We have recently been faced with a great number of inquiries regarding the use of secretin for Autistic Spectrum Disorders. We would like to take this opportunity to help sort out the facts in this matter.
Where did it start?
Recently some popular television shows described anecdotal reports of children with autism whose symptoms decreased after they received secretin. The secretin had been given in the course of gastrointestinal procedures. Based on this random observation, secretin has been administered outside of clinical trials to some children with autism. The parents of some of these children were interviewed on television and they described improvement in a range of symptoms.
What scientific information supports the use of secretin?
The physician who reported that secretin affected the symptoms of autism published a case series. This report is descriptive and does not include information regarding the other treatments or therapies that a child might be receiving, nor does it evaluate the outcome in a standard fashion. There is no information regarding the safety of repeated administration or the bioavailability by any route other than intravenous. There is no consistent data regarding effectiveness of drug, means of administration, appropriate dosing, or potential side effects and untoward responses to the drug.
Secretin is a naturally occurring substance in the body as it is a hormone. This does not automatically mean that it is safe to administer however. Think about some other naturally occurring hormones such as insulin. These are potentially very harmful if not given under appropriate conditions.
Need for more research
Many important scientific discoveries stem form clinical observations. Parents are often the simulating force behind research and implementation of interventions. We understand the enthusiasm and energy behind the requests for trials of secretin. The media coverage presented this option in a very favorable light and secretin may indeed prove to be beneficial in the future. However, it is important that safety and efficacy of treatments are thoroughly evaluated by appropriate methods prior to just giving it to any child with autistic symptoms.
Our current position
It is our current position at this time that secretin should be used for conventional investigation of gastrointestinal symptoms. Use outside of the FDA approved purpose should be in the context of controlled clinical trials. This position is supported by Chapter II Committee on Children with disabilities of the American Academy of Pediatric. Given the overwhelming community interest in this area, we are closely following developments surrounding this issue and are considering joining in controlled clinical trials if and when they become available in this area.
Background Information
Secretin is a polypeptide neurotransmitter(chemical messenger), one of the hormones that controls digestion. According to the manufacturer (Ferring laboratories, Suffern, NY) the primary action of secretin is to "increase the volume and bicarbonate content of secreted pancreatic juices." Secretin is currently prepared form the duodenum of pigs, although a synthetic human version may soon be available. The safety and efficacy of porcine(pig) secretin has been approved by US Food and Drug Administration (FDA) for singly dose use in diagnosing gastrointestinal problems such as impaired pancreatic function or gastric problems ulcers in adults (specially for diagnosis of pancreatic exocrine disease, as an adjunct in obtaining desquamated pancreatic cells for cytopathologic examination, and for diagnosis of gastrinoma – Zollinger-Ellison Syndrome). For those uses, a small amount(1 CU/kg of body weight) is administered by intravenous infusion and the consequent stimulation of pancreatic secretions is evaluated. The use of secretin for any other purpose is considered an "off-label"use, i.e. a use for which the FDA has not issued formal approval.
Although secretin generally considered safe for a single dose diagnostic use, no data are available yet as to the safety of repeated doses over time and no data have been submitted on its safety and efficacy for children. No double- blin, placebo-controlled studies of secretin treatment in autism have been conducted. No optimum dosage or recommended frequency of infusion in the treatment of autism have been determined at this time. At the present time, there is no agreed upon procedure to determine which children may potentially benefit for the use of this drug. physicians are advised that, like all drugs, there is the possibility of adverse events that may be associated with individual allergies or susceptibilities. An initial small test dose is recommended as a precaution against allergic reactions and appropriate measures for the treatment of acute hypersensitivity reactions should be available.
Research on Secretin
Although more that 100 children have received secretin injections for the treatment of autism, only one study on its use in three children has been published at this time. the authors of that study discus possible mechanisms of action in the context of "gut-brain" theories of autism that propose a link between the gastrointestinal disorders observed in many children with autism and their brain dysfunctions. The citation for that study and the study abstract are given below:
Horvath K*. Stefanos G, Sokolski KN, Wachtel R, Nabors L, and Tildon JT. "Improved social and language skills after secretin administration in patients with autistic spectrum disorders." Journal of the Association for Academic Minority Physicians 1998; 9:9-15.
Abstract - "We report three children with autistic spectrum disorders who underwent upper gastrointestinal endoscopy and intravenous administration of secretin to stimulate pancreaticobiliary secretion. All three had an increased pancreaticobiliary secretory response when compared with nonautistic patients (7.5 to 10 mL/min versus 1 to 2 mL/min). Within 5 weeks of the secretin infusion, a significant amelioration of the children's gastrointestinal symptoms was observed, as was a dramatic improvement in their behavior, manifested by improved eye contact, alertness, and expansion of expressive language. These clinical observations suggest an association between gastrointestinal and brain function in patients with autistic behavior."
