Robert Finn

SAN FRANCISCO — While the relationship of the human papillomavirus to cervical cancer is well known among the public and in the medical profession, it is less commonly recognized that oral HPV appears to be associated with head and neck cancers. Even among the cognoscenti, there is a good deal of confusion about the details of this association.

At the Seventh International Conference on Head and Neck Cancer, Dr. Maura L. Gillison of Johns Hopkins University, Baltimore, reviewed current studies to answer some of the most frequently asked questions about HPV and cancers of the head and neck:

▸ Which HPV types are most associated with cancers of the head and neck? HPV-16 is the most common cause of cervical cancer, accounting for about 54% of these cancers, followed by HPV-18 and HPV-45. HPV-16 may be even more prominent among cancers of the head and neck, with a 92% association in one study.

▸ What risk of cancer is associated with oral HPV infection? Published studies show little agreement on the magnitude of the risk associated with oral HPV-16, although all the studies that Dr. Gillison reviewed found statistically significant increases. The odds ratios in published studies range from 1.7 for all the head and neck cancers to 32.3 for cancers of the oropharynx to 99.3 for cancers of the tonsil. Dr. Gillison estimated the overall increase in the risk of oropharyngeal cancer from HPV-16 infection to be about 15-fold over the risk in people who are not infected.

▸ How common is oral HPV infection? Estimates of the prevalence of HPV infection in control populations range from 3% to 18%.

▸ What are the risk factors for oral HPV infection? As in urogenital infection, sexual behavior appears to be the prime culprit in oral HPV infection, although peripartum transmission has been documented. Several studies have found HPV-16-positive head and neck cancers to be associated with a history of sexually transmitted disease, a history of casual sex, infrequent condom use, infrequent barrier use during oral sex, the number of sexual partners, and the number of oral sex partners.

▸ How does oral infection relate to cervical infection? Oral HPV infection is about three times as likely in women with cervical infections, but in the overwhelming majority of these women—94% according to one study—different types of HPV are responsible for their oral and urogenital infections.

▸ How long is a patient with HPV-positive cancer infectious? Studies have found oral HPV infections to persist for about 2 years following treatment for head and neck cancers. These infections have not been associated with recurrences or second primary cancers, however.

▸ Will the HPV vaccine have any effect on oral HPV infection? There is no direct evidence bearing on this question, but the indirect evidence is encouraging. Following vaccination, HPV-16 IgG can be detected in oral fluid, and oral HPV-16 is seropositive with cervical HPV-16.

Dr. Gillison serves as a consultant to, receives research funding from, and collaborates with scientists employed by Merck & Co. The conference was sponsored by the American Head and Neck Society.

SAN FRANCISCO — While the relationship of the human papillomavirus to cervical cancer is well known among the public and in the medical profession, it is less commonly recognized that oral HPV appears to be associated with head and neck cancers. Even among the cognoscenti, there is a good deal of confusion about the details of this association.

At the Seventh International Conference on Head and Neck Cancer, Dr. Maura L. Gillison of Johns Hopkins University, Baltimore, reviewed current studies to answer some of the most frequently asked questions about HPV and cancers of the head and neck:

▸ Which HPV types are most associated with cancers of the head and neck? HPV-16 is the most common cause of cervical cancer, accounting for about 54% of these cancers, followed by HPV-18 and HPV-45. HPV-16 may be even more prominent among cancers of the head and neck, with a 92% association in one study.

▸ What risk of cancer is associated with oral HPV infection? Published studies show little agreement on the magnitude of the risk associated with oral HPV-16, although all the studies that Dr. Gillison reviewed found statistically significant increases. The odds ratios in published studies range from 1.7 for all the head and neck cancers to 32.3 for cancers of the oropharynx to 99.3 for cancers of the tonsil. Dr. Gillison estimated the overall increase in the risk of oropharyngeal cancer from HPV-16 infection to be about 15-fold over the risk in people who are not infected.

▸ How common is oral HPV infection? Estimates of the prevalence of HPV infection in control populations range from 3% to 18%.

▸ What are the risk factors for oral HPV infection? As in urogenital infection, sexual behavior appears to be the prime culprit in oral HPV infection, although peripartum transmission has been documented. Several studies have found HPV-16-positive head and neck cancers to be associated with a history of sexually transmitted disease, a history of casual sex, infrequent condom use, infrequent barrier use during oral sex, the number of sexual partners, and the number of oral sex partners.

▸ How does oral infection relate to cervical infection? Oral HPV infection is about three times as likely in women with cervical infections, but in the overwhelming majority of these women—94% according to one study—different types of HPV are responsible for their oral and urogenital infections.

▸ How long is a patient with HPV-positive cancer infectious? Studies have found oral HPV infections to persist for about 2 years following treatment for head and neck cancers. These infections have not been associated with recurrences or second primary cancers, however.

▸ Will the HPV vaccine have any effect on oral HPV infection? There is no direct evidence bearing on this question, but the indirect evidence is encouraging. Following vaccination, HPV-16 IgG can be detected in oral fluid, and oral HPV-16 is seropositive with cervical HPV-16.

Dr. Gillison serves as a consultant to, receives research funding from, and collaborates with scientists employed by Merck & Co. The conference was sponsored by the American Head and Neck Society.

SAN FRANCISCO — While the relationship of the human papillomavirus to cervical cancer is well known among the public and in the medical profession, it is less commonly recognized that oral HPV appears to be associated with head and neck cancers. Even among the cognoscenti, there is a good deal of confusion about the details of this association.

At the Seventh International Conference on Head and Neck Cancer, Dr. Maura L. Gillison of Johns Hopkins University, Baltimore, reviewed current studies to answer some of the most frequently asked questions about HPV and cancers of the head and neck:

▸ Which HPV types are most associated with cancers of the head and neck? HPV-16 is the most common cause of cervical cancer, accounting for about 54% of these cancers, followed by HPV-18 and HPV-45. HPV-16 may be even more prominent among cancers of the head and neck, with a 92% association in one study.

▸ What risk of cancer is associated with oral HPV infection? Published studies show little agreement on the magnitude of the risk associated with oral HPV-16, although all the studies that Dr. Gillison reviewed found statistically significant increases. The odds ratios in published studies range from 1.7 for all the head and neck cancers to 32.3 for cancers of the oropharynx to 99.3 for cancers of the tonsil. Dr. Gillison estimated the overall increase in the risk of oropharyngeal cancer from HPV-16 infection to be about 15-fold over the risk in people who are not infected.

▸ How common is oral HPV infection? Estimates of the prevalence of HPV infection in control populations range from 3% to 18%.

▸ What are the risk factors for oral HPV infection? As in urogenital infection, sexual behavior appears to be the prime culprit in oral HPV infection, although peripartum transmission has been documented. Several studies have found HPV-16-positive head and neck cancers to be associated with a history of sexually transmitted disease, a history of casual sex, infrequent condom use, infrequent barrier use during oral sex, the number of sexual partners, and the number of oral sex partners.

