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Doug Brunk is a San Diego-based award-winning reporter who began covering health care in 1991. Before joining the company, he wrote for the health sciences division of Columbia University and was an associate editor at Contemporary Long Term Care magazine when it won a Jesse H. Neal Award. His work has been syndicated by the Los Angeles Times and he is the author of two books related to the University of Kentucky Wildcats men's basketball program. Doug has a master’s degree in magazine journalism from the S.I. Newhouse School of Public Communications at Syracuse University. Follow him on Twitter @dougbrunk.
Patients Report Satisfaction, Some Pain With Fraxel
CARLSBAD, CALIF. The Fraxel laser is "not a panacea," but patients will see improvement, Dr. Elizabeth F. Rostan said at a symposium on laser and cosmetic surgery sponsored by SkinCare Physicians.
"Patients can achieve significant improvement in fine and deep lines, there's high patient satisfaction, and importantly, husbands, family members, and friends see improvement. Sometimes if we do a nonablative [procedure] with [intense pulsed light] they come back in and say 'my husband doesn't see any [difference],'" she said while explaining the pros and cons of fractional resurfacing for skin rejuvenation.
One negative is the pain caused by Fraxel treatment. This turns out to be a benefit, though, because any other procedure will probably be perceived as less painful by the patient. "I hear this all the time as I'm injecting filler into their faces: 'This is nothing compared to that Fraxel,'" she said.
Since many patients looking for improved appearance actually have significant photodamage, the "nonablative methods that we offer them really won't achieve everything that they want to achieve," said Dr. Rostan, a dermatologist who practices in Charlotte, N.C.
The Fraxel also is very effective for acne scars. "In fact, this is one of my primary mechanisms of treating acne scars, including younger patients," said Dr. Rostan, who disclosed that she has previously lectured about Fraxel on behalf of its manufacturer, Reliant Technologies Inc.
For patients who are not ideal candidates for ablative resurfacingincluding smokers, those with multiple medical problems, those on immunosuppressant medications, and those for whom close follow-up is not possiblethe Fraxel laser is a good option, especially since "I cannot give away CO2 resurfacing in my area," she said.
The side effects of ablative resurfacing, such as pigmentary lesions, poor wound healing, infection, and prolonged redness, "have not been fully observed in fractional resurfacing." On the downside, "there are limited results on lip lines and minimal skin tightening," Dr. Rostan said.
The procedure can be effective for melasma, but the results have been inconsistent. "I do have some patients who have not responded in a satisfactory way," she said.
It is, however, safe and effective for nonfacial rejuvenation. "You can get nice improvement on the neck, chest, and hands," but some areas are difficult to treat, including clavicles and the sternal notch.
Recovery downtime is minimal, but Dr. Rostan tells patients thatposttreatment redness and swelling can occur and last several days. Mild bronzing can last 314 days.
The need for multiple treatments can be a problem. For most patients, at least five treatments are required, and each visit involves applying the blue tint, anesthetic ointment, and time for cleanup.
This patient underwent Fraxel laser treatment for acne scars, lines, and wrinkles. At right is her outcome at 10 months after five treatments. Photos courtesy Dr. Elizabeth F. Rostan
CARLSBAD, CALIF. The Fraxel laser is "not a panacea," but patients will see improvement, Dr. Elizabeth F. Rostan said at a symposium on laser and cosmetic surgery sponsored by SkinCare Physicians.
"Patients can achieve significant improvement in fine and deep lines, there's high patient satisfaction, and importantly, husbands, family members, and friends see improvement. Sometimes if we do a nonablative [procedure] with [intense pulsed light] they come back in and say 'my husband doesn't see any [difference],'" she said while explaining the pros and cons of fractional resurfacing for skin rejuvenation.
One negative is the pain caused by Fraxel treatment. This turns out to be a benefit, though, because any other procedure will probably be perceived as less painful by the patient. "I hear this all the time as I'm injecting filler into their faces: 'This is nothing compared to that Fraxel,'" she said.
Since many patients looking for improved appearance actually have significant photodamage, the "nonablative methods that we offer them really won't achieve everything that they want to achieve," said Dr. Rostan, a dermatologist who practices in Charlotte, N.C.
The Fraxel also is very effective for acne scars. "In fact, this is one of my primary mechanisms of treating acne scars, including younger patients," said Dr. Rostan, who disclosed that she has previously lectured about Fraxel on behalf of its manufacturer, Reliant Technologies Inc.
For patients who are not ideal candidates for ablative resurfacingincluding smokers, those with multiple medical problems, those on immunosuppressant medications, and those for whom close follow-up is not possiblethe Fraxel laser is a good option, especially since "I cannot give away CO2 resurfacing in my area," she said.
The side effects of ablative resurfacing, such as pigmentary lesions, poor wound healing, infection, and prolonged redness, "have not been fully observed in fractional resurfacing." On the downside, "there are limited results on lip lines and minimal skin tightening," Dr. Rostan said.
The procedure can be effective for melasma, but the results have been inconsistent. "I do have some patients who have not responded in a satisfactory way," she said.
It is, however, safe and effective for nonfacial rejuvenation. "You can get nice improvement on the neck, chest, and hands," but some areas are difficult to treat, including clavicles and the sternal notch.
Recovery downtime is minimal, but Dr. Rostan tells patients thatposttreatment redness and swelling can occur and last several days. Mild bronzing can last 314 days.
The need for multiple treatments can be a problem. For most patients, at least five treatments are required, and each visit involves applying the blue tint, anesthetic ointment, and time for cleanup.
This patient underwent Fraxel laser treatment for acne scars, lines, and wrinkles. At right is her outcome at 10 months after five treatments. Photos courtesy Dr. Elizabeth F. Rostan
CARLSBAD, CALIF. The Fraxel laser is "not a panacea," but patients will see improvement, Dr. Elizabeth F. Rostan said at a symposium on laser and cosmetic surgery sponsored by SkinCare Physicians.
"Patients can achieve significant improvement in fine and deep lines, there's high patient satisfaction, and importantly, husbands, family members, and friends see improvement. Sometimes if we do a nonablative [procedure] with [intense pulsed light] they come back in and say 'my husband doesn't see any [difference],'" she said while explaining the pros and cons of fractional resurfacing for skin rejuvenation.
One negative is the pain caused by Fraxel treatment. This turns out to be a benefit, though, because any other procedure will probably be perceived as less painful by the patient. "I hear this all the time as I'm injecting filler into their faces: 'This is nothing compared to that Fraxel,'" she said.
Since many patients looking for improved appearance actually have significant photodamage, the "nonablative methods that we offer them really won't achieve everything that they want to achieve," said Dr. Rostan, a dermatologist who practices in Charlotte, N.C.
The Fraxel also is very effective for acne scars. "In fact, this is one of my primary mechanisms of treating acne scars, including younger patients," said Dr. Rostan, who disclosed that she has previously lectured about Fraxel on behalf of its manufacturer, Reliant Technologies Inc.
For patients who are not ideal candidates for ablative resurfacingincluding smokers, those with multiple medical problems, those on immunosuppressant medications, and those for whom close follow-up is not possiblethe Fraxel laser is a good option, especially since "I cannot give away CO2 resurfacing in my area," she said.
The side effects of ablative resurfacing, such as pigmentary lesions, poor wound healing, infection, and prolonged redness, "have not been fully observed in fractional resurfacing." On the downside, "there are limited results on lip lines and minimal skin tightening," Dr. Rostan said.
The procedure can be effective for melasma, but the results have been inconsistent. "I do have some patients who have not responded in a satisfactory way," she said.
It is, however, safe and effective for nonfacial rejuvenation. "You can get nice improvement on the neck, chest, and hands," but some areas are difficult to treat, including clavicles and the sternal notch.
Recovery downtime is minimal, but Dr. Rostan tells patients thatposttreatment redness and swelling can occur and last several days. Mild bronzing can last 314 days.
The need for multiple treatments can be a problem. For most patients, at least five treatments are required, and each visit involves applying the blue tint, anesthetic ointment, and time for cleanup.
This patient underwent Fraxel laser treatment for acne scars, lines, and wrinkles. At right is her outcome at 10 months after five treatments. Photos courtesy Dr. Elizabeth F. Rostan
Verteporfin, PDL Treat Port-Wine Stains
CARLSBAD, CALIF. Combining photodynamic therapy using the photosensitizer verteporfin with pulsed dye laser therapy may be a way to treat port-wine stains, preliminary results from an ongoing study suggest.
The finding is important because early studies of photodynamic therapy (PDT) for port-wine stains resulted in significant scarring and severe photosensitivity for up to 30 days.
"Of course, that was a significant disadvantage," Dr. Kristen M. Kelly said at a symposium on laser and cosmetic surgery sponsored by SkinCare Physicians.
In the new approach, which was first reported at the annual meeting of the American Society for Laser and Medicine and Surgery, Dr. Kelly and her associates treated four spots, each at 2 cm
For PDT, the subjects received IV verteporfin (Visudyne), a drug marketed by Novartis Ophthalmics Inc. that binds with low-density lipoprotein and is approved for treatment of age-related macular degeneration, pathologic myopia, and presumed ocular histoplasmosis. It causes photosensitivity for 25 days. The doses were 6 mg/m
This was followed by treatment with a 576-nm continuous-wave argon-pumped rhodamine dye laser.
The patients were followed at 3 days and at 1, 2, 4, 8, and 12 weeks.
So far, researchers have treated 10 sets of sites on seven patients, with a light dose of 1575 J/cm
One patient treated at 45 J/cm
"As we increase the dose [of the laser beam] we'll learn more about the potential of this treatment," she said.
