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Cell Phones Raise Brain Glucose Metabolism Near Device's Antenna
Acute cell phone exposure appears to increase glucose metabolism, a marker of neuronal activity, in the region of the brain adjacent to the device’s antenna, according to a report in the Feb. 23 issue of JAMA.
This brain region received the highest amplitude of radiofrequency-modulated electromagnetic fields (RF-EMFs) from the model of cell phone used in this study, given its position relative to the head during use. The finding suggests that brain absorption of RF-EMF energy emitted by cell phones "may enhance the excitability of brain tissue," wrote Dr. Nora D. Volkow, director of the National Institute on Drug Abuse, and her associates.
They studied brain glucose metabolism in 47 healthy volunteers using PET imaging with the injection of fluorodeoxyglucose-18. The volunteers wore devices that held cell phones in place simultaneously over both ears. As a part of the study’s randomized, crossover design, the investigators scanned the individuals on separate days, once with one cell phone activated but the sound turned off (the "on" condition) and once with both cell phones deactivated (the "off" condition).
Both ears were used "to avoid confounding effects from the expectation of a signal from the side of the brain at which the cell phone was located," the researchers explained.
After 50 minutes of exposure to radiation emitted during the on condition, there was a significant 7% increase in glucose metabolism (35.7 micromol/100 g per minute), compared with the off condition (33.3 micromol/100 g per minute). This occurred only in the right orbitofrontal cortex and the lower part of the right superior temporal gyrus – areas that corresponded to the location of the cell phone antenna.
Moreover, there was a linear relation between cell phone–related increases in metabolism and the estimated rate of radiofrequency energy absorption expected in various brain regions.
A 7% rise in regional metabolism is similar in magnitude to that reported after suprathreshold transcranial magnetic stimulation of the sensorimotor cortex, the investigators noted.
"These results provide evidence that the human brain is sensitive to the effects of RF-EMFs from acute cell phone exposures," Dr. Volkow and her colleagues wrote (JAMA 2011;305:808-14).
The clinical significance of the findings is not yet known. "The question that remains to be studied into the future is 'Could there be potential long-term consequences from repeated stimulation?'" Dr. Volkow said in a press teleconference. "The fact that we are observing changes really highlights the needs to do the studies to be properly able to answer the question of whether cell phone exposure could have harmful effects or not."
Although no safety risk can be inferred from the study, Dr. Volkow recommended that cell phone users who wish to take a conservative approach should use their phone in speaker phone mode or use a hands-free device, particularly for children, whose developing brains could be more at risk from RF activation and are likely to have many more years of cell phone use ahead of them.
The orbitofrontal cortex (OFC) helps to reinforce behaviors according to their context, such that hunger increases the value of food much more than when we are satiated, Dr. Volkow explained. If this area of the brain is damaged in animals, they will eat compulsively.
The OFC is also involved in social behaviors. Dr. Volkow noted the case of the 19th century railroad worker Phineas Gage, whose OFC was destroyed in an accident. Gage had been a very responsible man prior to the accident, but afterward the became completely unreliable and spent part of his life in prison, even though his intellectual abilities had not been disrupted.
However, Dr. Volkow noted that the areas of the brain that absorb RF energy will depend on the location of antenna in the cell phone and how it is held. The cell phone used in the current study was activated on the subject's right side and contained an antenna in the lower part of the phone near the receiver, thereby directing RF energy to the right OFC and lower part of the right superior temporal gyrus.
Previous PET imaging studies of cell phone use have been substantially smaller – the largest having 14 subjects – and may not have had the statistical power to detect small, but significant, signals. Those studies also measured brain activation via cerebral blood flow rather than the more sensitive method of measuring brain glucose metabolism.
The mechanism by which RF-EMFs from cell phones might affect brain glucose metabolism remains unclear. "However, based on findings from in vivo animal and in vitro experiments, it has been hypothesized" that the effect on neuronal activity may be "mediated by changes in cell membrane permeability, calcium efflux, cell excitability, and/or neurotransmitter release," they wrote.
It is important to note that these findings "provide no information as to their relevance regarding potential carcinogenic effects (or lack of such effects) from chronic cell phone use," the researchers added.
This study was performed at Brookhaven National Laboratory and supported by the National Institutes of Health and the Department of Energy. The authors said they had no relevant financial disclosures.
"The results by Volkow et al. add to the concern about possible acute and long-term health effects of radiofrequency emissions from wireless phones," said Henry Lai, Ph.D., and Dr. Lennart Hardell.
"Although the biological significance, if any, of increased glucose metabolism from acute cell phone exposure is unknown, the results warrant further investigation," they noted.
An important question to address is whether brain glucose metabolism would be chronically increased from regular cell phone use – particularly the use of devices with higher radiofrequency energy than those used in this study.
It is also important to note that the cell phones in this study were receiving a call (with the sound muted), which generates less radiofrequency radiation than when a user speaks into a phone. So the effects observed in this study could be even more pronounced "in normal-use situations," they added.
Dr. Lai is in the department of bioengineering at the University of Washington, Seattle. Dr. Hardell is in the department of oncology at University Hospital in Örebro, Sweden. Both said they had no relevant financial disclosures. Their comments were taken from their editorial accompanying Dr. Volkow’s report (JAMA 2011;305:828-9).
"The results by Volkow et al. add to the concern about possible acute and long-term health effects of radiofrequency emissions from wireless phones," said Henry Lai, Ph.D., and Dr. Lennart Hardell.
"Although the biological significance, if any, of increased glucose metabolism from acute cell phone exposure is unknown, the results warrant further investigation," they noted.
An important question to address is whether brain glucose metabolism would be chronically increased from regular cell phone use – particularly the use of devices with higher radiofrequency energy than those used in this study.
It is also important to note that the cell phones in this study were receiving a call (with the sound muted), which generates less radiofrequency radiation than when a user speaks into a phone. So the effects observed in this study could be even more pronounced "in normal-use situations," they added.
Dr. Lai is in the department of bioengineering at the University of Washington, Seattle. Dr. Hardell is in the department of oncology at University Hospital in Örebro, Sweden. Both said they had no relevant financial disclosures. Their comments were taken from their editorial accompanying Dr. Volkow’s report (JAMA 2011;305:828-9).
"The results by Volkow et al. add to the concern about possible acute and long-term health effects of radiofrequency emissions from wireless phones," said Henry Lai, Ph.D., and Dr. Lennart Hardell.
"Although the biological significance, if any, of increased glucose metabolism from acute cell phone exposure is unknown, the results warrant further investigation," they noted.
An important question to address is whether brain glucose metabolism would be chronically increased from regular cell phone use – particularly the use of devices with higher radiofrequency energy than those used in this study.
It is also important to note that the cell phones in this study were receiving a call (with the sound muted), which generates less radiofrequency radiation than when a user speaks into a phone. So the effects observed in this study could be even more pronounced "in normal-use situations," they added.
Dr. Lai is in the department of bioengineering at the University of Washington, Seattle. Dr. Hardell is in the department of oncology at University Hospital in Örebro, Sweden. Both said they had no relevant financial disclosures. Their comments were taken from their editorial accompanying Dr. Volkow’s report (JAMA 2011;305:828-9).
Acute cell phone exposure appears to increase glucose metabolism, a marker of neuronal activity, in the region of the brain adjacent to the device’s antenna, according to a report in the Feb. 23 issue of JAMA.
This brain region received the highest amplitude of radiofrequency-modulated electromagnetic fields (RF-EMFs) from the model of cell phone used in this study, given its position relative to the head during use. The finding suggests that brain absorption of RF-EMF energy emitted by cell phones "may enhance the excitability of brain tissue," wrote Dr. Nora D. Volkow, director of the National Institute on Drug Abuse, and her associates.
They studied brain glucose metabolism in 47 healthy volunteers using PET imaging with the injection of fluorodeoxyglucose-18. The volunteers wore devices that held cell phones in place simultaneously over both ears. As a part of the study’s randomized, crossover design, the investigators scanned the individuals on separate days, once with one cell phone activated but the sound turned off (the "on" condition) and once with both cell phones deactivated (the "off" condition).
Both ears were used "to avoid confounding effects from the expectation of a signal from the side of the brain at which the cell phone was located," the researchers explained.
After 50 minutes of exposure to radiation emitted during the on condition, there was a significant 7% increase in glucose metabolism (35.7 micromol/100 g per minute), compared with the off condition (33.3 micromol/100 g per minute). This occurred only in the right orbitofrontal cortex and the lower part of the right superior temporal gyrus – areas that corresponded to the location of the cell phone antenna.
Moreover, there was a linear relation between cell phone–related increases in metabolism and the estimated rate of radiofrequency energy absorption expected in various brain regions.
A 7% rise in regional metabolism is similar in magnitude to that reported after suprathreshold transcranial magnetic stimulation of the sensorimotor cortex, the investigators noted.
"These results provide evidence that the human brain is sensitive to the effects of RF-EMFs from acute cell phone exposures," Dr. Volkow and her colleagues wrote (JAMA 2011;305:808-14).
The clinical significance of the findings is not yet known. "The question that remains to be studied into the future is 'Could there be potential long-term consequences from repeated stimulation?'" Dr. Volkow said in a press teleconference. "The fact that we are observing changes really highlights the needs to do the studies to be properly able to answer the question of whether cell phone exposure could have harmful effects or not."
Although no safety risk can be inferred from the study, Dr. Volkow recommended that cell phone users who wish to take a conservative approach should use their phone in speaker phone mode or use a hands-free device, particularly for children, whose developing brains could be more at risk from RF activation and are likely to have many more years of cell phone use ahead of them.
The orbitofrontal cortex (OFC) helps to reinforce behaviors according to their context, such that hunger increases the value of food much more than when we are satiated, Dr. Volkow explained. If this area of the brain is damaged in animals, they will eat compulsively.
The OFC is also involved in social behaviors. Dr. Volkow noted the case of the 19th century railroad worker Phineas Gage, whose OFC was destroyed in an accident. Gage had been a very responsible man prior to the accident, but afterward the became completely unreliable and spent part of his life in prison, even though his intellectual abilities had not been disrupted.
However, Dr. Volkow noted that the areas of the brain that absorb RF energy will depend on the location of antenna in the cell phone and how it is held. The cell phone used in the current study was activated on the subject's right side and contained an antenna in the lower part of the phone near the receiver, thereby directing RF energy to the right OFC and lower part of the right superior temporal gyrus.
Previous PET imaging studies of cell phone use have been substantially smaller – the largest having 14 subjects – and may not have had the statistical power to detect small, but significant, signals. Those studies also measured brain activation via cerebral blood flow rather than the more sensitive method of measuring brain glucose metabolism.
The mechanism by which RF-EMFs from cell phones might affect brain glucose metabolism remains unclear. "However, based on findings from in vivo animal and in vitro experiments, it has been hypothesized" that the effect on neuronal activity may be "mediated by changes in cell membrane permeability, calcium efflux, cell excitability, and/or neurotransmitter release," they wrote.
It is important to note that these findings "provide no information as to their relevance regarding potential carcinogenic effects (or lack of such effects) from chronic cell phone use," the researchers added.
This study was performed at Brookhaven National Laboratory and supported by the National Institutes of Health and the Department of Energy. The authors said they had no relevant financial disclosures.
Acute cell phone exposure appears to increase glucose metabolism, a marker of neuronal activity, in the region of the brain adjacent to the device’s antenna, according to a report in the Feb. 23 issue of JAMA.
This brain region received the highest amplitude of radiofrequency-modulated electromagnetic fields (RF-EMFs) from the model of cell phone used in this study, given its position relative to the head during use. The finding suggests that brain absorption of RF-EMF energy emitted by cell phones "may enhance the excitability of brain tissue," wrote Dr. Nora D. Volkow, director of the National Institute on Drug Abuse, and her associates.
They studied brain glucose metabolism in 47 healthy volunteers using PET imaging with the injection of fluorodeoxyglucose-18. The volunteers wore devices that held cell phones in place simultaneously over both ears. As a part of the study’s randomized, crossover design, the investigators scanned the individuals on separate days, once with one cell phone activated but the sound turned off (the "on" condition) and once with both cell phones deactivated (the "off" condition).
Both ears were used "to avoid confounding effects from the expectation of a signal from the side of the brain at which the cell phone was located," the researchers explained.
After 50 minutes of exposure to radiation emitted during the on condition, there was a significant 7% increase in glucose metabolism (35.7 micromol/100 g per minute), compared with the off condition (33.3 micromol/100 g per minute). This occurred only in the right orbitofrontal cortex and the lower part of the right superior temporal gyrus – areas that corresponded to the location of the cell phone antenna.
Moreover, there was a linear relation between cell phone–related increases in metabolism and the estimated rate of radiofrequency energy absorption expected in various brain regions.
A 7% rise in regional metabolism is similar in magnitude to that reported after suprathreshold transcranial magnetic stimulation of the sensorimotor cortex, the investigators noted.
"These results provide evidence that the human brain is sensitive to the effects of RF-EMFs from acute cell phone exposures," Dr. Volkow and her colleagues wrote (JAMA 2011;305:808-14).
The clinical significance of the findings is not yet known. "The question that remains to be studied into the future is 'Could there be potential long-term consequences from repeated stimulation?'" Dr. Volkow said in a press teleconference. "The fact that we are observing changes really highlights the needs to do the studies to be properly able to answer the question of whether cell phone exposure could have harmful effects or not."
Although no safety risk can be inferred from the study, Dr. Volkow recommended that cell phone users who wish to take a conservative approach should use their phone in speaker phone mode or use a hands-free device, particularly for children, whose developing brains could be more at risk from RF activation and are likely to have many more years of cell phone use ahead of them.
The orbitofrontal cortex (OFC) helps to reinforce behaviors according to their context, such that hunger increases the value of food much more than when we are satiated, Dr. Volkow explained. If this area of the brain is damaged in animals, they will eat compulsively.
The OFC is also involved in social behaviors. Dr. Volkow noted the case of the 19th century railroad worker Phineas Gage, whose OFC was destroyed in an accident. Gage had been a very responsible man prior to the accident, but afterward the became completely unreliable and spent part of his life in prison, even though his intellectual abilities had not been disrupted.
However, Dr. Volkow noted that the areas of the brain that absorb RF energy will depend on the location of antenna in the cell phone and how it is held. The cell phone used in the current study was activated on the subject's right side and contained an antenna in the lower part of the phone near the receiver, thereby directing RF energy to the right OFC and lower part of the right superior temporal gyrus.
Previous PET imaging studies of cell phone use have been substantially smaller – the largest having 14 subjects – and may not have had the statistical power to detect small, but significant, signals. Those studies also measured brain activation via cerebral blood flow rather than the more sensitive method of measuring brain glucose metabolism.
The mechanism by which RF-EMFs from cell phones might affect brain glucose metabolism remains unclear. "However, based on findings from in vivo animal and in vitro experiments, it has been hypothesized" that the effect on neuronal activity may be "mediated by changes in cell membrane permeability, calcium efflux, cell excitability, and/or neurotransmitter release," they wrote.
It is important to note that these findings "provide no information as to their relevance regarding potential carcinogenic effects (or lack of such effects) from chronic cell phone use," the researchers added.
This study was performed at Brookhaven National Laboratory and supported by the National Institutes of Health and the Department of Energy. The authors said they had no relevant financial disclosures.
FROM JAMA
Major Finding: Exposure to an activated cell phone for 50 minutes raised glucose metabolism by 7% in brain regions adjacent to the device’s antenna.
Data Source: A randomized, crossover study of 47 healthy volunteers.
Disclosures: This study was performed at Brookhaven National Laboratory and supported by the National Institutes of Health and the Department of Energy. The authors said they had no relevant financial disclosures.
Cell Phones Raise Brain Glucose Metabolism Near Device's Antenna
Acute cell phone exposure appears to increase glucose metabolism, a marker of neuronal activity, in the region of the brain adjacent to the device’s antenna, according to a report in the Feb. 23 issue of JAMA.
