Michele G. Sullivan

Neither clinical nor subclinical hypothyroidism was associated with mild cognitive impairment in a large, population-based study.

Among almost 2,000 elderly subjects, mild cognitive impairment (MCI) was present in 16% of those with normal thyroid function, 17% of those with clinical hypothyroidism, and 18% of those with subclinical hypothyroidism, Dr. Ajay K. Parsaik and his colleagues reported in the Dec. 30 issue of JAMA Neurology (doi:10.1001/jamaneurol.2013.5402).

The findings question the usefulness of pursuing thyroid status as a possible contributor to MCI, wrote Dr. Parsaik of the department of psychiatry and behavior sciences, University of Texas Medical School, Houston, and his coauthors.

"Cognitive decline and thyroid dysfunction are common in the elderly, and a widely held view is that hypothyroidism is a reversible risk factor for cognitive impairment, even though several studies have shown no such association. Our population-based findings also argue against an association and suggest that neither clinical nor subclinical hypothyroidism is a risk factor for MCI. .... This raises questions about the need for routine testing of thyroid function as a part of the diagnostic work-up in patients with MCI."

The team examined thyroid function and cognitive status among 1,904 elderly subjects who were included in the Olmsted County (Minn.) health care records database. Most (1,588; 83%) were cognitively normal; 316 had MCI. Those with MCI were older (82 vs. 80 years), less educated (13 vs. 14 years), and more often carriers of the apolipoprotein E4 risk gene (30% vs. 22%).

Medical comorbidities, including hypertension, coronary artery disease, diabetes, stroke, and depression were significantly more common among those with MCI.

Most subjects (1,450) had normal thyroid function. Of these, 84% were cognitively normal and 16% had MCI.

Clinical hypothyroidism was present in 313; of these, 83% were cognitively normal, and 17% had MCI. All subjects were taking thyroid replacement therapy.

Subclinical hypothyroidism was present in 141; of these, 83% were cognitively normal and 18% had MCI. None of these subjects were getting thyroid replacement therapy.

In an analysis that controlled for age, education, sex, APOE E4 status, depression, and medical comorbidities, MCI was not significantly associated with either clinical or subclinical hypothyroidism. There was no significant interaction between APOE E4 status and hypothyroidism.

The authors noted that their findings should be validated in a larger, longitudinal study in a more varied population.

The study was sponsored by the National Institutes of Health. Dr. Parsaik had no financial disclosures. One of the coauthors, Dr. Bradley Boeve, reported multiple disclosures, some with pharmaceutical companies.

[email protected]

Neither clinical nor subclinical hypothyroidism was associated with mild cognitive impairment in a large, population-based study.

Among almost 2,000 elderly subjects, mild cognitive impairment (MCI) was present in 16% of those with normal thyroid function, 17% of those with clinical hypothyroidism, and 18% of those with subclinical hypothyroidism, Dr. Ajay K. Parsaik and his colleagues reported in the Dec. 30 issue of JAMA Neurology (doi:10.1001/jamaneurol.2013.5402).

The findings question the usefulness of pursuing thyroid status as a possible contributor to MCI, wrote Dr. Parsaik of the department of psychiatry and behavior sciences, University of Texas Medical School, Houston, and his coauthors.

"Cognitive decline and thyroid dysfunction are common in the elderly, and a widely held view is that hypothyroidism is a reversible risk factor for cognitive impairment, even though several studies have shown no such association. Our population-based findings also argue against an association and suggest that neither clinical nor subclinical hypothyroidism is a risk factor for MCI. .... This raises questions about the need for routine testing of thyroid function as a part of the diagnostic work-up in patients with MCI."

The team examined thyroid function and cognitive status among 1,904 elderly subjects who were included in the Olmsted County (Minn.) health care records database. Most (1,588; 83%) were cognitively normal; 316 had MCI. Those with MCI were older (82 vs. 80 years), less educated (13 vs. 14 years), and more often carriers of the apolipoprotein E4 risk gene (30% vs. 22%).

Medical comorbidities, including hypertension, coronary artery disease, diabetes, stroke, and depression were significantly more common among those with MCI.

Most subjects (1,450) had normal thyroid function. Of these, 84% were cognitively normal and 16% had MCI.

Clinical hypothyroidism was present in 313; of these, 83% were cognitively normal, and 17% had MCI. All subjects were taking thyroid replacement therapy.

Subclinical hypothyroidism was present in 141; of these, 83% were cognitively normal and 18% had MCI. None of these subjects were getting thyroid replacement therapy.

In an analysis that controlled for age, education, sex, APOE E4 status, depression, and medical comorbidities, MCI was not significantly associated with either clinical or subclinical hypothyroidism. There was no significant interaction between APOE E4 status and hypothyroidism.

The authors noted that their findings should be validated in a larger, longitudinal study in a more varied population.

The study was sponsored by the National Institutes of Health. Dr. Parsaik had no financial disclosures. One of the coauthors, Dr. Bradley Boeve, reported multiple disclosures, some with pharmaceutical companies.

[email protected]

Neither clinical nor subclinical hypothyroidism was associated with mild cognitive impairment in a large, population-based study.

Among almost 2,000 elderly subjects, mild cognitive impairment (MCI) was present in 16% of those with normal thyroid function, 17% of those with clinical hypothyroidism, and 18% of those with subclinical hypothyroidism, Dr. Ajay K. Parsaik and his colleagues reported in the Dec. 30 issue of JAMA Neurology (doi:10.1001/jamaneurol.2013.5402).

The findings question the usefulness of pursuing thyroid status as a possible contributor to MCI, wrote Dr. Parsaik of the department of psychiatry and behavior sciences, University of Texas Medical School, Houston, and his coauthors.

"Cognitive decline and thyroid dysfunction are common in the elderly, and a widely held view is that hypothyroidism is a reversible risk factor for cognitive impairment, even though several studies have shown no such association. Our population-based findings also argue against an association and suggest that neither clinical nor subclinical hypothyroidism is a risk factor for MCI. .... This raises questions about the need for routine testing of thyroid function as a part of the diagnostic work-up in patients with MCI."

The team examined thyroid function and cognitive status among 1,904 elderly subjects who were included in the Olmsted County (Minn.) health care records database. Most (1,588; 83%) were cognitively normal; 316 had MCI. Those with MCI were older (82 vs. 80 years), less educated (13 vs. 14 years), and more often carriers of the apolipoprotein E4 risk gene (30% vs. 22%).

Medical comorbidities, including hypertension, coronary artery disease, diabetes, stroke, and depression were significantly more common among those with MCI.

Most subjects (1,450) had normal thyroid function. Of these, 84% were cognitively normal and 16% had MCI.

Clinical hypothyroidism was present in 313; of these, 83% were cognitively normal, and 17% had MCI. All subjects were taking thyroid replacement therapy.

Subclinical hypothyroidism was present in 141; of these, 83% were cognitively normal and 18% had MCI. None of these subjects were getting thyroid replacement therapy.

In an analysis that controlled for age, education, sex, APOE E4 status, depression, and medical comorbidities, MCI was not significantly associated with either clinical or subclinical hypothyroidism. There was no significant interaction between APOE E4 status and hypothyroidism.

The authors noted that their findings should be validated in a larger, longitudinal study in a more varied population.

The study was sponsored by the National Institutes of Health. Dr. Parsaik had no financial disclosures. One of the coauthors, Dr. Bradley Boeve, reported multiple disclosures, some with pharmaceutical companies.

[email protected]

Discharging patients with uncomplicated diverticulitis from the emergency department on antibiotics was just as effective as hospitalization – and cost about a third as much, based on a study conducted in Spain.

Dr. Sebastiano Biondi and his colleagues conducted their randomized, parallel-group study at five hospitals. The cohort consisted of 132 adults, mean age 56 years, who presented to the emergency department with localized abdominal pain. All had an abdominal CT scan and received intravenous antibiotics, either an initial IV infusion of 1 g of amoxicillin per 125 mg of clavulanic acid, or, in the case of those with a penicillin allergy, ciprofloxacin 200 mg and metronidazole 500 mg.

Half of the patients were then assigned to either inpatient or outpatient antibiotic treatment. The admitted patients continued to receive IV antibiotics and fluids for 36-48 hours until they tolerated oral feeding. The outpatients were discharged on oral amoxicillin and clavulanic acid (875 mg per 125 mg every 8 hours) or, in those with penicillin allergy, the combination of ciprofloxacin (500 mg every 12 hours) and metronidazole (500 mg every 8 hours).

The study’s main endpoint was treatment failure rate (persistence, increase, or recurrence of abdominal pain and/or fever; inflammatory bowel obstruction; or the need for radiological abscess drainage or immediate surgery due to complicated diverticulitis). Patients were followed every day for 5 days, and then interviewed on day 14. Before the final follow-up at 60 days, patients underwent a colonoscopy to rule out malignancy.

Seven patients (5%) were readmitted due to treatment failure: 4 (6%) in the inpatient group and three (4.5%) in the outpatient group. The difference was not statistically significant. No one needed emergency surgery as part of readmission, and there were no deaths.

A quality of life assessment found that hospitalized patients reported a significantly higher level of physical health during the first 2 weeks of treatment, but that difference disappeared after 14 days.

Total treatment costs were significantly less in the outpatient group, with an average savings of $1,840 per patient ($895 for outpatient care compared with $2,735 for inpatient care). Almost all of that cost difference was due to hospital bed cost, with an average stay of 4 days.

"The outpatient protocol of this study is applicable to a selected group of patients with uncomplicated diverticulitis," Dr. Biondi reported in the January issue of Annals of Surgery (doi: 10.1097/SLA.0b013e3182965a11).

Widespread adoption of outpatient treatment could have a profound effect on the cost of treating diverticulitis, an ever more common gastrointestinal problem, said Dr. Biondi of the University of Barcelona and his coauthors. "According to data from the National Hospital Discharge Survey, diverticular disease is responsible for 314,000 hospital admissions per year in the United States, and the estimated annual cost in 1998 was about $2.6 billion."

The Spanish Ministry of Health funded the trial. The authors had no financial conflicts.

[email protected]

Discharging patients with uncomplicated diverticulitis from the emergency department on antibiotics was just as effective as hospitalization – and cost about a third as much, based on a study conducted in Spain.

Dr. Sebastiano Biondi and his colleagues conducted their randomized, parallel-group study at five hospitals. The cohort consisted of 132 adults, mean age 56 years, who presented to the emergency department with localized abdominal pain. All had an abdominal CT scan and received intravenous antibiotics, either an initial IV infusion of 1 g of amoxicillin per 125 mg of clavulanic acid, or, in the case of those with a penicillin allergy, ciprofloxacin 200 mg and metronidazole 500 mg.