The researchers received donations of verteporfin from QLT Inc., which developed the drug in conjunction with Novartis Ophthalmics. Dr. Kelly disclosed receiving research grants from 3M, Candela Corp., Reliant Pharmaceuticals LLC, and Thermage Inc. The surgery laser clinic where she works received equipment loans from Candela, Iridex Corp., and Reliant.
Posttreatment purpura is noted after PDT + PDL. Courtesy Dr. Kristen M. Kelly
CARLSBAD, CALIF. Combining photodynamic therapy using the photosensitizer verteporfin with pulsed dye laser therapy may be a way to treat port-wine stains, preliminary results from an ongoing study suggest.
The finding is important because early studies of photodynamic therapy (PDT) for port-wine stains resulted in significant scarring and severe photosensitivity for up to 30 days.
"Of course, that was a significant disadvantage," Dr. Kristen M. Kelly said at a symposium on laser and cosmetic surgery sponsored by SkinCare Physicians.
In the new approach, which was first reported at the annual meeting of the American Society for Laser and Medicine and Surgery, Dr. Kelly and her associates treated four spots, each at 2 cm
For PDT, the subjects received IV verteporfin (Visudyne), a drug marketed by Novartis Ophthalmics Inc. that binds with low-density lipoprotein and is approved for treatment of age-related macular degeneration, pathologic myopia, and presumed ocular histoplasmosis. It causes photosensitivity for 25 days. The doses were 6 mg/m
This was followed by treatment with a 576-nm continuous-wave argon-pumped rhodamine dye laser.
The patients were followed at 3 days and at 1, 2, 4, 8, and 12 weeks.
So far, researchers have treated 10 sets of sites on seven patients, with a light dose of 1575 J/cm
One patient treated at 45 J/cm
"As we increase the dose [of the laser beam] we'll learn more about the potential of this treatment," she said.
The researchers received donations of verteporfin from QLT Inc., which developed the drug in conjunction with Novartis Ophthalmics. Dr. Kelly disclosed receiving research grants from 3M, Candela Corp., Reliant Pharmaceuticals LLC, and Thermage Inc. The surgery laser clinic where she works received equipment loans from Candela, Iridex Corp., and Reliant.
Posttreatment purpura is noted after PDT + PDL. Courtesy Dr. Kristen M. Kelly
CARLSBAD, CALIF. Combining photodynamic therapy using the photosensitizer verteporfin with pulsed dye laser therapy may be a way to treat port-wine stains, preliminary results from an ongoing study suggest.
The finding is important because early studies of photodynamic therapy (PDT) for port-wine stains resulted in significant scarring and severe photosensitivity for up to 30 days.
"Of course, that was a significant disadvantage," Dr. Kristen M. Kelly said at a symposium on laser and cosmetic surgery sponsored by SkinCare Physicians.
In the new approach, which was first reported at the annual meeting of the American Society for Laser and Medicine and Surgery, Dr. Kelly and her associates treated four spots, each at 2 cm
For PDT, the subjects received IV verteporfin (Visudyne), a drug marketed by Novartis Ophthalmics Inc. that binds with low-density lipoprotein and is approved for treatment of age-related macular degeneration, pathologic myopia, and presumed ocular histoplasmosis. It causes photosensitivity for 25 days. The doses were 6 mg/m
This was followed by treatment with a 576-nm continuous-wave argon-pumped rhodamine dye laser.
The patients were followed at 3 days and at 1, 2, 4, 8, and 12 weeks.
So far, researchers have treated 10 sets of sites on seven patients, with a light dose of 1575 J/cm
One patient treated at 45 J/cm
"As we increase the dose [of the laser beam] we'll learn more about the potential of this treatment," she said.
The researchers received donations of verteporfin from QLT Inc., which developed the drug in conjunction with Novartis Ophthalmics. Dr. Kelly disclosed receiving research grants from 3M, Candela Corp., Reliant Pharmaceuticals LLC, and Thermage Inc. The surgery laser clinic where she works received equipment loans from Candela, Iridex Corp., and Reliant.
Posttreatment purpura is noted after PDT + PDL. Courtesy Dr. Kristen M. Kelly
Congenital LCMV Preventable if Patients Informed
TUCSON, ARIZ. — Although only 49 cases of lymphocytic choriomeningitis virus have been reported in the medical literature worldwide, Dr. Marilyn Baird Mets has a hunch that the prevalence could be much higher.
Since 1997, she has seen seven children with the condition present to Children's Memorial Hospital, Chicago, where she is head of ophthalmology.
Subsequently, three other clinicians have called her with reports of positive cases: one from the western suburbs of Chicago, one from Los Angeles, and one from Fort Collins, Colo.
“This virus is out there,” Dr. Mets said at the annual meeting of the Teratology Society. “Obstetricians should be telling their patients not to work around rats in medical labs during their pregnancy [and] not to get a hamster for their 4-year-old if they're going to have other children. It's a preventable disease, but people need to know about it.”
Discovered in 1933 and classified in the 1960s as a prototype for the arena virus, lymphocytic choriomeningitis virus (LCMV) is harbored in mice and transferred vertically by uterine infection. “There is documented infection to humans from wild mice, lab mice, rats, and hamsters,” said Dr. Mets, also professor of ophthalmology and surgery at Northwestern University, Chicago. “Transmission is thought to be airborne or contamination of food by infected mouse urine. There has also been experimental transmission demonstrated by ticks, fleas, mosquitos, and bedbugs.”
About one-third of adults who acquire LCMV are asymptomatic. Of the remaining two-thirds, about half have central nervous system disease. Illness occurs in a biphasic pattern. “First there's an acute febrile illness with myalgias and headache,” she said. “Later on, meningeal signs may develop, and rarely encephalitis, myocarditis, parotitis, orchitis, and pneumonia. Very rarely, fatal systemic disease is reported.”
It's the causative agent in about 10% of aseptic meningitis cases.
LCMV was first described as a fetal pathogen in Great Britain in 1955. The first case of congenital LCMV in the United States was reported in 1993. The baby was born with a birth weight of 2,898 grams. During pregnancy the mother lived in a well-maintained inner-city apartment. At 5 months' gestation, she had a febrile illness that lasted a week. The child was born with hydrocephalus and microphthalmos of the right eye. The right eye had leukocoria, a cloudy vitreous, and exudative retinitis.
A review of 26 infants with LCMV published in 1997 revealed that 88% had chorioretinopathy, 45% had hydrocephalus, and 13% had microcephaly. Diagnosis is made by IgG indirect fluorescent antibody, which is commercially available. “Or you can get an IgG ELISA at the [Centers for Disease Control and Prevention],” Dr. Mets said. “Complement fixation testing lacks the sensitivity” of the other two tests.
The differential diagnosis includes toxoplasmosis, rubella, cytomegalovirus, herpes simplex virus, enteroviruses, syphilis, parvovirus B19, and West Nile virus.
'Obstetricians should be telling their patients not to work around rats in a medical lab during their pregnancy.' DR. METS
An optical scan shows the eye of a 22-month-old with congenital LCMV who was referred for visual delay. Courtesy Dr. Marilyn Baird Mets
TUCSON, ARIZ. — Although only 49 cases of lymphocytic choriomeningitis virus have been reported in the medical literature worldwide, Dr. Marilyn Baird Mets has a hunch that the prevalence could be much higher.
Since 1997, she has seen seven children with the condition present to Children's Memorial Hospital, Chicago, where she is head of ophthalmology.
Subsequently, three other clinicians have called her with reports of positive cases: one from the western suburbs of Chicago, one from Los Angeles, and one from Fort Collins, Colo.
“This virus is out there,” Dr. Mets said at the annual meeting of the Teratology Society. “Obstetricians should be telling their patients not to work around rats in medical labs during their pregnancy [and] not to get a hamster for their 4-year-old if they're going to have other children. It's a preventable disease, but people need to know about it.”
Discovered in 1933 and classified in the 1960s as a prototype for the arena virus, lymphocytic choriomeningitis virus (LCMV) is harbored in mice and transferred vertically by uterine infection. “There is documented infection to humans from wild mice, lab mice, rats, and hamsters,” said Dr. Mets, also professor of ophthalmology and surgery at Northwestern University, Chicago. “Transmission is thought to be airborne or contamination of food by infected mouse urine. There has also been experimental transmission demonstrated by ticks, fleas, mosquitos, and bedbugs.”
About one-third of adults who acquire LCMV are asymptomatic. Of the remaining two-thirds, about half have central nervous system disease. Illness occurs in a biphasic pattern. “First there's an acute febrile illness with myalgias and headache,” she said. “Later on, meningeal signs may develop, and rarely encephalitis, myocarditis, parotitis, orchitis, and pneumonia. Very rarely, fatal systemic disease is reported.”
It's the causative agent in about 10% of aseptic meningitis cases.
LCMV was first described as a fetal pathogen in Great Britain in 1955. The first case of congenital LCMV in the United States was reported in 1993. The baby was born with a birth weight of 2,898 grams. During pregnancy the mother lived in a well-maintained inner-city apartment. At 5 months' gestation, she had a febrile illness that lasted a week. The child was born with hydrocephalus and microphthalmos of the right eye. The right eye had leukocoria, a cloudy vitreous, and exudative retinitis.
A review of 26 infants with LCMV published in 1997 revealed that 88% had chorioretinopathy, 45% had hydrocephalus, and 13% had microcephaly. Diagnosis is made by IgG indirect fluorescent antibody, which is commercially available. “Or you can get an IgG ELISA at the [Centers for Disease Control and Prevention],” Dr. Mets said. “Complement fixation testing lacks the sensitivity” of the other two tests.
The differential diagnosis includes toxoplasmosis, rubella, cytomegalovirus, herpes simplex virus, enteroviruses, syphilis, parvovirus B19, and West Nile virus.
