Michele G. Sullivan

BOSTON — Carvedilol is more effective than band ligation in preventing the first bleed from esophageal varices, Dr. Dhiraj Tripathi said at the annual meeting of the American Association for the Study of Liver Diseases.

Because the drug is also well tolerated, “it should be the first line of treatment for primary prophylaxis in these patients,” said Dr. Tripathi of the Royal Infirmary, Edinburgh.

His randomized, controlled trial included 152 patients with esophageal varices of grade II or larger that had not previously bled. The patients' mean age was 54 years, and 72% had cirrhosis due to alcoholic liver disease. The mean Child-Pugh Score was 8.

Patients were randomized to variceal band ligation performed twice weekly until eradication (77 patients) or to carvedilol at 6.25 mg/day for 1 week, up to 12.5 mg/day or as tolerated (75 patients).

By 24 months, a significantly higher percentage of the patients on carvedilol were free from a first variceal bleed (87% vs. 78%, respectively). No significant differences were seen in overall mortality or mortality from variceal bleeding.

Three patients did not tolerate the carvedilol dose escalation, and 10 withdrew from that arm because of side effects, mostly gastrointestinal effects and shortness of breath. Dr. Tripathi noted that the 10% withdrawal rate was significantly lower than the 30% rate that had been seen in studies of propranolol for variceal bleeding prophylaxis (Gastroenterology 2002;123:735–44).

Variceal eradication with banding was successful in 57% of patients. Dr. Tripathi said banding ligation remains a good option “for patients who can't tolerate β-blockers, or who would have problems with compliance.”

Dr. Tripathi had no disclosures related to the study drug.

BOSTON — Carvedilol is more effective than band ligation in preventing the first bleed from esophageal varices, Dr. Dhiraj Tripathi said at the annual meeting of the American Association for the Study of Liver Diseases.

Because the drug is also well tolerated, “it should be the first line of treatment for primary prophylaxis in these patients,” said Dr. Tripathi of the Royal Infirmary, Edinburgh.

His randomized, controlled trial included 152 patients with esophageal varices of grade II or larger that had not previously bled. The patients' mean age was 54 years, and 72% had cirrhosis due to alcoholic liver disease. The mean Child-Pugh Score was 8.

Patients were randomized to variceal band ligation performed twice weekly until eradication (77 patients) or to carvedilol at 6.25 mg/day for 1 week, up to 12.5 mg/day or as tolerated (75 patients).

By 24 months, a significantly higher percentage of the patients on carvedilol were free from a first variceal bleed (87% vs. 78%, respectively). No significant differences were seen in overall mortality or mortality from variceal bleeding.

Three patients did not tolerate the carvedilol dose escalation, and 10 withdrew from that arm because of side effects, mostly gastrointestinal effects and shortness of breath. Dr. Tripathi noted that the 10% withdrawal rate was significantly lower than the 30% rate that had been seen in studies of propranolol for variceal bleeding prophylaxis (Gastroenterology 2002;123:735–44).

Variceal eradication with banding was successful in 57% of patients. Dr. Tripathi said banding ligation remains a good option “for patients who can't tolerate β-blockers, or who would have problems with compliance.”

Dr. Tripathi had no disclosures related to the study drug.

BOSTON — Carvedilol is more effective than band ligation in preventing the first bleed from esophageal varices, Dr. Dhiraj Tripathi said at the annual meeting of the American Association for the Study of Liver Diseases.

Because the drug is also well tolerated, “it should be the first line of treatment for primary prophylaxis in these patients,” said Dr. Tripathi of the Royal Infirmary, Edinburgh.

His randomized, controlled trial included 152 patients with esophageal varices of grade II or larger that had not previously bled. The patients' mean age was 54 years, and 72% had cirrhosis due to alcoholic liver disease. The mean Child-Pugh Score was 8.

Patients were randomized to variceal band ligation performed twice weekly until eradication (77 patients) or to carvedilol at 6.25 mg/day for 1 week, up to 12.5 mg/day or as tolerated (75 patients).

By 24 months, a significantly higher percentage of the patients on carvedilol were free from a first variceal bleed (87% vs. 78%, respectively). No significant differences were seen in overall mortality or mortality from variceal bleeding.

Three patients did not tolerate the carvedilol dose escalation, and 10 withdrew from that arm because of side effects, mostly gastrointestinal effects and shortness of breath. Dr. Tripathi noted that the 10% withdrawal rate was significantly lower than the 30% rate that had been seen in studies of propranolol for variceal bleeding prophylaxis (Gastroenterology 2002;123:735–44).

Variceal eradication with banding was successful in 57% of patients. Dr. Tripathi said banding ligation remains a good option “for patients who can't tolerate β-blockers, or who would have problems with compliance.”

Dr. Tripathi had no disclosures related to the study drug.

Women who have an abnormal glucose tolerance test result during pregnancy but do not develop gestational diabetes still face an increased risk of developing type 2 diabetes later on, investigators reported.

The large retrospective study, published Jan. 25, concluded that even modestly elevated glucose levels double the risk of diabetes within the next 9 years. “The risk of subsequent diabetes … likely occurs since these women have an intermediate form of glucose intolerance” with impaired β-cell functioning, wrote Dr. Darcy B. Carr of the University of Washington, Seattle, and her coauthors (Diabetes Care 2008 Jan. 25 [doi 10.2337/dc07–1957]).

In this retrospective cohort study, the researchers analyzed diabetes risk over a mean 9-year follow-up period in 31,000 women without gestational diabetes who had an oral glucose tolerance test (OGTT) or oral glucose challenge test (OGCT) during their pregnancy. The mean age was 31 years; the median follow-up was 9 years.

The investigators found that the risk of later development of type 2 diabetes rose as the values of the OGCT rose. Compared with women whose levels were normal, women with glucose levels of 5.4–6.2 mmol/L and 6.4–7.3 mmol/L had double the risk of developing the disease, while women with levels greater than 7.3 mmol/L were three times more likely to do so. Women with no abnormal values on the OGTT were at no increased risk of developing type 2 diabetes, but those with one abnormal value were twice as likely to do so.

These associations remained significant even after the researchers controlled for age, primigravidity, and preterm delivery.

The finding is consistent with those from a previous, much smaller longitudinal study that reported higher frequencies of glucose intolerance in women with one abnormal OGTT value.

Dr. Carr and her colleagues noted that their study could not control for race, family history, or body mass index—all important factors to consider when assessing diabetes risk. In addition, subsequent diabetes was not systematically assessed, which may introduce bias in those who were selected for testing, they wrote.

They also said their conclusions are not sufficient for them to make any screening or treatment recommendations: “Whether women who fall within this intermediate range of glucose intolerance during pregnancy may benefit from increased diabetes surveillance as well as lifestyle recommendations proven to reduce the risk of developing diabetes is unknown.”

Women who have an abnormal glucose tolerance test result during pregnancy but do not develop gestational diabetes still face an increased risk of developing type 2 diabetes later on, investigators reported.

The large retrospective study, published Jan. 25, concluded that even modestly elevated glucose levels double the risk of diabetes within the next 9 years. “The risk of subsequent diabetes … likely occurs since these women have an intermediate form of glucose intolerance” with impaired β-cell functioning, wrote Dr. Darcy B. Carr of the University of Washington, Seattle, and her coauthors (Diabetes Care 2008 Jan. 25 [doi 10.2337/dc07–1957]).

In this retrospective cohort study, the researchers analyzed diabetes risk over a mean 9-year follow-up period in 31,000 women without gestational diabetes who had an oral glucose tolerance test (OGTT) or oral glucose challenge test (OGCT) during their pregnancy. The mean age was 31 years; the median follow-up was 9 years.

The investigators found that the risk of later development of type 2 diabetes rose as the values of the OGCT rose. Compared with women whose levels were normal, women with glucose levels of 5.4–6.2 mmol/L and 6.4–7.3 mmol/L had double the risk of developing the disease, while women with levels greater than 7.3 mmol/L were three times more likely to do so. Women with no abnormal values on the OGTT were at no increased risk of developing type 2 diabetes, but those with one abnormal value were twice as likely to do so.

These associations remained significant even after the researchers controlled for age, primigravidity, and preterm delivery.

The finding is consistent with those from a previous, much smaller longitudinal study that reported higher frequencies of glucose intolerance in women with one abnormal OGTT value.

Dr. Carr and her colleagues noted that their study could not control for race, family history, or body mass index—all important factors to consider when assessing diabetes risk. In addition, subsequent diabetes was not systematically assessed, which may introduce bias in those who were selected for testing, they wrote.

They also said their conclusions are not sufficient for them to make any screening or treatment recommendations: “Whether women who fall within this intermediate range of glucose intolerance during pregnancy may benefit from increased diabetes surveillance as well as lifestyle recommendations proven to reduce the risk of developing diabetes is unknown.”

Women who have an abnormal glucose tolerance test result during pregnancy but do not develop gestational diabetes still face an increased risk of developing type 2 diabetes later on, investigators reported.

The large retrospective study, published Jan. 25, concluded that even modestly elevated glucose levels double the risk of diabetes within the next 9 years. “The risk of subsequent diabetes … likely occurs since these women have an intermediate form of glucose intolerance” with impaired β-cell functioning, wrote Dr. Darcy B. Carr of the University of Washington, Seattle, and her coauthors (Diabetes Care 2008 Jan. 25 [doi 10.2337/dc07–1957]).

In this retrospective cohort study, the researchers analyzed diabetes risk over a mean 9-year follow-up period in 31,000 women without gestational diabetes who had an oral glucose tolerance test (OGTT) or oral glucose challenge test (OGCT) during their pregnancy. The mean age was 31 years; the median follow-up was 9 years.

The investigators found that the risk of later development of type 2 diabetes rose as the values of the OGCT rose. Compared with women whose levels were normal, women with glucose levels of 5.4–6.2 mmol/L and 6.4–7.3 mmol/L had double the risk of developing the disease, while women with levels greater than 7.3 mmol/L were three times more likely to do so. Women with no abnormal values on the OGTT were at no increased risk of developing type 2 diabetes, but those with one abnormal value were twice as likely to do so.

These associations remained significant even after the researchers controlled for age, primigravidity, and preterm delivery.

The finding is consistent with those from a previous, much smaller longitudinal study that reported higher frequencies of glucose intolerance in women with one abnormal OGTT value.

Dr. Carr and her colleagues noted that their study could not control for race, family history, or body mass index—all important factors to consider when assessing diabetes risk. In addition, subsequent diabetes was not systematically assessed, which may introduce bias in those who were selected for testing, they wrote.

They also said their conclusions are not sufficient for them to make any screening or treatment recommendations: “Whether women who fall within this intermediate range of glucose intolerance during pregnancy may benefit from increased diabetes surveillance as well as lifestyle recommendations proven to reduce the risk of developing diabetes is unknown.”

BOSTON – Erythropoietin is quickly becoming an integral part of hepatitis C virus treatment regimens, despite a lack of firm data supporting its long-term clinical benefit, Dr. Eric Yoshida said at the annual meeting of the American Association for the Study of Liver Diseases.

