Drug Shows Some Benefit for Kids With Autism

By Kathleen Doheny
HealthDay Reporter

WEDNESDAY, May 1 (HealthDay News) -- An experimental drug for autism did not improve levels of lethargy and social withdrawal in children who took it, but it did show some other benefits, a new study finds.

Children on arbaclofen did improve on an overall measure of autism severity when compared to kids taking an inactive placebo, said lead researcher Dr. Jeremy Veenstra-VanderWeele, an associate professor of psychiatry, pediatrics and pharmacology at Vanderbilt University.

He is to present the findings Thursday at the International Meeting for Autism Research (IMFAR) in Spain.

One of 88 children in the United States is now diagnosed with an autism spectrum disorder, the umbrella term for complex brain development disorders marked by problems in social interaction and communication.

Veenstra-VanderWeele focused on evaluating the social improvement with the drug because earlier research had suggested it could help. However, one of the earlier studies did not compare the drug to a placebo, but simply measured improvement in those who took the drug.

In the new study, Veenstra-VanderWeele and his team assigned 150 people with autism, aged 5 to 21, to take the medicine or a placebo, without knowing which group they were in, for eight weeks. The participants had been diagnosed with autistic disorder, Asperger's syndrome or another related condition known as pervasive developmental disorder.

In all, 130 finished the study. When no differences were found in social withdrawal or lethargy between the two groups, the researchers looked at a scale that measures severity and improvement of autism with treatment.

Those on the drug improved more on that scale. A child, for instance, who began the study evaluated as having marked severity might be described as moderate by the study's end, Veenstra-VanderWeele said.

"This is the sort of improvement that would motivate us to start a medicine," he said.

The drug is believed to work, Veenstra-VanderWeele said, by increasing inhibition, improving social functioning and interactions.

Right now, Veenstra-VanderWeele said, "there is no medication that has clear evidence to improve social function in autism."

Those on the drug did report side effects, including suicidal thoughts reported by one patient on the drug and one on the placebo. Some patients on the drug became upset more easily; others reported sleepiness.

The next phase of trials of the drug are in the planning stages, Veenstra-VanderWeele said.

But more research is needed, said Dr. Andrew Adesman, chief of developmental and behavioral pediatrics at the Steven and Alexandra Cohen Children's Medical Center of New York.

Even though the expected benefit did not materialize, Adesman sees a reason to continue to study the medication. "There is [still] some suggestion of benefit from the medicine," Adesman said. "It just didn't quite show up where they expected."

The drug may offer benefit to some children with autism, Adesman said. "But it's unclear which children may be the best candidates."

The trial received funding from the drug's maker, Seaside Therapeutics. The medication is not currently approved by the U.S. Food and Drug Administration.

The data and conclusions of research presented at medical meetings should be viewed as preliminary until published in a peer-reviewed journal.

Copyright © 2013 HealthDay. All rights reserved. SOURCES: Jeremy Veenstra-VanderWeele, M.D., associate professor, psychiatry, pediatrics and pharmacology, Vanderbilt University School of Medicine, Nashville, Tenn.; Andrew Adesman, M.D., chief of developmental and behavioral pediatrics, Steven and Alexandra Cohen Children's Medical Center of New York, New Hyde Park, N.Y.; May 2, 2013, presentation, International Meeting for Autism Research (IMFAR), San Donostia/San Sebastian, Spain

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Drug Shows Some Benefit for Kids With Autism

Study found no gains in lethargy, social withdrawal, but those on the drug improved in other ways

By Kathleen Doheny

HealthDay Reporter

WEDNESDAY, May 1 (HealthDay News) -- An experimental drug for autism did not improve levels of lethargy and social withdrawal in children who took it, but it did show some other benefits, a new study finds.

Children on arbaclofen did improve on an overall measure of autism severity when compared to kids taking an inactive placebo, said lead researcher Dr. Jeremy Veenstra-VanderWeele, an associate professor of psychiatry, pediatrics and pharmacology at Vanderbilt University.

He is to present the findings Thursday at the International Meeting for Autism Research (IMFAR) in Spain.

