Betsy Bates

SAN DIEGO – Rare is the pregnant patient whose obstetrician fails to ask whether she cleans her cat's litter, yet few are asked about conditions that pose far greater risks to them and their babies than toxoplasmosis: depression and partner abuse.

The risk of peripartum depression is 1 in 10, with consequences for mother and fetus that can be profound.

Domestic violence kills more pregnant women than any single medical complication of pregnancy.

Yet both conditions are underdiagnosed and undertreated, according to speakers at the annual meeting of the American College of Obstetricians and Gynecologists.

“As ob.gyns., we need to look at the bigger picture and understand that good prenatal and postpartum care involve a focus not just on our patients' physical health but also on their emotional and psychological health,” said Dr. Stanley Zinberg, deputy executive vice president of ACOG and vice president for practice activities.

Dr. Sharon T. Phelan, professor of obstetrics and gynecology at the University of New Mexico, Albuquerque, said she believes priorities may need to be restructured.

“It's interesting that we have laws in effect that we have to offer all women screening for certain birth defects that have a rate far lower than 10%. Yet 10% is the rate of peripartum depression,” she said.

For Dr. Paul Gluck, the need to screen for depression in perinatal visits became clear when he conducted a pilot survey of 50 obstetricians in the Miami area where he practices and found that just 2 of the respondents asked any questions about patients' mental well-being.

The potential impact of such screening struck home when he gave a longtime patient a depression screening tool as part of a research project and learned she was severely depressed.

“I'd been seeing her for years. It never dawned on me she was depressed,” he said during an ACOG press briefing.

Six weeks after he prescribed the patient an antidepressant, he received “the most beautiful letter” that he said changed his practice.

“I didn't realize how depressed I really was,” the patient wrote. “I didn't realize how much life I was missing. … The sun shines brighter.”

“I did as much good for this woman as for the woman I take to surgery to perform a hysterectomy,” Dr. Gluck said. “This is something we can be diagnosing and treating within the scope of an ob.gyn. practice.”

Dr. Zinberg said maternal depression seems to get little attention, “except when tragedies occur such as Andrea Yates [the Texas mother with postpartum depression who drowned her children] or when celebrities are involved.”

Postpartum psychosis, suicide, and homocide are only the most visible consequences of maternal depression, emphasized Dr. Phelan.

Depressed women self-medicate with cigarettes, alcohol, and other drugs. Their depression often prevents them from seeking prenatal care or following advice for a healthy pregnancy. They are more prone than are other women to preterm labor, delivery of small-for-gestational-age infants, and even fetal death. As mothers, they may be inattentive and have trouble bonding with their infants, while struggling to find energy and focus to care for their older children.

Screening tools are often helpful in spotting these patients, since many symptoms of depression overlap with normal occurrences in pregnancy and new parenthood, including fatigue, sleep problems, changes in appetite, and mood swings.

Dr. Gluck said that he has implemented a multipronged approach to screening.

His general intake questionnaire now includes two mental health questions: “Do you feel down or depressed?” and “Do you not enjoy doing things you used to enjoy?”

He has trained his nurses to weave several questions about psychological well-being into the conversation while patients are being weighed and having their blood pressure taken. For example, they will say, “How are things going in your life? Are you feeling down at all?”

If either the intake form or the nurse indicates there might be reason to suspect a patient has depression, he uses a validated, 20-question screening tool. Patients found to have suicidal ideation are handled as “a medical emergency as much as a ruptured appendix.” He refers to a trusted network of mental health professionals.

He refers other patients for psychotherapy and/or prescribes antidepressants himself, although he is fully supportive of colleagues who refer all patients with depression to mental health professionals. Not all ob.gyns. feel comfortable managing psychotropic medications, but all should make the effort to find out if their patients are depressed, he said.

“I think it's very important that we're the ones doing the screening. We're the ones who have contact with women throughout their pregnancies and … throughout their whole lifetimes,” he said.

Screening for intimate partner violence was also highlighted at the meeting, including an award-winning paper by Dr. Jennifer Ballard Dwan, a maternal-fetal medicine fellow at Brown University, Providence, R.I.

Dr. Dwan compared screening for toxoplasmosis, which has an estimated incidence of 0.001%, with intimate partner violence, which occurs in approximately 4%-8% of pregnancies.

Among 324 randomly selected pregnant women seen at private and public clinics, 68% were asked about cat exposure and 16% were screened for intimate partner violence. Of note, 15% of women screened positive for domestic violence when asked, she said.

Women attending public clinics were far more likely to be screened for domestic violence than were privately insured women, while the reverse was true for screening about cat exposure.

During the press briefing, Dr. Phelan said she “almost … worries more” about middle- to higher-income women being missed during depression screening as well. When it's a 16-year-old who's in a crisis pregnancy, people are more likely to accept that she might be depressed, she said.

Old myths die hard when it comes to a married, economically stable woman with a “very planned pregnancy” who becomes depressed. “There's an idea that if she were strong, she could overcome it,” certainly without taking a medication that has a remote chance of harming her baby.

“I don't see us hesitating to tell the overweight, type 2 diabetic patient [to take her diabetes medication],” said Dr. Phelan.

SAN DIEGO – Rare is the pregnant patient whose obstetrician fails to ask whether she cleans her cat's litter, yet few are asked about conditions that pose far greater risks to them and their babies than toxoplasmosis: depression and partner abuse.

The risk of peripartum depression is 1 in 10, with consequences for mother and fetus that can be profound.

Domestic violence kills more pregnant women than any single medical complication of pregnancy.

Yet both conditions are underdiagnosed and undertreated, according to speakers at the annual meeting of the American College of Obstetricians and Gynecologists.

“As ob.gyns., we need to look at the bigger picture and understand that good prenatal and postpartum care involve a focus not just on our patients' physical health but also on their emotional and psychological health,” said Dr. Stanley Zinberg, deputy executive vice president of ACOG and vice president for practice activities.

Dr. Sharon T. Phelan, professor of obstetrics and gynecology at the University of New Mexico, Albuquerque, said she believes priorities may need to be restructured.

“It's interesting that we have laws in effect that we have to offer all women screening for certain birth defects that have a rate far lower than 10%. Yet 10% is the rate of peripartum depression,” she said.

For Dr. Paul Gluck, the need to screen for depression in perinatal visits became clear when he conducted a pilot survey of 50 obstetricians in the Miami area where he practices and found that just 2 of the respondents asked any questions about patients' mental well-being.

The potential impact of such screening struck home when he gave a longtime patient a depression screening tool as part of a research project and learned she was severely depressed.

“I'd been seeing her for years. It never dawned on me she was depressed,” he said during an ACOG press briefing.

Six weeks after he prescribed the patient an antidepressant, he received “the most beautiful letter” that he said changed his practice.

“I didn't realize how depressed I really was,” the patient wrote. “I didn't realize how much life I was missing. … The sun shines brighter.”

“I did as much good for this woman as for the woman I take to surgery to perform a hysterectomy,” Dr. Gluck said. “This is something we can be diagnosing and treating within the scope of an ob.gyn. practice.”

Dr. Zinberg said maternal depression seems to get little attention, “except when tragedies occur such as Andrea Yates [the Texas mother with postpartum depression who drowned her children] or when celebrities are involved.”

Postpartum psychosis, suicide, and homocide are only the most visible consequences of maternal depression, emphasized Dr. Phelan.

Depressed women self-medicate with cigarettes, alcohol, and other drugs. Their depression often prevents them from seeking prenatal care or following advice for a healthy pregnancy. They are more prone than are other women to preterm labor, delivery of small-for-gestational-age infants, and even fetal death. As mothers, they may be inattentive and have trouble bonding with their infants, while struggling to find energy and focus to care for their older children.

Screening tools are often helpful in spotting these patients, since many symptoms of depression overlap with normal occurrences in pregnancy and new parenthood, including fatigue, sleep problems, changes in appetite, and mood swings.

Dr. Gluck said that he has implemented a multipronged approach to screening.

His general intake questionnaire now includes two mental health questions: “Do you feel down or depressed?” and “Do you not enjoy doing things you used to enjoy?”

He has trained his nurses to weave several questions about psychological well-being into the conversation while patients are being weighed and having their blood pressure taken. For example, they will say, “How are things going in your life? Are you feeling down at all?”

If either the intake form or the nurse indicates there might be reason to suspect a patient has depression, he uses a validated, 20-question screening tool. Patients found to have suicidal ideation are handled as “a medical emergency as much as a ruptured appendix.” He refers to a trusted network of mental health professionals.

He refers other patients for psychotherapy and/or prescribes antidepressants himself, although he is fully supportive of colleagues who refer all patients with depression to mental health professionals. Not all ob.gyns. feel comfortable managing psychotropic medications, but all should make the effort to find out if their patients are depressed, he said.

“I think it's very important that we're the ones doing the screening. We're the ones who have contact with women throughout their pregnancies and … throughout their whole lifetimes,” he said.

Screening for intimate partner violence was also highlighted at the meeting, including an award-winning paper by Dr. Jennifer Ballard Dwan, a maternal-fetal medicine fellow at Brown University, Providence, R.I.

Dr. Dwan compared screening for toxoplasmosis, which has an estimated incidence of 0.001%, with intimate partner violence, which occurs in approximately 4%-8% of pregnancies.

Among 324 randomly selected pregnant women seen at private and public clinics, 68% were asked about cat exposure and 16% were screened for intimate partner violence. Of note, 15% of women screened positive for domestic violence when asked, she said.

Women attending public clinics were far more likely to be screened for domestic violence than were privately insured women, while the reverse was true for screening about cat exposure.

During the press briefing, Dr. Phelan said she “almost … worries more” about middle- to higher-income women being missed during depression screening as well. When it's a 16-year-old who's in a crisis pregnancy, people are more likely to accept that she might be depressed, she said.

Old myths die hard when it comes to a married, economically stable woman with a “very planned pregnancy” who becomes depressed. “There's an idea that if she were strong, she could overcome it,” certainly without taking a medication that has a remote chance of harming her baby.

“I don't see us hesitating to tell the overweight, type 2 diabetic patient [to take her diabetes medication],” said Dr. Phelan.

SAN DIEGO – Rare is the pregnant patient whose obstetrician fails to ask whether she cleans her cat's litter, yet few are asked about conditions that pose far greater risks to them and their babies than toxoplasmosis: depression and partner abuse.

The risk of peripartum depression is 1 in 10, with consequences for mother and fetus that can be profound.

Domestic violence kills more pregnant women than any single medical complication of pregnancy.

Yet both conditions are underdiagnosed and undertreated, according to speakers at the annual meeting of the American College of Obstetricians and Gynecologists.

“As ob.gyns., we need to look at the bigger picture and understand that good prenatal and postpartum care involve a focus not just on our patients' physical health but also on their emotional and psychological health,” said Dr. Stanley Zinberg, deputy executive vice president of ACOG and vice president for practice activities.

Dr. Sharon T. Phelan, professor of obstetrics and gynecology at the University of New Mexico, Albuquerque, said she believes priorities may need to be restructured.

“It's interesting that we have laws in effect that we have to offer all women screening for certain birth defects that have a rate far lower than 10%. Yet 10% is the rate of peripartum depression,” she said.

For Dr. Paul Gluck, the need to screen for depression in perinatal visits became clear when he conducted a pilot survey of 50 obstetricians in the Miami area where he practices and found that just 2 of the respondents asked any questions about patients' mental well-being.

The potential impact of such screening struck home when he gave a longtime patient a depression screening tool as part of a research project and learned she was severely depressed.

“I'd been seeing her for years. It never dawned on me she was depressed,” he said during an ACOG press briefing.

Six weeks after he prescribed the patient an antidepressant, he received “the most beautiful letter” that he said changed his practice.

“I didn't realize how depressed I really was,” the patient wrote. “I didn't realize how much life I was missing. … The sun shines brighter.”

“I did as much good for this woman as for the woman I take to surgery to perform a hysterectomy,” Dr. Gluck said. “This is something we can be diagnosing and treating within the scope of an ob.gyn. practice.”

Dr. Zinberg said maternal depression seems to get little attention, “except when tragedies occur such as Andrea Yates [the Texas mother with postpartum depression who drowned her children] or when celebrities are involved.”

Postpartum psychosis, suicide, and homocide are only the most visible consequences of maternal depression, emphasized Dr. Phelan.

