Mary Ann Moon

The rate of hospitalization for heart failure in the United States declined approximately 30% between 1998 and 2008, according to a report in the Oct. 19 issue of JAMA.

This decrease is especially "remarkable" in light of the finding that survival after HF hospitalization also rose slightly at the same time, which means that there likely were more repeat hospitalizations for HF in any given year, said Dr. Jersey Chen of Yale University, New Haven, Conn., and his associates.

The researchers performed "the largest study to date examining trends in HF hospitalization rates across the United States" by analyzing a sample of 320,618,412 Medicare fee-for-service claims during that decade.

The overall risk-adjusted hospitalization rate decreased from 2,845 per 100,000 person-years to 2,007 per 100,000 person-years, a relative decline of 29.5%. In addition, the number of unique patients hospitalized at least once for HF in a given year dropped from 2,014 to 1,462 per 100,000 person-years.

This decrease represents an estimated savings of $4.1 billion in Medicare costs, the investigators said (JAMA 2011;306:1669-78).

Declines in HF hospitalization occurred across all age, sex, and race categories, although the amount of the decrease varied among these groups. For example, black men showed the lowest rate of decline among all categories of race and sex.

In addition, hospitalization for HF varied widely among the states. In 16 states, the decrease was significantly greater than the overall national decrease, while the decrease was significantly smaller in three states.

Dr. Chen and his colleagues also calculated 1-year mortality after HF hospitalization. Overall, this rate, adjusted for patient age, sex, race, and comorbidity, declined from 31.7% to 29.6%, a relative decrease of 6.6%.

The researchers characterized this reduction in HF mortality as "modest."

As with the hospitalization rates, the mortality rates varied substantially by state. Four states showed a more significant drop than the national average, and five showed a significant increase during the study period.

Such decreases were not found in previous studies of earlier time periods, such as the Framingham Heart Study, which examined trends in 1970-1999, and an Olmsted County (Minn.) study, which assessed trends in 1979-2004. "Our results may differ from these earlier studies because HF hospitalizations may have started to decline only recently," Dr. Chen and his associates noted.

Several more recent studies have indicated that HF hospitalization rates began to decline in the 1990s in Sweden, Scotland, Australia, and New Zealand, they added.

As an observational cohort study, this study was unable to determine the reasons for the marked decline in HF hospitalization and the more modest decline in HF mortality. However, the investigators speculated that improvements in underlying coronary artery disease, myocardial salvage after MI, and blood pressure control all may have played a role.

Improvements in secondary prevention also likely reduced HF exacerbations leading to hospitalization, including greater use of beta-blockers, ACE inhibitors, and angiotensin receptor blockers. In addition, clinical practice patterns may have changed, favoring outpatient rather than inpatient management of HF.

This study was limited in that it included only Medicare patients. "Trends in HF hospitalization and mortality may differ in younger patients with different types of insurance," Dr. Chen and his associates said.

The study was supported by the Agency for Healthcare Research and Quality and the National Heart, Lung, and Blood Institute. Dr. Chen’s associates reported ties to United Healthcare and Medtronic.

The rate of hospitalization for heart failure in the United States declined approximately 30% between 1998 and 2008, according to a report in the Oct. 19 issue of JAMA.

This decrease is especially "remarkable" in light of the finding that survival after HF hospitalization also rose slightly at the same time, which means that there likely were more repeat hospitalizations for HF in any given year, said Dr. Jersey Chen of Yale University, New Haven, Conn., and his associates.

The researchers performed "the largest study to date examining trends in HF hospitalization rates across the United States" by analyzing a sample of 320,618,412 Medicare fee-for-service claims during that decade.

The overall risk-adjusted hospitalization rate decreased from 2,845 per 100,000 person-years to 2,007 per 100,000 person-years, a relative decline of 29.5%. In addition, the number of unique patients hospitalized at least once for HF in a given year dropped from 2,014 to 1,462 per 100,000 person-years.

This decrease represents an estimated savings of $4.1 billion in Medicare costs, the investigators said (JAMA 2011;306:1669-78).

Declines in HF hospitalization occurred across all age, sex, and race categories, although the amount of the decrease varied among these groups. For example, black men showed the lowest rate of decline among all categories of race and sex.

In addition, hospitalization for HF varied widely among the states. In 16 states, the decrease was significantly greater than the overall national decrease, while the decrease was significantly smaller in three states.

Dr. Chen and his colleagues also calculated 1-year mortality after HF hospitalization. Overall, this rate, adjusted for patient age, sex, race, and comorbidity, declined from 31.7% to 29.6%, a relative decrease of 6.6%.

The researchers characterized this reduction in HF mortality as "modest."

As with the hospitalization rates, the mortality rates varied substantially by state. Four states showed a more significant drop than the national average, and five showed a significant increase during the study period.

Such decreases were not found in previous studies of earlier time periods, such as the Framingham Heart Study, which examined trends in 1970-1999, and an Olmsted County (Minn.) study, which assessed trends in 1979-2004. "Our results may differ from these earlier studies because HF hospitalizations may have started to decline only recently," Dr. Chen and his associates noted.

Several more recent studies have indicated that HF hospitalization rates began to decline in the 1990s in Sweden, Scotland, Australia, and New Zealand, they added.

As an observational cohort study, this study was unable to determine the reasons for the marked decline in HF hospitalization and the more modest decline in HF mortality. However, the investigators speculated that improvements in underlying coronary artery disease, myocardial salvage after MI, and blood pressure control all may have played a role.

Improvements in secondary prevention also likely reduced HF exacerbations leading to hospitalization, including greater use of beta-blockers, ACE inhibitors, and angiotensin receptor blockers. In addition, clinical practice patterns may have changed, favoring outpatient rather than inpatient management of HF.

This study was limited in that it included only Medicare patients. "Trends in HF hospitalization and mortality may differ in younger patients with different types of insurance," Dr. Chen and his associates said.

The study was supported by the Agency for Healthcare Research and Quality and the National Heart, Lung, and Blood Institute. Dr. Chen’s associates reported ties to United Healthcare and Medtronic.

The rate of hospitalization for heart failure in the United States declined approximately 30% between 1998 and 2008, according to a report in the Oct. 19 issue of JAMA.

This decrease is especially "remarkable" in light of the finding that survival after HF hospitalization also rose slightly at the same time, which means that there likely were more repeat hospitalizations for HF in any given year, said Dr. Jersey Chen of Yale University, New Haven, Conn., and his associates.

The researchers performed "the largest study to date examining trends in HF hospitalization rates across the United States" by analyzing a sample of 320,618,412 Medicare fee-for-service claims during that decade.

The overall risk-adjusted hospitalization rate decreased from 2,845 per 100,000 person-years to 2,007 per 100,000 person-years, a relative decline of 29.5%. In addition, the number of unique patients hospitalized at least once for HF in a given year dropped from 2,014 to 1,462 per 100,000 person-years.

This decrease represents an estimated savings of $4.1 billion in Medicare costs, the investigators said (JAMA 2011;306:1669-78).

Declines in HF hospitalization occurred across all age, sex, and race categories, although the amount of the decrease varied among these groups. For example, black men showed the lowest rate of decline among all categories of race and sex.

In addition, hospitalization for HF varied widely among the states. In 16 states, the decrease was significantly greater than the overall national decrease, while the decrease was significantly smaller in three states.

Dr. Chen and his colleagues also calculated 1-year mortality after HF hospitalization. Overall, this rate, adjusted for patient age, sex, race, and comorbidity, declined from 31.7% to 29.6%, a relative decrease of 6.6%.

The researchers characterized this reduction in HF mortality as "modest."

As with the hospitalization rates, the mortality rates varied substantially by state. Four states showed a more significant drop than the national average, and five showed a significant increase during the study period.

Such decreases were not found in previous studies of earlier time periods, such as the Framingham Heart Study, which examined trends in 1970-1999, and an Olmsted County (Minn.) study, which assessed trends in 1979-2004. "Our results may differ from these earlier studies because HF hospitalizations may have started to decline only recently," Dr. Chen and his associates noted.

Several more recent studies have indicated that HF hospitalization rates began to decline in the 1990s in Sweden, Scotland, Australia, and New Zealand, they added.

As an observational cohort study, this study was unable to determine the reasons for the marked decline in HF hospitalization and the more modest decline in HF mortality. However, the investigators speculated that improvements in underlying coronary artery disease, myocardial salvage after MI, and blood pressure control all may have played a role.

Improvements in secondary prevention also likely reduced HF exacerbations leading to hospitalization, including greater use of beta-blockers, ACE inhibitors, and angiotensin receptor blockers. In addition, clinical practice patterns may have changed, favoring outpatient rather than inpatient management of HF.

This study was limited in that it included only Medicare patients. "Trends in HF hospitalization and mortality may differ in younger patients with different types of insurance," Dr. Chen and his associates said.

The study was supported by the Agency for Healthcare Research and Quality and the National Heart, Lung, and Blood Institute. Dr. Chen’s associates reported ties to United Healthcare and Medtronic.

A new assay that is highly sensitive and specific for detecting all members of the Helicobacteraceae family found none of the bacteria in 78 specimens of hyperplastic adenoids, according to a report in the October issue of the Archives of Otolaryngology – Head & Neck Surgery.

"We believe that our findings show that adenoid tissue does not serve as a reservoir for species of the Helicobacteraceae family. This suggests that colonization of the tissue by these bacteria is not a factor contributing to adenoid hyperplasia," said Damian J. Hussey, Ph.D., of the department of surgery, Flinders Medical Center, Adelaide (Australia), and his associates.

When other researchers found evidence that gastric contents could reach the middle ear via the nasopharynx and eustachian tubes, it was hypothesized that gastroesophageal or laryngopharyngeal reflux might cause inflammatory changes that could eventually lead to adenoid hyperplasia. There have been several reports that H. pylori was detected in hyperplastic adenoids in children, but the detection rate has been extremely variable.

This is most likely because different methods of detection were used in each case, because until now no single method of identifying H. pylori in this tissue has proved to be very accurate, the investigators said.

Dr. Hussey and his colleagues developed a highly sensitive and specific reverse transcription–polymerase chain reaction (PCR) assay to detect all Helicobacter organisms. Their assay is capable of detecting the equivalent of a single Helicobacteraceae bacterium within a sample.

They then tested the assay in 78 biopsy specimens taken from children aged 2-10 years who underwent adenoidectomy for sleep-disordered breathing at two pediatric hospitals in Adelaide. They also examined specimens of normal adenoids collected from 15 children undergoing routine dental surgical procedures.

The assay readily detected H. pylori in positive control samples, but did not detect H. pylori in any of the hyperplastic or normal adenoid samples. One organism – Candidatus Wolinella africanus – was the only Helicobacteraceae family member identified, and it was found in only one hyperplastic adenoid (Arch. Otolaryngol. Head and Neck Surg. 2011;137:998-1004).

In addition, an experienced histopathologist who was blinded to the assay results examined a subset of 27 tissue samples to identify any micro-organisms that might have been present. "Special attention was paid to the crypts of the epithelium because this is where H. pylori is often detected in gastric biopsy specimens," the researchers noted.

Overall, "we found surprisingly few bacteria in our hyperplastic adenoid specimens." Only two rod-like bacterial organisms were detected in a single specimen, and they were not consistent with H. pylori.

"We conclude that H. pylori and other Helicobacteraceae family members are not major contributors to the development of hyperplastic adenoids in children," Dr. Hussey and his associates said.

"However, the detection of Candidatus W. africanus in a hyperplastic adenoid sample indicates that gastric contents can reach the adenoid, so occasional reflux episodes may form part of the pathophysiologic characteristics of this disease."

This study was supported in part by the Channel 7 Children’s Research Foundation. No financial conflicts of interest were reported.

A new assay that is highly sensitive and specific for detecting all members of the Helicobacteraceae family found none of the bacteria in 78 specimens of hyperplastic adenoids, according to a report in the October issue of the Archives of Otolaryngology – Head & Neck Surgery.

"We believe that our findings show that adenoid tissue does not serve as a reservoir for species of the Helicobacteraceae family. This suggests that colonization of the tissue by these bacteria is not a factor contributing to adenoid hyperplasia," said Damian J. Hussey, Ph.D., of the department of surgery, Flinders Medical Center, Adelaide (Australia), and his associates.

When other researchers found evidence that gastric contents could reach the middle ear via the nasopharynx and eustachian tubes, it was hypothesized that gastroesophageal or laryngopharyngeal reflux might cause inflammatory changes that could eventually lead to adenoid hyperplasia. There have been several reports that H. pylori was detected in hyperplastic adenoids in children, but the detection rate has been extremely variable.

This is most likely because different methods of detection were used in each case, because until now no single method of identifying H. pylori in this tissue has proved to be very accurate, the investigators said.

Dr. Hussey and his colleagues developed a highly sensitive and specific reverse transcription–polymerase chain reaction (PCR) assay to detect all Helicobacter organisms. Their assay is capable of detecting the equivalent of a single Helicobacteraceae bacterium within a sample.

They then tested the assay in 78 biopsy specimens taken from children aged 2-10 years who underwent adenoidectomy for sleep-disordered breathing at two pediatric hospitals in Adelaide. They also examined specimens of normal adenoids collected from 15 children undergoing routine dental surgical procedures.