Half of the patients were then assigned to either inpatient or outpatient antibiotic treatment. The admitted patients continued to receive IV antibiotics and fluids for 36-48 hours until they tolerated oral feeding. The outpatients were discharged on oral amoxicillin and clavulanic acid (875 mg per 125 mg every 8 hours) or, in those with penicillin allergy, the combination of ciprofloxacin (500 mg every 12 hours) and metronidazole (500 mg every 8 hours).

The study’s main endpoint was treatment failure rate (persistence, increase, or recurrence of abdominal pain and/or fever; inflammatory bowel obstruction; or the need for radiological abscess drainage or immediate surgery due to complicated diverticulitis). Patients were followed every day for 5 days, and then interviewed on day 14. Before the final follow-up at 60 days, patients underwent a colonoscopy to rule out malignancy.

Seven patients (5%) were readmitted due to treatment failure: 4 (6%) in the inpatient group and three (4.5%) in the outpatient group. The difference was not statistically significant. No one needed emergency surgery as part of readmission, and there were no deaths.

A quality of life assessment found that hospitalized patients reported a significantly higher level of physical health during the first 2 weeks of treatment, but that difference disappeared after 14 days.

Total treatment costs were significantly less in the outpatient group, with an average savings of $1,840 per patient ($895 for outpatient care compared with $2,735 for inpatient care). Almost all of that cost difference was due to hospital bed cost, with an average stay of 4 days.

"The outpatient protocol of this study is applicable to a selected group of patients with uncomplicated diverticulitis," Dr. Biondi reported in the January issue of Annals of Surgery (doi: 10.1097/SLA.0b013e3182965a11).

Widespread adoption of outpatient treatment could have a profound effect on the cost of treating diverticulitis, an ever more common gastrointestinal problem, said Dr. Biondi of the University of Barcelona and his coauthors. "According to data from the National Hospital Discharge Survey, diverticular disease is responsible for 314,000 hospital admissions per year in the United States, and the estimated annual cost in 1998 was about $2.6 billion."

The Spanish Ministry of Health funded the trial. The authors had no financial conflicts.

[email protected]

Discharging patients with uncomplicated diverticulitis from the emergency department on antibiotics was just as effective as hospitalization – and cost about a third as much, based on a study conducted in Spain.

Dr. Sebastiano Biondi and his colleagues conducted their randomized, parallel-group study at five hospitals. The cohort consisted of 132 adults, mean age 56 years, who presented to the emergency department with localized abdominal pain. All had an abdominal CT scan and received intravenous antibiotics, either an initial IV infusion of 1 g of amoxicillin per 125 mg of clavulanic acid, or, in the case of those with a penicillin allergy, ciprofloxacin 200 mg and metronidazole 500 mg.

Half of the patients were then assigned to either inpatient or outpatient antibiotic treatment. The admitted patients continued to receive IV antibiotics and fluids for 36-48 hours until they tolerated oral feeding. The outpatients were discharged on oral amoxicillin and clavulanic acid (875 mg per 125 mg every 8 hours) or, in those with penicillin allergy, the combination of ciprofloxacin (500 mg every 12 hours) and metronidazole (500 mg every 8 hours).

The study’s main endpoint was treatment failure rate (persistence, increase, or recurrence of abdominal pain and/or fever; inflammatory bowel obstruction; or the need for radiological abscess drainage or immediate surgery due to complicated diverticulitis). Patients were followed every day for 5 days, and then interviewed on day 14. Before the final follow-up at 60 days, patients underwent a colonoscopy to rule out malignancy.

Seven patients (5%) were readmitted due to treatment failure: 4 (6%) in the inpatient group and three (4.5%) in the outpatient group. The difference was not statistically significant. No one needed emergency surgery as part of readmission, and there were no deaths.

A quality of life assessment found that hospitalized patients reported a significantly higher level of physical health during the first 2 weeks of treatment, but that difference disappeared after 14 days.

Total treatment costs were significantly less in the outpatient group, with an average savings of $1,840 per patient ($895 for outpatient care compared with $2,735 for inpatient care). Almost all of that cost difference was due to hospital bed cost, with an average stay of 4 days.

"The outpatient protocol of this study is applicable to a selected group of patients with uncomplicated diverticulitis," Dr. Biondi reported in the January issue of Annals of Surgery (doi: 10.1097/SLA.0b013e3182965a11).

Widespread adoption of outpatient treatment could have a profound effect on the cost of treating diverticulitis, an ever more common gastrointestinal problem, said Dr. Biondi of the University of Barcelona and his coauthors. "According to data from the National Hospital Discharge Survey, diverticular disease is responsible for 314,000 hospital admissions per year in the United States, and the estimated annual cost in 1998 was about $2.6 billion."

The Spanish Ministry of Health funded the trial. The authors had no financial conflicts.

[email protected]

A remote history of cannabis use disorder appears to be associated with structural differences in brain areas related to working memory in both control subjects and patients with schizophrenia.

Within each group, the differences were significant between cannabis users and nonusers, Dr. Matthew J. Smith and colleagues reported Dec. 15 in Schizophrenia Bulletin. All of the regions involved are rich in cannabis type 1(CB1) receptors.

©ron hilton/iStockphoto.com

It’s not clear, though, whether cannabis caused the differences or whether they were pre-existing – and possibly predisposed the subjects to become dependent on the drug, wrote Dr. Smith of Northwestern University, Chicago, and his coauthors. "One could hypothesize that the observed asymmetry represents the effects of cannabis, which induces a loss of normal variation in subcortical nuclei. However, the observed asymmetry could also represent a neurobiological vulnerability that predisposes individuals to substance abuse, which has been suggested in studies of cocaine addiction."

Whatever the true nature of the association, it raises questions about the wisdom of legalizing marijuana use, the authors said (Schizophr. Bull. 2013 Dec. 15 [doi:10.1093/schbul/sbt176]).

"These findings argue that efforts to legalize recreational and medicinal cannabis use should more carefully consider the potential impact of cannabis use on [working memory] and the underlying structures that support it in vulnerable populations," they wrote. "Of special concern is that cannabis use could begin long before an adolescent or young adult would know if they were in one of these vulnerable groups."

The research group consisted of 54 controls (10 with a history of cannabis use disorder) and 43 patients with schizophrenia (15 with a history of cannabis use disorder). The researchers compared working memory and calculated structural and volumetric measures in the striatum, thalamus, and globus pallidus, both between and within the groups.

The control subjects were an average of 25 years old; the patients were 26 years. Schizophrenia had been present for about 8 years in the patients. In all subjects, cannabis use disorder (CUD) had ceased 2-3 years before the study began. During use, however, 80% of controls and 92% of patients used cannabis daily; the remainder used it weekly. Nearly 90% of the patients began using the drug before schizophrenia onset.

In measures of working memory, clean control subjects scored higher than CUD controls, clean patients, and CUD patients, but working memory was not different between the clean and CUD patients, Dr. Smith and his associates reported.

When measuring the striatum, the researchers found that CUD controls exhibited differences within the structure relative to clean controls. These differences occurred in the dorsal regions of the nucleus accumbens. CUD patients not only showed inward differences of the nucleus accumbens but also of anterior stratum, extending dorsally to the tail.

In the globus pallidus, differences were found within each group but not between the groups. Both CUD groups showed inward shape differences in the anteriodorsal and ventral regions, compared with their clean comparators.

The thalamus showed the same pattern of within-group differences. Both CUD groups displayed inward shape differences in the anterior, mediodorsal, ventrolateral, pulvinar, and lateral geniculate regions. In the control group, these differences appeared to be greater in the left hemispheres. In the patient group, they appeared greater in the right hemisphere.

The cannabis-related shape differences were inversely correlated with working memory in both groups, the investigators said.

The investigators cited several limitations. For example, because the data were cross-sectional, it was not possible to infer causality. Also, quantitative measures of cannabis use were not accessed.

Nevertheless, the findings suggest that a resolved CUD "may have parallel effects in [controls and patients] in the striatum and globus pallidus, and that a comorbid CUD could augment the underlying disease process associated with schizophrenia in the mediodorsal thalamus," Dr. Smith and his coauthors remarked.

Dr. Smith had no financial disclosures. The study was funded by the National Institute of Mental Health.

[email protected]

A remote history of cannabis use disorder appears to be associated with structural differences in brain areas related to working memory in both control subjects and patients with schizophrenia.

Within each group, the differences were significant between cannabis users and nonusers, Dr. Matthew J. Smith and colleagues reported Dec. 15 in Schizophrenia Bulletin. All of the regions involved are rich in cannabis type 1(CB1) receptors.

©ron hilton/iStockphoto.com

It’s not clear, though, whether cannabis caused the differences or whether they were pre-existing – and possibly predisposed the subjects to become dependent on the drug, wrote Dr. Smith of Northwestern University, Chicago, and his coauthors. "One could hypothesize that the observed asymmetry represents the effects of cannabis, which induces a loss of normal variation in subcortical nuclei. However, the observed asymmetry could also represent a neurobiological vulnerability that predisposes individuals to substance abuse, which has been suggested in studies of cocaine addiction."

Whatever the true nature of the association, it raises questions about the wisdom of legalizing marijuana use, the authors said (Schizophr. Bull. 2013 Dec. 15 [doi:10.1093/schbul/sbt176]).

"These findings argue that efforts to legalize recreational and medicinal cannabis use should more carefully consider the potential impact of cannabis use on [working memory] and the underlying structures that support it in vulnerable populations," they wrote. "Of special concern is that cannabis use could begin long before an adolescent or young adult would know if they were in one of these vulnerable groups."

The research group consisted of 54 controls (10 with a history of cannabis use disorder) and 43 patients with schizophrenia (15 with a history of cannabis use disorder). The researchers compared working memory and calculated structural and volumetric measures in the striatum, thalamus, and globus pallidus, both between and within the groups.

The control subjects were an average of 25 years old; the patients were 26 years. Schizophrenia had been present for about 8 years in the patients. In all subjects, cannabis use disorder (CUD) had ceased 2-3 years before the study began. During use, however, 80% of controls and 92% of patients used cannabis daily; the remainder used it weekly. Nearly 90% of the patients began using the drug before schizophrenia onset.

In measures of working memory, clean control subjects scored higher than CUD controls, clean patients, and CUD patients, but working memory was not different between the clean and CUD patients, Dr. Smith and his associates reported.

When measuring the striatum, the researchers found that CUD controls exhibited differences within the structure relative to clean controls. These differences occurred in the dorsal regions of the nucleus accumbens. CUD patients not only showed inward differences of the nucleus accumbens but also of anterior stratum, extending dorsally to the tail.

