Hormone widely used as an autism treatment shows no benefit
Multicenter study finds that oxytocin was safe, but ineffective at
boosting social skills among children with autism

Date:
October 13, 2021
Source:
Duke University Medical Center
Summary:
Oxytocin, a naturally occurring hormone that acts as a chemical
messenger in the brain, showed no evidence of helping children
with autism gain social skills, according to a large national study.



FULL STORY ========================================================================== Oxytocin, a naturally occurring hormone that acts as a chemical messenger
in the brain, showed no evidence of helping children with autism gain
social skills, according to a large national study appearing Oct. 13 in
the New England Journal of Medicine.


========================================================================== While disappointing for those holding hope that oxytocin could benefit
children with autism, the long-awaited finding provides clarity for a
drug that has shown mixed outcomes in smaller, less robust studies.

"There was a great deal of hope this drug would be effective," said
the study's principal investigator and lead author, Linmarie Sikich,
M.D., associate consulting professor in the Department of Psychiatry & Behavioral Sciences at Duke University School of Medicine. "All of us on
the study team were hugely disappointed, but oxytocin does not appear to
change social function of people with autism." Oxytocin is typically used
to induce labor, but because of its activity in the brain, it has been investigated as a treatment for autism. Evidence has been conflicting,
with several smaller studies suggesting it improved social and cognitive function among some children with autism, while other studies showed
no benefit.

Sikich and colleagues, including senior author Jeremy
Veenstra-VanderWeele, M.D., of New York State Psychiatric Institute and Columbia University, designed the multi-site trial to provide the best
evidence yet about whether oxytocin was a safe and effective treatment
for children with Autism Spectrum Disorder.

The research team enrolled 290 children ages 3-17, stratified by age and
the severity of their autism symptoms. The children were randomized in
similar, equal-sized groups to receive oxytocin or a placebo via a daily
nasal spray over 24 weeks.

The study aimed to see if the regimen of oxytocin would have a
measurable impact on the children's social abilities based on screenings
and assessments at the start of the trial, midway through and at the
end. Both researchers and the children's parents provided assessments
using standard analytic tools for autism.

While the oxytocin was well tolerated and had few side effects, it
showed no significant benefit among the group of children who received
it compared to those who received the placebo.

"Thousands of children with autism spectrum disorder were prescribed
intranasal oxytocin before it was adequately tested," Veenstra-VanderWeele said.

"Thankfully, our data show that it is safe. Unfortunately, it is no
better than placebo when used daily for months. These results indicate
that clinicians and families should insist that there is strong evidence
for the safety and benefit of new treatments before they are provided
to patients in the clinic." Sikich said no further study is likely of oxytocin, given the negative findings: "Our consensus as investigators
is that there is no evidence in this large study that is strong enough
to justify more investigation of oxytocin as a treatment for autism
spectrum disorders." In addition to Sikich and Veenstra-VanderWeele,
study authors include Alexander Kolevzon, Bryan H. King, Christopher
J. McDougle, Kevin B. Sanders, Soo-Jeong Kim, Marina Spanos, Tara Chandrasekhar, Pilar Trelles, Carol M. Rockhill, Michelle L. Palumbo,
Allyson Witters Cundiff, Alicia Montgomery, Paige Siper, Mendy Minjarez,
Lisa A. Nowinski, Sarah Marler, Lauren C. Shuffrey, Cheryl Alderman,
Jordana Weissman, Brooke Zappone, Jennifer E. Mullett, Hope Crosson,
Natalie Hong, Stephen K. Siecinski, Stephanie N. Giamberardino, Sheng Luo, Lilin She, Manjushri Bhapkar, Russell Dean and Abby Scheer.

The study received funding from the Eunice Kennedy Shriver National
Institute of Child Health and Human Development (U01HD073984) and the
National Center for Advancing Translational Sciences (UL1TR002489).

========================================================================== Story Source: Materials provided by Duke_University_Medical_Center. Note: Content may be edited for style and length.


========================================================================== Journal Reference:
1. Linmarie Sikich, Alexander Kolevzon, Bryan H. King, Christopher J.

McDougle, Kevin B. Sanders, Soo-Jeong Kim, Marina Spanos, Tara
Chandrasekhar, M.D. Pilar Trelles, Carol M. Rockhill, Michelle L.

Palumbo, Allyson Witters Cundiff, Alicia Montgomery, Paige Siper,
Mendy Minjarez, Lisa A. Nowinski, Sarah Marler, Lauren C. Shuffrey,
Cheryl Alderman, Jordana Weissman, Brooke Zappone, Jennifer
E. Mullett, Hope Crosson, Natalie Hong, Stephen K. Siecinski,
Stephanie N. Giamberardino, Sheng Luo, Lilin She, Manjushri Bhapkar,
Russell Dean, Abby Scheer, Jacqueline L. Johnson, Simon G. Gregory,
Jeremy Veenstra-VanderWeele.

Intranasal Oxytocin in Children and Adolescents with Autism
Spectrum Disorder. New England Journal of Medicine, 2021; 385
(16): 1462 DOI: 10.1056/NEJMoa2103583 ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2021/10/211013174014.htm

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