The assay readily detected H. pylori in positive control samples, but did not detect H. pylori in any of the hyperplastic or normal adenoid samples. One organism – Candidatus Wolinella africanus – was the only Helicobacteraceae family member identified, and it was found in only one hyperplastic adenoid (Arch. Otolaryngol. Head and Neck Surg. 2011;137:998-1004).

In addition, an experienced histopathologist who was blinded to the assay results examined a subset of 27 tissue samples to identify any micro-organisms that might have been present. "Special attention was paid to the crypts of the epithelium because this is where H. pylori is often detected in gastric biopsy specimens," the researchers noted.

Overall, "we found surprisingly few bacteria in our hyperplastic adenoid specimens." Only two rod-like bacterial organisms were detected in a single specimen, and they were not consistent with H. pylori.

"We conclude that H. pylori and other Helicobacteraceae family members are not major contributors to the development of hyperplastic adenoids in children," Dr. Hussey and his associates said.

"However, the detection of Candidatus W. africanus in a hyperplastic adenoid sample indicates that gastric contents can reach the adenoid, so occasional reflux episodes may form part of the pathophysiologic characteristics of this disease."

This study was supported in part by the Channel 7 Children’s Research Foundation. No financial conflicts of interest were reported.

A new assay that is highly sensitive and specific for detecting all members of the Helicobacteraceae family found none of the bacteria in 78 specimens of hyperplastic adenoids, according to a report in the October issue of the Archives of Otolaryngology – Head & Neck Surgery.

"We believe that our findings show that adenoid tissue does not serve as a reservoir for species of the Helicobacteraceae family. This suggests that colonization of the tissue by these bacteria is not a factor contributing to adenoid hyperplasia," said Damian J. Hussey, Ph.D., of the department of surgery, Flinders Medical Center, Adelaide (Australia), and his associates.

When other researchers found evidence that gastric contents could reach the middle ear via the nasopharynx and eustachian tubes, it was hypothesized that gastroesophageal or laryngopharyngeal reflux might cause inflammatory changes that could eventually lead to adenoid hyperplasia. There have been several reports that H. pylori was detected in hyperplastic adenoids in children, but the detection rate has been extremely variable.

This is most likely because different methods of detection were used in each case, because until now no single method of identifying H. pylori in this tissue has proved to be very accurate, the investigators said.

Dr. Hussey and his colleagues developed a highly sensitive and specific reverse transcription–polymerase chain reaction (PCR) assay to detect all Helicobacter organisms. Their assay is capable of detecting the equivalent of a single Helicobacteraceae bacterium within a sample.

They then tested the assay in 78 biopsy specimens taken from children aged 2-10 years who underwent adenoidectomy for sleep-disordered breathing at two pediatric hospitals in Adelaide. They also examined specimens of normal adenoids collected from 15 children undergoing routine dental surgical procedures.

The assay readily detected H. pylori in positive control samples, but did not detect H. pylori in any of the hyperplastic or normal adenoid samples. One organism – Candidatus Wolinella africanus – was the only Helicobacteraceae family member identified, and it was found in only one hyperplastic adenoid (Arch. Otolaryngol. Head and Neck Surg. 2011;137:998-1004).

In addition, an experienced histopathologist who was blinded to the assay results examined a subset of 27 tissue samples to identify any micro-organisms that might have been present. "Special attention was paid to the crypts of the epithelium because this is where H. pylori is often detected in gastric biopsy specimens," the researchers noted.

Overall, "we found surprisingly few bacteria in our hyperplastic adenoid specimens." Only two rod-like bacterial organisms were detected in a single specimen, and they were not consistent with H. pylori.

"We conclude that H. pylori and other Helicobacteraceae family members are not major contributors to the development of hyperplastic adenoids in children," Dr. Hussey and his associates said.

"However, the detection of Candidatus W. africanus in a hyperplastic adenoid sample indicates that gastric contents can reach the adenoid, so occasional reflux episodes may form part of the pathophysiologic characteristics of this disease."

This study was supported in part by the Channel 7 Children’s Research Foundation. No financial conflicts of interest were reported.

Bariatric surgery appears to exert a favorable influence on family members of the recipient, leading to weight loss, healthier eating habits, and greater activity levels among adults and children residing with the patient, according to results from a prospective, longitudinal study in the October Archives of Surgery.

"Previous studies have shown that obesity may be a social contagion and that by associating with obese individuals, a person is more likely to become obese. Our study may demonstrate that bariatric surgery in selected populations can provide a reverse corollary and induce weight loss and healthy behaviors in people surrounding the patient," Dr. Gavitt A. Woodard said.

Dr. Woodard and her associates at Stanford (Calif.) University assessed weight and lifestyle changes in spouses, parents, and children residing with patients during the year after the patients underwent Roux-en-Y gastric bypass surgery. They enrolled 35 families, including 35 patients, 26 spouses, 3 grandparents, 6 adult children, and 15 children younger than age 18 years during a 2-year period.

Patients and family members were required to attend three preoperative educational sessions and five postoperative visits in which lifestyle modification was emphasized. A high-protein, high-fiber, low-fat, low-sugar diet was recommended for the patients, which advised six small daily meals comprising 200-300 calories and including 4-6 ounces of protein.

Lifestyle modification included daily goals of increased physical activity (10,000 steps per day), 8 hours of sleep, moderation of alcohol intake, and avoidance of watching more than 2 hours of television.

After 1 year, the study subjects were evaluated by a physical examination as well as a battery of validated questionnaires assessing overall health, physical activity, sleep, risk behaviors, television viewing, alcohol consumption, and quality of life.

The gastric bypass patients lost weight as expected.

The mean weight of adult family members declined from 220 to 198 pounds, which was not statistically significant. However, when the family members were categorized by their own baseline weight, significant differences emerged.

"Bariatric surgery provides an opportunity for intervention for many individuals beyond the patient."

Obese adult family members showed significant weight loss, from a mean of 234 to 226 pounds. Nonobese adult family members showed a nonsignificant weight loss from 180 to 176 pounds. This pattern held true for decreases in body mass index as well.

The pattern also was the same for waist circumference, with obese adult family members showing a significant decrease from a mean of 119 cm to 111 cm and nonobese adult family members showing no change in waist circumference.

According to these findings, obese adult family members lost 3% of their total weight in 1 year, which falls within the range of a 2%-5% weight loss reported for people following the Atkins, Zone, Ornish, or LEARN diets. "Living with a gastric bypass patient and undertaking a structured diet plan along with the patient may have an equivalent effect on weight," the investigators said (Arch. Surg. 2011;146:1185-90).

Children were analyzed separately because of the expectation that their weight and waist circumference would increase due to natural growth.

Given the growth trajectories documented in their medical charts, obese children actually showed a smaller increase in BMI (29.6) than was expected (31.2). Nonobese children showed a slightly larger increase in BMI (19.8) than was expected (18.8).

As with the adults, children who were obese showed a significant reduction in waist circumference, from 119 cm to 111 cm, but nonobese children did not show any change in waist circumference.

Patients and their adult family members showed significant changes in their eating habits. Both groups had marked decreases in "uncontrolled eating" and in "emotional eating." In addition, patients, but not their relatives, showed significantly increased "cognitive control of eating."

However, children showed no changes in these measures. And neither adult family members nor children changed their food choices or decreased their intake of carbohydrates or junk food, while patients did achieve these goals.

Yet there was a significant increase in the percentage of children who reported that they were "on a diet," from 25% at baseline to 50% at 1 year.

Patients and their adult family members reported significant declines in alcohol consumption, from 5 to 0.2 drinks per month among patients and from 11 to 0.8 drinks per month among adult family members.

Patients, adult relatives, and children all showed significant gains in daily activity levels. Children also decreased the amount of time they spent watching TV or using a computer every day, although this reduction did not reach statistical significance.

Overall, the study findings indicate that "bariatric surgery provides an opportunity for intervention for many individuals beyond the patient," Dr. Woodard and her associates said.

This study was supported by the Medical Scholars Program at Stanford University. No financial conflicts of interest were reported.

Bariatric surgery appears to exert a favorable influence on family members of the recipient, leading to weight loss, healthier eating habits, and greater activity levels among adults and children residing with the patient, according to results from a prospective, longitudinal study in the October Archives of Surgery.

"Previous studies have shown that obesity may be a social contagion and that by associating with obese individuals, a person is more likely to become obese. Our study may demonstrate that bariatric surgery in selected populations can provide a reverse corollary and induce weight loss and healthy behaviors in people surrounding the patient," Dr. Gavitt A. Woodard said.

Dr. Woodard and her associates at Stanford (Calif.) University assessed weight and lifestyle changes in spouses, parents, and children residing with patients during the year after the patients underwent Roux-en-Y gastric bypass surgery. They enrolled 35 families, including 35 patients, 26 spouses, 3 grandparents, 6 adult children, and 15 children younger than age 18 years during a 2-year period.

Patients and family members were required to attend three preoperative educational sessions and five postoperative visits in which lifestyle modification was emphasized. A high-protein, high-fiber, low-fat, low-sugar diet was recommended for the patients, which advised six small daily meals comprising 200-300 calories and including 4-6 ounces of protein.

Lifestyle modification included daily goals of increased physical activity (10,000 steps per day), 8 hours of sleep, moderation of alcohol intake, and avoidance of watching more than 2 hours of television.

After 1 year, the study subjects were evaluated by a physical examination as well as a battery of validated questionnaires assessing overall health, physical activity, sleep, risk behaviors, television viewing, alcohol consumption, and quality of life.

The gastric bypass patients lost weight as expected.

The mean weight of adult family members declined from 220 to 198 pounds, which was not statistically significant. However, when the family members were categorized by their own baseline weight, significant differences emerged.

"Bariatric surgery provides an opportunity for intervention for many individuals beyond the patient."

Obese adult family members showed significant weight loss, from a mean of 234 to 226 pounds. Nonobese adult family members showed a nonsignificant weight loss from 180 to 176 pounds. This pattern held true for decreases in body mass index as well.

The pattern also was the same for waist circumference, with obese adult family members showing a significant decrease from a mean of 119 cm to 111 cm and nonobese adult family members showing no change in waist circumference.

According to these findings, obese adult family members lost 3% of their total weight in 1 year, which falls within the range of a 2%-5% weight loss reported for people following the Atkins, Zone, Ornish, or LEARN diets. "Living with a gastric bypass patient and undertaking a structured diet plan along with the patient may have an equivalent effect on weight," the investigators said (Arch. Surg. 2011;146:1185-90).

Children were analyzed separately because of the expectation that their weight and waist circumference would increase due to natural growth.

Given the growth trajectories documented in their medical charts, obese children actually showed a smaller increase in BMI (29.6) than was expected (31.2). Nonobese children showed a slightly larger increase in BMI (19.8) than was expected (18.8).

As with the adults, children who were obese showed a significant reduction in waist circumference, from 119 cm to 111 cm, but nonobese children did not show any change in waist circumference.

Patients and their adult family members showed significant changes in their eating habits. Both groups had marked decreases in "uncontrolled eating" and in "emotional eating." In addition, patients, but not their relatives, showed significantly increased "cognitive control of eating."

However, children showed no changes in these measures. And neither adult family members nor children changed their food choices or decreased their intake of carbohydrates or junk food, while patients did achieve these goals.

Yet there was a significant increase in the percentage of children who reported that they were "on a diet," from 25% at baseline to 50% at 1 year.

Patients and their adult family members reported significant declines in alcohol consumption, from 5 to 0.2 drinks per month among patients and from 11 to 0.8 drinks per month among adult family members.

Patients, adult relatives, and children all showed significant gains in daily activity levels. Children also decreased the amount of time they spent watching TV or using a computer every day, although this reduction did not reach statistical significance.

Overall, the study findings indicate that "bariatric surgery provides an opportunity for intervention for many individuals beyond the patient," Dr. Woodard and her associates said.

This study was supported by the Medical Scholars Program at Stanford University. No financial conflicts of interest were reported.

Bariatric surgery appears to exert a favorable influence on family members of the recipient, leading to weight loss, healthier eating habits, and greater activity levels among adults and children residing with the patient, according to results from a prospective, longitudinal study in the October Archives of Surgery.

"Previous studies have shown that obesity may be a social contagion and that by associating with obese individuals, a person is more likely to become obese. Our study may demonstrate that bariatric surgery in selected populations can provide a reverse corollary and induce weight loss and healthy behaviors in people surrounding the patient," Dr. Gavitt A. Woodard said.

Dr. Woodard and her associates at Stanford (Calif.) University assessed weight and lifestyle changes in spouses, parents, and children residing with patients during the year after the patients underwent Roux-en-Y gastric bypass surgery. They enrolled 35 families, including 35 patients, 26 spouses, 3 grandparents, 6 adult children, and 15 children younger than age 18 years during a 2-year period.

Patients and family members were required to attend three preoperative educational sessions and five postoperative visits in which lifestyle modification was emphasized. A high-protein, high-fiber, low-fat, low-sugar diet was recommended for the patients, which advised six small daily meals comprising 200-300 calories and including 4-6 ounces of protein.

Lifestyle modification included daily goals of increased physical activity (10,000 steps per day), 8 hours of sleep, moderation of alcohol intake, and avoidance of watching more than 2 hours of television.

After 1 year, the study subjects were evaluated by a physical examination as well as a battery of validated questionnaires assessing overall health, physical activity, sleep, risk behaviors, television viewing, alcohol consumption, and quality of life.

The gastric bypass patients lost weight as expected.

