise of members from academia, industry, patient advocacy groups, other government agencies, and nonprofit organizations to discover where ECG data can fill gaps where new cardiac biomarkers are needed and to prioritize research projects based on the findings.

One immediate application of the ECG database will be to review gender differences in the effects of drugs on ECG recordings, since it is not known if differences in drug responses drive the higher risk of drug-induced arrhythmias in women, compared with men, Dr. Woodcock said.

The electronic ECG database will help to identify new ways of detecting problems such as QT interval prolongation with greater precision and at earlier stages, said Dr. Robert Califf, director of DCRI.

“QT interval prolongation has been the downfall of many drugs, but also it is a side effect of many useful drugs, including all of the atypical antipsychotics,” Dr. Califf pointed out.

Other early work with the ECG database is involved in describing placebo groups in studies and differences in the parameters of the QT interval in men, women, and people of different body sizes and other clinical features, he added.

“For studies that help us refine how we measure ECGs, we can use that to improve the standards” for measuring drug safety, Dr. Woodcock said. “For example, we still don't know the meaning of some of the degrees of QT prolongation.”

“FDA might change its guidance [to pharmaceutical companies] based on information we get from this, and this might even change how drugs are developed,” she said.

Many other biomarkers outside of ECG data will be considered under the FDA-DCRI partnership, which is a part of the FDA's Critical Path Initiative to modernize the drug development process.

“All of industry that's interested in cardiac biomarkers will be participating in this to the extent that they wish,” Dr. Califf said.

The Food and Drug Administration has begun a new initiative aimed at improving the ability to identify and predict cardiac side effects of drugs and devices under development.

In partnership with the Duke Clinical Research Institute (DCRI), Durham, N.C., the FDA first will use an electronic database of 200,000–300,000 digital electrocardiogram recordings to understand the effects that some drugs and devices may have on heart function. The recordings have been submitted from about 30 clinical trials that were conducted as a part of new drug applications during the last 2 years, Dr. Norman Stockbridge, director of the division of cardiovascular and renal products at the Center for Drug Evaluation and Research, said in a teleconference.

The database standardizes recordings that have been pooled from different ECG waveforms into a single, digitized format for analysis.

For decades “we've received generally low-quality copies of ECGs on paper,” said Dr. Janet Woodcock, deputy commissioner for operations at the FDA. “We've been really limited in our ability to use this information to understand why some treatments affected a patient's heart or even to be able to predict whether treatment would affect someone's heart.”

The FDA and DCRI are developing a consortium to leverage the resources and expertise of members from academia, industry, patient advocacy groups, other government agencies, and nonprofit organizations to discover where ECG data can fill gaps where new cardiac biomarkers are needed and to prioritize research projects based on the findings.

One immediate application of the ECG database will be to review gender differences in the effects of drugs on ECG recordings, since it is not known if differences in drug responses drive the higher risk of drug-induced arrhythmias in women, compared with men, Dr. Woodcock said.

The electronic ECG database will help to identify new ways of detecting problems such as QT interval prolongation with greater precision and at earlier stages, said Dr. Robert Califf, director of DCRI.

“QT interval prolongation has been the downfall of many drugs, but also it is a side effect of many useful drugs, including all of the atypical antipsychotics,” Dr. Califf pointed out.

Other early work with the ECG database is involved in describing placebo groups in studies and differences in the parameters of the QT interval in men, women, and people of different body sizes and other clinical features, he added.

“For studies that help us refine how we measure ECGs, we can use that to improve the standards” for measuring drug safety, Dr. Woodcock said. “For example, we still don't know the meaning of some of the degrees of QT prolongation.”

“FDA might change its guidance [to pharmaceutical companies] based on information we get from this, and this might even change how drugs are developed,” she said.

Many other biomarkers outside of ECG data will be considered under the FDA-DCRI partnership, which is a part of the FDA's Critical Path Initiative to modernize the drug development process.

“All of industry that's interested in cardiac biomarkers will be participating in this to the extent that they wish,” Dr. Califf said.

The Food and Drug Administration has begun a new initiative aimed at improving the ability to identify and predict cardiac side effects of drugs and devices under development.

In partnership with the Duke Clinical Research Institute (DCRI), Durham, N.C., the FDA first will use an electronic database of 200,000–300,000 digital electrocardiogram recordings to understand the effects that some drugs and devices may have on heart function. The recordings have been submitted from about 30 clinical trials that were conducted as a part of new drug applications during the last 2 years, Dr. Norman Stockbridge, director of the division of cardiovascular and renal products at the Center for Drug Evaluation and Research, said in a teleconference.

The database standardizes recordings that have been pooled from different ECG waveforms into a single, digitized format for analysis.

