Researchers reported Wednesday that children with autism did not benefit from experimental therapy using a hormone believed to foster social bonding. This was the largest study of its kind.
"This is really an important setback," Dr. Linmarie Siskich, a Duke University researcher and who conducted the multi-site U.S. research published in The New England Journal of Medicine. "We really wanted to see a benefit, but couldn't find it anywhere."
The U.S. government funded the study with a synthetic version of oxytocin. This hormone is found in the brain and stimulates uterus contractions. It also helps mothers bond to their infants.
The hormone has been shown to promote social interaction in mice, according to experiments. Small studies also suggest that it may have similar effects on children with autism who struggle to interact with others.
Nearly 300 autistic children were initially enrolled and 250 completed the six-month study. For seven weeks, the children, aged 3-17, received daily nasal sprays containing oxytocin and an inactive ingredient. The dose was gradually increased over time. If required, the dose can be increased or decreased.
Vikich stated that both groups saw small behavior changes, but not enough to make a significant difference. She said that separate analyses did not show any difference in the outcome for children with severe or mild autism.
One patient in the oxytocin treatment group experienced sedation while driving, which led to an accident. The hormone and placebo groups did not pose any safety issues.
According to the Centers for Disease Control and Prevention, autism affects approximately 1 in 54 children in America. The most effective treatment is behavior therapy.
Oxytocin, a hormone and chemical messenger naturally found in the body, is one example. It is most well-known for its ability to trigger labor and breast milk production in women. To induce labor, synthetic oxytocin can be given intravenously to pregnant women.
Some doctors started prescribing it to children with autism based on early research results. It is often called "the love hormone", and sold online as pills and potions to boost mood and improve relationships.
Young stated that it makes the social world around us brighter in our brains, so we pay more attention to it.
He compared the potential impact on people with autism to removing frost off a windshield that blocks them from reading social cues.
He said that this effect could be detrimental if it doesn't come with guidance or behavior therapy. He gave an example of a child who has autism receiving a daily dose of oxytocin and then paying more attention to the other children on the school bus. What if this increased attention makes the child more aware that bullying and mean-spirited children are happening?
Young stated that "this is an important study because it does not say that simply giving oxytocin daily willy-nilly is going to lead to improvement." "Hopefully, parents and physicians will take this to heart and tell their children that oxytocin is not something they give as a supplement."
Joyce Galaverna was 13 years old when Joyce Galaverna enrolled him in the 2015 study. Although he tolerated the treatment, his behavior did not improve.
She said that anxiety and irritability levels remained the same throughout the study.
His North Carolina family did not know if he had been given oxytocin or placebo.
Galaverna stated that Andre did well after his puberty pains subsided and enrolled at a private school. He graduated from high school in June, and now works part-time.
Kevin Pelphrey, a University of Virginia autism researcher, said that other studies have shown that oxytocin given by the nose can cause changes in brain regions related to social behavior. He suggested that the effectiveness of the hormone may have been limited by the use of a behavior checklist in the study.
He said that brain-based measures could help determine which children might be most responsive to the hormone.
Pelphrey stated that "there is still much to be done in understanding how oxytocin could be used to improve social function in children with autism."