Only a few studies have prospectively examined the effect of erythropoietin in these patients, and whereas the studies have shown statistically significant improvements in terms of increasing hemoglobin levels and allowing for maintenance of ribavirin dosage, opinions vary on whether these differences translate into clinical benefit.

“Does this mean there is no place for erythropoietin for these patients? No … it means we should treat the patient–not the numbers,” said Dr. Yoshida, head of gastroenterology at the University of British Columbia, Vancouver.

Ribavirin, considered a mainstay of antiviral therapy for hepatitis patients, can cause a dose-dependent hemolytic anemia. Guidelines suggest decreasing the dosage of ribavirin when hemoglobin levels fall below 12 g/dL, and discontinuing the drug if levels fall below 8.5 g/dL.

But because ribavirin is so important to sustained viral response, some patients persist with it even when they develop an anemia that significantly impairs their quality of life, said Dr. Yoshida, who reviewed three studies that have examined the effect of erythropoietin in hepatitis C patients (Ann. Pharmacother. 2007;41:268-75).

The first study, a placebo-controlled trial, randomized 64 patients to either weekly erythropoietin injections for 16 weeks or placebo. At baseline, the mean hemoglobin level was 11 g/dL in both groups (Am. J. Gastroenterol. 2003;98:2491-9).

At the study's end, patients receiving erythropoietin had significantly higher mean hemoglobin levels (14 g/dL vs. 11 g/dL). Ribavirin dosage was similar in both groups, indicating that those taking the study drug were able to maintain their ribavirin dosage.

By the end of the trial, undetectable HCV RNA was seen in 69% of erythropoietin-treated patients and 60% of placebo patients. However, Dr. Yoshida noted there was a high dropout rate (42% of erythropoietin patients and 50% of placebo patients), which makes it difficult to conclude that the difference in percentage of patients with undetectable HCV RNA was related to erythropoietin therapy.

A second study randomized 185 patients to placebo or erythropoietin for 8 weeks, after which eligible patients from both groups entered into an 8-week open-label trial (Gastroenterology 2004;126:1302-11).

By the end of the first 8 weeks, significantly more erythropoietin-treated patients than placebo patients were still taking their baseline ribavirin dose (88% vs. 60%, respectively). At the end of the crossover phase, prior placebo patients had increased their ribavirin dosage significantly, from a mean of 852 mg/day to a mean of 921 mg/day.

Baseline hemoglobin levels (11 g/dL in both groups) rose to 13 g/dL in the erythropoietin group by the end of the first 8 weeks, but remained unchanged in the placebo group. By the end of the open-label phase, mean hemoglobin levels in prior placebo patients were the same as those in patients who had taken erythropoietin for the entire study (13 g/dL).

A post hoc analysis concluded that erythropoietin-treated patients also reported significant improvements in their quality of life (Hepatology 2004;40:1450-8). The importance of quality-of-life benefits should not be underestimated in hepatitis patients, Dr. Yoshida said, because quality-of-life scores of HCV patients on treatment can be lower than those of patients with diabetes and congestive heart failure.

The study found no significant differences between groups in HCV RNA levels.

These trials raise yet more questions, Dr. Yoshida said. The hemoglobin level that should trigger erythropoietin treatment is still unclear.

There are also no firm data on the duration of erythropoietin treatment that is beneficial, and the studies performed to date offer little guidance.

Still, noted Dr. Yoshida, the drug's expense along with its unproven survival benefit are enough to signal caution to many providers. “Hopefully, future trials will address these questions,” he said.

Dr. Yoshida declared no financial interest in any hematopoietic agent.

BOSTON – Erythropoietin is quickly becoming an integral part of hepatitis C virus treatment regimens, despite a lack of firm data supporting its long-term clinical benefit, Dr. Eric Yoshida said at the annual meeting of the American Association for the Study of Liver Diseases.

Only a few studies have prospectively examined the effect of erythropoietin in these patients, and whereas the studies have shown statistically significant improvements in terms of increasing hemoglobin levels and allowing for maintenance of ribavirin dosage, opinions vary on whether these differences translate into clinical benefit.

“Does this mean there is no place for erythropoietin for these patients? No … it means we should treat the patient–not the numbers,” said Dr. Yoshida, head of gastroenterology at the University of British Columbia, Vancouver.

Ribavirin, considered a mainstay of antiviral therapy for hepatitis patients, can cause a dose-dependent hemolytic anemia. Guidelines suggest decreasing the dosage of ribavirin when hemoglobin levels fall below 12 g/dL, and discontinuing the drug if levels fall below 8.5 g/dL.

But because ribavirin is so important to sustained viral response, some patients persist with it even when they develop an anemia that significantly impairs their quality of life, said Dr. Yoshida, who reviewed three studies that have examined the effect of erythropoietin in hepatitis C patients (Ann. Pharmacother. 2007;41:268-75).

The first study, a placebo-controlled trial, randomized 64 patients to either weekly erythropoietin injections for 16 weeks or placebo. At baseline, the mean hemoglobin level was 11 g/dL in both groups (Am. J. Gastroenterol. 2003;98:2491-9).

At the study's end, patients receiving erythropoietin had significantly higher mean hemoglobin levels (14 g/dL vs. 11 g/dL). Ribavirin dosage was similar in both groups, indicating that those taking the study drug were able to maintain their ribavirin dosage.

By the end of the trial, undetectable HCV RNA was seen in 69% of erythropoietin-treated patients and 60% of placebo patients. However, Dr. Yoshida noted there was a high dropout rate (42% of erythropoietin patients and 50% of placebo patients), which makes it difficult to conclude that the difference in percentage of patients with undetectable HCV RNA was related to erythropoietin therapy.

A second study randomized 185 patients to placebo or erythropoietin for 8 weeks, after which eligible patients from both groups entered into an 8-week open-label trial (Gastroenterology 2004;126:1302-11).

By the end of the first 8 weeks, significantly more erythropoietin-treated patients than placebo patients were still taking their baseline ribavirin dose (88% vs. 60%, respectively). At the end of the crossover phase, prior placebo patients had increased their ribavirin dosage significantly, from a mean of 852 mg/day to a mean of 921 mg/day.

Baseline hemoglobin levels (11 g/dL in both groups) rose to 13 g/dL in the erythropoietin group by the end of the first 8 weeks, but remained unchanged in the placebo group. By the end of the open-label phase, mean hemoglobin levels in prior placebo patients were the same as those in patients who had taken erythropoietin for the entire study (13 g/dL).

A post hoc analysis concluded that erythropoietin-treated patients also reported significant improvements in their quality of life (Hepatology 2004;40:1450-8). The importance of quality-of-life benefits should not be underestimated in hepatitis patients, Dr. Yoshida said, because quality-of-life scores of HCV patients on treatment can be lower than those of patients with diabetes and congestive heart failure.

The study found no significant differences between groups in HCV RNA levels.

These trials raise yet more questions, Dr. Yoshida said. The hemoglobin level that should trigger erythropoietin treatment is still unclear.

There are also no firm data on the duration of erythropoietin treatment that is beneficial, and the studies performed to date offer little guidance.

Still, noted Dr. Yoshida, the drug's expense along with its unproven survival benefit are enough to signal caution to many providers. “Hopefully, future trials will address these questions,” he said.

Dr. Yoshida declared no financial interest in any hematopoietic agent.

BOSTON – Erythropoietin is quickly becoming an integral part of hepatitis C virus treatment regimens, despite a lack of firm data supporting its long-term clinical benefit, Dr. Eric Yoshida said at the annual meeting of the American Association for the Study of Liver Diseases.

Only a few studies have prospectively examined the effect of erythropoietin in these patients, and whereas the studies have shown statistically significant improvements in terms of increasing hemoglobin levels and allowing for maintenance of ribavirin dosage, opinions vary on whether these differences translate into clinical benefit.

“Does this mean there is no place for erythropoietin for these patients? No … it means we should treat the patient–not the numbers,” said Dr. Yoshida, head of gastroenterology at the University of British Columbia, Vancouver.

Ribavirin, considered a mainstay of antiviral therapy for hepatitis patients, can cause a dose-dependent hemolytic anemia. Guidelines suggest decreasing the dosage of ribavirin when hemoglobin levels fall below 12 g/dL, and discontinuing the drug if levels fall below 8.5 g/dL.

But because ribavirin is so important to sustained viral response, some patients persist with it even when they develop an anemia that significantly impairs their quality of life, said Dr. Yoshida, who reviewed three studies that have examined the effect of erythropoietin in hepatitis C patients (Ann. Pharmacother. 2007;41:268-75).

The first study, a placebo-controlled trial, randomized 64 patients to either weekly erythropoietin injections for 16 weeks or placebo. At baseline, the mean hemoglobin level was 11 g/dL in both groups (Am. J. Gastroenterol. 2003;98:2491-9).

At the study's end, patients receiving erythropoietin had significantly higher mean hemoglobin levels (14 g/dL vs. 11 g/dL). Ribavirin dosage was similar in both groups, indicating that those taking the study drug were able to maintain their ribavirin dosage.

By the end of the trial, undetectable HCV RNA was seen in 69% of erythropoietin-treated patients and 60% of placebo patients. However, Dr. Yoshida noted there was a high dropout rate (42% of erythropoietin patients and 50% of placebo patients), which makes it difficult to conclude that the difference in percentage of patients with undetectable HCV RNA was related to erythropoietin therapy.

A second study randomized 185 patients to placebo or erythropoietin for 8 weeks, after which eligible patients from both groups entered into an 8-week open-label trial (Gastroenterology 2004;126:1302-11).

By the end of the first 8 weeks, significantly more erythropoietin-treated patients than placebo patients were still taking their baseline ribavirin dose (88% vs. 60%, respectively). At the end of the crossover phase, prior placebo patients had increased their ribavirin dosage significantly, from a mean of 852 mg/day to a mean of 921 mg/day.

Baseline hemoglobin levels (11 g/dL in both groups) rose to 13 g/dL in the erythropoietin group by the end of the first 8 weeks, but remained unchanged in the placebo group. By the end of the open-label phase, mean hemoglobin levels in prior placebo patients were the same as those in patients who had taken erythropoietin for the entire study (13 g/dL).

A post hoc analysis concluded that erythropoietin-treated patients also reported significant improvements in their quality of life (Hepatology 2004;40:1450-8). The importance of quality-of-life benefits should not be underestimated in hepatitis patients, Dr. Yoshida said, because quality-of-life scores of HCV patients on treatment can be lower than those of patients with diabetes and congestive heart failure.

The study found no significant differences between groups in HCV RNA levels.

These trials raise yet more questions, Dr. Yoshida said. The hemoglobin level that should trigger erythropoietin treatment is still unclear.

There are also no firm data on the duration of erythropoietin treatment that is beneficial, and the studies performed to date offer little guidance.

Still, noted Dr. Yoshida, the drug's expense along with its unproven survival benefit are enough to signal caution to many providers. “Hopefully, future trials will address these questions,” he said.