'Obstetricians should be telling their patients not to work around rats in a medical lab during their pregnancy.' DR. METS
An optical scan shows the eye of a 22-month-old with congenital LCMV who was referred for visual delay. Courtesy Dr. Marilyn Baird Mets
TUCSON, ARIZ. — Although only 49 cases of lymphocytic choriomeningitis virus have been reported in the medical literature worldwide, Dr. Marilyn Baird Mets has a hunch that the prevalence could be much higher.
Since 1997, she has seen seven children with the condition present to Children's Memorial Hospital, Chicago, where she is head of ophthalmology.
Subsequently, three other clinicians have called her with reports of positive cases: one from the western suburbs of Chicago, one from Los Angeles, and one from Fort Collins, Colo.
“This virus is out there,” Dr. Mets said at the annual meeting of the Teratology Society. “Obstetricians should be telling their patients not to work around rats in medical labs during their pregnancy [and] not to get a hamster for their 4-year-old if they're going to have other children. It's a preventable disease, but people need to know about it.”
Discovered in 1933 and classified in the 1960s as a prototype for the arena virus, lymphocytic choriomeningitis virus (LCMV) is harbored in mice and transferred vertically by uterine infection. “There is documented infection to humans from wild mice, lab mice, rats, and hamsters,” said Dr. Mets, also professor of ophthalmology and surgery at Northwestern University, Chicago. “Transmission is thought to be airborne or contamination of food by infected mouse urine. There has also been experimental transmission demonstrated by ticks, fleas, mosquitos, and bedbugs.”
About one-third of adults who acquire LCMV are asymptomatic. Of the remaining two-thirds, about half have central nervous system disease. Illness occurs in a biphasic pattern. “First there's an acute febrile illness with myalgias and headache,” she said. “Later on, meningeal signs may develop, and rarely encephalitis, myocarditis, parotitis, orchitis, and pneumonia. Very rarely, fatal systemic disease is reported.”
It's the causative agent in about 10% of aseptic meningitis cases.
LCMV was first described as a fetal pathogen in Great Britain in 1955. The first case of congenital LCMV in the United States was reported in 1993. The baby was born with a birth weight of 2,898 grams. During pregnancy the mother lived in a well-maintained inner-city apartment. At 5 months' gestation, she had a febrile illness that lasted a week. The child was born with hydrocephalus and microphthalmos of the right eye. The right eye had leukocoria, a cloudy vitreous, and exudative retinitis.
A review of 26 infants with LCMV published in 1997 revealed that 88% had chorioretinopathy, 45% had hydrocephalus, and 13% had microcephaly. Diagnosis is made by IgG indirect fluorescent antibody, which is commercially available. “Or you can get an IgG ELISA at the [Centers for Disease Control and Prevention],” Dr. Mets said. “Complement fixation testing lacks the sensitivity” of the other two tests.
The differential diagnosis includes toxoplasmosis, rubella, cytomegalovirus, herpes simplex virus, enteroviruses, syphilis, parvovirus B19, and West Nile virus.
'Obstetricians should be telling their patients not to work around rats in a medical lab during their pregnancy.' DR. METS
An optical scan shows the eye of a 22-month-old with congenital LCMV who was referred for visual delay. Courtesy Dr. Marilyn Baird Mets
Most Pre-Referral Foot, Ankle MRIs Are Useless
LA JOLLA, CALIF. — Almost 90% of pre-referral foot and ankle MRI scans obtained before evaluation by a specialist were unnecessary, according to results from a single-center study of 201 patients.
MRIs of the foot and ankle are expensive, “and the findings are often immaterial to patients,” Dr. Stephen L. Tocci said at the annual meeting of the American Orthopaedic Foot and Ankle Society.
He and his associates in the department of orthopedic surgery at Brown University, Providence, R.I., observed a trend toward evaluating patients with solely a screening MRI for foot and ankle problems. “As soon as a nonnormal report is received, they're referred over to a foot and ankle specialist. Our hypothesis is that MRI is being overutilized in the course of administering foot and ankle care,” he said.
To test their hypothesis, the researchers reviewed 221 consecutive new patients who were referred to an orthopedic foot and ankle specialist over a 3-month period for a lower extremity problem. They sought to identify the prevalence of patients presenting with foot and ankle MRI, the percentage of patients that actually required an MRI from the foot and ankle specialist's perspective, and how often the MRI readout from the radiologist correlated with the clinical diagnosis.
The researchers excluded 20 patients who had fractures, leaving 201 nonfracture patients. All MRIs were done within 6 months of the new patient visit, with a minimum of 1 year of treatment follow-up.
The new patient evaluation consisted of a history and physical exam, weight-bearing x-rays, and a review of all prior care. The foot and ankle specialist then made a diagnosis and reviewed any previous MRIs that were taken.
If no previous MRIs were taken, the specialist ordered one only if it seemed necessary for the care of the patient, said Dr. Tocci, of the department of orthopedics at the university.
Of the 201 patients, 31 (15.4%) arrived with an MRI from an outside source and 9 (4.5%) had MRIs ordered by the foot and ankle specialist, for a total of 40 patients (19.9%) who had MRIs during their treatment.
Only 12.9% of the preevaluation MRI scans were considered appropriate, Dr. Tocci said, while the rest (87.1%) were judged unnecessary. “So if all 221 patients had first been seen by the [foot and ankle specialist], then only 5.9% would have had an MRI,” he said.
When the researchers evaluated the MRI reports from the radiologists who took the preevaluation scans, they found that nearly half (48.4%) of the radiologists disagreed with the diagnosis made by the foot and ankle specialist. “They either had a different radiologic interpretation by the clinician, or there was just no correlation with the clinical diagnosis altogether,” Dr. Tocci said.
In contrast, all nine MRIs ordered by the foot and ankle specialist were in agreement with the radiologist's interpretation.
Dr. Tocci said that a foot and ankle MRI done at Brown costs about $1,900, while the reading fee costs about $350. In 2005, 84 foot and ankle MRIs were performed at Brown, for a total cost of about $186,000. “If we assume that 87% of these are unnecessary scans, it's a savings of about $162,000 just at our site,” he said.
He speculated that some clinicians might use MRI because the technology is accessible, because of potential medicolegal concerns, and possibly because of remuneration issues. He said that patients believe they are getting good care if an MRI is done. “They may even ask for one,” he said.
Limitations of the study include its retrospective design and the fact that it's based on the evaluation of a single foot and ankle specialist, whereas multiple radiologists at different sites interpreted results, he said.
“Further studies are needed to define the utility and cost-effectiveness of MRI in foot and ankle care,” he said.
'If we assume that 87% of these are unnecessary scans, it's a savings of about $162,000 just at our site.' DR. TOCCI
LA JOLLA, CALIF. — Almost 90% of pre-referral foot and ankle MRI scans obtained before evaluation by a specialist were unnecessary, according to results from a single-center study of 201 patients.
MRIs of the foot and ankle are expensive, “and the findings are often immaterial to patients,” Dr. Stephen L. Tocci said at the annual meeting of the American Orthopaedic Foot and Ankle Society.
He and his associates in the department of orthopedic surgery at Brown University, Providence, R.I., observed a trend toward evaluating patients with solely a screening MRI for foot and ankle problems. “As soon as a nonnormal report is received, they're referred over to a foot and ankle specialist. Our hypothesis is that MRI is being overutilized in the course of administering foot and ankle care,” he said.
To test their hypothesis, the researchers reviewed 221 consecutive new patients who were referred to an orthopedic foot and ankle specialist over a 3-month period for a lower extremity problem. They sought to identify the prevalence of patients presenting with foot and ankle MRI, the percentage of patients that actually required an MRI from the foot and ankle specialist's perspective, and how often the MRI readout from the radiologist correlated with the clinical diagnosis.
The researchers excluded 20 patients who had fractures, leaving 201 nonfracture patients. All MRIs were done within 6 months of the new patient visit, with a minimum of 1 year of treatment follow-up.
The new patient evaluation consisted of a history and physical exam, weight-bearing x-rays, and a review of all prior care. The foot and ankle specialist then made a diagnosis and reviewed any previous MRIs that were taken.
If no previous MRIs were taken, the specialist ordered one only if it seemed necessary for the care of the patient, said Dr. Tocci, of the department of orthopedics at the university.
Of the 201 patients, 31 (15.4%) arrived with an MRI from an outside source and 9 (4.5%) had MRIs ordered by the foot and ankle specialist, for a total of 40 patients (19.9%) who had MRIs during their treatment.
Only 12.9% of the preevaluation MRI scans were considered appropriate, Dr. Tocci said, while the rest (87.1%) were judged unnecessary. “So if all 221 patients had first been seen by the [foot and ankle specialist], then only 5.9% would have had an MRI,” he said.
When the researchers evaluated the MRI reports from the radiologists who took the preevaluation scans, they found that nearly half (48.4%) of the radiologists disagreed with the diagnosis made by the foot and ankle specialist. “They either had a different radiologic interpretation by the clinician, or there was just no correlation with the clinical diagnosis altogether,” Dr. Tocci said.
In contrast, all nine MRIs ordered by the foot and ankle specialist were in agreement with the radiologist's interpretation.
Dr. Tocci said that a foot and ankle MRI done at Brown costs about $1,900, while the reading fee costs about $350. In 2005, 84 foot and ankle MRIs were performed at Brown, for a total cost of about $186,000. “If we assume that 87% of these are unnecessary scans, it's a savings of about $162,000 just at our site,” he said.
He speculated that some clinicians might use MRI because the technology is accessible, because of potential medicolegal concerns, and possibly because of remuneration issues. He said that patients believe they are getting good care if an MRI is done. “They may even ask for one,” he said.
