Robert Finn

BEVERLY HILLS, CALIF. — The Food and Drug Administration provides little regulation of probiotic products, and those products available to the consumer vary greatly in quality and the level of evidence supporting their label claims, Lynne V. McFarland, Ph.D., said at the International Probiotic Association World Congress.

Even consumers who make concerted efforts to research probiotic products may come up short, said Dr. McFarland of the Veterans Affairs Puget Sound Healthcare System, Seattle. “When the consumers go in and they want to buy their own probiotic … it's chaos. There are so many different probiotic products out on the market, and the diversity of quality can be all the way from fine pharmaceutical manufacturers to [someone who makes it] in his bathtub.”

Dr. McFarland recently attempted to track down the contents and evidence base behind three probiotic products brought to her by patients. Using information from the manufacturers' Web sites—and a few persistent phone calls—she sought details on VitAdvance Flat Stomach capsules, Activia yogurt, and Culturelle capsules.

▸ VitAdvance Flat Stomach, manufactured by Avon Products Inc., has promotional literature that reads, in part, “Battling belly bulge means staying away from the bar and picking up a barbell. But a new pill is promising to beat bloat and tighten the tummy.”

On the manufacturer's Web site, Dr. McFarland found no information on the probiotic species in the capsules, the dose, or the evidence for the manufacturer's claims. After several phone calls to the manufacturer, she finally found a technician who was able to tell her that the product contains Lactobacillus acidophilus, although he was unable to determine the dosage.

The flat-stomach claim appears to be based on a single randomized, controlled trial involving 18 women with irritable bowel syndrome. In that trial, the L. acidophilus had no effect on global IBS symptoms, no effect on cramping, and no effect on flatulence, but did appear to reduce bloating.

“They have one little piece of the significant evidence, and they built their whole product around this, and called it Flat Stomach,” Dr. McFarland said. “We should not allow this kind of stuff to happen.”

▸ Activia yogurt, made by Dannon Co., claims to “help with the slow intestinal transit and contains a unique culture—Bifidus Regularis.” There is no recognized organism correctly classified as Bifidus regularis.

The product's Web site reveals that this is a trade name for Bifidobacterium animalis strain DN-173 010, but it includes no information on dose.

However, the Web site does have information on three randomized clinical trials involving a total of 113 normal volunteers showing a 9-hour reduction in transit time. Dr. McFarland pointed out that these normal volunteers are not likely to be representative of patients with constipation, and the company mentioned no trials in constipated patients.

Furthermore, the company recommends that consumers eat Activia yogurt daily, although there is no mention of long-term studies demonstrating the value of daily intake.

▸ Culturelle, made by Amerifit Brands Inc., has the best evidence base of the three products in support of its claims. The label includes the species (Lactobacillus rhamnosus GG), dose (1010 live organisms per capsule), and expiration date.

The product's Web site lists information on 42 randomized clinical trials, 25 of which had a positive effect directly related to the label's health claim. “This is a really nice example of what every Web site for a probiotic product should look like,” Dr. McFarland said.

Dr. McFarland acknowledged serving on the speakers bureau of Klaire Laboratories and Biocodex Inc.

BEVERLY HILLS, CALIF. — The Food and Drug Administration provides little regulation of probiotic products, and those products available to the consumer vary greatly in quality and the level of evidence supporting their label claims, Lynne V. McFarland, Ph.D., said at the International Probiotic Association World Congress.

Even consumers who make concerted efforts to research probiotic products may come up short, said Dr. McFarland of the Veterans Affairs Puget Sound Healthcare System, Seattle. “When the consumers go in and they want to buy their own probiotic … it's chaos. There are so many different probiotic products out on the market, and the diversity of quality can be all the way from fine pharmaceutical manufacturers to [someone who makes it] in his bathtub.”

Dr. McFarland recently attempted to track down the contents and evidence base behind three probiotic products brought to her by patients. Using information from the manufacturers' Web sites—and a few persistent phone calls—she sought details on VitAdvance Flat Stomach capsules, Activia yogurt, and Culturelle capsules.

▸ VitAdvance Flat Stomach, manufactured by Avon Products Inc., has promotional literature that reads, in part, “Battling belly bulge means staying away from the bar and picking up a barbell. But a new pill is promising to beat bloat and tighten the tummy.”

On the manufacturer's Web site, Dr. McFarland found no information on the probiotic species in the capsules, the dose, or the evidence for the manufacturer's claims. After several phone calls to the manufacturer, she finally found a technician who was able to tell her that the product contains Lactobacillus acidophilus, although he was unable to determine the dosage.

The flat-stomach claim appears to be based on a single randomized, controlled trial involving 18 women with irritable bowel syndrome. In that trial, the L. acidophilus had no effect on global IBS symptoms, no effect on cramping, and no effect on flatulence, but did appear to reduce bloating.

“They have one little piece of the significant evidence, and they built their whole product around this, and called it Flat Stomach,” Dr. McFarland said. “We should not allow this kind of stuff to happen.”

▸ Activia yogurt, made by Dannon Co., claims to “help with the slow intestinal transit and contains a unique culture—Bifidus Regularis.” There is no recognized organism correctly classified as Bifidus regularis.

The product's Web site reveals that this is a trade name for Bifidobacterium animalis strain DN-173 010, but it includes no information on dose.

However, the Web site does have information on three randomized clinical trials involving a total of 113 normal volunteers showing a 9-hour reduction in transit time. Dr. McFarland pointed out that these normal volunteers are not likely to be representative of patients with constipation, and the company mentioned no trials in constipated patients.

Furthermore, the company recommends that consumers eat Activia yogurt daily, although there is no mention of long-term studies demonstrating the value of daily intake.

▸ Culturelle, made by Amerifit Brands Inc., has the best evidence base of the three products in support of its claims. The label includes the species (Lactobacillus rhamnosus GG), dose (1010 live organisms per capsule), and expiration date.

The product's Web site lists information on 42 randomized clinical trials, 25 of which had a positive effect directly related to the label's health claim. “This is a really nice example of what every Web site for a probiotic product should look like,” Dr. McFarland said.

Dr. McFarland acknowledged serving on the speakers bureau of Klaire Laboratories and Biocodex Inc.

BEVERLY HILLS, CALIF. — The Food and Drug Administration provides little regulation of probiotic products, and those products available to the consumer vary greatly in quality and the level of evidence supporting their label claims, Lynne V. McFarland, Ph.D., said at the International Probiotic Association World Congress.

Even consumers who make concerted efforts to research probiotic products may come up short, said Dr. McFarland of the Veterans Affairs Puget Sound Healthcare System, Seattle. “When the consumers go in and they want to buy their own probiotic … it's chaos. There are so many different probiotic products out on the market, and the diversity of quality can be all the way from fine pharmaceutical manufacturers to [someone who makes it] in his bathtub.”

Dr. McFarland recently attempted to track down the contents and evidence base behind three probiotic products brought to her by patients. Using information from the manufacturers' Web sites—and a few persistent phone calls—she sought details on VitAdvance Flat Stomach capsules, Activia yogurt, and Culturelle capsules.

▸ VitAdvance Flat Stomach, manufactured by Avon Products Inc., has promotional literature that reads, in part, “Battling belly bulge means staying away from the bar and picking up a barbell. But a new pill is promising to beat bloat and tighten the tummy.”

On the manufacturer's Web site, Dr. McFarland found no information on the probiotic species in the capsules, the dose, or the evidence for the manufacturer's claims. After several phone calls to the manufacturer, she finally found a technician who was able to tell her that the product contains Lactobacillus acidophilus, although he was unable to determine the dosage.

The flat-stomach claim appears to be based on a single randomized, controlled trial involving 18 women with irritable bowel syndrome. In that trial, the L. acidophilus had no effect on global IBS symptoms, no effect on cramping, and no effect on flatulence, but did appear to reduce bloating.

“They have one little piece of the significant evidence, and they built their whole product around this, and called it Flat Stomach,” Dr. McFarland said. “We should not allow this kind of stuff to happen.”

▸ Activia yogurt, made by Dannon Co., claims to “help with the slow intestinal transit and contains a unique culture—Bifidus Regularis.” There is no recognized organism correctly classified as Bifidus regularis.

The product's Web site reveals that this is a trade name for Bifidobacterium animalis strain DN-173 010, but it includes no information on dose.

However, the Web site does have information on three randomized clinical trials involving a total of 113 normal volunteers showing a 9-hour reduction in transit time. Dr. McFarland pointed out that these normal volunteers are not likely to be representative of patients with constipation, and the company mentioned no trials in constipated patients.

Furthermore, the company recommends that consumers eat Activia yogurt daily, although there is no mention of long-term studies demonstrating the value of daily intake.

▸ Culturelle, made by Amerifit Brands Inc., has the best evidence base of the three products in support of its claims. The label includes the species (Lactobacillus rhamnosus GG), dose (1010 live organisms per capsule), and expiration date.

The product's Web site lists information on 42 randomized clinical trials, 25 of which had a positive effect directly related to the label's health claim. “This is a really nice example of what every Web site for a probiotic product should look like,” Dr. McFarland said.

Dr. McFarland acknowledged serving on the speakers bureau of Klaire Laboratories and Biocodex Inc.

SAN DIEGO — Interim results from a randomized, controlled trial suggest that radiofrequency ablation is more effective than frequent surveillance for Barrett's esophagus.

The study compared 84 patients who underwent ablation with 43 who underwent a sham operation. All patients received high-dose acid suppression (40 mg esomeprazole twice daily). The ablation patients with high-grade dysplasia underwent endoscopic biopsies at 3, 6, 9, and 12 months, whereas those with low-grade dysplasia underwent endoscopic biopsies at 6 and 12 months, Dr. Nicholas Shaheen reported at the annual Digestive Disease Week.

At the end of that time, 80% of the patients in the ablation group with high-grade dysplasia and 90% of those with low-grade dysplasia experienced a complete response, which the investigators defined as having all biopsies free of any histologic evidence of dysplasia, “not a single goblet cell,” said Dr. Shaheen of the University of North Carolina, Chapel Hill.