This brain region received the highest amplitude of radiofrequency-modulated electromagnetic fields (RF-EMFs) from the model of cell phone used in this study, given its position relative to the head during use. The finding suggests that brain absorption of RF-EMF energy emitted by cell phones "may enhance the excitability of brain tissue," wrote Dr. Nora D. Volkow, director of the National Institute on Drug Abuse, and her associates.
They studied brain glucose metabolism in 47 healthy volunteers using PET imaging with the injection of fluorodeoxyglucose-18. The volunteers wore devices that held cell phones in place simultaneously over both ears. As a part of the study’s randomized, crossover design, the investigators scanned the individuals on separate days, once with one cell phone activated but the sound turned off (the "on" condition) and once with both cell phones deactivated (the "off" condition).
Both ears were used "to avoid confounding effects from the expectation of a signal from the side of the brain at which the cell phone was located," the researchers explained.
After 50 minutes of exposure to radiation emitted during the on condition, there was a significant 7% increase in glucose metabolism (35.7 micromol/100 g per minute), compared with the off condition (33.3 micromol/100 g per minute). This occurred only in the right orbitofrontal cortex and the lower part of the right superior temporal gyrus – areas that corresponded to the location of the cell phone antenna.
Moreover, there was a linear relation between cell phone–related increases in metabolism and the estimated rate of radiofrequency energy absorption expected in various brain regions.
A 7% rise in regional metabolism is similar in magnitude to that reported after suprathreshold transcranial magnetic stimulation of the sensorimotor cortex, the investigators noted.
"These results provide evidence that the human brain is sensitive to the effects of RF-EMFs from acute cell phone exposures," Dr. Volkow and her colleagues wrote (JAMA 2011;305:808-14).
The clinical significance of the findings is not yet known. "The question that remains to be studied into the future is 'Could there be potential long-term consequences from repeated stimulation?'" Dr. Volkow said in a press teleconference. "The fact that we are observing changes really highlights the needs to do the studies to be properly able to answer the question of whether cell phone exposure could have harmful effects or not."
Although no safety risk can be inferred from the study, Dr. Volkow recommended that cell phone users who wish to take a conservative approach should use their phone in speaker phone mode or use a hands-free device, particularly for children, whose developing brains could be more at risk from RF activation and are likely to have many more years of cell phone use ahead of them.
The orbitofrontal cortex (OFC) helps to reinforce behaviors according to their context, such that hunger increases the value of food much more than when we are satiated, Dr. Volkow explained. If this area of the brain is damaged in animals, they will eat compulsively.
The OFC is also involved in social behaviors. Dr. Volkow noted the case of the 19th century railroad worker Phineas Gage, whose OFC was destroyed in an accident. Gage had been a very responsible man prior to the accident, but afterward the became completely unreliable and spent part of his life in prison, even though his intellectual abilities had not been disrupted.
However, Dr. Volkow noted that the areas of the brain that absorb RF energy will depend on the location of antenna in the cell phone and how it is held. The cell phone used in the current study was activated on the subject's right side and contained an antenna in the lower part of the phone near the receiver, thereby directing RF energy to the right OFC and lower part of the right superior temporal gyrus.
Previous PET imaging studies of cell phone use have been substantially smaller – the largest having 14 subjects – and may not have had the statistical power to detect small, but significant, signals. Those studies also measured brain activation via cerebral blood flow rather than the more sensitive method of measuring brain glucose metabolism.
The mechanism by which RF-EMFs from cell phones might affect brain glucose metabolism remains unclear. "However, based on findings from in vivo animal and in vitro experiments, it has been hypothesized" that the effect on neuronal activity may be "mediated by changes in cell membrane permeability, calcium efflux, cell excitability, and/or neurotransmitter release," they wrote.
It is important to note that these findings "provide no information as to their relevance regarding potential carcinogenic effects (or lack of such effects) from chronic cell phone use," the researchers added.
This study was performed at Brookhaven National Laboratory and supported by the National Institutes of Health and the Department of Energy. The authors said they had no relevant financial disclosures.
"The results by Volkow et al. add to the concern about possible acute and long-term health effects of radiofrequency emissions from wireless phones," said Henry Lai, Ph.D., and Dr. Lennart Hardell.
"Although the biological significance, if any, of increased glucose metabolism from acute cell phone exposure is unknown, the results warrant further investigation," they noted.
An important question to address is whether brain glucose metabolism would be chronically increased from regular cell phone use – particularly the use of devices with higher radiofrequency energy than those used in this study.
It is also important to note that the cell phones in this study were receiving a call (with the sound muted), which generates less radiofrequency radiation than when a user speaks into a phone. So the effects observed in this study could be even more pronounced "in normal-use situations," they added.
Dr. Lai is in the department of bioengineering at the University of Washington, Seattle. Dr. Hardell is in the department of oncology at University Hospital in Örebro, Sweden. Both said they had no relevant financial disclosures. Their comments were taken from their editorial accompanying Dr. Volkow’s report (JAMA 2011;305:828-9).
"The results by Volkow et al. add to the concern about possible acute and long-term health effects of radiofrequency emissions from wireless phones," said Henry Lai, Ph.D., and Dr. Lennart Hardell.
"Although the biological significance, if any, of increased glucose metabolism from acute cell phone exposure is unknown, the results warrant further investigation," they noted.
An important question to address is whether brain glucose metabolism would be chronically increased from regular cell phone use – particularly the use of devices with higher radiofrequency energy than those used in this study.
It is also important to note that the cell phones in this study were receiving a call (with the sound muted), which generates less radiofrequency radiation than when a user speaks into a phone. So the effects observed in this study could be even more pronounced "in normal-use situations," they added.
Dr. Lai is in the department of bioengineering at the University of Washington, Seattle. Dr. Hardell is in the department of oncology at University Hospital in Örebro, Sweden. Both said they had no relevant financial disclosures. Their comments were taken from their editorial accompanying Dr. Volkow’s report (JAMA 2011;305:828-9).
"The results by Volkow et al. add to the concern about possible acute and long-term health effects of radiofrequency emissions from wireless phones," said Henry Lai, Ph.D., and Dr. Lennart Hardell.
"Although the biological significance, if any, of increased glucose metabolism from acute cell phone exposure is unknown, the results warrant further investigation," they noted.
An important question to address is whether brain glucose metabolism would be chronically increased from regular cell phone use – particularly the use of devices with higher radiofrequency energy than those used in this study.
It is also important to note that the cell phones in this study were receiving a call (with the sound muted), which generates less radiofrequency radiation than when a user speaks into a phone. So the effects observed in this study could be even more pronounced "in normal-use situations," they added.
Dr. Lai is in the department of bioengineering at the University of Washington, Seattle. Dr. Hardell is in the department of oncology at University Hospital in Örebro, Sweden. Both said they had no relevant financial disclosures. Their comments were taken from their editorial accompanying Dr. Volkow’s report (JAMA 2011;305:828-9).
Acute cell phone exposure appears to increase glucose metabolism, a marker of neuronal activity, in the region of the brain adjacent to the device’s antenna, according to a report in the Feb. 23 issue of JAMA.
This brain region received the highest amplitude of radiofrequency-modulated electromagnetic fields (RF-EMFs) from the model of cell phone used in this study, given its position relative to the head during use. The finding suggests that brain absorption of RF-EMF energy emitted by cell phones "may enhance the excitability of brain tissue," wrote Dr. Nora D. Volkow, director of the National Institute on Drug Abuse, and her associates.
They studied brain glucose metabolism in 47 healthy volunteers using PET imaging with the injection of fluorodeoxyglucose-18. The volunteers wore devices that held cell phones in place simultaneously over both ears. As a part of the study’s randomized, crossover design, the investigators scanned the individuals on separate days, once with one cell phone activated but the sound turned off (the "on" condition) and once with both cell phones deactivated (the "off" condition).
Both ears were used "to avoid confounding effects from the expectation of a signal from the side of the brain at which the cell phone was located," the researchers explained.
After 50 minutes of exposure to radiation emitted during the on condition, there was a significant 7% increase in glucose metabolism (35.7 micromol/100 g per minute), compared with the off condition (33.3 micromol/100 g per minute). This occurred only in the right orbitofrontal cortex and the lower part of the right superior temporal gyrus – areas that corresponded to the location of the cell phone antenna.
Moreover, there was a linear relation between cell phone–related increases in metabolism and the estimated rate of radiofrequency energy absorption expected in various brain regions.
A 7% rise in regional metabolism is similar in magnitude to that reported after suprathreshold transcranial magnetic stimulation of the sensorimotor cortex, the investigators noted.
"These results provide evidence that the human brain is sensitive to the effects of RF-EMFs from acute cell phone exposures," Dr. Volkow and her colleagues wrote (JAMA 2011;305:808-14).
The clinical significance of the findings is not yet known. "The question that remains to be studied into the future is 'Could there be potential long-term consequences from repeated stimulation?'" Dr. Volkow said in a press teleconference. "The fact that we are observing changes really highlights the needs to do the studies to be properly able to answer the question of whether cell phone exposure could have harmful effects or not."
Although no safety risk can be inferred from the study, Dr. Volkow recommended that cell phone users who wish to take a conservative approach should use their phone in speaker phone mode or use a hands-free device, particularly for children, whose developing brains could be more at risk from RF activation and are likely to have many more years of cell phone use ahead of them.
The orbitofrontal cortex (OFC) helps to reinforce behaviors according to their context, such that hunger increases the value of food much more than when we are satiated, Dr. Volkow explained. If this area of the brain is damaged in animals, they will eat compulsively.
The OFC is also involved in social behaviors. Dr. Volkow noted the case of the 19th century railroad worker Phineas Gage, whose OFC was destroyed in an accident. Gage had been a very responsible man prior to the accident, but afterward the became completely unreliable and spent part of his life in prison, even though his intellectual abilities had not been disrupted.
However, Dr. Volkow noted that the areas of the brain that absorb RF energy will depend on the location of antenna in the cell phone and how it is held. The cell phone used in the current study was activated on the subject's right side and contained an antenna in the lower part of the phone near the receiver, thereby directing RF energy to the right OFC and lower part of the right superior temporal gyrus.
Previous PET imaging studies of cell phone use have been substantially smaller – the largest having 14 subjects – and may not have had the statistical power to detect small, but significant, signals. Those studies also measured brain activation via cerebral blood flow rather than the more sensitive method of measuring brain glucose metabolism.
The mechanism by which RF-EMFs from cell phones might affect brain glucose metabolism remains unclear. "However, based on findings from in vivo animal and in vitro experiments, it has been hypothesized" that the effect on neuronal activity may be "mediated by changes in cell membrane permeability, calcium efflux, cell excitability, and/or neurotransmitter release," they wrote.
It is important to note that these findings "provide no information as to their relevance regarding potential carcinogenic effects (or lack of such effects) from chronic cell phone use," the researchers added.
This study was performed at Brookhaven National Laboratory and supported by the National Institutes of Health and the Department of Energy. The authors said they had no relevant financial disclosures.
Acute cell phone exposure appears to increase glucose metabolism, a marker of neuronal activity, in the region of the brain adjacent to the device’s antenna, according to a report in the Feb. 23 issue of JAMA.
This brain region received the highest amplitude of radiofrequency-modulated electromagnetic fields (RF-EMFs) from the model of cell phone used in this study, given its position relative to the head during use. The finding suggests that brain absorption of RF-EMF energy emitted by cell phones "may enhance the excitability of brain tissue," wrote Dr. Nora D. Volkow, director of the National Institute on Drug Abuse, and her associates.
They studied brain glucose metabolism in 47 healthy volunteers using PET imaging with the injection of fluorodeoxyglucose-18. The volunteers wore devices that held cell phones in place simultaneously over both ears. As a part of the study’s randomized, crossover design, the investigators scanned the individuals on separate days, once with one cell phone activated but the sound turned off (the "on" condition) and once with both cell phones deactivated (the "off" condition).
Both ears were used "to avoid confounding effects from the expectation of a signal from the side of the brain at which the cell phone was located," the researchers explained.
After 50 minutes of exposure to radiation emitted during the on condition, there was a significant 7% increase in glucose metabolism (35.7 micromol/100 g per minute), compared with the off condition (33.3 micromol/100 g per minute). This occurred only in the right orbitofrontal cortex and the lower part of the right superior temporal gyrus – areas that corresponded to the location of the cell phone antenna.
Moreover, there was a linear relation between cell phone–related increases in metabolism and the estimated rate of radiofrequency energy absorption expected in various brain regions.
A 7% rise in regional metabolism is similar in magnitude to that reported after suprathreshold transcranial magnetic stimulation of the sensorimotor cortex, the investigators noted.
"These results provide evidence that the human brain is sensitive to the effects of RF-EMFs from acute cell phone exposures," Dr. Volkow and her colleagues wrote (JAMA 2011;305:808-14).
The clinical significance of the findings is not yet known. "The question that remains to be studied into the future is 'Could there be potential long-term consequences from repeated stimulation?'" Dr. Volkow said in a press teleconference. "The fact that we are observing changes really highlights the needs to do the studies to be properly able to answer the question of whether cell phone exposure could have harmful effects or not."
Although no safety risk can be inferred from the study, Dr. Volkow recommended that cell phone users who wish to take a conservative approach should use their phone in speaker phone mode or use a hands-free device, particularly for children, whose developing brains could be more at risk from RF activation and are likely to have many more years of cell phone use ahead of them.
The orbitofrontal cortex (OFC) helps to reinforce behaviors according to their context, such that hunger increases the value of food much more than when we are satiated, Dr. Volkow explained. If this area of the brain is damaged in animals, they will eat compulsively.
The OFC is also involved in social behaviors. Dr. Volkow noted the case of the 19th century railroad worker Phineas Gage, whose OFC was destroyed in an accident. Gage had been a very responsible man prior to the accident, but afterward the became completely unreliable and spent part of his life in prison, even though his intellectual abilities had not been disrupted.
However, Dr. Volkow noted that the areas of the brain that absorb RF energy will depend on the location of antenna in the cell phone and how it is held. The cell phone used in the current study was activated on the subject's right side and contained an antenna in the lower part of the phone near the receiver, thereby directing RF energy to the right OFC and lower part of the right superior temporal gyrus.
Previous PET imaging studies of cell phone use have been substantially smaller – the largest having 14 subjects – and may not have had the statistical power to detect small, but significant, signals. Those studies also measured brain activation via cerebral blood flow rather than the more sensitive method of measuring brain glucose metabolism.
The mechanism by which RF-EMFs from cell phones might affect brain glucose metabolism remains unclear. "However, based on findings from in vivo animal and in vitro experiments, it has been hypothesized" that the effect on neuronal activity may be "mediated by changes in cell membrane permeability, calcium efflux, cell excitability, and/or neurotransmitter release," they wrote.
It is important to note that these findings "provide no information as to their relevance regarding potential carcinogenic effects (or lack of such effects) from chronic cell phone use," the researchers added.
This study was performed at Brookhaven National Laboratory and supported by the National Institutes of Health and the Department of Energy. The authors said they had no relevant financial disclosures.
FROM JAMA
Major Finding: Exposure to an activated cell phone for 50 minutes raised glucose metabolism by 7% in brain regions adjacent to the device’s antenna.
Data Source: A randomized, crossover study of 47 healthy volunteers.
Disclosures: This study was performed at Brookhaven National Laboratory and supported by the National Institutes of Health and the Department of Energy. The authors said they had no relevant financial disclosures.
Gastric Bypass That Excludes Duodenum More Likely to Resolve Diabetes
For non–morbidly obese patients with poorly controlled type 2 diabetes, gastric bypass surgery with exclusion of the duodenum was much more likely to resolve diabetes than was a simpler, purely restrictive procedure that does not exclude the duodenum, according to a report in the February issue of the Archives of Surgery.
However, the relative safety of the purely restrictive procedure may make it a better first choice than gastric bypass surgery for many patients, the study’s authors said.