Depressed women self-medicate with cigarettes, alcohol, and other drugs. Their depression often prevents them from seeking prenatal care or following advice for a healthy pregnancy. They are more prone than are other women to preterm labor, delivery of small-for-gestational-age infants, and even fetal death. As mothers, they may be inattentive and have trouble bonding with their infants, while struggling to find energy and focus to care for their older children.

Screening tools are often helpful in spotting these patients, since many symptoms of depression overlap with normal occurrences in pregnancy and new parenthood, including fatigue, sleep problems, changes in appetite, and mood swings.

Dr. Gluck said that he has implemented a multipronged approach to screening.

His general intake questionnaire now includes two mental health questions: “Do you feel down or depressed?” and “Do you not enjoy doing things you used to enjoy?”

He has trained his nurses to weave several questions about psychological well-being into the conversation while patients are being weighed and having their blood pressure taken. For example, they will say, “How are things going in your life? Are you feeling down at all?”

If either the intake form or the nurse indicates there might be reason to suspect a patient has depression, he uses a validated, 20-question screening tool. Patients found to have suicidal ideation are handled as “a medical emergency as much as a ruptured appendix.” He refers to a trusted network of mental health professionals.

He refers other patients for psychotherapy and/or prescribes antidepressants himself, although he is fully supportive of colleagues who refer all patients with depression to mental health professionals. Not all ob.gyns. feel comfortable managing psychotropic medications, but all should make the effort to find out if their patients are depressed, he said.

“I think it's very important that we're the ones doing the screening. We're the ones who have contact with women throughout their pregnancies and … throughout their whole lifetimes,” he said.

Screening for intimate partner violence was also highlighted at the meeting, including an award-winning paper by Dr. Jennifer Ballard Dwan, a maternal-fetal medicine fellow at Brown University, Providence, R.I.

Dr. Dwan compared screening for toxoplasmosis, which has an estimated incidence of 0.001%, with intimate partner violence, which occurs in approximately 4%-8% of pregnancies.

Among 324 randomly selected pregnant women seen at private and public clinics, 68% were asked about cat exposure and 16% were screened for intimate partner violence. Of note, 15% of women screened positive for domestic violence when asked, she said.

Women attending public clinics were far more likely to be screened for domestic violence than were privately insured women, while the reverse was true for screening about cat exposure.

During the press briefing, Dr. Phelan said she “almost … worries more” about middle- to higher-income women being missed during depression screening as well. When it's a 16-year-old who's in a crisis pregnancy, people are more likely to accept that she might be depressed, she said.

Old myths die hard when it comes to a married, economically stable woman with a “very planned pregnancy” who becomes depressed. “There's an idea that if she were strong, she could overcome it,” certainly without taking a medication that has a remote chance of harming her baby.

“I don't see us hesitating to tell the overweight, type 2 diabetic patient [to take her diabetes medication],” said Dr. Phelan.

ANAHEIM, CALIF. – Women admitted to the hospital for nephrolithiasis in pregnancy have a nearly 80% elevated risk of preterm delivery, according to a retrospective cohort study of more than 2,000 cases in Washington State over 16 years.

The finding, announced at the annual meeting of the American Urological Association, may prompt more definitive treatment of small, asymptomatic kidney stones in women of childbearing age, especially those planning pregnancy.

Small case series dating back to the 1980s have raised the possibility that kidney stones during pregnancy may have an impact on birth outcomes, but the study conducted at the University of Washington in Seattle is believed to be the first large-scale attempt to track cases to delivery.

Dr. Mia A. Swartz and associates in the department of urology used birth certificate data and hospital discharge records to link peripartum records of 2,239 women who had been admitted to hospitals within the previous 9 months with a diagnosis of nephrolithiasis. These records were matched in a 3:1 ratio with 6,729 women of the same age who gave birth the same years.

The incidence of nephrolithiasis requiring hospital admission in pregnant women was 0.17%. The diagnosis was more frequently seen in white women, those with hypertension, and those with renal disease. Nearly 26% received at least one procedure for nephrolithiasis during hospitalization–most frequently, ureteral stents.

Women hospitalized with nephrolithiasis were significantly more likely to have a diagnosis of pyelonephritis at delivery. However, when investigators statistically controlled for the presence of pyelonephritis, relative risk of delivery at or before 37 weeks remained 1.79 (1.51-2.13).

About 10% of women admitted for kidney stones at any point in pregnancy gave birth early, compared with 6.4% of control women, a highly statistically significant difference.

Neither the trimester during which the nephrolithiasis admission occurred, nor the treatment procedure administered, influenced the results.

Use of tocolytics was highly correlated with preterm birth in the nephrolithiasis cohort, suggesting that the finding represents true preterm labor, rather than induction of early labor to permit treatment of symptomatic kidney stones, Dr. Swartz said during her podium presentation.

The database study captured only women who delivered a live infant after a hospital admission for nephrolithiasis, missing those treated on an outpatient basis and any who miscarried early in pregnancy, she noted. Further, “it was underpowered to detect rare outcomes, such as infant death.”

Dr. Swartz said that while a large, prospective study would be useful, the findings have “important implications.”

“I believe it provides a basis for counseling women with nephrolithiasis during pregnancy and may prompt definitive management or treatment of small, asymptomatic stones in women planning pregnancy,” she said.

An audience member questioned that conclusion, saying many young women have small, asymptomatic stones that may not require treatment, “even if they are recurrent stone formers.”

The session moderator, Dr. John D. Denstedt, interjected that his institution takes “a little more proactive approach” that appears to be justified based on the new University of Washington findings.

“We get into a full discussion with these patients with asymptomatic … stones and what the implications would be if the stone would become symptomatic in pregnancy,” said Dr. Denstedt, professor and chief of surgery at the University of Western Ontario in London.

The shock wave machine is not an option during pregnancy, he said. As a result, many such patients opt for shock wave lithotripsy in advance of becoming pregnant, Dr. Denstedt added.

ANAHEIM, CALIF. – Women admitted to the hospital for nephrolithiasis in pregnancy have a nearly 80% elevated risk of preterm delivery, according to a retrospective cohort study of more than 2,000 cases in Washington State over 16 years.

The finding, announced at the annual meeting of the American Urological Association, may prompt more definitive treatment of small, asymptomatic kidney stones in women of childbearing age, especially those planning pregnancy.

Small case series dating back to the 1980s have raised the possibility that kidney stones during pregnancy may have an impact on birth outcomes, but the study conducted at the University of Washington in Seattle is believed to be the first large-scale attempt to track cases to delivery.

Dr. Mia A. Swartz and associates in the department of urology used birth certificate data and hospital discharge records to link peripartum records of 2,239 women who had been admitted to hospitals within the previous 9 months with a diagnosis of nephrolithiasis. These records were matched in a 3:1 ratio with 6,729 women of the same age who gave birth the same years.

The incidence of nephrolithiasis requiring hospital admission in pregnant women was 0.17%. The diagnosis was more frequently seen in white women, those with hypertension, and those with renal disease. Nearly 26% received at least one procedure for nephrolithiasis during hospitalization–most frequently, ureteral stents.

Women hospitalized with nephrolithiasis were significantly more likely to have a diagnosis of pyelonephritis at delivery. However, when investigators statistically controlled for the presence of pyelonephritis, relative risk of delivery at or before 37 weeks remained 1.79 (1.51-2.13).

About 10% of women admitted for kidney stones at any point in pregnancy gave birth early, compared with 6.4% of control women, a highly statistically significant difference.

Neither the trimester during which the nephrolithiasis admission occurred, nor the treatment procedure administered, influenced the results.

Use of tocolytics was highly correlated with preterm birth in the nephrolithiasis cohort, suggesting that the finding represents true preterm labor, rather than induction of early labor to permit treatment of symptomatic kidney stones, Dr. Swartz said during her podium presentation.

The database study captured only women who delivered a live infant after a hospital admission for nephrolithiasis, missing those treated on an outpatient basis and any who miscarried early in pregnancy, she noted. Further, “it was underpowered to detect rare outcomes, such as infant death.”

Dr. Swartz said that while a large, prospective study would be useful, the findings have “important implications.”

“I believe it provides a basis for counseling women with nephrolithiasis during pregnancy and may prompt definitive management or treatment of small, asymptomatic stones in women planning pregnancy,” she said.

An audience member questioned that conclusion, saying many young women have small, asymptomatic stones that may not require treatment, “even if they are recurrent stone formers.”

The session moderator, Dr. John D. Denstedt, interjected that his institution takes “a little more proactive approach” that appears to be justified based on the new University of Washington findings.

“We get into a full discussion with these patients with asymptomatic … stones and what the implications would be if the stone would become symptomatic in pregnancy,” said Dr. Denstedt, professor and chief of surgery at the University of Western Ontario in London.

The shock wave machine is not an option during pregnancy, he said. As a result, many such patients opt for shock wave lithotripsy in advance of becoming pregnant, Dr. Denstedt added.

ANAHEIM, CALIF. – Women admitted to the hospital for nephrolithiasis in pregnancy have a nearly 80% elevated risk of preterm delivery, according to a retrospective cohort study of more than 2,000 cases in Washington State over 16 years.

The finding, announced at the annual meeting of the American Urological Association, may prompt more definitive treatment of small, asymptomatic kidney stones in women of childbearing age, especially those planning pregnancy.

Small case series dating back to the 1980s have raised the possibility that kidney stones during pregnancy may have an impact on birth outcomes, but the study conducted at the University of Washington in Seattle is believed to be the first large-scale attempt to track cases to delivery.

Dr. Mia A. Swartz and associates in the department of urology used birth certificate data and hospital discharge records to link peripartum records of 2,239 women who had been admitted to hospitals within the previous 9 months with a diagnosis of nephrolithiasis. These records were matched in a 3:1 ratio with 6,729 women of the same age who gave birth the same years.

The incidence of nephrolithiasis requiring hospital admission in pregnant women was 0.17%. The diagnosis was more frequently seen in white women, those with hypertension, and those with renal disease. Nearly 26% received at least one procedure for nephrolithiasis during hospitalization–most frequently, ureteral stents.

Women hospitalized with nephrolithiasis were significantly more likely to have a diagnosis of pyelonephritis at delivery. However, when investigators statistically controlled for the presence of pyelonephritis, relative risk of delivery at or before 37 weeks remained 1.79 (1.51-2.13).

About 10% of women admitted for kidney stones at any point in pregnancy gave birth early, compared with 6.4% of control women, a highly statistically significant difference.

Neither the trimester during which the nephrolithiasis admission occurred, nor the treatment procedure administered, influenced the results.

Use of tocolytics was highly correlated with preterm birth in the nephrolithiasis cohort, suggesting that the finding represents true preterm labor, rather than induction of early labor to permit treatment of symptomatic kidney stones, Dr. Swartz said during her podium presentation.

The database study captured only women who delivered a live infant after a hospital admission for nephrolithiasis, missing those treated on an outpatient basis and any who miscarried early in pregnancy, she noted. Further, “it was underpowered to detect rare outcomes, such as infant death.”

Dr. Swartz said that while a large, prospective study would be useful, the findings have “important implications.”

“I believe it provides a basis for counseling women with nephrolithiasis during pregnancy and may prompt definitive management or treatment of small, asymptomatic stones in women planning pregnancy,” she said.

An audience member questioned that conclusion, saying many young women have small, asymptomatic stones that may not require treatment, “even if they are recurrent stone formers.”

The session moderator, Dr. John D. Denstedt, interjected that his institution takes “a little more proactive approach” that appears to be justified based on the new University of Washington findings.

“We get into a full discussion with these patients with asymptomatic … stones and what the implications would be if the stone would become symptomatic in pregnancy,” said Dr. Denstedt, professor and chief of surgery at the University of Western Ontario in London.

The shock wave machine is not an option during pregnancy, he said. As a result, many such patients opt for shock wave lithotripsy in advance of becoming pregnant, Dr. Denstedt added.

STANFORD, CALIF. — Preliminary analysis of a randomized, double-blind, placebo-controlled study of donepezil suggests the Alzheimer's drug may slightly improve neuropsychologic function in children with autism, Dr. Antonio Hardan said at a pediatric update.

At the halfway point in a 20-week trial, improvements were seen in scores on some, but not all, neurocognitive tests among 10 autistic children aged 7–17 years receiving the drug, compared with 10 receiving placebo.