Limitations of the study include its retrospective design and the fact that it's based on the evaluation of a single foot and ankle specialist, whereas multiple radiologists at different sites interpreted results, he said.
“Further studies are needed to define the utility and cost-effectiveness of MRI in foot and ankle care,” he said.
'If we assume that 87% of these are unnecessary scans, it's a savings of about $162,000 just at our site.' DR. TOCCI
LA JOLLA, CALIF. — Almost 90% of pre-referral foot and ankle MRI scans obtained before evaluation by a specialist were unnecessary, according to results from a single-center study of 201 patients.
MRIs of the foot and ankle are expensive, “and the findings are often immaterial to patients,” Dr. Stephen L. Tocci said at the annual meeting of the American Orthopaedic Foot and Ankle Society.
He and his associates in the department of orthopedic surgery at Brown University, Providence, R.I., observed a trend toward evaluating patients with solely a screening MRI for foot and ankle problems. “As soon as a nonnormal report is received, they're referred over to a foot and ankle specialist. Our hypothesis is that MRI is being overutilized in the course of administering foot and ankle care,” he said.
To test their hypothesis, the researchers reviewed 221 consecutive new patients who were referred to an orthopedic foot and ankle specialist over a 3-month period for a lower extremity problem. They sought to identify the prevalence of patients presenting with foot and ankle MRI, the percentage of patients that actually required an MRI from the foot and ankle specialist's perspective, and how often the MRI readout from the radiologist correlated with the clinical diagnosis.
The researchers excluded 20 patients who had fractures, leaving 201 nonfracture patients. All MRIs were done within 6 months of the new patient visit, with a minimum of 1 year of treatment follow-up.
The new patient evaluation consisted of a history and physical exam, weight-bearing x-rays, and a review of all prior care. The foot and ankle specialist then made a diagnosis and reviewed any previous MRIs that were taken.
If no previous MRIs were taken, the specialist ordered one only if it seemed necessary for the care of the patient, said Dr. Tocci, of the department of orthopedics at the university.
Of the 201 patients, 31 (15.4%) arrived with an MRI from an outside source and 9 (4.5%) had MRIs ordered by the foot and ankle specialist, for a total of 40 patients (19.9%) who had MRIs during their treatment.
Only 12.9% of the preevaluation MRI scans were considered appropriate, Dr. Tocci said, while the rest (87.1%) were judged unnecessary. “So if all 221 patients had first been seen by the [foot and ankle specialist], then only 5.9% would have had an MRI,” he said.
When the researchers evaluated the MRI reports from the radiologists who took the preevaluation scans, they found that nearly half (48.4%) of the radiologists disagreed with the diagnosis made by the foot and ankle specialist. “They either had a different radiologic interpretation by the clinician, or there was just no correlation with the clinical diagnosis altogether,” Dr. Tocci said.
In contrast, all nine MRIs ordered by the foot and ankle specialist were in agreement with the radiologist's interpretation.
Dr. Tocci said that a foot and ankle MRI done at Brown costs about $1,900, while the reading fee costs about $350. In 2005, 84 foot and ankle MRIs were performed at Brown, for a total cost of about $186,000. “If we assume that 87% of these are unnecessary scans, it's a savings of about $162,000 just at our site,” he said.
He speculated that some clinicians might use MRI because the technology is accessible, because of potential medicolegal concerns, and possibly because of remuneration issues. He said that patients believe they are getting good care if an MRI is done. “They may even ask for one,” he said.
Limitations of the study include its retrospective design and the fact that it's based on the evaluation of a single foot and ankle specialist, whereas multiple radiologists at different sites interpreted results, he said.
“Further studies are needed to define the utility and cost-effectiveness of MRI in foot and ankle care,” he said.
'If we assume that 87% of these are unnecessary scans, it's a savings of about $162,000 just at our site.' DR. TOCCI
More Colorectal Polyps Found in Statin Users
LOS ANGELES — Statin users had an increased risk of colorectal adenomatous polyps in a large, single-center study, but study authors cautioned that “the numbers could look different” after the results are adjusted for other risk factors for polyps, such as diabetes and obesity.
Those factors will be examined in the second phase of the study, Dr. Nazia Qazi said in an interview during a poster session at the annual Digestive Disease Week.
She and her associates in the division of gastroenterology at Maimonides Medical Center and Coney Island Hospital, New York, evaluated 1,000 consecutive patients who underwent screening colonoscopy at the hospital. Patients were asked about their use of statins, aspirin, and NSAIDs, as well as family history of colon cancer.
Of the 1,000 patients, 352 were white, 317 were African American, 179 were Hispanic, and 150 were Asian. More than half (599) were women, and their average age was 62 years.
The researchers had complete data on 679 patients. Of those, 227 were using statins, and their mean duration of statin use was nearly 2 years.
During colonoscopy, adenomatous polyps were detected in 304 patients. Of the 227 taking statins, 118 had adenomatous polyps. Of the 452 not taking statins, 186 had polyps. The difference between the two groups was statistically significant.
“This association remained significant after adjustment for other risk factors, including family history of colon cancer, gender, age, and aspirin and NSAID use,” the researchers wrote in their poster. “There was no association between statin use and the size, number, or location of the polyps. Given the widely accepted 'adenoma to carcinoma sequence,' our study does not support the prior finding that statin use decreases the risk of colon cancer.”
LOS ANGELES — Statin users had an increased risk of colorectal adenomatous polyps in a large, single-center study, but study authors cautioned that “the numbers could look different” after the results are adjusted for other risk factors for polyps, such as diabetes and obesity.
Those factors will be examined in the second phase of the study, Dr. Nazia Qazi said in an interview during a poster session at the annual Digestive Disease Week.
She and her associates in the division of gastroenterology at Maimonides Medical Center and Coney Island Hospital, New York, evaluated 1,000 consecutive patients who underwent screening colonoscopy at the hospital. Patients were asked about their use of statins, aspirin, and NSAIDs, as well as family history of colon cancer.
Of the 1,000 patients, 352 were white, 317 were African American, 179 were Hispanic, and 150 were Asian. More than half (599) were women, and their average age was 62 years.
The researchers had complete data on 679 patients. Of those, 227 were using statins, and their mean duration of statin use was nearly 2 years.
During colonoscopy, adenomatous polyps were detected in 304 patients. Of the 227 taking statins, 118 had adenomatous polyps. Of the 452 not taking statins, 186 had polyps. The difference between the two groups was statistically significant.
“This association remained significant after adjustment for other risk factors, including family history of colon cancer, gender, age, and aspirin and NSAID use,” the researchers wrote in their poster. “There was no association between statin use and the size, number, or location of the polyps. Given the widely accepted 'adenoma to carcinoma sequence,' our study does not support the prior finding that statin use decreases the risk of colon cancer.”
LOS ANGELES — Statin users had an increased risk of colorectal adenomatous polyps in a large, single-center study, but study authors cautioned that “the numbers could look different” after the results are adjusted for other risk factors for polyps, such as diabetes and obesity.
Those factors will be examined in the second phase of the study, Dr. Nazia Qazi said in an interview during a poster session at the annual Digestive Disease Week.
She and her associates in the division of gastroenterology at Maimonides Medical Center and Coney Island Hospital, New York, evaluated 1,000 consecutive patients who underwent screening colonoscopy at the hospital. Patients were asked about their use of statins, aspirin, and NSAIDs, as well as family history of colon cancer.
Of the 1,000 patients, 352 were white, 317 were African American, 179 were Hispanic, and 150 were Asian. More than half (599) were women, and their average age was 62 years.
The researchers had complete data on 679 patients. Of those, 227 were using statins, and their mean duration of statin use was nearly 2 years.
During colonoscopy, adenomatous polyps were detected in 304 patients. Of the 227 taking statins, 118 had adenomatous polyps. Of the 452 not taking statins, 186 had polyps. The difference between the two groups was statistically significant.
“This association remained significant after adjustment for other risk factors, including family history of colon cancer, gender, age, and aspirin and NSAID use,” the researchers wrote in their poster. “There was no association between statin use and the size, number, or location of the polyps. Given the widely accepted 'adenoma to carcinoma sequence,' our study does not support the prior finding that statin use decreases the risk of colon cancer.”
Compression Stockings on Long Flights Reduce DVT Risk
Wearing compression stockings during airplane flights that last 7 hours or longer appears to reduce the risk of asymptomatic deep vein thrombosis, results of a Cochrane Library Review indicate.
In a review of 10 trials including a total of 2,637 passengers, 50 passengers developed symptomless deep vein thrombosis (DVT). Of them, 47 were not wearing compression stockings and 3 were wearing stockings, Mike Clarke, Ph.D., director of the UK Cochrane Center in Oxford, and his colleagues wrote.
“Wearing stockings might reduce the incidence of this outcome from a few tens per thousand passengers, to two or three per thousand,” they wrote. “Passengers who wear stockings will also experience less edema in their legs. However, this review is unable to identify whether these effects of wearing stockings translate into effects on outcomes such as death, pulmonary embolus, and symptomatic DVT.”
The researchers searched the Cochrane Centre Register of Controlled Trials, Medline, and other resources to locate randomized, controlled trials on the impact of compression stockings, compared with no stockings, on the incidence of DVT in passengers on flights lasting at least 4 hours.
Ten trials were identified: nine that involved 2,821 passengers and compared wearing stockings on both legs with not wearing them, and one trial that involved 35 passengers and compared wearing a stocking on one leg for the outbound flight with wearing one on the other leg for the return flight. All flights lasted at least 7 hours, and most stockings used in the trials were below the knee (Cochrane Database Syst. Rev. 2006;2:CD004002).
Of the nine trials involving 2,821 passengers, seven recruited a total of 1,548 passengers who were considered to be at low to medium risk of developing DVT, whereas the other two trials recruited 1,273 passengers who were considered to be at high risk.