Dr. Yoshida declared no financial interest in any hematopoietic agent.

NEW ORLEANS — Rather than unlocking a Pandora's box of nattering e-mails, an electronic patient portal that allows messaging and even access to test results can improve patient satisfaction and decrease patient visits.

“Many physicians think that this type of access is frightening,” Dr. Gretchen P. Purcell said at the annual clinical congress of the American College of Surgeons. “They think they'll be barraged with messages, that patients will misinterpret their test results, and that physicians could even be held legally liable if they don't respond in time to an urgent message.”

But health care providers, who are about 10 years behind the curve in the digital world, need to face up to the facts of the 21st century, said Dr. Purcell of the surgery department at the Children's Hospital at Vanderbilt in Nashville, Tenn. “Patients are demanding the same kind of online access to their medical information as they have for all other aspects of their lives. Those health care institutions that do not have a patient portal now probably will within the next 5 years.”

Patient portals can be designed to suit the needs of different practices and to fulfill various functions. At a minimum, they allow patients to pay bills, schedule or change appointments, and request prescription refills. Other portals are more robust and give patients the ability to review medical records, view test results, and send messages to their health care provider, said Dr. Purcell, who is also with the biomedical informatics department at Vanderbilt Medical Center.

Among the most controversial topics are messaging and the ability to access test results, she said.

“Messaging is probably the function physicians fear the most. Many think it's the equivalent of getting and sending personal e-mail, and this brings up all kinds of worries about security and privacy.”

E-mail and messaging, however, are not the same things. Messages don't go to a personal e-mail account; instead, they go to a dedicated in-box. “This message box is routinely checked by an administrative assistant or nurse—someone who can often answer many of the questions, and who would involve the physician only when necessary—similar to phone call triage.”

There also are concerns that these electronic exchanges aren't part of a patient's documented record. “Some portals can make messaging part of the medical record, and some physicians have found ways to charge for this 'online consultation,' “Dr. Purcell said.

It's important to set clear expectations about response time and emergency issues. Most messaging systems tell patients that they may have to wait 2-3 business days for a personal reply and advise them to call 911 for a medical emergency.

It's not unreasonable to assume that electronic communication could allow patients to bombard offices with questions and requests. Although data are still limited, the studies that are out there suggest just the opposite, Dr. Purcell said.

Two studies published in 2005 indicate that messaging increases patient satisfaction without any corresponding increase in workload. The first study randomized 200 patients to secure messaging or usual care. Only 46% of the patients who were given access sent any messages at all; the average was just 1.5 messages per patient per year. And although messaging didn't reduce the number of telephone calls the office received, the number of office visits in the intervention group did go down (Int. J. Med. Inform. 2005;74:705-10).

The second study randomized 606 patients to a patient communication portal or to a Web site with general health information. Only 31% of the patients given access used the portal. The message box received only one message per day per 250 patients. Again, there was no difference in the number of office telephone calls between the groups, but the patients in the portal group reported better satisfaction with communication and overall care, even if they never used the portal (J. Med. Internet Res. 2005;7:e48).

The same study indicated that secure messaging probably would not overwhelm anyone during working hours, Dr. Purcell said. “Patients tended to use the portal during nonclinic hours—the most convenient time for them—with about 73% of messaging occurring from 5 p.m. until midnight.”

Patients may even be willing to pay for the added convenience of messaging, the authors concluded. Of 341 patients surveyed, 162 (48%) were willing to pay for online correspondence with their physician, with $2 cited as the median payment they thought fair.

Patient access to test results is another area of clinician concern, she said. “Obtaining test results is probably the most commonly desired and most commonly used function of a patient portal, and one that makes physicians very nervous,” Dr. Purcell said.

The MyHealthAtVanderbilt system (www.myhealthatvanderbilt.com

“Some low-risk, high-value test results, such as cholesterol levels, are available immediately, and some results are available with a delay, such as tests that require interpretation in a specific clinical context,” Dr. Purcell said. “But some results, such as cancer pathology and HIV tests, and others that require intensive patient counseling, are never available though the portal.”

NEW ORLEANS — Rather than unlocking a Pandora's box of nattering e-mails, an electronic patient portal that allows messaging and even access to test results can improve patient satisfaction and decrease patient visits.

“Many physicians think that this type of access is frightening,” Dr. Gretchen P. Purcell said at the annual clinical congress of the American College of Surgeons. “They think they'll be barraged with messages, that patients will misinterpret their test results, and that physicians could even be held legally liable if they don't respond in time to an urgent message.”

But health care providers, who are about 10 years behind the curve in the digital world, need to face up to the facts of the 21st century, said Dr. Purcell of the surgery department at the Children's Hospital at Vanderbilt in Nashville, Tenn. “Patients are demanding the same kind of online access to their medical information as they have for all other aspects of their lives. Those health care institutions that do not have a patient portal now probably will within the next 5 years.”

Patient portals can be designed to suit the needs of different practices and to fulfill various functions. At a minimum, they allow patients to pay bills, schedule or change appointments, and request prescription refills. Other portals are more robust and give patients the ability to review medical records, view test results, and send messages to their health care provider, said Dr. Purcell, who is also with the biomedical informatics department at Vanderbilt Medical Center.

Among the most controversial topics are messaging and the ability to access test results, she said.

“Messaging is probably the function physicians fear the most. Many think it's the equivalent of getting and sending personal e-mail, and this brings up all kinds of worries about security and privacy.”

E-mail and messaging, however, are not the same things. Messages don't go to a personal e-mail account; instead, they go to a dedicated in-box. “This message box is routinely checked by an administrative assistant or nurse—someone who can often answer many of the questions, and who would involve the physician only when necessary—similar to phone call triage.”

There also are concerns that these electronic exchanges aren't part of a patient's documented record. “Some portals can make messaging part of the medical record, and some physicians have found ways to charge for this 'online consultation,' “Dr. Purcell said.

It's important to set clear expectations about response time and emergency issues. Most messaging systems tell patients that they may have to wait 2-3 business days for a personal reply and advise them to call 911 for a medical emergency.

It's not unreasonable to assume that electronic communication could allow patients to bombard offices with questions and requests. Although data are still limited, the studies that are out there suggest just the opposite, Dr. Purcell said.

Two studies published in 2005 indicate that messaging increases patient satisfaction without any corresponding increase in workload. The first study randomized 200 patients to secure messaging or usual care. Only 46% of the patients who were given access sent any messages at all; the average was just 1.5 messages per patient per year. And although messaging didn't reduce the number of telephone calls the office received, the number of office visits in the intervention group did go down (Int. J. Med. Inform. 2005;74:705-10).

The second study randomized 606 patients to a patient communication portal or to a Web site with general health information. Only 31% of the patients given access used the portal. The message box received only one message per day per 250 patients. Again, there was no difference in the number of office telephone calls between the groups, but the patients in the portal group reported better satisfaction with communication and overall care, even if they never used the portal (J. Med. Internet Res. 2005;7:e48).

The same study indicated that secure messaging probably would not overwhelm anyone during working hours, Dr. Purcell said. “Patients tended to use the portal during nonclinic hours—the most convenient time for them—with about 73% of messaging occurring from 5 p.m. until midnight.”

Patients may even be willing to pay for the added convenience of messaging, the authors concluded. Of 341 patients surveyed, 162 (48%) were willing to pay for online correspondence with their physician, with $2 cited as the median payment they thought fair.

Patient access to test results is another area of clinician concern, she said. “Obtaining test results is probably the most commonly desired and most commonly used function of a patient portal, and one that makes physicians very nervous,” Dr. Purcell said.

The MyHealthAtVanderbilt system (www.myhealthatvanderbilt.com

“Some low-risk, high-value test results, such as cholesterol levels, are available immediately, and some results are available with a delay, such as tests that require interpretation in a specific clinical context,” Dr. Purcell said. “But some results, such as cancer pathology and HIV tests, and others that require intensive patient counseling, are never available though the portal.”

NEW ORLEANS — Rather than unlocking a Pandora's box of nattering e-mails, an electronic patient portal that allows messaging and even access to test results can improve patient satisfaction and decrease patient visits.

“Many physicians think that this type of access is frightening,” Dr. Gretchen P. Purcell said at the annual clinical congress of the American College of Surgeons. “They think they'll be barraged with messages, that patients will misinterpret their test results, and that physicians could even be held legally liable if they don't respond in time to an urgent message.”

But health care providers, who are about 10 years behind the curve in the digital world, need to face up to the facts of the 21st century, said Dr. Purcell of the surgery department at the Children's Hospital at Vanderbilt in Nashville, Tenn. “Patients are demanding the same kind of online access to their medical information as they have for all other aspects of their lives. Those health care institutions that do not have a patient portal now probably will within the next 5 years.”

Patient portals can be designed to suit the needs of different practices and to fulfill various functions. At a minimum, they allow patients to pay bills, schedule or change appointments, and request prescription refills. Other portals are more robust and give patients the ability to review medical records, view test results, and send messages to their health care provider, said Dr. Purcell, who is also with the biomedical informatics department at Vanderbilt Medical Center.

Among the most controversial topics are messaging and the ability to access test results, she said.

“Messaging is probably the function physicians fear the most. Many think it's the equivalent of getting and sending personal e-mail, and this brings up all kinds of worries about security and privacy.”

E-mail and messaging, however, are not the same things. Messages don't go to a personal e-mail account; instead, they go to a dedicated in-box. “This message box is routinely checked by an administrative assistant or nurse—someone who can often answer many of the questions, and who would involve the physician only when necessary—similar to phone call triage.”

There also are concerns that these electronic exchanges aren't part of a patient's documented record. “Some portals can make messaging part of the medical record, and some physicians have found ways to charge for this 'online consultation,' “Dr. Purcell said.

It's important to set clear expectations about response time and emergency issues. Most messaging systems tell patients that they may have to wait 2-3 business days for a personal reply and advise them to call 911 for a medical emergency.

It's not unreasonable to assume that electronic communication could allow patients to bombard offices with questions and requests. Although data are still limited, the studies that are out there suggest just the opposite, Dr. Purcell said.

Two studies published in 2005 indicate that messaging increases patient satisfaction without any corresponding increase in workload. The first study randomized 200 patients to secure messaging or usual care. Only 46% of the patients who were given access sent any messages at all; the average was just 1.5 messages per patient per year. And although messaging didn't reduce the number of telephone calls the office received, the number of office visits in the intervention group did go down (Int. J. Med. Inform. 2005;74:705-10).

The second study randomized 606 patients to a patient communication portal or to a Web site with general health information. Only 31% of the patients given access used the portal. The message box received only one message per day per 250 patients. Again, there was no difference in the number of office telephone calls between the groups, but the patients in the portal group reported better satisfaction with communication and overall care, even if they never used the portal (J. Med. Internet Res. 2005;7:e48).

The same study indicated that secure messaging probably would not overwhelm anyone during working hours, Dr. Purcell said. “Patients tended to use the portal during nonclinic hours—the most convenient time for them—with about 73% of messaging occurring from 5 p.m. until midnight.”