Specifically, children somewhat improved their performance on tests aimed at measuring spatial executive functioning (the Design Fluency Test), selective attention (the Color-Word Interference Test) and the California Verbal Learning Test.

“We didn't see magic improvement or large improvements,” emphasized Dr. Hardan, director of the Autism and Developmental Disabilities Clinic at Lucile Packard Children's Hospital of Stanford (Calif.) University. No improvement was seen on the Expressive One-Word Vocabulary Test, which measures language skills.

At the pediatric update, sponsored by Stanford University, Dr. Hardan emphasized that the trial is small and incomplete, and the results should be interpreted with caution. “But what is nice about this is it opens up a whole group of medications to study,” he said.

The use of donepezil (Aricept) in autism was first studied by Dr. Hardan at the University of Pittsburgh in an open-label study of eight children, half of whom demonstrated improvement on the Aberrant Behavior Checklist and Clinical Global Impression Scale. Improvements were suggested in irritability and hyperactivity, but not in inappropriate speech, lethargy, or stereotypies, he reported (J. Child Adolesc. Psychopharmacol.2002;12:237–41).

Another novel study is ongoing at Indiana University, Indianapolis, where a broad-spectrum antibiotic once used to treat tuberculosis led to improvement in social withdrawal in a pilot study. A randomized, double-blind study pitting d-cycloserine, a partial agonist of the N-methyl-D-Aspartate (NMDA) glutamate receptor subtype, against placebo is underway.

Although these are small studies, it is encouraging to see research into existing drugs to determine whether they might be effective in treating children with autism spectrum disorders, he said.

It took 15 years for risperidone (Risperdal) to be approved for autism-related irritability, noted Dr. Hardan.

Parents who must wait so long for drug approval feel they are “losing a lot of time,” he said. “That's why they jump at any opportunity [to use a treatment, even one] that could be potentially hazardous for their child.”

Dr. Harden stressed that research must be driven by theories that make scientific sense, followed by proof-of-concept studies to see whether evidence exists that an agent may be helpful.

He pointed to “the [high] price of shortcuts,” such as secretin, hailed as a possible treatment based on one uncontrolled observational study that hinted it may have improved behavior in three children undergoing gastrointestinal procedures. No verification was made to determine whether the children actually met diagnostic criteria for autism, he noted. “Based on this, secretin was unfortunately the most studied medication in autism.”

Fifteen randomized, double-blind studies eventually produced uniformly negative results.

The scientific community must “get realistic and not waste our resources,” when it comes to allotting funding for potentially beneficial treatments, he urged.

Is Autism Prevalence Truly on the Rise?

An apparent increase in the prevalence of autism and autistic spectrum disorders may be explained by differences in diagnosis, said Dr. Hardan.

Much of the increase in prevalence is among children with mild symptoms: children with high-functioning autism, Asperger's syndrome, and pervasive developmental disorder, not otherwise specified.

“Fifteen or 20 years ago when somebody was verbal, it was very unlikely people were going to consider this an autism spectrum disorder,” he said. On the other hand, children with moderate to severe mental retardation were given that diagnosis in the past. Today many receive an autism diagnosis instead.

Traditionally, autism spectrum disorders were exclusively made in school-age children. “Now people in their 20s and 30s who are struggling in daily living activities come to us and ask: 'Do I have an autism spectrum disorder?' Sometimes, some people do,” said Dr. Hardan. An adulthood diagnosis would have been unthinkable years ago.

Another contributor to the apparently increasing prevalence of autism is simple misdiagnosis, he said. Children with ADHD very often have social deficits, difficulties in developing peer relationships, and “poor coherence between visual and verbal behaviors.”

Children misdiagnosed as autistic include those with severe anxiety symptoms and early-onset personality disorders. Children with reactive attachment disorders, often adopted from overseas, have features that could mistakenly lead a clinician to diagnose autism, including severe social deficits and stereotypical behaviors, he said.

STANFORD, CALIF. — Preliminary analysis of a randomized, double-blind, placebo-controlled study of donepezil suggests the Alzheimer's drug may slightly improve neuropsychologic function in children with autism, Dr. Antonio Hardan said at a pediatric update.

At the halfway point in a 20-week trial, improvements were seen in scores on some, but not all, neurocognitive tests among 10 autistic children aged 7–17 years receiving the drug, compared with 10 receiving placebo.

Specifically, children somewhat improved their performance on tests aimed at measuring spatial executive functioning (the Design Fluency Test), selective attention (the Color-Word Interference Test) and the California Verbal Learning Test.

“We didn't see magic improvement or large improvements,” emphasized Dr. Hardan, director of the Autism and Developmental Disabilities Clinic at Lucile Packard Children's Hospital of Stanford (Calif.) University. No improvement was seen on the Expressive One-Word Vocabulary Test, which measures language skills.

At the pediatric update, sponsored by Stanford University, Dr. Hardan emphasized that the trial is small and incomplete, and the results should be interpreted with caution. “But what is nice about this is it opens up a whole group of medications to study,” he said.

The use of donepezil (Aricept) in autism was first studied by Dr. Hardan at the University of Pittsburgh in an open-label study of eight children, half of whom demonstrated improvement on the Aberrant Behavior Checklist and Clinical Global Impression Scale. Improvements were suggested in irritability and hyperactivity, but not in inappropriate speech, lethargy, or stereotypies, he reported (J. Child Adolesc. Psychopharmacol.2002;12:237–41).

Another novel study is ongoing at Indiana University, Indianapolis, where a broad-spectrum antibiotic once used to treat tuberculosis led to improvement in social withdrawal in a pilot study. A randomized, double-blind study pitting d-cycloserine, a partial agonist of the N-methyl-D-Aspartate (NMDA) glutamate receptor subtype, against placebo is underway.

Although these are small studies, it is encouraging to see research into existing drugs to determine whether they might be effective in treating children with autism spectrum disorders, he said.

It took 15 years for risperidone (Risperdal) to be approved for autism-related irritability, noted Dr. Hardan.

Parents who must wait so long for drug approval feel they are “losing a lot of time,” he said. “That's why they jump at any opportunity [to use a treatment, even one] that could be potentially hazardous for their child.”

Dr. Harden stressed that research must be driven by theories that make scientific sense, followed by proof-of-concept studies to see whether evidence exists that an agent may be helpful.

He pointed to “the [high] price of shortcuts,” such as secretin, hailed as a possible treatment based on one uncontrolled observational study that hinted it may have improved behavior in three children undergoing gastrointestinal procedures. No verification was made to determine whether the children actually met diagnostic criteria for autism, he noted. “Based on this, secretin was unfortunately the most studied medication in autism.”

Fifteen randomized, double-blind studies eventually produced uniformly negative results.

The scientific community must “get realistic and not waste our resources,” when it comes to allotting funding for potentially beneficial treatments, he urged.

Is Autism Prevalence Truly on the Rise?

An apparent increase in the prevalence of autism and autistic spectrum disorders may be explained by differences in diagnosis, said Dr. Hardan.

Much of the increase in prevalence is among children with mild symptoms: children with high-functioning autism, Asperger's syndrome, and pervasive developmental disorder, not otherwise specified.

“Fifteen or 20 years ago when somebody was verbal, it was very unlikely people were going to consider this an autism spectrum disorder,” he said. On the other hand, children with moderate to severe mental retardation were given that diagnosis in the past. Today many receive an autism diagnosis instead.

Traditionally, autism spectrum disorders were exclusively made in school-age children. “Now people in their 20s and 30s who are struggling in daily living activities come to us and ask: 'Do I have an autism spectrum disorder?' Sometimes, some people do,” said Dr. Hardan. An adulthood diagnosis would have been unthinkable years ago.

Another contributor to the apparently increasing prevalence of autism is simple misdiagnosis, he said. Children with ADHD very often have social deficits, difficulties in developing peer relationships, and “poor coherence between visual and verbal behaviors.”

Children misdiagnosed as autistic include those with severe anxiety symptoms and early-onset personality disorders. Children with reactive attachment disorders, often adopted from overseas, have features that could mistakenly lead a clinician to diagnose autism, including severe social deficits and stereotypical behaviors, he said.

STANFORD, CALIF. — Preliminary analysis of a randomized, double-blind, placebo-controlled study of donepezil suggests the Alzheimer's drug may slightly improve neuropsychologic function in children with autism, Dr. Antonio Hardan said at a pediatric update.

At the halfway point in a 20-week trial, improvements were seen in scores on some, but not all, neurocognitive tests among 10 autistic children aged 7–17 years receiving the drug, compared with 10 receiving placebo.

Specifically, children somewhat improved their performance on tests aimed at measuring spatial executive functioning (the Design Fluency Test), selective attention (the Color-Word Interference Test) and the California Verbal Learning Test.

“We didn't see magic improvement or large improvements,” emphasized Dr. Hardan, director of the Autism and Developmental Disabilities Clinic at Lucile Packard Children's Hospital of Stanford (Calif.) University. No improvement was seen on the Expressive One-Word Vocabulary Test, which measures language skills.

At the pediatric update, sponsored by Stanford University, Dr. Hardan emphasized that the trial is small and incomplete, and the results should be interpreted with caution. “But what is nice about this is it opens up a whole group of medications to study,” he said.

The use of donepezil (Aricept) in autism was first studied by Dr. Hardan at the University of Pittsburgh in an open-label study of eight children, half of whom demonstrated improvement on the Aberrant Behavior Checklist and Clinical Global Impression Scale. Improvements were suggested in irritability and hyperactivity, but not in inappropriate speech, lethargy, or stereotypies, he reported (J. Child Adolesc. Psychopharmacol.2002;12:237–41).

Another novel study is ongoing at Indiana University, Indianapolis, where a broad-spectrum antibiotic once used to treat tuberculosis led to improvement in social withdrawal in a pilot study. A randomized, double-blind study pitting d-cycloserine, a partial agonist of the N-methyl-D-Aspartate (NMDA) glutamate receptor subtype, against placebo is underway.

Although these are small studies, it is encouraging to see research into existing drugs to determine whether they might be effective in treating children with autism spectrum disorders, he said.

It took 15 years for risperidone (Risperdal) to be approved for autism-related irritability, noted Dr. Hardan.

Parents who must wait so long for drug approval feel they are “losing a lot of time,” he said. “That's why they jump at any opportunity [to use a treatment, even one] that could be potentially hazardous for their child.”

Dr. Harden stressed that research must be driven by theories that make scientific sense, followed by proof-of-concept studies to see whether evidence exists that an agent may be helpful.

He pointed to “the [high] price of shortcuts,” such as secretin, hailed as a possible treatment based on one uncontrolled observational study that hinted it may have improved behavior in three children undergoing gastrointestinal procedures. No verification was made to determine whether the children actually met diagnostic criteria for autism, he noted. “Based on this, secretin was unfortunately the most studied medication in autism.”

Fifteen randomized, double-blind studies eventually produced uniformly negative results.

The scientific community must “get realistic and not waste our resources,” when it comes to allotting funding for potentially beneficial treatments, he urged.

Is Autism Prevalence Truly on the Rise?

An apparent increase in the prevalence of autism and autistic spectrum disorders may be explained by differences in diagnosis, said Dr. Hardan.

Much of the increase in prevalence is among children with mild symptoms: children with high-functioning autism, Asperger's syndrome, and pervasive developmental disorder, not otherwise specified.

“Fifteen or 20 years ago when somebody was verbal, it was very unlikely people were going to consider this an autism spectrum disorder,” he said. On the other hand, children with moderate to severe mental retardation were given that diagnosis in the past. Today many receive an autism diagnosis instead.

Traditionally, autism spectrum disorders were exclusively made in school-age children. “Now people in their 20s and 30s who are struggling in daily living activities come to us and ask: 'Do I have an autism spectrum disorder?' Sometimes, some people do,” said Dr. Hardan. An adulthood diagnosis would have been unthinkable years ago.

Another contributor to the apparently increasing prevalence of autism is simple misdiagnosis, he said. Children with ADHD very often have social deficits, difficulties in developing peer relationships, and “poor coherence between visual and verbal behaviors.”

Children misdiagnosed as autistic include those with severe anxiety symptoms and early-onset personality disorders. Children with reactive attachment disorders, often adopted from overseas, have features that could mistakenly lead a clinician to diagnose autism, including severe social deficits and stereotypical behaviors, he said.

