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A university in Chapel Hill, North Carolina, USA.
60 children who were 3–14 years of age (mean age 8 y) and had a previous diagnosis of autism were screened by using the DSM-IV, the Childhood Autism Rating Scale, and the Autism Behavior Checklist (ABC). 40 children met criteria for autism, and 20 met criteria for another pervasive developmental disorder. Exclusion criteria were previous secretin treatment; or diagnosis of pancreatitis, inflammatory bowel disease, or gastrinoma. Follow up was 87% for treatment response.
After stratification for age, children were allocated to a single infusion of secretin, 0.4 μg/kg of body weight (n=30), or placebo (n=30) by slow intravenous injection over 1 minute.
Main outcome measures
Communication skills (subscale of the Vineland Adaptive Behavior Scales completed by clinicians), autistic symptoms (ABC and Clinical Global Impression Scale [CGI] completed by parents), and adverse effects (Treatment Emergent Symptoms Scale completed by clinicians). Response to treatment was defined as a “much” or “very much” improved score on any of the 8 measures of the CGI.
The groups did not differ for treatment response (p=0.68) (table⇓). No differences existed between groups for any outcome. Children in both groups reported an improvement in symptoms from baseline for the ABC total score (p<0.001), ABC sensory-function score (p<0.001), ABC social relatedness score (p<0.001), ABC language score (p=0.05), ABC socialisation score (p<0.001), and CGI speech score (p=0.02). No child had adverse effects that limited treatment.
In children with autism or another pervasive developmental disorder, synthetic human secretin did not improve symptoms or communication skills more than did placebo.
The report by Sandler et al on treating symptoms of autistic spectrum disorders with the synthetic peptide hormone secretin has shown a complete lack of efficacy, with equal rates of parent reported improvement for both secretin and placebo in a double blind study with 4 weeks of follow up after a single infusion.
The findings are not surprising given the impetus for the study: a mother noted behavioural improvements anecdotally in her self described autistic child after secretin infusion. This improvement was subsequently reported as a reasonable causal occurrence, appearing in testimonial form on the internet (eg, http://www.feat.org). Subsequently, the same case was reported on a primetime US television news magazine (NBC Dateline) and received further credibility by being published on the front page of the Wall Street Journal.1 One medical journal published a report of 3 open label cases (including the child reported by Wall Street Journal and Dateline) and also claimed success.2 Opinion formulated from these sources blurred the line between scientific reporting, journalism, and hearsay. Nevertheless, demand for the treatment skyrocketed. The National Institutes of Health supported treatment trials, although the usually required scientific bases, such as convincing pilot data or sound theory, were lacking. All this creates a danger zone where opinion dictates treatment, research agenda, the spending of precious research dollars, and the efforts of highly trained investigators.
Autism is a debilitating and lifelong disorder. Children with autism, however, look “normal”. Parents who struggle to help their child may believe that the “hoped for” child exists—a homunculus inside the child with autism—but is held prisoner by a web of abnormal behavioural patterns. These conditions may be hazardous to generalist clinicians who, when prevailed upon to give secretin, may not know that secretin is likely to produce only the latest placebo effect seen in a long line of nominally plausible treatments for autism.3
Sources of funding: Thoms Health Services Foundation and National Institute of Child Health and Human Development.
For correspondence: Dr A D Sandler, Olson Huff Center for Child Development, Thoms Rehabilitation Hospital, 68 Sweeten Creek Road, Asheville, NC 28803, USA. Fax +1 828 277 4831.
↵† Information supplied by author.
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