This news release from the University of Sydney describes a published study on a group of 31 young children with autism (ages three to eight years old) who were treated twice a day with oxytocin nasal spray. The hormone oxytocin has been shown in previous studies to play an important role in bonding and establishing social relationships.
The release omitted many of the details contained in the published study, including quantified benefits and a description of the evidence. With so many aspects of autism generating controversy — from its incidence to its causes and treatment options — it’s crucial to provide the public with solid data. This release doesn’t do that.
The symptoms of autism spectrum disorder can vary widely in character and severity. To date, there is no medical cure for autism so it’s no wonder there is interest in finding a drug treatment to address its symptoms, especially one that is safe in children. A 2014 report by the Centers for Disease Control and Prevention estimated that 1 out of 68 children in the United States have been identified as having autism spectrum disorder and that about 1% of the global population suffers from autism spectrum disorder.
The release doesn’t mention the cost of the oxytocin nasal spray sold as a generic, or under the brand names Pitocin and Syntocinon. Medical-grade oxytocin shouldn’t be confused with the numerous brands of non-medical grade oxytocin sprays that are sold over-the-counter and online.
The release headline says that oxytocin “has social, emotional and behavioral benefits in young kids with autism.” But our reviewers found that claim questionable. Of numerous ratings done, one caregiver-measure of social responsiveness came out as statistically positive, and a clinician-rated measure of Clinical Global Improvement came out positive. Our reviewers did not think it was accurate to report that emotional and behavioral symptoms were affected since none of the measures that specifically evaluated these symptoms came out as positive.
The release also says that symptoms in children with autism were “significantly improved,” but it never quantifies the improvement. We are told only that children were said by their parents to be more socially responsive at home and that independent clinical ratings showed improvements in social responsiveness.
What were the exact measurable benefits? According to the published study, 72% of the patients were rated by the clinical staff to have improved in terms of social interaction and responsiveness compared to 41% who showed such improvement when treated with a placebo. The patents were assessed at baseline and at the end of 5 weeks of treatment.
The news release briefly describes the symptoms reported in the children taking part in the trial. The common side effects were thirst, urination and constipation.
Our reviewers thought it should be pointed out that the risks and long-term effects of treating children with oxytocin are unknown.
The release provides no evidence for the opening claim that oxytocin “significantly improved social, emotional and behavioral issues among children with autism.” Instead, the claims made provoke only questions.
What kind of trial was it? Was it a placebo-controlled, randomized?
What were the improvements?
How much improvement?
Which clinician ratings were used?
Did all of the children receiving treatment improve?
How long did the improvement last?
The release doesn’t engage in disease-mongering.
The funders of the study aren’t named in the release. In addition to Australian government and foundation grants, the project was supported by a private individual, and the lead investigator’s research work is currently supported by Servier Australia and Pfizer (manufacturer of Pitocin), according to the published study.
The release correctly states that behavioral therapies, the standard treatment for autism, are time-intensive, costly and sometimes offer minimal benefits.
The release doesn’t mention that synthetic oxtocin (in this trial Syntocinon was used) has been widely available for many years. It was first synthesized by American Nobel prize-winning biochemist Vincent du Vigneaud in 1955. It is most frequently used as an injectable to induce labor in pregnant women.
The release asserts the trial’s novelty but the claims aren’t very strong.
First, the release states the trial is “thought to be the first evidence of a medical treatment for social impairments in children with autism.” Second is the claim, “It is also the first clinical trial investigating the efficacy, tolerability and safety of intranasal-administered oxytocin in young children with autism.”
There have been larger multi-center trials of oxytocin for children in recent years. For example, investigators in Chapel Hill, NC, undertook an 8-week, placebo-controlled trial of oxytocin in 24 children, ages 3-17. Those results don’t appear to have been reported yet, but a look at clinicaltrials.gov shows that this is an active area of investigation with many studies underway or recently completed.
We’ll give the benefit of the doubt here but we wished for more context.
Other than making claims without backing them up with evidence, we found no unjustifiable language.