▸ How does oral infection relate to cervical infection? Oral HPV infection is about three times as likely in women with cervical infections, but in the overwhelming majority of these women—94% according to one study—different types of HPV are responsible for their oral and urogenital infections.

▸ How long is a patient with HPV-positive cancer infectious? Studies have found oral HPV infections to persist for about 2 years following treatment for head and neck cancers. These infections have not been associated with recurrences or second primary cancers, however.

▸ Will the HPV vaccine have any effect on oral HPV infection? There is no direct evidence bearing on this question, but the indirect evidence is encouraging. Following vaccination, HPV-16 IgG can be detected in oral fluid, and oral HPV-16 is seropositive with cervical HPV-16.

Dr. Gillison serves as a consultant to, receives research funding from, and collaborates with scientists employed by Merck & Co. The conference was sponsored by the American Head and Neck Society.

MONTEREY, CALIF. — Ingestion of flax oil by women during the second and third trimester of pregnancy is associated with almost a threefold increase in the rate of premature birth, according to the findings of a recent study.

The format of the study questionnaire did not allow investigators to estimate the dose of flax oil associated with preterm birth, study investigator Anick Bérard, Ph.D., of the University of Montreal said in an interview.

Dr. Bérard noted that the question about flax referred specifically to flax oil, which is often used for constipation during pregnancy, and not flax seed, a common foodstuff.

The investigators found no link between premature birth and ingestion of a number of other herbal products, including chamomile, peppermint, and green tea, wrote lead author Krystel Moussally, B.Sc., of the University of Montreal, and her colleagues in a poster presentation at the annual meeting of the Teratology Society.

The case-control study involved 3,354 women listed in the Quebec Pregnancy Registry who responded to a questionnaire. All gave birth to a live infant between 1998 and 2003 in Quebec hospitals and all were continuously insured by the Regie de l'assurance maladie du Québec drug plan for at least 12 months before and during pregnancy. In all, the investigators mailed 8,505 questionnaires, so the response rate was 39%.

Among the women who returned questionnaires, 22% had given birth before 37 weeks' gestation.

As expected, women who gave birth prematurely differed from the controls on a number of variables.

For example, they were more likely to have asthma, and they had fewer prenatal visits.

After controlling for health status, sociodemographic characteristics, lifestyle habits, medication use before and during pregnancy, pregnancy complications, and the baby's sex, the investigators found that women who used flax oil during their last two trimesters were 2.76 times more likely to give birth prematurely than were those who did not.

“Flax use should be avoided during pregnancy,” the investigators concluded. “Caution in the use of not-as-yet regulated [herbal products] during the last two trimesters of pregnancy is warranted.”

The investigators stated that they had no conflicts of interest to declare.

MONTEREY, CALIF. — Ingestion of flax oil by women during the second and third trimester of pregnancy is associated with almost a threefold increase in the rate of premature birth, according to the findings of a recent study.

The format of the study questionnaire did not allow investigators to estimate the dose of flax oil associated with preterm birth, study investigator Anick Bérard, Ph.D., of the University of Montreal said in an interview.

Dr. Bérard noted that the question about flax referred specifically to flax oil, which is often used for constipation during pregnancy, and not flax seed, a common foodstuff.

The investigators found no link between premature birth and ingestion of a number of other herbal products, including chamomile, peppermint, and green tea, wrote lead author Krystel Moussally, B.Sc., of the University of Montreal, and her colleagues in a poster presentation at the annual meeting of the Teratology Society.

The case-control study involved 3,354 women listed in the Quebec Pregnancy Registry who responded to a questionnaire. All gave birth to a live infant between 1998 and 2003 in Quebec hospitals and all were continuously insured by the Regie de l'assurance maladie du Québec drug plan for at least 12 months before and during pregnancy. In all, the investigators mailed 8,505 questionnaires, so the response rate was 39%.

Among the women who returned questionnaires, 22% had given birth before 37 weeks' gestation.

As expected, women who gave birth prematurely differed from the controls on a number of variables.

For example, they were more likely to have asthma, and they had fewer prenatal visits.

After controlling for health status, sociodemographic characteristics, lifestyle habits, medication use before and during pregnancy, pregnancy complications, and the baby's sex, the investigators found that women who used flax oil during their last two trimesters were 2.76 times more likely to give birth prematurely than were those who did not.

“Flax use should be avoided during pregnancy,” the investigators concluded. “Caution in the use of not-as-yet regulated [herbal products] during the last two trimesters of pregnancy is warranted.”

The investigators stated that they had no conflicts of interest to declare.

MONTEREY, CALIF. — Ingestion of flax oil by women during the second and third trimester of pregnancy is associated with almost a threefold increase in the rate of premature birth, according to the findings of a recent study.

The format of the study questionnaire did not allow investigators to estimate the dose of flax oil associated with preterm birth, study investigator Anick Bérard, Ph.D., of the University of Montreal said in an interview.

Dr. Bérard noted that the question about flax referred specifically to flax oil, which is often used for constipation during pregnancy, and not flax seed, a common foodstuff.

The investigators found no link between premature birth and ingestion of a number of other herbal products, including chamomile, peppermint, and green tea, wrote lead author Krystel Moussally, B.Sc., of the University of Montreal, and her colleagues in a poster presentation at the annual meeting of the Teratology Society.

The case-control study involved 3,354 women listed in the Quebec Pregnancy Registry who responded to a questionnaire. All gave birth to a live infant between 1998 and 2003 in Quebec hospitals and all were continuously insured by the Regie de l'assurance maladie du Québec drug plan for at least 12 months before and during pregnancy. In all, the investigators mailed 8,505 questionnaires, so the response rate was 39%.

Among the women who returned questionnaires, 22% had given birth before 37 weeks' gestation.

As expected, women who gave birth prematurely differed from the controls on a number of variables.

For example, they were more likely to have asthma, and they had fewer prenatal visits.

After controlling for health status, sociodemographic characteristics, lifestyle habits, medication use before and during pregnancy, pregnancy complications, and the baby's sex, the investigators found that women who used flax oil during their last two trimesters were 2.76 times more likely to give birth prematurely than were those who did not.

“Flax use should be avoided during pregnancy,” the investigators concluded. “Caution in the use of not-as-yet regulated [herbal products] during the last two trimesters of pregnancy is warranted.”

The investigators stated that they had no conflicts of interest to declare.

SAN DIEGO — A “suction pseudopolyp” technique is safe and effective for removing flat or nearly flat colorectal polyps, according to a study presented at the annual Digestive Disease Week.

In a case series involving 101 patients with a total of 126 small- and medium-sized flat polyps, the investigators were able to remove every polyp and retrieve 125 (99.2%) for histopathologic examination, said Dr. Venessa Pattullo of Westmead Hospital, Sydney, Australia.

The histology was definitive in all of the polyps that were retrieved, and the patients experienced no immediate or delayed complications, such as bleeding, perforation, or pain.