Complete follow-up data were available for 2,637 passengers. Among these, 50 developed a symptomless DVT that was detected by either ultrasound or D-dimer testing and fibrinogen testing. Of these 50 passengers, 47 were not wearing compression stockings, and 3 were wearing stockings.
The overall incidence of symptomless DVT was 2.43% in the two trials of passengers considered to be at high risk vs. 1.45% in the seven trials of passengers considered to be at low or medium risk.
Six of the trials also showed that compression stockings significantly reduced leg edema in those who wore them.
“This review shows that the question of the effects on symptomless DVT of wearing versus not wearing compression stockings in the types of people studied in these trials should now be regarded as answered,” Dr. Clarke and his associates concluded.
“Further research may be justified to investigate the relative effects of different strengths of stockings or of stockings compared to other preventative strategies,” they added.
Wearing compression stockings during airplane flights that last 7 hours or longer appears to reduce the risk of asymptomatic deep vein thrombosis, results of a Cochrane Library Review indicate.
In a review of 10 trials including a total of 2,637 passengers, 50 passengers developed symptomless deep vein thrombosis (DVT). Of them, 47 were not wearing compression stockings and 3 were wearing stockings, Mike Clarke, Ph.D., director of the UK Cochrane Center in Oxford, and his colleagues wrote.
“Wearing stockings might reduce the incidence of this outcome from a few tens per thousand passengers, to two or three per thousand,” they wrote. “Passengers who wear stockings will also experience less edema in their legs. However, this review is unable to identify whether these effects of wearing stockings translate into effects on outcomes such as death, pulmonary embolus, and symptomatic DVT.”
The researchers searched the Cochrane Centre Register of Controlled Trials, Medline, and other resources to locate randomized, controlled trials on the impact of compression stockings, compared with no stockings, on the incidence of DVT in passengers on flights lasting at least 4 hours.
Ten trials were identified: nine that involved 2,821 passengers and compared wearing stockings on both legs with not wearing them, and one trial that involved 35 passengers and compared wearing a stocking on one leg for the outbound flight with wearing one on the other leg for the return flight. All flights lasted at least 7 hours, and most stockings used in the trials were below the knee (Cochrane Database Syst. Rev. 2006;2:CD004002).
Of the nine trials involving 2,821 passengers, seven recruited a total of 1,548 passengers who were considered to be at low to medium risk of developing DVT, whereas the other two trials recruited 1,273 passengers who were considered to be at high risk.
Complete follow-up data were available for 2,637 passengers. Among these, 50 developed a symptomless DVT that was detected by either ultrasound or D-dimer testing and fibrinogen testing. Of these 50 passengers, 47 were not wearing compression stockings, and 3 were wearing stockings.
The overall incidence of symptomless DVT was 2.43% in the two trials of passengers considered to be at high risk vs. 1.45% in the seven trials of passengers considered to be at low or medium risk.
Six of the trials also showed that compression stockings significantly reduced leg edema in those who wore them.
“This review shows that the question of the effects on symptomless DVT of wearing versus not wearing compression stockings in the types of people studied in these trials should now be regarded as answered,” Dr. Clarke and his associates concluded.
“Further research may be justified to investigate the relative effects of different strengths of stockings or of stockings compared to other preventative strategies,” they added.
Wearing compression stockings during airplane flights that last 7 hours or longer appears to reduce the risk of asymptomatic deep vein thrombosis, results of a Cochrane Library Review indicate.
In a review of 10 trials including a total of 2,637 passengers, 50 passengers developed symptomless deep vein thrombosis (DVT). Of them, 47 were not wearing compression stockings and 3 were wearing stockings, Mike Clarke, Ph.D., director of the UK Cochrane Center in Oxford, and his colleagues wrote.
“Wearing stockings might reduce the incidence of this outcome from a few tens per thousand passengers, to two or three per thousand,” they wrote. “Passengers who wear stockings will also experience less edema in their legs. However, this review is unable to identify whether these effects of wearing stockings translate into effects on outcomes such as death, pulmonary embolus, and symptomatic DVT.”
The researchers searched the Cochrane Centre Register of Controlled Trials, Medline, and other resources to locate randomized, controlled trials on the impact of compression stockings, compared with no stockings, on the incidence of DVT in passengers on flights lasting at least 4 hours.
Ten trials were identified: nine that involved 2,821 passengers and compared wearing stockings on both legs with not wearing them, and one trial that involved 35 passengers and compared wearing a stocking on one leg for the outbound flight with wearing one on the other leg for the return flight. All flights lasted at least 7 hours, and most stockings used in the trials were below the knee (Cochrane Database Syst. Rev. 2006;2:CD004002).
Of the nine trials involving 2,821 passengers, seven recruited a total of 1,548 passengers who were considered to be at low to medium risk of developing DVT, whereas the other two trials recruited 1,273 passengers who were considered to be at high risk.
Complete follow-up data were available for 2,637 passengers. Among these, 50 developed a symptomless DVT that was detected by either ultrasound or D-dimer testing and fibrinogen testing. Of these 50 passengers, 47 were not wearing compression stockings, and 3 were wearing stockings.
The overall incidence of symptomless DVT was 2.43% in the two trials of passengers considered to be at high risk vs. 1.45% in the seven trials of passengers considered to be at low or medium risk.
Six of the trials also showed that compression stockings significantly reduced leg edema in those who wore them.
“This review shows that the question of the effects on symptomless DVT of wearing versus not wearing compression stockings in the types of people studied in these trials should now be regarded as answered,” Dr. Clarke and his associates concluded.
“Further research may be justified to investigate the relative effects of different strengths of stockings or of stockings compared to other preventative strategies,” they added.
Jury Still Out on West Nile as Possible Teratogen
TUCSON, ARIZ. — Recent published data suggest a risk of birth defects among live-born infants of mothers infected with West Nile virus, but much more work is needed to confirm the association, Dr. Dawn M. Wesson said at the annual meeting of the Teratology Society.
“There appears to be a slightly higher frequency of major birth defects in the West Nile-infected group as compared to the general population, but … even though this is suggestive it's certainly not proof,” cautioned Dr. Wesson, of the department of tropical medicine at Tulane University School of Public Health and Tropical Medicine in New Orleans.
She based her remarks on a clinical study of 77 women infected with West Nile virus (WNV) during pregnancy in 2003 and 2004 who were followed in 16 states. Of the 77 women, 71 delivered 72 live infants. Four women had miscarriages and two had abortions (Pediatrics 2006;117:e537–45).
Of the 72 live infants, 67 were born at term, 4 were born preterm, and the gestational age of 1 infant was unknown.
The researchers, led by Daniel R. O'Leary, D.V.M., of the division of vector-borne infectious diseases at the Centers for Disease Control and Prevention, found that nearly 11% of infants born to mothers infected with West Nile virus during pregnancy had major birth defects, compared with almost 6% of infants born to uninfected mothers in the general population.
The researchers cautioned that of the 72 infants followed to date, nearly all appeared to be normal, and none had conclusive laboratory evidence of congenital WNV infection.
Seven infants had major malformations, but “only three had defects that could have been caused by maternal WNV infection based on the timing of the infections and the sensitive developmental period for the specific malformations, and none had any conclusive evidence of WNV etiology,” Dr. O'Leary and his associates wrote.
At the meeting, Dr. Wesson said one of the key reasons researchers are unable to determine with certainty whether WNV is a teratogen is that the sensitivity and specificity of IgM testing of cord blood to detect WNV is really unknown.
“Also, congenital WNV infection among newborns with IgM-negative serology cannot be ruled out,” she said. “We need more studies.”
In a partnership between the Centers for Disease Control and Prevention and Tulane University, researchers are studying the effect of WNV on pregnancy outcomes in two groups of women: retrospectively in those infected while pregnant during 2003 and 2004, and prospectively in those infected while pregnant between 2005 and 2008.
In addition to performing all recommended tests during and after pregnancy, the researchers plan to follow case and control infants with ophthalmologic and developmental exams as well as a CT scan if indicated, and a dysmorphology exam in infected infants.
The final part of the effort is to perform morphologic, endocrine, and molecular assessments of the villous placenta, trophoblast, conceptus membranes, and maternal decidua.
“We don't know the answer to the question [about WNV's possible role as a teratogen], but I think the pieces that we have in place and the collaborators we have in line should help us to answer those questions in the future,” Dr. Wesson concluded.
The capacity of IgM testing of cord blood to detect West Nile virus (shown in electron micrograph) is still unknown. CDC
TUCSON, ARIZ. — Recent published data suggest a risk of birth defects among live-born infants of mothers infected with West Nile virus, but much more work is needed to confirm the association, Dr. Dawn M. Wesson said at the annual meeting of the Teratology Society.
“There appears to be a slightly higher frequency of major birth defects in the West Nile-infected group as compared to the general population, but … even though this is suggestive it's certainly not proof,” cautioned Dr. Wesson, of the department of tropical medicine at Tulane University School of Public Health and Tropical Medicine in New Orleans.
She based her remarks on a clinical study of 77 women infected with West Nile virus (WNV) during pregnancy in 2003 and 2004 who were followed in 16 states. Of the 77 women, 71 delivered 72 live infants. Four women had miscarriages and two had abortions (Pediatrics 2006;117:e537–45).
Of the 72 live infants, 67 were born at term, 4 were born preterm, and the gestational age of 1 infant was unknown.
The researchers, led by Daniel R. O'Leary, D.V.M., of the division of vector-borne infectious diseases at the Centers for Disease Control and Prevention, found that nearly 11% of infants born to mothers infected with West Nile virus during pregnancy had major birth defects, compared with almost 6% of infants born to uninfected mothers in the general population.