For decades “we've received generally low-quality copies of ECGs on paper,” said Dr. Janet Woodcock, deputy commissioner for operations at the FDA. “We've been really limited in our ability to use this information to understand why some treatments affected a patient's heart or even to be able to predict whether treatment would affect someone's heart.”

The FDA and DCRI are developing a consortium to leverage the resources and expertise of members from academia, industry, patient advocacy groups, other government agencies, and nonprofit organizations to discover where ECG data can fill gaps where new cardiac biomarkers are needed and to prioritize research projects based on the findings.

One immediate application of the ECG database will be to review gender differences in the effects of drugs on ECG recordings, since it is not known if differences in drug responses drive the higher risk of drug-induced arrhythmias in women, compared with men, Dr. Woodcock said.

The electronic ECG database will help to identify new ways of detecting problems such as QT interval prolongation with greater precision and at earlier stages, said Dr. Robert Califf, director of DCRI.

“QT interval prolongation has been the downfall of many drugs, but also it is a side effect of many useful drugs, including all of the atypical antipsychotics,” Dr. Califf pointed out.

Other early work with the ECG database is involved in describing placebo groups in studies and differences in the parameters of the QT interval in men, women, and people of different body sizes and other clinical features, he added.

“For studies that help us refine how we measure ECGs, we can use that to improve the standards” for measuring drug safety, Dr. Woodcock said. “For example, we still don't know the meaning of some of the degrees of QT prolongation.”

“FDA might change its guidance [to pharmaceutical companies] based on information we get from this, and this might even change how drugs are developed,” she said.

Many other biomarkers outside of ECG data will be considered under the FDA-DCRI partnership, which is a part of the FDA's Critical Path Initiative to modernize the drug development process.

“All of industry that's interested in cardiac biomarkers will be participating in this to the extent that they wish,” Dr. Califf said.

WASHINGTON — Patients with type 2 diabetes may be able to improve glycemic control, weight loss, and cholesterol levels significantly more with low-carbohydrate diets than with diets emphasizing a caloric deficit, according to the results of two randomized trials presented at the annual scientific sessions of the American Diabetes Association.

Uncontrolled pilot studies of low-carbohydrate diets (ranging from 7% to 20% of total calories) in patients with type 2 diabetes have shown declines in HbA_1c values ranging from 1.2 to 4.1 percentage points and decreases in weight of 7%–12% in up to a year of follow-up.

With such promising results in mind, Dr. Eric C. Westman and colleagues at Duke University, Durham, N.C., conducted a comparison of a low-glycemic index diet (LGI) with a low-carbohydrate, ketogenic diet (LCKD) in 97 type 2 diabetes patients, average age 50–51 years, who wanted to lose weight.

To be included in the trial, patients had to have no history of diabetic ketoacidosis, have an HbA_1c of greater than 6% at screening, and be able to self-monitor blood glucose levels if on insulin or oral hypoglycemic therapy. Patients were excluded if they had unstable cardiovascular disease (allowable if hypertension and hyperlipidemia were under control), kidney disease, or liver disease, or were pregnant or breast-feeding.

Participants in each group received exercise recommendations and nutritional supplementation (a multivitamin, chromium 1,000 mcg/day, and vanadyl sulfate 60 mg/day) and attended group meetings. The LGI diet consisted of an individualized 500-kcal reduction per day in energy intake, deriving 55% of energy from low-glycemic carbohydrates, whereas people on the LCKD restricted their carbohydrate intake to less than 20 g per day.

Among the 50 participants who completed the 24-week study, HbA_1c levels improved significantly more in the LCKD group (8.8% to 7.3%) than in the LGI group (8.3% to 7.8%). When dropouts were included in analyses using the last observation, the LCKD group still had a significantly greater, albeit smaller, HbA_1c improvement than the LGI group did (8.4% to 7.6% vs. 8.3% to 8%).

In a multivariate regression model, treatment group was independently predictive of change in HbA_1c after weight loss was controlled for “suggesting that [the LCKD] diet, even beyond weight loss, had an effect on HbA_1c,” said Dr. Westman, professor in the department of medicine at Duke University.

By the end of the trial, 18 of the 29 people who completed the LGI diet had eliminated or reduced the number of medications they were on, compared with 20 of 21 individuals in the LCKD group. Body weight changed significantly more among LCKD participants (107 kg to 97 kg) than in LGI participants (104 kg to 98 kg).

Both groups had similar improvement in total and low-density lipoprotein cholesterol as well as triglycerides. LCKD participants had a significant 5.5% increase in high-density lipoprotein cholesterol (HDL-C), compared with no change in the LGI individuals.

The study was funded by the Robert C. Atkins Foundation. Dr. Atkins is credited with popularizing a low-carbohydrate diet.