The pseudopolyp technique employs the suction channel of the colonoscope. Dr. Pattullo first aligns the suction channel with the center of the lesion. She then aspirates the lesion into the channel, maintaining continuous suction for 5 seconds as she withdraws the colonoscope a distance of 2-4 cm.

The result is a pseudopolyp containing both the flat lesion and some surrounding healthy tissue, all of which can easily be ensnared and removed with diathermy. This typically leaves clean cauterized edges and a clear margin, and carries little risk of transcolonic injury.

To be included, the patient's polyps had to fit into Paris classification 0-IIa (superficially elevated lesions) or 0-IIb (truly flat lesions). Patients were 18-80 years old, and the polyps were all less than 10 mm in diameter. The 101 patients and 126 flat polyps were part of a larger group of 2,640 colonoscopies during which 1,376 polyps were removed from 1,245 patients over a 12-month period.

Flat polyps are typically difficult to ensnare because there is no protuberant tissue to grab onto, Dr. Pattullo said. The traditional methods used to remove flat polyps have a number of shortcomings. For example, hot biopsy with electrocautery has been associated with a 16% complication rate. Cold biopsy often leaves residual adenoma.

Some colonoscopists “discount these diminutive lesions as clinically insignificant and [do] not attempt to remove them at all,” Dr. Pattullo said, describing this as an “unsatisfactory alternative.”

Dr. Pattullo said she had no conflicts of interest associated with her presentation.

SAN DIEGO — A “suction pseudopolyp” technique is safe and effective for removing flat or nearly flat colorectal polyps, according to a study presented at the annual Digestive Disease Week.

In a case series involving 101 patients with a total of 126 small- and medium-sized flat polyps, the investigators were able to remove every polyp and retrieve 125 (99.2%) for histopathologic examination, said Dr. Venessa Pattullo of Westmead Hospital, Sydney, Australia.

The histology was definitive in all of the polyps that were retrieved, and the patients experienced no immediate or delayed complications, such as bleeding, perforation, or pain.

The pseudopolyp technique employs the suction channel of the colonoscope. Dr. Pattullo first aligns the suction channel with the center of the lesion. She then aspirates the lesion into the channel, maintaining continuous suction for 5 seconds as she withdraws the colonoscope a distance of 2-4 cm.

The result is a pseudopolyp containing both the flat lesion and some surrounding healthy tissue, all of which can easily be ensnared and removed with diathermy. This typically leaves clean cauterized edges and a clear margin, and carries little risk of transcolonic injury.

To be included, the patient's polyps had to fit into Paris classification 0-IIa (superficially elevated lesions) or 0-IIb (truly flat lesions). Patients were 18-80 years old, and the polyps were all less than 10 mm in diameter. The 101 patients and 126 flat polyps were part of a larger group of 2,640 colonoscopies during which 1,376 polyps were removed from 1,245 patients over a 12-month period.

Flat polyps are typically difficult to ensnare because there is no protuberant tissue to grab onto, Dr. Pattullo said. The traditional methods used to remove flat polyps have a number of shortcomings. For example, hot biopsy with electrocautery has been associated with a 16% complication rate. Cold biopsy often leaves residual adenoma.

Some colonoscopists “discount these diminutive lesions as clinically insignificant and [do] not attempt to remove them at all,” Dr. Pattullo said, describing this as an “unsatisfactory alternative.”

Dr. Pattullo said she had no conflicts of interest associated with her presentation.

SAN DIEGO — A “suction pseudopolyp” technique is safe and effective for removing flat or nearly flat colorectal polyps, according to a study presented at the annual Digestive Disease Week.

In a case series involving 101 patients with a total of 126 small- and medium-sized flat polyps, the investigators were able to remove every polyp and retrieve 125 (99.2%) for histopathologic examination, said Dr. Venessa Pattullo of Westmead Hospital, Sydney, Australia.

The histology was definitive in all of the polyps that were retrieved, and the patients experienced no immediate or delayed complications, such as bleeding, perforation, or pain.

The pseudopolyp technique employs the suction channel of the colonoscope. Dr. Pattullo first aligns the suction channel with the center of the lesion. She then aspirates the lesion into the channel, maintaining continuous suction for 5 seconds as she withdraws the colonoscope a distance of 2-4 cm.

The result is a pseudopolyp containing both the flat lesion and some surrounding healthy tissue, all of which can easily be ensnared and removed with diathermy. This typically leaves clean cauterized edges and a clear margin, and carries little risk of transcolonic injury.

To be included, the patient's polyps had to fit into Paris classification 0-IIa (superficially elevated lesions) or 0-IIb (truly flat lesions). Patients were 18-80 years old, and the polyps were all less than 10 mm in diameter. The 101 patients and 126 flat polyps were part of a larger group of 2,640 colonoscopies during which 1,376 polyps were removed from 1,245 patients over a 12-month period.

Flat polyps are typically difficult to ensnare because there is no protuberant tissue to grab onto, Dr. Pattullo said. The traditional methods used to remove flat polyps have a number of shortcomings. For example, hot biopsy with electrocautery has been associated with a 16% complication rate. Cold biopsy often leaves residual adenoma.

Some colonoscopists “discount these diminutive lesions as clinically insignificant and [do] not attempt to remove them at all,” Dr. Pattullo said, describing this as an “unsatisfactory alternative.”

Dr. Pattullo said she had no conflicts of interest associated with her presentation.

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 between 2006 and 2007. At that institution, colonoscopy cases begin at 7:45 a.m. and typically end at 1 p.m. The investigators divided at 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, but there was no significant difference between the time periods in the ratio of hyperplastic to adenomatous polyps.

“We were finding fewer of all polyps, not just hyperplastic or adenomatous,” Dr. Spiegel said.

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. During his talk, Dr. Spiegel said that patients were assigned randomly to time slots, but by that he meant that no one intentionally assigned a specific type of case to a specific time period. But 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 has an impact on 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 wondered what could be done about this, “short of putting an electrical shock in the handle of the colonoscope.” He 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 proven to be 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 between 2006 and 2007. At that institution, colonoscopy cases begin at 7:45 a.m. and typically end at 1 p.m. The investigators divided at 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, but there was no significant difference between the time periods in the ratio of hyperplastic to adenomatous polyps.

“We were finding fewer of all polyps, not just hyperplastic or adenomatous,” Dr. Spiegel said.

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. During his talk, Dr. Spiegel said that patients were assigned randomly to time slots, but by that he meant that no one intentionally assigned a specific type of case to a specific time period. But 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 has an impact on 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 wondered what could be done about this, “short of putting an electrical shock in the handle of the colonoscope.” He 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 proven to be 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 between 2006 and 2007. At that institution, colonoscopy cases begin at 7:45 a.m. and typically end at 1 p.m. The investigators divided at 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, but there was no significant difference between the time periods in the ratio of hyperplastic to adenomatous polyps.

“We were finding fewer of all polyps, not just hyperplastic or adenomatous,” Dr. Spiegel said.