STANFORD, CALIF. – A preliminary analysis of a randomized, double-blind, placebo-controlled study of donepezil suggests that the Alzheimer's drug may slightly improve some neuropsychologic functions in children with autism, Dr. Antonio Hardan said at a pediatric update sponsored by Stanford University.

At the halfway point in a 20-week trial, improvements were seen in scores on the some, but not all, neurocognitive tests among 10 autistic children aged 7–17 years receiving the drug, compared with 10 receiving placebo.

Specifically, children somewhat improved their performance on tests aimed at measuring spatial executive functioning (the Design Fluency Test), selective attention (the Color-Word Interference Test) and the California Verbal Learning Test.

“We didn't see magic improvement or large improvements,” said Dr. Hardan, director of the autism and developmental disabilities clinic at Lucile Packard Children's Hospital of Stanford (Calif.) University.

No improvement was seen on the Expressive One-Word Vocabulary Test, which measures language skills.

The trial is small and incomplete, and the results should be interpreted with caution, Dr. Hardan said, but “it opens up a whole group of medications to study.”

The use of donepezil (Aricept) in autism was first studied by Dr. Hardan at the University of Pittsburgh in an open-label study of eight children, half of whom demonstrated improvement on the Aberrant Behavior Checklist and Clinical Global Impression Scale. Improvements were suggested in irritability and hyperactivity, but not in inappropriate speech, lethargy, or stereotypies, he reported (J. Child Adolesc. Psychopharmacol. 2002;12:237–41).

Another novel study of an existing drug in autism is ongoing at Indiana University, Indianapolis, where a broad-spectrum antibiotic once used to treat tuberculosis led to apparent improvement in social withdrawal in a pilot study. A randomized, double-blind study is currently underway, pitting d-cycloserine, a partial agonist of the N-methyl-D-Aspartate (NMDA) glutamate receptor subtype, against placebo, Dr. Hardan said. Although these are small studies, it is encouraging to see research into existing drugs to determine whether they might be effective in treating children with autism spectrum disorders, he said.

It took 15 years for risperidone (Risperdal) to be approved for the treatment of autism-related irritability, noted Dr. Hardan, who published an early case study suggesting the drug's efficacy in 1996. Parents who must wait so long for drug approval feel they are “losing a lot of time,” he said. “That's why they jump at any opportunity [to use a treatment, even one] that could be potentially hazardous for their child.”

Dr. Hardan stressed that research must be driven by theories that make scientific sense, followed by proof-of-concept studies to see whether evidence exists that an agent may be helpful.

He pointed to “the [high] price of shortcuts,” such as secretin, hailed as a possible treatment based on one uncontrolled observational study that hinted it may have improved behavior in three children undergoing gastrointestinal procedures. No verification was made to determine whether the children actually met diagnostic criteria for autism, he noted. “Based on this, secretin was unfortunately the most studied medication in autism.”

Fifteen randomized, double-blind studies eventually produced uniformly negative results. “You can't find anything consistent like that in medicine,” he said.

The scientific community needs to “get realistic” when it comes to funding potentially beneficial treatments, he urged.

Is Autism on the Rise or Is the Diagnosis Expanding?

An apparent increase in the prevalence of autism and autistic spectrum disorders (ASDs) may be largely explained by differences in diagnosis, rather than true differences in the number of children with these conditions, Dr. Hardan suggested.

“Is there an increase in incidence versus an increase in recognition?” asked Dr. Hardan. Several observations point to the latter, he said.

Much of the increase in prevalence is among children with mild symptoms: children with high-functioning autism, those with Asperger's syndrome, and children with pervasive developmental disorder, not otherwise specified.

“Fifteen or 20 years ago when somebody was verbal, it was very unlikely people were going to consider this an autism spectrum disorder,” he said.

On the other end of the spectrum, children with moderate to severe mental retardation were given that diagnosis decades ago, whereas today many children receive the autism diagnosis.

Traditionally, autism spectrum disorders were exclusively made in school-age children. “Now people in their 20s and 30s who are struggling in daily living activities come to us and ask: 'Do I have an autism spectrum disorder?' Sometimes, some people do,” said Dr. Hardan, but a diagnosis in adulthood would have been unthinkable years ago.

Another important contributor to the apparently increasingly prevalence of autism is simple misdiagnosis, he maintained.

Children with ADHD often have social deficits, difficulties in developing peer relationships, and what Dr. Hardan described as “poor coherence between visual and verbal behaviors.” But what may resemble autism or an autistic spectrum disorder, often is not.

Children frequently referred to the clinic at Stanford who are misdiagnosed as autistic include those with severe anxiety symptoms, early onset personality disorders, and reactive attachment disorders. Children in the latter category, often adopted from overseas, have many features that could lead a clinician to mistakenly diagnose autism, including severe social deficits and stereotypical behaviors.

Methodological factors may also have contributed to apparent increases in autism prevalence, as depicted in a recent article, “The autism epidemic: fact or artifact?” (J. Am. Acad. Child Adolesc. Psychiatry 2007;46:721–30).

STANFORD, CALIF. – A preliminary analysis of a randomized, double-blind, placebo-controlled study of donepezil suggests that the Alzheimer's drug may slightly improve some neuropsychologic functions in children with autism, Dr. Antonio Hardan said at a pediatric update sponsored by Stanford University.

At the halfway point in a 20-week trial, improvements were seen in scores on the some, but not all, neurocognitive tests among 10 autistic children aged 7–17 years receiving the drug, compared with 10 receiving placebo.

Specifically, children somewhat improved their performance on tests aimed at measuring spatial executive functioning (the Design Fluency Test), selective attention (the Color-Word Interference Test) and the California Verbal Learning Test.

“We didn't see magic improvement or large improvements,” said Dr. Hardan, director of the autism and developmental disabilities clinic at Lucile Packard Children's Hospital of Stanford (Calif.) University.

No improvement was seen on the Expressive One-Word Vocabulary Test, which measures language skills.

The trial is small and incomplete, and the results should be interpreted with caution, Dr. Hardan said, but “it opens up a whole group of medications to study.”

The use of donepezil (Aricept) in autism was first studied by Dr. Hardan at the University of Pittsburgh in an open-label study of eight children, half of whom demonstrated improvement on the Aberrant Behavior Checklist and Clinical Global Impression Scale. Improvements were suggested in irritability and hyperactivity, but not in inappropriate speech, lethargy, or stereotypies, he reported (J. Child Adolesc. Psychopharmacol. 2002;12:237–41).

Another novel study of an existing drug in autism is ongoing at Indiana University, Indianapolis, where a broad-spectrum antibiotic once used to treat tuberculosis led to apparent improvement in social withdrawal in a pilot study. A randomized, double-blind study is currently underway, pitting d-cycloserine, a partial agonist of the N-methyl-D-Aspartate (NMDA) glutamate receptor subtype, against placebo, Dr. Hardan said. Although these are small studies, it is encouraging to see research into existing drugs to determine whether they might be effective in treating children with autism spectrum disorders, he said.

It took 15 years for risperidone (Risperdal) to be approved for the treatment of autism-related irritability, noted Dr. Hardan, who published an early case study suggesting the drug's efficacy in 1996. Parents who must wait so long for drug approval feel they are “losing a lot of time,” he said. “That's why they jump at any opportunity [to use a treatment, even one] that could be potentially hazardous for their child.”

Dr. Hardan stressed that research must be driven by theories that make scientific sense, followed by proof-of-concept studies to see whether evidence exists that an agent may be helpful.

He pointed to “the [high] price of shortcuts,” such as secretin, hailed as a possible treatment based on one uncontrolled observational study that hinted it may have improved behavior in three children undergoing gastrointestinal procedures. No verification was made to determine whether the children actually met diagnostic criteria for autism, he noted. “Based on this, secretin was unfortunately the most studied medication in autism.”

Fifteen randomized, double-blind studies eventually produced uniformly negative results. “You can't find anything consistent like that in medicine,” he said.

The scientific community needs to “get realistic” when it comes to funding potentially beneficial treatments, he urged.

Is Autism on the Rise or Is the Diagnosis Expanding?

An apparent increase in the prevalence of autism and autistic spectrum disorders (ASDs) may be largely explained by differences in diagnosis, rather than true differences in the number of children with these conditions, Dr. Hardan suggested.

“Is there an increase in incidence versus an increase in recognition?” asked Dr. Hardan. Several observations point to the latter, he said.

Much of the increase in prevalence is among children with mild symptoms: children with high-functioning autism, those with Asperger's syndrome, and children with pervasive developmental disorder, not otherwise specified.

“Fifteen or 20 years ago when somebody was verbal, it was very unlikely people were going to consider this an autism spectrum disorder,” he said.

On the other end of the spectrum, children with moderate to severe mental retardation were given that diagnosis decades ago, whereas today many children receive the autism diagnosis.

Traditionally, autism spectrum disorders were exclusively made in school-age children. “Now people in their 20s and 30s who are struggling in daily living activities come to us and ask: 'Do I have an autism spectrum disorder?' Sometimes, some people do,” said Dr. Hardan, but a diagnosis in adulthood would have been unthinkable years ago.

Another important contributor to the apparently increasingly prevalence of autism is simple misdiagnosis, he maintained.

Children with ADHD often have social deficits, difficulties in developing peer relationships, and what Dr. Hardan described as “poor coherence between visual and verbal behaviors.” But what may resemble autism or an autistic spectrum disorder, often is not.

Children frequently referred to the clinic at Stanford who are misdiagnosed as autistic include those with severe anxiety symptoms, early onset personality disorders, and reactive attachment disorders. Children in the latter category, often adopted from overseas, have many features that could lead a clinician to mistakenly diagnose autism, including severe social deficits and stereotypical behaviors.

Methodological factors may also have contributed to apparent increases in autism prevalence, as depicted in a recent article, “The autism epidemic: fact or artifact?” (J. Am. Acad. Child Adolesc. Psychiatry 2007;46:721–30).

STANFORD, CALIF. – A preliminary analysis of a randomized, double-blind, placebo-controlled study of donepezil suggests that the Alzheimer's drug may slightly improve some neuropsychologic functions in children with autism, Dr. Antonio Hardan said at a pediatric update sponsored by Stanford University.

At the halfway point in a 20-week trial, improvements were seen in scores on the some, but not all, neurocognitive tests among 10 autistic children aged 7–17 years receiving the drug, compared with 10 receiving placebo.

Specifically, children somewhat improved their performance on tests aimed at measuring spatial executive functioning (the Design Fluency Test), selective attention (the Color-Word Interference Test) and the California Verbal Learning Test.

“We didn't see magic improvement or large improvements,” said Dr. Hardan, director of the autism and developmental disabilities clinic at Lucile Packard Children's Hospital of Stanford (Calif.) University.

No improvement was seen on the Expressive One-Word Vocabulary Test, which measures language skills.

The trial is small and incomplete, and the results should be interpreted with caution, Dr. Hardan said, but “it opens up a whole group of medications to study.”

The use of donepezil (Aricept) in autism was first studied by Dr. Hardan at the University of Pittsburgh in an open-label study of eight children, half of whom demonstrated improvement on the Aberrant Behavior Checklist and Clinical Global Impression Scale. Improvements were suggested in irritability and hyperactivity, but not in inappropriate speech, lethargy, or stereotypies, he reported (J. Child Adolesc. Psychopharmacol. 2002;12:237–41).

Another novel study of an existing drug in autism is ongoing at Indiana University, Indianapolis, where a broad-spectrum antibiotic once used to treat tuberculosis led to apparent improvement in social withdrawal in a pilot study. A randomized, double-blind study is currently underway, pitting d-cycloserine, a partial agonist of the N-methyl-D-Aspartate (NMDA) glutamate receptor subtype, against placebo, Dr. Hardan said. Although these are small studies, it is encouraging to see research into existing drugs to determine whether they might be effective in treating children with autism spectrum disorders, he said.

It took 15 years for risperidone (Risperdal) to be approved for the treatment of autism-related irritability, noted Dr. Hardan, who published an early case study suggesting the drug's efficacy in 1996. Parents who must wait so long for drug approval feel they are “losing a lot of time,” he said. “That's why they jump at any opportunity [to use a treatment, even one] that could be potentially hazardous for their child.”

Dr. Hardan stressed that research must be driven by theories that make scientific sense, followed by proof-of-concept studies to see whether evidence exists that an agent may be helpful.