In the globus pallidus, differences were found within each group but not between the groups. Both CUD groups showed inward shape differences in the anteriodorsal and ventral regions, compared with their clean comparators.

The thalamus showed the same pattern of within-group differences. Both CUD groups displayed inward shape differences in the anterior, mediodorsal, ventrolateral, pulvinar, and lateral geniculate regions. In the control group, these differences appeared to be greater in the left hemispheres. In the patient group, they appeared greater in the right hemisphere.

The cannabis-related shape differences were inversely correlated with working memory in both groups, the investigators said.

The investigators cited several limitations. For example, because the data were cross-sectional, it was not possible to infer causality. Also, quantitative measures of cannabis use were not accessed.

Nevertheless, the findings suggest that a resolved CUD "may have parallel effects in [controls and patients] in the striatum and globus pallidus, and that a comorbid CUD could augment the underlying disease process associated with schizophrenia in the mediodorsal thalamus," Dr. Smith and his coauthors remarked.

Dr. Smith had no financial disclosures. The study was funded by the National Institute of Mental Health.

[email protected]

A remote history of cannabis use disorder appears to be associated with structural differences in brain areas related to working memory in both control subjects and patients with schizophrenia.

Within each group, the differences were significant between cannabis users and nonusers, Dr. Matthew J. Smith and colleagues reported Dec. 15 in Schizophrenia Bulletin. All of the regions involved are rich in cannabis type 1(CB1) receptors.

©ron hilton/iStockphoto.com

It’s not clear, though, whether cannabis caused the differences or whether they were pre-existing – and possibly predisposed the subjects to become dependent on the drug, wrote Dr. Smith of Northwestern University, Chicago, and his coauthors. "One could hypothesize that the observed asymmetry represents the effects of cannabis, which induces a loss of normal variation in subcortical nuclei. However, the observed asymmetry could also represent a neurobiological vulnerability that predisposes individuals to substance abuse, which has been suggested in studies of cocaine addiction."

Whatever the true nature of the association, it raises questions about the wisdom of legalizing marijuana use, the authors said (Schizophr. Bull. 2013 Dec. 15 [doi:10.1093/schbul/sbt176]).

"These findings argue that efforts to legalize recreational and medicinal cannabis use should more carefully consider the potential impact of cannabis use on [working memory] and the underlying structures that support it in vulnerable populations," they wrote. "Of special concern is that cannabis use could begin long before an adolescent or young adult would know if they were in one of these vulnerable groups."

The research group consisted of 54 controls (10 with a history of cannabis use disorder) and 43 patients with schizophrenia (15 with a history of cannabis use disorder). The researchers compared working memory and calculated structural and volumetric measures in the striatum, thalamus, and globus pallidus, both between and within the groups.

The control subjects were an average of 25 years old; the patients were 26 years. Schizophrenia had been present for about 8 years in the patients. In all subjects, cannabis use disorder (CUD) had ceased 2-3 years before the study began. During use, however, 80% of controls and 92% of patients used cannabis daily; the remainder used it weekly. Nearly 90% of the patients began using the drug before schizophrenia onset.

In measures of working memory, clean control subjects scored higher than CUD controls, clean patients, and CUD patients, but working memory was not different between the clean and CUD patients, Dr. Smith and his associates reported.

When measuring the striatum, the researchers found that CUD controls exhibited differences within the structure relative to clean controls. These differences occurred in the dorsal regions of the nucleus accumbens. CUD patients not only showed inward differences of the nucleus accumbens but also of anterior stratum, extending dorsally to the tail.

In the globus pallidus, differences were found within each group but not between the groups. Both CUD groups showed inward shape differences in the anteriodorsal and ventral regions, compared with their clean comparators.

The thalamus showed the same pattern of within-group differences. Both CUD groups displayed inward shape differences in the anterior, mediodorsal, ventrolateral, pulvinar, and lateral geniculate regions. In the control group, these differences appeared to be greater in the left hemispheres. In the patient group, they appeared greater in the right hemisphere.

The cannabis-related shape differences were inversely correlated with working memory in both groups, the investigators said.

The investigators cited several limitations. For example, because the data were cross-sectional, it was not possible to infer causality. Also, quantitative measures of cannabis use were not accessed.

Nevertheless, the findings suggest that a resolved CUD "may have parallel effects in [controls and patients] in the striatum and globus pallidus, and that a comorbid CUD could augment the underlying disease process associated with schizophrenia in the mediodorsal thalamus," Dr. Smith and his coauthors remarked.

Dr. Smith had no financial disclosures. The study was funded by the National Institute of Mental Health.

[email protected]

In very rare cases, methylphenidate medications have been associated with priapism in both boys and men taking the drugs for attention-deficit/hyperactivity disorder, the Food and Drug Administration has reported.

Records of the FDA Adverse Event Reporting System, combined with data from the extant literature, identified 15 cases of priapism associated with the drug’s use. The cases occurred from 1997-2012; most (12) occurred in patients younger than 18 years. The patients’ mean age was 12, although ages ranged from 8-33 years.

In response to the findings, the FDA has updated the methylphenidate drug labels and patient information leaflets to include information about the condition. Patients who take methylphenidate and develop erections lasting longer than 4 hours should seek immediate medical treatment to prevent long-term problems with the penis.

Priapism occurred after withdrawal of methylphenidate in four patients, but also under other conditions, such as restarting the drug, or when there was a longer than typical time between doses, FDA noted in a safety announcement. Two patients required surgical intervention – one with a shunt and the other with needle aspiration of the corpus cavernosum.

In some patients, priapism resolved after the drug was restarted, the announcement said, adding: "It is possible that priapism may be more likely to occur with the use of immediate-release methylphenidate, which has a shorter half-life."

Amphetamine products also are used to treat ADHD, and the FDA has received reports of priapism in four patients taking one of those drugs. However, whether the amphetamine products caused the priapism is uncertain, the agency said, because all of these patients had been taking other medications that also could have caused the problem.

The risk of priapism might prompt some physicians to consider switching patients to atomoxetine (Strattera), FDA said. But that drug also has been associated with priapism in children, teens, and adults, the report said – and it appears to be more common than among patients taking methylphenidate medications. "However, because of limitations in available information, we do not know how often priapism occurs in patients taking either type of product. Use caution when switching patients from methylphenidate to atomoxetine."

The number of reported cases represents a tiny fraction of patients treated with methylphenidate. According to the FDA, 20 million prescriptions were written and 4 million patients received a dispensed prescription in 2012 alone. Most of those scrips (61%) were written for males.

The following methylphenidate drugs are marketed in the United States:

• Concerta (methylphenidate hydrochloride)

• Daytrana (methylphenidate)

• Focalin, Focalin XR (dexmethylphenidate hydrochloride)

• Metadate CD, Metadate ER (methylphenidate hydrochloride)

• Methylin, Methylin ER (methylphenidate hydrochloride)

• Quillivant XR (methylphenidate hydrochloride)

• Ritalin, Ritalin LA, Ritalin SR (methylphenidate hydrochloride

Although the condition appears to be exceedingly uncommon, the FDA recommended discussing the possibility with both patients and parents. "Younger males, especially those who have not yet reached puberty, may not recognize the problem or may be embarrassed to tell anyone if it occurs," the agency noted. "All male patients and their caregivers should be taught the signs and symptoms of priapism and the importance of seeking immediate medical treatment if it occurs."

[email protected]

In very rare cases, methylphenidate medications have been associated with priapism in both boys and men taking the drugs for attention-deficit/hyperactivity disorder, the Food and Drug Administration has reported.

Records of the FDA Adverse Event Reporting System, combined with data from the extant literature, identified 15 cases of priapism associated with the drug’s use. The cases occurred from 1997-2012; most (12) occurred in patients younger than 18 years. The patients’ mean age was 12, although ages ranged from 8-33 years.

In response to the findings, the FDA has updated the methylphenidate drug labels and patient information leaflets to include information about the condition. Patients who take methylphenidate and develop erections lasting longer than 4 hours should seek immediate medical treatment to prevent long-term problems with the penis.

Priapism occurred after withdrawal of methylphenidate in four patients, but also under other conditions, such as restarting the drug, or when there was a longer than typical time between doses, FDA noted in a safety announcement. Two patients required surgical intervention – one with a shunt and the other with needle aspiration of the corpus cavernosum.

In some patients, priapism resolved after the drug was restarted, the announcement said, adding: "It is possible that priapism may be more likely to occur with the use of immediate-release methylphenidate, which has a shorter half-life."

Amphetamine products also are used to treat ADHD, and the FDA has received reports of priapism in four patients taking one of those drugs. However, whether the amphetamine products caused the priapism is uncertain, the agency said, because all of these patients had been taking other medications that also could have caused the problem.

The risk of priapism might prompt some physicians to consider switching patients to atomoxetine (Strattera), FDA said. But that drug also has been associated with priapism in children, teens, and adults, the report said – and it appears to be more common than among patients taking methylphenidate medications. "However, because of limitations in available information, we do not know how often priapism occurs in patients taking either type of product. Use caution when switching patients from methylphenidate to atomoxetine."

The number of reported cases represents a tiny fraction of patients treated with methylphenidate. According to the FDA, 20 million prescriptions were written and 4 million patients received a dispensed prescription in 2012 alone. Most of those scrips (61%) were written for males.

The following methylphenidate drugs are marketed in the United States:

• Concerta (methylphenidate hydrochloride)

• Daytrana (methylphenidate)

• Focalin, Focalin XR (dexmethylphenidate hydrochloride)

• Metadate CD, Metadate ER (methylphenidate hydrochloride)

• Methylin, Methylin ER (methylphenidate hydrochloride)

• Quillivant XR (methylphenidate hydrochloride)

• Ritalin, Ritalin LA, Ritalin SR (methylphenidate hydrochloride

Although the condition appears to be exceedingly uncommon, the FDA recommended discussing the possibility with both patients and parents. "Younger males, especially those who have not yet reached puberty, may not recognize the problem or may be embarrassed to tell anyone if it occurs," the agency noted. "All male patients and their caregivers should be taught the signs and symptoms of priapism and the importance of seeking immediate medical treatment if it occurs."

[email protected]

In very rare cases, methylphenidate medications have been associated with priapism in both boys and men taking the drugs for attention-deficit/hyperactivity disorder, the Food and Drug Administration has reported.

Records of the FDA Adverse Event Reporting System, combined with data from the extant literature, identified 15 cases of priapism associated with the drug’s use. The cases occurred from 1997-2012; most (12) occurred in patients younger than 18 years. The patients’ mean age was 12, although ages ranged from 8-33 years.