The mean weight of adult family members declined from 220 to 198 pounds, which was not statistically significant. However, when the family members were categorized by their own baseline weight, significant differences emerged.

"Bariatric surgery provides an opportunity for intervention for many individuals beyond the patient."

Obese adult family members showed significant weight loss, from a mean of 234 to 226 pounds. Nonobese adult family members showed a nonsignificant weight loss from 180 to 176 pounds. This pattern held true for decreases in body mass index as well.

The pattern also was the same for waist circumference, with obese adult family members showing a significant decrease from a mean of 119 cm to 111 cm and nonobese adult family members showing no change in waist circumference.

According to these findings, obese adult family members lost 3% of their total weight in 1 year, which falls within the range of a 2%-5% weight loss reported for people following the Atkins, Zone, Ornish, or LEARN diets. "Living with a gastric bypass patient and undertaking a structured diet plan along with the patient may have an equivalent effect on weight," the investigators said (Arch. Surg. 2011;146:1185-90).

Children were analyzed separately because of the expectation that their weight and waist circumference would increase due to natural growth.

Given the growth trajectories documented in their medical charts, obese children actually showed a smaller increase in BMI (29.6) than was expected (31.2). Nonobese children showed a slightly larger increase in BMI (19.8) than was expected (18.8).

As with the adults, children who were obese showed a significant reduction in waist circumference, from 119 cm to 111 cm, but nonobese children did not show any change in waist circumference.

Patients and their adult family members showed significant changes in their eating habits. Both groups had marked decreases in "uncontrolled eating" and in "emotional eating." In addition, patients, but not their relatives, showed significantly increased "cognitive control of eating."

However, children showed no changes in these measures. And neither adult family members nor children changed their food choices or decreased their intake of carbohydrates or junk food, while patients did achieve these goals.

Yet there was a significant increase in the percentage of children who reported that they were "on a diet," from 25% at baseline to 50% at 1 year.

Patients and their adult family members reported significant declines in alcohol consumption, from 5 to 0.2 drinks per month among patients and from 11 to 0.8 drinks per month among adult family members.

Patients, adult relatives, and children all showed significant gains in daily activity levels. Children also decreased the amount of time they spent watching TV or using a computer every day, although this reduction did not reach statistical significance.

Overall, the study findings indicate that "bariatric surgery provides an opportunity for intervention for many individuals beyond the patient," Dr. Woodard and her associates said.

This study was supported by the Medical Scholars Program at Stanford University. No financial conflicts of interest were reported.

An adjuvant trivalent inactivated influenza vaccine in an oil-and-water emulsion that augments the immune response was found effective in a field trial of 4,707 German and Finnish children, according to a report in the Oct. 13 issue of the New England Journal of Medicine.

The novel vaccine showed 86% efficacy against all circulating viral strains of influenza during the 2 years of the trial, and 89% efficacy against vaccine-matched strains. In contrast, efficacy rates for the standard trivalent inactivated flu vaccine, which is known to be poorly immunogenic in children, were 43% and 45%, respectively, said Dr. Timo Vesikari of the University of Tampere (Finland) and his associates.

The oil-in-water emulsion (MF59), which enhances the immune response when combined with vaccine antigens, has been used since 1997 in the influenza vaccine for older adults, and has been licensed in 27 countries. In an earlier study, Dr. Vesikari and his colleagues reported that it induced a greater immune response in children aged 6-36 months than did the standard vaccine formulation.

They now report the results of a phase III trial in 654 children in Germany in year 1, as well as 2,104 children in Germany and 1,949 in Finland during year 2. These study subjects were aged 6-71 months of age.

The study participants were randomly assigned to one of three groups: the novel vaccine group (1,941 patients), those receiving the standard subunit trivalent inactivated vaccine that is poorly immunogenic in children (1,773 patients), or a control group receiving noninfluenza vaccine (993 patients).

The vaccines were administered in two doses, 1 month apart.

The absolute efficacy of the novel vaccine for both influenza seasons was 86% against all strains and 89% against vaccine-matched strains and the influenza A(H3N2) virus. In contrast, the standard vaccine had an efficacy of 43% against all strains and 45% against vaccine-matched strains and the H3N2 virus.

When the data were broken down by patient age, the novel vaccine showed efficacy against 64% of all strains and 68% of matched strains among children aged 6-35 months, and against 86% of all strains and 91% of matched strains among children aged 36-71 months, the investigators said (N. Engl. J. Med. 2011;365:1406-16).

Moreover, the study subjects frequently showed an immune response after only the first dose of the novel vaccine, but not so with the standard or control vaccines.

At ages 6-35 months, rates of seroprotection against influenza A(H1N1) and H3N2 strains after one dose were 92% and 95%, respectively, with the novel vaccine. The corresponding rates of seroprotection after one dose of the standard vaccine were only 20% and 12%, respectively.

In children aged 36-71 months of age, these proportions after one dose were 100% and 97% for the novel vaccine, compared with 63% and 60% for the standard vaccine.

Vaccine-related adverse events were generally mild to moderate and were similar across the three vaccine groups in the younger patients. In older patients aged 36-71 months, "systemic reactions, including mild fever, were slightly more frequent after receipt of the [novel] vaccine, as compared with the other vaccines, but these reactions were mostly mild and of short duration," Dr. Vesikari and his associates said.

In all, 13 children were withdrawn from the study because of serious adverse events, which were distributed evenly across the three study groups.

This study was funded by Novartis Vaccines. Novartis employees also designed and conducted the study and analyzed the data. Dr. Vesikari and his associates reported ties to Astra Zeneca, GlaxoSmithKline, MedImmune, Merck, Pfizer, Sanofi Pasteur, SPMSD, and Wyeth.

An adjuvant trivalent inactivated influenza vaccine in an oil-and-water emulsion that augments the immune response was found effective in a field trial of 4,707 German and Finnish children, according to a report in the Oct. 13 issue of the New England Journal of Medicine.

The novel vaccine showed 86% efficacy against all circulating viral strains of influenza during the 2 years of the trial, and 89% efficacy against vaccine-matched strains. In contrast, efficacy rates for the standard trivalent inactivated flu vaccine, which is known to be poorly immunogenic in children, were 43% and 45%, respectively, said Dr. Timo Vesikari of the University of Tampere (Finland) and his associates.

The oil-in-water emulsion (MF59), which enhances the immune response when combined with vaccine antigens, has been used since 1997 in the influenza vaccine for older adults, and has been licensed in 27 countries. In an earlier study, Dr. Vesikari and his colleagues reported that it induced a greater immune response in children aged 6-36 months than did the standard vaccine formulation.

They now report the results of a phase III trial in 654 children in Germany in year 1, as well as 2,104 children in Germany and 1,949 in Finland during year 2. These study subjects were aged 6-71 months of age.

The study participants were randomly assigned to one of three groups: the novel vaccine group (1,941 patients), those receiving the standard subunit trivalent inactivated vaccine that is poorly immunogenic in children (1,773 patients), or a control group receiving noninfluenza vaccine (993 patients).

The vaccines were administered in two doses, 1 month apart.

The absolute efficacy of the novel vaccine for both influenza seasons was 86% against all strains and 89% against vaccine-matched strains and the influenza A(H3N2) virus. In contrast, the standard vaccine had an efficacy of 43% against all strains and 45% against vaccine-matched strains and the H3N2 virus.

When the data were broken down by patient age, the novel vaccine showed efficacy against 64% of all strains and 68% of matched strains among children aged 6-35 months, and against 86% of all strains and 91% of matched strains among children aged 36-71 months, the investigators said (N. Engl. J. Med. 2011;365:1406-16).

Moreover, the study subjects frequently showed an immune response after only the first dose of the novel vaccine, but not so with the standard or control vaccines.

At ages 6-35 months, rates of seroprotection against influenza A(H1N1) and H3N2 strains after one dose were 92% and 95%, respectively, with the novel vaccine. The corresponding rates of seroprotection after one dose of the standard vaccine were only 20% and 12%, respectively.

In children aged 36-71 months of age, these proportions after one dose were 100% and 97% for the novel vaccine, compared with 63% and 60% for the standard vaccine.

Vaccine-related adverse events were generally mild to moderate and were similar across the three vaccine groups in the younger patients. In older patients aged 36-71 months, "systemic reactions, including mild fever, were slightly more frequent after receipt of the [novel] vaccine, as compared with the other vaccines, but these reactions were mostly mild and of short duration," Dr. Vesikari and his associates said.

In all, 13 children were withdrawn from the study because of serious adverse events, which were distributed evenly across the three study groups.

This study was funded by Novartis Vaccines. Novartis employees also designed and conducted the study and analyzed the data. Dr. Vesikari and his associates reported ties to Astra Zeneca, GlaxoSmithKline, MedImmune, Merck, Pfizer, Sanofi Pasteur, SPMSD, and Wyeth.

An adjuvant trivalent inactivated influenza vaccine in an oil-and-water emulsion that augments the immune response was found effective in a field trial of 4,707 German and Finnish children, according to a report in the Oct. 13 issue of the New England Journal of Medicine.

The novel vaccine showed 86% efficacy against all circulating viral strains of influenza during the 2 years of the trial, and 89% efficacy against vaccine-matched strains. In contrast, efficacy rates for the standard trivalent inactivated flu vaccine, which is known to be poorly immunogenic in children, were 43% and 45%, respectively, said Dr. Timo Vesikari of the University of Tampere (Finland) and his associates.

The oil-in-water emulsion (MF59), which enhances the immune response when combined with vaccine antigens, has been used since 1997 in the influenza vaccine for older adults, and has been licensed in 27 countries. In an earlier study, Dr. Vesikari and his colleagues reported that it induced a greater immune response in children aged 6-36 months than did the standard vaccine formulation.

They now report the results of a phase III trial in 654 children in Germany in year 1, as well as 2,104 children in Germany and 1,949 in Finland during year 2. These study subjects were aged 6-71 months of age.

The study participants were randomly assigned to one of three groups: the novel vaccine group (1,941 patients), those receiving the standard subunit trivalent inactivated vaccine that is poorly immunogenic in children (1,773 patients), or a control group receiving noninfluenza vaccine (993 patients).

The vaccines were administered in two doses, 1 month apart.

The absolute efficacy of the novel vaccine for both influenza seasons was 86% against all strains and 89% against vaccine-matched strains and the influenza A(H3N2) virus. In contrast, the standard vaccine had an efficacy of 43% against all strains and 45% against vaccine-matched strains and the H3N2 virus.

When the data were broken down by patient age, the novel vaccine showed efficacy against 64% of all strains and 68% of matched strains among children aged 6-35 months, and against 86% of all strains and 91% of matched strains among children aged 36-71 months, the investigators said (N. Engl. J. Med. 2011;365:1406-16).

Moreover, the study subjects frequently showed an immune response after only the first dose of the novel vaccine, but not so with the standard or control vaccines.

At ages 6-35 months, rates of seroprotection against influenza A(H1N1) and H3N2 strains after one dose were 92% and 95%, respectively, with the novel vaccine. The corresponding rates of seroprotection after one dose of the standard vaccine were only 20% and 12%, respectively.

In children aged 36-71 months of age, these proportions after one dose were 100% and 97% for the novel vaccine, compared with 63% and 60% for the standard vaccine.

Vaccine-related adverse events were generally mild to moderate and were similar across the three vaccine groups in the younger patients. In older patients aged 36-71 months, "systemic reactions, including mild fever, were slightly more frequent after receipt of the [novel] vaccine, as compared with the other vaccines, but these reactions were mostly mild and of short duration," Dr. Vesikari and his associates said.

In all, 13 children were withdrawn from the study because of serious adverse events, which were distributed evenly across the three study groups.

This study was funded by Novartis Vaccines. Novartis employees also designed and conducted the study and analyzed the data. Dr. Vesikari and his associates reported ties to Astra Zeneca, GlaxoSmithKline, MedImmune, Merck, Pfizer, Sanofi Pasteur, SPMSD, and Wyeth.

The incidence of esophageal adenocarcinoma among patients with Barrett’s esophagus was only 1.2 cases per 1,000 person-years in a study of the entire population of Denmark reported in the Oct. 13 issue of the New England Journal of Medicine.

That rate is four to five times lower than rates reported previously, said Dr. Frederik Hvid-Jensen of the department of surgical gastroenterology at Aarhus (Denmark) University and his associates.

"Our study provides solid evidence that esophageal adenocarcinoma will develop in very few patients with Barrett’s esophagus. Together with another recent study, as well as studies of cost-effectiveness and patients’ quality of life, the results of our study suggest that the risk of esophageal adenocarcinoma among patients with Barrett’s esophagus is so minor that in the absence of dysplasia, routine surveillance of such patients is of doubtful value," the investigators said.

The relevance of such surveillance programs has been questioned before because they have never been shown to improve survival and because an estimated 95% of patients with a new diagnosis of esophageal adenocarcinoma do not have a previous diagnosis of Barrett’s esophagus, they noted.

Dr. Hvid-Jensen and his colleagues used data from Denmark’s nationwide pathology and cancer registries to calculate the incidence of adenocarcinoma among patients with Barrett’s esophagus and compare it with the expected incidence in the general population of 5.4 million people.

A total of 11,028 patients underwent endoscopic biopsy and received a diagnosis of Barrett’s esophagus during 1992-2009. The median age at baseline was 63 years, and patients were followed for a median of 5.2 years.