Patients may even be willing to pay for the added convenience of messaging, the authors concluded. Of 341 patients surveyed, 162 (48%) were willing to pay for online correspondence with their physician, with $2 cited as the median payment they thought fair.

Patient access to test results is another area of clinician concern, she said. “Obtaining test results is probably the most commonly desired and most commonly used function of a patient portal, and one that makes physicians very nervous,” Dr. Purcell said.

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“Some low-risk, high-value test results, such as cholesterol levels, are available immediately, and some results are available with a delay, such as tests that require interpretation in a specific clinical context,” Dr. Purcell said. “But some results, such as cancer pathology and HIV tests, and others that require intensive patient counseling, are never available though the portal.”

Carotid artery stenting is associated with twice the incidence of postoperative stroke and in-hospital mortality seen with carotid endarterectomy, Dr. James T. McPhee and colleagues reported.

The disparity in outcomes is even greater among patients with symptomatic stenosis, who faced a fourfold increase in stroke and a sevenfold increase in mortality after stenting, compared with endarterectomy (J. Vasc. Surg. 2007;46:1112–8).

These conclusions suggest that carotid artery stenting is not ready for wide application, wrote Dr. McPhee of the University of Massachusetts, Worcester, and his coauthors. “Further randomized controlled studies with homogenous symptomatic and asymptomatic cohorts should be performed to determine what role carotid artery stenting will play in the treatment of patients with carotid stenosis.”

The investigators drew their information from the Healthcare Cost and Utilization Project's 2003 and 2004 Nationwide Inpatient Sample database. During those two years, 259,000 carotid revascularization procedures were performed in the United States. Most (95%) were endarterectomy; the rest were stenting procedures. Almost all of the patients (92%) had asymptomatic stenoses. The patients' mean age was 71 years; however, the 8% of patients with symptomatic stenoses were significantly older (75 years).

The postoperative stroke rate for all patients was 1.8% after stenting and 0.9% after endarterectomy. A multivariate analysis identified stenting as an independent risk factor for both stroke (odds ratio 2.5) and in-hospital mortality (OR 2.4).

When the investigators examined symptomatic patients only, they found even more profound differences. Among these patients, the postoperative stroke rate after stenting was four times higher than it was after endarterectomy (4% vs. 1%). Symptomatic patients were seven times more likely to die in the hospital after stenting than after endarterectomy (7.5% vs. 1%).

The study adds to the already conflicted body of data on the safety of carotid artery stenting, Dr. McPhee and his coauthors wrote. While several independent studies have found an increased risk of stroke and death with carotid stenting, industry-sponsored registries have concluded that the technique is noninferior to endarterectomy. “[These studies] have been criticized by others because of their methodology … the power of the study, and the validity of a noninferiority study on nonrandomized data using a historical control for the surgical arm,” the authors wrote.

The study provides a valuable insight into this confusing picture, said Dr. Wesley S. Moore, professor and chief emeritus of vascular surgery at the University of California, Los Angeles. “This analysis represents actual, everyday practice data in contrast to very selective clinical trials and registries, most of which are industry sponsored, suffer from design flaws, and are open to criticism for lack of objectivity because the industrial sponsor has control of the data and is unlikely to publish unfavorable results,” Dr. Moore said in an interview.

Critics of the McPhee study may note that carotid stenting is an evolving technique, and that newer safety data will probably be better than those seen in 2003 and 2004, Dr. Moore said. “While this may be true, it is also important to point out that two prospective randomized controlled European studies—not industry supported—have reported similar results in favor of endarterectomy.”

Indeed, he said, because carotid stenting is still a relatively new procedure, “It should only be used in well-designed, objective clinical trials that will yield meaningful data, as opposed to so-called clinical registries, which only serve to skirt federal regulations and permit the unmonitored use of a yet-to-be proven procedure.”

Finally, Dr. Moore said, data have yet to emerge regarding the comparative durability of the two techniques. “We currently have a large prospective randomized controlled study, supported by the National Institutes of Health [CREST or the Carotid Revascularization Endarterectomy vs. Stenting Trial], which is nearing completion of patient acquisition. Once that trial is complete, with 5-year follow-up, we should then have a final word as to the relative safety and benefit of the two procedures.”

Dr. McPhee and his associates stated that they have no financial conflicts of interest.

Angiogram shows a narrowing of the internal carotid artery (near the center of the image).

A completion angiogram, taken after stenting, shows that the stenosis has been treated. PHOTOS COURTESY OR-LIVE.COM

Carotid artery stenting is associated with twice the incidence of postoperative stroke and in-hospital mortality seen with carotid endarterectomy, Dr. James T. McPhee and colleagues reported.

The disparity in outcomes is even greater among patients with symptomatic stenosis, who faced a fourfold increase in stroke and a sevenfold increase in mortality after stenting, compared with endarterectomy (J. Vasc. Surg. 2007;46:1112–8).

These conclusions suggest that carotid artery stenting is not ready for wide application, wrote Dr. McPhee of the University of Massachusetts, Worcester, and his coauthors. “Further randomized controlled studies with homogenous symptomatic and asymptomatic cohorts should be performed to determine what role carotid artery stenting will play in the treatment of patients with carotid stenosis.”

The investigators drew their information from the Healthcare Cost and Utilization Project's 2003 and 2004 Nationwide Inpatient Sample database. During those two years, 259,000 carotid revascularization procedures were performed in the United States. Most (95%) were endarterectomy; the rest were stenting procedures. Almost all of the patients (92%) had asymptomatic stenoses. The patients' mean age was 71 years; however, the 8% of patients with symptomatic stenoses were significantly older (75 years).

The postoperative stroke rate for all patients was 1.8% after stenting and 0.9% after endarterectomy. A multivariate analysis identified stenting as an independent risk factor for both stroke (odds ratio 2.5) and in-hospital mortality (OR 2.4).

When the investigators examined symptomatic patients only, they found even more profound differences. Among these patients, the postoperative stroke rate after stenting was four times higher than it was after endarterectomy (4% vs. 1%). Symptomatic patients were seven times more likely to die in the hospital after stenting than after endarterectomy (7.5% vs. 1%).

The study adds to the already conflicted body of data on the safety of carotid artery stenting, Dr. McPhee and his coauthors wrote. While several independent studies have found an increased risk of stroke and death with carotid stenting, industry-sponsored registries have concluded that the technique is noninferior to endarterectomy. “[These studies] have been criticized by others because of their methodology … the power of the study, and the validity of a noninferiority study on nonrandomized data using a historical control for the surgical arm,” the authors wrote.

The study provides a valuable insight into this confusing picture, said Dr. Wesley S. Moore, professor and chief emeritus of vascular surgery at the University of California, Los Angeles. “This analysis represents actual, everyday practice data in contrast to very selective clinical trials and registries, most of which are industry sponsored, suffer from design flaws, and are open to criticism for lack of objectivity because the industrial sponsor has control of the data and is unlikely to publish unfavorable results,” Dr. Moore said in an interview.

Critics of the McPhee study may note that carotid stenting is an evolving technique, and that newer safety data will probably be better than those seen in 2003 and 2004, Dr. Moore said. “While this may be true, it is also important to point out that two prospective randomized controlled European studies—not industry supported—have reported similar results in favor of endarterectomy.”

Indeed, he said, because carotid stenting is still a relatively new procedure, “It should only be used in well-designed, objective clinical trials that will yield meaningful data, as opposed to so-called clinical registries, which only serve to skirt federal regulations and permit the unmonitored use of a yet-to-be proven procedure.”

Finally, Dr. Moore said, data have yet to emerge regarding the comparative durability of the two techniques. “We currently have a large prospective randomized controlled study, supported by the National Institutes of Health [CREST or the Carotid Revascularization Endarterectomy vs. Stenting Trial], which is nearing completion of patient acquisition. Once that trial is complete, with 5-year follow-up, we should then have a final word as to the relative safety and benefit of the two procedures.”

Dr. McPhee and his associates stated that they have no financial conflicts of interest.

Angiogram shows a narrowing of the internal carotid artery (near the center of the image).

A completion angiogram, taken after stenting, shows that the stenosis has been treated. PHOTOS COURTESY OR-LIVE.COM

Carotid artery stenting is associated with twice the incidence of postoperative stroke and in-hospital mortality seen with carotid endarterectomy, Dr. James T. McPhee and colleagues reported.

The disparity in outcomes is even greater among patients with symptomatic stenosis, who faced a fourfold increase in stroke and a sevenfold increase in mortality after stenting, compared with endarterectomy (J. Vasc. Surg. 2007;46:1112–8).

These conclusions suggest that carotid artery stenting is not ready for wide application, wrote Dr. McPhee of the University of Massachusetts, Worcester, and his coauthors. “Further randomized controlled studies with homogenous symptomatic and asymptomatic cohorts should be performed to determine what role carotid artery stenting will play in the treatment of patients with carotid stenosis.”

The investigators drew their information from the Healthcare Cost and Utilization Project's 2003 and 2004 Nationwide Inpatient Sample database. During those two years, 259,000 carotid revascularization procedures were performed in the United States. Most (95%) were endarterectomy; the rest were stenting procedures. Almost all of the patients (92%) had asymptomatic stenoses. The patients' mean age was 71 years; however, the 8% of patients with symptomatic stenoses were significantly older (75 years).

The postoperative stroke rate for all patients was 1.8% after stenting and 0.9% after endarterectomy. A multivariate analysis identified stenting as an independent risk factor for both stroke (odds ratio 2.5) and in-hospital mortality (OR 2.4).

When the investigators examined symptomatic patients only, they found even more profound differences. Among these patients, the postoperative stroke rate after stenting was four times higher than it was after endarterectomy (4% vs. 1%). Symptomatic patients were seven times more likely to die in the hospital after stenting than after endarterectomy (7.5% vs. 1%).

The study adds to the already conflicted body of data on the safety of carotid artery stenting, Dr. McPhee and his coauthors wrote. While several independent studies have found an increased risk of stroke and death with carotid stenting, industry-sponsored registries have concluded that the technique is noninferior to endarterectomy. “[These studies] have been criticized by others because of their methodology … the power of the study, and the validity of a noninferiority study on nonrandomized data using a historical control for the surgical arm,” the authors wrote.

The study provides a valuable insight into this confusing picture, said Dr. Wesley S. Moore, professor and chief emeritus of vascular surgery at the University of California, Los Angeles. “This analysis represents actual, everyday practice data in contrast to very selective clinical trials and registries, most of which are industry sponsored, suffer from design flaws, and are open to criticism for lack of objectivity because the industrial sponsor has control of the data and is unlikely to publish unfavorable results,” Dr. Moore said in an interview.

Critics of the McPhee study may note that carotid stenting is an evolving technique, and that newer safety data will probably be better than those seen in 2003 and 2004, Dr. Moore said. “While this may be true, it is also important to point out that two prospective randomized controlled European studies—not industry supported—have reported similar results in favor of endarterectomy.”