He pointed to “the [high] price of shortcuts,” such as secretin, hailed as a possible treatment based on one uncontrolled observational study that hinted it may have improved behavior in three children undergoing gastrointestinal procedures. No verification was made to determine whether the children actually met diagnostic criteria for autism, he noted. “Based on this, secretin was unfortunately the most studied medication in autism.”

Fifteen randomized, double-blind studies eventually produced uniformly negative results. “You can't find anything consistent like that in medicine,” he said.

The scientific community needs to “get realistic” when it comes to funding potentially beneficial treatments, he urged.

Is Autism on the Rise or Is the Diagnosis Expanding?

An apparent increase in the prevalence of autism and autistic spectrum disorders (ASDs) may be largely explained by differences in diagnosis, rather than true differences in the number of children with these conditions, Dr. Hardan suggested.

“Is there an increase in incidence versus an increase in recognition?” asked Dr. Hardan. Several observations point to the latter, he said.

Much of the increase in prevalence is among children with mild symptoms: children with high-functioning autism, those with Asperger's syndrome, and children with pervasive developmental disorder, not otherwise specified.

“Fifteen or 20 years ago when somebody was verbal, it was very unlikely people were going to consider this an autism spectrum disorder,” he said.

On the other end of the spectrum, children with moderate to severe mental retardation were given that diagnosis decades ago, whereas today many children receive the autism diagnosis.

Traditionally, autism spectrum disorders were exclusively made in school-age children. “Now people in their 20s and 30s who are struggling in daily living activities come to us and ask: 'Do I have an autism spectrum disorder?' Sometimes, some people do,” said Dr. Hardan, but a diagnosis in adulthood would have been unthinkable years ago.

Another important contributor to the apparently increasingly prevalence of autism is simple misdiagnosis, he maintained.

Children with ADHD often have social deficits, difficulties in developing peer relationships, and what Dr. Hardan described as “poor coherence between visual and verbal behaviors.” But what may resemble autism or an autistic spectrum disorder, often is not.

Children frequently referred to the clinic at Stanford who are misdiagnosed as autistic include those with severe anxiety symptoms, early onset personality disorders, and reactive attachment disorders. Children in the latter category, often adopted from overseas, have many features that could lead a clinician to mistakenly diagnose autism, including severe social deficits and stereotypical behaviors.

Methodological factors may also have contributed to apparent increases in autism prevalence, as depicted in a recent article, “The autism epidemic: fact or artifact?” (J. Am. Acad. Child Adolesc. Psychiatry 2007;46:721–30).

ANAHEIM, CALIF. — Only about a third of men with moderate to severe lower urinary tract symptoms and evidence of an enlarged prostate intended to discuss these issues during a routine visit to their primary care physicians, according to a national, multisite study presented at the annual meeting of the American Urological Association.

Dr. Michael J. Naslund and his associates from the University of Maryland, Baltimore, distributed a questionnaire to 448 men older than age 50 years when they arrived for routine appointments at one of six primary care practices across the United States. The men were roughly evenly distributed by age categories, with 153 in their 50s, 151 in their 60s, and 144 in their 70s.

The men were asked the reason for their visit, their current lower urinary tract symptoms (LUTS), prior history of use of drugs and herbal remedies to treat LUTS, and whether they were planning to discuss their symptoms with the physician. A total of 42% of the men described moderate to severe LUTS on the International Prostate Symptom Score (IPSS) scale.

Upon enrollment, 48% of the men had an enlarged prostate on digital rectal examination (DRE) and 43% had a prostate-specific antigen (PSA) level of 1.5 ng/mL or greater. Two-thirds of the men had either an enlarged prostate on DRE or an elevated PSA level.

An estimated 29% of the men in the study would be considered at risk for progression of symptoms of benign prostatic hypertrophy, based on a high score on the IPSS scale and either a positive DRE or elevated PSA level.

Just 33% of men in this at-risk group—who were fairly evenly distributed by age—said they intended to discuss LUTS or prostate issues with their primary care physicians.

This finding raises the possibility that physicians may need to increase their efforts to detect men with LUTS, said Dr. Naslund, professor of surgery and interim head of urology at the university, and a consultant and on the speaker's bureau for GlaxoSmithKline Inc. and Sanofi Aventis.

ANAHEIM, CALIF. — Only about a third of men with moderate to severe lower urinary tract symptoms and evidence of an enlarged prostate intended to discuss these issues during a routine visit to their primary care physicians, according to a national, multisite study presented at the annual meeting of the American Urological Association.

Dr. Michael J. Naslund and his associates from the University of Maryland, Baltimore, distributed a questionnaire to 448 men older than age 50 years when they arrived for routine appointments at one of six primary care practices across the United States. The men were roughly evenly distributed by age categories, with 153 in their 50s, 151 in their 60s, and 144 in their 70s.

The men were asked the reason for their visit, their current lower urinary tract symptoms (LUTS), prior history of use of drugs and herbal remedies to treat LUTS, and whether they were planning to discuss their symptoms with the physician. A total of 42% of the men described moderate to severe LUTS on the International Prostate Symptom Score (IPSS) scale.

Upon enrollment, 48% of the men had an enlarged prostate on digital rectal examination (DRE) and 43% had a prostate-specific antigen (PSA) level of 1.5 ng/mL or greater. Two-thirds of the men had either an enlarged prostate on DRE or an elevated PSA level.

An estimated 29% of the men in the study would be considered at risk for progression of symptoms of benign prostatic hypertrophy, based on a high score on the IPSS scale and either a positive DRE or elevated PSA level.

Just 33% of men in this at-risk group—who were fairly evenly distributed by age—said they intended to discuss LUTS or prostate issues with their primary care physicians.

This finding raises the possibility that physicians may need to increase their efforts to detect men with LUTS, said Dr. Naslund, professor of surgery and interim head of urology at the university, and a consultant and on the speaker's bureau for GlaxoSmithKline Inc. and Sanofi Aventis.

ANAHEIM, CALIF. — Only about a third of men with moderate to severe lower urinary tract symptoms and evidence of an enlarged prostate intended to discuss these issues during a routine visit to their primary care physicians, according to a national, multisite study presented at the annual meeting of the American Urological Association.

Dr. Michael J. Naslund and his associates from the University of Maryland, Baltimore, distributed a questionnaire to 448 men older than age 50 years when they arrived for routine appointments at one of six primary care practices across the United States. The men were roughly evenly distributed by age categories, with 153 in their 50s, 151 in their 60s, and 144 in their 70s.

The men were asked the reason for their visit, their current lower urinary tract symptoms (LUTS), prior history of use of drugs and herbal remedies to treat LUTS, and whether they were planning to discuss their symptoms with the physician. A total of 42% of the men described moderate to severe LUTS on the International Prostate Symptom Score (IPSS) scale.

Upon enrollment, 48% of the men had an enlarged prostate on digital rectal examination (DRE) and 43% had a prostate-specific antigen (PSA) level of 1.5 ng/mL or greater. Two-thirds of the men had either an enlarged prostate on DRE or an elevated PSA level.

An estimated 29% of the men in the study would be considered at risk for progression of symptoms of benign prostatic hypertrophy, based on a high score on the IPSS scale and either a positive DRE or elevated PSA level.

Just 33% of men in this at-risk group—who were fairly evenly distributed by age—said they intended to discuss LUTS or prostate issues with their primary care physicians.

This finding raises the possibility that physicians may need to increase their efforts to detect men with LUTS, said Dr. Naslund, professor of surgery and interim head of urology at the university, and a consultant and on the speaker's bureau for GlaxoSmithKline Inc. and Sanofi Aventis.

ANAHEIM, CALIF. — A tape measure may not only help predict whether a patient has metabolic syndrome; it also may be one of the most useful tools to predict the presence of hypertension, dyslipidemia, coronary artery disease, erectile dysfunction, a large prostate, a high prostate-specific-antigen level, and ejaculatory dysfunction.

In a study of 88 men aged 50–75 years with moderate to severe lower urinary tract symptoms, waist circumference was powerfully correlated with numerous components of male pelvic health as well as with metabolic syndrome and male pelvic health, making it a “home run in terms of prediction,” said Dr. Steven Kaplan, who is professor of urology at Cornell University, New York.

“The results are simply remarkable,” said Dr. Kaplan at the annual meeting of the American Urological Association, where he presented his study during a podium session and at a press briefing. “The results even surprised us.”

Men with moderate to severe lower urinary tract symptoms (International Prostate Symptom Scores of 8 or greater) but no prior treatment were divided into three groups based on their waist sizes: 30–36 inches; 36–40 inches; or greater than 40 inches. Their waists were measured at the level of the uppermost border of the iliac crest.

Waist measurement was highly correlated with every parameter included in the study, including prostate volume, prostate-specific antigen (PSA), prostate symptom score, erectile dysfunction, ejaculatory dysfunction, and incidence of hypertension, coronary artery disease, and diabetes mellitus.

For example, the mean prostate volumes in cubic centimeters, as measured by rectal ultrasound, were 28.53, 31.67, and 36.78, respectively, for the three categories of waist circumference.

Incidence of diabetes was 11.2%, 22.3%, and 34.5%, respectively.

Percentages of patients with hypertension were 12.6%, 24.7%, and 37.8%.

Erectile dysfunction was seen in 34.6%, 49.5%, and 78.6%, respectively, of men in the three waist-circumference groups.

Dr. Kaplan said waist circumference may be a more accurate predictor of metabolic problems than body mass index (BMI), because it takes into account very muscular individuals, such as professional baseball player Barry Bonds.

“He's got a high BMI, however he got it,” Dr. Kaplan mused. “But certainly he doesn't have a problem with a big gut.”

Physicians may want to begin thinking about belly fat as “almost a separate organ … a new gland, if you will,” he said.

High aromatase levels within visceral fat may interfere not only with metabolism, but also with testosterone homeostasis.

“Theoretically, by altering that metabolism, perhaps you fuel prostate growth,” Dr. Kaplan said during the press briefing.

A second study presented by Dr. Kaplan at the meeting found a high correlation between obesity and prostate volume (P less than .0001) in the 9,000-subject Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial. The same study found high correlations between prostate volume and glucose, insulin resistance, high HDL cholesterol, total cholesterol, and hypertension.

Physicians may need to pay heed to increasing evidence from these and other studies that male pelvic health and metabolic syndrome are highly linked, according to Dr. Kaplan.

“Perhaps [one] component of the metabolic syndrome should be male pelvic dysfunction,” which includes voiding dysfunction, erectile dysfunction, and ejaculatory dysfunction, Dr. Kaplan said.

A large waist measurement was highly correlated with a high PSA level and with erectile dysfunction in an 88-patient study. ©Keith Frith/FOTOLIA

ANAHEIM, CALIF. — A tape measure may not only help predict whether a patient has metabolic syndrome; it also may be one of the most useful tools to predict the presence of hypertension, dyslipidemia, coronary artery disease, erectile dysfunction, a large prostate, a high prostate-specific-antigen level, and ejaculatory dysfunction.

In a study of 88 men aged 50–75 years with moderate to severe lower urinary tract symptoms, waist circumference was powerfully correlated with numerous components of male pelvic health as well as with metabolic syndrome and male pelvic health, making it a “home run in terms of prediction,” said Dr. Steven Kaplan, who is professor of urology at Cornell University, New York.

“The results are simply remarkable,” said Dr. Kaplan at the annual meeting of the American Urological Association, where he presented his study during a podium session and at a press briefing. “The results even surprised us.”

Men with moderate to severe lower urinary tract symptoms (International Prostate Symptom Scores of 8 or greater) but no prior treatment were divided into three groups based on their waist sizes: 30–36 inches; 36–40 inches; or greater than 40 inches. Their waists were measured at the level of the uppermost border of the iliac crest.

Waist measurement was highly correlated with every parameter included in the study, including prostate volume, prostate-specific antigen (PSA), prostate symptom score, erectile dysfunction, ejaculatory dysfunction, and incidence of hypertension, coronary artery disease, and diabetes mellitus.

For example, the mean prostate volumes in cubic centimeters, as measured by rectal ultrasound, were 28.53, 31.67, and 36.78, respectively, for the three categories of waist circumference.

Incidence of diabetes was 11.2%, 22.3%, and 34.5%, respectively.

Percentages of patients with hypertension were 12.6%, 24.7%, and 37.8%.

Erectile dysfunction was seen in 34.6%, 49.5%, and 78.6%, respectively, of men in the three waist-circumference groups.