In response to the findings, the FDA has updated the methylphenidate drug labels and patient information leaflets to include information about the condition. Patients who take methylphenidate and develop erections lasting longer than 4 hours should seek immediate medical treatment to prevent long-term problems with the penis.

Priapism occurred after withdrawal of methylphenidate in four patients, but also under other conditions, such as restarting the drug, or when there was a longer than typical time between doses, FDA noted in a safety announcement. Two patients required surgical intervention – one with a shunt and the other with needle aspiration of the corpus cavernosum.

In some patients, priapism resolved after the drug was restarted, the announcement said, adding: "It is possible that priapism may be more likely to occur with the use of immediate-release methylphenidate, which has a shorter half-life."

Amphetamine products also are used to treat ADHD, and the FDA has received reports of priapism in four patients taking one of those drugs. However, whether the amphetamine products caused the priapism is uncertain, the agency said, because all of these patients had been taking other medications that also could have caused the problem.

The risk of priapism might prompt some physicians to consider switching patients to atomoxetine (Strattera), FDA said. But that drug also has been associated with priapism in children, teens, and adults, the report said – and it appears to be more common than among patients taking methylphenidate medications. "However, because of limitations in available information, we do not know how often priapism occurs in patients taking either type of product. Use caution when switching patients from methylphenidate to atomoxetine."

The number of reported cases represents a tiny fraction of patients treated with methylphenidate. According to the FDA, 20 million prescriptions were written and 4 million patients received a dispensed prescription in 2012 alone. Most of those scrips (61%) were written for males.

The following methylphenidate drugs are marketed in the United States:

• Concerta (methylphenidate hydrochloride)

• Daytrana (methylphenidate)

• Focalin, Focalin XR (dexmethylphenidate hydrochloride)

• Metadate CD, Metadate ER (methylphenidate hydrochloride)

• Methylin, Methylin ER (methylphenidate hydrochloride)

• Quillivant XR (methylphenidate hydrochloride)

• Ritalin, Ritalin LA, Ritalin SR (methylphenidate hydrochloride

Although the condition appears to be exceedingly uncommon, the FDA recommended discussing the possibility with both patients and parents. "Younger males, especially those who have not yet reached puberty, may not recognize the problem or may be embarrassed to tell anyone if it occurs," the agency noted. "All male patients and their caregivers should be taught the signs and symptoms of priapism and the importance of seeking immediate medical treatment if it occurs."

[email protected]

Endoscopic esophageal ultrasound understages many early-stage esophageal cancers, possibly leading to undertreatment for many patients, a study has shown.

A review of more than 100 patients with esophageal cancer found that the procedure correctly staged tumor depth in just 39% of pT1a tumors and 51% of pT1b tumors, Dr. Edward Bergeron and his colleagues reported online Dec. 5 in the Journal of Thoracic and Cardiovascular Surgery (2013 [doi:10.1016/j.jtcvs.2013.10.003]).

"Esophageal ultrasound has [been] shown to be inadequate for the definitive evaluation of lymph nodes in early-stage esophageal cancers," wrote Dr. Bergeron and his coauthors. "As a result, [it] should have a limited role beyond the initial staging examination to rule out more advanced lesions that would require neoadjuvant therapy before surgery."

Dr. Bergeron of the University of Michigan, Ann Arbor, and his team conducted a retrospective study of 107 patients who underwent esophagectomy for early esophageal cancers. The patients’ mean age was 66 years. The majority of the tumors (91%) were in the distal esophagus. Most (83%) were adenocarcinomas, and 63% showed signs of Barrett’s metaplasia.

For those with visible lesions, the average tumor size was 9 mm. More than half of the tumors (55%) were confined to the mucosa; 33% were pT1b with submucosal involvement.

Esophageal ultrasound understaged tumor depth in 32% of the pT1a tumors and 49% of the pT1b tumors. Ultrasound overstaged 29% of the pT1a and 51% of the pT1b tumors.

"In particular, three tumors on esophageal ultrasound invaded into but not through the muscularis mucosa," the authors wrote. "Two of these tumors were staged as pT2 [adenocarcinomas], and one of these tumors was staged as a pT3 squamous cell carcinoma on histology."

The sensitivity of esophageal ultrasound for detecting cT1a tumor invasion was 42%; the specificity was 81%.

Of the 1,083 lymph nodes harvested, 14 from nine patients showed metastatic disease. All of these patients had adenocarcinomas that were understaged by esophageal ultrasound, with no evidence of lymph node involvement.

Among these, disease had spread to the muscularis mucosa in one, to the submucosa in six, and to the muscularis propria in two.

"Thus, eight of the nine patients with positive pathologic lymph nodes had tumor invasion into the submucosal level or further," the authors wrote.

In addition, they noted, two of the nine patients also had multiple metastatic nodes, which led to reclassification as pN2 disease. One of these had tumor invasion into the submucosa and one into the muscularis propria.

"It is notable that 48 patients with pathologic T1a-1p disease had no evidence of lymph node spread," the authors wrote.

Esophageal ultrasound understaged 10% (9/90) of patients with lymph node metastases who had been preoperatively staged as cN0. In addition, 17 patients proved to be node negative after ultrasound staged them as having nodes suspicious of metastasis.

All patients underwent esophagectomy. The median blood loss was 250 mL. One patient needed a splenectomy after an intraoperative injury. The median length of stay was 8 days. One patient died after an unexplained respiratory arrest on postoperative day 2.

None of the authors declared any relevant financial conflicts.

Endoscopic esophageal ultrasound understages many early-stage esophageal cancers, possibly leading to undertreatment for many patients, a study has shown.

A review of more than 100 patients with esophageal cancer found that the procedure correctly staged tumor depth in just 39% of pT1a tumors and 51% of pT1b tumors, Dr. Edward Bergeron and his colleagues reported online Dec. 5 in the Journal of Thoracic and Cardiovascular Surgery (2013 [doi:10.1016/j.jtcvs.2013.10.003]).

"Esophageal ultrasound has [been] shown to be inadequate for the definitive evaluation of lymph nodes in early-stage esophageal cancers," wrote Dr. Bergeron and his coauthors. "As a result, [it] should have a limited role beyond the initial staging examination to rule out more advanced lesions that would require neoadjuvant therapy before surgery."

Dr. Bergeron of the University of Michigan, Ann Arbor, and his team conducted a retrospective study of 107 patients who underwent esophagectomy for early esophageal cancers. The patients’ mean age was 66 years. The majority of the tumors (91%) were in the distal esophagus. Most (83%) were adenocarcinomas, and 63% showed signs of Barrett’s metaplasia.

For those with visible lesions, the average tumor size was 9 mm. More than half of the tumors (55%) were confined to the mucosa; 33% were pT1b with submucosal involvement.

Esophageal ultrasound understaged tumor depth in 32% of the pT1a tumors and 49% of the pT1b tumors. Ultrasound overstaged 29% of the pT1a and 51% of the pT1b tumors.

"In particular, three tumors on esophageal ultrasound invaded into but not through the muscularis mucosa," the authors wrote. "Two of these tumors were staged as pT2 [adenocarcinomas], and one of these tumors was staged as a pT3 squamous cell carcinoma on histology."

The sensitivity of esophageal ultrasound for detecting cT1a tumor invasion was 42%; the specificity was 81%.

Of the 1,083 lymph nodes harvested, 14 from nine patients showed metastatic disease. All of these patients had adenocarcinomas that were understaged by esophageal ultrasound, with no evidence of lymph node involvement.

Among these, disease had spread to the muscularis mucosa in one, to the submucosa in six, and to the muscularis propria in two.

"Thus, eight of the nine patients with positive pathologic lymph nodes had tumor invasion into the submucosal level or further," the authors wrote.

In addition, they noted, two of the nine patients also had multiple metastatic nodes, which led to reclassification as pN2 disease. One of these had tumor invasion into the submucosa and one into the muscularis propria.

"It is notable that 48 patients with pathologic T1a-1p disease had no evidence of lymph node spread," the authors wrote.

Esophageal ultrasound understaged 10% (9/90) of patients with lymph node metastases who had been preoperatively staged as cN0. In addition, 17 patients proved to be node negative after ultrasound staged them as having nodes suspicious of metastasis.

All patients underwent esophagectomy. The median blood loss was 250 mL. One patient needed a splenectomy after an intraoperative injury. The median length of stay was 8 days. One patient died after an unexplained respiratory arrest on postoperative day 2.

None of the authors declared any relevant financial conflicts.

Endoscopic esophageal ultrasound understages many early-stage esophageal cancers, possibly leading to undertreatment for many patients, a study has shown.

A review of more than 100 patients with esophageal cancer found that the procedure correctly staged tumor depth in just 39% of pT1a tumors and 51% of pT1b tumors, Dr. Edward Bergeron and his colleagues reported online Dec. 5 in the Journal of Thoracic and Cardiovascular Surgery (2013 [doi:10.1016/j.jtcvs.2013.10.003]).

"Esophageal ultrasound has [been] shown to be inadequate for the definitive evaluation of lymph nodes in early-stage esophageal cancers," wrote Dr. Bergeron and his coauthors. "As a result, [it] should have a limited role beyond the initial staging examination to rule out more advanced lesions that would require neoadjuvant therapy before surgery."

Dr. Bergeron of the University of Michigan, Ann Arbor, and his team conducted a retrospective study of 107 patients who underwent esophagectomy for early esophageal cancers. The patients’ mean age was 66 years. The majority of the tumors (91%) were in the distal esophagus. Most (83%) were adenocarcinomas, and 63% showed signs of Barrett’s metaplasia.

For those with visible lesions, the average tumor size was 9 mm. More than half of the tumors (55%) were confined to the mucosa; 33% were pT1b with submucosal involvement.

Esophageal ultrasound understaged tumor depth in 32% of the pT1a tumors and 49% of the pT1b tumors. Ultrasound overstaged 29% of the pT1a and 51% of the pT1b tumors.

"In particular, three tumors on esophageal ultrasound invaded into but not through the muscularis mucosa," the authors wrote. "Two of these tumors were staged as pT2 [adenocarcinomas], and one of these tumors was staged as a pT3 squamous cell carcinoma on histology."

The sensitivity of esophageal ultrasound for detecting cT1a tumor invasion was 42%; the specificity was 81%.

Of the 1,083 lymph nodes harvested, 14 from nine patients showed metastatic disease. All of these patients had adenocarcinomas that were understaged by esophageal ultrasound, with no evidence of lymph node involvement.

Among these, disease had spread to the muscularis mucosa in one, to the submucosa in six, and to the muscularis propria in two.

"Thus, eight of the nine patients with positive pathologic lymph nodes had tumor invasion into the submucosal level or further," the authors wrote.

In addition, they noted, two of the nine patients also had multiple metastatic nodes, which led to reclassification as pN2 disease. One of these had tumor invasion into the submucosa and one into the muscularis propria.