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. During his talk, Dr. Spiegel said that patients were assigned randomly to time slots, but by that he meant that no one intentionally assigned a specific type of case to a specific time period. But 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 has an impact on 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 wondered what could be done about this, “short of putting an electrical shock in the handle of the colonoscope.” He 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 proven to be helpful.

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

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.

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 (MMWR 2006;55[No. RR-10]:11-12).

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 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.

Dr. Steinhoff disclosed that he has served on Sanofi's speakers bureau and has received research support from Sanofi-Aventis, Wyeth, and Merck & Co.

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.

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 (MMWR 2006;55[No. RR-10]:11-12).

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 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.

Dr. Steinhoff disclosed that he has served on Sanofi's speakers bureau and has received research support from Sanofi-Aventis, Wyeth, and Merck & Co.

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.

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 (MMWR 2006;55[No. RR-10]:11-12).

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 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.

Dr. Steinhoff disclosed that he has served on Sanofi's speakers bureau and has received research support from Sanofi-Aventis, Wyeth, and Merck & Co.

SAN FRANCISCO — Consider the partners of diabetes patients when talking about sexual problems in diabetes, Lawrence Fisher, Ph.D., suggested.

Although only one member of a couple may have diabetes, “Partners are very often hidden patients,” Dr. Fisher said at the annual scientific sessions of the American Diabetes Association. “Diabetes [exists] in interpersonal settings. It doesn't happen in social isolation. The most powerful and emotionally charged interpersonal setting is the adult couple.” He listed six issues related to sexual intimacy that affect patients with diabetes:

Clinical depression is very common among people with diabetes, and even in patients without a formal diagnosis of depression, it's typical to find high levels of depressive affect and diabetes distress. Many of these patients are taking antidepressants, which have well-known sexual side effects. On top of that, “Being in a lousy mood is not the greatest time to have sex,” said Dr. Fisher of the University of California, San Francisco.

Self-blame and shame are often issues in patients with diabetes, especially those with type 2. Consciously or unconsciously, many people think, “If only I had taken care of myself better, I wouldn't be having these sexual problems.” Partners also may blame the diabetes patient for sexual problems, further damaging the patient's self-esteem.

People with diabetes, especially with type 2, often feel socially and physically unattractive. An obese patient can have a poor body image that might inhibit him or her from initiating sexual activity. The other side of the coin is that partners may take it as a judgment about their own attractiveness when a man with diabetes is unable to achieve an erection.

Patients and partners often have specific worries about the effect of diabetes on sexual activity. Sexual intercourse can be physically demanding, and they worry about cardiovascular events and hypoglycemia. Having to plan for this, with blood testing before bed and snacks on the nightstand, for example, takes some of the spontaneity and fun out of sex. Furthermore, simply knowing that diabetes can lead to sexual failure can be a self-fulfilling prophecy.

Patients and their partners often suffer from a lack of knowledge about diabetes and its effects on sexual intimacy. And they also tend to be ignorant about the normal effects of aging on sexuality. “This creates what I like to call 'diabetes scapegoating,' “Dr. Fisher said. “Any time anything happens, it's [the fault of] diabetes. And it may not be. It may be normal functioning for people of that age.”

Cultural and personal beliefs, values, and sentiments about sexuality can often amplify the effects of diabetes. Some couples lack the language to talk about sexual difficulties. “In some cultures, even in long-standing relationships between partners, it is considered inappropriate for the partners to talk about their sexual activity,” Dr. Fisher said.

SAN FRANCISCO — Consider the partners of diabetes patients when talking about sexual problems in diabetes, Lawrence Fisher, Ph.D., suggested.

Although only one member of a couple may have diabetes, “Partners are very often hidden patients,” Dr. Fisher said at the annual scientific sessions of the American Diabetes Association. “Diabetes [exists] in interpersonal settings. It doesn't happen in social isolation. The most powerful and emotionally charged interpersonal setting is the adult couple.” He listed six issues related to sexual intimacy that affect patients with diabetes:

Clinical depression is very common among people with diabetes, and even in patients without a formal diagnosis of depression, it's typical to find high levels of depressive affect and diabetes distress. Many of these patients are taking antidepressants, which have well-known sexual side effects. On top of that, “Being in a lousy mood is not the greatest time to have sex,” said Dr. Fisher of the University of California, San Francisco.

Self-blame and shame are often issues in patients with diabetes, especially those with type 2. Consciously or unconsciously, many people think, “If only I had taken care of myself better, I wouldn't be having these sexual problems.” Partners also may blame the diabetes patient for sexual problems, further damaging the patient's self-esteem.

People with diabetes, especially with type 2, often feel socially and physically unattractive. An obese patient can have a poor body image that might inhibit him or her from initiating sexual activity. The other side of the coin is that partners may take it as a judgment about their own attractiveness when a man with diabetes is unable to achieve an erection.

Patients and partners often have specific worries about the effect of diabetes on sexual activity. Sexual intercourse can be physically demanding, and they worry about cardiovascular events and hypoglycemia. Having to plan for this, with blood testing before bed and snacks on the nightstand, for example, takes some of the spontaneity and fun out of sex. Furthermore, simply knowing that diabetes can lead to sexual failure can be a self-fulfilling prophecy.

Patients and their partners often suffer from a lack of knowledge about diabetes and its effects on sexual intimacy. And they also tend to be ignorant about the normal effects of aging on sexuality. “This creates what I like to call 'diabetes scapegoating,' “Dr. Fisher said. “Any time anything happens, it's [the fault of] diabetes. And it may not be. It may be normal functioning for people of that age.”

Cultural and personal beliefs, values, and sentiments about sexuality can often amplify the effects of diabetes. Some couples lack the language to talk about sexual difficulties. “In some cultures, even in long-standing relationships between partners, it is considered inappropriate for the partners to talk about their sexual activity,” Dr. Fisher said.

SAN FRANCISCO — Consider the partners of diabetes patients when talking about sexual problems in diabetes, Lawrence Fisher, Ph.D., suggested.

Although only one member of a couple may have diabetes, “Partners are very often hidden patients,” Dr. Fisher said at the annual scientific sessions of the American Diabetes Association. “Diabetes [exists] in interpersonal settings. It doesn't happen in social isolation. The most powerful and emotionally charged interpersonal setting is the adult couple.” He listed six issues related to sexual intimacy that affect patients with diabetes:

Clinical depression is very common among people with diabetes, and even in patients without a formal diagnosis of depression, it's typical to find high levels of depressive affect and diabetes distress. Many of these patients are taking antidepressants, which have well-known sexual side effects. On top of that, “Being in a lousy mood is not the greatest time to have sex,” said Dr. Fisher of the University of California, San Francisco.

Self-blame and shame are often issues in patients with diabetes, especially those with type 2. Consciously or unconsciously, many people think, “If only I had taken care of myself better, I wouldn't be having these sexual problems.” Partners also may blame the diabetes patient for sexual problems, further damaging the patient's self-esteem.

People with diabetes, especially with type 2, often feel socially and physically unattractive. An obese patient can have a poor body image that might inhibit him or her from initiating sexual activity. The other side of the coin is that partners may take it as a judgment about their own attractiveness when a man with diabetes is unable to achieve an erection.