In a separate 2-year trial, an interim analysis of 6 months of data showed that a diet restricted to about 70 g of carbohydrates (half from fruit and milk) significantly improved weight and waist circumference in patients with type 2 diabetes, compared with a diet with a 500-kcal per day calorie restriction, reported Dr. Michael E. Daly, a diabetologist at the Royal Devon and Exeter NHS Trust, Exeter, England.

Six-month data were available for 206 of 259 (80%) patients randomized in the trial. This 20% dropout rate was lower than that of other low-carbohydrate studies, Dr. Daly said (N. Engl. J. Med. 2003;348:2074–81; 2082–90). Participants had an average age of 59, a mean weight of 99 kg, and a mean BMI of 35 kg/m

Significantly more weight loss occurred in carbohydrate-restricted patients (3.7 kg) than in those on the energy-deficit diet (1.2 kg). Both diets improved body fat percentage, HbA_1c, total cholesterol:HDL cholesterol ratio, triglycerides, and blood pressure, but no differences emerged between the two groups on any of these measures. In both groups, calcium excretion declined to a similar extent and microalbumin excretion did not change substantially (Diabet. Med. 2006;23:15–20).

WASHINGTON — Patients with type 2 diabetes may be able to improve glycemic control, weight loss, and cholesterol levels significantly more with low-carbohydrate diets than with diets emphasizing a caloric deficit, according to the results of two randomized trials presented at the annual scientific sessions of the American Diabetes Association.

Uncontrolled pilot studies of low-carbohydrate diets (ranging from 7% to 20% of total calories) in patients with type 2 diabetes have shown declines in HbA_1c values ranging from 1.2 to 4.1 percentage points and decreases in weight of 7%–12% in up to a year of follow-up.

With such promising results in mind, Dr. Eric C. Westman and colleagues at Duke University, Durham, N.C., conducted a comparison of a low-glycemic index diet (LGI) with a low-carbohydrate, ketogenic diet (LCKD) in 97 type 2 diabetes patients, average age 50–51 years, who wanted to lose weight.

To be included in the trial, patients had to have no history of diabetic ketoacidosis, have an HbA_1c of greater than 6% at screening, and be able to self-monitor blood glucose levels if on insulin or oral hypoglycemic therapy. Patients were excluded if they had unstable cardiovascular disease (allowable if hypertension and hyperlipidemia were under control), kidney disease, or liver disease, or were pregnant or breast-feeding.

Participants in each group received exercise recommendations and nutritional supplementation (a multivitamin, chromium 1,000 mcg/day, and vanadyl sulfate 60 mg/day) and attended group meetings. The LGI diet consisted of an individualized 500-kcal reduction per day in energy intake, deriving 55% of energy from low-glycemic carbohydrates, whereas people on the LCKD restricted their carbohydrate intake to less than 20 g per day.

Among the 50 participants who completed the 24-week study, HbA_1c levels improved significantly more in the LCKD group (8.8% to 7.3%) than in the LGI group (8.3% to 7.8%). When dropouts were included in analyses using the last observation, the LCKD group still had a significantly greater, albeit smaller, HbA_1c improvement than the LGI group did (8.4% to 7.6% vs. 8.3% to 8%).

In a multivariate regression model, treatment group was independently predictive of change in HbA_1c after weight loss was controlled for “suggesting that [the LCKD] diet, even beyond weight loss, had an effect on HbA_1c,” said Dr. Westman, professor in the department of medicine at Duke University.

By the end of the trial, 18 of the 29 people who completed the LGI diet had eliminated or reduced the number of medications they were on, compared with 20 of 21 individuals in the LCKD group. Body weight changed significantly more among LCKD participants (107 kg to 97 kg) than in LGI participants (104 kg to 98 kg).

Both groups had similar improvement in total and low-density lipoprotein cholesterol as well as triglycerides. LCKD participants had a significant 5.5% increase in high-density lipoprotein cholesterol (HDL-C), compared with no change in the LGI individuals.

The study was funded by the Robert C. Atkins Foundation. Dr. Atkins is credited with popularizing a low-carbohydrate diet.

In a separate 2-year trial, an interim analysis of 6 months of data showed that a diet restricted to about 70 g of carbohydrates (half from fruit and milk) significantly improved weight and waist circumference in patients with type 2 diabetes, compared with a diet with a 500-kcal per day calorie restriction, reported Dr. Michael E. Daly, a diabetologist at the Royal Devon and Exeter NHS Trust, Exeter, England.