Diabetes resolved in 28 of 30 (93%) patients who underwent gastric bypass that prevented contact between ingested food and the duodenum, compared with only 14 of 30 (47%) who underwent sleeve gastrectomy that did not prevent such contact. The study is the first randomized trial to examine surgical treatment’s effect on non–morbidly obese patients with a body mass index (BMI) less than 35 kg/m2 and poorly controlled type 2 diabetes, the researchers said.
Both groups of patients showed significant weight loss and improvement in such metabolic measures as waist circumference, HbA1c levels, and insulin levels. But those improvements were more frequent and more extensive in the patients who underwent full gastric bypass.
The findings strongly support the hypothesis that the duodenum plays a large role in the resolution of diabetes following bariatric surgery. "The mechanism seems to relate to postprandial glucose metabolism rather than to an increase in insulin secretion, and is independent of weight reduction," said Dr. Wei-Jei Lee of Min-Sheng General Hospital, National Taiwan (China) University, and associates (Arch. Surg. 2011;146:143-8).
In the double-blind study, 60 patients aged 34-58 years were randomly assigned to undergo one of the two operations using standard laparoscopic techniques. The mean BMI was 30.3, and the average age was 45 years. All patients had been seeing an endocrinologist for type 2 diabetes for at least 6 months but continued to have poorly controlled disease, with a mean HbA1c level of 10% (range, 7.5%-15%).
The primary end point – glycemic control at 12 months without the use of oral hypoglycemic agents or insulin – was achieved by significantly more patients in the gastric bypass group (93%) than in the sleeve gastrectomy group (47%).
"These results corroborate previous reports that gastric bypass may achieve an 80% diabetes mellitus remission and pure restrictive-type procedures may achieve a rate of approximately 50%," the researchers wrote.
Although weight loss was similar between the two groups, patients who underwent full gastric bypass also showed a smaller waist circumference, lower fasting plasma glucose levels, lower HbA1c levels, and lower blood lipid levels – in short, a higher rate of remission of the metabolic syndrome (93% vs. 40%). Their blood pressure, insulin levels, and C-peptide levels also were lower than were those in the sleeve gastrectomy group.
There were no deaths or major complications, and minor complications developed in three patients in each group.
However, it is important to note that restrictive procedures such as sleeve gastrectomy or gastric banding are 10-fold safer than the more-complex gastric bypass procedures, the investigators cautioned. In addition, those two restrictive procedures avoid the long-term sequela of micronutrient deficiency that sometimes follows duodenum exclusion. Thus should be considered the first choice for many patients, Dr. Lee and colleagues said.
In contrast, gastric bypass might be a better choice for patients with metabolic syndrome or hyperlipidemia, they noted.
The mechanism by which exclusion of the duodenum and upper jejunum reverses diabetes (the so-called foregut theory) has not been fully explained, and "without data regarding the change in gut hormones, such as glucagon, gastric inhibitory peptide, and glucagon-like peptide 1, we cannot elucidate the underlying mechanisms," the researchers added.
Given the 1-year follow-up of the study, the study’s authors said they also could not confirm the durability of diabetes remission in such patients, or the influence of future changes in weight.
No financial conflicts of interest were reported.
For non–morbidly obese patients with poorly controlled type 2 diabetes, gastric bypass surgery with exclusion of the duodenum was much more likely to resolve diabetes than was a simpler, purely restrictive procedure that does not exclude the duodenum, according to a report in the February issue of the Archives of Surgery.
However, the relative safety of the purely restrictive procedure may make it a better first choice than gastric bypass surgery for many patients, the study’s authors said.
Diabetes resolved in 28 of 30 (93%) patients who underwent gastric bypass that prevented contact between ingested food and the duodenum, compared with only 14 of 30 (47%) who underwent sleeve gastrectomy that did not prevent such contact. The study is the first randomized trial to examine surgical treatment’s effect on non–morbidly obese patients with a body mass index (BMI) less than 35 kg/m2 and poorly controlled type 2 diabetes, the researchers said.
Both groups of patients showed significant weight loss and improvement in such metabolic measures as waist circumference, HbA1c levels, and insulin levels. But those improvements were more frequent and more extensive in the patients who underwent full gastric bypass.
The findings strongly support the hypothesis that the duodenum plays a large role in the resolution of diabetes following bariatric surgery. "The mechanism seems to relate to postprandial glucose metabolism rather than to an increase in insulin secretion, and is independent of weight reduction," said Dr. Wei-Jei Lee of Min-Sheng General Hospital, National Taiwan (China) University, and associates (Arch. Surg. 2011;146:143-8).
In the double-blind study, 60 patients aged 34-58 years were randomly assigned to undergo one of the two operations using standard laparoscopic techniques. The mean BMI was 30.3, and the average age was 45 years. All patients had been seeing an endocrinologist for type 2 diabetes for at least 6 months but continued to have poorly controlled disease, with a mean HbA1c level of 10% (range, 7.5%-15%).
The primary end point – glycemic control at 12 months without the use of oral hypoglycemic agents or insulin – was achieved by significantly more patients in the gastric bypass group (93%) than in the sleeve gastrectomy group (47%).
"These results corroborate previous reports that gastric bypass may achieve an 80% diabetes mellitus remission and pure restrictive-type procedures may achieve a rate of approximately 50%," the researchers wrote.
Although weight loss was similar between the two groups, patients who underwent full gastric bypass also showed a smaller waist circumference, lower fasting plasma glucose levels, lower HbA1c levels, and lower blood lipid levels – in short, a higher rate of remission of the metabolic syndrome (93% vs. 40%). Their blood pressure, insulin levels, and C-peptide levels also were lower than were those in the sleeve gastrectomy group.
There were no deaths or major complications, and minor complications developed in three patients in each group.
However, it is important to note that restrictive procedures such as sleeve gastrectomy or gastric banding are 10-fold safer than the more-complex gastric bypass procedures, the investigators cautioned. In addition, those two restrictive procedures avoid the long-term sequela of micronutrient deficiency that sometimes follows duodenum exclusion. Thus should be considered the first choice for many patients, Dr. Lee and colleagues said.
In contrast, gastric bypass might be a better choice for patients with metabolic syndrome or hyperlipidemia, they noted.
The mechanism by which exclusion of the duodenum and upper jejunum reverses diabetes (the so-called foregut theory) has not been fully explained, and "without data regarding the change in gut hormones, such as glucagon, gastric inhibitory peptide, and glucagon-like peptide 1, we cannot elucidate the underlying mechanisms," the researchers added.
Given the 1-year follow-up of the study, the study’s authors said they also could not confirm the durability of diabetes remission in such patients, or the influence of future changes in weight.
No financial conflicts of interest were reported.
For non–morbidly obese patients with poorly controlled type 2 diabetes, gastric bypass surgery with exclusion of the duodenum was much more likely to resolve diabetes than was a simpler, purely restrictive procedure that does not exclude the duodenum, according to a report in the February issue of the Archives of Surgery.
However, the relative safety of the purely restrictive procedure may make it a better first choice than gastric bypass surgery for many patients, the study’s authors said.
Diabetes resolved in 28 of 30 (93%) patients who underwent gastric bypass that prevented contact between ingested food and the duodenum, compared with only 14 of 30 (47%) who underwent sleeve gastrectomy that did not prevent such contact. The study is the first randomized trial to examine surgical treatment’s effect on non–morbidly obese patients with a body mass index (BMI) less than 35 kg/m2 and poorly controlled type 2 diabetes, the researchers said.
Both groups of patients showed significant weight loss and improvement in such metabolic measures as waist circumference, HbA1c levels, and insulin levels. But those improvements were more frequent and more extensive in the patients who underwent full gastric bypass.
The findings strongly support the hypothesis that the duodenum plays a large role in the resolution of diabetes following bariatric surgery. "The mechanism seems to relate to postprandial glucose metabolism rather than to an increase in insulin secretion, and is independent of weight reduction," said Dr. Wei-Jei Lee of Min-Sheng General Hospital, National Taiwan (China) University, and associates (Arch. Surg. 2011;146:143-8).
In the double-blind study, 60 patients aged 34-58 years were randomly assigned to undergo one of the two operations using standard laparoscopic techniques. The mean BMI was 30.3, and the average age was 45 years. All patients had been seeing an endocrinologist for type 2 diabetes for at least 6 months but continued to have poorly controlled disease, with a mean HbA1c level of 10% (range, 7.5%-15%).
The primary end point – glycemic control at 12 months without the use of oral hypoglycemic agents or insulin – was achieved by significantly more patients in the gastric bypass group (93%) than in the sleeve gastrectomy group (47%).
"These results corroborate previous reports that gastric bypass may achieve an 80% diabetes mellitus remission and pure restrictive-type procedures may achieve a rate of approximately 50%," the researchers wrote.
Although weight loss was similar between the two groups, patients who underwent full gastric bypass also showed a smaller waist circumference, lower fasting plasma glucose levels, lower HbA1c levels, and lower blood lipid levels – in short, a higher rate of remission of the metabolic syndrome (93% vs. 40%). Their blood pressure, insulin levels, and C-peptide levels also were lower than were those in the sleeve gastrectomy group.
There were no deaths or major complications, and minor complications developed in three patients in each group.
However, it is important to note that restrictive procedures such as sleeve gastrectomy or gastric banding are 10-fold safer than the more-complex gastric bypass procedures, the investigators cautioned. In addition, those two restrictive procedures avoid the long-term sequela of micronutrient deficiency that sometimes follows duodenum exclusion. Thus should be considered the first choice for many patients, Dr. Lee and colleagues said.
In contrast, gastric bypass might be a better choice for patients with metabolic syndrome or hyperlipidemia, they noted.
The mechanism by which exclusion of the duodenum and upper jejunum reverses diabetes (the so-called foregut theory) has not been fully explained, and "without data regarding the change in gut hormones, such as glucagon, gastric inhibitory peptide, and glucagon-like peptide 1, we cannot elucidate the underlying mechanisms," the researchers added.
Given the 1-year follow-up of the study, the study’s authors said they also could not confirm the durability of diabetes remission in such patients, or the influence of future changes in weight.
No financial conflicts of interest were reported.
FROM THE ARCHIVES OF SURGERY
Gastric Bypass That Excludes Duodenum More Likely to Resolve Diabetes
For non–morbidly obese patients with poorly controlled type 2 diabetes, gastric bypass surgery with exclusion of the duodenum was much more likely to resolve diabetes than was a simpler, purely restrictive procedure that does not exclude the duodenum, according to a report in the February issue of the Archives of Surgery.
However, the relative safety of the purely restrictive procedure may make it a better first choice than gastric bypass surgery for many patients, the study’s authors said.
Diabetes resolved in 28 of 30 (93%) patients who underwent gastric bypass that prevented contact between ingested food and the duodenum, compared with only 14 of 30 (47%) who underwent sleeve gastrectomy that did not prevent such contact. The study is the first randomized trial to examine surgical treatment’s effect on non–morbidly obese patients with a body mass index (BMI) less than 35 kg/m2 and poorly controlled type 2 diabetes, the researchers said.
Both groups of patients showed significant weight loss and improvement in such metabolic measures as waist circumference, HbA1c levels, and insulin levels. But those improvements were more frequent and more extensive in the patients who underwent full gastric bypass.
The findings strongly support the hypothesis that the duodenum plays a large role in the resolution of diabetes following bariatric surgery. "The mechanism seems to relate to postprandial glucose metabolism rather than to an increase in insulin secretion, and is independent of weight reduction," said Dr. Wei-Jei Lee of Min-Sheng General Hospital, National Taiwan (China) University, and associates (Arch. Surg. 2011;146:143-8).
In the double-blind study, 60 patients aged 34-58 years were randomly assigned to undergo one of the two operations using standard laparoscopic techniques. The mean BMI was 30.3, and the average age was 45 years. All patients had been seeing an endocrinologist for type 2 diabetes for at least 6 months but continued to have poorly controlled disease, with a mean HbA1c level of 10% (range, 7.5%-15%).
The primary end point – glycemic control at 12 months without the use of oral hypoglycemic agents or insulin – was achieved by significantly more patients in the gastric bypass group (93%) than in the sleeve gastrectomy group (47%).
"These results corroborate previous reports that gastric bypass may achieve an 80% diabetes mellitus remission and pure restrictive-type procedures may achieve a rate of approximately 50%," the researchers wrote.
Although weight loss was similar between the two groups, patients who underwent full gastric bypass also showed a smaller waist circumference, lower fasting plasma glucose levels, lower HbA1c levels, and lower blood lipid levels – in short, a higher rate of remission of the metabolic syndrome (93% vs. 40%). Their blood pressure, insulin levels, and C-peptide levels also were lower than were those in the sleeve gastrectomy group.
There were no deaths or major complications, and minor complications developed in three patients in each group.
However, it is important to note that restrictive procedures such as sleeve gastrectomy or gastric banding are 10-fold safer than the more-complex gastric bypass procedures, the investigators cautioned. In addition, those two restrictive procedures avoid the long-term sequela of micronutrient deficiency that sometimes follows duodenum exclusion. Thus should be considered the first choice for many patients, Dr. Lee and colleagues said.
In contrast, gastric bypass might be a better choice for patients with metabolic syndrome or hyperlipidemia, they noted.
The mechanism by which exclusion of the duodenum and upper jejunum reverses diabetes (the so-called foregut theory) has not been fully explained, and "without data regarding the change in gut hormones, such as glucagon, gastric inhibitory peptide, and glucagon-like peptide 1, we cannot elucidate the underlying mechanisms," the researchers added.
Given the 1-year follow-up of the study, the study’s authors said they also could not confirm the durability of diabetes remission in such patients, or the influence of future changes in weight.
No financial conflicts of interest were reported.
For non–morbidly obese patients with poorly controlled type 2 diabetes, gastric bypass surgery with exclusion of the duodenum was much more likely to resolve diabetes than was a simpler, purely restrictive procedure that does not exclude the duodenum, according to a report in the February issue of the Archives of Surgery.
However, the relative safety of the purely restrictive procedure may make it a better first choice than gastric bypass surgery for many patients, the study’s authors said.
Diabetes resolved in 28 of 30 (93%) patients who underwent gastric bypass that prevented contact between ingested food and the duodenum, compared with only 14 of 30 (47%) who underwent sleeve gastrectomy that did not prevent such contact. The study is the first randomized trial to examine surgical treatment’s effect on non–morbidly obese patients with a body mass index (BMI) less than 35 kg/m2 and poorly controlled type 2 diabetes, the researchers said.
Both groups of patients showed significant weight loss and improvement in such metabolic measures as waist circumference, HbA1c levels, and insulin levels. But those improvements were more frequent and more extensive in the patients who underwent full gastric bypass.
The findings strongly support the hypothesis that the duodenum plays a large role in the resolution of diabetes following bariatric surgery. "The mechanism seems to relate to postprandial glucose metabolism rather than to an increase in insulin secretion, and is independent of weight reduction," said Dr. Wei-Jei Lee of Min-Sheng General Hospital, National Taiwan (China) University, and associates (Arch. Surg. 2011;146:143-8).
In the double-blind study, 60 patients aged 34-58 years were randomly assigned to undergo one of the two operations using standard laparoscopic techniques. The mean BMI was 30.3, and the average age was 45 years. All patients had been seeing an endocrinologist for type 2 diabetes for at least 6 months but continued to have poorly controlled disease, with a mean HbA1c level of 10% (range, 7.5%-15%).
The primary end point – glycemic control at 12 months without the use of oral hypoglycemic agents or insulin – was achieved by significantly more patients in the gastric bypass group (93%) than in the sleeve gastrectomy group (47%).
"These results corroborate previous reports that gastric bypass may achieve an 80% diabetes mellitus remission and pure restrictive-type procedures may achieve a rate of approximately 50%," the researchers wrote.
Although weight loss was similar between the two groups, patients who underwent full gastric bypass also showed a smaller waist circumference, lower fasting plasma glucose levels, lower HbA1c levels, and lower blood lipid levels – in short, a higher rate of remission of the metabolic syndrome (93% vs. 40%). Their blood pressure, insulin levels, and C-peptide levels also were lower than were those in the sleeve gastrectomy group.