In contrast, 26% of the control patients experienced a complete response. The difference between the ablation and control patients was statistically significant in the intent-to-treat analysis.

Of all the patients who underwent ablation, 77% experienced a complete response for intestinal metaplasia, compared with none of the control patients. Once again, this difference was statistically significant.

There was also a significant difference in the rate of histologic progression from low-grade dysplasia to high-grade dysplasia, and from high-grade dysplasia to cancer. Of the patients who received a sham operation, 19% experienced progression of the disease, compared with just 5% of the ablated patients.

Adverse events in the study were relatively minor. Of the ablated patients, 6% experienced strictures, but all resolved after a mean of two dilations. There were three serious adverse events among the ablated patients and none among the patients who received a sham operation. One patient experienced an upper GI bleed, and two others experienced chest pain and were admitted overnight for observation.

“Patients often do have chest pain after the procedure,” Dr. Shaheen said in an interview. “This pain is usually mild to moderate, and was managed successfully in 295 of the 297 procedures performed in the trial with oral pain medications or no medications. Two patients did have to be admitted for chest pain. This is in contrast to our older therapies, such as PDT [photodynamic therapy], after which we hospitalized everyone for pain control.”

The study, which is ongoing, is being conducted at 19 medical centers in the United States. It was funded by BÂRRX Medical Inc., which manufactures the radiofrequency ablation system used in the study.

Dr. Shaheen acknowledged receiving “other financial benefits” from that company, as well as receiving consulting fees, speaking fees, research support, and/or other financial benefits from AstraZeneca Pharmaceuticals LP, TAP Pharmaceutical Products Inc., Procter & Gamble Co., Eisai Co., Merck & Co., and Ethicon Endo-Surgery Inc.

Significantly more ablation than control patients achieved a complete response of 'not a single goblet cell.' DR. SHAHEEN

Dysplasia resolved after ablation in 80%-90% of Barrett's esophagus patients. Courtesy Dr. Nicholas Shaheen

SAN DIEGO — Interim results from a randomized, controlled trial suggest that radiofrequency ablation is more effective than frequent surveillance for Barrett's esophagus.

The study compared 84 patients who underwent ablation with 43 who underwent a sham operation. All patients received high-dose acid suppression (40 mg esomeprazole twice daily). The ablation patients with high-grade dysplasia underwent endoscopic biopsies at 3, 6, 9, and 12 months, whereas those with low-grade dysplasia underwent endoscopic biopsies at 6 and 12 months, Dr. Nicholas Shaheen reported at the annual Digestive Disease Week.

At the end of that time, 80% of the patients in the ablation group with high-grade dysplasia and 90% of those with low-grade dysplasia experienced a complete response, which the investigators defined as having all biopsies free of any histologic evidence of dysplasia, “not a single goblet cell,” said Dr. Shaheen of the University of North Carolina, Chapel Hill.

In contrast, 26% of the control patients experienced a complete response. The difference between the ablation and control patients was statistically significant in the intent-to-treat analysis.

Of all the patients who underwent ablation, 77% experienced a complete response for intestinal metaplasia, compared with none of the control patients. Once again, this difference was statistically significant.

There was also a significant difference in the rate of histologic progression from low-grade dysplasia to high-grade dysplasia, and from high-grade dysplasia to cancer. Of the patients who received a sham operation, 19% experienced progression of the disease, compared with just 5% of the ablated patients.

Adverse events in the study were relatively minor. Of the ablated patients, 6% experienced strictures, but all resolved after a mean of two dilations. There were three serious adverse events among the ablated patients and none among the patients who received a sham operation. One patient experienced an upper GI bleed, and two others experienced chest pain and were admitted overnight for observation.

“Patients often do have chest pain after the procedure,” Dr. Shaheen said in an interview. “This pain is usually mild to moderate, and was managed successfully in 295 of the 297 procedures performed in the trial with oral pain medications or no medications. Two patients did have to be admitted for chest pain. This is in contrast to our older therapies, such as PDT [photodynamic therapy], after which we hospitalized everyone for pain control.”

The study, which is ongoing, is being conducted at 19 medical centers in the United States. It was funded by BÂRRX Medical Inc., which manufactures the radiofrequency ablation system used in the study.

Dr. Shaheen acknowledged receiving “other financial benefits” from that company, as well as receiving consulting fees, speaking fees, research support, and/or other financial benefits from AstraZeneca Pharmaceuticals LP, TAP Pharmaceutical Products Inc., Procter & Gamble Co., Eisai Co., Merck & Co., and Ethicon Endo-Surgery Inc.

Significantly more ablation than control patients achieved a complete response of 'not a single goblet cell.' DR. SHAHEEN

Dysplasia resolved after ablation in 80%-90% of Barrett's esophagus patients. Courtesy Dr. Nicholas Shaheen

SAN DIEGO — Interim results from a randomized, controlled trial suggest that radiofrequency ablation is more effective than frequent surveillance for Barrett's esophagus.

The study compared 84 patients who underwent ablation with 43 who underwent a sham operation. All patients received high-dose acid suppression (40 mg esomeprazole twice daily). The ablation patients with high-grade dysplasia underwent endoscopic biopsies at 3, 6, 9, and 12 months, whereas those with low-grade dysplasia underwent endoscopic biopsies at 6 and 12 months, Dr. Nicholas Shaheen reported at the annual Digestive Disease Week.

At the end of that time, 80% of the patients in the ablation group with high-grade dysplasia and 90% of those with low-grade dysplasia experienced a complete response, which the investigators defined as having all biopsies free of any histologic evidence of dysplasia, “not a single goblet cell,” said Dr. Shaheen of the University of North Carolina, Chapel Hill.

In contrast, 26% of the control patients experienced a complete response. The difference between the ablation and control patients was statistically significant in the intent-to-treat analysis.

Of all the patients who underwent ablation, 77% experienced a complete response for intestinal metaplasia, compared with none of the control patients. Once again, this difference was statistically significant.

There was also a significant difference in the rate of histologic progression from low-grade dysplasia to high-grade dysplasia, and from high-grade dysplasia to cancer. Of the patients who received a sham operation, 19% experienced progression of the disease, compared with just 5% of the ablated patients.

Adverse events in the study were relatively minor. Of the ablated patients, 6% experienced strictures, but all resolved after a mean of two dilations. There were three serious adverse events among the ablated patients and none among the patients who received a sham operation. One patient experienced an upper GI bleed, and two others experienced chest pain and were admitted overnight for observation.

“Patients often do have chest pain after the procedure,” Dr. Shaheen said in an interview. “This pain is usually mild to moderate, and was managed successfully in 295 of the 297 procedures performed in the trial with oral pain medications or no medications. Two patients did have to be admitted for chest pain. This is in contrast to our older therapies, such as PDT [photodynamic therapy], after which we hospitalized everyone for pain control.”

The study, which is ongoing, is being conducted at 19 medical centers in the United States. It was funded by BÂRRX Medical Inc., which manufactures the radiofrequency ablation system used in the study.

Dr. Shaheen acknowledged receiving “other financial benefits” from that company, as well as receiving consulting fees, speaking fees, research support, and/or other financial benefits from AstraZeneca Pharmaceuticals LP, TAP Pharmaceutical Products Inc., Procter & Gamble Co., Eisai Co., Merck & Co., and Ethicon Endo-Surgery Inc.

Significantly more ablation than control patients achieved a complete response of 'not a single goblet cell.' DR. SHAHEEN

Dysplasia resolved after ablation in 80%-90% of Barrett's esophagus patients. Courtesy Dr. Nicholas Shaheen

HONOLULU – Patients on a pediatric hospitalist service spent a mean 38% fewer days in the hospital and had 29% lower direct costs, on average, than did patients on traditional house staff services, according to a 1-year study of more than 900 patients.

Dr. Arpi Bekmezian of the University of California, Los Angeles, and colleagues retrospectively compared 816 pediatric cases assigned to GI and hematology/oncology subspecialty services with 109 cases assigned to a pediatric hospitalist service between July 1, 2005, and June 30, 2006.

Patients were admitted to the hospitalist service when the faculty/house staff services reached their maximum capacity. The assignments were made solely on the basis of the hospital census, not on diagnosis, acuity, or complexity.

The study was conducted at the UCLA Hospital and Medical Center, a nonprofit tertiary care teaching hospital with 70 pediatric beds. The patients' mean age was 8 years, and there were no statistically significant differences on the all-patient refined diagnostic-related group severity scale.

Neither were there any statistically significant differences in the proportion of patients with private insurance, Medicaid, or other insurance, Dr. Bekmezian reported in a poster presentation at the annual meeting of the Pediatric Academic Societies.

The mean length of stay was 10 days in the subspecialty services vs. 7 days in the hospitalist service.

The average variable of direct cost of stay excluding physician fees was $16,500 in the subspecialty services vs. $11,000 in the hospitalist service.

Both differences were statistically significant.

Rates of readmission also were significantly different: a mean 4% for patients in the subspecialty services, compared with 0% for patients in the hospitalist service.

There were no statistically significant differences in mortality: a mean 2% in the subspecialty services, compared with a mean 1% in the hospitalist service, Dr. Bekmezian said.

Dr. Bekmezian declared that he had no conflicts of interest related to his presentation.

HONOLULU – Patients on a pediatric hospitalist service spent a mean 38% fewer days in the hospital and had 29% lower direct costs, on average, than did patients on traditional house staff services, according to a 1-year study of more than 900 patients.

Dr. Arpi Bekmezian of the University of California, Los Angeles, and colleagues retrospectively compared 816 pediatric cases assigned to GI and hematology/oncology subspecialty services with 109 cases assigned to a pediatric hospitalist service between July 1, 2005, and June 30, 2006.

Patients were admitted to the hospitalist service when the faculty/house staff services reached their maximum capacity. The assignments were made solely on the basis of the hospital census, not on diagnosis, acuity, or complexity.