"It is notable that 48 patients with pathologic T1a-1p disease had no evidence of lymph node spread," the authors wrote.

Esophageal ultrasound understaged 10% (9/90) of patients with lymph node metastases who had been preoperatively staged as cN0. In addition, 17 patients proved to be node negative after ultrasound staged them as having nodes suspicious of metastasis.

All patients underwent esophagectomy. The median blood loss was 250 mL. One patient needed a splenectomy after an intraoperative injury. The median length of stay was 8 days. One patient died after an unexplained respiratory arrest on postoperative day 2.

None of the authors declared any relevant financial conflicts.

The federal government is turning to the farm in an effort to combat the rise of antibiotic-resistant bacteria.

The Food and Drug Administration has asked animal pharmaceutical companies to remove indications allowing some antibiotics to be routinely used as growth promoters for food animals. If drug companies comply, these medications would be used only to prevent or treat disease in flocks and herds – a move the agency said would significantly reduce the development of antibiotic-resistant bacteria.

The completely voluntary recommendation gives companies 3 years to phase in the changes – plenty of time to allow for "an orderly and minimally disruptive transition," according to the document.

Only antibiotics deemed "medically important" to humans are covered under the recommendation. However, these include a wide variety of commonly prescribed medications.

© Scott Leigh/istockphoto.com

The recommendation requires that animal pharmaceutical manufactures notify the FDA within 3 months of their intent to comply. After 3 months, the FDA will publicly post a list of companies that don’t sign on to the process. If enough has not been done by the 3-year mark, the FDA may seek to legally ban the drugs’ use as growth promoters.

"If ... we determine that adequate progress has not been made, we will consider whether further action under the existing provisions of the Federal Food, Drug, and Cosmetics Act may be appropriate," the statement says.

The FDA also wants veterinarians to shoulder the responsibility for clinically responsible use of these antibiotics. Currently, many of the drugs are available over the counter.

The recommendation may be a fine first step, but it probably won’t be enough, according to Dr. Jeff Duchin, chief of communicable disease, epidemiology, and immunization at the Seattle and King County Public Health Department.

"It’s a potential step in the right direction," Dr. Duchin said in an interview. "We really think it’s the right idea but we are skeptical about the utility of a voluntary approach. It’s very important to make sure the FDA assesses this to see that it’s working, and moves aggressively to a regulatory approach if it doesn’t."

Such a federally mandated approach has been effective in several European countries, including Denmark, which banned the use of growth-promoting antibiotics in 1998. At the time of the ban, Denmark had one of the world’s lowest levels of animal antibiotic use, while the United States had the highest level (60 mg/kg of meat produced vs. 300 mg/kg).

After the Danish ban, bacterial resistance to each of the antibiotic classes and individual drugs included decreased among swine and chickens, according to data from a 2006 report by the World Health Organization. Some of these data also suggest a parallel effect in humans, although certain drug-resistant strains were already extremely low in human populations.

Research on the human impact continues, Dr. Duchin said. But although the data linking resistant strains in animals to those in humans are strong, it’s impossible to predict how long it would take for a change in animal husbandry to translate into human benefit.

"A matter of years, for sure," he said. "It’s not a rapid progress into the human population. But there is good reason to believe this type of policy would be useful in reducing human health risks."

Legislation has been introduced in Congress to control the use of animal antibiotics. H.R. 1150, the Preservation of Antibiotics for Medical Treatment Act of 2013, would amend the Federal Food, Drug, and Cosmetic Act "to preserve the effectiveness of medically important antimicrobials used in the treatment of human and animal diseases."

The law would prohibit the administration of a medically important antimicrobial to a food-producing animal except for medically necessary situations, and when given to the smallest possible number of animals in a group, for the shortest time clinically necessary.

Originally introduced in 2011, the bill failed to make it out of committee. It was reintroduced in March by Rep. Louise Slaughter (D-N.Y.) but has not been addressed since.

Dr. Duchin had no financial disclosures.

[email protected]

The federal government is turning to the farm in an effort to combat the rise of antibiotic-resistant bacteria.

The Food and Drug Administration has asked animal pharmaceutical companies to remove indications allowing some antibiotics to be routinely used as growth promoters for food animals. If drug companies comply, these medications would be used only to prevent or treat disease in flocks and herds – a move the agency said would significantly reduce the development of antibiotic-resistant bacteria.

The completely voluntary recommendation gives companies 3 years to phase in the changes – plenty of time to allow for "an orderly and minimally disruptive transition," according to the document.

Only antibiotics deemed "medically important" to humans are covered under the recommendation. However, these include a wide variety of commonly prescribed medications.

© Scott Leigh/istockphoto.com

The recommendation requires that animal pharmaceutical manufactures notify the FDA within 3 months of their intent to comply. After 3 months, the FDA will publicly post a list of companies that don’t sign on to the process. If enough has not been done by the 3-year mark, the FDA may seek to legally ban the drugs’ use as growth promoters.

"If ... we determine that adequate progress has not been made, we will consider whether further action under the existing provisions of the Federal Food, Drug, and Cosmetics Act may be appropriate," the statement says.

The FDA also wants veterinarians to shoulder the responsibility for clinically responsible use of these antibiotics. Currently, many of the drugs are available over the counter.

The recommendation may be a fine first step, but it probably won’t be enough, according to Dr. Jeff Duchin, chief of communicable disease, epidemiology, and immunization at the Seattle and King County Public Health Department.

"It’s a potential step in the right direction," Dr. Duchin said in an interview. "We really think it’s the right idea but we are skeptical about the utility of a voluntary approach. It’s very important to make sure the FDA assesses this to see that it’s working, and moves aggressively to a regulatory approach if it doesn’t."

Such a federally mandated approach has been effective in several European countries, including Denmark, which banned the use of growth-promoting antibiotics in 1998. At the time of the ban, Denmark had one of the world’s lowest levels of animal antibiotic use, while the United States had the highest level (60 mg/kg of meat produced vs. 300 mg/kg).

After the Danish ban, bacterial resistance to each of the antibiotic classes and individual drugs included decreased among swine and chickens, according to data from a 2006 report by the World Health Organization. Some of these data also suggest a parallel effect in humans, although certain drug-resistant strains were already extremely low in human populations.

Research on the human impact continues, Dr. Duchin said. But although the data linking resistant strains in animals to those in humans are strong, it’s impossible to predict how long it would take for a change in animal husbandry to translate into human benefit.

"A matter of years, for sure," he said. "It’s not a rapid progress into the human population. But there is good reason to believe this type of policy would be useful in reducing human health risks."

Legislation has been introduced in Congress to control the use of animal antibiotics. H.R. 1150, the Preservation of Antibiotics for Medical Treatment Act of 2013, would amend the Federal Food, Drug, and Cosmetic Act "to preserve the effectiveness of medically important antimicrobials used in the treatment of human and animal diseases."

The law would prohibit the administration of a medically important antimicrobial to a food-producing animal except for medically necessary situations, and when given to the smallest possible number of animals in a group, for the shortest time clinically necessary.

Originally introduced in 2011, the bill failed to make it out of committee. It was reintroduced in March by Rep. Louise Slaughter (D-N.Y.) but has not been addressed since.

Dr. Duchin had no financial disclosures.

[email protected]

The federal government is turning to the farm in an effort to combat the rise of antibiotic-resistant bacteria.

The Food and Drug Administration has asked animal pharmaceutical companies to remove indications allowing some antibiotics to be routinely used as growth promoters for food animals. If drug companies comply, these medications would be used only to prevent or treat disease in flocks and herds – a move the agency said would significantly reduce the development of antibiotic-resistant bacteria.

The completely voluntary recommendation gives companies 3 years to phase in the changes – plenty of time to allow for "an orderly and minimally disruptive transition," according to the document.

Only antibiotics deemed "medically important" to humans are covered under the recommendation. However, these include a wide variety of commonly prescribed medications.

© Scott Leigh/istockphoto.com

The recommendation requires that animal pharmaceutical manufactures notify the FDA within 3 months of their intent to comply. After 3 months, the FDA will publicly post a list of companies that don’t sign on to the process. If enough has not been done by the 3-year mark, the FDA may seek to legally ban the drugs’ use as growth promoters.

"If ... we determine that adequate progress has not been made, we will consider whether further action under the existing provisions of the Federal Food, Drug, and Cosmetics Act may be appropriate," the statement says.

The FDA also wants veterinarians to shoulder the responsibility for clinically responsible use of these antibiotics. Currently, many of the drugs are available over the counter.

The recommendation may be a fine first step, but it probably won’t be enough, according to Dr. Jeff Duchin, chief of communicable disease, epidemiology, and immunization at the Seattle and King County Public Health Department.

"It’s a potential step in the right direction," Dr. Duchin said in an interview. "We really think it’s the right idea but we are skeptical about the utility of a voluntary approach. It’s very important to make sure the FDA assesses this to see that it’s working, and moves aggressively to a regulatory approach if it doesn’t."

Such a federally mandated approach has been effective in several European countries, including Denmark, which banned the use of growth-promoting antibiotics in 1998. At the time of the ban, Denmark had one of the world’s lowest levels of animal antibiotic use, while the United States had the highest level (60 mg/kg of meat produced vs. 300 mg/kg).

After the Danish ban, bacterial resistance to each of the antibiotic classes and individual drugs included decreased among swine and chickens, according to data from a 2006 report by the World Health Organization. Some of these data also suggest a parallel effect in humans, although certain drug-resistant strains were already extremely low in human populations.

Research on the human impact continues, Dr. Duchin said. But although the data linking resistant strains in animals to those in humans are strong, it’s impossible to predict how long it would take for a change in animal husbandry to translate into human benefit.

"A matter of years, for sure," he said. "It’s not a rapid progress into the human population. But there is good reason to believe this type of policy would be useful in reducing human health risks."

Legislation has been introduced in Congress to control the use of animal antibiotics. H.R. 1150, the Preservation of Antibiotics for Medical Treatment Act of 2013, would amend the Federal Food, Drug, and Cosmetic Act "to preserve the effectiveness of medically important antimicrobials used in the treatment of human and animal diseases."

The law would prohibit the administration of a medically important antimicrobial to a food-producing animal except for medically necessary situations, and when given to the smallest possible number of animals in a group, for the shortest time clinically necessary.

Originally introduced in 2011, the bill failed to make it out of committee. It was reintroduced in March by Rep. Louise Slaughter (D-N.Y.) but has not been addressed since.

Dr. Duchin had no financial disclosures.

[email protected]

The federal government is turning to the farm in an effort to combat the rise of antibiotic-resistant bacteria.