One of 88 children in the United States is now diagnosed with an autism spectrum disorder, the umbrella term for complex brain development disorders marked by problems in social interaction and communication.

Veenstra-VanderWeele focused on evaluating the social improvement with the drug because earlier research had suggested it could help. However, one of the earlier studies did not compare the drug to a placebo, but simply measured improvement in those who took the drug.

In the new study, Veenstra-VanderWeele and his team assigned 150 people with autism, aged 5 to 21, to take the medicine or a placebo, without knowing which group they were in, for eight weeks. The participants had been diagnosed with autistic disorder, Asperger's syndrome or another related condition known as pervasive developmental disorder.

In all, 130 finished the study. When no differences were found in social withdrawal or lethargy between the two groups, the researchers looked at a scale that measures severity and improvement of autism with treatment.

Those on the drug improved more on that scale. A child, for instance, who began the study evaluated as having marked severity might be described as moderate by the study's end, Veenstra-VanderWeele said.

"This is the sort of improvement that would motivate us to start a medicine," he said.

The drug is believed to work, Veenstra-VanderWeele said, by increasing inhibition, improving social functioning and interactions.

Right now, Veenstra-VanderWeele said, "there is no medication that has clear evidence to improve social function in autism."

Those on the drug did report side effects, including suicidal thoughts reported by one patient on the drug and one on the placebo. Some patients on the drug became upset more easily; others reported sleepiness.

The next phase of trials of the drug are in the planning stages, Veenstra-VanderWeele said.

But more research is needed, said Dr. Andrew Adesman, chief of developmental and behavioral pediatrics at the Steven and Alexandra Cohen Children's Medical Center of New York.

Even though the expected benefit did not materialize, Adesman sees a reason to continue to study the medication. "There is [still] some suggestion of benefit from the medicine," Adesman said. "It just didn't quite show up where they expected."

The drug may offer benefit to some children with autism, Adesman said. "But it's unclear which children may be the best candidates."

The trial received funding from the drug's maker, Seaside Therapeutics. The medication is not currently approved by the U.S. Food and Drug Administration.

The data and conclusions of research presented at medical meetings should be viewed as preliminary until published in a peer-reviewed journal.

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Community Gardening May Reap Body Weight Benefit

FRIDAY, April 19 (HealthDay News) -- People with plots in community gardens are less likely to be overweight or obese than those who don't garden, a new study suggests.

"It has been shown previously that community gardens can provide a variety of social and nutritional benefits to neighborhoods," study author Cathleen Zick, a professor of family and consumer studies at the University of Utah, said in a university news release. "But until now, we did not have data to show a measurable health benefit for those who use the gardens."

She and her colleagues looked at the body-mass index (BMI) of 198 community gardeners in Salt Lake City and compared them to non-gardening neighbors. BMI is a measurement of body fat based on height and weight.

The BMI of female community gardeners was an average 1.84 points lower than their neighbors, a difference of 11 pounds for a 5-foot-5 woman. The BMI of male community gardeners was 2.36 points lower than their neighbors, a difference of 16 pounds for a man at 5 feet 10 inches.

Compared to nongardeners, the likelihood of being overweight or obese was 62 percent lower for male gardeners and 46 percent lower for female gardeners, according to the study appearing online April 18 in the American Journal of Public Health.

The researchers also found that gardeners had lower BMIs than their same-sex siblings. The average BMI was 1.88 lower for female community gardeners compared to their sisters and 1.33 lower for male community gardeners compared to their brothers.

There was no difference in BMI or the risk of being overweight between married gardeners and their spouses. That is not surprising because spouses would likely help out with gardening and benefit from eating the healthy foods produced in the garden, the study authors noted.

These findings support "the idea that community gardens are a valuable neighborhood asset that can promote healthier living. That could be of interest to urban planners, public health officials and others focused on designing new neighborhoods and revitalizing old ones," Zick said.

But while "these data are intriguing," she noted, "they were drawn from participants in a single community gardening organization in Salt Lake City and may not apply broadly until more research is done."