The study was conducted at the UCLA Hospital and Medical Center, a nonprofit tertiary care teaching hospital with 70 pediatric beds. The patients' mean age was 8 years, and there were no statistically significant differences on the all-patient refined diagnostic-related group severity scale.

Neither were there any statistically significant differences in the proportion of patients with private insurance, Medicaid, or other insurance, Dr. Bekmezian reported in a poster presentation at the annual meeting of the Pediatric Academic Societies.

The mean length of stay was 10 days in the subspecialty services vs. 7 days in the hospitalist service.

The average variable of direct cost of stay excluding physician fees was $16,500 in the subspecialty services vs. $11,000 in the hospitalist service.

Both differences were statistically significant.

Rates of readmission also were significantly different: a mean 4% for patients in the subspecialty services, compared with 0% for patients in the hospitalist service.

There were no statistically significant differences in mortality: a mean 2% in the subspecialty services, compared with a mean 1% in the hospitalist service, Dr. Bekmezian said.

Dr. Bekmezian declared that he had no conflicts of interest related to his presentation.

HONOLULU – Patients on a pediatric hospitalist service spent a mean 38% fewer days in the hospital and had 29% lower direct costs, on average, than did patients on traditional house staff services, according to a 1-year study of more than 900 patients.

Dr. Arpi Bekmezian of the University of California, Los Angeles, and colleagues retrospectively compared 816 pediatric cases assigned to GI and hematology/oncology subspecialty services with 109 cases assigned to a pediatric hospitalist service between July 1, 2005, and June 30, 2006.

Patients were admitted to the hospitalist service when the faculty/house staff services reached their maximum capacity. The assignments were made solely on the basis of the hospital census, not on diagnosis, acuity, or complexity.

The study was conducted at the UCLA Hospital and Medical Center, a nonprofit tertiary care teaching hospital with 70 pediatric beds. The patients' mean age was 8 years, and there were no statistically significant differences on the all-patient refined diagnostic-related group severity scale.

Neither were there any statistically significant differences in the proportion of patients with private insurance, Medicaid, or other insurance, Dr. Bekmezian reported in a poster presentation at the annual meeting of the Pediatric Academic Societies.

The mean length of stay was 10 days in the subspecialty services vs. 7 days in the hospitalist service.

The average variable of direct cost of stay excluding physician fees was $16,500 in the subspecialty services vs. $11,000 in the hospitalist service.

Both differences were statistically significant.

Rates of readmission also were significantly different: a mean 4% for patients in the subspecialty services, compared with 0% for patients in the hospitalist service.

There were no statistically significant differences in mortality: a mean 2% in the subspecialty services, compared with a mean 1% in the hospitalist service, Dr. Bekmezian said.

Dr. Bekmezian declared that he had no conflicts of interest related to his presentation.

HONOLULU – When women are given influenza vaccine in their third trimester of pregnancy, their infants receive protection against flu infection, results of a randomized controlled trial of more than 300 pregnant women confirm.

“This is the first randomized controlled trial of maternal immunization with influenza vaccine,” Dr. Mark C. Steinhoff reported at the annual meeting of the Pediatric Academic Societies. “Although [maternal immunization] is a U.S. government policy, it's one of the few not based on randomized controlled trials.”

The study was part of the Maternal Gift Study, which involved 340 pregnant women and 331 live births in a middle-class urban population in Bangladesh. Women in the study were randomized to receive either influenza vaccine or pneumococcal conjugate vaccine during their third trimester of pregnancy. For the purposes of this analysis, the investigators used the mother-infant pairs receiving pneumococcal vaccine as the control group.

The mothers were an average 25 years old, and were vaccinated an average 55 days before giving birth. Ninety-two percent gave birth in a hospital or clinic, 46% by cesarean delivery. The infants averaged just above 3 kg at birth and were breast-fed exclusively an average of 14 weeks.

The investigators looked both at proven influenza illness and at all febrile respiratory illnesses as outcome measures. The trivalent influenza vaccine was associated with a 63% reduction in proven influenza in infants 0-6 months of age and a 30% reduction in all febrile respiratory illnesses in infants and their mothers.

The fact that the influenza vaccine was compared with the pneumococcal vaccine and not with placebo probably resulted in an underestimate of the influenza vaccine's effectiveness, said Dr. Steinhoff of Johns Hopkins University, Baltimore. “It's possible that pneumococcal vaccine could reduce some of the viral illnesses.”

Furthermore, the vaccine's protective effect appeared to last at least until the infants were 5 months old. This is particularly important because current U.S. guidelines do not recommend influenza vaccine for children younger than 6 months old.

And it's those very children who are responsible for almost half of childhood influenza hospitalizations. According to one study, children 0-6 months old accounted for 48% of all the influenza hospitalizations among children below the age of 5 years (N. Engl. J. Med. 2006;355:31-40).

Dr. Steinhoff disclosed that he has served on Sanofi's speakers' bureau and has received research support from Sanofi-Aventis, Wyeth, and Merck & Co. “None of these interactions had any bearing on this particular study.”

HONOLULU – When women are given influenza vaccine in their third trimester of pregnancy, their infants receive protection against flu infection, results of a randomized controlled trial of more than 300 pregnant women confirm.

“This is the first randomized controlled trial of maternal immunization with influenza vaccine,” Dr. Mark C. Steinhoff reported at the annual meeting of the Pediatric Academic Societies. “Although [maternal immunization] is a U.S. government policy, it's one of the few not based on randomized controlled trials.”

The study was part of the Maternal Gift Study, which involved 340 pregnant women and 331 live births in a middle-class urban population in Bangladesh. Women in the study were randomized to receive either influenza vaccine or pneumococcal conjugate vaccine during their third trimester of pregnancy. For the purposes of this analysis, the investigators used the mother-infant pairs receiving pneumococcal vaccine as the control group.

The mothers were an average 25 years old, and were vaccinated an average 55 days before giving birth. Ninety-two percent gave birth in a hospital or clinic, 46% by cesarean delivery. The infants averaged just above 3 kg at birth and were breast-fed exclusively an average of 14 weeks.

The investigators looked both at proven influenza illness and at all febrile respiratory illnesses as outcome measures. The trivalent influenza vaccine was associated with a 63% reduction in proven influenza in infants 0-6 months of age and a 30% reduction in all febrile respiratory illnesses in infants and their mothers.

The fact that the influenza vaccine was compared with the pneumococcal vaccine and not with placebo probably resulted in an underestimate of the influenza vaccine's effectiveness, said Dr. Steinhoff of Johns Hopkins University, Baltimore. “It's possible that pneumococcal vaccine could reduce some of the viral illnesses.”

Furthermore, the vaccine's protective effect appeared to last at least until the infants were 5 months old. This is particularly important because current U.S. guidelines do not recommend influenza vaccine for children younger than 6 months old.

And it's those very children who are responsible for almost half of childhood influenza hospitalizations. According to one study, children 0-6 months old accounted for 48% of all the influenza hospitalizations among children below the age of 5 years (N. Engl. J. Med. 2006;355:31-40).

Dr. Steinhoff disclosed that he has served on Sanofi's speakers' bureau and has received research support from Sanofi-Aventis, Wyeth, and Merck & Co. “None of these interactions had any bearing on this particular study.”

HONOLULU – When women are given influenza vaccine in their third trimester of pregnancy, their infants receive protection against flu infection, results of a randomized controlled trial of more than 300 pregnant women confirm.

“This is the first randomized controlled trial of maternal immunization with influenza vaccine,” Dr. Mark C. Steinhoff reported at the annual meeting of the Pediatric Academic Societies. “Although [maternal immunization] is a U.S. government policy, it's one of the few not based on randomized controlled trials.”

The study was part of the Maternal Gift Study, which involved 340 pregnant women and 331 live births in a middle-class urban population in Bangladesh. Women in the study were randomized to receive either influenza vaccine or pneumococcal conjugate vaccine during their third trimester of pregnancy. For the purposes of this analysis, the investigators used the mother-infant pairs receiving pneumococcal vaccine as the control group.

The mothers were an average 25 years old, and were vaccinated an average 55 days before giving birth. Ninety-two percent gave birth in a hospital or clinic, 46% by cesarean delivery. The infants averaged just above 3 kg at birth and were breast-fed exclusively an average of 14 weeks.

The investigators looked both at proven influenza illness and at all febrile respiratory illnesses as outcome measures. The trivalent influenza vaccine was associated with a 63% reduction in proven influenza in infants 0-6 months of age and a 30% reduction in all febrile respiratory illnesses in infants and their mothers.

The fact that the influenza vaccine was compared with the pneumococcal vaccine and not with placebo probably resulted in an underestimate of the influenza vaccine's effectiveness, said Dr. Steinhoff of Johns Hopkins University, Baltimore. “It's possible that pneumococcal vaccine could reduce some of the viral illnesses.”

Furthermore, the vaccine's protective effect appeared to last at least until the infants were 5 months old. This is particularly important because current U.S. guidelines do not recommend influenza vaccine for children younger than 6 months old.

And it's those very children who are responsible for almost half of childhood influenza hospitalizations. According to one study, children 0-6 months old accounted for 48% of all the influenza hospitalizations among children below the age of 5 years (N. Engl. J. Med. 2006;355:31-40).

Dr. Steinhoff disclosed that he has served on Sanofi's speakers' bureau and has received research support from Sanofi-Aventis, Wyeth, and Merck & Co. “None of these interactions had any bearing on this particular study.”

HONOLULU – One year after the Centers for Disease Control and Prevention issued new recommendations on vaccinating adolescents against pertussis, 96% of pediatricians but only 75% of family physicians were recommending the vaccine routinely, according to a mail-based survey.

In a multivariate analysis, the only two variables independently associated with recommending Tdap were medical specialty (pediatrics vs. family practice) and whether the physician stocked the combined tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in their offices, wrote Dr. Amanda F. Dempsey of the University of Michigan, Ann Arbor, and her colleagues.

In March 2006, the CDC's Advisory Committee on Immunization Practices (ACIP) issued recommendations on replacing the adolescent tetanus and diphtheria toxoids (Td) with Tdap. The committee suggested age 11-12 years as the preferred age for Tdap vaccination, and recommended the catch-up vaccination of adolescents aged 13-18 years.