"Our study provides solid evidence that esophageal adenocarcinoma will develop in very few patients with Barrett’s esophagus."

During that time, 197 of these patients with Barrett’s esophagus developed new esophageal adenocarcinomas, which comprised 7.6% of all the 2,602 incident esophageal adenocarcinomas diagnosed in the general Danish population during 1992-2009.

After excluding cancer cases that developed in the first year after a diagnosis of Barrett’s esophagus, the incidence of esophageal adenocarcinoma among patients with Barrett’s esophagus was found to be 1.2 cases per 1,000 person-years, the investigators said (N. Engl. J. Med. 2011;365:1375-83).

The annual risk of developing the malignancy was 0.12%, or one case of adenocarcinoma per 860 patient-years.

In contrast, four reviews of the literature published in the past decade, which pooled the results of numerous small studies conducted in the United States and Europe, calculated esophageal adenocarcinoma incidence as ranging from 5.2 to 7.0 cases per 1,000 person-years. And two previous registry studies calculated incidences of 4.0 and 5.0 cases per 1,000 person-years.

Current surveillance guidelines are based on these earlier studies, which appear to have overstated the risks, Dr. Hvid-Jensen and his associates said.

Their population-based, nationwide study is one of the largest studies of the issue; it included patients of all ages and both sexes and had almost no loss to follow-up. Because of Denmark’s universal health care plan, this study also had no referral bias or diagnostic bias. "The generalizability of our results is therefore high," they noted.

Moreover, a recent population-based study in Northern Ireland found remarkably similar results: an incidence of 1.3 cases of esophageal adenocarcinoma per 1,000 patient-years among people with Barrett’s esophagus. And another recent study "in which Markov models were used to evaluate available data on the incidence of adenocarcinoma supports our findings ... [and suggests] that surveillance is not beneficial," the researchers added.

This study was supported by the University of Aarhus Clinical Institute. No financial conflicts of interest were reported.

The incidence of esophageal adenocarcinoma among patients with Barrett’s esophagus was only 1.2 cases per 1,000 person-years in a study of the entire population of Denmark reported in the Oct. 13 issue of the New England Journal of Medicine.

That rate is four to five times lower than rates reported previously, said Dr. Frederik Hvid-Jensen of the department of surgical gastroenterology at Aarhus (Denmark) University and his associates.

"Our study provides solid evidence that esophageal adenocarcinoma will develop in very few patients with Barrett’s esophagus. Together with another recent study, as well as studies of cost-effectiveness and patients’ quality of life, the results of our study suggest that the risk of esophageal adenocarcinoma among patients with Barrett’s esophagus is so minor that in the absence of dysplasia, routine surveillance of such patients is of doubtful value," the investigators said.

The relevance of such surveillance programs has been questioned before because they have never been shown to improve survival and because an estimated 95% of patients with a new diagnosis of esophageal adenocarcinoma do not have a previous diagnosis of Barrett’s esophagus, they noted.

Dr. Hvid-Jensen and his colleagues used data from Denmark’s nationwide pathology and cancer registries to calculate the incidence of adenocarcinoma among patients with Barrett’s esophagus and compare it with the expected incidence in the general population of 5.4 million people.

A total of 11,028 patients underwent endoscopic biopsy and received a diagnosis of Barrett’s esophagus during 1992-2009. The median age at baseline was 63 years, and patients were followed for a median of 5.2 years.

"Our study provides solid evidence that esophageal adenocarcinoma will develop in very few patients with Barrett’s esophagus."

During that time, 197 of these patients with Barrett’s esophagus developed new esophageal adenocarcinomas, which comprised 7.6% of all the 2,602 incident esophageal adenocarcinomas diagnosed in the general Danish population during 1992-2009.

After excluding cancer cases that developed in the first year after a diagnosis of Barrett’s esophagus, the incidence of esophageal adenocarcinoma among patients with Barrett’s esophagus was found to be 1.2 cases per 1,000 person-years, the investigators said (N. Engl. J. Med. 2011;365:1375-83).

The annual risk of developing the malignancy was 0.12%, or one case of adenocarcinoma per 860 patient-years.

In contrast, four reviews of the literature published in the past decade, which pooled the results of numerous small studies conducted in the United States and Europe, calculated esophageal adenocarcinoma incidence as ranging from 5.2 to 7.0 cases per 1,000 person-years. And two previous registry studies calculated incidences of 4.0 and 5.0 cases per 1,000 person-years.

Current surveillance guidelines are based on these earlier studies, which appear to have overstated the risks, Dr. Hvid-Jensen and his associates said.

Their population-based, nationwide study is one of the largest studies of the issue; it included patients of all ages and both sexes and had almost no loss to follow-up. Because of Denmark’s universal health care plan, this study also had no referral bias or diagnostic bias. "The generalizability of our results is therefore high," they noted.

Moreover, a recent population-based study in Northern Ireland found remarkably similar results: an incidence of 1.3 cases of esophageal adenocarcinoma per 1,000 patient-years among people with Barrett’s esophagus. And another recent study "in which Markov models were used to evaluate available data on the incidence of adenocarcinoma supports our findings ... [and suggests] that surveillance is not beneficial," the researchers added.

This study was supported by the University of Aarhus Clinical Institute. No financial conflicts of interest were reported.

The incidence of esophageal adenocarcinoma among patients with Barrett’s esophagus was only 1.2 cases per 1,000 person-years in a study of the entire population of Denmark reported in the Oct. 13 issue of the New England Journal of Medicine.

That rate is four to five times lower than rates reported previously, said Dr. Frederik Hvid-Jensen of the department of surgical gastroenterology at Aarhus (Denmark) University and his associates.

"Our study provides solid evidence that esophageal adenocarcinoma will develop in very few patients with Barrett’s esophagus. Together with another recent study, as well as studies of cost-effectiveness and patients’ quality of life, the results of our study suggest that the risk of esophageal adenocarcinoma among patients with Barrett’s esophagus is so minor that in the absence of dysplasia, routine surveillance of such patients is of doubtful value," the investigators said.

The relevance of such surveillance programs has been questioned before because they have never been shown to improve survival and because an estimated 95% of patients with a new diagnosis of esophageal adenocarcinoma do not have a previous diagnosis of Barrett’s esophagus, they noted.

Dr. Hvid-Jensen and his colleagues used data from Denmark’s nationwide pathology and cancer registries to calculate the incidence of adenocarcinoma among patients with Barrett’s esophagus and compare it with the expected incidence in the general population of 5.4 million people.

A total of 11,028 patients underwent endoscopic biopsy and received a diagnosis of Barrett’s esophagus during 1992-2009. The median age at baseline was 63 years, and patients were followed for a median of 5.2 years.

"Our study provides solid evidence that esophageal adenocarcinoma will develop in very few patients with Barrett’s esophagus."

During that time, 197 of these patients with Barrett’s esophagus developed new esophageal adenocarcinomas, which comprised 7.6% of all the 2,602 incident esophageal adenocarcinomas diagnosed in the general Danish population during 1992-2009.

After excluding cancer cases that developed in the first year after a diagnosis of Barrett’s esophagus, the incidence of esophageal adenocarcinoma among patients with Barrett’s esophagus was found to be 1.2 cases per 1,000 person-years, the investigators said (N. Engl. J. Med. 2011;365:1375-83).

The annual risk of developing the malignancy was 0.12%, or one case of adenocarcinoma per 860 patient-years.

In contrast, four reviews of the literature published in the past decade, which pooled the results of numerous small studies conducted in the United States and Europe, calculated esophageal adenocarcinoma incidence as ranging from 5.2 to 7.0 cases per 1,000 person-years. And two previous registry studies calculated incidences of 4.0 and 5.0 cases per 1,000 person-years.

Current surveillance guidelines are based on these earlier studies, which appear to have overstated the risks, Dr. Hvid-Jensen and his associates said.

Their population-based, nationwide study is one of the largest studies of the issue; it included patients of all ages and both sexes and had almost no loss to follow-up. Because of Denmark’s universal health care plan, this study also had no referral bias or diagnostic bias. "The generalizability of our results is therefore high," they noted.

Moreover, a recent population-based study in Northern Ireland found remarkably similar results: an incidence of 1.3 cases of esophageal adenocarcinoma per 1,000 patient-years among people with Barrett’s esophagus. And another recent study "in which Markov models were used to evaluate available data on the incidence of adenocarcinoma supports our findings ... [and suggests] that surveillance is not beneficial," the researchers added.

This study was supported by the University of Aarhus Clinical Institute. No financial conflicts of interest were reported.

In patients with hepatitis C who develop hepatocellular carcinoma, the serum alpha-fetoprotein level around the time when the cancer is diagnosed is an independent predictor of mortality, Dr. Gia L. Tyson and her colleagues reported in the November issue of Clinical Gastroenterology and Hepatology.

Serum alpha-fetoprotein (AFP) level has been incorporated into at least three of the major staging and prognostic scoring systems for hepatocellular carcinoma, all of which were developed in patient populations outside the United States. But until now it was unknown whether AFP level would be predictive in U.S. patients in general, or in U.S. patients whose HCC is related to hepatitis C in particular.

This retrospective cohort study of 1,480 patients shows that these staging and prognostic systems are relevant in the United States, and that testing for serum AFP when HCC is diagnosed would be useful. Such testing is inexpensive, widely available, and easily interpretable, said Dr. Tyson of the Houston VA Health Services Research and Development Center of Excellence and Baylor College of Medicine, and her associates.

The investigators reviewed the records of adults enrolled in a national VA registry of hepatitis C patients who developed HCC between 1998 and 2007, and followed them through 2009 to determine whether serum AFP level correlated with mortality (Clin. Gastroenterol. Hepatol. 2011 November [doi: 10.1016/j.cgh.2011.07.026]).

As veterans, most of the patients (99%) were men and about half (56%) were white. The mean age was 58 years, and 40% of the subjects had cirrhosis. The interval between hepatitis C diagnosis and liver cancer diagnosis was a mean of 3.86 years.

Overall mortality was 87% during a mean follow-up of 1.8 years. After HCC diagnosis, median 1-year survival was 43%, median 3-year survival was 19%, and median 5-year survival was 12% in the study population as a whole.

Median survival was found to be significantly shorter in patients who had high AFP levels around the time of HCC diagnosis.

"This is the largest study in a United States HCV-infected cohort to report serum AFP levels are predictive of mortality after HCC diagnosis."

Specifically, the median survival was 709 days for patients with an AFP level less than 10 ng/mL, 422 days for those with an AFP level of 10-99 ng/mL, 208 days for those with an AFP level of 100-999 ng/mL, and 68 days for those with an AFP level of 1,000 ng/mL or more. Similarly, survival rates at 1 year, 3 years, and 5 years after HCC diagnosis were progressively lower as AFP levels increased.

The 5-year survival rate for HCC was low overall at only 12%, but it was extremely low, at 1%, in patients with serum AFP levels of 1,000 ng/mL or more. In comparison, those with AFP levels less than 10 ng/mL had a 24% survival rate at 5 years, Dr. Tyson and her colleagues said.

The risk of death increased with increasing AFP level independently of patient factors such as age, sex, and race/ethnicity; independently of clinical factors such as the presence of ascites, encephalopathy, and congestive heart failure; and independently of treatment received, including liver transplantation, resection, radiofrequency ablation, or transarterial chemoembolization.

The results of two sensitivity analyses confirmed that mortality increased significantly with increasing AFP level, with hazard ratios of 1.51 for an AFP level of 10-99 ng/mL, 2.29 for an AFP level of 100-999 ng/mL, and 4.22 for an AFP level of 1,000 ng/mL or more, compared with an AFP level less than 10 ng/mL.

"This is the largest study in a United States HCV-infected cohort to report serum AFP levels are predictive of mortality after HCC diagnosis," the investigators noted.

The dose-response relationship between AFP level and mortality risk further strengthens the role of AFP as a predictor of prognosis, they added. These findings are consistent with results from Italian, French, and Chinese patient populations.

"The main limitation" of this study was the lack of data concerning tumor size and staging. However, numerous studies elsewhere, including those in Italy, France, and China, have demonstrated that AFP as a prognostic factor is independent of tumor size and stage, Dr. Tyson and her associates noted.

This study also was limited in that nearly all of the patients were men and most were white, so the findings may not be generalizable to women and other racial/ethnic groups.

This study was supported in part by the National Institute of Diabetes and Digestive and Kidney Diseases, and the Houston Veterans Affairs Health Services Research and Development Center of Excellence. No financial conflicts of interest were reported.

In patients with hepatitis C who develop hepatocellular carcinoma, the serum alpha-fetoprotein level around the time when the cancer is diagnosed is an independent predictor of mortality, Dr. Gia L. Tyson and her colleagues reported in the November issue of Clinical Gastroenterology and Hepatology.

Serum alpha-fetoprotein (AFP) level has been incorporated into at least three of the major staging and prognostic scoring systems for hepatocellular carcinoma, all of which were developed in patient populations outside the United States. But until now it was unknown whether AFP level would be predictive in U.S. patients in general, or in U.S. patients whose HCC is related to hepatitis C in particular.

This retrospective cohort study of 1,480 patients shows that these staging and prognostic systems are relevant in the United States, and that testing for serum AFP when HCC is diagnosed would be useful. Such testing is inexpensive, widely available, and easily interpretable, said Dr. Tyson of the Houston VA Health Services Research and Development Center of Excellence and Baylor College of Medicine, and her associates.