Six-month data were available for 206 of 259 (80%) patients randomized in the trial. This 20% dropout rate was lower than that of other low-carbohydrate studies, Dr. Daly said (N. Engl. J. Med. 2003;348:2074–81; 2082–90). Participants had an average age of 59, a mean weight of 99 kg, and a mean BMI of 35 kg/m

Significantly more weight loss occurred in carbohydrate-restricted patients (3.7 kg) than in those on the energy-deficit diet (1.2 kg). Both diets improved body fat percentage, HbA_1c, total cholesterol:HDL cholesterol ratio, triglycerides, and blood pressure, but no differences emerged between the two groups on any of these measures. In both groups, calcium excretion declined to a similar extent and microalbumin excretion did not change substantially (Diabet. Med. 2006;23:15–20).

WASHINGTON — Patients with type 2 diabetes may be able to improve glycemic control, weight loss, and cholesterol levels significantly more with low-carbohydrate diets than with diets emphasizing a caloric deficit, according to the results of two randomized trials presented at the annual scientific sessions of the American Diabetes Association.

Uncontrolled pilot studies of low-carbohydrate diets (ranging from 7% to 20% of total calories) in patients with type 2 diabetes have shown declines in HbA_1c values ranging from 1.2 to 4.1 percentage points and decreases in weight of 7%–12% in up to a year of follow-up.

With such promising results in mind, Dr. Eric C. Westman and colleagues at Duke University, Durham, N.C., conducted a comparison of a low-glycemic index diet (LGI) with a low-carbohydrate, ketogenic diet (LCKD) in 97 type 2 diabetes patients, average age 50–51 years, who wanted to lose weight.

To be included in the trial, patients had to have no history of diabetic ketoacidosis, have an HbA_1c of greater than 6% at screening, and be able to self-monitor blood glucose levels if on insulin or oral hypoglycemic therapy. Patients were excluded if they had unstable cardiovascular disease (allowable if hypertension and hyperlipidemia were under control), kidney disease, or liver disease, or were pregnant or breast-feeding.

Participants in each group received exercise recommendations and nutritional supplementation (a multivitamin, chromium 1,000 mcg/day, and vanadyl sulfate 60 mg/day) and attended group meetings. The LGI diet consisted of an individualized 500-kcal reduction per day in energy intake, deriving 55% of energy from low-glycemic carbohydrates, whereas people on the LCKD restricted their carbohydrate intake to less than 20 g per day.

Among the 50 participants who completed the 24-week study, HbA_1c levels improved significantly more in the LCKD group (8.8% to 7.3%) than in the LGI group (8.3% to 7.8%). When dropouts were included in analyses using the last observation, the LCKD group still had a significantly greater, albeit smaller, HbA_1c improvement than the LGI group did (8.4% to 7.6% vs. 8.3% to 8%).

In a multivariate regression model, treatment group was independently predictive of change in HbA_1c after weight loss was controlled for “suggesting that [the LCKD] diet, even beyond weight loss, had an effect on HbA_1c,” said Dr. Westman, professor in the department of medicine at Duke University.

By the end of the trial, 18 of the 29 people who completed the LGI diet had eliminated or reduced the number of medications they were on, compared with 20 of 21 individuals in the LCKD group. Body weight changed significantly more among LCKD participants (107 kg to 97 kg) than in LGI participants (104 kg to 98 kg).

Both groups had similar improvement in total and low-density lipoprotein cholesterol as well as triglycerides. LCKD participants had a significant 5.5% increase in high-density lipoprotein cholesterol (HDL-C), compared with no change in the LGI individuals.

The study was funded by the Robert C. Atkins Foundation. Dr. Atkins is credited with popularizing a low-carbohydrate diet.

In a separate 2-year trial, an interim analysis of 6 months of data showed that a diet restricted to about 70 g of carbohydrates (half from fruit and milk) significantly improved weight and waist circumference in patients with type 2 diabetes, compared with a diet with a 500-kcal per day calorie restriction, reported Dr. Michael E. Daly, a diabetologist at the Royal Devon and Exeter NHS Trust, Exeter, England.

Six-month data were available for 206 of 259 (80%) patients randomized in the trial. This 20% dropout rate was lower than that of other low-carbohydrate studies, Dr. Daly said (N. Engl. J. Med. 2003;348:2074–81; 2082–90). Participants had an average age of 59, a mean weight of 99 kg, and a mean BMI of 35 kg/m

Significantly more weight loss occurred in carbohydrate-restricted patients (3.7 kg) than in those on the energy-deficit diet (1.2 kg). Both diets improved body fat percentage, HbA_1c, total cholesterol:HDL cholesterol ratio, triglycerides, and blood pressure, but no differences emerged between the two groups on any of these measures. In both groups, calcium excretion declined to a similar extent and microalbumin excretion did not change substantially (Diabet. Med. 2006;23:15–20).