There were no deaths or major complications, and minor complications developed in three patients in each group.
However, it is important to note that restrictive procedures such as sleeve gastrectomy or gastric banding are 10-fold safer than the more-complex gastric bypass procedures, the investigators cautioned. In addition, those two restrictive procedures avoid the long-term sequela of micronutrient deficiency that sometimes follows duodenum exclusion. Thus should be considered the first choice for many patients, Dr. Lee and colleagues said.
In contrast, gastric bypass might be a better choice for patients with metabolic syndrome or hyperlipidemia, they noted.
The mechanism by which exclusion of the duodenum and upper jejunum reverses diabetes (the so-called foregut theory) has not been fully explained, and "without data regarding the change in gut hormones, such as glucagon, gastric inhibitory peptide, and glucagon-like peptide 1, we cannot elucidate the underlying mechanisms," the researchers added.
Given the 1-year follow-up of the study, the study’s authors said they also could not confirm the durability of diabetes remission in such patients, or the influence of future changes in weight.
No financial conflicts of interest were reported.
For non–morbidly obese patients with poorly controlled type 2 diabetes, gastric bypass surgery with exclusion of the duodenum was much more likely to resolve diabetes than was a simpler, purely restrictive procedure that does not exclude the duodenum, according to a report in the February issue of the Archives of Surgery.
However, the relative safety of the purely restrictive procedure may make it a better first choice than gastric bypass surgery for many patients, the study’s authors said.
Diabetes resolved in 28 of 30 (93%) patients who underwent gastric bypass that prevented contact between ingested food and the duodenum, compared with only 14 of 30 (47%) who underwent sleeve gastrectomy that did not prevent such contact. The study is the first randomized trial to examine surgical treatment’s effect on non–morbidly obese patients with a body mass index (BMI) less than 35 kg/m2 and poorly controlled type 2 diabetes, the researchers said.
Both groups of patients showed significant weight loss and improvement in such metabolic measures as waist circumference, HbA1c levels, and insulin levels. But those improvements were more frequent and more extensive in the patients who underwent full gastric bypass.
The findings strongly support the hypothesis that the duodenum plays a large role in the resolution of diabetes following bariatric surgery. "The mechanism seems to relate to postprandial glucose metabolism rather than to an increase in insulin secretion, and is independent of weight reduction," said Dr. Wei-Jei Lee of Min-Sheng General Hospital, National Taiwan (China) University, and associates (Arch. Surg. 2011;146:143-8).
In the double-blind study, 60 patients aged 34-58 years were randomly assigned to undergo one of the two operations using standard laparoscopic techniques. The mean BMI was 30.3, and the average age was 45 years. All patients had been seeing an endocrinologist for type 2 diabetes for at least 6 months but continued to have poorly controlled disease, with a mean HbA1c level of 10% (range, 7.5%-15%).
The primary end point – glycemic control at 12 months without the use of oral hypoglycemic agents or insulin – was achieved by significantly more patients in the gastric bypass group (93%) than in the sleeve gastrectomy group (47%).
"These results corroborate previous reports that gastric bypass may achieve an 80% diabetes mellitus remission and pure restrictive-type procedures may achieve a rate of approximately 50%," the researchers wrote.
Although weight loss was similar between the two groups, patients who underwent full gastric bypass also showed a smaller waist circumference, lower fasting plasma glucose levels, lower HbA1c levels, and lower blood lipid levels – in short, a higher rate of remission of the metabolic syndrome (93% vs. 40%). Their blood pressure, insulin levels, and C-peptide levels also were lower than were those in the sleeve gastrectomy group.
There were no deaths or major complications, and minor complications developed in three patients in each group.
However, it is important to note that restrictive procedures such as sleeve gastrectomy or gastric banding are 10-fold safer than the more-complex gastric bypass procedures, the investigators cautioned. In addition, those two restrictive procedures avoid the long-term sequela of micronutrient deficiency that sometimes follows duodenum exclusion. Thus should be considered the first choice for many patients, Dr. Lee and colleagues said.
In contrast, gastric bypass might be a better choice for patients with metabolic syndrome or hyperlipidemia, they noted.
The mechanism by which exclusion of the duodenum and upper jejunum reverses diabetes (the so-called foregut theory) has not been fully explained, and "without data regarding the change in gut hormones, such as glucagon, gastric inhibitory peptide, and glucagon-like peptide 1, we cannot elucidate the underlying mechanisms," the researchers added.
Given the 1-year follow-up of the study, the study’s authors said they also could not confirm the durability of diabetes remission in such patients, or the influence of future changes in weight.
No financial conflicts of interest were reported.
FROM THE ARCHIVES OF SURGERY
Major Finding: Type 2 diabetes resolved in 93% of patients who underwent gastric bypass surgery with exclusion of the duodenum, compared with 47% of patients who underwent sleeve gastrectomy.
Data Source: A double-blind, randomized trial comparing gastric bypass surgery that excludes the duodenum against the simpler sleeve gastrectomy procedure that does not, in 60 patients with poorly controlled type 2 diabetes and a BMI of 25-35 kg/m2.
Disclosures: No financial conflicts of interest were reported.
Quadruple Treatment Including Bismuth Found Superior Against H. pylori
Quadruple therapy consisting of omeprazole plus a capsule combining bismuth subcitrate potassium, metronidazole, and tetracycline was superior at eradicating Helicobacter pylori infection, compared with the "gold standard" of three separate capsules containing omeprazole, amoxicillin, and clarithromycin, according to a report published online Feb. 21 in the Lancet.
The eradication rate in the intention-to-treat population was 80% with quadruple therapy and 55% with standard triple therapy (given for 10 days and 7 days, respectively), and the main reason for this difference was resistance to the clarithromycin in standard therapy. "Although rates of metronidazole resistance are also high, clarithromycin resistance reduces the efficacy of standard therapy, whereas metronidazole resistance has little effect on the efficacy of quadruple therapy," said Dr. Peter Malfertheiner of Otto-von-Guericke University in Magdeburg, Germany, and his associates in the Pylera Study Group.
This randomized, multicenter, phase III clinical trial is "the first large-scale comparative study of the efficacy and safety of standard and quadruple therapy for the eradication of H. pylori in nearly a decade." Antimicrobial resistance has increased during that time, and newer formulations of quadruple therapy needed to be assessed, the authors noted.
Although this study was designed as a noninferiority trial, it was powered to detect superiority.
The trial was conducted at 39 sites in France, Germany, Ireland, Italy, Poland, Spain, and the United Kingdom. The study was completed by a total of 204 patients who were assigned to receive quadruple therapy, and 195 who were assigned to receive standard triple therapy.
The primary efficacy outcome was eradication of H. pylori as established by two negative urea breath tests performed approximately 6 weeks and 10 weeks after treatment was concluded. This outcome was achieved in 93% of the quadruple therapy group in the per-protocol population, compared with 70% of the standard therapy group.
"Treatment with quadruple therapy fulfilled criteria for noninferiority to standard therapy in the per-protocol population. Accordingly, the intention-to-treat population was used for superiority testing, and quadruple therapy was significantly better than standard therapy in eradicating H. pylori," the investigators said (Lancet 2011 [doi:10.1016/S0140-6736(11)60020-2]).
Post hoc analysis confirmed the superiority of quadruple therapy in the study population as a whole. Further analyses of subgroups of patients showed that it remained superior regardless of whether patients had peptic ulcer disease or nonulcer dyspepsia.
The percentage of patients with treatment-emergent adverse events was similar between the two groups (approximately 50%), as was the percentage who discontinued therapy because of adverse effects (fewer than 2%). Severe adverse effects were more frequent with standard therapy.
Previous reports have raised concerns about toxic effects related to bismuth, with rare reports of heavy-metal poisoning and encephalopathy. "In our trial, with little bismuth exposure and use of a colloidal-bismuth subcitrate formulation, bismuth concentrations were below the toxic threshold," which should reassure clinicians on this point, Dr. Malfertheiner and his colleagues said.
The study findings suggest that "in regions with high levels of clarithromycin resistance, treatment with quadruple therapy should be considered as first-line therapy for H. pylori eradication."
This study was designed and funded by Axcan Pharma, maker of the bismuth-metronidazole-tetracycline capsule. Some of the authors received payment from Axcan for research and clinical trials. Two of the authors are Axcan employees.
Dr. Malfertheiner and colleagues "nicely show that bismuth-containing quadruple therapy is effective and acceptable for first-line therapy to eradicate H. pylori in regions with high levels of clarithromycin resistance," wrote Dr. Byoung Hwan Lee and Dr. Nayoung Kim.
In previous studies in which the four drug components of quadruple therapy were taken in separate capsules, adverse effects were more common and more severe. This interfered with compliance, which resulted in a lower eradication rate, they wrote.
It is intriguing that the side-effect profile was much better when the bismuth, metronidazole, and tetracycline were combined in a single capsule in this study. Compliance was not affected, and the eradication rate was much improved, they noted.
However, the ideal treatment duration with bismuth-containing therapy still remains controversial, and the optimal dose of tetracycline in the combination capsule warrants further study, Dr. Lee and Dr. Kim added.
Dr. Lee and Dr. Kim are in the department of internal medicine at Seoul (South Korea) National University. They reported no financial conflicts of interest. These remarks were taken from their editorial comment (Lancet 2011 Feb. 21 [doi:10.1016/S0140-6736(11)60168-2]) accompanying Dr. Malfertheiner’s report.
Dr. Malfertheiner and colleagues "nicely show that bismuth-containing quadruple therapy is effective and acceptable for first-line therapy to eradicate H. pylori in regions with high levels of clarithromycin resistance," wrote Dr. Byoung Hwan Lee and Dr. Nayoung Kim.
In previous studies in which the four drug components of quadruple therapy were taken in separate capsules, adverse effects were more common and more severe. This interfered with compliance, which resulted in a lower eradication rate, they wrote.
It is intriguing that the side-effect profile was much better when the bismuth, metronidazole, and tetracycline were combined in a single capsule in this study. Compliance was not affected, and the eradication rate was much improved, they noted.
However, the ideal treatment duration with bismuth-containing therapy still remains controversial, and the optimal dose of tetracycline in the combination capsule warrants further study, Dr. Lee and Dr. Kim added.
Dr. Lee and Dr. Kim are in the department of internal medicine at Seoul (South Korea) National University. They reported no financial conflicts of interest. These remarks were taken from their editorial comment (Lancet 2011 Feb. 21 [doi:10.1016/S0140-6736(11)60168-2]) accompanying Dr. Malfertheiner’s report.
Dr. Malfertheiner and colleagues "nicely show that bismuth-containing quadruple therapy is effective and acceptable for first-line therapy to eradicate H. pylori in regions with high levels of clarithromycin resistance," wrote Dr. Byoung Hwan Lee and Dr. Nayoung Kim.
In previous studies in which the four drug components of quadruple therapy were taken in separate capsules, adverse effects were more common and more severe. This interfered with compliance, which resulted in a lower eradication rate, they wrote.
It is intriguing that the side-effect profile was much better when the bismuth, metronidazole, and tetracycline were combined in a single capsule in this study. Compliance was not affected, and the eradication rate was much improved, they noted.
However, the ideal treatment duration with bismuth-containing therapy still remains controversial, and the optimal dose of tetracycline in the combination capsule warrants further study, Dr. Lee and Dr. Kim added.
Dr. Lee and Dr. Kim are in the department of internal medicine at Seoul (South Korea) National University. They reported no financial conflicts of interest. These remarks were taken from their editorial comment (Lancet 2011 Feb. 21 [doi:10.1016/S0140-6736(11)60168-2]) accompanying Dr. Malfertheiner’s report.
Quadruple therapy consisting of omeprazole plus a capsule combining bismuth subcitrate potassium, metronidazole, and tetracycline was superior at eradicating Helicobacter pylori infection, compared with the "gold standard" of three separate capsules containing omeprazole, amoxicillin, and clarithromycin, according to a report published online Feb. 21 in the Lancet.
The eradication rate in the intention-to-treat population was 80% with quadruple therapy and 55% with standard triple therapy (given for 10 days and 7 days, respectively), and the main reason for this difference was resistance to the clarithromycin in standard therapy. "Although rates of metronidazole resistance are also high, clarithromycin resistance reduces the efficacy of standard therapy, whereas metronidazole resistance has little effect on the efficacy of quadruple therapy," said Dr. Peter Malfertheiner of Otto-von-Guericke University in Magdeburg, Germany, and his associates in the Pylera Study Group.
This randomized, multicenter, phase III clinical trial is "the first large-scale comparative study of the efficacy and safety of standard and quadruple therapy for the eradication of H. pylori in nearly a decade." Antimicrobial resistance has increased during that time, and newer formulations of quadruple therapy needed to be assessed, the authors noted.
Although this study was designed as a noninferiority trial, it was powered to detect superiority.
The trial was conducted at 39 sites in France, Germany, Ireland, Italy, Poland, Spain, and the United Kingdom. The study was completed by a total of 204 patients who were assigned to receive quadruple therapy, and 195 who were assigned to receive standard triple therapy.
The primary efficacy outcome was eradication of H. pylori as established by two negative urea breath tests performed approximately 6 weeks and 10 weeks after treatment was concluded. This outcome was achieved in 93% of the quadruple therapy group in the per-protocol population, compared with 70% of the standard therapy group.
"Treatment with quadruple therapy fulfilled criteria for noninferiority to standard therapy in the per-protocol population. Accordingly, the intention-to-treat population was used for superiority testing, and quadruple therapy was significantly better than standard therapy in eradicating H. pylori," the investigators said (Lancet 2011 [doi:10.1016/S0140-6736(11)60020-2]).
Post hoc analysis confirmed the superiority of quadruple therapy in the study population as a whole. Further analyses of subgroups of patients showed that it remained superior regardless of whether patients had peptic ulcer disease or nonulcer dyspepsia.
The percentage of patients with treatment-emergent adverse events was similar between the two groups (approximately 50%), as was the percentage who discontinued therapy because of adverse effects (fewer than 2%). Severe adverse effects were more frequent with standard therapy.
Previous reports have raised concerns about toxic effects related to bismuth, with rare reports of heavy-metal poisoning and encephalopathy. "In our trial, with little bismuth exposure and use of a colloidal-bismuth subcitrate formulation, bismuth concentrations were below the toxic threshold," which should reassure clinicians on this point, Dr. Malfertheiner and his colleagues said.
The study findings suggest that "in regions with high levels of clarithromycin resistance, treatment with quadruple therapy should be considered as first-line therapy for H. pylori eradication."
This study was designed and funded by Axcan Pharma, maker of the bismuth-metronidazole-tetracycline capsule. Some of the authors received payment from Axcan for research and clinical trials. Two of the authors are Axcan employees.
Quadruple therapy consisting of omeprazole plus a capsule combining bismuth subcitrate potassium, metronidazole, and tetracycline was superior at eradicating Helicobacter pylori infection, compared with the "gold standard" of three separate capsules containing omeprazole, amoxicillin, and clarithromycin, according to a report published online Feb. 21 in the Lancet.
The eradication rate in the intention-to-treat population was 80% with quadruple therapy and 55% with standard triple therapy (given for 10 days and 7 days, respectively), and the main reason for this difference was resistance to the clarithromycin in standard therapy. "Although rates of metronidazole resistance are also high, clarithromycin resistance reduces the efficacy of standard therapy, whereas metronidazole resistance has little effect on the efficacy of quadruple therapy," said Dr. Peter Malfertheiner of Otto-von-Guericke University in Magdeburg, Germany, and his associates in the Pylera Study Group.
This randomized, multicenter, phase III clinical trial is "the first large-scale comparative study of the efficacy and safety of standard and quadruple therapy for the eradication of H. pylori in nearly a decade." Antimicrobial resistance has increased during that time, and newer formulations of quadruple therapy needed to be assessed, the authors noted.
Although this study was designed as a noninferiority trial, it was powered to detect superiority.