Patients and partners often have specific worries about the effect of diabetes on sexual activity. Sexual intercourse can be physically demanding, and they worry about cardiovascular events and hypoglycemia. Having to plan for this, with blood testing before bed and snacks on the nightstand, for example, takes some of the spontaneity and fun out of sex. Furthermore, simply knowing that diabetes can lead to sexual failure can be a self-fulfilling prophecy.

Patients and their partners often suffer from a lack of knowledge about diabetes and its effects on sexual intimacy. And they also tend to be ignorant about the normal effects of aging on sexuality. “This creates what I like to call 'diabetes scapegoating,' “Dr. Fisher said. “Any time anything happens, it's [the fault of] diabetes. And it may not be. It may be normal functioning for people of that age.”

Cultural and personal beliefs, values, and sentiments about sexuality can often amplify the effects of diabetes. Some couples lack the language to talk about sexual difficulties. “In some cultures, even in long-standing relationships between partners, it is considered inappropriate for the partners to talk about their sexual activity,” Dr. Fisher said.

SAN FRANCISCO — People with diabetes frequently experience sexual problems, but few physicians have received training in dealing with these issues, and many are reluctant to broach the subject.

However, “you don't need to be Dr. Ruth to open up these conversations,” Mitchell S. Tepper, Ph.D., said at the annual scientific sessions of the American Diabetes Association. “You don't need to be a sex therapist. It's not your job to finish or address every issue.” He offered the following tips on discussing sexual issues with patients:

▸ Your emphasis should be in talking with patients, not to them, about sexual issues. “I have an 11-year-old,” said Dr. Tepper of the Morehouse School of Medicine, Atlanta. “When I talk to him, [he doesn't respond well]. People want to be in conversation and dialogue.”

▸ Demonstrate respect. Provide privacy for the discussion. Ask permission to talk about sensitive issues. Be patient. People who feel respected will be more likely to open up.

▸ Establish rapport and build trust. Avoid judgmental or shaming remarks. Normalize and legitimize the patient's questions and concerns. For example, you could open the discussion by saying, “Many patients with diabetes report changes in their sexual function or response. What have you experienced?”

▸ Validate the patient's concerns. It's disrespectful to say things like, “Don't worry,” or “It'll take time,” or “You'll figure it out,” or “That really isn't a big problem.” Instead, say something like, “I understand this is upsetting to you. I understand that you may be worrying about how this may affect your relationships.”

▸ Capitalize on teachable moments. For example, if you notice circulation problems in a patient's foot, use that opening to explain how circulation problems can also affect sexual function.

▸ Don't overwhelm patients by trying to cover everything in one session. One way to do this is to ask, “What is your most pressing sexual question or problem?”

▸ Use open-ended questions and let the patient tell his or her story without interruption. Dr. Tepper suggested many questions that can open the door to discussion, these among them: How long have you been experiencing this problem? How much of a problem is this for you and your relationships? Do you experience the problem when you masturbate? What do you think is the cause of your problem? What have you tried on your own to solve it? What are the most important results you hope to receive from treatment?

Finally, Dr. Tepper said that it's important to be cognizant of cultural issues surrounding sexuality. “Sexuality is not only about connecting with the genitals. It's also about connecting with the mind and the soul.”

SAN FRANCISCO — People with diabetes frequently experience sexual problems, but few physicians have received training in dealing with these issues, and many are reluctant to broach the subject.

However, “you don't need to be Dr. Ruth to open up these conversations,” Mitchell S. Tepper, Ph.D., said at the annual scientific sessions of the American Diabetes Association. “You don't need to be a sex therapist. It's not your job to finish or address every issue.” He offered the following tips on discussing sexual issues with patients:

▸ Your emphasis should be in talking with patients, not to them, about sexual issues. “I have an 11-year-old,” said Dr. Tepper of the Morehouse School of Medicine, Atlanta. “When I talk to him, [he doesn't respond well]. People want to be in conversation and dialogue.”

▸ Demonstrate respect. Provide privacy for the discussion. Ask permission to talk about sensitive issues. Be patient. People who feel respected will be more likely to open up.

▸ Establish rapport and build trust. Avoid judgmental or shaming remarks. Normalize and legitimize the patient's questions and concerns. For example, you could open the discussion by saying, “Many patients with diabetes report changes in their sexual function or response. What have you experienced?”

▸ Validate the patient's concerns. It's disrespectful to say things like, “Don't worry,” or “It'll take time,” or “You'll figure it out,” or “That really isn't a big problem.” Instead, say something like, “I understand this is upsetting to you. I understand that you may be worrying about how this may affect your relationships.”

▸ Capitalize on teachable moments. For example, if you notice circulation problems in a patient's foot, use that opening to explain how circulation problems can also affect sexual function.

▸ Don't overwhelm patients by trying to cover everything in one session. One way to do this is to ask, “What is your most pressing sexual question or problem?”

▸ Use open-ended questions and let the patient tell his or her story without interruption. Dr. Tepper suggested many questions that can open the door to discussion, these among them: How long have you been experiencing this problem? How much of a problem is this for you and your relationships? Do you experience the problem when you masturbate? What do you think is the cause of your problem? What have you tried on your own to solve it? What are the most important results you hope to receive from treatment?

Finally, Dr. Tepper said that it's important to be cognizant of cultural issues surrounding sexuality. “Sexuality is not only about connecting with the genitals. It's also about connecting with the mind and the soul.”

SAN FRANCISCO — People with diabetes frequently experience sexual problems, but few physicians have received training in dealing with these issues, and many are reluctant to broach the subject.

However, “you don't need to be Dr. Ruth to open up these conversations,” Mitchell S. Tepper, Ph.D., said at the annual scientific sessions of the American Diabetes Association. “You don't need to be a sex therapist. It's not your job to finish or address every issue.” He offered the following tips on discussing sexual issues with patients:

▸ Your emphasis should be in talking with patients, not to them, about sexual issues. “I have an 11-year-old,” said Dr. Tepper of the Morehouse School of Medicine, Atlanta. “When I talk to him, [he doesn't respond well]. People want to be in conversation and dialogue.”

▸ Demonstrate respect. Provide privacy for the discussion. Ask permission to talk about sensitive issues. Be patient. People who feel respected will be more likely to open up.

▸ Establish rapport and build trust. Avoid judgmental or shaming remarks. Normalize and legitimize the patient's questions and concerns. For example, you could open the discussion by saying, “Many patients with diabetes report changes in their sexual function or response. What have you experienced?”

▸ Validate the patient's concerns. It's disrespectful to say things like, “Don't worry,” or “It'll take time,” or “You'll figure it out,” or “That really isn't a big problem.” Instead, say something like, “I understand this is upsetting to you. I understand that you may be worrying about how this may affect your relationships.”

▸ Capitalize on teachable moments. For example, if you notice circulation problems in a patient's foot, use that opening to explain how circulation problems can also affect sexual function.