The researchers cautioned that of the 72 infants followed to date, nearly all appeared to be normal, and none had conclusive laboratory evidence of congenital WNV infection.
Seven infants had major malformations, but “only three had defects that could have been caused by maternal WNV infection based on the timing of the infections and the sensitive developmental period for the specific malformations, and none had any conclusive evidence of WNV etiology,” Dr. O'Leary and his associates wrote.
At the meeting, Dr. Wesson said one of the key reasons researchers are unable to determine with certainty whether WNV is a teratogen is that the sensitivity and specificity of IgM testing of cord blood to detect WNV is really unknown.
“Also, congenital WNV infection among newborns with IgM-negative serology cannot be ruled out,” she said. “We need more studies.”
In a partnership between the Centers for Disease Control and Prevention and Tulane University, researchers are studying the effect of WNV on pregnancy outcomes in two groups of women: retrospectively in those infected while pregnant during 2003 and 2004, and prospectively in those infected while pregnant between 2005 and 2008.
In addition to performing all recommended tests during and after pregnancy, the researchers plan to follow case and control infants with ophthalmologic and developmental exams as well as a CT scan if indicated, and a dysmorphology exam in infected infants.
The final part of the effort is to perform morphologic, endocrine, and molecular assessments of the villous placenta, trophoblast, conceptus membranes, and maternal decidua.
“We don't know the answer to the question [about WNV's possible role as a teratogen], but I think the pieces that we have in place and the collaborators we have in line should help us to answer those questions in the future,” Dr. Wesson concluded.
The capacity of IgM testing of cord blood to detect West Nile virus (shown in electron micrograph) is still unknown. CDC
TUCSON, ARIZ. — Recent published data suggest a risk of birth defects among live-born infants of mothers infected with West Nile virus, but much more work is needed to confirm the association, Dr. Dawn M. Wesson said at the annual meeting of the Teratology Society.
“There appears to be a slightly higher frequency of major birth defects in the West Nile-infected group as compared to the general population, but … even though this is suggestive it's certainly not proof,” cautioned Dr. Wesson, of the department of tropical medicine at Tulane University School of Public Health and Tropical Medicine in New Orleans.
She based her remarks on a clinical study of 77 women infected with West Nile virus (WNV) during pregnancy in 2003 and 2004 who were followed in 16 states. Of the 77 women, 71 delivered 72 live infants. Four women had miscarriages and two had abortions (Pediatrics 2006;117:e537–45).
Of the 72 live infants, 67 were born at term, 4 were born preterm, and the gestational age of 1 infant was unknown.
The researchers, led by Daniel R. O'Leary, D.V.M., of the division of vector-borne infectious diseases at the Centers for Disease Control and Prevention, found that nearly 11% of infants born to mothers infected with West Nile virus during pregnancy had major birth defects, compared with almost 6% of infants born to uninfected mothers in the general population.
The researchers cautioned that of the 72 infants followed to date, nearly all appeared to be normal, and none had conclusive laboratory evidence of congenital WNV infection.
Seven infants had major malformations, but “only three had defects that could have been caused by maternal WNV infection based on the timing of the infections and the sensitive developmental period for the specific malformations, and none had any conclusive evidence of WNV etiology,” Dr. O'Leary and his associates wrote.
At the meeting, Dr. Wesson said one of the key reasons researchers are unable to determine with certainty whether WNV is a teratogen is that the sensitivity and specificity of IgM testing of cord blood to detect WNV is really unknown.
“Also, congenital WNV infection among newborns with IgM-negative serology cannot be ruled out,” she said. “We need more studies.”
In a partnership between the Centers for Disease Control and Prevention and Tulane University, researchers are studying the effect of WNV on pregnancy outcomes in two groups of women: retrospectively in those infected while pregnant during 2003 and 2004, and prospectively in those infected while pregnant between 2005 and 2008.
In addition to performing all recommended tests during and after pregnancy, the researchers plan to follow case and control infants with ophthalmologic and developmental exams as well as a CT scan if indicated, and a dysmorphology exam in infected infants.
The final part of the effort is to perform morphologic, endocrine, and molecular assessments of the villous placenta, trophoblast, conceptus membranes, and maternal decidua.
“We don't know the answer to the question [about WNV's possible role as a teratogen], but I think the pieces that we have in place and the collaborators we have in line should help us to answer those questions in the future,” Dr. Wesson concluded.
The capacity of IgM testing of cord blood to detect West Nile virus (shown in electron micrograph) is still unknown. CDC
Migraine With Aura Raises Risk of Coronary Heart Disease
SAN DIEGO — Healthy women aged 45 years and older who have migraine with aura have a significantly increased risk of coronary heart disease, myocardial infarction, coronary revascularization, and angina, results from the largest study of its kind demonstrated.
On the other hand, migraine without aura was not associated with any such outcome, Dr. Tobias Kurth reported at the annual meeting of the American Academy of Neurology. “Since migraine without aura is far more common than migraine with aura, for most migraine patients our data indicate no increased risk of coronary heart disease,” said Dr. Kurth of the preventive medicine division at Brigham and Women's Hospital, Boston.
Dr. Richard B. Lipton, who was invited to discuss the work, said the findings warrant being vigilant for coronary heart disease (CHD) risk factors in patients who have migraine with aura. This would include working with patients to modify CHD risk factors, noted Dr. Lipton, vice chair of neurology at Albert Einstein College of Medicine, New York. “It may be possible to devise risk factor modification strategies that might include aspirin or folate,” he said.
In a study funded by the National Institutes of Health, Dr. Kurth and his associates followed 27,840 women aged 45 years and older who were enrolled in the Women's Health Study. All study participants were free of cardiovascular disease at baseline. The researchers used a Cox proportional hazards model to evaluate the association between migraine and risk of subsequent CHD and angina, while adjusting for cardiovascular risk factors including age, blood pressure, smoking status, body mass index, alcohol consumption, and exercise habits. The average follow-up was 10 years. “All women were age 45 or older, health professionals, and mostly white,” Dr. Kurth added.
In the baseline questionnaire study, participants were asked if they ever had a migraine, and if they had a migraine in the previous year. “If the woman answered yes to the latter question, we asked further details about her migraine, including a question about aura,” Dr. Kurth said. Women who did not report migraine served as the referent group.
At baseline, 5,125 (18%) reported a history of migraine and 3,610 (13%) reported current migraine. Of those who reported current migraine, 1,434 (40%) reported aura.
During 10 years of follow-up, 625 coronary heart disease events and 408 angina events occurred.
Compared with women who reported no history of migraine, women who reported migraine with aura had a 1.7-fold increased risk for CHD; a 2-fold increased risk for myocardial infarction; a 1.7-fold increased risk for coronary revascularization; and a 1.7-fold increased risk for angina. On average, the risk for all of these factors reached statistical significance in the sixth year of follow-up, said Dr. Kurth, also of Harvard Medical School, Boston.
Migraineurs without aura had no increased risk for any of the outcome events.
The findings warrant being vigilant for CHD risk factors in all patients who have migraine with aura. DR. LIPTON
SAN DIEGO — Healthy women aged 45 years and older who have migraine with aura have a significantly increased risk of coronary heart disease, myocardial infarction, coronary revascularization, and angina, results from the largest study of its kind demonstrated.
On the other hand, migraine without aura was not associated with any such outcome, Dr. Tobias Kurth reported at the annual meeting of the American Academy of Neurology. “Since migraine without aura is far more common than migraine with aura, for most migraine patients our data indicate no increased risk of coronary heart disease,” said Dr. Kurth of the preventive medicine division at Brigham and Women's Hospital, Boston.
Dr. Richard B. Lipton, who was invited to discuss the work, said the findings warrant being vigilant for coronary heart disease (CHD) risk factors in patients who have migraine with aura. This would include working with patients to modify CHD risk factors, noted Dr. Lipton, vice chair of neurology at Albert Einstein College of Medicine, New York. “It may be possible to devise risk factor modification strategies that might include aspirin or folate,” he said.
In a study funded by the National Institutes of Health, Dr. Kurth and his associates followed 27,840 women aged 45 years and older who were enrolled in the Women's Health Study. All study participants were free of cardiovascular disease at baseline. The researchers used a Cox proportional hazards model to evaluate the association between migraine and risk of subsequent CHD and angina, while adjusting for cardiovascular risk factors including age, blood pressure, smoking status, body mass index, alcohol consumption, and exercise habits. The average follow-up was 10 years. “All women were age 45 or older, health professionals, and mostly white,” Dr. Kurth added.
In the baseline questionnaire study, participants were asked if they ever had a migraine, and if they had a migraine in the previous year. “If the woman answered yes to the latter question, we asked further details about her migraine, including a question about aura,” Dr. Kurth said. Women who did not report migraine served as the referent group.
At baseline, 5,125 (18%) reported a history of migraine and 3,610 (13%) reported current migraine. Of those who reported current migraine, 1,434 (40%) reported aura.
During 10 years of follow-up, 625 coronary heart disease events and 408 angina events occurred.
Compared with women who reported no history of migraine, women who reported migraine with aura had a 1.7-fold increased risk for CHD; a 2-fold increased risk for myocardial infarction; a 1.7-fold increased risk for coronary revascularization; and a 1.7-fold increased risk for angina. On average, the risk for all of these factors reached statistical significance in the sixth year of follow-up, said Dr. Kurth, also of Harvard Medical School, Boston.
Migraineurs without aura had no increased risk for any of the outcome events.
The findings warrant being vigilant for CHD risk factors in all patients who have migraine with aura. DR. LIPTON
SAN DIEGO — Healthy women aged 45 years and older who have migraine with aura have a significantly increased risk of coronary heart disease, myocardial infarction, coronary revascularization, and angina, results from the largest study of its kind demonstrated.