The study involved a mail-based survey of a national sample of 725 pediatricians and 725 family physicians drawn randomly from the American Medical Association's Physician Masterfile. The survey was conducted between January and March 2007. The response rates were 68% for pediatricians and 53% for family physicians, Dr. Dempsey reported in a poster presentation at the joint meeting of the Pediatric Academic Societies.

Survey results showed that 68% of pediatricians were significantly more likely than were family physicians to have adolescent patient volumes above 25%, although most respondents reported that at least 10% of their patients were adolescents.

On the question of Tdap recommendation patterns for 11- to 12-year-old patients, 96% of pediatricians said that they routinely issued such recommendations, 3% said that they sometimes did, and 1% said that they rarely or never did. In contrast, 75% of family physicians said that they routinely recommended the vaccine for their 11- to 12-year-old patients, 12% said they sometimes did, and 13% said that they rarely or never did. These differences were statistically significant.

The results were similar regarding recommendations for Tdap boosters for 13- to 18-year-old patients without a previous Td booster. Among pediatricians, 96% routinely recommended this booster, 3% sometimes did, and 1% rarely or never did. Among family physicians, 80% routinely recommended the booster, 10% sometimes did, and 10% rarely or never did. Once again, the differences were statistically significant.

A lack of adolescent visits was the most frequently cited barrier to administering the Tdap vaccine, with about 33% of physicians citing this as a major barrier and 38% citing it as a minor barrier.

The majority of physicians surveyed said that they found no barriers with regard to Tdap supply, reimbursement, record keeping, or the problem of other priorities during visits.

“Specialty-based differences in immunization practices suggest an ongoing need for provider education, particularly among [family physicians],” they wrote.

The study was funded by the CDC, and Dr. Dempsey reported that she had no conflicts of interest related to her presentation.

HONOLULU – One year after the Centers for Disease Control and Prevention issued new recommendations on vaccinating adolescents against pertussis, 96% of pediatricians but only 75% of family physicians were recommending the vaccine routinely, according to a mail-based survey.

In a multivariate analysis, the only two variables independently associated with recommending Tdap were medical specialty (pediatrics vs. family practice) and whether the physician stocked the combined tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in their offices, wrote Dr. Amanda F. Dempsey of the University of Michigan, Ann Arbor, and her colleagues.

In March 2006, the CDC's Advisory Committee on Immunization Practices (ACIP) issued recommendations on replacing the adolescent tetanus and diphtheria toxoids (Td) with Tdap. The committee suggested age 11-12 years as the preferred age for Tdap vaccination, and recommended the catch-up vaccination of adolescents aged 13-18 years.

The study involved a mail-based survey of a national sample of 725 pediatricians and 725 family physicians drawn randomly from the American Medical Association's Physician Masterfile. The survey was conducted between January and March 2007. The response rates were 68% for pediatricians and 53% for family physicians, Dr. Dempsey reported in a poster presentation at the joint meeting of the Pediatric Academic Societies.

Survey results showed that 68% of pediatricians were significantly more likely than were family physicians to have adolescent patient volumes above 25%, although most respondents reported that at least 10% of their patients were adolescents.

On the question of Tdap recommendation patterns for 11- to 12-year-old patients, 96% of pediatricians said that they routinely issued such recommendations, 3% said that they sometimes did, and 1% said that they rarely or never did. In contrast, 75% of family physicians said that they routinely recommended the vaccine for their 11- to 12-year-old patients, 12% said they sometimes did, and 13% said that they rarely or never did. These differences were statistically significant.

The results were similar regarding recommendations for Tdap boosters for 13- to 18-year-old patients without a previous Td booster. Among pediatricians, 96% routinely recommended this booster, 3% sometimes did, and 1% rarely or never did. Among family physicians, 80% routinely recommended the booster, 10% sometimes did, and 10% rarely or never did. Once again, the differences were statistically significant.

A lack of adolescent visits was the most frequently cited barrier to administering the Tdap vaccine, with about 33% of physicians citing this as a major barrier and 38% citing it as a minor barrier.

The majority of physicians surveyed said that they found no barriers with regard to Tdap supply, reimbursement, record keeping, or the problem of other priorities during visits.

“Specialty-based differences in immunization practices suggest an ongoing need for provider education, particularly among [family physicians],” they wrote.

The study was funded by the CDC, and Dr. Dempsey reported that she had no conflicts of interest related to her presentation.

HONOLULU – One year after the Centers for Disease Control and Prevention issued new recommendations on vaccinating adolescents against pertussis, 96% of pediatricians but only 75% of family physicians were recommending the vaccine routinely, according to a mail-based survey.

In a multivariate analysis, the only two variables independently associated with recommending Tdap were medical specialty (pediatrics vs. family practice) and whether the physician stocked the combined tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in their offices, wrote Dr. Amanda F. Dempsey of the University of Michigan, Ann Arbor, and her colleagues.

In March 2006, the CDC's Advisory Committee on Immunization Practices (ACIP) issued recommendations on replacing the adolescent tetanus and diphtheria toxoids (Td) with Tdap. The committee suggested age 11-12 years as the preferred age for Tdap vaccination, and recommended the catch-up vaccination of adolescents aged 13-18 years.

The study involved a mail-based survey of a national sample of 725 pediatricians and 725 family physicians drawn randomly from the American Medical Association's Physician Masterfile. The survey was conducted between January and March 2007. The response rates were 68% for pediatricians and 53% for family physicians, Dr. Dempsey reported in a poster presentation at the joint meeting of the Pediatric Academic Societies.

Survey results showed that 68% of pediatricians were significantly more likely than were family physicians to have adolescent patient volumes above 25%, although most respondents reported that at least 10% of their patients were adolescents.

On the question of Tdap recommendation patterns for 11- to 12-year-old patients, 96% of pediatricians said that they routinely issued such recommendations, 3% said that they sometimes did, and 1% said that they rarely or never did. In contrast, 75% of family physicians said that they routinely recommended the vaccine for their 11- to 12-year-old patients, 12% said they sometimes did, and 13% said that they rarely or never did. These differences were statistically significant.

The results were similar regarding recommendations for Tdap boosters for 13- to 18-year-old patients without a previous Td booster. Among pediatricians, 96% routinely recommended this booster, 3% sometimes did, and 1% rarely or never did. Among family physicians, 80% routinely recommended the booster, 10% sometimes did, and 10% rarely or never did. Once again, the differences were statistically significant.

A lack of adolescent visits was the most frequently cited barrier to administering the Tdap vaccine, with about 33% of physicians citing this as a major barrier and 38% citing it as a minor barrier.

The majority of physicians surveyed said that they found no barriers with regard to Tdap supply, reimbursement, record keeping, or the problem of other priorities during visits.

“Specialty-based differences in immunization practices suggest an ongoing need for provider education, particularly among [family physicians],” they wrote.

The study was funded by the CDC, and Dr. Dempsey reported that she had no conflicts of interest related to her presentation.

HONOLULU – Of 526 children presenting to an emergency department with wheezing–but no fever or hypoxia–only 3.7% turned out to have radiographically diagnosed pneumonia.

On the other hand, of 308 children without the classic lower respiratory tract signs and symptoms, 6.8% had definite pneumonia and another 4.2% had equivocal results from chest x-rays, according to two related poster presentations at the annual meeting of the Pediatric Academic Societies.

Taken together, the results of the two studies make the decision of whether to order a chest x-ray a complex one.

According to Dr. Bonnie Mathews of the emergency department at Children's Hospital Boston, routine chest x-rays should be discouraged in children with wheezing but without fever or hypoxia because so few of them turn out to have pneumonia. Dr. Mathews was the lead investigator in the study of the children referred to chest x-ray with lower respiratory signs and symptoms.

But the decision is much more difficult in children without these signs, said Dr. Sonal Shah, also of the emergency department at Children's. Dr. Shah was lead investigator in the study of the children without the classic pneumonia signs and symptoms who were referred to chest x-ray. Of those children, 21 turned out to have definite occult pneumonia, and in another 13, radiographic findings were equivocal. (Dr. Shah and Dr. Mathews were among the coauthors of each other's paper.)

In an interview, Dr. Shah said that the investigators had hoped to find some predictors indicating which patients without lower respiratory tract findings are more likely to have occult pneumonia. Unfortunately, of the 20 variables they examined, only 2 showed significant associations with positive radiographic signs, and those associations were relatively weak statistically. Patients with confirmed pneumonia tended to have a more acute onset of chest pain (under 1 day) than those without pneumonia. And children with confirmed or equivocal occult pneumonia tended to have a longer duration of fever (more than 1 day). But few children had both acute onset of chest pain and longer duration of fever, and the P values–0.5 and 0.4, respectively–were so close to the statistical cutoff for determining significance that it would not be appropriate to give recommendations on that basis, said Dr. Shah, also of Harvard Medical School, Boston.

The situation among children with wheezing was more definitive, Dr. Mathews said in an interview. Of 526 children between the ages of 0 and 21 years in her study, 30 (5.7%) turned out to have pneumonia on chest x-ray. Of those 30, 23 (77%) had a fever and 7 (23%) had an oxygen saturation of less than 93%. In a bivariate analysis, children with low oxygen saturation turned out to be 2.74 times more likely to have confirmed pneumonia than those without, and those with a triage temperature of 38° C (100.4° F) or more were 1.75 times more likely to have confirmed pneumonia, said Dr. Mathews, also of Harvard.

In all, only 3.7% of the children without fever or low oxygen saturation turned out to have pneumonia as confirmed by chest x-ray.

“A lot of kids get x-rays that don't need them,” Dr. Mathews said. “A lot of health care dollars are spent, and there's a lot of radiation that these kids undergo.” This situation is particularly worrisome for children who return to the emergency department with wheezing on several occasions.