* Department of Pediatrics, University of Maryland at Baltimore, 22 South Greene Street, Box 140/N5W70. Baltimore, Maryland 21201-1595(Fax:410 328-1072).
Supplies of secretin are not available from the National Institutes of Health. Information about ordering secretin can be obtained from the Autism research Institute(fax:619 563 -8840) or form the manufacturer, Ferring Laboratories, Suffern, NY (914 333-8900). A booklet containing information about secretin, including summaries of non-autism studies of secretin and answers to frequently asked questions, can be obtained for $15 form the Autism Research Institute (ARI), 4182 Adams Avenue, San Diego, CA 921116 (websites: autism.com/ari/ and secretin.com) or via fax to ARI with credit card information (fax: 619 563-6840).
Whether secretin will prove to be an effective treatment for autism and/or for gastrointestinal disorders Associated with autism cannot be determined at this time. the NICHD invites qualified applicants to submit applications for research funding to explore its safety, efficacy, and mechanism of action.
Secretin is a peptide whose function in the human body is to release pancreatic juices that aid in digestion and motility in the intestines. It is conventionally used intravenously on a one time basis during procedures to diagnose gastrointestinal illness. Based on anecdotal reports of children with autism whose symptoms decreased after they received secretin in the course of endoscopy (passage of a tube through the mouth to the stomach and intestines to investigate illness; it is performed under sedation), secretin has been administered outside of clinical trails to some children by intravenous, sublingual (drops under the tongue), and transcutaneous (gel on the skin) routes. Parents of children with autism were interviewed on several popular television shows and described subjective improvement in a range of symptoms.
The physician who reported the secretin affected the symptoms of autism published a case series; a historical description of what was reported after children with autism received secretin as part of a gastrointestinal work up. This report is descriptive and does not include information regarding the other treatments or therapies that the children were receiving. No comparison group was reported, nor was outcome described in a standard fashion. Therefore, it is difficult to interpret this information except to say that controlled clinical trails are indicated. No information is available regarding the safety of repeated administration or the bioavailability or sublingual or transcutaneous administration. The reference for the case report is:
Horvath K, Stefantos G, Sokoloski KN, Wachtel R, Nabors L, Tildon JT; Improved social and language skills after secretin administration in patients with autistic spectrum disorders. Journal of the Association of Minority Physicians. (1998);9(1):9-15
Many important scientific discoveries stem from clinical observations. However, unless treatments are evaluated for safety and efficacy in an appropriate fashion using double blind placebo controlled studies, we will not know what therapies to use and recommend. It is our position at this time that secretin should be used for conventional investigation of gastrointestinal symptoms. Until further scientific data is available, use outside of the FDA approved purpose should be in the context of controlled clinical trials. This opinion is shared by the Pediatric Gastroenterologists at the Children's Hospital at Strong; the Developmental Pediatricians at the Children's Hospital at Strong, Genesee Developmental Unit, and a private practice in the Rochester area; and the Child Neurologists at Strong Memorial Hospital. It is endorsed by the regional chapter of the Committee on Children with Disabilities of the American Academy of Pediatrics.
Given the overwhelming community interest in this area, we are pursuing the possibility of controlled clinical trials, but no active studies are ongoing at present.
Further information about secretin can be obtained from the National Institues of Health at http://www.nih.gov/nichd/html/secretin.htm
Barbara Quinn, R.N. (Albany Medical Center) is handling parent questions on secretin: 262-6317
She is telling parents that there have been NO clinical trials or double-blind studies conducted. All the information, thus far, appears to be coming from single case designs which have not been clinical or under the conditions of controlled research.
Questions regarding the correlation between insulin for diabetes and secretin for autism have been answered by reminding parents that many children died in the early uses of insulin. Until clinicians are able to answer questions regarding min/max dose requirements, and toxicity, as well as other protocols, it is still NOT considered a treatment for autism.
Recommendations for parents:
1) Contact the National Institute of Health to advocate and inquire about clinical studies @ (301) 496-4000
2) Contact various institutions that are conducting studies and become involved in trials
University of Maryland Office of Research and Development (410) 706-6723; 515 West Lombard Street, 5th Floor, Baltimore, MD 21201
3) Refer to the official statement made by the Committee for Children with Disabilities (put out by the Children's Hospital at AMC; included in this section)
4) The Autism Research Institute has made an official statement which is on the NYAN website (www.albany.edu/psy/autism/autism.html)
Another source of information on secretin:
Susan Varsames-Young (Westchester Center for Educational and Emotional Development ) - (914) 428-4280
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Last updated: 12/1/98