Dr. Kaplan said waist circumference may be a more accurate predictor of metabolic problems than body mass index (BMI), because it takes into account very muscular individuals, such as professional baseball player Barry Bonds.

“He's got a high BMI, however he got it,” Dr. Kaplan mused. “But certainly he doesn't have a problem with a big gut.”

Physicians may want to begin thinking about belly fat as “almost a separate organ … a new gland, if you will,” he said.

High aromatase levels within visceral fat may interfere not only with metabolism, but also with testosterone homeostasis.

“Theoretically, by altering that metabolism, perhaps you fuel prostate growth,” Dr. Kaplan said during the press briefing.

A second study presented by Dr. Kaplan at the meeting found a high correlation between obesity and prostate volume (P less than .0001) in the 9,000-subject Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial. The same study found high correlations between prostate volume and glucose, insulin resistance, high HDL cholesterol, total cholesterol, and hypertension.

Physicians may need to pay heed to increasing evidence from these and other studies that male pelvic health and metabolic syndrome are highly linked, according to Dr. Kaplan.

“Perhaps [one] component of the metabolic syndrome should be male pelvic dysfunction,” which includes voiding dysfunction, erectile dysfunction, and ejaculatory dysfunction, Dr. Kaplan said.

A large waist measurement was highly correlated with a high PSA level and with erectile dysfunction in an 88-patient study. ©Keith Frith/FOTOLIA

ANAHEIM, CALIF. — A tape measure may not only help predict whether a patient has metabolic syndrome; it also may be one of the most useful tools to predict the presence of hypertension, dyslipidemia, coronary artery disease, erectile dysfunction, a large prostate, a high prostate-specific-antigen level, and ejaculatory dysfunction.

In a study of 88 men aged 50–75 years with moderate to severe lower urinary tract symptoms, waist circumference was powerfully correlated with numerous components of male pelvic health as well as with metabolic syndrome and male pelvic health, making it a “home run in terms of prediction,” said Dr. Steven Kaplan, who is professor of urology at Cornell University, New York.

“The results are simply remarkable,” said Dr. Kaplan at the annual meeting of the American Urological Association, where he presented his study during a podium session and at a press briefing. “The results even surprised us.”

Men with moderate to severe lower urinary tract symptoms (International Prostate Symptom Scores of 8 or greater) but no prior treatment were divided into three groups based on their waist sizes: 30–36 inches; 36–40 inches; or greater than 40 inches. Their waists were measured at the level of the uppermost border of the iliac crest.

Waist measurement was highly correlated with every parameter included in the study, including prostate volume, prostate-specific antigen (PSA), prostate symptom score, erectile dysfunction, ejaculatory dysfunction, and incidence of hypertension, coronary artery disease, and diabetes mellitus.

For example, the mean prostate volumes in cubic centimeters, as measured by rectal ultrasound, were 28.53, 31.67, and 36.78, respectively, for the three categories of waist circumference.

Incidence of diabetes was 11.2%, 22.3%, and 34.5%, respectively.

Percentages of patients with hypertension were 12.6%, 24.7%, and 37.8%.

Erectile dysfunction was seen in 34.6%, 49.5%, and 78.6%, respectively, of men in the three waist-circumference groups.

Dr. Kaplan said waist circumference may be a more accurate predictor of metabolic problems than body mass index (BMI), because it takes into account very muscular individuals, such as professional baseball player Barry Bonds.

“He's got a high BMI, however he got it,” Dr. Kaplan mused. “But certainly he doesn't have a problem with a big gut.”

Physicians may want to begin thinking about belly fat as “almost a separate organ … a new gland, if you will,” he said.

High aromatase levels within visceral fat may interfere not only with metabolism, but also with testosterone homeostasis.

“Theoretically, by altering that metabolism, perhaps you fuel prostate growth,” Dr. Kaplan said during the press briefing.

A second study presented by Dr. Kaplan at the meeting found a high correlation between obesity and prostate volume (P less than .0001) in the 9,000-subject Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial. The same study found high correlations between prostate volume and glucose, insulin resistance, high HDL cholesterol, total cholesterol, and hypertension.

Physicians may need to pay heed to increasing evidence from these and other studies that male pelvic health and metabolic syndrome are highly linked, according to Dr. Kaplan.

“Perhaps [one] component of the metabolic syndrome should be male pelvic dysfunction,” which includes voiding dysfunction, erectile dysfunction, and ejaculatory dysfunction, Dr. Kaplan said.

A large waist measurement was highly correlated with a high PSA level and with erectile dysfunction in an 88-patient study. ©Keith Frith/FOTOLIA

RENO, NEV. — Patients taking extended-cycle oral contraceptives had about the same number of total bleeding days over 6 months as women taking a standard, 28-day oral contraception regimen but had significantly fewer days of moderate to heavy bleeding.

“There is lower serum and urinary estrogen, [as well as] smaller ovaries and follicles, thinner endometrium, and improved patient symptomatology with a continuous oral contraceptive pill regimen,” Dr. Richard S. Legro reported at the annual meeting of the Society for Gynecologic Investigation.

The findings support the use of extended cycle suppression with oral estrogen (20 mcg) and progestin norethindrone acetate (1 mg) in a continuous regimen for indications such as endometriosis, hirsutism, and acne, Dr. Legro said at the meeting, where he presented the findings in poster form.

No pharmaceutical companies contributed funding for the study, which was financed in part by the National Institutes of Health, said Dr. Legro, a reproductive endocrinologist at Pennsylvania State University in Hershey, Pa.

Dr. Legro and his coinvestigators enrolled 62 normally cycling women in a double-blind, randomized, controlled trial and followed them for symptoms, bleeding patterns, endometrial histology, follicular development, and serum and urinary levels of sex steroids as they took oral contraceptives for 28 days per month with the traditional 7-day pill-free interval or continuously.

The number of moderate to heavy bleeding days dropped to 1 day/month or less by cycle 2 in the continuous OC group, decreasing more slowly over time in women taking the 28-day OC regimen.

Women taking continuous OC pills had a 25%–30% greater suppression of serum estrogen levels than those on the 28-day regimen. Total ovarian volume, maximum diameter of the largest follicle, and endometrial thickness were all reduced significantly more in patients on the continuous regimen. Scores on premenstrual pain, behavior, and distress scales were also lower for women assigned to receive continuous OC pills.

RENO, NEV. — Patients taking extended-cycle oral contraceptives had about the same number of total bleeding days over 6 months as women taking a standard, 28-day oral contraception regimen but had significantly fewer days of moderate to heavy bleeding.

“There is lower serum and urinary estrogen, [as well as] smaller ovaries and follicles, thinner endometrium, and improved patient symptomatology with a continuous oral contraceptive pill regimen,” Dr. Richard S. Legro reported at the annual meeting of the Society for Gynecologic Investigation.

The findings support the use of extended cycle suppression with oral estrogen (20 mcg) and progestin norethindrone acetate (1 mg) in a continuous regimen for indications such as endometriosis, hirsutism, and acne, Dr. Legro said at the meeting, where he presented the findings in poster form.

No pharmaceutical companies contributed funding for the study, which was financed in part by the National Institutes of Health, said Dr. Legro, a reproductive endocrinologist at Pennsylvania State University in Hershey, Pa.

Dr. Legro and his coinvestigators enrolled 62 normally cycling women in a double-blind, randomized, controlled trial and followed them for symptoms, bleeding patterns, endometrial histology, follicular development, and serum and urinary levels of sex steroids as they took oral contraceptives for 28 days per month with the traditional 7-day pill-free interval or continuously.

The number of moderate to heavy bleeding days dropped to 1 day/month or less by cycle 2 in the continuous OC group, decreasing more slowly over time in women taking the 28-day OC regimen.

Women taking continuous OC pills had a 25%–30% greater suppression of serum estrogen levels than those on the 28-day regimen. Total ovarian volume, maximum diameter of the largest follicle, and endometrial thickness were all reduced significantly more in patients on the continuous regimen. Scores on premenstrual pain, behavior, and distress scales were also lower for women assigned to receive continuous OC pills.

RENO, NEV. — Patients taking extended-cycle oral contraceptives had about the same number of total bleeding days over 6 months as women taking a standard, 28-day oral contraception regimen but had significantly fewer days of moderate to heavy bleeding.

“There is lower serum and urinary estrogen, [as well as] smaller ovaries and follicles, thinner endometrium, and improved patient symptomatology with a continuous oral contraceptive pill regimen,” Dr. Richard S. Legro reported at the annual meeting of the Society for Gynecologic Investigation.

The findings support the use of extended cycle suppression with oral estrogen (20 mcg) and progestin norethindrone acetate (1 mg) in a continuous regimen for indications such as endometriosis, hirsutism, and acne, Dr. Legro said at the meeting, where he presented the findings in poster form.

No pharmaceutical companies contributed funding for the study, which was financed in part by the National Institutes of Health, said Dr. Legro, a reproductive endocrinologist at Pennsylvania State University in Hershey, Pa.

Dr. Legro and his coinvestigators enrolled 62 normally cycling women in a double-blind, randomized, controlled trial and followed them for symptoms, bleeding patterns, endometrial histology, follicular development, and serum and urinary levels of sex steroids as they took oral contraceptives for 28 days per month with the traditional 7-day pill-free interval or continuously.

The number of moderate to heavy bleeding days dropped to 1 day/month or less by cycle 2 in the continuous OC group, decreasing more slowly over time in women taking the 28-day OC regimen.

Women taking continuous OC pills had a 25%–30% greater suppression of serum estrogen levels than those on the 28-day regimen. Total ovarian volume, maximum diameter of the largest follicle, and endometrial thickness were all reduced significantly more in patients on the continuous regimen. Scores on premenstrual pain, behavior, and distress scales were also lower for women assigned to receive continuous OC pills.

NEW ORLEANS — Hawthorn extract, a widely used over-the-counter remedy, was found to be safe in heart failure patients in the first large, randomized, placebo-controlled mortality trial involving an herbal compound.

At several time points in the 2-year study, the extract made from the Crataegus tree appeared to improve cardiac mortality; however, this was a secondary end point and was not a potent enough indicator to broadly suggest the extract was beneficial over and above standard medications for heart failure, said Dr. Christian J.F. Holubarsch at the annual meeting of the American College of Cardiology.

“Hawthorn extract has been used for centuries in traditional European medicine for the treatment of heart diseases,” said Dr. Holubarsch of Median Kliniken in Bad Krozingen, Germany, at a press conference following his oral presentation.

Today, heart patients in Europe, Asia, and North America buy various concentrations of extracts made from the leaves, flowers, and berries of the tree in the belief that the herb relieves mild cardiac symptoms, yet neither its safety nor its efficacy has been well studied prior to this trial.

A total of 2,681 patients in 156 centers in 13 European countries were enrolled to receive either a placebo or twice-daily pills containing 450 mg of Crataegus extract WS 1442, a “moderately high” dose of a 20% concentration marketed in Europe by Schwabe Pharmaceuticals, which sponsored the trial.

Patients were included if they met criteria for New York Heart Association Class II-III heart failure with a reduced (35% or less) left ventricular ejection fraction (LVEF). They were already receiving pharmacologic therapy, which at baseline included diuretics (85%), ACE inhibitors (83%), β-blockers (64%), glycosides (57%), spirolactone (39%), and nitrates (55%).

The primary end point was a composite of cardiac mortality, nonfatal myocardial infarction, or hospitalization due to progression of heart failure. On this composite measure, “we always saw superiority of Crataegus when compared to placebo, but this superiority was not significant through the whole course of the 2-year observational period,” Dr. Holubarsch reported.

Over 24 months, 441 of 1,338 patients taking the herbal extract died, compared with 542 of 1,343 patients receiving placebo. However, the differences in deaths at the time points studied—6, 12, 18, and 24 months—were statistically significant only at months 6 and 12.

A subanalysis found that sudden cardiac death was significantly reduced in patients with LVEF of at least 25%.

Dr. Holubarsch and associates concluded that the herbal extract was “safe and postpones death due to cardiac cause, especially in the subgroup of patients with LVEF greater than or equal to 25%.”

This conclusion drew skepticism from the panelists presiding over the late-breaking clinical trials session, who applauded the trial's design but questioned whether any conclusion could be drawn about mortality in a trial that failed to achieve significance on its primary end point.