On the other hand, migraine without aura was not associated with any such outcome, Dr. Tobias Kurth reported at the annual meeting of the American Academy of Neurology. “Since migraine without aura is far more common than migraine with aura, for most migraine patients our data indicate no increased risk of coronary heart disease,” said Dr. Kurth of the preventive medicine division at Brigham and Women's Hospital, Boston.
Dr. Richard B. Lipton, who was invited to discuss the work, said the findings warrant being vigilant for coronary heart disease (CHD) risk factors in patients who have migraine with aura. This would include working with patients to modify CHD risk factors, noted Dr. Lipton, vice chair of neurology at Albert Einstein College of Medicine, New York. “It may be possible to devise risk factor modification strategies that might include aspirin or folate,” he said.
In a study funded by the National Institutes of Health, Dr. Kurth and his associates followed 27,840 women aged 45 years and older who were enrolled in the Women's Health Study. All study participants were free of cardiovascular disease at baseline. The researchers used a Cox proportional hazards model to evaluate the association between migraine and risk of subsequent CHD and angina, while adjusting for cardiovascular risk factors including age, blood pressure, smoking status, body mass index, alcohol consumption, and exercise habits. The average follow-up was 10 years. “All women were age 45 or older, health professionals, and mostly white,” Dr. Kurth added.
In the baseline questionnaire study, participants were asked if they ever had a migraine, and if they had a migraine in the previous year. “If the woman answered yes to the latter question, we asked further details about her migraine, including a question about aura,” Dr. Kurth said. Women who did not report migraine served as the referent group.
At baseline, 5,125 (18%) reported a history of migraine and 3,610 (13%) reported current migraine. Of those who reported current migraine, 1,434 (40%) reported aura.
During 10 years of follow-up, 625 coronary heart disease events and 408 angina events occurred.
Compared with women who reported no history of migraine, women who reported migraine with aura had a 1.7-fold increased risk for CHD; a 2-fold increased risk for myocardial infarction; a 1.7-fold increased risk for coronary revascularization; and a 1.7-fold increased risk for angina. On average, the risk for all of these factors reached statistical significance in the sixth year of follow-up, said Dr. Kurth, also of Harvard Medical School, Boston.
Migraineurs without aura had no increased risk for any of the outcome events.
The findings warrant being vigilant for CHD risk factors in all patients who have migraine with aura. DR. LIPTON
Celecoxib Deemed Safer Than NSAIDs in Osteoarthritis Patients
Celecoxib is just as effective as naproxen and diclofenac for treating osteoarthritis, and it causes significantly fewer serious upper GI events than the other agents, according to data from a large international study.
The finding “shows conclusively that celecoxib does reduce the risk of upper GI complications, compared to conventional NSAIDs,” the study's lead author, Dr. Gurkirpal Singh, said in an interview. “Until now managed care has been saying there is no evidence in a randomized, clinical trial that celecoxib is better than NSAIDs in reducing GI bleeding. But here it is—these are level 1 data that conclusively prove that.”
However, Dr. Brennan M.R. Spiegel noted that although the difference favoring celecoxib reached significance, the actual difference was only 1 patient per 100 patient-years. This tiny difference “is not enough to warrant spending as much as we do on Cox-2 inhibitors,” said Dr. Spiegel of the digestive diseases division at the University of California, Los Angeles. He added that the study is “notable because it's very large, [but] I believed it before that GI events are less common with coxibs than with NSAIDs.”
In a trial called the Successive Celecoxib Efficacy and Safety Study-1 (SUCCESS-1), Dr. Singh and his associates randomized 13,194 osteoarthritis (OA) patients from 39 countries to double-blinded treatment with celecoxib 100 mg b.i.d., celecoxib 200 mg b.i.d., or nonselective NSAID therapy for 12 weeks. The NSAID therapy consisted of diclofenac 50 mg b.i.d. or naproxen 500 mg b.i.d. (Am. J. Med. 2006; 119:255–66).
Patients with a history of two or more episodes of active peptic ulceration were excluded from the study, as were those with GI bleeding or recurrent gastric or duodenal ulcers and those with an esophageal, gastric, or duodenal ulcer within a month prior to randomization. Patients with active GI disease or any condition that required NSAID therapy were also excluded.
Participants' mean age was 62 years, 76% were women, and 80% were white, reported Dr. Singh of the division of gastroenterology and hepatology at Stanford (Calif.) University. The mean duration of OA was 8 years.
Instruments used to measure efficacy included the Patient's Assessment of Arthritis Pain-Visual Analog Scale, Patients' Global Assessment of Arthritis, and the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index. Serious GI events were evaluated by two independent committees that were blinded to patient randomization.
The researchers reported that the primary efficacy measures showed that both doses of celecoxib were equally as effective as the NSAIDs in treating OA.
There were 37 confirmed upper GI events: 19 in the patients who took the NSAIDs and 18 in the patients who took celecoxib. That translated into a rate of 2.1 per 100 patient-years for patients who took the NSAIDS vs. a rate of 1.0 per 100 patient-years for those who took celecoxib. The difference was statistically significant.
A key limitation of the study, Dr. Singh said, is that it was not powered to detect differences in cardiovascular adverse events.
Dr. Spiegel said that the current standard of care for older patients with OA has “overtaken” the overall impact of the SUCCESS-1 study findings. “The reality is that people are moving to adding a proton pump inhibitor to an NSAID when [osteoarthritis] patients exceed the age of 65 or if they're put on aspirin,” he said.
Dr. Singh disclosed that he received research support from Searle Pharmaceuticals, Pharmacia, Pfizer, Merck & Co., Boehringer Ingelheim, TAP Pharmaceuticals, Wyeth, Altana Pharma, GlaxoSmithKline, Novartis Pharmaceuticals Corp., and Centocor Inc.
'Celecoxib does reduce the risk of upper GI complications, compared to conventional NSAIDs.' DR. SINGH
Celecoxib is just as effective as naproxen and diclofenac for treating osteoarthritis, and it causes significantly fewer serious upper GI events than the other agents, according to data from a large international study.
The finding “shows conclusively that celecoxib does reduce the risk of upper GI complications, compared to conventional NSAIDs,” the study's lead author, Dr. Gurkirpal Singh, said in an interview. “Until now managed care has been saying there is no evidence in a randomized, clinical trial that celecoxib is better than NSAIDs in reducing GI bleeding. But here it is—these are level 1 data that conclusively prove that.”
However, Dr. Brennan M.R. Spiegel noted that although the difference favoring celecoxib reached significance, the actual difference was only 1 patient per 100 patient-years. This tiny difference “is not enough to warrant spending as much as we do on Cox-2 inhibitors,” said Dr. Spiegel of the digestive diseases division at the University of California, Los Angeles. He added that the study is “notable because it's very large, [but] I believed it before that GI events are less common with coxibs than with NSAIDs.”
In a trial called the Successive Celecoxib Efficacy and Safety Study-1 (SUCCESS-1), Dr. Singh and his associates randomized 13,194 osteoarthritis (OA) patients from 39 countries to double-blinded treatment with celecoxib 100 mg b.i.d., celecoxib 200 mg b.i.d., or nonselective NSAID therapy for 12 weeks. The NSAID therapy consisted of diclofenac 50 mg b.i.d. or naproxen 500 mg b.i.d. (Am. J. Med. 2006; 119:255–66).
Patients with a history of two or more episodes of active peptic ulceration were excluded from the study, as were those with GI bleeding or recurrent gastric or duodenal ulcers and those with an esophageal, gastric, or duodenal ulcer within a month prior to randomization. Patients with active GI disease or any condition that required NSAID therapy were also excluded.
Participants' mean age was 62 years, 76% were women, and 80% were white, reported Dr. Singh of the division of gastroenterology and hepatology at Stanford (Calif.) University. The mean duration of OA was 8 years.
Instruments used to measure efficacy included the Patient's Assessment of Arthritis Pain-Visual Analog Scale, Patients' Global Assessment of Arthritis, and the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index. Serious GI events were evaluated by two independent committees that were blinded to patient randomization.
The researchers reported that the primary efficacy measures showed that both doses of celecoxib were equally as effective as the NSAIDs in treating OA.
There were 37 confirmed upper GI events: 19 in the patients who took the NSAIDs and 18 in the patients who took celecoxib. That translated into a rate of 2.1 per 100 patient-years for patients who took the NSAIDS vs. a rate of 1.0 per 100 patient-years for those who took celecoxib. The difference was statistically significant.
A key limitation of the study, Dr. Singh said, is that it was not powered to detect differences in cardiovascular adverse events.
Dr. Spiegel said that the current standard of care for older patients with OA has “overtaken” the overall impact of the SUCCESS-1 study findings. “The reality is that people are moving to adding a proton pump inhibitor to an NSAID when [osteoarthritis] patients exceed the age of 65 or if they're put on aspirin,” he said.
Dr. Singh disclosed that he received research support from Searle Pharmaceuticals, Pharmacia, Pfizer, Merck & Co., Boehringer Ingelheim, TAP Pharmaceuticals, Wyeth, Altana Pharma, GlaxoSmithKline, Novartis Pharmaceuticals Corp., and Centocor Inc.
'Celecoxib does reduce the risk of upper GI complications, compared to conventional NSAIDs.' DR. SINGH
Celecoxib is just as effective as naproxen and diclofenac for treating osteoarthritis, and it causes significantly fewer serious upper GI events than the other agents, according to data from a large international study.
The finding “shows conclusively that celecoxib does reduce the risk of upper GI complications, compared to conventional NSAIDs,” the study's lead author, Dr. Gurkirpal Singh, said in an interview. “Until now managed care has been saying there is no evidence in a randomized, clinical trial that celecoxib is better than NSAIDs in reducing GI bleeding. But here it is—these are level 1 data that conclusively prove that.”