Indeed, he said, because carotid stenting is still a relatively new procedure, “It should only be used in well-designed, objective clinical trials that will yield meaningful data, as opposed to so-called clinical registries, which only serve to skirt federal regulations and permit the unmonitored use of a yet-to-be proven procedure.”

Finally, Dr. Moore said, data have yet to emerge regarding the comparative durability of the two techniques. “We currently have a large prospective randomized controlled study, supported by the National Institutes of Health [CREST or the Carotid Revascularization Endarterectomy vs. Stenting Trial], which is nearing completion of patient acquisition. Once that trial is complete, with 5-year follow-up, we should then have a final word as to the relative safety and benefit of the two procedures.”

Dr. McPhee and his associates stated that they have no financial conflicts of interest.

Angiogram shows a narrowing of the internal carotid artery (near the center of the image).

A completion angiogram, taken after stenting, shows that the stenosis has been treated. PHOTOS COURTESY OR-LIVE.COM

A family dietary program that offered monthly nutritional counseling and online computer support helped parents and children cut their daily intake of fat and sugar.

Although the counseling lasted for only 8 months, changes were sustained throughout the 12-month study, wrote Damien Paineau of Nutri-Health, in Rueil-Malmaison, France.

Nutri-Health is a company that conducts clinical trials and writes reports in support of the nutritional effects and health benefits of food products.

The study shows that an inexpensive counseling intervention, priced at about $1.50/person per day, may be a beneficial tool in the fight against obesity, wrote the investigators (Arch. Ped. Adolesc. Med. 2008;162:34–43).

The randomized controlled trial included 1,013 parent/child pairs (2,026 individuals) who underwent anthropometric measurements, including height, weight, and body mass index (BMI), and were asked to track their nutritional intake for 1 year.

Group A was told to cut fat to less than 35% of daily calories and increase complex carbohydrates to more than 50% of daily calories; Group B was told to cut fat to less than 35% of daily calories, limit sugar to 25% of daily calories, and increase complex carbohydrates to more than 50%; Group C was given general nutritional information and asked to track their nutritional intake but not given any individual advice.

The intervention groups also received monthly 30-minute phone counseling sessions, and access to a Web site with support information (questionnaires on diet, activity, meal preparation and quality of life; updated study information; and an individual, interactive agenda).

At baseline, parents' mean age was 40 years, and mean BMI was 24 kg/m

Compared with the control group, both adults and children in the intervention groups successfully decreased daily caloric intake, with Group B achieving a greater reduction than Group A (children, 96 vs. 60 calories; adults, 153 vs. 107 calories).

Both intervention groups achieved the nutritional goal for fat reduction. Only Group B achieved the goal of reducing sugar intake, and only Group A achieved the goal of increasing complex carbohydrates.

As expected for growing children of this age, there were no significant differences between the intervention and control groups in any anthropometric measures, with the exception of a trend toward decreasing BMI in all three groups.

When the researchers divided the children by BMI, however, they saw that overweight children in the intervention groups stabilized their BMI.

“This finding is interesting because the BMIs of 27 overweight children not participating in the study but attending the same schools increased during the year [by 36%]. The result may indicate that participating in an educational program may improve BMI in overweight children, whatever the intensity of dietary coaching,” they wrote.

Parents in Group B benefited the most, with small but significant decreases in BMI, fat mass, and hip circumference, compared with parents in the control group.

There were no differences in activity levels in any group among adults or children.

The nutritional changes occurred in the first 3 months of the study and were maintained, even after the monthly counseling sessions ended, “suggesting that such changes were sustainable in the context of the study,” the authors wrote.

A family dietary program that offered monthly nutritional counseling and online computer support helped parents and children cut their daily intake of fat and sugar.

Although the counseling lasted for only 8 months, changes were sustained throughout the 12-month study, wrote Damien Paineau of Nutri-Health, in Rueil-Malmaison, France.

Nutri-Health is a company that conducts clinical trials and writes reports in support of the nutritional effects and health benefits of food products.

The study shows that an inexpensive counseling intervention, priced at about $1.50/person per day, may be a beneficial tool in the fight against obesity, wrote the investigators (Arch. Ped. Adolesc. Med. 2008;162:34–43).

The randomized controlled trial included 1,013 parent/child pairs (2,026 individuals) who underwent anthropometric measurements, including height, weight, and body mass index (BMI), and were asked to track their nutritional intake for 1 year.

Group A was told to cut fat to less than 35% of daily calories and increase complex carbohydrates to more than 50% of daily calories; Group B was told to cut fat to less than 35% of daily calories, limit sugar to 25% of daily calories, and increase complex carbohydrates to more than 50%; Group C was given general nutritional information and asked to track their nutritional intake but not given any individual advice.

The intervention groups also received monthly 30-minute phone counseling sessions, and access to a Web site with support information (questionnaires on diet, activity, meal preparation and quality of life; updated study information; and an individual, interactive agenda).

At baseline, parents' mean age was 40 years, and mean BMI was 24 kg/m

Compared with the control group, both adults and children in the intervention groups successfully decreased daily caloric intake, with Group B achieving a greater reduction than Group A (children, 96 vs. 60 calories; adults, 153 vs. 107 calories).

Both intervention groups achieved the nutritional goal for fat reduction. Only Group B achieved the goal of reducing sugar intake, and only Group A achieved the goal of increasing complex carbohydrates.

As expected for growing children of this age, there were no significant differences between the intervention and control groups in any anthropometric measures, with the exception of a trend toward decreasing BMI in all three groups.

When the researchers divided the children by BMI, however, they saw that overweight children in the intervention groups stabilized their BMI.

“This finding is interesting because the BMIs of 27 overweight children not participating in the study but attending the same schools increased during the year [by 36%]. The result may indicate that participating in an educational program may improve BMI in overweight children, whatever the intensity of dietary coaching,” they wrote.

Parents in Group B benefited the most, with small but significant decreases in BMI, fat mass, and hip circumference, compared with parents in the control group.

There were no differences in activity levels in any group among adults or children.

The nutritional changes occurred in the first 3 months of the study and were maintained, even after the monthly counseling sessions ended, “suggesting that such changes were sustainable in the context of the study,” the authors wrote.

A family dietary program that offered monthly nutritional counseling and online computer support helped parents and children cut their daily intake of fat and sugar.

Although the counseling lasted for only 8 months, changes were sustained throughout the 12-month study, wrote Damien Paineau of Nutri-Health, in Rueil-Malmaison, France.

Nutri-Health is a company that conducts clinical trials and writes reports in support of the nutritional effects and health benefits of food products.

The study shows that an inexpensive counseling intervention, priced at about $1.50/person per day, may be a beneficial tool in the fight against obesity, wrote the investigators (Arch. Ped. Adolesc. Med. 2008;162:34–43).

The randomized controlled trial included 1,013 parent/child pairs (2,026 individuals) who underwent anthropometric measurements, including height, weight, and body mass index (BMI), and were asked to track their nutritional intake for 1 year.

Group A was told to cut fat to less than 35% of daily calories and increase complex carbohydrates to more than 50% of daily calories; Group B was told to cut fat to less than 35% of daily calories, limit sugar to 25% of daily calories, and increase complex carbohydrates to more than 50%; Group C was given general nutritional information and asked to track their nutritional intake but not given any individual advice.

The intervention groups also received monthly 30-minute phone counseling sessions, and access to a Web site with support information (questionnaires on diet, activity, meal preparation and quality of life; updated study information; and an individual, interactive agenda).

At baseline, parents' mean age was 40 years, and mean BMI was 24 kg/m

Compared with the control group, both adults and children in the intervention groups successfully decreased daily caloric intake, with Group B achieving a greater reduction than Group A (children, 96 vs. 60 calories; adults, 153 vs. 107 calories).

Both intervention groups achieved the nutritional goal for fat reduction. Only Group B achieved the goal of reducing sugar intake, and only Group A achieved the goal of increasing complex carbohydrates.

As expected for growing children of this age, there were no significant differences between the intervention and control groups in any anthropometric measures, with the exception of a trend toward decreasing BMI in all three groups.

When the researchers divided the children by BMI, however, they saw that overweight children in the intervention groups stabilized their BMI.

“This finding is interesting because the BMIs of 27 overweight children not participating in the study but attending the same schools increased during the year [by 36%]. The result may indicate that participating in an educational program may improve BMI in overweight children, whatever the intensity of dietary coaching,” they wrote.

Parents in Group B benefited the most, with small but significant decreases in BMI, fat mass, and hip circumference, compared with parents in the control group.

There were no differences in activity levels in any group among adults or children.

The nutritional changes occurred in the first 3 months of the study and were maintained, even after the monthly counseling sessions ended, “suggesting that such changes were sustainable in the context of the study,” the authors wrote.

Weight gain does not necessarily follow the institution of insulin therapy in type 2 diabetes patients already taking oral hypoglycemics, results of a 7-year longitudinal study suggest.

Study investigators concluded that weight gain following the addition of insulin therapy is mostly the result of a correction of the glycemia that often causes weight loss, and brings most patients closer to their normal physiologically controlled weight.

“Thus, concern over an increase in body weight should not deter patients and physicians from adding insulin and appropriate oral medications in order to achieve therapeutic goals,” Dr. Ohad Cohen of Tel Aviv University, and his coauthors wrote in Diabetes Research and Clinical Practice.

The study included 366 adults (mean age 67 years) with type 2 diabetes. Most (310) were on only oral hypoglycemic medications at baseline; the remaining 56 were also taking insulin (Diabetes Res. Clin. Pract. 2008;79:128–32). Compared with those taking oral medications, patients also on insulin had an earlier age of diabetes onset (51 vs. 55 years) and longer duration of diabetes (13 vs. 6 years).

Mean baseline weight was 79 kg; the mean self-reported weight before diagnosis was 83 kg.

Patients followed a stepwise diabetes therapy, beginning with modified nutritional therapy followed by oral medications. Insulin was added if oral therapy failed to reach the glycemic goal of a hemoglobin A_1c level of less than 8%.

Weight among those taking only the oral medications stayed constant throughout the 7-year follow-up period, with no changes occurring after the transition from nutritional therapy to oral medication, and no significant difference from baseline to the end of follow-up.

In contrast, patients who added insulin to their treatment regimen experienced significant weight gain, gaining a mean of 2 kg in the period between the change and the end of the study.

However, the investigators noted, insulin was added at a time when the patients' blood glucose levels increased significantly to a mean of 9.4%; this increase was accompanied by a nonsignificant weight decrease. The mean weight increase of 2 kg did not cause patients to exceed their self-reported prediagnosis weight, or to significantly exceed their weight when treated by diet alone.

A large weight increase of more than 10 kg occurred in 22 subjects. Multivariate analysis identified younger age, higher HbA_1c levels, lower initial body mass index, and the absence of atherosclerotic heart disease as risk factors for high weight gain.

“The data uniquely present clear evidence that the increase in weight of diabetic patients, who in real life use insulin, is relative to their previous uncontrolled state preceding insulin usage and does not surpass the weight during previous stages of the disease,” the authors said.

