‘Sociability’ hormone didn’t help in autism
NEW YORK, Oct 17, (AP): Children with autism didn’t benefit from an experimental therapy made with a hormone thought to promote social bonding, researchers reported Wednesday in the largest study of its kind.
“This is really a major setback,” said Dr. Linmarie Sikich, a Duke University researcher who led the multi-site US study published in the New England Journal of Medicine. “We were really hoping to find a benefit and just couldn’t see it anywhere.”
The US government-funded study used a synthetic form of oxytocin, a hormone made in the brain that stimulates uterus contractions and helps mothers bond with their newborns.
Experiments in mice have suggested the hormone may promote sociability, and small studies have hinted that it might have similar effects in children with autism, who often struggle with social interaction.
Nearly 300 children with autism initially enrolled, and 250 of them completed the six-month study. The kids, ages 3 to 17, received daily squirts of nasal spray containing oxytocin or an inactive ingredient for seven weeks, with gradual dose increases after that. The dose could be maintained or reduced if requested.
Small behavior improvements occurred in both groups, but they had no meaningful impact, Vikich said. Separate analyses showed no difference in outcome in kids with mild or severe autism, she said.
One patient in the oxytocin group had a serious side effect thought to be caused by the hormone — sedation while driving that led to a car accident. Otherwise there were no major safety concerns in the hormone and placebo groups.
About 1 in 54 US children have autism, according to the Centers for Disease Control and Prevention. Behavior therapy is the most effective treatment.
Oxytocin is a naturally occurring hormone and chemical messenger. It is best known for its role in triggering labor and the release of breast milk in women. Synthetic oxytocin is sometimes given to pregnant women by IV to induce labor.
Based on the early research findings, some doctors began prescribing it for children with autism. Some promoters call it “the love hormone” and it is sold online in potions and pills as a mood and relationship booster.
Larry Young, an Emory University scientist who does animal research with oxytocin, said it’s too soon to give up on it for treating autism. He said the hormone is better understood today than when the study began nearly eight years ago.
“It makes the social world around us more vibrant in our brain, so we pay attention to it,” Young said.
He likened the potential effect in people with autism to removing frost from a windshield that prevents them from reading social cues and emotions.
Without accompanying behavior therapy or guidance, however, that effect could be negative, he said. He cited a hypothetical example in which a child with autism gets a squirt of oxytocin each morning and starts paying more attention to other kids on the school bus. What if the enhanced attention helps the child realize that the kids are being mean and bullying?
“This is a very important study because it does say that just willy-nilly giving daily administrations of oxytocin is not going to lead to improvement,” Young said. “Hopefully physicians and parents will learn from this and say this is not something we give as a vitamin” without other treatment.
Joyce Galaverna’s son was 13 when he enrolled in the study in 2015. He tolerated the treatments but his behavior showed no improvement.
“The irritability and anxiety levels pretty much stayed the same throughout the study,” she said.
The North Carolina family never learned if he had received oxytocin or the placebo.
While the study outcome was a disappointment, Galaverna said her son, Andre, did improve after puberty pangs eased and he enrolled in a nurturing private school. He finished high school in June and now has a part-time job.
University of Virginia autism researcher Kevin Pelphrey said other studies have shown that giving oxytocin by nose may lead to changes in brain regions involved in social behavior. He said the study’s use of a behavior checklist to assess the hormone’s effectiveness may have limited its findings.
Brain-based measures could be helpful in determining which kids might respond best to the hormone, he said.
“There is still much work to be done in the area of understanding how oxytocin might be utilized to improve social function in kids with autism,” Pelphrey said.
E-cigarette: For the first time, the Food and Drug Administration on Tuesday authorized an electronic cigarette, saying the vaping device from R.J. Reynolds can help smokers cut back on conventional cigarettes.
E-cigarettes have been sold in the US for more than a decade with minimal government oversight or research. Facing a court deadline, the FDA has been conducting a sweeping review of vaping products to determine which ones should be allowed to remain on the market.
The agency said in September it had rejected applications for more than a million e-cigarettes and related products, mainly due to their potential appeal to underage teens. But regulators delayed making decisions on most of the major vaping companies, including market leader Juul, which is still pending.
Tuesday’s decision only applies to Vuse’s Solo e-cigarette and its tobacco-flavored nicotine cartridges. The agency said data from the company showed the e-cigarette helped smokers significantly reduce their exposure to the harmful chemicals in traditional cigarettes.
While the products can now be legally sold in the US, the FDA stressed they are neither safe nor “FDA approved,” and that people who don’t smoke shouldn’t use them.
Launched in 2013, Vuse Solo is a rechargeable metallic device that’s shaped like a traditional cigarette. The FDA said it rejected 10 other requests from the company for other flavored products. The agency is still reviewing the company’s request to sell a menthol-flavored nicotine formula.
“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation,” said Mitch Zeller, director of the FDA’s tobacco center, in a statement.
“The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption.”
E-cigarettes first appeared in the US around 2007 with the promise of providing smokers with a less harmful alternative to smoking traditional tobacco cigarettes. The devices heat a nicotine solution into a vapor that’s inhaled.
But there has been little rigorous study of whether e-cigarettes truly help smokers quit. And efforts by the FDA to begin vetting vaping products and their claims were repeatedly slowed by industry lobbying and competing political interests.
In recent years, the vaping market grew to include hundreds of companies selling an array of devices and nicotine solutions in various flavors and strengths. But the vast majority of the market is controlled by a few companies including Juul Labs, which is partially owned by Altria, and Vuse.
Vuse is the No. 2 vaping brand in the US behind Juul, accounting for about a third of all retail sales. Its parent company R.J. Reynolds sells Newport, Camel and other leading cigarettes.