And although the study found an association between gardening and lower BMI, it did not prove a cause-and-effect relationship.

-- Robert Preidt
Copyright © 2013 HealthDay. All rights reserved. SOURCE: University of Utah, news release, April 18, 2013

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Alzheimer's Drugs May Benefit Heart, Study Finds

Fewer heart attacks, deaths for patients taking cholinesterase inhibitors

By Robert Preidt

HealthDay Reporter

WEDNESDAY, June 5 (HealthDay News) -- Drugs used to treat early-stage Alzheimer's disease may also reduce patients' risk of heart attack and death, according to a new study.

Researchers followed more than 7,000 Alzheimer's disease patients in Sweden for more than three years. Those taking cholinesterase inhibitors had a 38 percent lower risk of heart attack, a 26 percent lower risk of death from cardiovascular causes such as stroke and a 36 percent lower risk of death from any cause, compared to those who did not take the drugs.

Patients who took the highest recommended doses of cholinesterase inhibitors (ChEIs) had the lowest risk of heart attack or death -- 65 percent and 46 percent lower, respectively, than those who never took the drugs, according to the study, which was published online June 5 in the European Heart Journal.

"If you translate these reductions in risk into absolute figures, it means that for every 100,000 people with Alzheimer's disease, there would be 180 fewer heart attacks (295 as opposed to 475) and 1,125 fewer deaths from all causes (2,000 versus 3,125) every year among those taking ChEIs compared to those not using them," study author Professor Peter Nordstrom, of Umea University in Sweden, said in a journal news release.

No cure exists for Alzheimer's disease, an age-related brain disorder and the most common form of dementia. However, cholinesterase inhibitors, such as donepezil (brand name Aricept), galantamine (Razadyne, Reminyl) and rivastigmine (Exelon), are prescribed to help manage symptoms and slow disease progression in people with early- to moderate-stage disease.

Previous research has found that these drugs have a beneficial effect on the vagus nerve, which controls heart rate, and may have anti-inflammatory properties.

"As far as we know, this is the first time that the use of ChEIs has been linked to a reduced risk of heart attacks and deaths from cardiovascular disease in general or from any cause," Nordstrom said.

"As this is an observational study, we cannot say that ChEI use is causing the reduction in risk, only that it is associated with a reduction," he said. "However, the strengths of the associations make them very interesting from the clinical point of view, although no clinical recommendations should be made on the basis of the results from our study."

An analysis of previous randomized, controlled trials would produce answers on which clinical recommendations could be based, Nordstrom added.

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Modest Cardiac Benefit From Chelation Therapy Not Enough to OK Use: Experts

New study shows slight effect, but arduous 'leaching' treatment has side effects, doctors say

By E.J. Mundell

HealthDay Reporter

TUESDAY, March 26 (HealthDay News) -- Results from a major trial on controversial chelation therapy for patients with a history of heart attack find a modest benefit from the expensive treatment, but experts conclude there's no clear evidence supporting its use.

Still, "groups that advocate for chelation and groups that oppose chelation will both find comfort in the results," said one expert not connected to the study, Dr. Stephen Green, associate chairman in the department of cardiology at North Shore University Hospital in Manhasset, N.Y.

Chelation therapy involves dozens of arduous infusions conducted over a period of years, aimed at leaching excess metals from the body. Patients typically also receive high doses of vitamins and minerals. The therapy has been offered to heart patients by some clinics across the United States for decades, although its use for this purpose has been considered controversial and it has never received approval as a heart disease treatment from the U.S. Food and Drug Administration.

The results of this latest study are published in the March 27 issue of the Journal of the American Medical Association. Findings from the same study were also presented earlier this month at the annual meeting of the American College of Cardiology (ACC) in San Francisco, and at last fall's annual meeting of the American Heart Association.

Speaking at the ACC meeting on March 10, the study's lead researcher said that the modest benefit noted in the study had not made him any more ready to recommend chelation therapy.