The investigators reviewed the records of adults enrolled in a national VA registry of hepatitis C patients who developed HCC between 1998 and 2007, and followed them through 2009 to determine whether serum AFP level correlated with mortality (Clin. Gastroenterol. Hepatol. 2011 November [doi: 10.1016/j.cgh.2011.07.026]).

As veterans, most of the patients (99%) were men and about half (56%) were white. The mean age was 58 years, and 40% of the subjects had cirrhosis. The interval between hepatitis C diagnosis and liver cancer diagnosis was a mean of 3.86 years.

Overall mortality was 87% during a mean follow-up of 1.8 years. After HCC diagnosis, median 1-year survival was 43%, median 3-year survival was 19%, and median 5-year survival was 12% in the study population as a whole.

Median survival was found to be significantly shorter in patients who had high AFP levels around the time of HCC diagnosis.

"This is the largest study in a United States HCV-infected cohort to report serum AFP levels are predictive of mortality after HCC diagnosis."

Specifically, the median survival was 709 days for patients with an AFP level less than 10 ng/mL, 422 days for those with an AFP level of 10-99 ng/mL, 208 days for those with an AFP level of 100-999 ng/mL, and 68 days for those with an AFP level of 1,000 ng/mL or more. Similarly, survival rates at 1 year, 3 years, and 5 years after HCC diagnosis were progressively lower as AFP levels increased.

The 5-year survival rate for HCC was low overall at only 12%, but it was extremely low, at 1%, in patients with serum AFP levels of 1,000 ng/mL or more. In comparison, those with AFP levels less than 10 ng/mL had a 24% survival rate at 5 years, Dr. Tyson and her colleagues said.

The risk of death increased with increasing AFP level independently of patient factors such as age, sex, and race/ethnicity; independently of clinical factors such as the presence of ascites, encephalopathy, and congestive heart failure; and independently of treatment received, including liver transplantation, resection, radiofrequency ablation, or transarterial chemoembolization.

The results of two sensitivity analyses confirmed that mortality increased significantly with increasing AFP level, with hazard ratios of 1.51 for an AFP level of 10-99 ng/mL, 2.29 for an AFP level of 100-999 ng/mL, and 4.22 for an AFP level of 1,000 ng/mL or more, compared with an AFP level less than 10 ng/mL.

"This is the largest study in a United States HCV-infected cohort to report serum AFP levels are predictive of mortality after HCC diagnosis," the investigators noted.

The dose-response relationship between AFP level and mortality risk further strengthens the role of AFP as a predictor of prognosis, they added. These findings are consistent with results from Italian, French, and Chinese patient populations.

"The main limitation" of this study was the lack of data concerning tumor size and staging. However, numerous studies elsewhere, including those in Italy, France, and China, have demonstrated that AFP as a prognostic factor is independent of tumor size and stage, Dr. Tyson and her associates noted.

This study also was limited in that nearly all of the patients were men and most were white, so the findings may not be generalizable to women and other racial/ethnic groups.

This study was supported in part by the National Institute of Diabetes and Digestive and Kidney Diseases, and the Houston Veterans Affairs Health Services Research and Development Center of Excellence. No financial conflicts of interest were reported.

In patients with hepatitis C who develop hepatocellular carcinoma, the serum alpha-fetoprotein level around the time when the cancer is diagnosed is an independent predictor of mortality, Dr. Gia L. Tyson and her colleagues reported in the November issue of Clinical Gastroenterology and Hepatology.

Serum alpha-fetoprotein (AFP) level has been incorporated into at least three of the major staging and prognostic scoring systems for hepatocellular carcinoma, all of which were developed in patient populations outside the United States. But until now it was unknown whether AFP level would be predictive in U.S. patients in general, or in U.S. patients whose HCC is related to hepatitis C in particular.

This retrospective cohort study of 1,480 patients shows that these staging and prognostic systems are relevant in the United States, and that testing for serum AFP when HCC is diagnosed would be useful. Such testing is inexpensive, widely available, and easily interpretable, said Dr. Tyson of the Houston VA Health Services Research and Development Center of Excellence and Baylor College of Medicine, and her associates.

The investigators reviewed the records of adults enrolled in a national VA registry of hepatitis C patients who developed HCC between 1998 and 2007, and followed them through 2009 to determine whether serum AFP level correlated with mortality (Clin. Gastroenterol. Hepatol. 2011 November [doi: 10.1016/j.cgh.2011.07.026]).

As veterans, most of the patients (99%) were men and about half (56%) were white. The mean age was 58 years, and 40% of the subjects had cirrhosis. The interval between hepatitis C diagnosis and liver cancer diagnosis was a mean of 3.86 years.

Overall mortality was 87% during a mean follow-up of 1.8 years. After HCC diagnosis, median 1-year survival was 43%, median 3-year survival was 19%, and median 5-year survival was 12% in the study population as a whole.

Median survival was found to be significantly shorter in patients who had high AFP levels around the time of HCC diagnosis.

"This is the largest study in a United States HCV-infected cohort to report serum AFP levels are predictive of mortality after HCC diagnosis."

Specifically, the median survival was 709 days for patients with an AFP level less than 10 ng/mL, 422 days for those with an AFP level of 10-99 ng/mL, 208 days for those with an AFP level of 100-999 ng/mL, and 68 days for those with an AFP level of 1,000 ng/mL or more. Similarly, survival rates at 1 year, 3 years, and 5 years after HCC diagnosis were progressively lower as AFP levels increased.

The 5-year survival rate for HCC was low overall at only 12%, but it was extremely low, at 1%, in patients with serum AFP levels of 1,000 ng/mL or more. In comparison, those with AFP levels less than 10 ng/mL had a 24% survival rate at 5 years, Dr. Tyson and her colleagues said.

The risk of death increased with increasing AFP level independently of patient factors such as age, sex, and race/ethnicity; independently of clinical factors such as the presence of ascites, encephalopathy, and congestive heart failure; and independently of treatment received, including liver transplantation, resection, radiofrequency ablation, or transarterial chemoembolization.

The results of two sensitivity analyses confirmed that mortality increased significantly with increasing AFP level, with hazard ratios of 1.51 for an AFP level of 10-99 ng/mL, 2.29 for an AFP level of 100-999 ng/mL, and 4.22 for an AFP level of 1,000 ng/mL or more, compared with an AFP level less than 10 ng/mL.

"This is the largest study in a United States HCV-infected cohort to report serum AFP levels are predictive of mortality after HCC diagnosis," the investigators noted.

The dose-response relationship between AFP level and mortality risk further strengthens the role of AFP as a predictor of prognosis, they added. These findings are consistent with results from Italian, French, and Chinese patient populations.

"The main limitation" of this study was the lack of data concerning tumor size and staging. However, numerous studies elsewhere, including those in Italy, France, and China, have demonstrated that AFP as a prognostic factor is independent of tumor size and stage, Dr. Tyson and her associates noted.

This study also was limited in that nearly all of the patients were men and most were white, so the findings may not be generalizable to women and other racial/ethnic groups.

This study was supported in part by the National Institute of Diabetes and Digestive and Kidney Diseases, and the Houston Veterans Affairs Health Services Research and Development Center of Excellence. No financial conflicts of interest were reported.

Mutations in the BRCA2 gene appear to confer better survival in women who have ovarian cancer, according to a report in the Oct. 12 issue of JAMA.

The BRCA2 mutations appear to improve survival by enhancing sensitivity to platinum-based chemotherapy, thus improving treatment response, said Da Yang, Ph.D., of the department of pathology at the University of Texas M.D. Anderson Cancer Center, Houston, and associates.

BRCA1 mutations showed no such effects, they noted.

Women with either BRCA1 or BRCA2 mutations are known to be at increased risk of developing ovarian cancer, but the findings regarding their outcomes after the malignancy is diagnosed are conflicting. Some studies have reported favorable clinical courses, while others have shown the opposite. Most of these studies have pooled the results on BRCA1 and BRCA2 carriers together.

Dr. Yang and colleagues assessed possible associations between each genetic mutation separately and survival. They used the Cancer Genome Atlas (TCGA) database, which included genomic and clinical data on 316 high-grade serous ovarian cancer patients. All tumors were stage III or IV.

Most of the study subjects (86%) were non-Ashkenazi Jewish white women; 7% were Ashkenazi Jewish, 3% were African American, and 3% were Asian. All were treated with platinum-based adjuvant chemotherapy, and 94% also received a taxane.

A total of 29 women (9.2%) carried BRCA2 mutations, 37 (11.7%) BRCA1 mutations, and 219 had BRCA wild-type mutations.

The 5-year survival was 61% for BRCA2 carriers, significantly higher than the 25% 5-year survival seen in wild-type BRCA cases. In contrast, there was no significant difference in survival between BRCA1 carriers (44%) and wild-type BRCA cases, the investigators said (JAMA 2011;306:1557-65).

In further analysis of treatment response, BRCA2 mutations were associated with significantly improved chemotherapy response and longer platinum-free durations than were BRCA1 mutations and wild-type BRCA.

In addition, "BRCA2-mutated cases, but not BRCA1-mutated cases, exhibited a ‘mutator phenotype’ that contained significantly more mutations as determined from whole-exome mutation data. These findings suggest that the different associations between survival and BRCA1 and BRCA2 deficiencies likely result from patients’ distinct responses to platinum-based treatment, which may be caused by the differing nature of the dysfunction of these two genes," the researchers said.

"Functionally, both BRCA1 and BRCA2 have been reported to play key roles in DNA damage repair, but they appear to have distinct but complementary functions," they added.

This study population "represents the most comprehensive data composition (both genomic and clinical) assembled" to date. However, the cohort was still "relatively small, and our findings should be further validated" in additional studies, Dr. Yang and associates said.

This study was supported by the National Institutes of Health, the Blanton-Davis Ovarian Cancer Research Program, and an Ovarian Cancer SPORE grant. No financial conflicts of interest were reported.

Mutations in the BRCA2 gene appear to confer better survival in women who have ovarian cancer, according to a report in the Oct. 12 issue of JAMA.

The BRCA2 mutations appear to improve survival by enhancing sensitivity to platinum-based chemotherapy, thus improving treatment response, said Da Yang, Ph.D., of the department of pathology at the University of Texas M.D. Anderson Cancer Center, Houston, and associates.

BRCA1 mutations showed no such effects, they noted.

Women with either BRCA1 or BRCA2 mutations are known to be at increased risk of developing ovarian cancer, but the findings regarding their outcomes after the malignancy is diagnosed are conflicting. Some studies have reported favorable clinical courses, while others have shown the opposite. Most of these studies have pooled the results on BRCA1 and BRCA2 carriers together.

Dr. Yang and colleagues assessed possible associations between each genetic mutation separately and survival. They used the Cancer Genome Atlas (TCGA) database, which included genomic and clinical data on 316 high-grade serous ovarian cancer patients. All tumors were stage III or IV.

Most of the study subjects (86%) were non-Ashkenazi Jewish white women; 7% were Ashkenazi Jewish, 3% were African American, and 3% were Asian. All were treated with platinum-based adjuvant chemotherapy, and 94% also received a taxane.

A total of 29 women (9.2%) carried BRCA2 mutations, 37 (11.7%) BRCA1 mutations, and 219 had BRCA wild-type mutations.

The 5-year survival was 61% for BRCA2 carriers, significantly higher than the 25% 5-year survival seen in wild-type BRCA cases. In contrast, there was no significant difference in survival between BRCA1 carriers (44%) and wild-type BRCA cases, the investigators said (JAMA 2011;306:1557-65).

In further analysis of treatment response, BRCA2 mutations were associated with significantly improved chemotherapy response and longer platinum-free durations than were BRCA1 mutations and wild-type BRCA.

In addition, "BRCA2-mutated cases, but not BRCA1-mutated cases, exhibited a ‘mutator phenotype’ that contained significantly more mutations as determined from whole-exome mutation data. These findings suggest that the different associations between survival and BRCA1 and BRCA2 deficiencies likely result from patients’ distinct responses to platinum-based treatment, which may be caused by the differing nature of the dysfunction of these two genes," the researchers said.

"Functionally, both BRCA1 and BRCA2 have been reported to play key roles in DNA damage repair, but they appear to have distinct but complementary functions," they added.

This study population "represents the most comprehensive data composition (both genomic and clinical) assembled" to date. However, the cohort was still "relatively small, and our findings should be further validated" in additional studies, Dr. Yang and associates said.

This study was supported by the National Institutes of Health, the Blanton-Davis Ovarian Cancer Research Program, and an Ovarian Cancer SPORE grant. No financial conflicts of interest were reported.

Mutations in the BRCA2 gene appear to confer better survival in women who have ovarian cancer, according to a report in the Oct. 12 issue of JAMA.

The BRCA2 mutations appear to improve survival by enhancing sensitivity to platinum-based chemotherapy, thus improving treatment response, said Da Yang, Ph.D., of the department of pathology at the University of Texas M.D. Anderson Cancer Center, Houston, and associates.

BRCA1 mutations showed no such effects, they noted.

Women with either BRCA1 or BRCA2 mutations are known to be at increased risk of developing ovarian cancer, but the findings regarding their outcomes after the malignancy is diagnosed are conflicting. Some studies have reported favorable clinical courses, while others have shown the opposite. Most of these studies have pooled the results on BRCA1 and BRCA2 carriers together.