However, Dr. Brennan M.R. Spiegel noted that although the difference favoring celecoxib reached significance, the actual difference was only 1 patient per 100 patient-years. This tiny difference “is not enough to warrant spending as much as we do on Cox-2 inhibitors,” said Dr. Spiegel of the digestive diseases division at the University of California, Los Angeles. He added that the study is “notable because it's very large, [but] I believed it before that GI events are less common with coxibs than with NSAIDs.”
In a trial called the Successive Celecoxib Efficacy and Safety Study-1 (SUCCESS-1), Dr. Singh and his associates randomized 13,194 osteoarthritis (OA) patients from 39 countries to double-blinded treatment with celecoxib 100 mg b.i.d., celecoxib 200 mg b.i.d., or nonselective NSAID therapy for 12 weeks. The NSAID therapy consisted of diclofenac 50 mg b.i.d. or naproxen 500 mg b.i.d. (Am. J. Med. 2006; 119:255–66).
Patients with a history of two or more episodes of active peptic ulceration were excluded from the study, as were those with GI bleeding or recurrent gastric or duodenal ulcers and those with an esophageal, gastric, or duodenal ulcer within a month prior to randomization. Patients with active GI disease or any condition that required NSAID therapy were also excluded.
Participants' mean age was 62 years, 76% were women, and 80% were white, reported Dr. Singh of the division of gastroenterology and hepatology at Stanford (Calif.) University. The mean duration of OA was 8 years.
Instruments used to measure efficacy included the Patient's Assessment of Arthritis Pain-Visual Analog Scale, Patients' Global Assessment of Arthritis, and the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index. Serious GI events were evaluated by two independent committees that were blinded to patient randomization.
The researchers reported that the primary efficacy measures showed that both doses of celecoxib were equally as effective as the NSAIDs in treating OA.
There were 37 confirmed upper GI events: 19 in the patients who took the NSAIDs and 18 in the patients who took celecoxib. That translated into a rate of 2.1 per 100 patient-years for patients who took the NSAIDS vs. a rate of 1.0 per 100 patient-years for those who took celecoxib. The difference was statistically significant.
A key limitation of the study, Dr. Singh said, is that it was not powered to detect differences in cardiovascular adverse events.
Dr. Spiegel said that the current standard of care for older patients with OA has “overtaken” the overall impact of the SUCCESS-1 study findings. “The reality is that people are moving to adding a proton pump inhibitor to an NSAID when [osteoarthritis] patients exceed the age of 65 or if they're put on aspirin,” he said.
Dr. Singh disclosed that he received research support from Searle Pharmaceuticals, Pharmacia, Pfizer, Merck & Co., Boehringer Ingelheim, TAP Pharmaceuticals, Wyeth, Altana Pharma, GlaxoSmithKline, Novartis Pharmaceuticals Corp., and Centocor Inc.
'Celecoxib does reduce the risk of upper GI complications, compared to conventional NSAIDs.' DR. SINGH
Anticonvulsants May Not Affect Child's IQ
TUCSON, ARIZ. — The use of carbamazepine, phenytoin, or phenobarbital as monotherapy by pregnant women was not associated with significant deficits in full-scale IQ in their offspring, a small study showed.
However, these data counter previous reports of lowered intellectual ability in children born to mothers who took anticonvulsant medications during pregnancy, Dr. Kenneth Lyons Jones said at the annual meeting of the Teratology Society.
“The results, then, should be considered in conjunction with previous studies when evaluating the risks associated with use of these medications during pregnancy,” cautioned Dr. Jones, chief of the division of dysmorphology and teratology in the department of pediatrics at the University of California, San Diego.
Despite the documented increased risk for certain major malformations following prenatal exposure to anticonvulsants, he said that “substantial controversy” exists regarding their impact on neurobehavioral outcomes.
“Compounding these concerns is the fact that in the United States, between 7.6 million and 12.7 million women have epilepsy, and 95% of them are being treated with anticonvulsant drugs,” Dr. Jones said. “In addition, 1 in every 200 pregnant women in the general population requires antiepileptic medication during her pregnancy.”
He and his associates studied 82 children aged 4–14 years whose mothers were on anticonvulsant monotherapy and contacted the California Teratogen Information Service (CTIS) during their pregnancy. Of the 82 children, 30 were exposed to carbamazepine, 23 were exposed to phenytoin, and 29 were exposed to phenobarbital.
The researchers randomly selected 50 matched controls born to women who contacted CTIS due to an exposure not deemed to be teratogenic.
All children underwent neuropsychiatric testing that included a measure of full-scale IQ (FSIQ). Testing was conducted at the Center for Behavioral Teratology at San Diego State University or in a location near the child's home.
Dr. Jones reported that 26% of children exposed to phenytoin were rated as affected with features of the anticonvulsant facies based on ratings of minor malformations, compared with 24% of those exposed to phenobarbital and only 3% of those exposed to carbamazepine. No one in the control group was considered affected.
In terms of the FSIQ, there were no statistically significant differences in scores between exposed children and controls, nor did any of the exposed children differ from each other, even after controlling for age and socioeconomic status.
Dr. Jones acknowledged certain limitations of the study, including the fact that the population studied was homogeneous, the sample size was small, and there was potential for selection bias.
TUCSON, ARIZ. — The use of carbamazepine, phenytoin, or phenobarbital as monotherapy by pregnant women was not associated with significant deficits in full-scale IQ in their offspring, a small study showed.
However, these data counter previous reports of lowered intellectual ability in children born to mothers who took anticonvulsant medications during pregnancy, Dr. Kenneth Lyons Jones said at the annual meeting of the Teratology Society.
“The results, then, should be considered in conjunction with previous studies when evaluating the risks associated with use of these medications during pregnancy,” cautioned Dr. Jones, chief of the division of dysmorphology and teratology in the department of pediatrics at the University of California, San Diego.
Despite the documented increased risk for certain major malformations following prenatal exposure to anticonvulsants, he said that “substantial controversy” exists regarding their impact on neurobehavioral outcomes.
“Compounding these concerns is the fact that in the United States, between 7.6 million and 12.7 million women have epilepsy, and 95% of them are being treated with anticonvulsant drugs,” Dr. Jones said. “In addition, 1 in every 200 pregnant women in the general population requires antiepileptic medication during her pregnancy.”
He and his associates studied 82 children aged 4–14 years whose mothers were on anticonvulsant monotherapy and contacted the California Teratogen Information Service (CTIS) during their pregnancy. Of the 82 children, 30 were exposed to carbamazepine, 23 were exposed to phenytoin, and 29 were exposed to phenobarbital.
The researchers randomly selected 50 matched controls born to women who contacted CTIS due to an exposure not deemed to be teratogenic.
All children underwent neuropsychiatric testing that included a measure of full-scale IQ (FSIQ). Testing was conducted at the Center for Behavioral Teratology at San Diego State University or in a location near the child's home.
Dr. Jones reported that 26% of children exposed to phenytoin were rated as affected with features of the anticonvulsant facies based on ratings of minor malformations, compared with 24% of those exposed to phenobarbital and only 3% of those exposed to carbamazepine. No one in the control group was considered affected.
In terms of the FSIQ, there were no statistically significant differences in scores between exposed children and controls, nor did any of the exposed children differ from each other, even after controlling for age and socioeconomic status.
Dr. Jones acknowledged certain limitations of the study, including the fact that the population studied was homogeneous, the sample size was small, and there was potential for selection bias.
TUCSON, ARIZ. — The use of carbamazepine, phenytoin, or phenobarbital as monotherapy by pregnant women was not associated with significant deficits in full-scale IQ in their offspring, a small study showed.
However, these data counter previous reports of lowered intellectual ability in children born to mothers who took anticonvulsant medications during pregnancy, Dr. Kenneth Lyons Jones said at the annual meeting of the Teratology Society.
“The results, then, should be considered in conjunction with previous studies when evaluating the risks associated with use of these medications during pregnancy,” cautioned Dr. Jones, chief of the division of dysmorphology and teratology in the department of pediatrics at the University of California, San Diego.
Despite the documented increased risk for certain major malformations following prenatal exposure to anticonvulsants, he said that “substantial controversy” exists regarding their impact on neurobehavioral outcomes.
“Compounding these concerns is the fact that in the United States, between 7.6 million and 12.7 million women have epilepsy, and 95% of them are being treated with anticonvulsant drugs,” Dr. Jones said. “In addition, 1 in every 200 pregnant women in the general population requires antiepileptic medication during her pregnancy.”
He and his associates studied 82 children aged 4–14 years whose mothers were on anticonvulsant monotherapy and contacted the California Teratogen Information Service (CTIS) during their pregnancy. Of the 82 children, 30 were exposed to carbamazepine, 23 were exposed to phenytoin, and 29 were exposed to phenobarbital.
The researchers randomly selected 50 matched controls born to women who contacted CTIS due to an exposure not deemed to be teratogenic.
All children underwent neuropsychiatric testing that included a measure of full-scale IQ (FSIQ). Testing was conducted at the Center for Behavioral Teratology at San Diego State University or in a location near the child's home.
Dr. Jones reported that 26% of children exposed to phenytoin were rated as affected with features of the anticonvulsant facies based on ratings of minor malformations, compared with 24% of those exposed to phenobarbital and only 3% of those exposed to carbamazepine. No one in the control group was considered affected.
In terms of the FSIQ, there were no statistically significant differences in scores between exposed children and controls, nor did any of the exposed children differ from each other, even after controlling for age and socioeconomic status.
Dr. Jones acknowledged certain limitations of the study, including the fact that the population studied was homogeneous, the sample size was small, and there was potential for selection bias.