"These findings should stimulate further research, but are not by themselves sufficient to recommend the routine use of chelation therapy and high-dose vitamins in most patients," said Dr. Gervasio Lamas, chief of the Columbia University division of cardiology at Mount Sinai Medical Center, in Miami Beach, Fla.

The trial, which was funded by the U.S. National Institutes of Health, involved more than 1,700 patients from the United States and Canada who had suffered a previous heart attack. Most were already taking standard therapies such as daily aspirin, cholesterol-lowering statins or blood pressure medications.

In the new analysis of the data, the patients were divided into two groups: high-dose vitamin/mineral supplements plus chelation or "dummy" placebo infusions/supplements. Chelation therapy consisted of 40 three-hour sessions with the IV infusions spread over anywhere between 50 and 110 weeks. Doses of vitamins and minerals given were much higher than recommended daily intakes.

After an average follow-up of more than four and a half years, the team did see a slight benefit among the group who took the vitamins/minerals in combination with chelation therapy. Twenty-six percent of people in this group experienced some kind of cardiovascular event such as heart attack, stroke or hospitalization for angina (chest pain) -- less than the 30 percent seen among those who got placebo/placebo therapy only.

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Women's Weight-Loss Surgery May Benefit Later Offspring

Study links procedure to genetic activity in children

By Randy Dotinga

HealthDay Reporter

TUESDAY, May 28 (HealthDay News) -- Weight-loss operations in women could be a genetic bonus for the health of their future children, a new study suggests.

Researchers found differences in the activity of genes in children born to women after they'd had gastric bypass surgery compared to their siblings born before surgery. The changes suggest that the kids born after surgery, to thinner mothers, will fare better in terms of heart health because of benefits gained in the womb.

"It appears that there's an effect that is transmitted to the next generation," said study co-author Marie-Claude Vohl, a professor at Laval University in Quebec City. "This may have some consequence later in life for the health of the children."

The study isn't definitive, and researchers don't know exactly how much the health of kids may be affected by being born to a thinner mother. It's also not clear if there's something unique about weight-loss surgery or if the key is to simply drop pounds.

Weight-loss surgery, which aims to limit the amount of food that patients can eat, is no simple matter. It's expensive, involves risk and is not always covered by insurance. However, severe obesity is itself a major health risk.

In the new study, researchers examined the genetic makeup of 50 children who were born to 20 mothers before or after they underwent gastric bypass surgery.

The researchers suspected that the genes of children born after surgery would act differently than those born before. They found several thousand genes that did just that, and the differences in the post-surgery children suggest they're in better shape health-wise.

As far as physical differences, children born to mothers before weight-loss surgery weighed more and had greater waist and hip girth compared to the others. Children born to mothers after weight loss-surgery had better fasting insulin levels and lower blood pressure.

"It's more evidence that the benefits of gastric bypass surgery extend beyond the original aim of weight loss," said Dr. Francesco Rubino, a metabolic and bariatric surgeon with the Catholic University of Rome, who was not involved with the study. Other research has linked weight-loss surgery, in some cases, to major improvements in diabetes.

What's going on? It's not a matter of the mothers transferring different genes to the children based on whether they'd had surgery. Instead, weight-loss surgery seems to affect the activity of the genes in the children's bodies even outside the womb, he said.

Dr. Edward Phillips, vice chair of the department of surgery at Cedars-Sinai Medical Center, in Los Angeles, said it's a mystery how that might happen.

"If you're a fetus, you're bathed in a bunch of chemicals and hormones," Phillips said. "But when you're out in the real world, why wouldn't your own genes go back to the basic set of what they were supposed to be?"

Could weight-loss surgery in fathers have a similar effect on their subsequent children? Researchers don't know. There are other questions too. Might the children born after their mothers had surgery be exposed to a different kind of environment than their older siblings, especially in regard to food? Could that affect how their genes act?

Phillips said those questions need to be answered. But, he said, this is still "an exciting early study" that opens the door toward greater understanding of genes and weight.

The study appeared online May 27 in the Proceedings of the National Academy of Sciences.

More information

For more about gastric bypass surgery, try the U.S. National Library of Medicine.

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