Dr. Yang and colleagues assessed possible associations between each genetic mutation separately and survival. They used the Cancer Genome Atlas (TCGA) database, which included genomic and clinical data on 316 high-grade serous ovarian cancer patients. All tumors were stage III or IV.

Most of the study subjects (86%) were non-Ashkenazi Jewish white women; 7% were Ashkenazi Jewish, 3% were African American, and 3% were Asian. All were treated with platinum-based adjuvant chemotherapy, and 94% also received a taxane.

A total of 29 women (9.2%) carried BRCA2 mutations, 37 (11.7%) BRCA1 mutations, and 219 had BRCA wild-type mutations.

The 5-year survival was 61% for BRCA2 carriers, significantly higher than the 25% 5-year survival seen in wild-type BRCA cases. In contrast, there was no significant difference in survival between BRCA1 carriers (44%) and wild-type BRCA cases, the investigators said (JAMA 2011;306:1557-65).

In further analysis of treatment response, BRCA2 mutations were associated with significantly improved chemotherapy response and longer platinum-free durations than were BRCA1 mutations and wild-type BRCA.

In addition, "BRCA2-mutated cases, but not BRCA1-mutated cases, exhibited a ‘mutator phenotype’ that contained significantly more mutations as determined from whole-exome mutation data. These findings suggest that the different associations between survival and BRCA1 and BRCA2 deficiencies likely result from patients’ distinct responses to platinum-based treatment, which may be caused by the differing nature of the dysfunction of these two genes," the researchers said.

"Functionally, both BRCA1 and BRCA2 have been reported to play key roles in DNA damage repair, but they appear to have distinct but complementary functions," they added.

This study population "represents the most comprehensive data composition (both genomic and clinical) assembled" to date. However, the cohort was still "relatively small, and our findings should be further validated" in additional studies, Dr. Yang and associates said.

This study was supported by the National Institutes of Health, the Blanton-Davis Ovarian Cancer Research Program, and an Ovarian Cancer SPORE grant. No financial conflicts of interest were reported.

Far from preventing prostate cancer, vitamin E supplements actually raise the risk of the malignancy by 17% in the general population of healthy men, according to a report in the Oct. 12 JAMA.

The increase in risk became evident after extended follow-up in SELECT (Selenium and Vitamin E Cancer Prevention Trial), a large international study that was discontinued earlier than planned, in 2008, because an interim analysis showed that neither vitamin E nor selenium supplements reduced the risk of prostate cancer.

© Juanmonino/iStockphoto

"Given that more than 50% of individuals 60 years or older are taking supplements containing vitamin E and that 23% of them are taking at least 400 IU per day, despite a recommended daily dietary allowance of only 22.4 IU for adult men, the implications of our observations are substantial," said Dr. Eric A. Klein of the Glickman Urological and Kidney Institute at the Cleveland Clinic, and his associates.

The 35,533 men enrolled in the study at 427 sites were randomly assigned to receive oral selenium (200 mcg/day) plus placebo, vitamin E (400 IU/day) plus placebo, both active agents, or two placebos, and were followed for a median of 5.5 years. When the trial was halted early, the data and safety monitoring committee "expressed concern about the increased risk of prostate cancer observed in the vitamin E plus placebo group, which approached statistical significance," the investigators said.

Follow-up has since continued for an additional 3 years. "The current report includes data as of July 5, 2011. There are 54,464 additional person-years of follow-up since the primary report, an increase of 23%," Dr. Klein and his colleagues explained.

There have been no differences among the study groups in the intensity of PSA testing or in absolute PSA levels.

An additional 521 prostate cancers have been diagnosed since the initial SELECT results were published. These included 113 in the placebo group, 147 in the vitamin E group, 143 in the selenium group, and 118 in the combined therapy group.

The incidence of prostate cancer rose significantly only in the vitamin E group. This elevated risk occurred with both low-grade and high-grade tumors (JAMA 2011;306:1549-56).

"The difference in rates of prostate cancer between vitamin E and placebo became apparent during the participants’ third year in the trial, at which point the [hazard ratio] was 1.10, and increased slightly each year thereafter. ... The unadjusted absolute increase in risk of cases of prostate cancer per 1,000 person-years compared with placebo was 1.6 for vitamin E, 0.8 for selenium, and 0.4 for the combination," the investigators noted.

Extended follow-up also showed that there were no significant differences among the study groups in rates of type 2 diabetes; lung, colorectal, and total cancers; mortality; or grade 4 cardiovascular events. This suggests "neither benefit nor harm from dietary supplementation with selenium or vitamin E for these end points," they added.

No biological explanation for the increased risk of prostate cancer is apparent yet. Since there was no increased risk with combined vitamin E plus selenium, selenium may exert a "dampening" influence on vitamin E’s effect.

"Tests of this hypothesis and other potential explanations for the results will be addressed" in future analyses of SELECT data and in further follow-up of the study subjects. Meanwhile, the findings demonstrate "the potential for seemingly innocuous yet biologically active substances such as vitamins to cause harm," Dr. Klein and his associates said.

The lack of benefit from vitamin E demonstrated in this study, together with its potential for harm, "underscore the need for consumers to be skeptical of health claims for unregulated over-the-counter products," they added.

This study was supported by the National Cancer Institute and the National Center for Complementary and Alternative Medicine. Study drugs and packaging were provided by Perrigo, Sabinsa, Tishcon, and DSM Nutritional Products. Dr. Klein’s associates reported ties to numerous industry sources.

Far from preventing prostate cancer, vitamin E supplements actually raise the risk of the malignancy by 17% in the general population of healthy men, according to a report in the Oct. 12 JAMA.

The increase in risk became evident after extended follow-up in SELECT (Selenium and Vitamin E Cancer Prevention Trial), a large international study that was discontinued earlier than planned, in 2008, because an interim analysis showed that neither vitamin E nor selenium supplements reduced the risk of prostate cancer.

© Juanmonino/iStockphoto

"Given that more than 50% of individuals 60 years or older are taking supplements containing vitamin E and that 23% of them are taking at least 400 IU per day, despite a recommended daily dietary allowance of only 22.4 IU for adult men, the implications of our observations are substantial," said Dr. Eric A. Klein of the Glickman Urological and Kidney Institute at the Cleveland Clinic, and his associates.

The 35,533 men enrolled in the study at 427 sites were randomly assigned to receive oral selenium (200 mcg/day) plus placebo, vitamin E (400 IU/day) plus placebo, both active agents, or two placebos, and were followed for a median of 5.5 years. When the trial was halted early, the data and safety monitoring committee "expressed concern about the increased risk of prostate cancer observed in the vitamin E plus placebo group, which approached statistical significance," the investigators said.

Follow-up has since continued for an additional 3 years. "The current report includes data as of July 5, 2011. There are 54,464 additional person-years of follow-up since the primary report, an increase of 23%," Dr. Klein and his colleagues explained.

There have been no differences among the study groups in the intensity of PSA testing or in absolute PSA levels.

An additional 521 prostate cancers have been diagnosed since the initial SELECT results were published. These included 113 in the placebo group, 147 in the vitamin E group, 143 in the selenium group, and 118 in the combined therapy group.

The incidence of prostate cancer rose significantly only in the vitamin E group. This elevated risk occurred with both low-grade and high-grade tumors (JAMA 2011;306:1549-56).

"The difference in rates of prostate cancer between vitamin E and placebo became apparent during the participants’ third year in the trial, at which point the [hazard ratio] was 1.10, and increased slightly each year thereafter. ... The unadjusted absolute increase in risk of cases of prostate cancer per 1,000 person-years compared with placebo was 1.6 for vitamin E, 0.8 for selenium, and 0.4 for the combination," the investigators noted.

Extended follow-up also showed that there were no significant differences among the study groups in rates of type 2 diabetes; lung, colorectal, and total cancers; mortality; or grade 4 cardiovascular events. This suggests "neither benefit nor harm from dietary supplementation with selenium or vitamin E for these end points," they added.

No biological explanation for the increased risk of prostate cancer is apparent yet. Since there was no increased risk with combined vitamin E plus selenium, selenium may exert a "dampening" influence on vitamin E’s effect.

"Tests of this hypothesis and other potential explanations for the results will be addressed" in future analyses of SELECT data and in further follow-up of the study subjects. Meanwhile, the findings demonstrate "the potential for seemingly innocuous yet biologically active substances such as vitamins to cause harm," Dr. Klein and his associates said.

The lack of benefit from vitamin E demonstrated in this study, together with its potential for harm, "underscore the need for consumers to be skeptical of health claims for unregulated over-the-counter products," they added.

This study was supported by the National Cancer Institute and the National Center for Complementary and Alternative Medicine. Study drugs and packaging were provided by Perrigo, Sabinsa, Tishcon, and DSM Nutritional Products. Dr. Klein’s associates reported ties to numerous industry sources.

Far from preventing prostate cancer, vitamin E supplements actually raise the risk of the malignancy by 17% in the general population of healthy men, according to a report in the Oct. 12 JAMA.

The increase in risk became evident after extended follow-up in SELECT (Selenium and Vitamin E Cancer Prevention Trial), a large international study that was discontinued earlier than planned, in 2008, because an interim analysis showed that neither vitamin E nor selenium supplements reduced the risk of prostate cancer.

© Juanmonino/iStockphoto

"Given that more than 50% of individuals 60 years or older are taking supplements containing vitamin E and that 23% of them are taking at least 400 IU per day, despite a recommended daily dietary allowance of only 22.4 IU for adult men, the implications of our observations are substantial," said Dr. Eric A. Klein of the Glickman Urological and Kidney Institute at the Cleveland Clinic, and his associates.

The 35,533 men enrolled in the study at 427 sites were randomly assigned to receive oral selenium (200 mcg/day) plus placebo, vitamin E (400 IU/day) plus placebo, both active agents, or two placebos, and were followed for a median of 5.5 years. When the trial was halted early, the data and safety monitoring committee "expressed concern about the increased risk of prostate cancer observed in the vitamin E plus placebo group, which approached statistical significance," the investigators said.

Follow-up has since continued for an additional 3 years. "The current report includes data as of July 5, 2011. There are 54,464 additional person-years of follow-up since the primary report, an increase of 23%," Dr. Klein and his colleagues explained.

There have been no differences among the study groups in the intensity of PSA testing or in absolute PSA levels.

An additional 521 prostate cancers have been diagnosed since the initial SELECT results were published. These included 113 in the placebo group, 147 in the vitamin E group, 143 in the selenium group, and 118 in the combined therapy group.

The incidence of prostate cancer rose significantly only in the vitamin E group. This elevated risk occurred with both low-grade and high-grade tumors (JAMA 2011;306:1549-56).

"The difference in rates of prostate cancer between vitamin E and placebo became apparent during the participants’ third year in the trial, at which point the [hazard ratio] was 1.10, and increased slightly each year thereafter. ... The unadjusted absolute increase in risk of cases of prostate cancer per 1,000 person-years compared with placebo was 1.6 for vitamin E, 0.8 for selenium, and 0.4 for the combination," the investigators noted.

Extended follow-up also showed that there were no significant differences among the study groups in rates of type 2 diabetes; lung, colorectal, and total cancers; mortality; or grade 4 cardiovascular events. This suggests "neither benefit nor harm from dietary supplementation with selenium or vitamin E for these end points," they added.

No biological explanation for the increased risk of prostate cancer is apparent yet. Since there was no increased risk with combined vitamin E plus selenium, selenium may exert a "dampening" influence on vitamin E’s effect.

"Tests of this hypothesis and other potential explanations for the results will be addressed" in future analyses of SELECT data and in further follow-up of the study subjects. Meanwhile, the findings demonstrate "the potential for seemingly innocuous yet biologically active substances such as vitamins to cause harm," Dr. Klein and his associates said.

The lack of benefit from vitamin E demonstrated in this study, together with its potential for harm, "underscore the need for consumers to be skeptical of health claims for unregulated over-the-counter products," they added.

This study was supported by the National Cancer Institute and the National Center for Complementary and Alternative Medicine. Study drugs and packaging were provided by Perrigo, Sabinsa, Tishcon, and DSM Nutritional Products. Dr. Klein’s associates reported ties to numerous industry sources.

A diabetes education intervention that focused on individual telephone "coaching" failed to improve hemoglobin A_1c levels in a study of poor, uninsured, ethnic minority patients with poorly controlled diabetes that was reported online Oct. 10 in Archives of Internal Medicine.

"The intervention tested in this trial appeared to be insufficient to make a statistically significant difference compared with the control condition, despite anecdotal reports from participants that the intervention was valuable to them and provided support they had not previously received as part of their diabetes care," said Dominick L. Frosch, Ph.D., of the department of health services research, Palo Alto (Calif.) Medical Foundation Research Institute, and his associates.

The study findings were unexpected, given that "previous telephone intervention studies with different patient populations ... showed significant increases in self-care and in some cases significant improvements in glycemic control," the investigators said.

The intervention package they assessed included "a 24-minute video [for] behavior support ... [and] a workbook as well as five sessions of telephone coaching provided by a [bilingual] trained diabetes nurse." This was compared with a control condition: a 20-page brochure on diabetes self-care developed by the National Institutes of Health’s National Diabetes Education Program.

"We expected that the experimental group would be more likely to review the educational materials provided because a DVD might be perceived as more engaging than a printed brochure, thereby resulting in higher diabetes knowledge, and that the additional telephone support provided would be more likely to facilitate behavior change compared with the control condition," Dr. Frosch and his colleagues said.