She said, however, that she had not done a formal cost-benefit analysis, acknowledging that the monetary and radiation-burden costs could perhaps be balanced, at least to some extent, by the benefit involved in detecting pneumonia in that small proportion of wheezing children without fever or low oxygen saturation.

Dr. Mathews and Dr. Shah declared they had no relevant conflicts of interest.

HONOLULU – Of 526 children presenting to an emergency department with wheezing–but no fever or hypoxia–only 3.7% turned out to have radiographically diagnosed pneumonia.

On the other hand, of 308 children without the classic lower respiratory tract signs and symptoms, 6.8% had definite pneumonia and another 4.2% had equivocal results from chest x-rays, according to two related poster presentations at the annual meeting of the Pediatric Academic Societies.

Taken together, the results of the two studies make the decision of whether to order a chest x-ray a complex one.

According to Dr. Bonnie Mathews of the emergency department at Children's Hospital Boston, routine chest x-rays should be discouraged in children with wheezing but without fever or hypoxia because so few of them turn out to have pneumonia. Dr. Mathews was the lead investigator in the study of the children referred to chest x-ray with lower respiratory signs and symptoms.

But the decision is much more difficult in children without these signs, said Dr. Sonal Shah, also of the emergency department at Children's. Dr. Shah was lead investigator in the study of the children without the classic pneumonia signs and symptoms who were referred to chest x-ray. Of those children, 21 turned out to have definite occult pneumonia, and in another 13, radiographic findings were equivocal. (Dr. Shah and Dr. Mathews were among the coauthors of each other's paper.)

In an interview, Dr. Shah said that the investigators had hoped to find some predictors indicating which patients without lower respiratory tract findings are more likely to have occult pneumonia. Unfortunately, of the 20 variables they examined, only 2 showed significant associations with positive radiographic signs, and those associations were relatively weak statistically. Patients with confirmed pneumonia tended to have a more acute onset of chest pain (under 1 day) than those without pneumonia. And children with confirmed or equivocal occult pneumonia tended to have a longer duration of fever (more than 1 day). But few children had both acute onset of chest pain and longer duration of fever, and the P values–0.5 and 0.4, respectively–were so close to the statistical cutoff for determining significance that it would not be appropriate to give recommendations on that basis, said Dr. Shah, also of Harvard Medical School, Boston.

The situation among children with wheezing was more definitive, Dr. Mathews said in an interview. Of 526 children between the ages of 0 and 21 years in her study, 30 (5.7%) turned out to have pneumonia on chest x-ray. Of those 30, 23 (77%) had a fever and 7 (23%) had an oxygen saturation of less than 93%. In a bivariate analysis, children with low oxygen saturation turned out to be 2.74 times more likely to have confirmed pneumonia than those without, and those with a triage temperature of 38° C (100.4° F) or more were 1.75 times more likely to have confirmed pneumonia, said Dr. Mathews, also of Harvard.

In all, only 3.7% of the children without fever or low oxygen saturation turned out to have pneumonia as confirmed by chest x-ray.

“A lot of kids get x-rays that don't need them,” Dr. Mathews said. “A lot of health care dollars are spent, and there's a lot of radiation that these kids undergo.” This situation is particularly worrisome for children who return to the emergency department with wheezing on several occasions.

She said, however, that she had not done a formal cost-benefit analysis, acknowledging that the monetary and radiation-burden costs could perhaps be balanced, at least to some extent, by the benefit involved in detecting pneumonia in that small proportion of wheezing children without fever or low oxygen saturation.

Dr. Mathews and Dr. Shah declared they had no relevant conflicts of interest.

HONOLULU – Of 526 children presenting to an emergency department with wheezing–but no fever or hypoxia–only 3.7% turned out to have radiographically diagnosed pneumonia.

On the other hand, of 308 children without the classic lower respiratory tract signs and symptoms, 6.8% had definite pneumonia and another 4.2% had equivocal results from chest x-rays, according to two related poster presentations at the annual meeting of the Pediatric Academic Societies.

Taken together, the results of the two studies make the decision of whether to order a chest x-ray a complex one.

According to Dr. Bonnie Mathews of the emergency department at Children's Hospital Boston, routine chest x-rays should be discouraged in children with wheezing but without fever or hypoxia because so few of them turn out to have pneumonia. Dr. Mathews was the lead investigator in the study of the children referred to chest x-ray with lower respiratory signs and symptoms.

But the decision is much more difficult in children without these signs, said Dr. Sonal Shah, also of the emergency department at Children's. Dr. Shah was lead investigator in the study of the children without the classic pneumonia signs and symptoms who were referred to chest x-ray. Of those children, 21 turned out to have definite occult pneumonia, and in another 13, radiographic findings were equivocal. (Dr. Shah and Dr. Mathews were among the coauthors of each other's paper.)

In an interview, Dr. Shah said that the investigators had hoped to find some predictors indicating which patients without lower respiratory tract findings are more likely to have occult pneumonia. Unfortunately, of the 20 variables they examined, only 2 showed significant associations with positive radiographic signs, and those associations were relatively weak statistically. Patients with confirmed pneumonia tended to have a more acute onset of chest pain (under 1 day) than those without pneumonia. And children with confirmed or equivocal occult pneumonia tended to have a longer duration of fever (more than 1 day). But few children had both acute onset of chest pain and longer duration of fever, and the P values–0.5 and 0.4, respectively–were so close to the statistical cutoff for determining significance that it would not be appropriate to give recommendations on that basis, said Dr. Shah, also of Harvard Medical School, Boston.

The situation among children with wheezing was more definitive, Dr. Mathews said in an interview. Of 526 children between the ages of 0 and 21 years in her study, 30 (5.7%) turned out to have pneumonia on chest x-ray. Of those 30, 23 (77%) had a fever and 7 (23%) had an oxygen saturation of less than 93%. In a bivariate analysis, children with low oxygen saturation turned out to be 2.74 times more likely to have confirmed pneumonia than those without, and those with a triage temperature of 38° C (100.4° F) or more were 1.75 times more likely to have confirmed pneumonia, said Dr. Mathews, also of Harvard.

In all, only 3.7% of the children without fever or low oxygen saturation turned out to have pneumonia as confirmed by chest x-ray.

“A lot of kids get x-rays that don't need them,” Dr. Mathews said. “A lot of health care dollars are spent, and there's a lot of radiation that these kids undergo.” This situation is particularly worrisome for children who return to the emergency department with wheezing on several occasions.

She said, however, that she had not done a formal cost-benefit analysis, acknowledging that the monetary and radiation-burden costs could perhaps be balanced, at least to some extent, by the benefit involved in detecting pneumonia in that small proportion of wheezing children without fever or low oxygen saturation.

Dr. Mathews and Dr. Shah declared they had no relevant conflicts of interest.

HONOLULU — One year after the Centers for Disease Control and Prevention issued new recommendations on vaccinating adolescents against pertussis, 96% of pediatricians but only 75% of family physicians were recommending the vaccine routinely, according to a mail-based survey.

In a multivariate analysis, the only two variables independently associated with recommending Tdap were medical specialty (pediatrics vs. family practice) and whether the physician stocked the combined tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in their offices, wrote Dr. Amanda F. Dempsey of the University of Michigan, Ann Arbor, and her colleagues.

In March 2006, the CDC's Advisory Committee on Immunization Practices (ACIP) issued recommendations on replacing the adolescent tetanus and diphtheria toxoids (Td) with Tdap. The committee suggested age 11–12 years as the preferred age for Tdap vaccination, and recommended the catch-up vaccination of adolescents aged 13–18 years.

The study involved a mail-based survey of a national sample of 725 pediatricians and 725 family physicians drawn randomly from the American Medical Association's Physician Masterfile. The survey was conducted between January and March 2007. The response rates were 68% for pediatricians and 53% for family physicians, Dr. Dempsey reported in a poster presentation at the joint meeting of the Pediatric Academic Societies and the Asian Society for Pediatric Research.

Survey results showed that 68% of pediatricians were significantly more likely than were family physicians to have adolescent patient volumes above 25%, although most respondents reported that at least 10% of their patients were adolescents.

On the question of Tdap recommendation patterns for 11- to 12-year-old patients, 96% of pediatricians said that they routinely issued such recommendations, 3% said that they sometimes did, and 1% said that they rarely or never did. In contrast, 75% of family physicians said that they routinely recommended the vaccine for their 11- to 12-year-old patients, 12% said they sometimes did, and 13% said that they rarely or never did. These differences were statistically significant.

The results were similar regarding recommendations for Tdap boosters for 13- to 18-year-old patients without a previous Td booster. Among pediatricians, 96% routinely recommended this booster, 3% sometimes did, and 1% rarely or never did. Among family physicians, 80% routinely recommended the booster, 10% sometimes did, and 10% rarely or never did. Once again, the differences were statistically significant.

A lack of adolescent visits was the most frequently cited barrier to administering the Tdap vaccine, with about 33% of physicians citing this as a major barrier and 38% citing it as a minor barrier. The majority of physicians surveyed said that they found no barriers with regard to Tdap supply, reimbursement, record keeping, or the problem of other priorities during visits.

“Specialty-based differences in immunization practices suggest an ongoing need for provider education, particularly among [family physicians],” the investigators wrote. They also suggested that a reduction in practice-level barriers for purchasing vaccine may improve adolescent Tdap vaccination rates.

The study was funded by the CDC, and Dr. Dempsey reported that she had no conflicts of interest related to her presentation.

HONOLULU — One year after the Centers for Disease Control and Prevention issued new recommendations on vaccinating adolescents against pertussis, 96% of pediatricians but only 75% of family physicians were recommending the vaccine routinely, according to a mail-based survey.

In a multivariate analysis, the only two variables independently associated with recommending Tdap were medical specialty (pediatrics vs. family practice) and whether the physician stocked the combined tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in their offices, wrote Dr. Amanda F. Dempsey of the University of Michigan, Ann Arbor, and her colleagues.

In March 2006, the CDC's Advisory Committee on Immunization Practices (ACIP) issued recommendations on replacing the adolescent tetanus and diphtheria toxoids (Td) with Tdap. The committee suggested age 11–12 years as the preferred age for Tdap vaccination, and recommended the catch-up vaccination of adolescents aged 13–18 years.