▸ Don't overwhelm patients by trying to cover everything in one session. One way to do this is to ask, “What is your most pressing sexual question or problem?”

▸ Use open-ended questions and let the patient tell his or her story without interruption. Dr. Tepper suggested many questions that can open the door to discussion, these among them: How long have you been experiencing this problem? How much of a problem is this for you and your relationships? Do you experience the problem when you masturbate? What do you think is the cause of your problem? What have you tried on your own to solve it? What are the most important results you hope to receive from treatment?

Finally, Dr. Tepper said that it's important to be cognizant of cultural issues surrounding sexuality. “Sexuality is not only about connecting with the genitals. It's also about connecting with the mind and the soul.”

SAN FRANCISCO — Standard therapies for type 2 diabetes are effective at maintaining glycemic control over at least 5 years in community settings, Dr. James Best reported at the annual scientific sessions of the American Diabetes Association.

Dr. Best, of the University of Melbourne, and his colleagues observed a cohort of 4,900 patients with type 2 diabetes who served as controls for the FIELD (Fenofibrate Intervention and Event Lowering in Diabetes) trial. Community-based family physicians at 63 sites in three countries treated these patients—mean age of 63 years—with diet, sulfonureas, metformin, and insulin in a standard progression.

Over a median of 5 years of follow-up, the patients' median hemoglobin A1c level rose only slightly, from 6.85% to 6.9%. Their median body weight declined slightly, from 86.3 kg (190.3 pounds) at baseline to 85.0 kg (187.4 pounds) at the end of the study. While both of those differences reached statistical significance, it's arguable whether such small changes had clinical significance.

In discussing these results, Dr. Best drew a distinction between “efficacy” and “effectiveness.” While any new treatment may show significant efficacy in a clinical trial, it's only truly useful if it proves to be effective in real-world settings.

“I think the glycemic effectiveness of new therapies for type 2 diabetes need to be assessed against what is achievable with standard and widely available current therapy,” Dr. Best said. “An HbA1c target of less than 7% is generally safe and generally achievable.”

Dr. Best conceded that the patients in the FIELD study were self-selected to a certain extent, which might compromise the generalizability of the results. On the other hand, the FIELD study was intended to evaluate cardiovascular outcomes, not glycemic control, in patients given fenofibrate. “They were fairly representative of patients with type 2 diabetes in the community,” he said. And the care they received was representative of the standard diabetes care that type 2 patients would receive anywhere in the community setting.

At the beginning of the study, 1,287 of the control patients were being treated with diet alone. By the end of the 5-year follow-up period, about half of these had been started on one or two oral agents.

Dr. Best said that he had no conflicts of interest related to his presentation.

SAN FRANCISCO — Standard therapies for type 2 diabetes are effective at maintaining glycemic control over at least 5 years in community settings, Dr. James Best reported at the annual scientific sessions of the American Diabetes Association.

Dr. Best, of the University of Melbourne, and his colleagues observed a cohort of 4,900 patients with type 2 diabetes who served as controls for the FIELD (Fenofibrate Intervention and Event Lowering in Diabetes) trial. Community-based family physicians at 63 sites in three countries treated these patients—mean age of 63 years—with diet, sulfonureas, metformin, and insulin in a standard progression.

Over a median of 5 years of follow-up, the patients' median hemoglobin A1c level rose only slightly, from 6.85% to 6.9%. Their median body weight declined slightly, from 86.3 kg (190.3 pounds) at baseline to 85.0 kg (187.4 pounds) at the end of the study. While both of those differences reached statistical significance, it's arguable whether such small changes had clinical significance.

In discussing these results, Dr. Best drew a distinction between “efficacy” and “effectiveness.” While any new treatment may show significant efficacy in a clinical trial, it's only truly useful if it proves to be effective in real-world settings.

“I think the glycemic effectiveness of new therapies for type 2 diabetes need to be assessed against what is achievable with standard and widely available current therapy,” Dr. Best said. “An HbA1c target of less than 7% is generally safe and generally achievable.”

Dr. Best conceded that the patients in the FIELD study were self-selected to a certain extent, which might compromise the generalizability of the results. On the other hand, the FIELD study was intended to evaluate cardiovascular outcomes, not glycemic control, in patients given fenofibrate. “They were fairly representative of patients with type 2 diabetes in the community,” he said. And the care they received was representative of the standard diabetes care that type 2 patients would receive anywhere in the community setting.

At the beginning of the study, 1,287 of the control patients were being treated with diet alone. By the end of the 5-year follow-up period, about half of these had been started on one or two oral agents.

Dr. Best said that he had no conflicts of interest related to his presentation.

SAN FRANCISCO — Standard therapies for type 2 diabetes are effective at maintaining glycemic control over at least 5 years in community settings, Dr. James Best reported at the annual scientific sessions of the American Diabetes Association.

Dr. Best, of the University of Melbourne, and his colleagues observed a cohort of 4,900 patients with type 2 diabetes who served as controls for the FIELD (Fenofibrate Intervention and Event Lowering in Diabetes) trial. Community-based family physicians at 63 sites in three countries treated these patients—mean age of 63 years—with diet, sulfonureas, metformin, and insulin in a standard progression.

Over a median of 5 years of follow-up, the patients' median hemoglobin A1c level rose only slightly, from 6.85% to 6.9%. Their median body weight declined slightly, from 86.3 kg (190.3 pounds) at baseline to 85.0 kg (187.4 pounds) at the end of the study. While both of those differences reached statistical significance, it's arguable whether such small changes had clinical significance.

In discussing these results, Dr. Best drew a distinction between “efficacy” and “effectiveness.” While any new treatment may show significant efficacy in a clinical trial, it's only truly useful if it proves to be effective in real-world settings.

“I think the glycemic effectiveness of new therapies for type 2 diabetes need to be assessed against what is achievable with standard and widely available current therapy,” Dr. Best said. “An HbA1c target of less than 7% is generally safe and generally achievable.”

Dr. Best conceded that the patients in the FIELD study were self-selected to a certain extent, which might compromise the generalizability of the results. On the other hand, the FIELD study was intended to evaluate cardiovascular outcomes, not glycemic control, in patients given fenofibrate. “They were fairly representative of patients with type 2 diabetes in the community,” he said. And the care they received was representative of the standard diabetes care that type 2 patients would receive anywhere in the community setting.

At the beginning of the study, 1,287 of the control patients were being treated with diet alone. By the end of the 5-year follow-up period, about half of these had been started on one or two oral agents.

Dr. Best said that he had no conflicts of interest related to his presentation.

MONTEREY, CALIF. — Women who take anti-inflammatories for asthma during the first trimester of pregnancy have an elevated risk of giving birth to an infant with anorectal atresia, according to results of a multicenter, case-control study of more than 7,000 women.

Anti-inflammatory use was not associated with any other birth defects, nor was the use of bronchodilators, Shao Lin, Ph.D., and colleagues at the New York State Department of Health reported in a poster presentation at the annual meeting of the Teratology Society.