The trial was conducted at 39 sites in France, Germany, Ireland, Italy, Poland, Spain, and the United Kingdom. The study was completed by a total of 204 patients who were assigned to receive quadruple therapy, and 195 who were assigned to receive standard triple therapy.
The primary efficacy outcome was eradication of H. pylori as established by two negative urea breath tests performed approximately 6 weeks and 10 weeks after treatment was concluded. This outcome was achieved in 93% of the quadruple therapy group in the per-protocol population, compared with 70% of the standard therapy group.
"Treatment with quadruple therapy fulfilled criteria for noninferiority to standard therapy in the per-protocol population. Accordingly, the intention-to-treat population was used for superiority testing, and quadruple therapy was significantly better than standard therapy in eradicating H. pylori," the investigators said (Lancet 2011 [doi:10.1016/S0140-6736(11)60020-2]).
Post hoc analysis confirmed the superiority of quadruple therapy in the study population as a whole. Further analyses of subgroups of patients showed that it remained superior regardless of whether patients had peptic ulcer disease or nonulcer dyspepsia.
The percentage of patients with treatment-emergent adverse events was similar between the two groups (approximately 50%), as was the percentage who discontinued therapy because of adverse effects (fewer than 2%). Severe adverse effects were more frequent with standard therapy.
Previous reports have raised concerns about toxic effects related to bismuth, with rare reports of heavy-metal poisoning and encephalopathy. "In our trial, with little bismuth exposure and use of a colloidal-bismuth subcitrate formulation, bismuth concentrations were below the toxic threshold," which should reassure clinicians on this point, Dr. Malfertheiner and his colleagues said.
The study findings suggest that "in regions with high levels of clarithromycin resistance, treatment with quadruple therapy should be considered as first-line therapy for H. pylori eradication."
This study was designed and funded by Axcan Pharma, maker of the bismuth-metronidazole-tetracycline capsule. Some of the authors received payment from Axcan for research and clinical trials. Two of the authors are Axcan employees.
FROM THE LANCET
Quadruple Treatment Including Bismuth Found Superior Against H. pylori
Quadruple therapy consisting of omeprazole plus a capsule combining bismuth subcitrate potassium, metronidazole, and tetracycline was superior at eradicating Helicobacter pylori infection, compared with the "gold standard" of three separate capsules containing omeprazole, amoxicillin, and clarithromycin, according to a report published online Feb. 21 in the Lancet.
The eradication rate in the intention-to-treat population was 80% with quadruple therapy and 55% with standard triple therapy (given for 10 days and 7 days, respectively), and the main reason for this difference was resistance to the clarithromycin in standard therapy. "Although rates of metronidazole resistance are also high, clarithromycin resistance reduces the efficacy of standard therapy, whereas metronidazole resistance has little effect on the efficacy of quadruple therapy," said Dr. Peter Malfertheiner of Otto-von-Guericke University in Magdeburg, Germany, and his associates in the Pylera Study Group.
This randomized, multicenter, phase III clinical trial is "the first large-scale comparative study of the efficacy and safety of standard and quadruple therapy for the eradication of H. pylori in nearly a decade." Antimicrobial resistance has increased during that time, and newer formulations of quadruple therapy needed to be assessed, the authors noted.
Although this study was designed as a noninferiority trial, it was powered to detect superiority.
The trial was conducted at 39 sites in France, Germany, Ireland, Italy, Poland, Spain, and the United Kingdom. The study was completed by a total of 204 patients who were assigned to receive quadruple therapy, and 195 who were assigned to receive standard triple therapy.
The primary efficacy outcome was eradication of H. pylori as established by two negative urea breath tests performed approximately 6 weeks and 10 weeks after treatment was concluded. This outcome was achieved in 93% of the quadruple therapy group in the per-protocol population, compared with 70% of the standard therapy group.
"Treatment with quadruple therapy fulfilled criteria for noninferiority to standard therapy in the per-protocol population. Accordingly, the intention-to-treat population was used for superiority testing, and quadruple therapy was significantly better than standard therapy in eradicating H. pylori," the investigators said (Lancet 2011 [doi:10.1016/S0140-6736(11)60020-2]).
Post hoc analysis confirmed the superiority of quadruple therapy in the study population as a whole. Further analyses of subgroups of patients showed that it remained superior regardless of whether patients had peptic ulcer disease or nonulcer dyspepsia.
The percentage of patients with treatment-emergent adverse events was similar between the two groups (approximately 50%), as was the percentage who discontinued therapy because of adverse effects (fewer than 2%). Severe adverse effects were more frequent with standard therapy.
Previous reports have raised concerns about toxic effects related to bismuth, with rare reports of heavy-metal poisoning and encephalopathy. "In our trial, with little bismuth exposure and use of a colloidal-bismuth subcitrate formulation, bismuth concentrations were below the toxic threshold," which should reassure clinicians on this point, Dr. Malfertheiner and his colleagues said.
The study findings suggest that "in regions with high levels of clarithromycin resistance, treatment with quadruple therapy should be considered as first-line therapy for H. pylori eradication."
This study was designed and funded by Axcan Pharma, maker of the bismuth-metronidazole-tetracycline capsule. Some of the authors received payment from Axcan for research and clinical trials. Two of the authors are Axcan employees.
Dr. Malfertheiner and colleagues "nicely show that bismuth-containing quadruple therapy is effective and acceptable for first-line therapy to eradicate H. pylori in regions with high levels of clarithromycin resistance," wrote Dr. Byoung Hwan Lee and Dr. Nayoung Kim.
In previous studies in which the four drug components of quadruple therapy were taken in separate capsules, adverse effects were more common and more severe. This interfered with compliance, which resulted in a lower eradication rate, they wrote.
It is intriguing that the side-effect profile was much better when the bismuth, metronidazole, and tetracycline were combined in a single capsule in this study. Compliance was not affected, and the eradication rate was much improved, they noted.
However, the ideal treatment duration with bismuth-containing therapy still remains controversial, and the optimal dose of tetracycline in the combination capsule warrants further study, Dr. Lee and Dr. Kim added.
Dr. Lee and Dr. Kim are in the department of internal medicine at Seoul (South Korea) National University. They reported no financial conflicts of interest. These remarks were taken from their editorial comment (Lancet 2011 Feb. 21 [doi:10.1016/S0140-6736(11)60168-2]) accompanying Dr. Malfertheiner’s report.
Dr. Malfertheiner and colleagues "nicely show that bismuth-containing quadruple therapy is effective and acceptable for first-line therapy to eradicate H. pylori in regions with high levels of clarithromycin resistance," wrote Dr. Byoung Hwan Lee and Dr. Nayoung Kim.
In previous studies in which the four drug components of quadruple therapy were taken in separate capsules, adverse effects were more common and more severe. This interfered with compliance, which resulted in a lower eradication rate, they wrote.
It is intriguing that the side-effect profile was much better when the bismuth, metronidazole, and tetracycline were combined in a single capsule in this study. Compliance was not affected, and the eradication rate was much improved, they noted.
However, the ideal treatment duration with bismuth-containing therapy still remains controversial, and the optimal dose of tetracycline in the combination capsule warrants further study, Dr. Lee and Dr. Kim added.
Dr. Lee and Dr. Kim are in the department of internal medicine at Seoul (South Korea) National University. They reported no financial conflicts of interest. These remarks were taken from their editorial comment (Lancet 2011 Feb. 21 [doi:10.1016/S0140-6736(11)60168-2]) accompanying Dr. Malfertheiner’s report.
Dr. Malfertheiner and colleagues "nicely show that bismuth-containing quadruple therapy is effective and acceptable for first-line therapy to eradicate H. pylori in regions with high levels of clarithromycin resistance," wrote Dr. Byoung Hwan Lee and Dr. Nayoung Kim.
In previous studies in which the four drug components of quadruple therapy were taken in separate capsules, adverse effects were more common and more severe. This interfered with compliance, which resulted in a lower eradication rate, they wrote.
It is intriguing that the side-effect profile was much better when the bismuth, metronidazole, and tetracycline were combined in a single capsule in this study. Compliance was not affected, and the eradication rate was much improved, they noted.
However, the ideal treatment duration with bismuth-containing therapy still remains controversial, and the optimal dose of tetracycline in the combination capsule warrants further study, Dr. Lee and Dr. Kim added.
Dr. Lee and Dr. Kim are in the department of internal medicine at Seoul (South Korea) National University. They reported no financial conflicts of interest. These remarks were taken from their editorial comment (Lancet 2011 Feb. 21 [doi:10.1016/S0140-6736(11)60168-2]) accompanying Dr. Malfertheiner’s report.
Quadruple therapy consisting of omeprazole plus a capsule combining bismuth subcitrate potassium, metronidazole, and tetracycline was superior at eradicating Helicobacter pylori infection, compared with the "gold standard" of three separate capsules containing omeprazole, amoxicillin, and clarithromycin, according to a report published online Feb. 21 in the Lancet.
The eradication rate in the intention-to-treat population was 80% with quadruple therapy and 55% with standard triple therapy (given for 10 days and 7 days, respectively), and the main reason for this difference was resistance to the clarithromycin in standard therapy. "Although rates of metronidazole resistance are also high, clarithromycin resistance reduces the efficacy of standard therapy, whereas metronidazole resistance has little effect on the efficacy of quadruple therapy," said Dr. Peter Malfertheiner of Otto-von-Guericke University in Magdeburg, Germany, and his associates in the Pylera Study Group.
This randomized, multicenter, phase III clinical trial is "the first large-scale comparative study of the efficacy and safety of standard and quadruple therapy for the eradication of H. pylori in nearly a decade." Antimicrobial resistance has increased during that time, and newer formulations of quadruple therapy needed to be assessed, the authors noted.
Although this study was designed as a noninferiority trial, it was powered to detect superiority.
The trial was conducted at 39 sites in France, Germany, Ireland, Italy, Poland, Spain, and the United Kingdom. The study was completed by a total of 204 patients who were assigned to receive quadruple therapy, and 195 who were assigned to receive standard triple therapy.
The primary efficacy outcome was eradication of H. pylori as established by two negative urea breath tests performed approximately 6 weeks and 10 weeks after treatment was concluded. This outcome was achieved in 93% of the quadruple therapy group in the per-protocol population, compared with 70% of the standard therapy group.
"Treatment with quadruple therapy fulfilled criteria for noninferiority to standard therapy in the per-protocol population. Accordingly, the intention-to-treat population was used for superiority testing, and quadruple therapy was significantly better than standard therapy in eradicating H. pylori," the investigators said (Lancet 2011 [doi:10.1016/S0140-6736(11)60020-2]).
Post hoc analysis confirmed the superiority of quadruple therapy in the study population as a whole. Further analyses of subgroups of patients showed that it remained superior regardless of whether patients had peptic ulcer disease or nonulcer dyspepsia.
The percentage of patients with treatment-emergent adverse events was similar between the two groups (approximately 50%), as was the percentage who discontinued therapy because of adverse effects (fewer than 2%). Severe adverse effects were more frequent with standard therapy.
Previous reports have raised concerns about toxic effects related to bismuth, with rare reports of heavy-metal poisoning and encephalopathy. "In our trial, with little bismuth exposure and use of a colloidal-bismuth subcitrate formulation, bismuth concentrations were below the toxic threshold," which should reassure clinicians on this point, Dr. Malfertheiner and his colleagues said.
The study findings suggest that "in regions with high levels of clarithromycin resistance, treatment with quadruple therapy should be considered as first-line therapy for H. pylori eradication."
This study was designed and funded by Axcan Pharma, maker of the bismuth-metronidazole-tetracycline capsule. Some of the authors received payment from Axcan for research and clinical trials. Two of the authors are Axcan employees.
Quadruple therapy consisting of omeprazole plus a capsule combining bismuth subcitrate potassium, metronidazole, and tetracycline was superior at eradicating Helicobacter pylori infection, compared with the "gold standard" of three separate capsules containing omeprazole, amoxicillin, and clarithromycin, according to a report published online Feb. 21 in the Lancet.
The eradication rate in the intention-to-treat population was 80% with quadruple therapy and 55% with standard triple therapy (given for 10 days and 7 days, respectively), and the main reason for this difference was resistance to the clarithromycin in standard therapy. "Although rates of metronidazole resistance are also high, clarithromycin resistance reduces the efficacy of standard therapy, whereas metronidazole resistance has little effect on the efficacy of quadruple therapy," said Dr. Peter Malfertheiner of Otto-von-Guericke University in Magdeburg, Germany, and his associates in the Pylera Study Group.
This randomized, multicenter, phase III clinical trial is "the first large-scale comparative study of the efficacy and safety of standard and quadruple therapy for the eradication of H. pylori in nearly a decade." Antimicrobial resistance has increased during that time, and newer formulations of quadruple therapy needed to be assessed, the authors noted.
Although this study was designed as a noninferiority trial, it was powered to detect superiority.
The trial was conducted at 39 sites in France, Germany, Ireland, Italy, Poland, Spain, and the United Kingdom. The study was completed by a total of 204 patients who were assigned to receive quadruple therapy, and 195 who were assigned to receive standard triple therapy.
The primary efficacy outcome was eradication of H. pylori as established by two negative urea breath tests performed approximately 6 weeks and 10 weeks after treatment was concluded. This outcome was achieved in 93% of the quadruple therapy group in the per-protocol population, compared with 70% of the standard therapy group.
"Treatment with quadruple therapy fulfilled criteria for noninferiority to standard therapy in the per-protocol population. Accordingly, the intention-to-treat population was used for superiority testing, and quadruple therapy was significantly better than standard therapy in eradicating H. pylori," the investigators said (Lancet 2011 [doi:10.1016/S0140-6736(11)60020-2]).
Post hoc analysis confirmed the superiority of quadruple therapy in the study population as a whole. Further analyses of subgroups of patients showed that it remained superior regardless of whether patients had peptic ulcer disease or nonulcer dyspepsia.
The percentage of patients with treatment-emergent adverse events was similar between the two groups (approximately 50%), as was the percentage who discontinued therapy because of adverse effects (fewer than 2%). Severe adverse effects were more frequent with standard therapy.
Previous reports have raised concerns about toxic effects related to bismuth, with rare reports of heavy-metal poisoning and encephalopathy. "In our trial, with little bismuth exposure and use of a colloidal-bismuth subcitrate formulation, bismuth concentrations were below the toxic threshold," which should reassure clinicians on this point, Dr. Malfertheiner and his colleagues said.
The study findings suggest that "in regions with high levels of clarithromycin resistance, treatment with quadruple therapy should be considered as first-line therapy for H. pylori eradication."
This study was designed and funded by Axcan Pharma, maker of the bismuth-metronidazole-tetracycline capsule. Some of the authors received payment from Axcan for research and clinical trials. Two of the authors are Axcan employees.
FROM THE LANCET
Major Finding: Eradication of H. pylori was achieved in 80% of patients treated with quadruple therapy, compared with only 55% treated with the "gold standard" of triple therapy, in the intention-to-treat population. The corresponding eradication rates were 93% and 70%, respectively, in the per-protocol population.
Data Source: A randomized, open-label, noninferiority, phase III clinical trial involving 399 patients treated at 39 sites across Europe.
Disclosures: This study was designed and funded by Axcan Pharma, maker of the bismuth-metronidazole-tetracycline capsule. Some of the authors received payment for Axcan for research and clinical trials. Two of the authors are Axcan employees.
Epidemiology of Chronic Pancreatitis Shows Major Shift
The profile of patients with chronic pancreatitis has changed dramatically, with a precipitous drop in the proportion of cases related to alcohol and an upsurge in those with other etiologies, Dr. Gregory A. Coté and his colleagues reported online in Clinical Gastroenterology and Hepatology.
"The era of dismissing all cases of chronic pancreatitis as alcohol induced has undoubtedly come to a close," said Dr. Coté of Indiana University, Indianapolis, and his associates.