Weight gain does not necessarily follow the institution of insulin therapy in type 2 diabetes patients already taking oral hypoglycemics, results of a 7-year longitudinal study suggest.

Study investigators concluded that weight gain following the addition of insulin therapy is mostly the result of a correction of the glycemia that often causes weight loss, and brings most patients closer to their normal physiologically controlled weight.

“Thus, concern over an increase in body weight should not deter patients and physicians from adding insulin and appropriate oral medications in order to achieve therapeutic goals,” Dr. Ohad Cohen of Tel Aviv University, and his coauthors wrote in Diabetes Research and Clinical Practice.

The study included 366 adults (mean age 67 years) with type 2 diabetes. Most (310) were on only oral hypoglycemic medications at baseline; the remaining 56 were also taking insulin (Diabetes Res. Clin. Pract. 2008;79:128–32). Compared with those taking oral medications, patients also on insulin had an earlier age of diabetes onset (51 vs. 55 years) and longer duration of diabetes (13 vs. 6 years).

Mean baseline weight was 79 kg; the mean self-reported weight before diagnosis was 83 kg.

Patients followed a stepwise diabetes therapy, beginning with modified nutritional therapy followed by oral medications. Insulin was added if oral therapy failed to reach the glycemic goal of a hemoglobin A_1c level of less than 8%.

Weight among those taking only the oral medications stayed constant throughout the 7-year follow-up period, with no changes occurring after the transition from nutritional therapy to oral medication, and no significant difference from baseline to the end of follow-up.

In contrast, patients who added insulin to their treatment regimen experienced significant weight gain, gaining a mean of 2 kg in the period between the change and the end of the study.

However, the investigators noted, insulin was added at a time when the patients' blood glucose levels increased significantly to a mean of 9.4%; this increase was accompanied by a nonsignificant weight decrease. The mean weight increase of 2 kg did not cause patients to exceed their self-reported prediagnosis weight, or to significantly exceed their weight when treated by diet alone.

A large weight increase of more than 10 kg occurred in 22 subjects. Multivariate analysis identified younger age, higher HbA_1c levels, lower initial body mass index, and the absence of atherosclerotic heart disease as risk factors for high weight gain.

“The data uniquely present clear evidence that the increase in weight of diabetic patients, who in real life use insulin, is relative to their previous uncontrolled state preceding insulin usage and does not surpass the weight during previous stages of the disease,” the authors said.

Weight gain does not necessarily follow the institution of insulin therapy in type 2 diabetes patients already taking oral hypoglycemics, results of a 7-year longitudinal study suggest.

Study investigators concluded that weight gain following the addition of insulin therapy is mostly the result of a correction of the glycemia that often causes weight loss, and brings most patients closer to their normal physiologically controlled weight.

“Thus, concern over an increase in body weight should not deter patients and physicians from adding insulin and appropriate oral medications in order to achieve therapeutic goals,” Dr. Ohad Cohen of Tel Aviv University, and his coauthors wrote in Diabetes Research and Clinical Practice.

The study included 366 adults (mean age 67 years) with type 2 diabetes. Most (310) were on only oral hypoglycemic medications at baseline; the remaining 56 were also taking insulin (Diabetes Res. Clin. Pract. 2008;79:128–32). Compared with those taking oral medications, patients also on insulin had an earlier age of diabetes onset (51 vs. 55 years) and longer duration of diabetes (13 vs. 6 years).

Mean baseline weight was 79 kg; the mean self-reported weight before diagnosis was 83 kg.

Patients followed a stepwise diabetes therapy, beginning with modified nutritional therapy followed by oral medications. Insulin was added if oral therapy failed to reach the glycemic goal of a hemoglobin A_1c level of less than 8%.

Weight among those taking only the oral medications stayed constant throughout the 7-year follow-up period, with no changes occurring after the transition from nutritional therapy to oral medication, and no significant difference from baseline to the end of follow-up.

In contrast, patients who added insulin to their treatment regimen experienced significant weight gain, gaining a mean of 2 kg in the period between the change and the end of the study.

However, the investigators noted, insulin was added at a time when the patients' blood glucose levels increased significantly to a mean of 9.4%; this increase was accompanied by a nonsignificant weight decrease. The mean weight increase of 2 kg did not cause patients to exceed their self-reported prediagnosis weight, or to significantly exceed their weight when treated by diet alone.

A large weight increase of more than 10 kg occurred in 22 subjects. Multivariate analysis identified younger age, higher HbA_1c levels, lower initial body mass index, and the absence of atherosclerotic heart disease as risk factors for high weight gain.

“The data uniquely present clear evidence that the increase in weight of diabetic patients, who in real life use insulin, is relative to their previous uncontrolled state preceding insulin usage and does not surpass the weight during previous stages of the disease,” the authors said.

NEW ORLEANS – Rather than unlocking a Pandora's box of nattering e-mails, an electronic patient portal that allows messaging and even access to test results can improve patient satisfaction and decrease patient visits.

“Many physicians think that this type of access is frightening,” Dr. Gretchen P. Purcell said at the annual clinical congress of the American College of Surgeons. “They think they'll be barraged with messages, that patients will misinterpret their test results, and that physicians could even be held legally liable if they don't respond in time to an urgent message.”

But health care providers, who are about 10 years behind the curve in the digital world, need to face up to the facts of the 21st century, said Dr. Purcell of the surgery department at the Children's Hospital at Vanderbilt in Nashville, Tenn. “Patients are demanding the same kind of online access to their medical information as they have for all other aspects of their lives. Those health care institutions that do not have a patient portal now probably will within the next 5 years.”

Patient portals can be designed to suit the needs of different practices and to fulfill various functions. At a minimum, they allow patients to pay bills, schedule or change appointments, and request prescription refills. Other portals are more robust and give patients the ability to review medical records, view test results, and send messages to their health care provider, said Dr. Purcell, who is also with the biomedical informatics department at Vanderbilt Medical Center.

Among the most controversial topics are messaging and the ability to access test results, she said.

“Messaging is probably the function physicians fear the most. Many think it's the equivalent of getting and sending personal e-mail, and this brings up all kinds of worries about security and privacy.”

E-mail and messaging, however, are not the same things. Messages don't go to a personal e-mail account; instead, they go to a dedicated in-box. “This message box is routinely checked by an administrative assistant or nurse–someone who can often answer many of the questions, and who would involve the physician only when necessary–similar to phone call triage.”

There also are concerns that these electronic exchanges aren't part of a patient's documented record. “Some portals can make messaging part of the medical record, and some physicians have found ways to charge for this 'online consultation,' “Dr. Purcell said.

It's important to set clear expectations about response time and emergency issues. Most messaging systems tell patients that they may have to wait 2-3 business days for a personal reply and advise them to call 911 for a medical emergency.

It's not unreasonable to assume that electronic communication could allow patients to bombard offices with questions and requests. Although data are still limited, the studies that are out there suggest just the opposite, Dr. Purcell said.

Two studies published in 2005 indicate that messaging increases patient satisfaction without any corresponding increase in workload. The first study randomized 200 patients to secure messaging or usual care. Only 46% of the patients who were given access sent any messages at all; the average was just 1.5 messages per patient per year. And although messaging didn't reduce the number of telephone calls the office received, the number of office visits in the intervention group did go down (Int. J. Med. Inform. 2005;74:705-10).

The second study randomized 606 patients to a patient communication portal or to a Web site with general health information. Only 31% of the patients given access used the portal. The message box received only one message per day per 250 patients. Again, there was no difference in the number of office telephone calls between the groups, but the patients in the portal group reported better satisfaction with communication and overall care, even if they never used the portal (J. Med. Internet Res. 2005;7:e48).

The same study indicated that secure messaging probably would not overwhelm anyone during working hours, Dr. Purcell said. “Patients tended to use the portal during nonclinic hours–the most convenient time for them–with about 73% of messaging occurring from 5 p.m. until midnight.”

Patients may even be willing to pay for the added convenience of messaging, the authors concluded. Of 341 patients surveyed, 162 (48%) were willing to pay for online correspondence with their physician, with $2 cited as the median payment they thought fair.

Patient access to test results is another area of clinician concern, she said. “Obtaining test results is probably the most commonly desired and most commonly used function of a patient portal, and one that makes physicians very nervous,” Dr. Purcell said.

The MyHealthAtVanderbilt system (www.myhealthatvanderbilt.com

NEW ORLEANS – Rather than unlocking a Pandora's box of nattering e-mails, an electronic patient portal that allows messaging and even access to test results can improve patient satisfaction and decrease patient visits.

“Many physicians think that this type of access is frightening,” Dr. Gretchen P. Purcell said at the annual clinical congress of the American College of Surgeons. “They think they'll be barraged with messages, that patients will misinterpret their test results, and that physicians could even be held legally liable if they don't respond in time to an urgent message.”

But health care providers, who are about 10 years behind the curve in the digital world, need to face up to the facts of the 21st century, said Dr. Purcell of the surgery department at the Children's Hospital at Vanderbilt in Nashville, Tenn. “Patients are demanding the same kind of online access to their medical information as they have for all other aspects of their lives. Those health care institutions that do not have a patient portal now probably will within the next 5 years.”

Patient portals can be designed to suit the needs of different practices and to fulfill various functions. At a minimum, they allow patients to pay bills, schedule or change appointments, and request prescription refills. Other portals are more robust and give patients the ability to review medical records, view test results, and send messages to their health care provider, said Dr. Purcell, who is also with the biomedical informatics department at Vanderbilt Medical Center.

Among the most controversial topics are messaging and the ability to access test results, she said.

“Messaging is probably the function physicians fear the most. Many think it's the equivalent of getting and sending personal e-mail, and this brings up all kinds of worries about security and privacy.”

E-mail and messaging, however, are not the same things. Messages don't go to a personal e-mail account; instead, they go to a dedicated in-box. “This message box is routinely checked by an administrative assistant or nurse–someone who can often answer many of the questions, and who would involve the physician only when necessary–similar to phone call triage.”

There also are concerns that these electronic exchanges aren't part of a patient's documented record. “Some portals can make messaging part of the medical record, and some physicians have found ways to charge for this 'online consultation,' “Dr. Purcell said.

It's important to set clear expectations about response time and emergency issues. Most messaging systems tell patients that they may have to wait 2-3 business days for a personal reply and advise them to call 911 for a medical emergency.

It's not unreasonable to assume that electronic communication could allow patients to bombard offices with questions and requests. Although data are still limited, the studies that are out there suggest just the opposite, Dr. Purcell said.

Two studies published in 2005 indicate that messaging increases patient satisfaction without any corresponding increase in workload. The first study randomized 200 patients to secure messaging or usual care. Only 46% of the patients who were given access sent any messages at all; the average was just 1.5 messages per patient per year. And although messaging didn't reduce the number of telephone calls the office received, the number of office visits in the intervention group did go down (Int. J. Med. Inform. 2005;74:705-10).