“The subgroup analysis should be taken with a large sack of salt,” said Dr. Salim Yusuf of Hamilton, Ont. “The safest and the wisest thing is to say that you did a good trial, you have an empiric result. It's safe, but it's not effective,” he said.

Such trials are very important in light of how many patients take herbal preparations along with prescribed medications, but their conclusions cannot be extrapolated to other herbal preparations using different concentrations, cautioned Dr. Marc A. Pfeffer of Duke Clinical Research Institute in Durham, N.C.

Dr. Holubarsch agreed, noting that the compound used in the trial uses flowers and leaves of the Crataegus tree and is produced at a fixed concentration. Extract potencies can vary depending on where the herb is harvested, which part of the plant is used, and the season in which it is collected.

'We always saw superiority of Crataegus when compared to placebo, but this superiority was not significant.' DR. HOLUBARSCH

NEW ORLEANS — Hawthorn extract, a widely used over-the-counter remedy, was found to be safe in heart failure patients in the first large, randomized, placebo-controlled mortality trial involving an herbal compound.

At several time points in the 2-year study, the extract made from the Crataegus tree appeared to improve cardiac mortality; however, this was a secondary end point and was not a potent enough indicator to broadly suggest the extract was beneficial over and above standard medications for heart failure, said Dr. Christian J.F. Holubarsch at the annual meeting of the American College of Cardiology.

“Hawthorn extract has been used for centuries in traditional European medicine for the treatment of heart diseases,” said Dr. Holubarsch of Median Kliniken in Bad Krozingen, Germany, at a press conference following his oral presentation.

Today, heart patients in Europe, Asia, and North America buy various concentrations of extracts made from the leaves, flowers, and berries of the tree in the belief that the herb relieves mild cardiac symptoms, yet neither its safety nor its efficacy has been well studied prior to this trial.

A total of 2,681 patients in 156 centers in 13 European countries were enrolled to receive either a placebo or twice-daily pills containing 450 mg of Crataegus extract WS 1442, a “moderately high” dose of a 20% concentration marketed in Europe by Schwabe Pharmaceuticals, which sponsored the trial.

Patients were included if they met criteria for New York Heart Association Class II-III heart failure with a reduced (35% or less) left ventricular ejection fraction (LVEF). They were already receiving pharmacologic therapy, which at baseline included diuretics (85%), ACE inhibitors (83%), β-blockers (64%), glycosides (57%), spirolactone (39%), and nitrates (55%).

The primary end point was a composite of cardiac mortality, nonfatal myocardial infarction, or hospitalization due to progression of heart failure. On this composite measure, “we always saw superiority of Crataegus when compared to placebo, but this superiority was not significant through the whole course of the 2-year observational period,” Dr. Holubarsch reported.

Over 24 months, 441 of 1,338 patients taking the herbal extract died, compared with 542 of 1,343 patients receiving placebo. However, the differences in deaths at the time points studied—6, 12, 18, and 24 months—were statistically significant only at months 6 and 12.

A subanalysis found that sudden cardiac death was significantly reduced in patients with LVEF of at least 25%.

Dr. Holubarsch and associates concluded that the herbal extract was “safe and postpones death due to cardiac cause, especially in the subgroup of patients with LVEF greater than or equal to 25%.”

This conclusion drew skepticism from the panelists presiding over the late-breaking clinical trials session, who applauded the trial's design but questioned whether any conclusion could be drawn about mortality in a trial that failed to achieve significance on its primary end point.

“The subgroup analysis should be taken with a large sack of salt,” said Dr. Salim Yusuf of Hamilton, Ont. “The safest and the wisest thing is to say that you did a good trial, you have an empiric result. It's safe, but it's not effective,” he said.

Such trials are very important in light of how many patients take herbal preparations along with prescribed medications, but their conclusions cannot be extrapolated to other herbal preparations using different concentrations, cautioned Dr. Marc A. Pfeffer of Duke Clinical Research Institute in Durham, N.C.

Dr. Holubarsch agreed, noting that the compound used in the trial uses flowers and leaves of the Crataegus tree and is produced at a fixed concentration. Extract potencies can vary depending on where the herb is harvested, which part of the plant is used, and the season in which it is collected.

'We always saw superiority of Crataegus when compared to placebo, but this superiority was not significant.' DR. HOLUBARSCH

NEW ORLEANS — Hawthorn extract, a widely used over-the-counter remedy, was found to be safe in heart failure patients in the first large, randomized, placebo-controlled mortality trial involving an herbal compound.

At several time points in the 2-year study, the extract made from the Crataegus tree appeared to improve cardiac mortality; however, this was a secondary end point and was not a potent enough indicator to broadly suggest the extract was beneficial over and above standard medications for heart failure, said Dr. Christian J.F. Holubarsch at the annual meeting of the American College of Cardiology.

“Hawthorn extract has been used for centuries in traditional European medicine for the treatment of heart diseases,” said Dr. Holubarsch of Median Kliniken in Bad Krozingen, Germany, at a press conference following his oral presentation.

Today, heart patients in Europe, Asia, and North America buy various concentrations of extracts made from the leaves, flowers, and berries of the tree in the belief that the herb relieves mild cardiac symptoms, yet neither its safety nor its efficacy has been well studied prior to this trial.

A total of 2,681 patients in 156 centers in 13 European countries were enrolled to receive either a placebo or twice-daily pills containing 450 mg of Crataegus extract WS 1442, a “moderately high” dose of a 20% concentration marketed in Europe by Schwabe Pharmaceuticals, which sponsored the trial.

Patients were included if they met criteria for New York Heart Association Class II-III heart failure with a reduced (35% or less) left ventricular ejection fraction (LVEF). They were already receiving pharmacologic therapy, which at baseline included diuretics (85%), ACE inhibitors (83%), β-blockers (64%), glycosides (57%), spirolactone (39%), and nitrates (55%).

The primary end point was a composite of cardiac mortality, nonfatal myocardial infarction, or hospitalization due to progression of heart failure. On this composite measure, “we always saw superiority of Crataegus when compared to placebo, but this superiority was not significant through the whole course of the 2-year observational period,” Dr. Holubarsch reported.

Over 24 months, 441 of 1,338 patients taking the herbal extract died, compared with 542 of 1,343 patients receiving placebo. However, the differences in deaths at the time points studied—6, 12, 18, and 24 months—were statistically significant only at months 6 and 12.

A subanalysis found that sudden cardiac death was significantly reduced in patients with LVEF of at least 25%.

Dr. Holubarsch and associates concluded that the herbal extract was “safe and postpones death due to cardiac cause, especially in the subgroup of patients with LVEF greater than or equal to 25%.”

This conclusion drew skepticism from the panelists presiding over the late-breaking clinical trials session, who applauded the trial's design but questioned whether any conclusion could be drawn about mortality in a trial that failed to achieve significance on its primary end point.

“The subgroup analysis should be taken with a large sack of salt,” said Dr. Salim Yusuf of Hamilton, Ont. “The safest and the wisest thing is to say that you did a good trial, you have an empiric result. It's safe, but it's not effective,” he said.

Such trials are very important in light of how many patients take herbal preparations along with prescribed medications, but their conclusions cannot be extrapolated to other herbal preparations using different concentrations, cautioned Dr. Marc A. Pfeffer of Duke Clinical Research Institute in Durham, N.C.

Dr. Holubarsch agreed, noting that the compound used in the trial uses flowers and leaves of the Crataegus tree and is produced at a fixed concentration. Extract potencies can vary depending on where the herb is harvested, which part of the plant is used, and the season in which it is collected.

'We always saw superiority of Crataegus when compared to placebo, but this superiority was not significant.' DR. HOLUBARSCH

SAN DIEGO — Roughly two-thirds of new chlamydia cases are currently being missed because of lax attention to screening guidelines by primary care physicians, obstetrician-gynecologists, and pediatricians, Dr. David E. Soper said at the annual meeting of the American College of Obstetricians and Gynecologists.

A sexually transmitted bacterial infection, chlamydia remains the most common sexually transmitted disease in the United States, with more than 976,000 new cases reported each year and an estimated 2 million cases going undiagnosed.

Women with undetected, untreated chlamydia face at least a 40% chance of being diagnosed with pelvic inflammatory disease (PID).

“We're not screening like we really should, despite highly sensitive and very specific tests,” said Dr. Soper, professor of ob.gyn. at the Medical University of South Carolina, Charleston. “I think collectively we're not doing a good job.”

Screening is particularly lacking for adolescents, who have the highest rates of chlamydia in the United States, and for privately insured women, he said during a press conference highlighting the issue.

Among women covered by Medicare, “modest gains” were made in 2006, with almost half of sexually active women aged 25 and younger being screened annually, as recommended by ACOG, the Centers for Disease Control and Prevention, and the U.S. Preventive Services Task Force.

Far fewer commercially insured women—“maybe 35% or 40%”—are receiving annual screening, according to data from State of Health Care Quality reports, he said.

“We'd like to see these rates go up to the 90% range,” Dr. Soper said.

Besides the annual screening of women aged 25 years and younger, screening is recommended for other women in high-risk groups as well, including those with new or multiple sexual partners and those with a prior history of sexually transmitted disease. Routine screening of men is not currently recommended, although it may be considered in areas of high prevalence.

Currently, the prevalence of chlamydia ranges from 4% to 12%; recent testing of asymptomatic female Army recruits in the San Francisco area identified 9% with the infection.

If women were screened as recommended and treated, if infected, with a single dose of 1 g of azithromycin, an estimated 140,000 cases of PID a year could be prevented, Dr. Soper said.

This has the potential of saving $45 in health costs for every woman screened, making chlamydia screening one of the most effective but underutilized preventive health services targeted by the CDC and the Agency for Healthcare Research and Quality.

Treatment of PID and its consequences—including infertility, ectopic pregnancy, and chronic pelvic pain—now exceeds $3.5 billion a year.

Dr. Laura E. Riley, medical director of labor and delivery at Massachusetts General Hospital, Boston, called the sequelae of untreated chlamydia “devastating,” for both women and their exposed infants.

Babies born to mothers with untreated chlamydia have a 25%–30% chance of developing chlamydial conjunctivitis, and up to a 40% chance of developing chlamydial pneumonia.

During pregnancy, a single dose of azithromycin can be used to treat chlamydia, but women should be retested for proof of cure after 3 weeks to ensure that the disease has cleared. Infants can be treated with erythromycin; however, many require retreatment, she said.

Both physicians stressed the efficacy of the nucleic acid amplification testing (NAAT) method and noted that urine samples, as well as endocervical or vaginal swabs, may be used to make the diagnosis.

They urged physicians not only to screen for chlamydia, but also to regularly talk with their patients about STD prevention strategies, including abstinence, monogamy, or use of a condom during every sexual contact.

SAN DIEGO — Roughly two-thirds of new chlamydia cases are currently being missed because of lax attention to screening guidelines by primary care physicians, obstetrician-gynecologists, and pediatricians, Dr. David E. Soper said at the annual meeting of the American College of Obstetricians and Gynecologists.

A sexually transmitted bacterial infection, chlamydia remains the most common sexually transmitted disease in the United States, with more than 976,000 new cases reported each year and an estimated 2 million cases going undiagnosed.

Women with undetected, untreated chlamydia face at least a 40% chance of being diagnosed with pelvic inflammatory disease (PID).

“We're not screening like we really should, despite highly sensitive and very specific tests,” said Dr. Soper, professor of ob.gyn. at the Medical University of South Carolina, Charleston. “I think collectively we're not doing a good job.”

Screening is particularly lacking for adolescents, who have the highest rates of chlamydia in the United States, and for privately insured women, he said during a press conference highlighting the issue.

Among women covered by Medicare, “modest gains” were made in 2006, with almost half of sexually active women aged 25 and younger being screened annually, as recommended by ACOG, the Centers for Disease Control and Prevention, and the U.S. Preventive Services Task Force.

Far fewer commercially insured women—“maybe 35% or 40%”—are receiving annual screening, according to data from State of Health Care Quality reports, he said.

“We'd like to see these rates go up to the 90% range,” Dr. Soper said.

Besides the annual screening of women aged 25 years and younger, screening is recommended for other women in high-risk groups as well, including those with new or multiple sexual partners and those with a prior history of sexually transmitted disease. Routine screening of men is not currently recommended, although it may be considered in areas of high prevalence.

Currently, the prevalence of chlamydia ranges from 4% to 12%; recent testing of asymptomatic female Army recruits in the San Francisco area identified 9% with the infection.