Historically, heavy alcohol use has been implicated as the cause of chronic pancreatitis in 60%-90% of cases diagnosed in Western countries, but recent reports from Europe and Japan have suggested that a wider spectrum of etiologies is emerging. Dr. Coté and his colleagues in the North American Pancreatitis Study 2 used information in the NAPS2 database to characterize the current epidemiology of the disease in the United States (Clin. Gastroenterol. Hepatol. 2011 March [doi:10.1016/j.cgh.2010.10.015]).
The database includes prospectively enrolled patients treated at 19 academic and community practice referral centers with expertise in pancreatic disorders. This analysis, which the researchers described as "the largest epidemiologic study of chronic pancreatitis from the United States," included 539 patients (mean age, 49 years), of whom 53% were men and 85% were white; the study also included 695 controls.
Referring physicians cited one or more possible etiologies for each patient’s chronic pancreatitis from the following list: alcohol related; idiopathic (no known cause); or unrelated to alcohol, a category that included hereditary diseases, cystic fibrosis, pancreas divisum, autoimmune disorders, hyperlipidemia, hypercalcemia, trauma, or other known causes.
The referring physicians identified alcohol as the sole cause in 35% of cases and as a contributing factor in another 9%. This represents a marked decrease from the 60%-90% of cases attributed to alcohol historically, the investigators noted.
The majority of subjects in whom alcohol was not a contributing factor were equally distributed among the other etiologic categories.
Another "remarkable finding" was that more than one-fourth of all patients had no identifiable cause for their chronic pancreatitis. Data on trends in alcohol consumption are mixed "and do not explain the impressive shift in the etiologic profile," Dr. Coté and his associates said. They posited several reasons that might explain these findings.
First, there may have been referral bias in that patients who are actively drinking might be less likely to seek a referral to expert centers, and physicians caring for such patients might be less likely to make a referral because they already know the cause and the treatment for the disorder. Patients typically are referred if the cause of their disease is unclear or if treatment is not available in their communities, the researchers said.
Second, genetic research in recent years has improved the ability to detect genetic factors that may contribute to chronic pancreatitis. "For example, mutations in PRSS1, CFTR, SPINK1, and chymotrypsin C genes [now] can be detected in a significant subset of patients previously considered to have idiopathic disease," they said.
Third, advances in imaging technology may have led to the discovery of more anatomical abnormalities, such as strictures, pseudocysts, or pancreas divisum, that cause the pancreatitis. "Obstructive causes were considered as the [sole] working diagnosis in over 10% of all the subjects in our study," the investigators noted.
"Perhaps the most intriguing" finding in this study was an association with cigarette smoking. "After controlling for age, sex, BMI, and alcohol intake, ever smoking (odds ratio, 1.65), current smoking (OR, 1.80), and smoking 1 or more packs per day (OR, 1.87) were independently associated with idiopathic chronic pancreatitis," they said.
The discovery of this link "stresses the need to incorporate smoking cessation into the treatment algorithm for patients with chronic pancreatitis," they added. Patients with idiopathic disease were also significantly more likely than controls to have a history of chronic kidney disease or failure (5% vs. 1%, respectively).
This study was funded by the National Institutes of Health, the National Pancreas Foundation, Robert and Vicki Hall, and Andrew and Michelle Aloe. No financial conflicts of interest were reported.
The profile of patients with chronic pancreatitis has changed dramatically, with a precipitous drop in the proportion of cases related to alcohol and an upsurge in those with other etiologies, Dr. Gregory A. Coté and his colleagues reported online in Clinical Gastroenterology and Hepatology.
"The era of dismissing all cases of chronic pancreatitis as alcohol induced has undoubtedly come to a close," said Dr. Coté of Indiana University, Indianapolis, and his associates.
Historically, heavy alcohol use has been implicated as the cause of chronic pancreatitis in 60%-90% of cases diagnosed in Western countries, but recent reports from Europe and Japan have suggested that a wider spectrum of etiologies is emerging. Dr. Coté and his colleagues in the North American Pancreatitis Study 2 used information in the NAPS2 database to characterize the current epidemiology of the disease in the United States (Clin. Gastroenterol. Hepatol. 2011 March [doi:10.1016/j.cgh.2010.10.015]).
The database includes prospectively enrolled patients treated at 19 academic and community practice referral centers with expertise in pancreatic disorders. This analysis, which the researchers described as "the largest epidemiologic study of chronic pancreatitis from the United States," included 539 patients (mean age, 49 years), of whom 53% were men and 85% were white; the study also included 695 controls.
Referring physicians cited one or more possible etiologies for each patient’s chronic pancreatitis from the following list: alcohol related; idiopathic (no known cause); or unrelated to alcohol, a category that included hereditary diseases, cystic fibrosis, pancreas divisum, autoimmune disorders, hyperlipidemia, hypercalcemia, trauma, or other known causes.
The referring physicians identified alcohol as the sole cause in 35% of cases and as a contributing factor in another 9%. This represents a marked decrease from the 60%-90% of cases attributed to alcohol historically, the investigators noted.
The majority of subjects in whom alcohol was not a contributing factor were equally distributed among the other etiologic categories.
Another "remarkable finding" was that more than one-fourth of all patients had no identifiable cause for their chronic pancreatitis. Data on trends in alcohol consumption are mixed "and do not explain the impressive shift in the etiologic profile," Dr. Coté and his associates said. They posited several reasons that might explain these findings.
First, there may have been referral bias in that patients who are actively drinking might be less likely to seek a referral to expert centers, and physicians caring for such patients might be less likely to make a referral because they already know the cause and the treatment for the disorder. Patients typically are referred if the cause of their disease is unclear or if treatment is not available in their communities, the researchers said.
Second, genetic research in recent years has improved the ability to detect genetic factors that may contribute to chronic pancreatitis. "For example, mutations in PRSS1, CFTR, SPINK1, and chymotrypsin C genes [now] can be detected in a significant subset of patients previously considered to have idiopathic disease," they said.
Third, advances in imaging technology may have led to the discovery of more anatomical abnormalities, such as strictures, pseudocysts, or pancreas divisum, that cause the pancreatitis. "Obstructive causes were considered as the [sole] working diagnosis in over 10% of all the subjects in our study," the investigators noted.
"Perhaps the most intriguing" finding in this study was an association with cigarette smoking. "After controlling for age, sex, BMI, and alcohol intake, ever smoking (odds ratio, 1.65), current smoking (OR, 1.80), and smoking 1 or more packs per day (OR, 1.87) were independently associated with idiopathic chronic pancreatitis," they said.
The discovery of this link "stresses the need to incorporate smoking cessation into the treatment algorithm for patients with chronic pancreatitis," they added. Patients with idiopathic disease were also significantly more likely than controls to have a history of chronic kidney disease or failure (5% vs. 1%, respectively).
This study was funded by the National Institutes of Health, the National Pancreas Foundation, Robert and Vicki Hall, and Andrew and Michelle Aloe. No financial conflicts of interest were reported.
The profile of patients with chronic pancreatitis has changed dramatically, with a precipitous drop in the proportion of cases related to alcohol and an upsurge in those with other etiologies, Dr. Gregory A. Coté and his colleagues reported online in Clinical Gastroenterology and Hepatology.
"The era of dismissing all cases of chronic pancreatitis as alcohol induced has undoubtedly come to a close," said Dr. Coté of Indiana University, Indianapolis, and his associates.
Historically, heavy alcohol use has been implicated as the cause of chronic pancreatitis in 60%-90% of cases diagnosed in Western countries, but recent reports from Europe and Japan have suggested that a wider spectrum of etiologies is emerging. Dr. Coté and his colleagues in the North American Pancreatitis Study 2 used information in the NAPS2 database to characterize the current epidemiology of the disease in the United States (Clin. Gastroenterol. Hepatol. 2011 March [doi:10.1016/j.cgh.2010.10.015]).
The database includes prospectively enrolled patients treated at 19 academic and community practice referral centers with expertise in pancreatic disorders. This analysis, which the researchers described as "the largest epidemiologic study of chronic pancreatitis from the United States," included 539 patients (mean age, 49 years), of whom 53% were men and 85% were white; the study also included 695 controls.
Referring physicians cited one or more possible etiologies for each patient’s chronic pancreatitis from the following list: alcohol related; idiopathic (no known cause); or unrelated to alcohol, a category that included hereditary diseases, cystic fibrosis, pancreas divisum, autoimmune disorders, hyperlipidemia, hypercalcemia, trauma, or other known causes.
The referring physicians identified alcohol as the sole cause in 35% of cases and as a contributing factor in another 9%. This represents a marked decrease from the 60%-90% of cases attributed to alcohol historically, the investigators noted.
The majority of subjects in whom alcohol was not a contributing factor were equally distributed among the other etiologic categories.
Another "remarkable finding" was that more than one-fourth of all patients had no identifiable cause for their chronic pancreatitis. Data on trends in alcohol consumption are mixed "and do not explain the impressive shift in the etiologic profile," Dr. Coté and his associates said. They posited several reasons that might explain these findings.
First, there may have been referral bias in that patients who are actively drinking might be less likely to seek a referral to expert centers, and physicians caring for such patients might be less likely to make a referral because they already know the cause and the treatment for the disorder. Patients typically are referred if the cause of their disease is unclear or if treatment is not available in their communities, the researchers said.
Second, genetic research in recent years has improved the ability to detect genetic factors that may contribute to chronic pancreatitis. "For example, mutations in PRSS1, CFTR, SPINK1, and chymotrypsin C genes [now] can be detected in a significant subset of patients previously considered to have idiopathic disease," they said.
Third, advances in imaging technology may have led to the discovery of more anatomical abnormalities, such as strictures, pseudocysts, or pancreas divisum, that cause the pancreatitis. "Obstructive causes were considered as the [sole] working diagnosis in over 10% of all the subjects in our study," the investigators noted.
"Perhaps the most intriguing" finding in this study was an association with cigarette smoking. "After controlling for age, sex, BMI, and alcohol intake, ever smoking (odds ratio, 1.65), current smoking (OR, 1.80), and smoking 1 or more packs per day (OR, 1.87) were independently associated with idiopathic chronic pancreatitis," they said.
The discovery of this link "stresses the need to incorporate smoking cessation into the treatment algorithm for patients with chronic pancreatitis," they added. Patients with idiopathic disease were also significantly more likely than controls to have a history of chronic kidney disease or failure (5% vs. 1%, respectively).
This study was funded by the National Institutes of Health, the National Pancreas Foundation, Robert and Vicki Hall, and Andrew and Michelle Aloe. No financial conflicts of interest were reported.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Epidemiology of Chronic Pancreatitis Shows Major Shift
The profile of patients with chronic pancreatitis has changed dramatically, with a precipitous drop in the proportion of cases related to alcohol and an upsurge in those with other etiologies, Dr. Gregory A. Coté and his colleagues reported online in Clinical Gastroenterology and Hepatology.
"The era of dismissing all cases of chronic pancreatitis as alcohol induced has undoubtedly come to a close," said Dr. Coté of Indiana University, Indianapolis, and his associates.
Historically, heavy alcohol use has been implicated as the cause of chronic pancreatitis in 60%-90% of cases diagnosed in Western countries, but recent reports from Europe and Japan have suggested that a wider spectrum of etiologies is emerging. Dr. Coté and his colleagues in the North American Pancreatitis Study 2 used information in the NAPS2 database to characterize the current epidemiology of the disease in the United States (Clin. Gastroenterol. Hepatol. 2011 March [doi:10.1016/j.cgh.2010.10.015]).
The database includes prospectively enrolled patients treated at 19 academic and community practice referral centers with expertise in pancreatic disorders. This analysis, which the researchers described as "the largest epidemiologic study of chronic pancreatitis from the United States," included 539 patients (mean age, 49 years), of whom 53% were men and 85% were white; the study also included 695 controls.
Referring physicians cited one or more possible etiologies for each patient’s chronic pancreatitis from the following list: alcohol related; idiopathic (no known cause); or unrelated to alcohol, a category that included hereditary diseases, cystic fibrosis, pancreas divisum, autoimmune disorders, hyperlipidemia, hypercalcemia, trauma, or other known causes.
The referring physicians identified alcohol as the sole cause in 35% of cases and as a contributing factor in another 9%. This represents a marked decrease from the 60%-90% of cases attributed to alcohol historically, the investigators noted.
The majority of subjects in whom alcohol was not a contributing factor were equally distributed among the other etiologic categories.
Another "remarkable finding" was that more than one-fourth of all patients had no identifiable cause for their chronic pancreatitis. Data on trends in alcohol consumption are mixed "and do not explain the impressive shift in the etiologic profile," Dr. Coté and his associates said. They posited several reasons that might explain these findings.
First, there may have been referral bias in that patients who are actively drinking might be less likely to seek a referral to expert centers, and physicians caring for such patients might be less likely to make a referral because they already know the cause and the treatment for the disorder. Patients typically are referred if the cause of their disease is unclear or if treatment is not available in their communities, the researchers said.
Second, genetic research in recent years has improved the ability to detect genetic factors that may contribute to chronic pancreatitis. "For example, mutations in PRSS1, CFTR, SPINK1, and chymotrypsin C genes [now] can be detected in a significant subset of patients previously considered to have idiopathic disease," they said.
Third, advances in imaging technology may have led to the discovery of more anatomical abnormalities, such as strictures, pseudocysts, or pancreas divisum, that cause the pancreatitis. "Obstructive causes were considered as the [sole] working diagnosis in over 10% of all the subjects in our study," the investigators noted.
"Perhaps the most intriguing" finding in this study was an association with cigarette smoking. "After controlling for age, sex, BMI, and alcohol intake, ever smoking (odds ratio, 1.65), current smoking (OR, 1.80), and smoking 1 or more packs per day (OR, 1.87) were independently associated with idiopathic chronic pancreatitis," they said.
The discovery of this link "stresses the need to incorporate smoking cessation into the treatment algorithm for patients with chronic pancreatitis," they added. Patients with idiopathic disease were also significantly more likely than controls to have a history of chronic kidney disease or failure (5% vs. 1%, respectively).
This study was funded by the National Institutes of Health, the National Pancreas Foundation, Robert and Vicki Hall, and Andrew and Michelle Aloe. No financial conflicts of interest were reported.
The profile of patients with chronic pancreatitis has changed dramatically, with a precipitous drop in the proportion of cases related to alcohol and an upsurge in those with other etiologies, Dr. Gregory A. Coté and his colleagues reported online in Clinical Gastroenterology and Hepatology.
"The era of dismissing all cases of chronic pancreatitis as alcohol induced has undoubtedly come to a close," said Dr. Coté of Indiana University, Indianapolis, and his associates.
Historically, heavy alcohol use has been implicated as the cause of chronic pancreatitis in 60%-90% of cases diagnosed in Western countries, but recent reports from Europe and Japan have suggested that a wider spectrum of etiologies is emerging. Dr. Coté and his colleagues in the North American Pancreatitis Study 2 used information in the NAPS2 database to characterize the current epidemiology of the disease in the United States (Clin. Gastroenterol. Hepatol. 2011 March [doi:10.1016/j.cgh.2010.10.015]).
The database includes prospectively enrolled patients treated at 19 academic and community practice referral centers with expertise in pancreatic disorders. This analysis, which the researchers described as "the largest epidemiologic study of chronic pancreatitis from the United States," included 539 patients (mean age, 49 years), of whom 53% were men and 85% were white; the study also included 695 controls.
Referring physicians cited one or more possible etiologies for each patient’s chronic pancreatitis from the following list: alcohol related; idiopathic (no known cause); or unrelated to alcohol, a category that included hereditary diseases, cystic fibrosis, pancreas divisum, autoimmune disorders, hyperlipidemia, hypercalcemia, trauma, or other known causes.
The referring physicians identified alcohol as the sole cause in 35% of cases and as a contributing factor in another 9%. This represents a marked decrease from the 60%-90% of cases attributed to alcohol historically, the investigators noted.
The majority of subjects in whom alcohol was not a contributing factor were equally distributed among the other etiologic categories.