The second study randomized 606 patients to a patient communication portal or to a Web site with general health information. Only 31% of the patients given access used the portal. The message box received only one message per day per 250 patients. Again, there was no difference in the number of office telephone calls between the groups, but the patients in the portal group reported better satisfaction with communication and overall care, even if they never used the portal (J. Med. Internet Res. 2005;7:e48).

The same study indicated that secure messaging probably would not overwhelm anyone during working hours, Dr. Purcell said. “Patients tended to use the portal during nonclinic hours–the most convenient time for them–with about 73% of messaging occurring from 5 p.m. until midnight.”

Patients may even be willing to pay for the added convenience of messaging, the authors concluded. Of 341 patients surveyed, 162 (48%) were willing to pay for online correspondence with their physician, with $2 cited as the median payment they thought fair.

Patient access to test results is another area of clinician concern, she said. “Obtaining test results is probably the most commonly desired and most commonly used function of a patient portal, and one that makes physicians very nervous,” Dr. Purcell said.

The MyHealthAtVanderbilt system (www.myhealthatvanderbilt.com

NEW ORLEANS – Rather than unlocking a Pandora's box of nattering e-mails, an electronic patient portal that allows messaging and even access to test results can improve patient satisfaction and decrease patient visits.

“Many physicians think that this type of access is frightening,” Dr. Gretchen P. Purcell said at the annual clinical congress of the American College of Surgeons. “They think they'll be barraged with messages, that patients will misinterpret their test results, and that physicians could even be held legally liable if they don't respond in time to an urgent message.”

But health care providers, who are about 10 years behind the curve in the digital world, need to face up to the facts of the 21st century, said Dr. Purcell of the surgery department at the Children's Hospital at Vanderbilt in Nashville, Tenn. “Patients are demanding the same kind of online access to their medical information as they have for all other aspects of their lives. Those health care institutions that do not have a patient portal now probably will within the next 5 years.”

Patient portals can be designed to suit the needs of different practices and to fulfill various functions. At a minimum, they allow patients to pay bills, schedule or change appointments, and request prescription refills. Other portals are more robust and give patients the ability to review medical records, view test results, and send messages to their health care provider, said Dr. Purcell, who is also with the biomedical informatics department at Vanderbilt Medical Center.

Among the most controversial topics are messaging and the ability to access test results, she said.

“Messaging is probably the function physicians fear the most. Many think it's the equivalent of getting and sending personal e-mail, and this brings up all kinds of worries about security and privacy.”

E-mail and messaging, however, are not the same things. Messages don't go to a personal e-mail account; instead, they go to a dedicated in-box. “This message box is routinely checked by an administrative assistant or nurse–someone who can often answer many of the questions, and who would involve the physician only when necessary–similar to phone call triage.”

There also are concerns that these electronic exchanges aren't part of a patient's documented record. “Some portals can make messaging part of the medical record, and some physicians have found ways to charge for this 'online consultation,' “Dr. Purcell said.

It's important to set clear expectations about response time and emergency issues. Most messaging systems tell patients that they may have to wait 2-3 business days for a personal reply and advise them to call 911 for a medical emergency.

It's not unreasonable to assume that electronic communication could allow patients to bombard offices with questions and requests. Although data are still limited, the studies that are out there suggest just the opposite, Dr. Purcell said.

Two studies published in 2005 indicate that messaging increases patient satisfaction without any corresponding increase in workload. The first study randomized 200 patients to secure messaging or usual care. Only 46% of the patients who were given access sent any messages at all; the average was just 1.5 messages per patient per year. And although messaging didn't reduce the number of telephone calls the office received, the number of office visits in the intervention group did go down (Int. J. Med. Inform. 2005;74:705-10).

The second study randomized 606 patients to a patient communication portal or to a Web site with general health information. Only 31% of the patients given access used the portal. The message box received only one message per day per 250 patients. Again, there was no difference in the number of office telephone calls between the groups, but the patients in the portal group reported better satisfaction with communication and overall care, even if they never used the portal (J. Med. Internet Res. 2005;7:e48).

The same study indicated that secure messaging probably would not overwhelm anyone during working hours, Dr. Purcell said. “Patients tended to use the portal during nonclinic hours–the most convenient time for them–with about 73% of messaging occurring from 5 p.m. until midnight.”

Patients may even be willing to pay for the added convenience of messaging, the authors concluded. Of 341 patients surveyed, 162 (48%) were willing to pay for online correspondence with their physician, with $2 cited as the median payment they thought fair.

Patient access to test results is another area of clinician concern, she said. “Obtaining test results is probably the most commonly desired and most commonly used function of a patient portal, and one that makes physicians very nervous,” Dr. Purcell said.

The MyHealthAtVanderbilt system (www.myhealthatvanderbilt.com

Preschoolers whose tantrums consistently include self-injurious or outwardly projected aggression may be at risk of major depressive disorder, disruptive behavior disorder, or both, Andy C. Belden, Ph.D., and his colleagues reported.

“We propose that preschoolers who consistently exhibit the behaviors outlined may be in need of a referral to a mental health clinician for further evaluation,” Dr. Belden and his associates concluded.

The investigators asked the parents of 279 preschoolers aged 3-6 years to complete the Preschool Age Psychiatric Assessment. The results enabled them to divide the children into four diagnostic categories: healthy (n = 150); major depressive disorder without comorbid disruptive disorders (MDD/no dis, n = 21); disruptive disorders without depression (DIS/no mdd, n = 54); and those with both depression and disruptive disorders (MDD/DIS, n = 54).

The investigators also grouped the children by tantrum characteristics: normative (tantrums that rarely escalated to excess); excessive tantrums without aggression (shouting, crying, and flailing, but no aggression); and excessive tantrums with aggression (self-directed, or directed at other people or objects).

The MDD/DIS groups and DIS/no mdd were significantly more likely than were the other children to engage in excessive tantrums. The MDD/DIS group also was nine times more likely than were healthy and MDD/no dis groups to engage in tantrums with violent or destructive aggression, while those in the DIS/no mdd groups were five times more likely to do so, wrote Dr. Belden of Washington University, St. Louis, and his associates (J. Pediatr. 2008;152:117-22).

Both MDD groups had significantly higher scores on destruction and self-injurious behaviors than did non-MDD groups. The MDD/DIS and the DIS/no mdd groups had significantly higher scores on oral aggression than did the other two groups. The MDD/DIS group also had a significantly longer tantrum recovery time and displayed significantly more tantrums in the home than did the other groups. The MDD/no dis group and MDD/DIS groups had significantly more tantrums in school.

Compared with children in the healthy group, those in the MDD/DIS group were six times more likely to be reported by caregivers as having difficulty recovering from tantrums.

“Healthy children showed significantly fewer violent, self-injurious, destructive, and orally aggressive tantrums than children with mood disorders, disruptive disorders, or both,” the investigators wrote. “Furthermore, healthy preschoolers had less severe and shorter tantrums and required less recovery time…. Although replication of these findings is needed, results indicated that the 'anatomy' of a tantrum in healthy preschoolers was significantly different from same-age peers with mood disorders, disruptive disorders, or both.”

The researchers cautioned that violent outbursts should not automatically trigger a psychiatric referral. About 30% of the healthy preschoolers also displayed some of these characteristics, and maladaptive behaviors in tantrums associated with hunger, sleep problems, or illness should not be considered alarming.

Nonetheless, they suggested that a consistent pattern of maladaptive tantrum behaviors should spark concern and a possible psychiatric evaluation.

The study was supported by a grant from the National Institute of Mental Health; none of the authors reported a conflict of interest.

Preschoolers whose tantrums consistently include self-injurious or outwardly projected aggression may be at risk of major depressive disorder, disruptive behavior disorder, or both, Andy C. Belden, Ph.D., and his colleagues reported.

“We propose that preschoolers who consistently exhibit the behaviors outlined may be in need of a referral to a mental health clinician for further evaluation,” Dr. Belden and his associates concluded.

The investigators asked the parents of 279 preschoolers aged 3-6 years to complete the Preschool Age Psychiatric Assessment. The results enabled them to divide the children into four diagnostic categories: healthy (n = 150); major depressive disorder without comorbid disruptive disorders (MDD/no dis, n = 21); disruptive disorders without depression (DIS/no mdd, n = 54); and those with both depression and disruptive disorders (MDD/DIS, n = 54).

The investigators also grouped the children by tantrum characteristics: normative (tantrums that rarely escalated to excess); excessive tantrums without aggression (shouting, crying, and flailing, but no aggression); and excessive tantrums with aggression (self-directed, or directed at other people or objects).

The MDD/DIS groups and DIS/no mdd were significantly more likely than were the other children to engage in excessive tantrums. The MDD/DIS group also was nine times more likely than were healthy and MDD/no dis groups to engage in tantrums with violent or destructive aggression, while those in the DIS/no mdd groups were five times more likely to do so, wrote Dr. Belden of Washington University, St. Louis, and his associates (J. Pediatr. 2008;152:117-22).

Both MDD groups had significantly higher scores on destruction and self-injurious behaviors than did non-MDD groups. The MDD/DIS and the DIS/no mdd groups had significantly higher scores on oral aggression than did the other two groups. The MDD/DIS group also had a significantly longer tantrum recovery time and displayed significantly more tantrums in the home than did the other groups. The MDD/no dis group and MDD/DIS groups had significantly more tantrums in school.

Compared with children in the healthy group, those in the MDD/DIS group were six times more likely to be reported by caregivers as having difficulty recovering from tantrums.

“Healthy children showed significantly fewer violent, self-injurious, destructive, and orally aggressive tantrums than children with mood disorders, disruptive disorders, or both,” the investigators wrote. “Furthermore, healthy preschoolers had less severe and shorter tantrums and required less recovery time…. Although replication of these findings is needed, results indicated that the 'anatomy' of a tantrum in healthy preschoolers was significantly different from same-age peers with mood disorders, disruptive disorders, or both.”

The researchers cautioned that violent outbursts should not automatically trigger a psychiatric referral. About 30% of the healthy preschoolers also displayed some of these characteristics, and maladaptive behaviors in tantrums associated with hunger, sleep problems, or illness should not be considered alarming.

Nonetheless, they suggested that a consistent pattern of maladaptive tantrum behaviors should spark concern and a possible psychiatric evaluation.

The study was supported by a grant from the National Institute of Mental Health; none of the authors reported a conflict of interest.

Preschoolers whose tantrums consistently include self-injurious or outwardly projected aggression may be at risk of major depressive disorder, disruptive behavior disorder, or both, Andy C. Belden, Ph.D., and his colleagues reported.

“We propose that preschoolers who consistently exhibit the behaviors outlined may be in need of a referral to a mental health clinician for further evaluation,” Dr. Belden and his associates concluded.

The investigators asked the parents of 279 preschoolers aged 3-6 years to complete the Preschool Age Psychiatric Assessment. The results enabled them to divide the children into four diagnostic categories: healthy (n = 150); major depressive disorder without comorbid disruptive disorders (MDD/no dis, n = 21); disruptive disorders without depression (DIS/no mdd, n = 54); and those with both depression and disruptive disorders (MDD/DIS, n = 54).