The multicenter case-control study was part of the National Birth Defects Prevention Study, which collects data from 10 regions in the United States.

The investigators included women exposed to asthma medications at least once during a critical period defined as from 1 month prior to pregnancy to the end of the third pregnancy month. They focused on babies born between 1997 and 2003 with one of seven birth defects: diaphragmatic hernia, esophageal atresia, intestinal atresia, anorectal atresia, neural tube defects, omphalocele, and limb reduction.

In all, the investigators identified 2,248 infants with birth defects born to mothers taking asthma medications. They compared them with 4,986 nonmalformed, live-born infants identified by birth certificates or birth hospitals.

After adjusting for age, body mass index, parity, race/ethnicity, education, alcohol use, smoking, gender, folic acid use, fever, cocaine use, and the use of seven different vasoactive medications, the investigators found no significantly increased risks of birth defects associated with maternal bronchodilator use.

Maternal anti-inflammatory use, on the other hand, was associated with a statistically significant 2.6-fold increase in the risk of anorectal atresia. There were no other statistically significant associations between anti-inflammatory use and birth defects.

The investigators acknowledged that their study could not determine whether it was the anti-inflammatories or the asthma itself that was the causal agent. The use of asthma medications during the entire critical period could be an indication of especially severe asthma. They wrote that further studies would be needed to separate the effects of asthma from the effects of asthma treatment.

The risk of a rectal atresia was significantly elevated when the mother used anti-inflammatories during the entire critical period from 1 month prior to conception to the end of the third month. They also found a dose-response relationship because the risk was higher in those who used the drugs throughout the critical period compared with those who used anti-inflammatory drugs infrequently.

The investigators concluded that using asthma medications during the critical period of pregnancy carried no increased risk of isolated neural tube defects, omphalocele, or limb reduction.

In an interview, Gerald Briggs, B.Pharm., a pharmacist clinical specialist at the Women's Pavilion, Miller Children's Hospital, Long Beach, Calif., commented on Dr. Lin's study. “While a dose-response relationship is important for determining causation, the timing of the exposure also is critical,” he said. “Saying that some subjects used the drugs 'infrequently' is very subjective. What if some of the 'infrequent' users avoided the critical time (weeks 6-7) for causing anorectal atresia? That would reduce or eliminate the argument for a dose response. Moreover, at least three different classes of anti-inflammatory drugs were grouped together.”

Given these concerns, Mr. Briggs said, “I completely agree with the investigators that the study could only raise a hypothesis that requires further study. I would be reluctant to recommend that physicians change the way they counsel women with asthma until more information is available.”

Dr. Lin disclosed no conflicts of interest associated with the study.

MONTEREY, CALIF. — Women who take anti-inflammatories for asthma during the first trimester of pregnancy have an elevated risk of giving birth to an infant with anorectal atresia, according to results of a multicenter, case-control study of more than 7,000 women.

Anti-inflammatory use was not associated with any other birth defects, nor was the use of bronchodilators, Shao Lin, Ph.D., and colleagues at the New York State Department of Health reported in a poster presentation at the annual meeting of the Teratology Society.

The multicenter case-control study was part of the National Birth Defects Prevention Study, which collects data from 10 regions in the United States.

The investigators included women exposed to asthma medications at least once during a critical period defined as from 1 month prior to pregnancy to the end of the third pregnancy month. They focused on babies born between 1997 and 2003 with one of seven birth defects: diaphragmatic hernia, esophageal atresia, intestinal atresia, anorectal atresia, neural tube defects, omphalocele, and limb reduction.

In all, the investigators identified 2,248 infants with birth defects born to mothers taking asthma medications. They compared them with 4,986 nonmalformed, live-born infants identified by birth certificates or birth hospitals.

After adjusting for age, body mass index, parity, race/ethnicity, education, alcohol use, smoking, gender, folic acid use, fever, cocaine use, and the use of seven different vasoactive medications, the investigators found no significantly increased risks of birth defects associated with maternal bronchodilator use.

Maternal anti-inflammatory use, on the other hand, was associated with a statistically significant 2.6-fold increase in the risk of anorectal atresia. There were no other statistically significant associations between anti-inflammatory use and birth defects.

The investigators acknowledged that their study could not determine whether it was the anti-inflammatories or the asthma itself that was the causal agent. The use of asthma medications during the entire critical period could be an indication of especially severe asthma. They wrote that further studies would be needed to separate the effects of asthma from the effects of asthma treatment.

The risk of a rectal atresia was significantly elevated when the mother used anti-inflammatories during the entire critical period from 1 month prior to conception to the end of the third month. They also found a dose-response relationship because the risk was higher in those who used the drugs throughout the critical period compared with those who used anti-inflammatory drugs infrequently.

The investigators concluded that using asthma medications during the critical period of pregnancy carried no increased risk of isolated neural tube defects, omphalocele, or limb reduction.

In an interview, Gerald Briggs, B.Pharm., a pharmacist clinical specialist at the Women's Pavilion, Miller Children's Hospital, Long Beach, Calif., commented on Dr. Lin's study. “While a dose-response relationship is important for determining causation, the timing of the exposure also is critical,” he said. “Saying that some subjects used the drugs 'infrequently' is very subjective. What if some of the 'infrequent' users avoided the critical time (weeks 6-7) for causing anorectal atresia? That would reduce or eliminate the argument for a dose response. Moreover, at least three different classes of anti-inflammatory drugs were grouped together.”

Given these concerns, Mr. Briggs said, “I completely agree with the investigators that the study could only raise a hypothesis that requires further study. I would be reluctant to recommend that physicians change the way they counsel women with asthma until more information is available.”

Dr. Lin disclosed no conflicts of interest associated with the study.

MONTEREY, CALIF. — Women who take anti-inflammatories for asthma during the first trimester of pregnancy have an elevated risk of giving birth to an infant with anorectal atresia, according to results of a multicenter, case-control study of more than 7,000 women.

Anti-inflammatory use was not associated with any other birth defects, nor was the use of bronchodilators, Shao Lin, Ph.D., and colleagues at the New York State Department of Health reported in a poster presentation at the annual meeting of the Teratology Society.

The multicenter case-control study was part of the National Birth Defects Prevention Study, which collects data from 10 regions in the United States.

The investigators included women exposed to asthma medications at least once during a critical period defined as from 1 month prior to pregnancy to the end of the third pregnancy month. They focused on babies born between 1997 and 2003 with one of seven birth defects: diaphragmatic hernia, esophageal atresia, intestinal atresia, anorectal atresia, neural tube defects, omphalocele, and limb reduction.

In all, the investigators identified 2,248 infants with birth defects born to mothers taking asthma medications. They compared them with 4,986 nonmalformed, live-born infants identified by birth certificates or birth hospitals.

After adjusting for age, body mass index, parity, race/ethnicity, education, alcohol use, smoking, gender, folic acid use, fever, cocaine use, and the use of seven different vasoactive medications, the investigators found no significantly increased risks of birth defects associated with maternal bronchodilator use.