The Food and Drug Administration has asked animal pharmaceutical companies to remove indications allowing some antibiotics to be routinely used as growth promoters for food animals. If drug companies comply, these medications would be used only to prevent or treat disease in flocks and herds – a move the agency said would significantly reduce the development of antibiotic-resistant bacteria.

The completely voluntary recommendation gives companies 3 years to phase in the changes – plenty of time to allow for "an orderly and minimally disruptive transition," according to the document.

Only antibiotics deemed "medically important" to humans are covered under the recommendation. However, these include a wide variety of commonly prescribed medications.

© Scott Leigh/istockphoto.com

The recommendation requires that animal pharmaceutical manufactures notify the FDA within 3 months of their intent to comply. After 3 months, the FDA will publicly post a list of companies that don’t sign on to the process. If enough has not been done by the 3-year mark, the FDA may seek to legally ban the drugs’ use as growth promoters.

"If ... we determine that adequate progress has not been made, we will consider whether further action under the existing provisions of the Federal Food, Drug, and Cosmetics Act may be appropriate," the statement says.

The FDA also wants veterinarians to shoulder the responsibility for clinically responsible use of these antibiotics. Currently, many of the drugs are available over the counter.

The recommendation may be a fine first step, but it probably won’t be enough, according to Dr. Jeff Duchin, chief of communicable disease, epidemiology, and immunization at the Seattle and King County Public Health Department.

"It’s a potential step in the right direction," Dr. Duchin said in an interview. "We really think it’s the right idea but we are skeptical about the utility of a voluntary approach. It’s very important to make sure the FDA assesses this to see that it’s working, and moves aggressively to a regulatory approach if it doesn’t."

Such a federally mandated approach has been effective in several European countries, including Denmark, which banned the use of growth-promoting antibiotics in 1998. At the time of the ban, Denmark had one of the world’s lowest levels of animal antibiotic use, while the United States had the highest level (60 mg/kg of meat produced vs. 300 mg/kg).

After the Danish ban, bacterial resistance to each of the antibiotic classes and individual drugs included decreased among swine and chickens, according to data from a 2006 report by the World Health Organization. Some of these data also suggest a parallel effect in humans, although certain drug-resistant strains were already extremely low in human populations.

Research on the human impact continues, Dr. Duchin said. But although the data linking resistant strains in animals to those in humans are strong, it’s impossible to predict how long it would take for a change in animal husbandry to translate into human benefit.

"A matter of years, for sure," he said. "It’s not a rapid progress into the human population. But there is good reason to believe this type of policy would be useful in reducing human health risks."

Legislation has been introduced in Congress to control the use of animal antibiotics. H.R. 1150, the Preservation of Antibiotics for Medical Treatment Act of 2013, would amend the Federal Food, Drug, and Cosmetic Act "to preserve the effectiveness of medically important antimicrobials used in the treatment of human and animal diseases."

The law would prohibit the administration of a medically important antimicrobial to a food-producing animal except for medically necessary situations, and when given to the smallest possible number of animals in a group, for the shortest time clinically necessary.

Originally introduced in 2011, the bill failed to make it out of committee. It was reintroduced in March by Rep. Louise Slaughter (D-N.Y.) but has not been addressed since.

Dr. Duchin had no financial disclosures.

[email protected]

The federal government is turning to the farm in an effort to combat the rise of antibiotic-resistant bacteria.

The Food and Drug Administration has asked animal pharmaceutical companies to remove indications allowing some antibiotics to be routinely used as growth promoters for food animals. If drug companies comply, these medications would be used only to prevent or treat disease in flocks and herds – a move the agency said would significantly reduce the development of antibiotic-resistant bacteria.

The completely voluntary recommendation gives companies 3 years to phase in the changes – plenty of time to allow for "an orderly and minimally disruptive transition," according to the document.

Only antibiotics deemed "medically important" to humans are covered under the recommendation. However, these include a wide variety of commonly prescribed medications.

© Scott Leigh/istockphoto.com

The recommendation requires that animal pharmaceutical manufactures notify the FDA within 3 months of their intent to comply. After 3 months, the FDA will publicly post a list of companies that don’t sign on to the process. If enough has not been done by the 3-year mark, the FDA may seek to legally ban the drugs’ use as growth promoters.

"If ... we determine that adequate progress has not been made, we will consider whether further action under the existing provisions of the Federal Food, Drug, and Cosmetics Act may be appropriate," the statement says.

The FDA also wants veterinarians to shoulder the responsibility for clinically responsible use of these antibiotics. Currently, many of the drugs are available over the counter.

The recommendation may be a fine first step, but it probably won’t be enough, according to Dr. Jeff Duchin, chief of communicable disease, epidemiology, and immunization at the Seattle and King County Public Health Department.

"It’s a potential step in the right direction," Dr. Duchin said in an interview. "We really think it’s the right idea but we are skeptical about the utility of a voluntary approach. It’s very important to make sure the FDA assesses this to see that it’s working, and moves aggressively to a regulatory approach if it doesn’t."

Such a federally mandated approach has been effective in several European countries, including Denmark, which banned the use of growth-promoting antibiotics in 1998. At the time of the ban, Denmark had one of the world’s lowest levels of animal antibiotic use, while the United States had the highest level (60 mg/kg of meat produced vs. 300 mg/kg).

After the Danish ban, bacterial resistance to each of the antibiotic classes and individual drugs included decreased among swine and chickens, according to data from a 2006 report by the World Health Organization. Some of these data also suggest a parallel effect in humans, although certain drug-resistant strains were already extremely low in human populations.

Research on the human impact continues, Dr. Duchin said. But although the data linking resistant strains in animals to those in humans are strong, it’s impossible to predict how long it would take for a change in animal husbandry to translate into human benefit.

"A matter of years, for sure," he said. "It’s not a rapid progress into the human population. But there is good reason to believe this type of policy would be useful in reducing human health risks."

Legislation has been introduced in Congress to control the use of animal antibiotics. H.R. 1150, the Preservation of Antibiotics for Medical Treatment Act of 2013, would amend the Federal Food, Drug, and Cosmetic Act "to preserve the effectiveness of medically important antimicrobials used in the treatment of human and animal diseases."

The law would prohibit the administration of a medically important antimicrobial to a food-producing animal except for medically necessary situations, and when given to the smallest possible number of animals in a group, for the shortest time clinically necessary.

Originally introduced in 2011, the bill failed to make it out of committee. It was reintroduced in March by Rep. Louise Slaughter (D-N.Y.) but has not been addressed since.

Dr. Duchin had no financial disclosures.

[email protected]

The federal government is turning to the farm in an effort to combat the rise of antibiotic-resistant bacteria.

The Food and Drug Administration has asked animal pharmaceutical companies to remove indications allowing some antibiotics to be routinely used as growth promoters for food animals. If drug companies comply, these medications would be used only to prevent or treat disease in flocks and herds – a move the agency said would significantly reduce the development of antibiotic-resistant bacteria.

The completely voluntary recommendation gives companies 3 years to phase in the changes – plenty of time to allow for "an orderly and minimally disruptive transition," according to the document.

Only antibiotics deemed "medically important" to humans are covered under the recommendation. However, these include a wide variety of commonly prescribed medications.

© Scott Leigh/istockphoto.com

The recommendation requires that animal pharmaceutical manufactures notify the FDA within 3 months of their intent to comply. After 3 months, the FDA will publicly post a list of companies that don’t sign on to the process. If enough has not been done by the 3-year mark, the FDA may seek to legally ban the drugs’ use as growth promoters.

"If ... we determine that adequate progress has not been made, we will consider whether further action under the existing provisions of the Federal Food, Drug, and Cosmetics Act may be appropriate," the statement says.

The FDA also wants veterinarians to shoulder the responsibility for clinically responsible use of these antibiotics. Currently, many of the drugs are available over the counter.

The recommendation may be a fine first step, but it probably won’t be enough, according to Dr. Jeff Duchin, chief of communicable disease, epidemiology, and immunization at the Seattle and King County Public Health Department.

"It’s a potential step in the right direction," Dr. Duchin said in an interview. "We really think it’s the right idea but we are skeptical about the utility of a voluntary approach. It’s very important to make sure the FDA assesses this to see that it’s working, and moves aggressively to a regulatory approach if it doesn’t."

Such a federally mandated approach has been effective in several European countries, including Denmark, which banned the use of growth-promoting antibiotics in 1998. At the time of the ban, Denmark had one of the world’s lowest levels of animal antibiotic use, while the United States had the highest level (60 mg/kg of meat produced vs. 300 mg/kg).

After the Danish ban, bacterial resistance to each of the antibiotic classes and individual drugs included decreased among swine and chickens, according to data from a 2006 report by the World Health Organization. Some of these data also suggest a parallel effect in humans, although certain drug-resistant strains were already extremely low in human populations.

Research on the human impact continues, Dr. Duchin said. But although the data linking resistant strains in animals to those in humans are strong, it’s impossible to predict how long it would take for a change in animal husbandry to translate into human benefit.

"A matter of years, for sure," he said. "It’s not a rapid progress into the human population. But there is good reason to believe this type of policy would be useful in reducing human health risks."

Legislation has been introduced in Congress to control the use of animal antibiotics. H.R. 1150, the Preservation of Antibiotics for Medical Treatment Act of 2013, would amend the Federal Food, Drug, and Cosmetic Act "to preserve the effectiveness of medically important antimicrobials used in the treatment of human and animal diseases."

The law would prohibit the administration of a medically important antimicrobial to a food-producing animal except for medically necessary situations, and when given to the smallest possible number of animals in a group, for the shortest time clinically necessary.

Originally introduced in 2011, the bill failed to make it out of committee. It was reintroduced in March by Rep. Louise Slaughter (D-N.Y.) but has not been addressed since.

Dr. Duchin had no financial disclosures.

[email protected]

WASHINGTON – Patients who underwent a robotically assisted laparoscopic hysterectomy required significantly more postoperative analgesia than did those who had a conventional laparoscopic hysterectomy.

The findings of a retrospective review may help determine which procedure to go with, when postoperative pain is an important recovery factor, Dr. Megan Wasson said at a meeting sponsored by the AAGL.

Dr. Wasson, a fourth-year ob.gyn. resident at the Christiana Care Health System in Wilmington, Del., reviewed the postoperative analgesic requirements of 353 women who underwent minimally invasive hysterectomy for benign conditions at the facility from 2009 to 2012.

Among the group, 116 had a conventional procedure – 78 had a laparoscopic-assisted supracervical hysterectomy and 38 had a total laparoscopic hysterectomy. Robotically assisted hysterectomy was performed for 237 women – three of these were supracervical hysterectomies and 234 were total hysterectomies.