The investigators also grouped the children by tantrum characteristics: normative (tantrums that rarely escalated to excess); excessive tantrums without aggression (shouting, crying, and flailing, but no aggression); and excessive tantrums with aggression (self-directed, or directed at other people or objects).

The MDD/DIS groups and DIS/no mdd were significantly more likely than were the other children to engage in excessive tantrums. The MDD/DIS group also was nine times more likely than were healthy and MDD/no dis groups to engage in tantrums with violent or destructive aggression, while those in the DIS/no mdd groups were five times more likely to do so, wrote Dr. Belden of Washington University, St. Louis, and his associates (J. Pediatr. 2008;152:117-22).

Both MDD groups had significantly higher scores on destruction and self-injurious behaviors than did non-MDD groups. The MDD/DIS and the DIS/no mdd groups had significantly higher scores on oral aggression than did the other two groups. The MDD/DIS group also had a significantly longer tantrum recovery time and displayed significantly more tantrums in the home than did the other groups. The MDD/no dis group and MDD/DIS groups had significantly more tantrums in school.

Compared with children in the healthy group, those in the MDD/DIS group were six times more likely to be reported by caregivers as having difficulty recovering from tantrums.

“Healthy children showed significantly fewer violent, self-injurious, destructive, and orally aggressive tantrums than children with mood disorders, disruptive disorders, or both,” the investigators wrote. “Furthermore, healthy preschoolers had less severe and shorter tantrums and required less recovery time…. Although replication of these findings is needed, results indicated that the 'anatomy' of a tantrum in healthy preschoolers was significantly different from same-age peers with mood disorders, disruptive disorders, or both.”

The researchers cautioned that violent outbursts should not automatically trigger a psychiatric referral. About 30% of the healthy preschoolers also displayed some of these characteristics, and maladaptive behaviors in tantrums associated with hunger, sleep problems, or illness should not be considered alarming.

Nonetheless, they suggested that a consistent pattern of maladaptive tantrum behaviors should spark concern and a possible psychiatric evaluation.

The study was supported by a grant from the National Institute of Mental Health; none of the authors reported a conflict of interest.

CHICAGO – Topiramate reduced the frequency of basilar migraine by up to 75% in almost 90% of children who took the drug for migraine prevention, Dr. Donald Lewis reported in a poster presentation at the annual meeting of the American Headache Society.

Migraine drugs are considered successful if they produce at least a 50% improvement in at least 50% of patients, said Dr. Lewis, a pediatric neurologist at Children's Hospital of the King's Daughters, Norfolk, Va.

Using this standard, 86% of the patients in Dr. Lewis' study responded to the medication.

Although the study was small–just 14 children–the robust results are a significant finding, he said in an interview.

“We had a much-better-than-usual clinical response for migraine preventatives. This study cries out to be replicated in a large multicenter trial,” he said.

Topiramate (Topamax), manufactured by Ortho-McNeil, previously has been approved as an adjunctive therapy for seizures. However, the drug is not approved for any headache indication in children, but is used off label, Dr. Lewis said.

The study randomized 14 children with basilar migraine to 25 mg or 100 mg/day of topiramate. Their mean age was 13 years; age of onset of basilar migraine ranged from age 2 to 13 years.

At baseline, they had from 4 to 12 migraine days per month, with most reporting severe or excruciating pain (only two reported moderate pain). The mean duration of migraine was 5 hours (range 1-10 hours).

After a 4-week washout period, the children took topiramate for 12 weeks. Both groups experienced a significant decrease in mean monthly migraine days: 3 days (64%) for the 25-mg group and 3.6 days (75%) for the 100-mg group.

Patients in the 25-mg group experienced a 75% reduction in the mean monthly rate of basilar type migraine, while those in the 100-mg group experienced an 82% reduction.

The overall reduction of basilar type migraine attacks per month was 79%.

There also was a median decrease in migraine duration (18 minutes for the 25-mg group and 89 minutes for the 100-mg group). There were no significant differences in migraine severity between the two groups.

Parents rated six of the seven children taking 25 mg/day as very much or much improved, Dr. Lewis reported. In the 100-mg group, parents rated three of the seven children as very much or much improved.

Dr. Lewis used the PedMidas functionality scale to assess disability. The mean rating decreased from severe to moderate.

There were 35 adverse events noted among 10 children (five children in each group). Only 15 events were possibly or probably related to the study drug, and there were no significant differences in adverse events between the groups.

Adverse events included tingling in the face, intermittent numbness and tingling of the upper extremities, nausea, increased thirst, fatigue, and cognitive issues, including blocked thoughts, difficulty with word finding, and learning problems.

In light of the similar efficacy in both groups and slightly higher responder rate in the 25-mg group (100% vs. 71% in the 100-mg group), Dr. Lewis recommends the “start low, go slow” approach to topiramate titration for basilar migraine in children.

“Sometimes in pediatrics, we have a mindset based on a dose per kilogram. In this situation, we should start with the lower dose, reassess how the patient is doing, then go up slowly. “A titration to 'effectiveness' rather than a targeted dose per weight is the way to go.”

The study was investigator initiated, and Ortho-McNeil provided financial support.

CHICAGO – Topiramate reduced the frequency of basilar migraine by up to 75% in almost 90% of children who took the drug for migraine prevention, Dr. Donald Lewis reported in a poster presentation at the annual meeting of the American Headache Society.

Migraine drugs are considered successful if they produce at least a 50% improvement in at least 50% of patients, said Dr. Lewis, a pediatric neurologist at Children's Hospital of the King's Daughters, Norfolk, Va.

Using this standard, 86% of the patients in Dr. Lewis' study responded to the medication.

Although the study was small–just 14 children–the robust results are a significant finding, he said in an interview.

“We had a much-better-than-usual clinical response for migraine preventatives. This study cries out to be replicated in a large multicenter trial,” he said.

Topiramate (Topamax), manufactured by Ortho-McNeil, previously has been approved as an adjunctive therapy for seizures. However, the drug is not approved for any headache indication in children, but is used off label, Dr. Lewis said.

The study randomized 14 children with basilar migraine to 25 mg or 100 mg/day of topiramate. Their mean age was 13 years; age of onset of basilar migraine ranged from age 2 to 13 years.

At baseline, they had from 4 to 12 migraine days per month, with most reporting severe or excruciating pain (only two reported moderate pain). The mean duration of migraine was 5 hours (range 1-10 hours).

After a 4-week washout period, the children took topiramate for 12 weeks. Both groups experienced a significant decrease in mean monthly migraine days: 3 days (64%) for the 25-mg group and 3.6 days (75%) for the 100-mg group.

Patients in the 25-mg group experienced a 75% reduction in the mean monthly rate of basilar type migraine, while those in the 100-mg group experienced an 82% reduction.

The overall reduction of basilar type migraine attacks per month was 79%.

There also was a median decrease in migraine duration (18 minutes for the 25-mg group and 89 minutes for the 100-mg group). There were no significant differences in migraine severity between the two groups.

Parents rated six of the seven children taking 25 mg/day as very much or much improved, Dr. Lewis reported. In the 100-mg group, parents rated three of the seven children as very much or much improved.

Dr. Lewis used the PedMidas functionality scale to assess disability. The mean rating decreased from severe to moderate.

There were 35 adverse events noted among 10 children (five children in each group). Only 15 events were possibly or probably related to the study drug, and there were no significant differences in adverse events between the groups.

Adverse events included tingling in the face, intermittent numbness and tingling of the upper extremities, nausea, increased thirst, fatigue, and cognitive issues, including blocked thoughts, difficulty with word finding, and learning problems.

In light of the similar efficacy in both groups and slightly higher responder rate in the 25-mg group (100% vs. 71% in the 100-mg group), Dr. Lewis recommends the “start low, go slow” approach to topiramate titration for basilar migraine in children.

“Sometimes in pediatrics, we have a mindset based on a dose per kilogram. In this situation, we should start with the lower dose, reassess how the patient is doing, then go up slowly. “A titration to 'effectiveness' rather than a targeted dose per weight is the way to go.”

The study was investigator initiated, and Ortho-McNeil provided financial support.

CHICAGO – Topiramate reduced the frequency of basilar migraine by up to 75% in almost 90% of children who took the drug for migraine prevention, Dr. Donald Lewis reported in a poster presentation at the annual meeting of the American Headache Society.

Migraine drugs are considered successful if they produce at least a 50% improvement in at least 50% of patients, said Dr. Lewis, a pediatric neurologist at Children's Hospital of the King's Daughters, Norfolk, Va.

Using this standard, 86% of the patients in Dr. Lewis' study responded to the medication.

Although the study was small–just 14 children–the robust results are a significant finding, he said in an interview.

“We had a much-better-than-usual clinical response for migraine preventatives. This study cries out to be replicated in a large multicenter trial,” he said.

Topiramate (Topamax), manufactured by Ortho-McNeil, previously has been approved as an adjunctive therapy for seizures. However, the drug is not approved for any headache indication in children, but is used off label, Dr. Lewis said.

The study randomized 14 children with basilar migraine to 25 mg or 100 mg/day of topiramate. Their mean age was 13 years; age of onset of basilar migraine ranged from age 2 to 13 years.

At baseline, they had from 4 to 12 migraine days per month, with most reporting severe or excruciating pain (only two reported moderate pain). The mean duration of migraine was 5 hours (range 1-10 hours).

After a 4-week washout period, the children took topiramate for 12 weeks. Both groups experienced a significant decrease in mean monthly migraine days: 3 days (64%) for the 25-mg group and 3.6 days (75%) for the 100-mg group.

Patients in the 25-mg group experienced a 75% reduction in the mean monthly rate of basilar type migraine, while those in the 100-mg group experienced an 82% reduction.

The overall reduction of basilar type migraine attacks per month was 79%.

There also was a median decrease in migraine duration (18 minutes for the 25-mg group and 89 minutes for the 100-mg group). There were no significant differences in migraine severity between the two groups.

Parents rated six of the seven children taking 25 mg/day as very much or much improved, Dr. Lewis reported. In the 100-mg group, parents rated three of the seven children as very much or much improved.

Dr. Lewis used the PedMidas functionality scale to assess disability. The mean rating decreased from severe to moderate.

There were 35 adverse events noted among 10 children (five children in each group). Only 15 events were possibly or probably related to the study drug, and there were no significant differences in adverse events between the groups.

Adverse events included tingling in the face, intermittent numbness and tingling of the upper extremities, nausea, increased thirst, fatigue, and cognitive issues, including blocked thoughts, difficulty with word finding, and learning problems.

In light of the similar efficacy in both groups and slightly higher responder rate in the 25-mg group (100% vs. 71% in the 100-mg group), Dr. Lewis recommends the “start low, go slow” approach to topiramate titration for basilar migraine in children.

“Sometimes in pediatrics, we have a mindset based on a dose per kilogram. In this situation, we should start with the lower dose, reassess how the patient is doing, then go up slowly. “A titration to 'effectiveness' rather than a targeted dose per weight is the way to go.”

The study was investigator initiated, and Ortho-McNeil provided financial support.