Another "remarkable finding" was that more than one-fourth of all patients had no identifiable cause for their chronic pancreatitis. Data on trends in alcohol consumption are mixed "and do not explain the impressive shift in the etiologic profile," Dr. Coté and his associates said. They posited several reasons that might explain these findings.
First, there may have been referral bias in that patients who are actively drinking might be less likely to seek a referral to expert centers, and physicians caring for such patients might be less likely to make a referral because they already know the cause and the treatment for the disorder. Patients typically are referred if the cause of their disease is unclear or if treatment is not available in their communities, the researchers said.
Second, genetic research in recent years has improved the ability to detect genetic factors that may contribute to chronic pancreatitis. "For example, mutations in PRSS1, CFTR, SPINK1, and chymotrypsin C genes [now] can be detected in a significant subset of patients previously considered to have idiopathic disease," they said.
Third, advances in imaging technology may have led to the discovery of more anatomical abnormalities, such as strictures, pseudocysts, or pancreas divisum, that cause the pancreatitis. "Obstructive causes were considered as the [sole] working diagnosis in over 10% of all the subjects in our study," the investigators noted.
"Perhaps the most intriguing" finding in this study was an association with cigarette smoking. "After controlling for age, sex, BMI, and alcohol intake, ever smoking (odds ratio, 1.65), current smoking (OR, 1.80), and smoking 1 or more packs per day (OR, 1.87) were independently associated with idiopathic chronic pancreatitis," they said.
The discovery of this link "stresses the need to incorporate smoking cessation into the treatment algorithm for patients with chronic pancreatitis," they added. Patients with idiopathic disease were also significantly more likely than controls to have a history of chronic kidney disease or failure (5% vs. 1%, respectively).
This study was funded by the National Institutes of Health, the National Pancreas Foundation, Robert and Vicki Hall, and Andrew and Michelle Aloe. No financial conflicts of interest were reported.
The profile of patients with chronic pancreatitis has changed dramatically, with a precipitous drop in the proportion of cases related to alcohol and an upsurge in those with other etiologies, Dr. Gregory A. Coté and his colleagues reported online in Clinical Gastroenterology and Hepatology.
"The era of dismissing all cases of chronic pancreatitis as alcohol induced has undoubtedly come to a close," said Dr. Coté of Indiana University, Indianapolis, and his associates.
Historically, heavy alcohol use has been implicated as the cause of chronic pancreatitis in 60%-90% of cases diagnosed in Western countries, but recent reports from Europe and Japan have suggested that a wider spectrum of etiologies is emerging. Dr. Coté and his colleagues in the North American Pancreatitis Study 2 used information in the NAPS2 database to characterize the current epidemiology of the disease in the United States (Clin. Gastroenterol. Hepatol. 2011 March [doi:10.1016/j.cgh.2010.10.015]).
The database includes prospectively enrolled patients treated at 19 academic and community practice referral centers with expertise in pancreatic disorders. This analysis, which the researchers described as "the largest epidemiologic study of chronic pancreatitis from the United States," included 539 patients (mean age, 49 years), of whom 53% were men and 85% were white; the study also included 695 controls.
Referring physicians cited one or more possible etiologies for each patient’s chronic pancreatitis from the following list: alcohol related; idiopathic (no known cause); or unrelated to alcohol, a category that included hereditary diseases, cystic fibrosis, pancreas divisum, autoimmune disorders, hyperlipidemia, hypercalcemia, trauma, or other known causes.
The referring physicians identified alcohol as the sole cause in 35% of cases and as a contributing factor in another 9%. This represents a marked decrease from the 60%-90% of cases attributed to alcohol historically, the investigators noted.
The majority of subjects in whom alcohol was not a contributing factor were equally distributed among the other etiologic categories.
Another "remarkable finding" was that more than one-fourth of all patients had no identifiable cause for their chronic pancreatitis. Data on trends in alcohol consumption are mixed "and do not explain the impressive shift in the etiologic profile," Dr. Coté and his associates said. They posited several reasons that might explain these findings.
First, there may have been referral bias in that patients who are actively drinking might be less likely to seek a referral to expert centers, and physicians caring for such patients might be less likely to make a referral because they already know the cause and the treatment for the disorder. Patients typically are referred if the cause of their disease is unclear or if treatment is not available in their communities, the researchers said.
Second, genetic research in recent years has improved the ability to detect genetic factors that may contribute to chronic pancreatitis. "For example, mutations in PRSS1, CFTR, SPINK1, and chymotrypsin C genes [now] can be detected in a significant subset of patients previously considered to have idiopathic disease," they said.
Third, advances in imaging technology may have led to the discovery of more anatomical abnormalities, such as strictures, pseudocysts, or pancreas divisum, that cause the pancreatitis. "Obstructive causes were considered as the [sole] working diagnosis in over 10% of all the subjects in our study," the investigators noted.
"Perhaps the most intriguing" finding in this study was an association with cigarette smoking. "After controlling for age, sex, BMI, and alcohol intake, ever smoking (odds ratio, 1.65), current smoking (OR, 1.80), and smoking 1 or more packs per day (OR, 1.87) were independently associated with idiopathic chronic pancreatitis," they said.
The discovery of this link "stresses the need to incorporate smoking cessation into the treatment algorithm for patients with chronic pancreatitis," they added. Patients with idiopathic disease were also significantly more likely than controls to have a history of chronic kidney disease or failure (5% vs. 1%, respectively).
This study was funded by the National Institutes of Health, the National Pancreas Foundation, Robert and Vicki Hall, and Andrew and Michelle Aloe. No financial conflicts of interest were reported.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Site of Care Trumps Race in Hospital Readmissions
Black Medicare patients have higher 30-day readmission rates for three common medical conditions than do their white counterparts, but this discrepancy has more to do with the sites where patients receive care than with race itself, according to a report in the Feb. 16 issue of JAMA.
"We found that the association of readmission rates with the site of care was consistently greater than the association with race, suggesting that racial disparities in readmissions are, at least in part, a systems problem," said Dr. Karen E. Joynt of Harvard School of Public Health, Boston, and her associates.
In what they described as the first study to examine racial disparities in readmission rates at the national level, the investigators used Medicare records to assess 30-day readmissions after acute myocardial infarction, congestive heart failure, or pneumonia during a 3-year period. The sample included 3,163,011 discharges: 579,492 discharges for acute MI from 4,322 hospitals, 1,346,768 discharges for CHF from 4,560 hospitals, and 1,236,751 discharges for pneumonia from 4,588 hospitals.
A total of 8.7% of patients were black.
Approximately 40% of black patients and 6% of white patients were cared for at hospitals designated as primarily "minority serving." These centers were more likely to be large public hospitals, to be located in the South, to have a high proportion of Medicaid patients, to have fewer nurses per patient days, and to have "somewhat lower performance" on measures of health care quality than other hospitals.
Overall, black patients had a 13% higher rate of readmission for any cause than white patients.
However, patients discharged from minority-serving hospitals had a 23% higher rate of readmission than did those discharged from non–minority-serving hospitals, and readmission rates were higher for white patients who were treated at minority-serving hospitals than they were for black patients treated at non–minority-serving hospitals. These findings show that the site of hospitalization had a greater effect on readmission rates than did race per se.
When readmissions for the same cause as initial hospitalization were considered, the same pattern was found. Black MI patients and black CHF patients both had 13% higher rates of readmission than did white MI patients with those diagnoses. However, patients discharged from minority-serving hospitals had much higher rates of readmission for those diagnoses than did patients discharged from non–minority-serving hospitals.
This pattern persisted when the data were adjusted to account for hospital characteristics such as teaching status, size, and ownership. It also did not change when data on Hispanic, Asian-American, and other nonwhite, nonblack ethnic groups were excluded.
It is important to note that "factors beyond hospitals’ control may explain our findings," Dr. Joynt and her colleagues said.
These include the quality of early outpatient follow-up and disease management after the initial hospitalization. "It may be that the availability of high-quality outpatient care is limited for patients discharged from minority-serving hospitals; these issues should be better understood before hospitals are held solely accountable for high readmission rates," they stressed (JAMA 2011;305:675-81).
The researchers added that their study did not include data on specific medications and treatment procedures, so discrepancies in these important factors between black and white patients could not be addressed. Similarly, their sample included only older patients, so it is not clear whether the findings apply to younger patients or those with other medical conditions.
This study was supported in part by the National Institutes of Health. One coauthor reported financial ties to UpToDate Inc.
This study "raises important questions about the unintended consequences of policies designed to improve the quality of health care," according to Dr. Adrian F. Hernandez and Lesley H. Curtis, Ph.D.
Joynt et al. noted that readmission rates are now considered an important component of hospital performance. Financial incentives based on readmission rates may unfairly penalize minority-serving hospitals "and thereby widen the gap in care for disadvantaged minorities," Dr. Hernandez and Dr. Curtis noted.
It is still debatable whether 30-day readmission rates constitute a good measure of hospital quality. How well patients understand their disease, how they manage their symptoms, and their access to follow-up care are all critical variables that are beyond the hospital’s purview. So are traits specific to the patient population in this study – "aging patients with complex disease processes, a high burden of comorbidity, impaired functional status, and limited social support." For such patients, readmission may well constitute "the right care at the right time" rather than a failure on the hospital’s part.
"The consequences of policies that inadvertently reward the rich and penalize the poor must be carefully considered, especially given the thin evidence base on which readmission reduction strategies rest," Dr. Hernandez and Dr. Curtis wrote.
Dr. Hernandez and Dr. Curtis are at Duke Clinical Research Institute and the department of medicine at Duke University, Durham, N.C. These comments were taken from their editorial accompanying Dr. Joynt’s report (JAMA 2011;305:715-16). Dr. Hernandez reported receiving research support from Johnson &
Johnson, Proventys, and Amylin, and honoraria from AstraZeneca,
Corthera, and Amgen. Dr. Curtis reported receiving research support from
Johnson & Johnson and Medtronic.
This study "raises important questions about the unintended consequences of policies designed to improve the quality of health care," according to Dr. Adrian F. Hernandez and Lesley H. Curtis, Ph.D.
Joynt et al. noted that readmission rates are now considered an important component of hospital performance. Financial incentives based on readmission rates may unfairly penalize minority-serving hospitals "and thereby widen the gap in care for disadvantaged minorities," Dr. Hernandez and Dr. Curtis noted.
It is still debatable whether 30-day readmission rates constitute a good measure of hospital quality. How well patients understand their disease, how they manage their symptoms, and their access to follow-up care are all critical variables that are beyond the hospital’s purview. So are traits specific to the patient population in this study – "aging patients with complex disease processes, a high burden of comorbidity, impaired functional status, and limited social support." For such patients, readmission may well constitute "the right care at the right time" rather than a failure on the hospital’s part.
"The consequences of policies that inadvertently reward the rich and penalize the poor must be carefully considered, especially given the thin evidence base on which readmission reduction strategies rest," Dr. Hernandez and Dr. Curtis wrote.
Dr. Hernandez and Dr. Curtis are at Duke Clinical Research Institute and the department of medicine at Duke University, Durham, N.C. These comments were taken from their editorial accompanying Dr. Joynt’s report (JAMA 2011;305:715-16). Dr. Hernandez reported receiving research support from Johnson &
Johnson, Proventys, and Amylin, and honoraria from AstraZeneca,
Corthera, and Amgen. Dr. Curtis reported receiving research support from
Johnson & Johnson and Medtronic.
This study "raises important questions about the unintended consequences of policies designed to improve the quality of health care," according to Dr. Adrian F. Hernandez and Lesley H. Curtis, Ph.D.
Joynt et al. noted that readmission rates are now considered an important component of hospital performance. Financial incentives based on readmission rates may unfairly penalize minority-serving hospitals "and thereby widen the gap in care for disadvantaged minorities," Dr. Hernandez and Dr. Curtis noted.
It is still debatable whether 30-day readmission rates constitute a good measure of hospital quality. How well patients understand their disease, how they manage their symptoms, and their access to follow-up care are all critical variables that are beyond the hospital’s purview. So are traits specific to the patient population in this study – "aging patients with complex disease processes, a high burden of comorbidity, impaired functional status, and limited social support." For such patients, readmission may well constitute "the right care at the right time" rather than a failure on the hospital’s part.
"The consequences of policies that inadvertently reward the rich and penalize the poor must be carefully considered, especially given the thin evidence base on which readmission reduction strategies rest," Dr. Hernandez and Dr. Curtis wrote.
Dr. Hernandez and Dr. Curtis are at Duke Clinical Research Institute and the department of medicine at Duke University, Durham, N.C. These comments were taken from their editorial accompanying Dr. Joynt’s report (JAMA 2011;305:715-16). Dr. Hernandez reported receiving research support from Johnson &
Johnson, Proventys, and Amylin, and honoraria from AstraZeneca,
Corthera, and Amgen. Dr. Curtis reported receiving research support from
Johnson & Johnson and Medtronic.
Black Medicare patients have higher 30-day readmission rates for three common medical conditions than do their white counterparts, but this discrepancy has more to do with the sites where patients receive care than with race itself, according to a report in the Feb. 16 issue of JAMA.
"We found that the association of readmission rates with the site of care was consistently greater than the association with race, suggesting that racial disparities in readmissions are, at least in part, a systems problem," said Dr. Karen E. Joynt of Harvard School of Public Health, Boston, and her associates.
In what they described as the first study to examine racial disparities in readmission rates at the national level, the investigators used Medicare records to assess 30-day readmissions after acute myocardial infarction, congestive heart failure, or pneumonia during a 3-year period. The sample included 3,163,011 discharges: 579,492 discharges for acute MI from 4,322 hospitals, 1,346,768 discharges for CHF from 4,560 hospitals, and 1,236,751 discharges for pneumonia from 4,588 hospitals.
A total of 8.7% of patients were black.
Approximately 40% of black patients and 6% of white patients were cared for at hospitals designated as primarily "minority serving." These centers were more likely to be large public hospitals, to be located in the South, to have a high proportion of Medicaid patients, to have fewer nurses per patient days, and to have "somewhat lower performance" on measures of health care quality than other hospitals.
Overall, black patients had a 13% higher rate of readmission for any cause than white patients.
However, patients discharged from minority-serving hospitals had a 23% higher rate of readmission than did those discharged from non–minority-serving hospitals, and readmission rates were higher for white patients who were treated at minority-serving hospitals than they were for black patients treated at non–minority-serving hospitals. These findings show that the site of hospitalization had a greater effect on readmission rates than did race per se.
When readmissions for the same cause as initial hospitalization were considered, the same pattern was found. Black MI patients and black CHF patients both had 13% higher rates of readmission than did white MI patients with those diagnoses. However, patients discharged from minority-serving hospitals had much higher rates of readmission for those diagnoses than did patients discharged from non–minority-serving hospitals.
This pattern persisted when the data were adjusted to account for hospital characteristics such as teaching status, size, and ownership. It also did not change when data on Hispanic, Asian-American, and other nonwhite, nonblack ethnic groups were excluded.
It is important to note that "factors beyond hospitals’ control may explain our findings," Dr. Joynt and her colleagues said.
These include the quality of early outpatient follow-up and disease management after the initial hospitalization. "It may be that the availability of high-quality outpatient care is limited for patients discharged from minority-serving hospitals; these issues should be better understood before hospitals are held solely accountable for high readmission rates," they stressed (JAMA 2011;305:675-81).
The researchers added that their study did not include data on specific medications and treatment procedures, so discrepancies in these important factors between black and white patients could not be addressed. Similarly, their sample included only older patients, so it is not clear whether the findings apply to younger patients or those with other medical conditions.
This study was supported in part by the National Institutes of Health. One coauthor reported financial ties to UpToDate Inc.
Black Medicare patients have higher 30-day readmission rates for three common medical conditions than do their white counterparts, but this discrepancy has more to do with the sites where patients receive care than with race itself, according to a report in the Feb. 16 issue of JAMA.
"We found that the association of readmission rates with the site of care was consistently greater than the association with race, suggesting that racial disparities in readmissions are, at least in part, a systems problem," said Dr. Karen E. Joynt of Harvard School of Public Health, Boston, and her associates.