If women were screened as recommended and treated, if infected, with a single dose of 1 g of azithromycin, an estimated 140,000 cases of PID a year could be prevented, Dr. Soper said.

This has the potential of saving $45 in health costs for every woman screened, making chlamydia screening one of the most effective but underutilized preventive health services targeted by the CDC and the Agency for Healthcare Research and Quality.

Treatment of PID and its consequences—including infertility, ectopic pregnancy, and chronic pelvic pain—now exceeds $3.5 billion a year.

Dr. Laura E. Riley, medical director of labor and delivery at Massachusetts General Hospital, Boston, called the sequelae of untreated chlamydia “devastating,” for both women and their exposed infants.

Babies born to mothers with untreated chlamydia have a 25%–30% chance of developing chlamydial conjunctivitis, and up to a 40% chance of developing chlamydial pneumonia.

During pregnancy, a single dose of azithromycin can be used to treat chlamydia, but women should be retested for proof of cure after 3 weeks to ensure that the disease has cleared. Infants can be treated with erythromycin; however, many require retreatment, she said.

Both physicians stressed the efficacy of the nucleic acid amplification testing (NAAT) method and noted that urine samples, as well as endocervical or vaginal swabs, may be used to make the diagnosis.

They urged physicians not only to screen for chlamydia, but also to regularly talk with their patients about STD prevention strategies, including abstinence, monogamy, or use of a condom during every sexual contact.

SAN DIEGO — Roughly two-thirds of new chlamydia cases are currently being missed because of lax attention to screening guidelines by primary care physicians, obstetrician-gynecologists, and pediatricians, Dr. David E. Soper said at the annual meeting of the American College of Obstetricians and Gynecologists.

A sexually transmitted bacterial infection, chlamydia remains the most common sexually transmitted disease in the United States, with more than 976,000 new cases reported each year and an estimated 2 million cases going undiagnosed.

Women with undetected, untreated chlamydia face at least a 40% chance of being diagnosed with pelvic inflammatory disease (PID).

“We're not screening like we really should, despite highly sensitive and very specific tests,” said Dr. Soper, professor of ob.gyn. at the Medical University of South Carolina, Charleston. “I think collectively we're not doing a good job.”

Screening is particularly lacking for adolescents, who have the highest rates of chlamydia in the United States, and for privately insured women, he said during a press conference highlighting the issue.

Among women covered by Medicare, “modest gains” were made in 2006, with almost half of sexually active women aged 25 and younger being screened annually, as recommended by ACOG, the Centers for Disease Control and Prevention, and the U.S. Preventive Services Task Force.

Far fewer commercially insured women—“maybe 35% or 40%”—are receiving annual screening, according to data from State of Health Care Quality reports, he said.

“We'd like to see these rates go up to the 90% range,” Dr. Soper said.

Besides the annual screening of women aged 25 years and younger, screening is recommended for other women in high-risk groups as well, including those with new or multiple sexual partners and those with a prior history of sexually transmitted disease. Routine screening of men is not currently recommended, although it may be considered in areas of high prevalence.

Currently, the prevalence of chlamydia ranges from 4% to 12%; recent testing of asymptomatic female Army recruits in the San Francisco area identified 9% with the infection.

If women were screened as recommended and treated, if infected, with a single dose of 1 g of azithromycin, an estimated 140,000 cases of PID a year could be prevented, Dr. Soper said.

This has the potential of saving $45 in health costs for every woman screened, making chlamydia screening one of the most effective but underutilized preventive health services targeted by the CDC and the Agency for Healthcare Research and Quality.

Treatment of PID and its consequences—including infertility, ectopic pregnancy, and chronic pelvic pain—now exceeds $3.5 billion a year.

Dr. Laura E. Riley, medical director of labor and delivery at Massachusetts General Hospital, Boston, called the sequelae of untreated chlamydia “devastating,” for both women and their exposed infants.

Babies born to mothers with untreated chlamydia have a 25%–30% chance of developing chlamydial conjunctivitis, and up to a 40% chance of developing chlamydial pneumonia.

During pregnancy, a single dose of azithromycin can be used to treat chlamydia, but women should be retested for proof of cure after 3 weeks to ensure that the disease has cleared. Infants can be treated with erythromycin; however, many require retreatment, she said.

Both physicians stressed the efficacy of the nucleic acid amplification testing (NAAT) method and noted that urine samples, as well as endocervical or vaginal swabs, may be used to make the diagnosis.

They urged physicians not only to screen for chlamydia, but also to regularly talk with their patients about STD prevention strategies, including abstinence, monogamy, or use of a condom during every sexual contact.

LOS ANGELES — Relatively healthy individuals who opted to discontinue highly active antiretroviral therapy did not appear to suffer any neurocognitive repercussions and in fact performed better on a standard battery of neuropsychological tests during their drug vacations.

“This was not what we expected,” said Kevin Robertson, Ph.D., who presented the findings at the 14th Conference on Retroviruses and Opportunistic Infections.

An initial group of 167 HIV-infected patients was enrolled in the observational, multicenter study when they made a decision to discontinue highly active antiretroviral therapy (HAART).

At study entry, their mean age was 42 years and they had spent 4.5 years on HAART. They represented a “uniquely healthy population,” Dr. Robertson stressed, with a mean baseline peripheral blood CD4 count of 833 cells/mcL and a low viral load (71% had fewer than 50 copies/mL plasma HIV RNA).

A brief neuropsychological battery of tests, including Trailmaking A/B and Digit Symbol, was administered at 24 weeks, 48 weeks, 72 weeks, and 96 weeks to assess psychomotor speed, attention, concentration, cognitive sequencing, and shifting cognitive sets—skills known to be affected by HIV.

“We felt that when subjects stopped HAART, it would lead to a decline in neuropsychological performance,” said Dr. Robertson, director of neuropsychology and a member of the NeuroAIDS Working Group at the University of North Carolina at Chapel Hill.

In fact, the opposite occurred, with mean neuropsychological summary (NPZ3) scores improving by 0.22, 0.39, 0.52, and 0.74 over the course of the 96-week study.

Among a group of 46 subjects who eventually decided to reinitiate HAART, there was no significant change in composite neurocognitive scores over 72 weeks of follow-up, although Dr. Robertson noted that the final study group represented a “very small sample size” of 37 patients by week 24 of the follow-up study.

Numerous possible confounding factors were explored by the investigative team from the University of North Carolina; Harvard University, Boston; the University of California, San Francisco; and Baystate Medical Center, Springfield, Mass. However, they statistically ruled out a practice effect, selection bias, or a possible link between neurocognitive function and efavirenz-containing HIV regimens.

“Many people in this room, myself included, have shown improvement [in neurocognitive function] with ART, especially in later disease,” said Dr. Robertson from the podium during his presentation.

“This study does not suggest you shouldn't take your antiretroviral treatment at all.

“What we know is that HIV gets into the CNS within days. … The virus is presumably chipping away,” he said.

He suggested that further research should focus on “potential sources of HAART toxicity on CNS function,” because neurocognitive decline did not follow discontinuation of the powerful therapies in healthy subjects who were able to remain off HAART for extended periods of time.

ELSEVIER GLOBAL MEDICAL NEWS

LOS ANGELES — Relatively healthy individuals who opted to discontinue highly active antiretroviral therapy did not appear to suffer any neurocognitive repercussions and in fact performed better on a standard battery of neuropsychological tests during their drug vacations.

“This was not what we expected,” said Kevin Robertson, Ph.D., who presented the findings at the 14th Conference on Retroviruses and Opportunistic Infections.

An initial group of 167 HIV-infected patients was enrolled in the observational, multicenter study when they made a decision to discontinue highly active antiretroviral therapy (HAART).

At study entry, their mean age was 42 years and they had spent 4.5 years on HAART. They represented a “uniquely healthy population,” Dr. Robertson stressed, with a mean baseline peripheral blood CD4 count of 833 cells/mcL and a low viral load (71% had fewer than 50 copies/mL plasma HIV RNA).

A brief neuropsychological battery of tests, including Trailmaking A/B and Digit Symbol, was administered at 24 weeks, 48 weeks, 72 weeks, and 96 weeks to assess psychomotor speed, attention, concentration, cognitive sequencing, and shifting cognitive sets—skills known to be affected by HIV.

“We felt that when subjects stopped HAART, it would lead to a decline in neuropsychological performance,” said Dr. Robertson, director of neuropsychology and a member of the NeuroAIDS Working Group at the University of North Carolina at Chapel Hill.

In fact, the opposite occurred, with mean neuropsychological summary (NPZ3) scores improving by 0.22, 0.39, 0.52, and 0.74 over the course of the 96-week study.

Among a group of 46 subjects who eventually decided to reinitiate HAART, there was no significant change in composite neurocognitive scores over 72 weeks of follow-up, although Dr. Robertson noted that the final study group represented a “very small sample size” of 37 patients by week 24 of the follow-up study.

Numerous possible confounding factors were explored by the investigative team from the University of North Carolina; Harvard University, Boston; the University of California, San Francisco; and Baystate Medical Center, Springfield, Mass. However, they statistically ruled out a practice effect, selection bias, or a possible link between neurocognitive function and efavirenz-containing HIV regimens.

“Many people in this room, myself included, have shown improvement [in neurocognitive function] with ART, especially in later disease,” said Dr. Robertson from the podium during his presentation.

“This study does not suggest you shouldn't take your antiretroviral treatment at all.

“What we know is that HIV gets into the CNS within days. … The virus is presumably chipping away,” he said.

He suggested that further research should focus on “potential sources of HAART toxicity on CNS function,” because neurocognitive decline did not follow discontinuation of the powerful therapies in healthy subjects who were able to remain off HAART for extended periods of time.

ELSEVIER GLOBAL MEDICAL NEWS

LOS ANGELES — Relatively healthy individuals who opted to discontinue highly active antiretroviral therapy did not appear to suffer any neurocognitive repercussions and in fact performed better on a standard battery of neuropsychological tests during their drug vacations.

“This was not what we expected,” said Kevin Robertson, Ph.D., who presented the findings at the 14th Conference on Retroviruses and Opportunistic Infections.

An initial group of 167 HIV-infected patients was enrolled in the observational, multicenter study when they made a decision to discontinue highly active antiretroviral therapy (HAART).

At study entry, their mean age was 42 years and they had spent 4.5 years on HAART. They represented a “uniquely healthy population,” Dr. Robertson stressed, with a mean baseline peripheral blood CD4 count of 833 cells/mcL and a low viral load (71% had fewer than 50 copies/mL plasma HIV RNA).

A brief neuropsychological battery of tests, including Trailmaking A/B and Digit Symbol, was administered at 24 weeks, 48 weeks, 72 weeks, and 96 weeks to assess psychomotor speed, attention, concentration, cognitive sequencing, and shifting cognitive sets—skills known to be affected by HIV.

“We felt that when subjects stopped HAART, it would lead to a decline in neuropsychological performance,” said Dr. Robertson, director of neuropsychology and a member of the NeuroAIDS Working Group at the University of North Carolina at Chapel Hill.

In fact, the opposite occurred, with mean neuropsychological summary (NPZ3) scores improving by 0.22, 0.39, 0.52, and 0.74 over the course of the 96-week study.

Among a group of 46 subjects who eventually decided to reinitiate HAART, there was no significant change in composite neurocognitive scores over 72 weeks of follow-up, although Dr. Robertson noted that the final study group represented a “very small sample size” of 37 patients by week 24 of the follow-up study.

Numerous possible confounding factors were explored by the investigative team from the University of North Carolina; Harvard University, Boston; the University of California, San Francisco; and Baystate Medical Center, Springfield, Mass. However, they statistically ruled out a practice effect, selection bias, or a possible link between neurocognitive function and efavirenz-containing HIV regimens.

“Many people in this room, myself included, have shown improvement [in neurocognitive function] with ART, especially in later disease,” said Dr. Robertson from the podium during his presentation.

“This study does not suggest you shouldn't take your antiretroviral treatment at all.

“What we know is that HIV gets into the CNS within days. … The virus is presumably chipping away,” he said.

He suggested that further research should focus on “potential sources of HAART toxicity on CNS function,” because neurocognitive decline did not follow discontinuation of the powerful therapies in healthy subjects who were able to remain off HAART for extended periods of time.

ELSEVIER GLOBAL MEDICAL NEWS