The study involved a mail-based survey of a national sample of 725 pediatricians and 725 family physicians drawn randomly from the American Medical Association's Physician Masterfile. The survey was conducted between January and March 2007. The response rates were 68% for pediatricians and 53% for family physicians, Dr. Dempsey reported in a poster presentation at the joint meeting of the Pediatric Academic Societies and the Asian Society for Pediatric Research.

Survey results showed that 68% of pediatricians were significantly more likely than were family physicians to have adolescent patient volumes above 25%, although most respondents reported that at least 10% of their patients were adolescents.

On the question of Tdap recommendation patterns for 11- to 12-year-old patients, 96% of pediatricians said that they routinely issued such recommendations, 3% said that they sometimes did, and 1% said that they rarely or never did. In contrast, 75% of family physicians said that they routinely recommended the vaccine for their 11- to 12-year-old patients, 12% said they sometimes did, and 13% said that they rarely or never did. These differences were statistically significant.

The results were similar regarding recommendations for Tdap boosters for 13- to 18-year-old patients without a previous Td booster. Among pediatricians, 96% routinely recommended this booster, 3% sometimes did, and 1% rarely or never did. Among family physicians, 80% routinely recommended the booster, 10% sometimes did, and 10% rarely or never did. Once again, the differences were statistically significant.

A lack of adolescent visits was the most frequently cited barrier to administering the Tdap vaccine, with about 33% of physicians citing this as a major barrier and 38% citing it as a minor barrier. The majority of physicians surveyed said that they found no barriers with regard to Tdap supply, reimbursement, record keeping, or the problem of other priorities during visits.

“Specialty-based differences in immunization practices suggest an ongoing need for provider education, particularly among [family physicians],” the investigators wrote. They also suggested that a reduction in practice-level barriers for purchasing vaccine may improve adolescent Tdap vaccination rates.

The study was funded by the CDC, and Dr. Dempsey reported that she had no conflicts of interest related to her presentation.

HONOLULU — One year after the Centers for Disease Control and Prevention issued new recommendations on vaccinating adolescents against pertussis, 96% of pediatricians but only 75% of family physicians were recommending the vaccine routinely, according to a mail-based survey.

In a multivariate analysis, the only two variables independently associated with recommending Tdap were medical specialty (pediatrics vs. family practice) and whether the physician stocked the combined tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in their offices, wrote Dr. Amanda F. Dempsey of the University of Michigan, Ann Arbor, and her colleagues.

In March 2006, the CDC's Advisory Committee on Immunization Practices (ACIP) issued recommendations on replacing the adolescent tetanus and diphtheria toxoids (Td) with Tdap. The committee suggested age 11–12 years as the preferred age for Tdap vaccination, and recommended the catch-up vaccination of adolescents aged 13–18 years.

The study involved a mail-based survey of a national sample of 725 pediatricians and 725 family physicians drawn randomly from the American Medical Association's Physician Masterfile. The survey was conducted between January and March 2007. The response rates were 68% for pediatricians and 53% for family physicians, Dr. Dempsey reported in a poster presentation at the joint meeting of the Pediatric Academic Societies and the Asian Society for Pediatric Research.

Survey results showed that 68% of pediatricians were significantly more likely than were family physicians to have adolescent patient volumes above 25%, although most respondents reported that at least 10% of their patients were adolescents.

On the question of Tdap recommendation patterns for 11- to 12-year-old patients, 96% of pediatricians said that they routinely issued such recommendations, 3% said that they sometimes did, and 1% said that they rarely or never did. In contrast, 75% of family physicians said that they routinely recommended the vaccine for their 11- to 12-year-old patients, 12% said they sometimes did, and 13% said that they rarely or never did. These differences were statistically significant.

The results were similar regarding recommendations for Tdap boosters for 13- to 18-year-old patients without a previous Td booster. Among pediatricians, 96% routinely recommended this booster, 3% sometimes did, and 1% rarely or never did. Among family physicians, 80% routinely recommended the booster, 10% sometimes did, and 10% rarely or never did. Once again, the differences were statistically significant.

A lack of adolescent visits was the most frequently cited barrier to administering the Tdap vaccine, with about 33% of physicians citing this as a major barrier and 38% citing it as a minor barrier. The majority of physicians surveyed said that they found no barriers with regard to Tdap supply, reimbursement, record keeping, or the problem of other priorities during visits.

“Specialty-based differences in immunization practices suggest an ongoing need for provider education, particularly among [family physicians],” the investigators wrote. They also suggested that a reduction in practice-level barriers for purchasing vaccine may improve adolescent Tdap vaccination rates.

The study was funded by the CDC, and Dr. Dempsey reported that she had no conflicts of interest related to her presentation.

HONOLULU – Children born at less than 26 weeks' gestation are significantly more likely to have symptoms indicative of autism spectrum disorders at school age than are their classmates, according to a study of 219 children born extremely preterm matched with 153 children born at term.

Samantha Johnson, Ph.D., who is a psychologist at the University of Nottingham (England), and her colleagues compared these extremely preterm children with term classmates matched for age, sex, and ethnic group.

The mean age of children in both groups was 11 years, the researchers wrote in a poster presentation at the annual meeting of the Pediatric Academic Societies.

Parents completed the Social Communication Questionnaire (SCQ), which evaluates autism spectrum symptoms, and psychologists administered the Kaufman Assessment Battery for Children (K-ABC), an IQ test.

Compared with the control group, the extremely preterm children had significantly higher total scores on the SCQ as well as significantly higher scores on each of the three component scales: social interaction, communication, and repetitive behavior. These significant differences persisted even after adjustments for both IQ and sex.

A total score of 15 or above on the SCQ is often used to define a threshold for autism spectrum disorders, and a score of 22 or above is used to define a threshold for autism. Of the preterm children, 8% had SCQ scores between 15 and 21, and another 8% had scores of 22 or above.

In contrast, only 3% of their term classmates passed the threshold for autism spectrum disorders, and none passed the threshold for autism. Compared with their classmates, the extremely preterm children were 6.3 times more likely to have scores of 15 or above.

In an interview, coinvestigator Dr. Neil Marlow, professor of neonatal medicine at the University of Nottingham, emphasized that it would not be appropriate to interpret the results as indicating that extreme prematurity is associated with a formal diagnosis of autism. The results show an association between prematurity and autism spectrum disorder symptoms, not autism itself.

Although other studies have found associations between prematurity and autism spectrum disorder symptoms at the age of 2 years, the investigators stated that this is the first study to find that association among school-age children. The investigators reported that they had no relevant conflicts of interest.

HONOLULU – Children born at less than 26 weeks' gestation are significantly more likely to have symptoms indicative of autism spectrum disorders at school age than are their classmates, according to a study of 219 children born extremely preterm matched with 153 children born at term.

Samantha Johnson, Ph.D., who is a psychologist at the University of Nottingham (England), and her colleagues compared these extremely preterm children with term classmates matched for age, sex, and ethnic group.

The mean age of children in both groups was 11 years, the researchers wrote in a poster presentation at the annual meeting of the Pediatric Academic Societies.

Parents completed the Social Communication Questionnaire (SCQ), which evaluates autism spectrum symptoms, and psychologists administered the Kaufman Assessment Battery for Children (K-ABC), an IQ test.

Compared with the control group, the extremely preterm children had significantly higher total scores on the SCQ as well as significantly higher scores on each of the three component scales: social interaction, communication, and repetitive behavior. These significant differences persisted even after adjustments for both IQ and sex.

A total score of 15 or above on the SCQ is often used to define a threshold for autism spectrum disorders, and a score of 22 or above is used to define a threshold for autism. Of the preterm children, 8% had SCQ scores between 15 and 21, and another 8% had scores of 22 or above.

In contrast, only 3% of their term classmates passed the threshold for autism spectrum disorders, and none passed the threshold for autism. Compared with their classmates, the extremely preterm children were 6.3 times more likely to have scores of 15 or above.

In an interview, coinvestigator Dr. Neil Marlow, professor of neonatal medicine at the University of Nottingham, emphasized that it would not be appropriate to interpret the results as indicating that extreme prematurity is associated with a formal diagnosis of autism. The results show an association between prematurity and autism spectrum disorder symptoms, not autism itself.

Although other studies have found associations between prematurity and autism spectrum disorder symptoms at the age of 2 years, the investigators stated that this is the first study to find that association among school-age children. The investigators reported that they had no relevant conflicts of interest.

HONOLULU – Children born at less than 26 weeks' gestation are significantly more likely to have symptoms indicative of autism spectrum disorders at school age than are their classmates, according to a study of 219 children born extremely preterm matched with 153 children born at term.

Samantha Johnson, Ph.D., who is a psychologist at the University of Nottingham (England), and her colleagues compared these extremely preterm children with term classmates matched for age, sex, and ethnic group.

The mean age of children in both groups was 11 years, the researchers wrote in a poster presentation at the annual meeting of the Pediatric Academic Societies.

Parents completed the Social Communication Questionnaire (SCQ), which evaluates autism spectrum symptoms, and psychologists administered the Kaufman Assessment Battery for Children (K-ABC), an IQ test.

Compared with the control group, the extremely preterm children had significantly higher total scores on the SCQ as well as significantly higher scores on each of the three component scales: social interaction, communication, and repetitive behavior. These significant differences persisted even after adjustments for both IQ and sex.

A total score of 15 or above on the SCQ is often used to define a threshold for autism spectrum disorders, and a score of 22 or above is used to define a threshold for autism. Of the preterm children, 8% had SCQ scores between 15 and 21, and another 8% had scores of 22 or above.

In contrast, only 3% of their term classmates passed the threshold for autism spectrum disorders, and none passed the threshold for autism. Compared with their classmates, the extremely preterm children were 6.3 times more likely to have scores of 15 or above.