In what they described as the first study to examine racial disparities in readmission rates at the national level, the investigators used Medicare records to assess 30-day readmissions after acute myocardial infarction, congestive heart failure, or pneumonia during a 3-year period. The sample included 3,163,011 discharges: 579,492 discharges for acute MI from 4,322 hospitals, 1,346,768 discharges for CHF from 4,560 hospitals, and 1,236,751 discharges for pneumonia from 4,588 hospitals.
A total of 8.7% of patients were black.
Approximately 40% of black patients and 6% of white patients were cared for at hospitals designated as primarily "minority serving." These centers were more likely to be large public hospitals, to be located in the South, to have a high proportion of Medicaid patients, to have fewer nurses per patient days, and to have "somewhat lower performance" on measures of health care quality than other hospitals.
Overall, black patients had a 13% higher rate of readmission for any cause than white patients.
However, patients discharged from minority-serving hospitals had a 23% higher rate of readmission than did those discharged from non–minority-serving hospitals, and readmission rates were higher for white patients who were treated at minority-serving hospitals than they were for black patients treated at non–minority-serving hospitals. These findings show that the site of hospitalization had a greater effect on readmission rates than did race per se.
When readmissions for the same cause as initial hospitalization were considered, the same pattern was found. Black MI patients and black CHF patients both had 13% higher rates of readmission than did white MI patients with those diagnoses. However, patients discharged from minority-serving hospitals had much higher rates of readmission for those diagnoses than did patients discharged from non–minority-serving hospitals.
This pattern persisted when the data were adjusted to account for hospital characteristics such as teaching status, size, and ownership. It also did not change when data on Hispanic, Asian-American, and other nonwhite, nonblack ethnic groups were excluded.
It is important to note that "factors beyond hospitals’ control may explain our findings," Dr. Joynt and her colleagues said.
These include the quality of early outpatient follow-up and disease management after the initial hospitalization. "It may be that the availability of high-quality outpatient care is limited for patients discharged from minority-serving hospitals; these issues should be better understood before hospitals are held solely accountable for high readmission rates," they stressed (JAMA 2011;305:675-81).
The researchers added that their study did not include data on specific medications and treatment procedures, so discrepancies in these important factors between black and white patients could not be addressed. Similarly, their sample included only older patients, so it is not clear whether the findings apply to younger patients or those with other medical conditions.
This study was supported in part by the National Institutes of Health. One coauthor reported financial ties to UpToDate Inc.
FROM JAMA
Site of Care Trumps Race in Hospital Readmissions
Black Medicare patients have higher 30-day readmission rates for three common medical conditions than do their white counterparts, but this discrepancy has more to do with the sites where patients receive care than with race itself, according to a report in the Feb. 16 issue of JAMA.
"We found that the association of readmission rates with the site of care was consistently greater than the association with race, suggesting that racial disparities in readmissions are, at least in part, a systems problem," said Dr. Karen E. Joynt of Harvard School of Public Health, Boston, and her associates.
In what they described as the first study to examine racial disparities in readmission rates at the national level, the investigators used Medicare records to assess 30-day readmissions after acute myocardial infarction, congestive heart failure, or pneumonia during a 3-year period. The sample included 3,163,011 discharges: 579,492 discharges for acute MI from 4,322 hospitals, 1,346,768 discharges for CHF from 4,560 hospitals, and 1,236,751 discharges for pneumonia from 4,588 hospitals.
A total of 8.7% of patients were black.
Approximately 40% of black patients and 6% of white patients were cared for at hospitals designated as primarily "minority serving." These centers were more likely to be large public hospitals, to be located in the South, to have a high proportion of Medicaid patients, to have fewer nurses per patient days, and to have "somewhat lower performance" on measures of health care quality than other hospitals.
Overall, black patients had a 13% higher rate of readmission for any cause than white patients.
However, patients discharged from minority-serving hospitals had a 23% higher rate of readmission than did those discharged from non–minority-serving hospitals, and readmission rates were higher for white patients who were treated at minority-serving hospitals than they were for black patients treated at non–minority-serving hospitals. These findings show that the site of hospitalization had a greater effect on readmission rates than did race per se.
When readmissions for the same cause as initial hospitalization were considered, the same pattern was found. Black MI patients and black CHF patients both had 13% higher rates of readmission than did white MI patients with those diagnoses. However, patients discharged from minority-serving hospitals had much higher rates of readmission for those diagnoses than did patients discharged from non–minority-serving hospitals.
This pattern persisted when the data were adjusted to account for hospital characteristics such as teaching status, size, and ownership. It also did not change when data on Hispanic, Asian-American, and other nonwhite, nonblack ethnic groups were excluded.
It is important to note that "factors beyond hospitals’ control may explain our findings," Dr. Joynt and her colleagues said.
These include the quality of early outpatient follow-up and disease management after the initial hospitalization. "It may be that the availability of high-quality outpatient care is limited for patients discharged from minority-serving hospitals; these issues should be better understood before hospitals are held solely accountable for high readmission rates," they stressed (JAMA 2011;305:675-81).
The researchers added that their study did not include data on specific medications and treatment procedures, so discrepancies in these important factors between black and white patients could not be addressed. Similarly, their sample included only older patients, so it is not clear whether the findings apply to younger patients or those with other medical conditions.
This study was supported in part by the National Institutes of Health. One coauthor reported financial ties to UpToDate Inc.
This study "raises important questions about the unintended consequences of policies designed to improve the quality of health care," according to Dr. Adrian F. Hernandez and Lesley H. Curtis, Ph.D.
Joynt et al. noted that readmission rates are now considered an important component of hospital performance. Financial incentives based on readmission rates may unfairly penalize minority-serving hospitals "and thereby widen the gap in care for disadvantaged minorities," Dr. Hernandez and Dr. Curtis noted.
It is still debatable whether 30-day readmission rates constitute a good measure of hospital quality. How well patients understand their disease, how they manage their symptoms, and their access to follow-up care are all critical variables that are beyond the hospital’s purview. So are traits specific to the patient population in this study – "aging patients with complex disease processes, a high burden of comorbidity, impaired functional status, and limited social support." For such patients, readmission may well constitute "the right care at the right time" rather than a failure on the hospital’s part.
"The consequences of policies that inadvertently reward the rich and penalize the poor must be carefully considered, especially given the thin evidence base on which readmission reduction strategies rest," Dr. Hernandez and Dr. Curtis wrote.
Dr. Hernandez and Dr. Curtis are at Duke Clinical Research Institute and the department of medicine at Duke University, Durham, N.C. These comments were taken from their editorial accompanying Dr. Joynt’s report (JAMA 2011;305:715-16). Dr. Hernandez reported receiving research support from Johnson &
Johnson, Proventys, and Amylin, and honoraria from AstraZeneca,
Corthera, and Amgen. Dr. Curtis reported receiving research support from
Johnson & Johnson and Medtronic.
This study "raises important questions about the unintended consequences of policies designed to improve the quality of health care," according to Dr. Adrian F. Hernandez and Lesley H. Curtis, Ph.D.
Joynt et al. noted that readmission rates are now considered an important component of hospital performance. Financial incentives based on readmission rates may unfairly penalize minority-serving hospitals "and thereby widen the gap in care for disadvantaged minorities," Dr. Hernandez and Dr. Curtis noted.
It is still debatable whether 30-day readmission rates constitute a good measure of hospital quality. How well patients understand their disease, how they manage their symptoms, and their access to follow-up care are all critical variables that are beyond the hospital’s purview. So are traits specific to the patient population in this study – "aging patients with complex disease processes, a high burden of comorbidity, impaired functional status, and limited social support." For such patients, readmission may well constitute "the right care at the right time" rather than a failure on the hospital’s part.
"The consequences of policies that inadvertently reward the rich and penalize the poor must be carefully considered, especially given the thin evidence base on which readmission reduction strategies rest," Dr. Hernandez and Dr. Curtis wrote.
Dr. Hernandez and Dr. Curtis are at Duke Clinical Research Institute and the department of medicine at Duke University, Durham, N.C. These comments were taken from their editorial accompanying Dr. Joynt’s report (JAMA 2011;305:715-16). Dr. Hernandez reported receiving research support from Johnson &
Johnson, Proventys, and Amylin, and honoraria from AstraZeneca,
Corthera, and Amgen. Dr. Curtis reported receiving research support from
Johnson & Johnson and Medtronic.
This study "raises important questions about the unintended consequences of policies designed to improve the quality of health care," according to Dr. Adrian F. Hernandez and Lesley H. Curtis, Ph.D.
Joynt et al. noted that readmission rates are now considered an important component of hospital performance. Financial incentives based on readmission rates may unfairly penalize minority-serving hospitals "and thereby widen the gap in care for disadvantaged minorities," Dr. Hernandez and Dr. Curtis noted.
It is still debatable whether 30-day readmission rates constitute a good measure of hospital quality. How well patients understand their disease, how they manage their symptoms, and their access to follow-up care are all critical variables that are beyond the hospital’s purview. So are traits specific to the patient population in this study – "aging patients with complex disease processes, a high burden of comorbidity, impaired functional status, and limited social support." For such patients, readmission may well constitute "the right care at the right time" rather than a failure on the hospital’s part.
"The consequences of policies that inadvertently reward the rich and penalize the poor must be carefully considered, especially given the thin evidence base on which readmission reduction strategies rest," Dr. Hernandez and Dr. Curtis wrote.
Dr. Hernandez and Dr. Curtis are at Duke Clinical Research Institute and the department of medicine at Duke University, Durham, N.C. These comments were taken from their editorial accompanying Dr. Joynt’s report (JAMA 2011;305:715-16). Dr. Hernandez reported receiving research support from Johnson &
Johnson, Proventys, and Amylin, and honoraria from AstraZeneca,
Corthera, and Amgen. Dr. Curtis reported receiving research support from
Johnson & Johnson and Medtronic.
Black Medicare patients have higher 30-day readmission rates for three common medical conditions than do their white counterparts, but this discrepancy has more to do with the sites where patients receive care than with race itself, according to a report in the Feb. 16 issue of JAMA.
"We found that the association of readmission rates with the site of care was consistently greater than the association with race, suggesting that racial disparities in readmissions are, at least in part, a systems problem," said Dr. Karen E. Joynt of Harvard School of Public Health, Boston, and her associates.
In what they described as the first study to examine racial disparities in readmission rates at the national level, the investigators used Medicare records to assess 30-day readmissions after acute myocardial infarction, congestive heart failure, or pneumonia during a 3-year period. The sample included 3,163,011 discharges: 579,492 discharges for acute MI from 4,322 hospitals, 1,346,768 discharges for CHF from 4,560 hospitals, and 1,236,751 discharges for pneumonia from 4,588 hospitals.
A total of 8.7% of patients were black.
Approximately 40% of black patients and 6% of white patients were cared for at hospitals designated as primarily "minority serving." These centers were more likely to be large public hospitals, to be located in the South, to have a high proportion of Medicaid patients, to have fewer nurses per patient days, and to have "somewhat lower performance" on measures of health care quality than other hospitals.
Overall, black patients had a 13% higher rate of readmission for any cause than white patients.
However, patients discharged from minority-serving hospitals had a 23% higher rate of readmission than did those discharged from non–minority-serving hospitals, and readmission rates were higher for white patients who were treated at minority-serving hospitals than they were for black patients treated at non–minority-serving hospitals. These findings show that the site of hospitalization had a greater effect on readmission rates than did race per se.
When readmissions for the same cause as initial hospitalization were considered, the same pattern was found. Black MI patients and black CHF patients both had 13% higher rates of readmission than did white MI patients with those diagnoses. However, patients discharged from minority-serving hospitals had much higher rates of readmission for those diagnoses than did patients discharged from non–minority-serving hospitals.
This pattern persisted when the data were adjusted to account for hospital characteristics such as teaching status, size, and ownership. It also did not change when data on Hispanic, Asian-American, and other nonwhite, nonblack ethnic groups were excluded.
It is important to note that "factors beyond hospitals’ control may explain our findings," Dr. Joynt and her colleagues said.
These include the quality of early outpatient follow-up and disease management after the initial hospitalization. "It may be that the availability of high-quality outpatient care is limited for patients discharged from minority-serving hospitals; these issues should be better understood before hospitals are held solely accountable for high readmission rates," they stressed (JAMA 2011;305:675-81).
The researchers added that their study did not include data on specific medications and treatment procedures, so discrepancies in these important factors between black and white patients could not be addressed. Similarly, their sample included only older patients, so it is not clear whether the findings apply to younger patients or those with other medical conditions.
This study was supported in part by the National Institutes of Health. One coauthor reported financial ties to UpToDate Inc.
Black Medicare patients have higher 30-day readmission rates for three common medical conditions than do their white counterparts, but this discrepancy has more to do with the sites where patients receive care than with race itself, according to a report in the Feb. 16 issue of JAMA.
"We found that the association of readmission rates with the site of care was consistently greater than the association with race, suggesting that racial disparities in readmissions are, at least in part, a systems problem," said Dr. Karen E. Joynt of Harvard School of Public Health, Boston, and her associates.
In what they described as the first study to examine racial disparities in readmission rates at the national level, the investigators used Medicare records to assess 30-day readmissions after acute myocardial infarction, congestive heart failure, or pneumonia during a 3-year period. The sample included 3,163,011 discharges: 579,492 discharges for acute MI from 4,322 hospitals, 1,346,768 discharges for CHF from 4,560 hospitals, and 1,236,751 discharges for pneumonia from 4,588 hospitals.
A total of 8.7% of patients were black.
Approximately 40% of black patients and 6% of white patients were cared for at hospitals designated as primarily "minority serving." These centers were more likely to be large public hospitals, to be located in the South, to have a high proportion of Medicaid patients, to have fewer nurses per patient days, and to have "somewhat lower performance" on measures of health care quality than other hospitals.
Overall, black patients had a 13% higher rate of readmission for any cause than white patients.
However, patients discharged from minority-serving hospitals had a 23% higher rate of readmission than did those discharged from non–minority-serving hospitals, and readmission rates were higher for white patients who were treated at minority-serving hospitals than they were for black patients treated at non–minority-serving hospitals. These findings show that the site of hospitalization had a greater effect on readmission rates than did race per se.
When readmissions for the same cause as initial hospitalization were considered, the same pattern was found. Black MI patients and black CHF patients both had 13% higher rates of readmission than did white MI patients with those diagnoses. However, patients discharged from minority-serving hospitals had much higher rates of readmission for those diagnoses than did patients discharged from non–minority-serving hospitals.
This pattern persisted when the data were adjusted to account for hospital characteristics such as teaching status, size, and ownership. It also did not change when data on Hispanic, Asian-American, and other nonwhite, nonblack ethnic groups were excluded.
It is important to note that "factors beyond hospitals’ control may explain our findings," Dr. Joynt and her colleagues said.
These include the quality of early outpatient follow-up and disease management after the initial hospitalization. "It may be that the availability of high-quality outpatient care is limited for patients discharged from minority-serving hospitals; these issues should be better understood before hospitals are held solely accountable for high readmission rates," they stressed (JAMA 2011;305:675-81).
The researchers added that their study did not include data on specific medications and treatment procedures, so discrepancies in these important factors between black and white patients could not be addressed. Similarly, their sample included only older patients, so it is not clear whether the findings apply to younger patients or those with other medical conditions.
This study was supported in part by the National Institutes of Health. One coauthor reported financial ties to UpToDate Inc.
FROM JAMA
Major Finding: Black Medicare patients had a 13% rate of readmission within 30 days of hospital discharge following acute MI, congestive heart failure, or pneumonia, compared with white Medicare patients. However, this discrepancy was more strongly related to the hospitals where patients were treated than to race itself.
Data Source: A review of the Medicare records of more than 3 million patients discharged from hospitals during a 3-year period.
Disclosures: This study was supported in part by the National Institutes of Health. One coauthor reported financial ties to UpToDate Inc.