Lack of Benefit of a Single Dose of Synthetic Human Secretin in the Treatment of Autism and Pervasive Developmental Disorder
Adrian D. Sandler, M.D., Kelly A. Sutton, M.A., Jeffrey DeWeese, B.S., Mary Alice Girardi, P.N.P., Victoria Sheppard, M.D., and James W. Bodfish, Ph.D.
Background Secretin is a peptide hormone that stimulates pancreaticsecretion. After recent publicity about a child with autismwhose condition markedly improved after a single dose of secretin,thousands of children with autistic disorders may have receivedsecretin injections.
Methods We conducted a double-blind, placebo-controlled trialof a single intravenous dose of synthetic human secretin in60 children (age, 3 to 14 years) with autism or pervasive developmentaldisorder. The children were randomly assigned to treatment withan intravenous infusion of synthetic human secretin (0.4 µgper kilogram of body weight) or saline placebo. We used standardizedbehavioral measures of the primary and secondary features ofautism, including the Autism Behavior Checklist, to assess thedegree of impairment at base line and over the course of a four-weekperiod after treatment.
Results Of the 60 children, 4 could not be evaluated 2 received secretin outside the study, and 2 did not returnfor follow-up. Thus, 56 children (28 in each group) completedthe study. As compared with placebo, secretin treatment wasnot associated with significant improvements in any of the outcomemeasures. Among the children in the secretin group, the meantotal score on the Autism Behavior Checklist at base line was59.0 (range of possible values, 0 to 158, with a larger valuecorresponding to greater impairment), and among those in theplacebo group it was 63.2. The mean decreases in scores overthe four-week period were 8.9 in the secretin group and 17.8in the placebo group (mean difference, 8.9; 95 percentconfidence interval, 19.4 to 1.6; P=0.11). None of thechildren had treatment-limiting adverse effects. After theywere told the results, 69 percent of the parents of the childrenin this study said they remained interested in secretin as atreatment for their children.
Conclusions A single dose of synthetic human secretin is notan effective treatment for autism or pervasive developmentaldisorder.
Source Information
From the Olson Huff Center for Child Development, Thoms Rehabilitation Hospital, Asheville, N.C. (A.D.S., J.D., M.A.G., V.S.); the Human Development Research and Training Institute, Western Carolina Center, Morganton, N.C. (K.A.S., J.W.B.); and the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (J.W.B.).
Address reprint requests to Dr. Sandler at the Olson Huff Center for Child Development, Thoms Rehabilitation Hospital, 68 Sweeten Creek Rd., Asheville, NC 28803, or at adsandler{at}pol.net.
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