In an interview, coinvestigator Dr. Neil Marlow, professor of neonatal medicine at the University of Nottingham, emphasized that it would not be appropriate to interpret the results as indicating that extreme prematurity is associated with a formal diagnosis of autism. The results show an association between prematurity and autism spectrum disorder symptoms, not autism itself.

Although other studies have found associations between prematurity and autism spectrum disorder symptoms at the age of 2 years, the investigators stated that this is the first study to find that association among school-age children. The investigators reported that they had no relevant conflicts of interest.

SAN DIEGO — Colonoscopies performed first thing in the morning yielded significantly more polyps and more histologically confirmed polyps than did those performed later in the day, according to a study presented at the annual Digestive Disease Week.

“In medicine it's well known that errors accumulate, particularly in anesthesia and surgery, as the day progresses,” said Dr. Brennan M. Spiegel of the University of California, Los Angeles. “Any surgeon will tell you that he'd rather be the first case of the day if he has to go under the knife.” The study he presented appears to extend these results to both surveillance and screening colonoscopy.

Dr. Spiegel and his colleagues performed a retrospective analysis of 500 consecutive patients seen at the West Los Angeles Veterans Administration Medical Center in 2006–2007. At that institution, colonoscopy cases begin at 7:45 a.m. and typically end at 1 p.m. The investigators divided that time into five segments that they analyzed separately.

Colonoscopists found a mean of 2.6 polyps per patient seen before 8:30 a.m., 2.1 polyps between 10 a.m. and 11:30 a.m., and 1.2 polyps after 1 p.m. On average, the first colonoscopy of the day found 20% more polyps than did those performed later in the day, a statistically significant difference. The trend line was also statistically significant.

The investigators noticed a similar pattern when they restricted their analysis to histologically confirmed polyps. The colonoscopists found a mean of 2.1 hyperplastic polyps during the first case of the day, 1.6 in cases between 10 a.m. and 11:30 a.m., and 1.1 in cases after 1 p.m. That trend line also was statistically significant.

The first case of the day remained a significant independent predictor of polyp yield even after the investigators controlled for a host of potential confounders in a multivariate analysis (P = .004). They controlled for patient-level factors such as age and body mass index, provider-level factors such as which individual colonoscopist performed the procedure and whether he or she was a fellow, and procedure-level factors such as the quality of the bowel prep and the withdrawal time.

Of those factors, the only other independent predictor of polyp yield was whether or not a fellow was participating in the procedure. Fellow participation was a strong predictor of higher yield (P = .00001). Dr. Spiegel suggested that one reason the presence of fellows may have improved yield is that there were “two [sets of] eyes on the screen instead of one.”

The study generated some critical comment during the question-and-answer period. Although no one intentionally assigned a specific type of case to a specific time period, one audience member said that there might be some undetected bias in appointment times, with a certain type of patient choosing earlier or later appointments.

Another physician noted that some colonoscopy centers perform many more procedures per day than does the West Los Angeles VA Medical Center, and suggested that the result might have been different if the study had been conducted elsewhere.

Another audience member commented, “I worry that when the New York Times or the Wall Street Journal gets ahold of this paper and publishes it widely, we're going to begin to have great difficulties scheduling patients in the afternoon.”

Dr. Spiegel agreed that the study should be repeated elsewhere before anyone takes it too seriously. “And whether it's the New York Times or anyone else, we have to emphasize that we have no idea that this impacts advanced adenomatous cancer” in terms of survival, he said.

But if the results are generalizable and colonoscopists are simply more vigilant earlier in the day, Dr. Spiegel suggested that clinicians look to other industries, such as air-traffic control and long-distance trucking, that depend on constant vigilance. In those industries, strategies such as split-shift scheduling, visible prompts, and frequent reminders to be vigilant have proved helpful.

Dr. Spiegel acknowledged receiving consulting fees, research support, and/or other financial benefits from AstraZeneca, Ethicon, TAP Pharmaceutical, Novartis, and Procter & Gamble.

SAN DIEGO — Colonoscopies performed first thing in the morning yielded significantly more polyps and more histologically confirmed polyps than did those performed later in the day, according to a study presented at the annual Digestive Disease Week.

“In medicine it's well known that errors accumulate, particularly in anesthesia and surgery, as the day progresses,” said Dr. Brennan M. Spiegel of the University of California, Los Angeles. “Any surgeon will tell you that he'd rather be the first case of the day if he has to go under the knife.” The study he presented appears to extend these results to both surveillance and screening colonoscopy.

Dr. Spiegel and his colleagues performed a retrospective analysis of 500 consecutive patients seen at the West Los Angeles Veterans Administration Medical Center in 2006–2007. At that institution, colonoscopy cases begin at 7:45 a.m. and typically end at 1 p.m. The investigators divided that time into five segments that they analyzed separately.

Colonoscopists found a mean of 2.6 polyps per patient seen before 8:30 a.m., 2.1 polyps between 10 a.m. and 11:30 a.m., and 1.2 polyps after 1 p.m. On average, the first colonoscopy of the day found 20% more polyps than did those performed later in the day, a statistically significant difference. The trend line was also statistically significant.

The investigators noticed a similar pattern when they restricted their analysis to histologically confirmed polyps. The colonoscopists found a mean of 2.1 hyperplastic polyps during the first case of the day, 1.6 in cases between 10 a.m. and 11:30 a.m., and 1.1 in cases after 1 p.m. That trend line also was statistically significant.

The first case of the day remained a significant independent predictor of polyp yield even after the investigators controlled for a host of potential confounders in a multivariate analysis (P = .004). They controlled for patient-level factors such as age and body mass index, provider-level factors such as which individual colonoscopist performed the procedure and whether he or she was a fellow, and procedure-level factors such as the quality of the bowel prep and the withdrawal time.

Of those factors, the only other independent predictor of polyp yield was whether or not a fellow was participating in the procedure. Fellow participation was a strong predictor of higher yield (P = .00001). Dr. Spiegel suggested that one reason the presence of fellows may have improved yield is that there were “two [sets of] eyes on the screen instead of one.”

The study generated some critical comment during the question-and-answer period. Although no one intentionally assigned a specific type of case to a specific time period, one audience member said that there might be some undetected bias in appointment times, with a certain type of patient choosing earlier or later appointments.

Another physician noted that some colonoscopy centers perform many more procedures per day than does the West Los Angeles VA Medical Center, and suggested that the result might have been different if the study had been conducted elsewhere.

Another audience member commented, “I worry that when the New York Times or the Wall Street Journal gets ahold of this paper and publishes it widely, we're going to begin to have great difficulties scheduling patients in the afternoon.”

Dr. Spiegel agreed that the study should be repeated elsewhere before anyone takes it too seriously. “And whether it's the New York Times or anyone else, we have to emphasize that we have no idea that this impacts advanced adenomatous cancer” in terms of survival, he said.

But if the results are generalizable and colonoscopists are simply more vigilant earlier in the day, Dr. Spiegel suggested that clinicians look to other industries, such as air-traffic control and long-distance trucking, that depend on constant vigilance. In those industries, strategies such as split-shift scheduling, visible prompts, and frequent reminders to be vigilant have proved helpful.

Dr. Spiegel acknowledged receiving consulting fees, research support, and/or other financial benefits from AstraZeneca, Ethicon, TAP Pharmaceutical, Novartis, and Procter & Gamble.

SAN DIEGO — Colonoscopies performed first thing in the morning yielded significantly more polyps and more histologically confirmed polyps than did those performed later in the day, according to a study presented at the annual Digestive Disease Week.

“In medicine it's well known that errors accumulate, particularly in anesthesia and surgery, as the day progresses,” said Dr. Brennan M. Spiegel of the University of California, Los Angeles. “Any surgeon will tell you that he'd rather be the first case of the day if he has to go under the knife.” The study he presented appears to extend these results to both surveillance and screening colonoscopy.

Dr. Spiegel and his colleagues performed a retrospective analysis of 500 consecutive patients seen at the West Los Angeles Veterans Administration Medical Center in 2006–2007. At that institution, colonoscopy cases begin at 7:45 a.m. and typically end at 1 p.m. The investigators divided that time into five segments that they analyzed separately.

Colonoscopists found a mean of 2.6 polyps per patient seen before 8:30 a.m., 2.1 polyps between 10 a.m. and 11:30 a.m., and 1.2 polyps after 1 p.m. On average, the first colonoscopy of the day found 20% more polyps than did those performed later in the day, a statistically significant difference. The trend line was also statistically significant.

The investigators noticed a similar pattern when they restricted their analysis to histologically confirmed polyps. The colonoscopists found a mean of 2.1 hyperplastic polyps during the first case of the day, 1.6 in cases between 10 a.m. and 11:30 a.m., and 1.1 in cases after 1 p.m. That trend line also was statistically significant.

The first case of the day remained a significant independent predictor of polyp yield even after the investigators controlled for a host of potential confounders in a multivariate analysis (P = .004). They controlled for patient-level factors such as age and body mass index, provider-level factors such as which individual colonoscopist performed the procedure and whether he or she was a fellow, and procedure-level factors such as the quality of the bowel prep and the withdrawal time.

Of those factors, the only other independent predictor of polyp yield was whether or not a fellow was participating in the procedure. Fellow participation was a strong predictor of higher yield (P = .00001). Dr. Spiegel suggested that one reason the presence of fellows may have improved yield is that there were “two [sets of] eyes on the screen instead of one.”

The study generated some critical comment during the question-and-answer period. Although no one intentionally assigned a specific type of case to a specific time period, one audience member said that there might be some undetected bias in appointment times, with a certain type of patient choosing earlier or later appointments.

Another physician noted that some colonoscopy centers perform many more procedures per day than does the West Los Angeles VA Medical Center, and suggested that the result might have been different if the study had been conducted elsewhere.

Another audience member commented, “I worry that when the New York Times or the Wall Street Journal gets ahold of this paper and publishes it widely, we're going to begin to have great difficulties scheduling patients in the afternoon.”

Dr. Spiegel agreed that the study should be repeated elsewhere before anyone takes it too seriously. “And whether it's the New York Times or anyone else, we have to emphasize that we have no idea that this impacts advanced adenomatous cancer” in terms of survival, he said.