Because patients received different kinds of pain medication, Dr. Wasson and her colleagues converted all of the pain treatment to oxycodone equivalents.

While the oral oxycodone equivalent intake was not significantly different between the groups, the parenteral oxycodone equivalent was higher (14 mg vs. 26 mg). When both oral and parenteral were combined, the total oxycodone equivalent was 28 mg in the laparoscopic group and almost 38 mg in the robotically assisted group – a significant difference.

Women who had conventional laparoscopic surgery were significantly younger than those who had the robotically assisted surgery (42 vs. 46 years). Significantly more black than white women had laparoscopic surgery (51% vs.14%), while significantly more white women had robotically assisted surgery (83% vs. 41%). There were no differences in the rate of prior cesarean section, laparotomy, or laparoscopy.

The uterus was significantly larger in the laparoscopic group (281 g vs. 203 g). Significantly fewer of these women also had a concomitant salpingo-oophorectomy (25% vs. 29%). In the laparoscopic group, intraoperative blood loss was significantly less (131 mL vs. 170 mL), as was hemoglobin decrease (1.68 g/dL vs. 2.26 g/dL). The composite port size was significantly smaller (25.8 mm vs. 41.6 mm). Total procedure time was similar (176 vs. 170 minutes).

Dr. Wasson had no financial declarations.

[email protected]

WASHINGTON – Patients who underwent a robotically assisted laparoscopic hysterectomy required significantly more postoperative analgesia than did those who had a conventional laparoscopic hysterectomy.

The findings of a retrospective review may help determine which procedure to go with, when postoperative pain is an important recovery factor, Dr. Megan Wasson said at a meeting sponsored by the AAGL.

Dr. Wasson, a fourth-year ob.gyn. resident at the Christiana Care Health System in Wilmington, Del., reviewed the postoperative analgesic requirements of 353 women who underwent minimally invasive hysterectomy for benign conditions at the facility from 2009 to 2012.

Among the group, 116 had a conventional procedure – 78 had a laparoscopic-assisted supracervical hysterectomy and 38 had a total laparoscopic hysterectomy. Robotically assisted hysterectomy was performed for 237 women – three of these were supracervical hysterectomies and 234 were total hysterectomies.

Because patients received different kinds of pain medication, Dr. Wasson and her colleagues converted all of the pain treatment to oxycodone equivalents.

While the oral oxycodone equivalent intake was not significantly different between the groups, the parenteral oxycodone equivalent was higher (14 mg vs. 26 mg). When both oral and parenteral were combined, the total oxycodone equivalent was 28 mg in the laparoscopic group and almost 38 mg in the robotically assisted group – a significant difference.

Women who had conventional laparoscopic surgery were significantly younger than those who had the robotically assisted surgery (42 vs. 46 years). Significantly more black than white women had laparoscopic surgery (51% vs.14%), while significantly more white women had robotically assisted surgery (83% vs. 41%). There were no differences in the rate of prior cesarean section, laparotomy, or laparoscopy.

The uterus was significantly larger in the laparoscopic group (281 g vs. 203 g). Significantly fewer of these women also had a concomitant salpingo-oophorectomy (25% vs. 29%). In the laparoscopic group, intraoperative blood loss was significantly less (131 mL vs. 170 mL), as was hemoglobin decrease (1.68 g/dL vs. 2.26 g/dL). The composite port size was significantly smaller (25.8 mm vs. 41.6 mm). Total procedure time was similar (176 vs. 170 minutes).

Dr. Wasson had no financial declarations.

[email protected]

WASHINGTON – Patients who underwent a robotically assisted laparoscopic hysterectomy required significantly more postoperative analgesia than did those who had a conventional laparoscopic hysterectomy.

The findings of a retrospective review may help determine which procedure to go with, when postoperative pain is an important recovery factor, Dr. Megan Wasson said at a meeting sponsored by the AAGL.

Dr. Wasson, a fourth-year ob.gyn. resident at the Christiana Care Health System in Wilmington, Del., reviewed the postoperative analgesic requirements of 353 women who underwent minimally invasive hysterectomy for benign conditions at the facility from 2009 to 2012.

Among the group, 116 had a conventional procedure – 78 had a laparoscopic-assisted supracervical hysterectomy and 38 had a total laparoscopic hysterectomy. Robotically assisted hysterectomy was performed for 237 women – three of these were supracervical hysterectomies and 234 were total hysterectomies.

Because patients received different kinds of pain medication, Dr. Wasson and her colleagues converted all of the pain treatment to oxycodone equivalents.

While the oral oxycodone equivalent intake was not significantly different between the groups, the parenteral oxycodone equivalent was higher (14 mg vs. 26 mg). When both oral and parenteral were combined, the total oxycodone equivalent was 28 mg in the laparoscopic group and almost 38 mg in the robotically assisted group – a significant difference.

Women who had conventional laparoscopic surgery were significantly younger than those who had the robotically assisted surgery (42 vs. 46 years). Significantly more black than white women had laparoscopic surgery (51% vs.14%), while significantly more white women had robotically assisted surgery (83% vs. 41%). There were no differences in the rate of prior cesarean section, laparotomy, or laparoscopy.

The uterus was significantly larger in the laparoscopic group (281 g vs. 203 g). Significantly fewer of these women also had a concomitant salpingo-oophorectomy (25% vs. 29%). In the laparoscopic group, intraoperative blood loss was significantly less (131 mL vs. 170 mL), as was hemoglobin decrease (1.68 g/dL vs. 2.26 g/dL). The composite port size was significantly smaller (25.8 mm vs. 41.6 mm). Total procedure time was similar (176 vs. 170 minutes).

Dr. Wasson had no financial declarations.

[email protected]

NATIONAL HARBOR, MD. – Surgery is a safe option for elderly women who have endometrial cancer, significantly extending life with a low rate of surgical complications, findings from a small study showed.

A review of 68 women aged 75-94 years found that those who underwent surgery lived about 2 years longer than those who didn’t, Dr. Eloise Chapman-Davis reported at a meeting sponsored by the AAGL.

"Age, multiple comorbidities, high-risk endometrial histology, and stage alone should not exclude elderly patients from surgical treatment options," said Dr. Chapman-Davis, a gynecologic oncologist at Tufts Medical Center, Boston. "Survival may be improved in patients with endometrial cancer who undergo surgery as a part of their treatment."

The women in the current study were treated for endometrial cancer from 2005 to 2012. The first analysis broke the cohort down into those who had surgery (55) and those who did not. Significantly more women in the surgery group were younger than 80 years (85% vs. 45% of the nonsurgery group).

Stage 3 cancer was present in 16% of the surgical group and in 8% of the nonsurgical group. Stage 4 cancer was present in 3% of the surgical group and 31% of the nonsurgical group.

There were no significant differences in baseline comorbidities, including hypertension, diabetes, and pulmonary and coronary artery disease.

Every woman in the nonsurgical group underwent chemotherapy and 46% had radiation. In the surgical group, 20% had radiation and 20%, chemotherapy.

Surgical management changed over the course of the study. The facility implemented robotic surgery in 2009; after 2011, only one patient had laparotomy. The oldest patient who underwent open surgery was 87 years; the oldest patient who had robotic surgery was 94 years.

The surgical group was divided into those who had open (36) and robotic hysterectomies (19). Node sampling was significantly greater in the open group for both pelvic (83% vs. 53%) and aortic nodes (61% vs. 5%).

Robotic surgery took significantly longer than open surgery (mean, 196 vs. 137 minutes). However, blood loss was significantly less in the robotic surgery group (113 vs. 287 mL). Four patients in the open group needed more than 2 U of blood, and one patient lost more than 1,000 mL of blood.

In the robotic group, there was one conversion to open surgery, one cardiac event, and one ileus. In the open group, there were six cardiac events and six cases of prolonged ileus. The mean length of stay was 2 days in the robotic group and 6 days in the open group – a significant difference.

Age did not significantly affect survival. By 3.5 years, 60% of those up to age 79 years and 60% of those 80 and older were still living. Treatment, however, did exert a significant effect. The mean survival of patients who had no surgery was 3 years, compared with about 4 years for those who did have surgery.

The study did not address any survival differences between open and robotic procedures.

Dr. Chapman-Davis said she had no relevant financial disclosures.

[email protected]

NATIONAL HARBOR, MD. – Surgery is a safe option for elderly women who have endometrial cancer, significantly extending life with a low rate of surgical complications, findings from a small study showed.

A review of 68 women aged 75-94 years found that those who underwent surgery lived about 2 years longer than those who didn’t, Dr. Eloise Chapman-Davis reported at a meeting sponsored by the AAGL.

"Age, multiple comorbidities, high-risk endometrial histology, and stage alone should not exclude elderly patients from surgical treatment options," said Dr. Chapman-Davis, a gynecologic oncologist at Tufts Medical Center, Boston. "Survival may be improved in patients with endometrial cancer who undergo surgery as a part of their treatment."

The women in the current study were treated for endometrial cancer from 2005 to 2012. The first analysis broke the cohort down into those who had surgery (55) and those who did not. Significantly more women in the surgery group were younger than 80 years (85% vs. 45% of the nonsurgery group).

Stage 3 cancer was present in 16% of the surgical group and in 8% of the nonsurgical group. Stage 4 cancer was present in 3% of the surgical group and 31% of the nonsurgical group.

There were no significant differences in baseline comorbidities, including hypertension, diabetes, and pulmonary and coronary artery disease.

Every woman in the nonsurgical group underwent chemotherapy and 46% had radiation. In the surgical group, 20% had radiation and 20%, chemotherapy.

Surgical management changed over the course of the study. The facility implemented robotic surgery in 2009; after 2011, only one patient had laparotomy. The oldest patient who underwent open surgery was 87 years; the oldest patient who had robotic surgery was 94 years.

The surgical group was divided into those who had open (36) and robotic hysterectomies (19). Node sampling was significantly greater in the open group for both pelvic (83% vs. 53%) and aortic nodes (61% vs. 5%).

Robotic surgery took significantly longer than open surgery (mean, 196 vs. 137 minutes). However, blood loss was significantly less in the robotic surgery group (113 vs. 287 mL). Four patients in the open group needed more than 2 U of blood, and one patient lost more than 1,000 mL of blood.

In the robotic group, there was one conversion to open surgery, one cardiac event, and one ileus. In the open group, there were six cardiac events and six cases of prolonged ileus. The mean length of stay was 2 days in the robotic group and 6 days in the open group – a significant difference.

Age did not significantly affect survival. By 3.5 years, 60% of those up to age 79 years and 60% of those 80 and older were still living. Treatment, however, did exert a significant effect. The mean survival of patients who had no surgery was 3 years, compared with about 4 years for those who did have surgery.