The study subjects were patients aged 40 years and older who had type 2 diabetes and an HbA_1c value of 8% or higher. Most were obese. More than 70% had annual incomes of $15,000 or less. They were recruited from two internal medicine practices, one family medicine practice, and a community-based "safety net" clinic in the Los Angeles area.

"The participants in this trial had considerable deficits in their understanding of diabetes and what successful management of the condition requires."

The study subjects were randomly assigned to either the coaching intervention (100 patients) or the control condition (101 patients) and were followed up at 1 month and 6 months. Three-fourths of the intervention group completed all five possible telephone coaching sessions.

Nearly 90% of the subjects in both groups rated the clarity of the information they received as good, very good, or excellent. A total of 93% of the intervention group and 90% of the control group said they felt somewhat or very positive about other patients using the DVD or the brochure to learn about managing their diabetes.

The primary end point was change in HbA_1c value at 6 months, as compared with the baseline value. Both groups showed a significant decline, from a mean of 9.6% to a mean of 9.1%. However, the difference between the groups was not significant, the investigators said (Arch. Intern. Med. 2011 Oct. 10 [doi:10.1001/archinternmed.2011.497]).

Both groups of patients demonstrated significant increases in knowledge about their disease, as measured by the 23-item Diabetes Knowledge Test and the 25-item Summary of Diabetes Self-Care Activities, which assess diet, exercise, blood glucose testing, foot care, and smoking. However, the difference between the intervention group and the control group was not significant.

The researchers noted that the study results may have been influenced by certain unique circumstances. "Enrollment began just as it was becoming clear that the global economy was entering a severe recession," and the study subjects clearly were adversely affected by the economic downturn.

"Reports of job loss were common, leading many participants to have to struggle for basic survival. Making wise nutritious choices became impossible when the first priority was making sure that one could maintain shelter and have any food to eat at all," Dr. Frosch and his associates said.

In addition, the coaching intervention in this study differed from coaching interventions in previous studies that reported more positive results in that the "dose" of coaching was a maximum of five calls totaling 150 minutes of telephone contact. Previous studies assessed more frequent telephone contacts (up to 18 calls) as well as more total minutes of contact (up to 420 minutes).

"Our results at least suggest that five sessions lasting 150 minutes is not sufficient for the most vulnerable and disadvantaged patients with diabetes," they noted.

"The participants in this trial had considerable deficits in their understanding of diabetes and what successful management of the condition requires. The combination of this with the severe economic disadvantage and stress experienced by this population could not be overcome by the limited intervention tested in this trial," the researchers added.

This study was supported by the Robert Wood Johnson Foundation, the Foundation for Informed Medical Decision Making, the National Institute on Aging, and the National Institutes of Health. Dr. Frosch reported receiving honoraria from the Foundation for Informed Medical Decision Making.

A diabetes education intervention that focused on individual telephone "coaching" failed to improve hemoglobin A_1c levels in a study of poor, uninsured, ethnic minority patients with poorly controlled diabetes that was reported online Oct. 10 in Archives of Internal Medicine.

"The intervention tested in this trial appeared to be insufficient to make a statistically significant difference compared with the control condition, despite anecdotal reports from participants that the intervention was valuable to them and provided support they had not previously received as part of their diabetes care," said Dominick L. Frosch, Ph.D., of the department of health services research, Palo Alto (Calif.) Medical Foundation Research Institute, and his associates.

The study findings were unexpected, given that "previous telephone intervention studies with different patient populations ... showed significant increases in self-care and in some cases significant improvements in glycemic control," the investigators said.

The intervention package they assessed included "a 24-minute video [for] behavior support ... [and] a workbook as well as five sessions of telephone coaching provided by a [bilingual] trained diabetes nurse." This was compared with a control condition: a 20-page brochure on diabetes self-care developed by the National Institutes of Health’s National Diabetes Education Program.

"We expected that the experimental group would be more likely to review the educational materials provided because a DVD might be perceived as more engaging than a printed brochure, thereby resulting in higher diabetes knowledge, and that the additional telephone support provided would be more likely to facilitate behavior change compared with the control condition," Dr. Frosch and his colleagues said.

The study subjects were patients aged 40 years and older who had type 2 diabetes and an HbA_1c value of 8% or higher. Most were obese. More than 70% had annual incomes of $15,000 or less. They were recruited from two internal medicine practices, one family medicine practice, and a community-based "safety net" clinic in the Los Angeles area.

"The participants in this trial had considerable deficits in their understanding of diabetes and what successful management of the condition requires."

The study subjects were randomly assigned to either the coaching intervention (100 patients) or the control condition (101 patients) and were followed up at 1 month and 6 months. Three-fourths of the intervention group completed all five possible telephone coaching sessions.

Nearly 90% of the subjects in both groups rated the clarity of the information they received as good, very good, or excellent. A total of 93% of the intervention group and 90% of the control group said they felt somewhat or very positive about other patients using the DVD or the brochure to learn about managing their diabetes.

The primary end point was change in HbA_1c value at 6 months, as compared with the baseline value. Both groups showed a significant decline, from a mean of 9.6% to a mean of 9.1%. However, the difference between the groups was not significant, the investigators said (Arch. Intern. Med. 2011 Oct. 10 [doi:10.1001/archinternmed.2011.497]).

Both groups of patients demonstrated significant increases in knowledge about their disease, as measured by the 23-item Diabetes Knowledge Test and the 25-item Summary of Diabetes Self-Care Activities, which assess diet, exercise, blood glucose testing, foot care, and smoking. However, the difference between the intervention group and the control group was not significant.

The researchers noted that the study results may have been influenced by certain unique circumstances. "Enrollment began just as it was becoming clear that the global economy was entering a severe recession," and the study subjects clearly were adversely affected by the economic downturn.

"Reports of job loss were common, leading many participants to have to struggle for basic survival. Making wise nutritious choices became impossible when the first priority was making sure that one could maintain shelter and have any food to eat at all," Dr. Frosch and his associates said.

In addition, the coaching intervention in this study differed from coaching interventions in previous studies that reported more positive results in that the "dose" of coaching was a maximum of five calls totaling 150 minutes of telephone contact. Previous studies assessed more frequent telephone contacts (up to 18 calls) as well as more total minutes of contact (up to 420 minutes).

"Our results at least suggest that five sessions lasting 150 minutes is not sufficient for the most vulnerable and disadvantaged patients with diabetes," they noted.

"The participants in this trial had considerable deficits in their understanding of diabetes and what successful management of the condition requires. The combination of this with the severe economic disadvantage and stress experienced by this population could not be overcome by the limited intervention tested in this trial," the researchers added.

This study was supported by the Robert Wood Johnson Foundation, the Foundation for Informed Medical Decision Making, the National Institute on Aging, and the National Institutes of Health. Dr. Frosch reported receiving honoraria from the Foundation for Informed Medical Decision Making.

A diabetes education intervention that focused on individual telephone "coaching" failed to improve hemoglobin A_1c levels in a study of poor, uninsured, ethnic minority patients with poorly controlled diabetes that was reported online Oct. 10 in Archives of Internal Medicine.

"The intervention tested in this trial appeared to be insufficient to make a statistically significant difference compared with the control condition, despite anecdotal reports from participants that the intervention was valuable to them and provided support they had not previously received as part of their diabetes care," said Dominick L. Frosch, Ph.D., of the department of health services research, Palo Alto (Calif.) Medical Foundation Research Institute, and his associates.

The study findings were unexpected, given that "previous telephone intervention studies with different patient populations ... showed significant increases in self-care and in some cases significant improvements in glycemic control," the investigators said.

The intervention package they assessed included "a 24-minute video [for] behavior support ... [and] a workbook as well as five sessions of telephone coaching provided by a [bilingual] trained diabetes nurse." This was compared with a control condition: a 20-page brochure on diabetes self-care developed by the National Institutes of Health’s National Diabetes Education Program.

"We expected that the experimental group would be more likely to review the educational materials provided because a DVD might be perceived as more engaging than a printed brochure, thereby resulting in higher diabetes knowledge, and that the additional telephone support provided would be more likely to facilitate behavior change compared with the control condition," Dr. Frosch and his colleagues said.

The study subjects were patients aged 40 years and older who had type 2 diabetes and an HbA_1c value of 8% or higher. Most were obese. More than 70% had annual incomes of $15,000 or less. They were recruited from two internal medicine practices, one family medicine practice, and a community-based "safety net" clinic in the Los Angeles area.

"The participants in this trial had considerable deficits in their understanding of diabetes and what successful management of the condition requires."

The study subjects were randomly assigned to either the coaching intervention (100 patients) or the control condition (101 patients) and were followed up at 1 month and 6 months. Three-fourths of the intervention group completed all five possible telephone coaching sessions.

Nearly 90% of the subjects in both groups rated the clarity of the information they received as good, very good, or excellent. A total of 93% of the intervention group and 90% of the control group said they felt somewhat or very positive about other patients using the DVD or the brochure to learn about managing their diabetes.

The primary end point was change in HbA_1c value at 6 months, as compared with the baseline value. Both groups showed a significant decline, from a mean of 9.6% to a mean of 9.1%. However, the difference between the groups was not significant, the investigators said (Arch. Intern. Med. 2011 Oct. 10 [doi:10.1001/archinternmed.2011.497]).

Both groups of patients demonstrated significant increases in knowledge about their disease, as measured by the 23-item Diabetes Knowledge Test and the 25-item Summary of Diabetes Self-Care Activities, which assess diet, exercise, blood glucose testing, foot care, and smoking. However, the difference between the intervention group and the control group was not significant.

The researchers noted that the study results may have been influenced by certain unique circumstances. "Enrollment began just as it was becoming clear that the global economy was entering a severe recession," and the study subjects clearly were adversely affected by the economic downturn.

"Reports of job loss were common, leading many participants to have to struggle for basic survival. Making wise nutritious choices became impossible when the first priority was making sure that one could maintain shelter and have any food to eat at all," Dr. Frosch and his associates said.

In addition, the coaching intervention in this study differed from coaching interventions in previous studies that reported more positive results in that the "dose" of coaching was a maximum of five calls totaling 150 minutes of telephone contact. Previous studies assessed more frequent telephone contacts (up to 18 calls) as well as more total minutes of contact (up to 420 minutes).

"Our results at least suggest that five sessions lasting 150 minutes is not sufficient for the most vulnerable and disadvantaged patients with diabetes," they noted.

"The participants in this trial had considerable deficits in their understanding of diabetes and what successful management of the condition requires. The combination of this with the severe economic disadvantage and stress experienced by this population could not be overcome by the limited intervention tested in this trial," the researchers added.

This study was supported by the Robert Wood Johnson Foundation, the Foundation for Informed Medical Decision Making, the National Institute on Aging, and the National Institutes of Health. Dr. Frosch reported receiving honoraria from the Foundation for Informed Medical Decision Making.

Two patient education interventions improved poorly controlled diabetes modestly in separate studies reported online Oct. 10 in Archives of Internal Medicine.

The first clinical trial compared a "highly structured" group behavioral diabetes education intervention against one group and one individual control education condition in adults who had longstanding, poorly controlled type 1 or type 2 diabetes. The 222 study subjects (110 with type 1 and 112 with type 2 disease) had baseline hemoglobin A_1c levels of 7.5% or higher.

Diabetes nurses or dietitians who were certified diabetes educators ran each program, said Katie Weinger, Ed.D., of the Joslin Diabetes Center and Harvard Medical School, Boston, and her associates.

The highly structured group intervention involved five 2-hour sessions during a 6-week period in which a small group of patients reviewed daily glucose logs and discussed food choices and physical activity. The educators used a structured cognitive-behavioral curriculum to facilitate self-care goal-setting and to help patients identify and overcome barriers to self-care.

The investigators hoped that this intervention would provide "a scaffold that [would] allow participants to integrate specific dietary and physical activity behaviors into their busy schedules."

The group control condition involved the same length of time and the same amount of contact with health professionals but didn’t include any of the cognitive behavior strategies or structured goal-setting activities. The individual control condition gave patients unlimited access to one-on-one appointments with the diabetes educators for 6 months, but did not require that they attend appointments.

"Patients with type 1 diabetes who struggle with achieving glycemic targets [may] need more help with emotional and psychological issues than support with diabetes self-management skills."

The primary outcome measure was improvement in HbA_1c level to a target of less than 7% at 3-, 6-, and 12-month follow-up.

Patients in all three study groups showed statistically significant but modest improvement in glycemic control. Most did not achieve their HbA_1c target level of less than 7%.

Study subjects who received the highly structured group intervention showed the most improvement, with a mean decrease of 0.8 percentage points in HbA_1c at 3 months, compared with mean decreases of 0.4 percentage points in both control groups, the investigators said (Arch. Intern. Med. 2011 Oct. 10 [doi:10.1001/archinternmed.2011.502]).

Glycemic control deteriorated slightly but "was basically maintained at 12 months" for both group interventions but not for the individual control condition.

Patients with type 2 diabetes showed more improvement with the structured intervention than did those with type 1 diabetes, with a reduction in HbA_1c of 0.7 percentage points at 3 months, compared with only 0.3 for type 1 diabetes. It may be that patients with type 1 diabetes receive more educational and behavioral support at diagnosis and throughout the course of their disease, and thus do not benefit as much from this intervention, compared with those with type 2 diabetes, Dr. Weinger and her colleagues said.