But if the results are generalizable and colonoscopists are simply more vigilant earlier in the day, Dr. Spiegel suggested that clinicians look to other industries, such as air-traffic control and long-distance trucking, that depend on constant vigilance. In those industries, strategies such as split-shift scheduling, visible prompts, and frequent reminders to be vigilant have proved helpful.

Dr. Spiegel acknowledged receiving consulting fees, research support, and/or other financial benefits from AstraZeneca, Ethicon, TAP Pharmaceutical, Novartis, and Procter & Gamble.

SAN DIEGO — A single dose of a nonsteroidal anti-inflammatory drug administered rectally decreases the risk of a common and dreaded complication of endoscopic retrograde cholangiopancreatography by 64%, according to a meta-analysis presented at the annual Digestive Disease Week.

About 5% of all endoscopic retrograde cholangiopancreatography (ERCP) procedures, which are performed to diagnose and sometimes to treat disease in the bile and pancreatic ducts, result in pancreatitis.

According to Dr. B. Joseph Elmunzer, the senior author of the study, pancreatitis can occur in 1%–2% of low-risk patients and in up to 40% of high-risk patients following ERCP.

The meta-analysis involved four randomized, controlled studies and a total of 912 patients who were given 100 mg of rectal diclofenac, 100 mg of rectal indomethacin, or placebo immediately prior to or immediately after they underwent ERCP.

In addition to the statistically significant 64% reduction in cases of total pancreatitis, the meta-analysis found a 90% reduction in cases of moderate to severe pancreatitis.

In all, 15 patients would have to be treated to prevent one case of pancreatitis, and 38 patients would have to be treated to prevent one case of moderate to severe pancreatitis.

In a press conference, Dr. Elmunzer of the University of Michigan Medical Center, Ann Arbor, described this as “a reasonable number … particularly because NSAIDs are widely available, they're inexpensive, [and] they're well tolerated as a one-time dose.”

Dr. Elmunzer acknowledged that the investigators eliminated a fifth trial, which returned negative results, from the meta-analysis.

That trial, which involved 154 patients, used oral rather than rectal diclofenac, and would therefore have decreased the degree of homogeneity in the meta-analysis.

But he noted that the meta-analysis would still have found a positive effect of NSAIDs even if that trial had been included, although the decrease in the risk of pancreatitis would have changed from 64% to 49%.

He hypothesized that oral administration might be less effective because peak serum concentrations are reached about an hour earlier from the rectal route. “In a condition like ECRP pancreatitis, when you know the insult begins at a particular time point and then progresses quickly, it may be that the oral administration of NSAIDs just misses the boat.”

In spite of the encouraging results in the meta-analysis, Dr. Elmunzer urged caution in interpreting his results.

“With regard to medication prevention, this story has repeated itself on multiple occasions. There have been multiple agents that looked good initially, gained a lot of momentum, [and] even looked good on meta-analyses, and subsequent investigation has shown that there's absolutely no benefit.”

When asked whether he uses NSAIDs with his ERCP patients at the University of Michigan Medical Center, Dr. Elmunzer said, “As an institution, we don't have a widespread policy of using NSAIDs. I personally use NSAIDs in my patients. While I'm not 100% convinced that this will pan out in the long term, the way I look at it is as a risk-benefit ratio. And I find that in most patients the risk of a single dose of diclofenac or indomethacin is so low that even if there's any chance that there might be a benefit… the risk-benefit ratio falls on the side of giving it.”

However, the present study is not strong enough to generate widespread clinical practice changes, he added.

Dr. Elmunzer declared that he had no conflicts of interest related to his presentation.

'As an institution, we don't have a widespread policy of using NSAIDs. I personally use NSAIDs in my patients.' DR. ELMUNZER

SAN DIEGO — A single dose of a nonsteroidal anti-inflammatory drug administered rectally decreases the risk of a common and dreaded complication of endoscopic retrograde cholangiopancreatography by 64%, according to a meta-analysis presented at the annual Digestive Disease Week.

About 5% of all endoscopic retrograde cholangiopancreatography (ERCP) procedures, which are performed to diagnose and sometimes to treat disease in the bile and pancreatic ducts, result in pancreatitis.

According to Dr. B. Joseph Elmunzer, the senior author of the study, pancreatitis can occur in 1%–2% of low-risk patients and in up to 40% of high-risk patients following ERCP.

The meta-analysis involved four randomized, controlled studies and a total of 912 patients who were given 100 mg of rectal diclofenac, 100 mg of rectal indomethacin, or placebo immediately prior to or immediately after they underwent ERCP.

In addition to the statistically significant 64% reduction in cases of total pancreatitis, the meta-analysis found a 90% reduction in cases of moderate to severe pancreatitis.

In all, 15 patients would have to be treated to prevent one case of pancreatitis, and 38 patients would have to be treated to prevent one case of moderate to severe pancreatitis.

In a press conference, Dr. Elmunzer of the University of Michigan Medical Center, Ann Arbor, described this as “a reasonable number … particularly because NSAIDs are widely available, they're inexpensive, [and] they're well tolerated as a one-time dose.”

Dr. Elmunzer acknowledged that the investigators eliminated a fifth trial, which returned negative results, from the meta-analysis.

That trial, which involved 154 patients, used oral rather than rectal diclofenac, and would therefore have decreased the degree of homogeneity in the meta-analysis.

But he noted that the meta-analysis would still have found a positive effect of NSAIDs even if that trial had been included, although the decrease in the risk of pancreatitis would have changed from 64% to 49%.

He hypothesized that oral administration might be less effective because peak serum concentrations are reached about an hour earlier from the rectal route. “In a condition like ECRP pancreatitis, when you know the insult begins at a particular time point and then progresses quickly, it may be that the oral administration of NSAIDs just misses the boat.”

In spite of the encouraging results in the meta-analysis, Dr. Elmunzer urged caution in interpreting his results.

“With regard to medication prevention, this story has repeated itself on multiple occasions. There have been multiple agents that looked good initially, gained a lot of momentum, [and] even looked good on meta-analyses, and subsequent investigation has shown that there's absolutely no benefit.”

When asked whether he uses NSAIDs with his ERCP patients at the University of Michigan Medical Center, Dr. Elmunzer said, “As an institution, we don't have a widespread policy of using NSAIDs. I personally use NSAIDs in my patients. While I'm not 100% convinced that this will pan out in the long term, the way I look at it is as a risk-benefit ratio. And I find that in most patients the risk of a single dose of diclofenac or indomethacin is so low that even if there's any chance that there might be a benefit… the risk-benefit ratio falls on the side of giving it.”

However, the present study is not strong enough to generate widespread clinical practice changes, he added.

Dr. Elmunzer declared that he had no conflicts of interest related to his presentation.

'As an institution, we don't have a widespread policy of using NSAIDs. I personally use NSAIDs in my patients.' DR. ELMUNZER

SAN DIEGO — A single dose of a nonsteroidal anti-inflammatory drug administered rectally decreases the risk of a common and dreaded complication of endoscopic retrograde cholangiopancreatography by 64%, according to a meta-analysis presented at the annual Digestive Disease Week.

About 5% of all endoscopic retrograde cholangiopancreatography (ERCP) procedures, which are performed to diagnose and sometimes to treat disease in the bile and pancreatic ducts, result in pancreatitis.

According to Dr. B. Joseph Elmunzer, the senior author of the study, pancreatitis can occur in 1%–2% of low-risk patients and in up to 40% of high-risk patients following ERCP.

The meta-analysis involved four randomized, controlled studies and a total of 912 patients who were given 100 mg of rectal diclofenac, 100 mg of rectal indomethacin, or placebo immediately prior to or immediately after they underwent ERCP.

In addition to the statistically significant 64% reduction in cases of total pancreatitis, the meta-analysis found a 90% reduction in cases of moderate to severe pancreatitis.

In all, 15 patients would have to be treated to prevent one case of pancreatitis, and 38 patients would have to be treated to prevent one case of moderate to severe pancreatitis.

In a press conference, Dr. Elmunzer of the University of Michigan Medical Center, Ann Arbor, described this as “a reasonable number … particularly because NSAIDs are widely available, they're inexpensive, [and] they're well tolerated as a one-time dose.”

Dr. Elmunzer acknowledged that the investigators eliminated a fifth trial, which returned negative results, from the meta-analysis.

That trial, which involved 154 patients, used oral rather than rectal diclofenac, and would therefore have decreased the degree of homogeneity in the meta-analysis.

But he noted that the meta-analysis would still have found a positive effect of NSAIDs even if that trial had been included, although the decrease in the risk of pancreatitis would have changed from 64% to 49%.

He hypothesized that oral administration might be less effective because peak serum concentrations are reached about an hour earlier from the rectal route. “In a condition like ECRP pancreatitis, when you know the insult begins at a particular time point and then progresses quickly, it may be that the oral administration of NSAIDs just misses the boat.”

In spite of the encouraging results in the meta-analysis, Dr. Elmunzer urged caution in interpreting his results.

“With regard to medication prevention, this story has repeated itself on multiple occasions. There have been multiple agents that looked good initially, gained a lot of momentum, [and] even looked good on meta-analyses, and subsequent investigation has shown that there's absolutely no benefit.”

When asked whether he uses NSAIDs with his ERCP patients at the University of Michigan Medical Center, Dr. Elmunzer said, “As an institution, we don't have a widespread policy of using NSAIDs. I personally use NSAIDs in my patients. While I'm not 100% convinced that this will pan out in the long term, the way I look at it is as a risk-benefit ratio. And I find that in most patients the risk of a single dose of diclofenac or indomethacin is so low that even if there's any chance that there might be a benefit… the risk-benefit ratio falls on the side of giving it.”

However, the present study is not strong enough to generate widespread clinical practice changes, he added.

Dr. Elmunzer declared that he had no conflicts of interest related to his presentation.

'As an institution, we don't have a widespread policy of using NSAIDs. I personally use NSAIDs in my patients.' DR. ELMUNZER