The study did not address any survival differences between open and robotic procedures.

Dr. Chapman-Davis said she had no relevant financial disclosures.

[email protected]

NATIONAL HARBOR, MD. – Surgery is a safe option for elderly women who have endometrial cancer, significantly extending life with a low rate of surgical complications, findings from a small study showed.

A review of 68 women aged 75-94 years found that those who underwent surgery lived about 2 years longer than those who didn’t, Dr. Eloise Chapman-Davis reported at a meeting sponsored by the AAGL.

"Age, multiple comorbidities, high-risk endometrial histology, and stage alone should not exclude elderly patients from surgical treatment options," said Dr. Chapman-Davis, a gynecologic oncologist at Tufts Medical Center, Boston. "Survival may be improved in patients with endometrial cancer who undergo surgery as a part of their treatment."

The women in the current study were treated for endometrial cancer from 2005 to 2012. The first analysis broke the cohort down into those who had surgery (55) and those who did not. Significantly more women in the surgery group were younger than 80 years (85% vs. 45% of the nonsurgery group).

Stage 3 cancer was present in 16% of the surgical group and in 8% of the nonsurgical group. Stage 4 cancer was present in 3% of the surgical group and 31% of the nonsurgical group.

There were no significant differences in baseline comorbidities, including hypertension, diabetes, and pulmonary and coronary artery disease.

Every woman in the nonsurgical group underwent chemotherapy and 46% had radiation. In the surgical group, 20% had radiation and 20%, chemotherapy.

Surgical management changed over the course of the study. The facility implemented robotic surgery in 2009; after 2011, only one patient had laparotomy. The oldest patient who underwent open surgery was 87 years; the oldest patient who had robotic surgery was 94 years.

The surgical group was divided into those who had open (36) and robotic hysterectomies (19). Node sampling was significantly greater in the open group for both pelvic (83% vs. 53%) and aortic nodes (61% vs. 5%).

Robotic surgery took significantly longer than open surgery (mean, 196 vs. 137 minutes). However, blood loss was significantly less in the robotic surgery group (113 vs. 287 mL). Four patients in the open group needed more than 2 U of blood, and one patient lost more than 1,000 mL of blood.

In the robotic group, there was one conversion to open surgery, one cardiac event, and one ileus. In the open group, there were six cardiac events and six cases of prolonged ileus. The mean length of stay was 2 days in the robotic group and 6 days in the open group – a significant difference.

Age did not significantly affect survival. By 3.5 years, 60% of those up to age 79 years and 60% of those 80 and older were still living. Treatment, however, did exert a significant effect. The mean survival of patients who had no surgery was 3 years, compared with about 4 years for those who did have surgery.

The study did not address any survival differences between open and robotic procedures.

Dr. Chapman-Davis said she had no relevant financial disclosures.

[email protected]

WASHINGTON – Laparoscopic radical trachelectomy can be performed safely in well-selected patients with early cervical cancer who wish to preserve their fertility.

In a small retrospective analysis of 10 women, potential fertility was preserved in 8 women, Dr. Rene Pareja said at the AAGL Global Congress.

By 12 months, no pregnancies had been achieved, reported Dr. Pareja of the Instituto de Cancerología–Clinica las Américas (IDC) in Medellin, Colombia. However, conception should be possible for those who desire to have a child, he said at the meeting sponsored by AAGL.

Patients in the series were treated from 2009 to 2013. All had stage IB1 disease. In nine women, the lesion was less than 2 cm; in one woman, it was 3 cm. Half of the cancers were squamous, and the other half were adenocarcinomas.

All 10 patients underwent a minimally invasive radical trachelectomy. The mean surgical time was 240 minutes, with an estimated blood loss of 100 cc. There were no transfusions and no conversions to open surgery. One cystotomy was repaired laparoscopically. The mean hospital stay was 2 days.

Surgeons recovered a mean of 16 nodes from each patient (range, 10-24); none of these were positive. Four women had no residual disease. One had a positive endocervical margin on pathology; she underwent a hysterectomy. None of the patients required either chemotherapy or radiation therapy.

In addition to the hysterectomy, there were four postoperative complications: one necrosis of the right uterine cornua, one ureterovaginal fistula, and two lymphocysts.

At a mean follow-up of 12 months, there have been no cancer recurrences. One patient is attempting to conceive, although she has not yet done so.

The extant literature supports Dr. Pareja’s experience of laparoscopic radical trachelectomy. Since 2003, the procedure has been reported in 150 patients. Among these, there have been 38 pregnancies, 13 miscarriages, and 20 live births. Dr. Pareja did not say what percentage of women in these studies were attempting to conceive, however.

Five patients reported in the literature have had recurrent cancer and three have died, although Dr. Pareja did not mention whether these deaths were related to the cancers.

So far, the safety and obstetrical outcomes of his patients compare well with those reported in other forms of cervical cancer surgery. Among the 150 reported cases of laparoscopic radical trachelectomy, the relapse rate was 3.3% and death rate 2.9%. The total pregnancy rate was 25% and the delivery rate 13%.

Among the 1,088 reported cases of vaginal radical trachelectomy, there was a 4% relapse rate and 2.9% death rate. The total pregnancy rate was 24% and the delivery rate 28%.

Among the 485 reported cases of abdominal radical trachelectomy, the relapse rate was 3.8% and the death rate 0.4%. The pregnancy rate was 16% and the delivery rate 11%.

Dr. Pareja had no financial disclosures.

[email protected]

WASHINGTON – Laparoscopic radical trachelectomy can be performed safely in well-selected patients with early cervical cancer who wish to preserve their fertility.

In a small retrospective analysis of 10 women, potential fertility was preserved in 8 women, Dr. Rene Pareja said at the AAGL Global Congress.

By 12 months, no pregnancies had been achieved, reported Dr. Pareja of the Instituto de Cancerología–Clinica las Américas (IDC) in Medellin, Colombia. However, conception should be possible for those who desire to have a child, he said at the meeting sponsored by AAGL.

Patients in the series were treated from 2009 to 2013. All had stage IB1 disease. In nine women, the lesion was less than 2 cm; in one woman, it was 3 cm. Half of the cancers were squamous, and the other half were adenocarcinomas.

All 10 patients underwent a minimally invasive radical trachelectomy. The mean surgical time was 240 minutes, with an estimated blood loss of 100 cc. There were no transfusions and no conversions to open surgery. One cystotomy was repaired laparoscopically. The mean hospital stay was 2 days.

Surgeons recovered a mean of 16 nodes from each patient (range, 10-24); none of these were positive. Four women had no residual disease. One had a positive endocervical margin on pathology; she underwent a hysterectomy. None of the patients required either chemotherapy or radiation therapy.

In addition to the hysterectomy, there were four postoperative complications: one necrosis of the right uterine cornua, one ureterovaginal fistula, and two lymphocysts.

At a mean follow-up of 12 months, there have been no cancer recurrences. One patient is attempting to conceive, although she has not yet done so.

The extant literature supports Dr. Pareja’s experience of laparoscopic radical trachelectomy. Since 2003, the procedure has been reported in 150 patients. Among these, there have been 38 pregnancies, 13 miscarriages, and 20 live births. Dr. Pareja did not say what percentage of women in these studies were attempting to conceive, however.

Five patients reported in the literature have had recurrent cancer and three have died, although Dr. Pareja did not mention whether these deaths were related to the cancers.

So far, the safety and obstetrical outcomes of his patients compare well with those reported in other forms of cervical cancer surgery. Among the 150 reported cases of laparoscopic radical trachelectomy, the relapse rate was 3.3% and death rate 2.9%. The total pregnancy rate was 25% and the delivery rate 13%.

Among the 1,088 reported cases of vaginal radical trachelectomy, there was a 4% relapse rate and 2.9% death rate. The total pregnancy rate was 24% and the delivery rate 28%.

Among the 485 reported cases of abdominal radical trachelectomy, the relapse rate was 3.8% and the death rate 0.4%. The pregnancy rate was 16% and the delivery rate 11%.

Dr. Pareja had no financial disclosures.

[email protected]

WASHINGTON – Laparoscopic radical trachelectomy can be performed safely in well-selected patients with early cervical cancer who wish to preserve their fertility.

In a small retrospective analysis of 10 women, potential fertility was preserved in 8 women, Dr. Rene Pareja said at the AAGL Global Congress.

By 12 months, no pregnancies had been achieved, reported Dr. Pareja of the Instituto de Cancerología–Clinica las Américas (IDC) in Medellin, Colombia. However, conception should be possible for those who desire to have a child, he said at the meeting sponsored by AAGL.

Patients in the series were treated from 2009 to 2013. All had stage IB1 disease. In nine women, the lesion was less than 2 cm; in one woman, it was 3 cm. Half of the cancers were squamous, and the other half were adenocarcinomas.

All 10 patients underwent a minimally invasive radical trachelectomy. The mean surgical time was 240 minutes, with an estimated blood loss of 100 cc. There were no transfusions and no conversions to open surgery. One cystotomy was repaired laparoscopically. The mean hospital stay was 2 days.

Surgeons recovered a mean of 16 nodes from each patient (range, 10-24); none of these were positive. Four women had no residual disease. One had a positive endocervical margin on pathology; she underwent a hysterectomy. None of the patients required either chemotherapy or radiation therapy.

In addition to the hysterectomy, there were four postoperative complications: one necrosis of the right uterine cornua, one ureterovaginal fistula, and two lymphocysts.

At a mean follow-up of 12 months, there have been no cancer recurrences. One patient is attempting to conceive, although she has not yet done so.

The extant literature supports Dr. Pareja’s experience of laparoscopic radical trachelectomy. Since 2003, the procedure has been reported in 150 patients. Among these, there have been 38 pregnancies, 13 miscarriages, and 20 live births. Dr. Pareja did not say what percentage of women in these studies were attempting to conceive, however.

Five patients reported in the literature have had recurrent cancer and three have died, although Dr. Pareja did not mention whether these deaths were related to the cancers.

So far, the safety and obstetrical outcomes of his patients compare well with those reported in other forms of cervical cancer surgery. Among the 150 reported cases of laparoscopic radical trachelectomy, the relapse rate was 3.3% and death rate 2.9%. The total pregnancy rate was 25% and the delivery rate 13%.

Among the 1,088 reported cases of vaginal radical trachelectomy, there was a 4% relapse rate and 2.9% death rate. The total pregnancy rate was 24% and the delivery rate 28%.

Among the 485 reported cases of abdominal radical trachelectomy, the relapse rate was 3.8% and the death rate 0.4%. The pregnancy rate was 16% and the delivery rate 11%.

Dr. Pareja had no financial disclosures.

[email protected]