"Another explanation may be that patients with type 1 diabetes who struggle with achieving glycemic targets need more help with emotional and psychological issues than support with diabetes self-management skills," they added.

Neither the highly structured intervention nor the control conditions significantly improved diabetes-related quality of life, the number of daily meter checks, or the frequency of self-care behaviors.

"Although our participants did not achieve glycemic targets of less than 7% ... we believe that a 0.67% reduction in HbA_1c level observed at 12 months, if sustained over the long term, should by itself result in about a 20% reduction in microvascular end points and about a 10% reduction in cardiovascular end points," Dr. Weinger and her associates wrote.

In the second clinical trial, Dr. JoAnn Sperl-Hillen of HealthPartners Research Foundation, Minneapolis, and her associates also studied patients with poorly controlled type 2 diabetes (HbA_1c levels of 7% or higher). The study subjects were 337 adults residing in Minnesota and 286 in New Mexico. The mean age was 62 years, and the mean duration of diabetes was 12 years.

The researchers assessed a group education program endorsed by the American Diabetes Association that included "Conversation Maps" – a highly interactive group approach using large, laminated tabletop visual aids to facilitate discussions. Topics covered during the 8 hours of the program included healthy eating, monitoring blood sugar, taking medications, problem solving, risk reduction, healthy coping, and increasing physical activity.

This intervention was compared against standard individual diabetes education – three 1-hour sessions with a certified diabetes educator at 1-month intervals – and usual care (no specific diabetes education).

At 6-month follow-up, HbA_1c levels decreased more, by 0.51 percentage points, with the individual diabetes education than with the group intervention (0.24%) or usual care (0.27%). Scores on measures of physical health, nutrition, and physical activity also improved significantly with the individual education but not with group education, compared with usual care, Dr. Sperl-Hillen and her colleagues said (Arch. Intern. Med. 2011 Oct. 10 [doi:10.1001/archinternmed.2011.507]).

Fewer subjects receiving the group intervention than those receiving the individual intervention completed the program, probably because of scheduling difficulties, the authors wrote. Nevertheless, in an analysis restricted to subjects who completed their programs, the results were still better with the individual than with the group intervention.

"We believe that these short-term results support the use of individual diabetes education for this patient population," the investigators said.

Dr. Weinger’s study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institutes of Health, and the Joslin Diabetes Center Clinical Research Center. Abbott Laboratories, LifeScan, and Roche Diagnostics contributed glucose meters and test strips. Dr. Weinger’s associate reported ties to Eli Lilly, Amylin Pharmaceuticals, Takeda, Sanofi-Aventis, and Daiichi-Sankyo. Dr. Sperl-Hillen’s study was funded by Merck. Dr. Sperl-Hillen reported ties to Merck, GlaxoSmithKline, Lilly, and Schering-Plough.

Two patient education interventions improved poorly controlled diabetes modestly in separate studies reported online Oct. 10 in Archives of Internal Medicine.

The first clinical trial compared a "highly structured" group behavioral diabetes education intervention against one group and one individual control education condition in adults who had longstanding, poorly controlled type 1 or type 2 diabetes. The 222 study subjects (110 with type 1 and 112 with type 2 disease) had baseline hemoglobin A_1c levels of 7.5% or higher.

Diabetes nurses or dietitians who were certified diabetes educators ran each program, said Katie Weinger, Ed.D., of the Joslin Diabetes Center and Harvard Medical School, Boston, and her associates.

The highly structured group intervention involved five 2-hour sessions during a 6-week period in which a small group of patients reviewed daily glucose logs and discussed food choices and physical activity. The educators used a structured cognitive-behavioral curriculum to facilitate self-care goal-setting and to help patients identify and overcome barriers to self-care.

The investigators hoped that this intervention would provide "a scaffold that [would] allow participants to integrate specific dietary and physical activity behaviors into their busy schedules."

The group control condition involved the same length of time and the same amount of contact with health professionals but didn’t include any of the cognitive behavior strategies or structured goal-setting activities. The individual control condition gave patients unlimited access to one-on-one appointments with the diabetes educators for 6 months, but did not require that they attend appointments.

"Patients with type 1 diabetes who struggle with achieving glycemic targets [may] need more help with emotional and psychological issues than support with diabetes self-management skills."

The primary outcome measure was improvement in HbA_1c level to a target of less than 7% at 3-, 6-, and 12-month follow-up.

Patients in all three study groups showed statistically significant but modest improvement in glycemic control. Most did not achieve their HbA_1c target level of less than 7%.

Study subjects who received the highly structured group intervention showed the most improvement, with a mean decrease of 0.8 percentage points in HbA_1c at 3 months, compared with mean decreases of 0.4 percentage points in both control groups, the investigators said (Arch. Intern. Med. 2011 Oct. 10 [doi:10.1001/archinternmed.2011.502]).

Glycemic control deteriorated slightly but "was basically maintained at 12 months" for both group interventions but not for the individual control condition.

Patients with type 2 diabetes showed more improvement with the structured intervention than did those with type 1 diabetes, with a reduction in HbA_1c of 0.7 percentage points at 3 months, compared with only 0.3 for type 1 diabetes. It may be that patients with type 1 diabetes receive more educational and behavioral support at diagnosis and throughout the course of their disease, and thus do not benefit as much from this intervention, compared with those with type 2 diabetes, Dr. Weinger and her colleagues said.

"Another explanation may be that patients with type 1 diabetes who struggle with achieving glycemic targets need more help with emotional and psychological issues than support with diabetes self-management skills," they added.

Neither the highly structured intervention nor the control conditions significantly improved diabetes-related quality of life, the number of daily meter checks, or the frequency of self-care behaviors.

"Although our participants did not achieve glycemic targets of less than 7% ... we believe that a 0.67% reduction in HbA_1c level observed at 12 months, if sustained over the long term, should by itself result in about a 20% reduction in microvascular end points and about a 10% reduction in cardiovascular end points," Dr. Weinger and her associates wrote.

In the second clinical trial, Dr. JoAnn Sperl-Hillen of HealthPartners Research Foundation, Minneapolis, and her associates also studied patients with poorly controlled type 2 diabetes (HbA_1c levels of 7% or higher). The study subjects were 337 adults residing in Minnesota and 286 in New Mexico. The mean age was 62 years, and the mean duration of diabetes was 12 years.

The researchers assessed a group education program endorsed by the American Diabetes Association that included "Conversation Maps" – a highly interactive group approach using large, laminated tabletop visual aids to facilitate discussions. Topics covered during the 8 hours of the program included healthy eating, monitoring blood sugar, taking medications, problem solving, risk reduction, healthy coping, and increasing physical activity.

This intervention was compared against standard individual diabetes education – three 1-hour sessions with a certified diabetes educator at 1-month intervals – and usual care (no specific diabetes education).

At 6-month follow-up, HbA_1c levels decreased more, by 0.51 percentage points, with the individual diabetes education than with the group intervention (0.24%) or usual care (0.27%). Scores on measures of physical health, nutrition, and physical activity also improved significantly with the individual education but not with group education, compared with usual care, Dr. Sperl-Hillen and her colleagues said (Arch. Intern. Med. 2011 Oct. 10 [doi:10.1001/archinternmed.2011.507]).

Fewer subjects receiving the group intervention than those receiving the individual intervention completed the program, probably because of scheduling difficulties, the authors wrote. Nevertheless, in an analysis restricted to subjects who completed their programs, the results were still better with the individual than with the group intervention.

"We believe that these short-term results support the use of individual diabetes education for this patient population," the investigators said.

Dr. Weinger’s study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institutes of Health, and the Joslin Diabetes Center Clinical Research Center. Abbott Laboratories, LifeScan, and Roche Diagnostics contributed glucose meters and test strips. Dr. Weinger’s associate reported ties to Eli Lilly, Amylin Pharmaceuticals, Takeda, Sanofi-Aventis, and Daiichi-Sankyo. Dr. Sperl-Hillen’s study was funded by Merck. Dr. Sperl-Hillen reported ties to Merck, GlaxoSmithKline, Lilly, and Schering-Plough.

Two patient education interventions improved poorly controlled diabetes modestly in separate studies reported online Oct. 10 in Archives of Internal Medicine.

The first clinical trial compared a "highly structured" group behavioral diabetes education intervention against one group and one individual control education condition in adults who had longstanding, poorly controlled type 1 or type 2 diabetes. The 222 study subjects (110 with type 1 and 112 with type 2 disease) had baseline hemoglobin A_1c levels of 7.5% or higher.

Diabetes nurses or dietitians who were certified diabetes educators ran each program, said Katie Weinger, Ed.D., of the Joslin Diabetes Center and Harvard Medical School, Boston, and her associates.

The highly structured group intervention involved five 2-hour sessions during a 6-week period in which a small group of patients reviewed daily glucose logs and discussed food choices and physical activity. The educators used a structured cognitive-behavioral curriculum to facilitate self-care goal-setting and to help patients identify and overcome barriers to self-care.

The investigators hoped that this intervention would provide "a scaffold that [would] allow participants to integrate specific dietary and physical activity behaviors into their busy schedules."

The group control condition involved the same length of time and the same amount of contact with health professionals but didn’t include any of the cognitive behavior strategies or structured goal-setting activities. The individual control condition gave patients unlimited access to one-on-one appointments with the diabetes educators for 6 months, but did not require that they attend appointments.

"Patients with type 1 diabetes who struggle with achieving glycemic targets [may] need more help with emotional and psychological issues than support with diabetes self-management skills."

The primary outcome measure was improvement in HbA_1c level to a target of less than 7% at 3-, 6-, and 12-month follow-up.

Patients in all three study groups showed statistically significant but modest improvement in glycemic control. Most did not achieve their HbA_1c target level of less than 7%.

Study subjects who received the highly structured group intervention showed the most improvement, with a mean decrease of 0.8 percentage points in HbA_1c at 3 months, compared with mean decreases of 0.4 percentage points in both control groups, the investigators said (Arch. Intern. Med. 2011 Oct. 10 [doi:10.1001/archinternmed.2011.502]).

Glycemic control deteriorated slightly but "was basically maintained at 12 months" for both group interventions but not for the individual control condition.

Patients with type 2 diabetes showed more improvement with the structured intervention than did those with type 1 diabetes, with a reduction in HbA_1c of 0.7 percentage points at 3 months, compared with only 0.3 for type 1 diabetes. It may be that patients with type 1 diabetes receive more educational and behavioral support at diagnosis and throughout the course of their disease, and thus do not benefit as much from this intervention, compared with those with type 2 diabetes, Dr. Weinger and her colleagues said.

"Another explanation may be that patients with type 1 diabetes who struggle with achieving glycemic targets need more help with emotional and psychological issues than support with diabetes self-management skills," they added.

Neither the highly structured intervention nor the control conditions significantly improved diabetes-related quality of life, the number of daily meter checks, or the frequency of self-care behaviors.

"Although our participants did not achieve glycemic targets of less than 7% ... we believe that a 0.67% reduction in HbA_1c level observed at 12 months, if sustained over the long term, should by itself result in about a 20% reduction in microvascular end points and about a 10% reduction in cardiovascular end points," Dr. Weinger and her associates wrote.

In the second clinical trial, Dr. JoAnn Sperl-Hillen of HealthPartners Research Foundation, Minneapolis, and her associates also studied patients with poorly controlled type 2 diabetes (HbA_1c levels of 7% or higher). The study subjects were 337 adults residing in Minnesota and 286 in New Mexico. The mean age was 62 years, and the mean duration of diabetes was 12 years.

The researchers assessed a group education program endorsed by the American Diabetes Association that included "Conversation Maps" – a highly interactive group approach using large, laminated tabletop visual aids to facilitate discussions. Topics covered during the 8 hours of the program included healthy eating, monitoring blood sugar, taking medications, problem solving, risk reduction, healthy coping, and increasing physical activity.

This intervention was compared against standard individual diabetes education – three 1-hour sessions with a certified diabetes educator at 1-month intervals – and usual care (no specific diabetes education).

At 6-month follow-up, HbA_1c levels decreased more, by 0.51 percentage points, with the individual diabetes education than with the group intervention (0.24%) or usual care (0.27%). Scores on measures of physical health, nutrition, and physical activity also improved significantly with the individual education but not with group education, compared with usual care, Dr. Sperl-Hillen and her colleagues said (Arch. Intern. Med. 2011 Oct. 10 [doi:10.1001/archinternmed.2011.507]).

Fewer subjects receiving the group intervention than those receiving the individual intervention completed the program, probably because of scheduling difficulties, the authors wrote. Nevertheless, in an analysis restricted to subjects who completed their programs, the results were still better with the individual than with the group intervention.

"We believe that these short-term results support the use of individual diabetes education for this patient population," the investigators said.

Dr. Weinger’s study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institutes of Health, and the Joslin Diabetes Center Clinical Research Center. Abbott Laboratories, LifeScan, and Roche Diagnostics contributed glucose meters and test strips. Dr. Weinger’s associate reported ties to Eli Lilly, Amylin Pharmaceuticals, Takeda, Sanofi-Aventis, and Daiichi-Sankyo. Dr. Sperl-Hillen’s study was funded by Merck. Dr. Sperl-Hillen reported ties to Merck, GlaxoSmithKline, Lilly, and Schering-Plough.