Maternal anti-inflammatory use, on the other hand, was associated with a statistically significant 2.6-fold increase in the risk of anorectal atresia. There were no other statistically significant associations between anti-inflammatory use and birth defects.

The investigators acknowledged that their study could not determine whether it was the anti-inflammatories or the asthma itself that was the causal agent. The use of asthma medications during the entire critical period could be an indication of especially severe asthma. They wrote that further studies would be needed to separate the effects of asthma from the effects of asthma treatment.

The risk of a rectal atresia was significantly elevated when the mother used anti-inflammatories during the entire critical period from 1 month prior to conception to the end of the third month. They also found a dose-response relationship because the risk was higher in those who used the drugs throughout the critical period compared with those who used anti-inflammatory drugs infrequently.

The investigators concluded that using asthma medications during the critical period of pregnancy carried no increased risk of isolated neural tube defects, omphalocele, or limb reduction.

In an interview, Gerald Briggs, B.Pharm., a pharmacist clinical specialist at the Women's Pavilion, Miller Children's Hospital, Long Beach, Calif., commented on Dr. Lin's study. “While a dose-response relationship is important for determining causation, the timing of the exposure also is critical,” he said. “Saying that some subjects used the drugs 'infrequently' is very subjective. What if some of the 'infrequent' users avoided the critical time (weeks 6-7) for causing anorectal atresia? That would reduce or eliminate the argument for a dose response. Moreover, at least three different classes of anti-inflammatory drugs were grouped together.”

Given these concerns, Mr. Briggs said, “I completely agree with the investigators that the study could only raise a hypothesis that requires further study. I would be reluctant to recommend that physicians change the way they counsel women with asthma until more information is available.”

Dr. Lin disclosed no conflicts of interest associated with the study.

MONTEREY, CALIF. — There is no statistically significant association between paroxetine usage during the first trimester of pregnancy and an increased risk of cardiac malformations in the infants, according to a meta-analysis of nine studies.

A selective serotonin reuptake inhibitor frequently prescribed for depression and anxiety, paroxetine (Paxil) was the subject of a 2005 warning by the Food and Drug Administration, Health Canada, and its manufacturer referencing unpublished findings of cardiac malformations in infants exposed during the first trimester of pregnancy.

Several other studies appeared to confirm these findings, Lisa O'Brien reported in a poster session at the annual meeting of the Teratology Society.

And a meta-analysis published in 2007 that included all of the studies published up until that time found that first-trimester paroxetine presented a modest increased risk of cardiac malformations (Clin. Ther. 2007;29:918-26).

Since then, however, several more studies have been published.

Ms. O'Brien of the Hospital for Sick Children, Toronto, and her colleagues identified a total of nine studies that could be included in their analysis—six cohort studies and three case-control studies—which they analyzed separately.

The case-control studies together included 30,247 women and, with a summary odds ratio of 1.18, found no statistically significant association between paroxetine and cardiac malformations.

The cohort studies included 66,409 women.

The rate of cardiac malformation was 1.14% among the 3,428 infants exposed to paroxetine and 1.09% among the 62,981 controls.

The weighted average difference in cardiac malformation rates between the two groups was 0.3%, which the investigators described as small and nonsignificant.

“First-trimester exposure to paroxetine appears not to be associated with an increased risk of cardiac malformations,” the investigators concluded.

“This evidence-based information will assist women, together with their physicians and other health care providers, to make an informed decision regarding the use of paroxetine during pregnancy.”

The investigators disclosed no conflicts of interest related to their presentation.

MONTEREY, CALIF. — There is no statistically significant association between paroxetine usage during the first trimester of pregnancy and an increased risk of cardiac malformations in the infants, according to a meta-analysis of nine studies.

A selective serotonin reuptake inhibitor frequently prescribed for depression and anxiety, paroxetine (Paxil) was the subject of a 2005 warning by the Food and Drug Administration, Health Canada, and its manufacturer referencing unpublished findings of cardiac malformations in infants exposed during the first trimester of pregnancy.

Several other studies appeared to confirm these findings, Lisa O'Brien reported in a poster session at the annual meeting of the Teratology Society.

And a meta-analysis published in 2007 that included all of the studies published up until that time found that first-trimester paroxetine presented a modest increased risk of cardiac malformations (Clin. Ther. 2007;29:918-26).

Since then, however, several more studies have been published.

Ms. O'Brien of the Hospital for Sick Children, Toronto, and her colleagues identified a total of nine studies that could be included in their analysis—six cohort studies and three case-control studies—which they analyzed separately.

The case-control studies together included 30,247 women and, with a summary odds ratio of 1.18, found no statistically significant association between paroxetine and cardiac malformations.

The cohort studies included 66,409 women.

The rate of cardiac malformation was 1.14% among the 3,428 infants exposed to paroxetine and 1.09% among the 62,981 controls.

The weighted average difference in cardiac malformation rates between the two groups was 0.3%, which the investigators described as small and nonsignificant.

“First-trimester exposure to paroxetine appears not to be associated with an increased risk of cardiac malformations,” the investigators concluded.

“This evidence-based information will assist women, together with their physicians and other health care providers, to make an informed decision regarding the use of paroxetine during pregnancy.”

The investigators disclosed no conflicts of interest related to their presentation.

MONTEREY, CALIF. — There is no statistically significant association between paroxetine usage during the first trimester of pregnancy and an increased risk of cardiac malformations in the infants, according to a meta-analysis of nine studies.

A selective serotonin reuptake inhibitor frequently prescribed for depression and anxiety, paroxetine (Paxil) was the subject of a 2005 warning by the Food and Drug Administration, Health Canada, and its manufacturer referencing unpublished findings of cardiac malformations in infants exposed during the first trimester of pregnancy.

Several other studies appeared to confirm these findings, Lisa O'Brien reported in a poster session at the annual meeting of the Teratology Society.

And a meta-analysis published in 2007 that included all of the studies published up until that time found that first-trimester paroxetine presented a modest increased risk of cardiac malformations (Clin. Ther. 2007;29:918-26).

Since then, however, several more studies have been published.

Ms. O'Brien of the Hospital for Sick Children, Toronto, and her colleagues identified a total of nine studies that could be included in their analysis—six cohort studies and three case-control studies—which they analyzed separately.

The case-control studies together included 30,247 women and, with a summary odds ratio of 1.18, found no statistically significant association between paroxetine and cardiac malformations.

The cohort studies included 66,409 women.

The rate of cardiac malformation was 1.14% among the 3,428 infants exposed to paroxetine and 1.09% among the 62,981 controls.

The weighted average difference in cardiac malformation rates between the two groups was 0.3%, which the investigators described as small and nonsignificant.

“First-trimester exposure to paroxetine appears not to be associated with an increased risk of cardiac malformations,” the investigators concluded.

“This evidence-based information will assist women, together with their physicians and other health care providers, to make an informed decision regarding the use of paroxetine during pregnancy.”

The investigators disclosed no conflicts of interest related to their presentation.