Study Flops Secretin: Double-Blnd, Placebo-Contrld / Rollens on Epidemic

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Study Flops Secretin: Double-Blnd, Placebo-Contrld / Rollens on Epidemic

Friday, October 08, 1999

A Double-Blind, Placebo-Controlled Trial of Secretin for the Treatment

of Autistic Disorder

Owley, MD, Steele, MS, Corsello, MA, Risi,

PhD, McKaig, MS, Lord, PhD, L. Leventhal, MD,

Edwin H. Cook Jr, MD, Section of Child and Adolescent Psychiatry, Department

of Psychiatry, University of Chicago, Chicago, Ill.

Abstract

Objective: This study examines the efficacy of intravenous porcine

secretin for the treatment of autism. Methods: Using a randomized,

double-blind, placebo-controlled crossover design, 20 subjects with autistic

disorder received either a secretin or placebo infusion at baseline and the

other substance at week 4. Subjects were given the Autism Diagnostic

Interview-Revised, the Autism Diagnostic Observation Schedule-Generic

(ADOS-G), and other pertinent developmental measures at baseline and at

weeks 4 and 8 to assess drug effects. Results: For the primary efficacy

analysis, change of ADOS-G social-communication total score from week 0 to

week 4, no statistically significant difference was obtained between placebo

(-1.0 ± 2.4) and secretin groups (-0.7 ± 1.4; t 0.34, df 18, P <.74). No

significant differences were obtained for the other measures, including when

all 20 subjects were compared by paired t-test from baseline to 4 weeks

after secretin infusion. Conclusion: There was no evidence for efficacy of

secretin in this preliminary randomized controlled trial. These data were

collected as part of a multicenter study with the University of

California-Irvine and the University of Utah. [MedGenMed October 6, 1999. ©

1999 Medscape, Inc.]

Introduction

Autism is a disorder characterized by impairments in reciprocal social

interactions, verbal and nonverbal communication, and preoccupations with

unusual activities or interests, particularly stereotyped or repetitive

movements. This debilitating disorder is estimated to occur in 2-10/10,000

births. The prognosis of autistic disorder is frequently poor, with up to

two thirds of autistic individuals not attaining independent social

functioning.[1]

The deficits in social interaction include a failure to develop peer

relationships appropriate for chronological age, marked impairment in the

use of nonverbal behaviors such as gestures and eye-to-eye gaze, and a lack

of spontaneous seeking to share enjoyment and interests with others. Among

those individuals with autism who do express an interest in making

friendships, the disorder continues to hamper their ability to understand

many of the conventions of social interaction. The communication deficits

manifest in both the semantic (understanding the meaning of words and

phrases) and the pragmatic (the use of language in context) aspects of

language. Language is usually significantly delayed, and up to 50% of

autistic individuals remain without spoken language. Individuals with

autistic disorder show restricted, repetitive, and stereotyped behaviors,

interests, and activities. Their interests are often severely focused to the

point of preoccupation. Changes in routines are often met with resistance

and inflexibility. Often, there are stereotyped and repetitive motor

mannerisms, especially hand flapping.[1]

The goals of treatment in autism are to reduce behavioral symptoms and

to promote learning and development. Psychopharmacologically, there has been

very little to offer the autistic individual with regard to the core social

and communication symptoms described above. Early findings from open trials

with medications such as naltrexone[2] and fenfluramine,[3] although

promising, have subsequently not been confirmed in placebo-controlled

trials.[4-6] Thus, the primary focus in clinical work has been on using

medications to treat specific target symptoms such as hyperactivity and

aggression.[7-9]

Because the core social and communication symptoms of the disorder have

been so resistant to treatment, it was of great interest to those in the

autistic community when a case series claimed that three patients had

dramatic improvement in core symptoms after receiving the hormone

secretin.[10] Secretin is an endogenous gastrointestinal polypeptide

composed of 27 amino acids. It stimulates the secretion of digestive fluids

from the pancreas, the production of pepsin from the stomach, and the

production of bile from the liver. Physicians have primarily utilized

porcine secretin in a provocation test to better characterize

gastrointestinal complaints.[11] In the Horvath study, the effects of

secretin in autistic disorder were discovered serendipitously following the

administration of intravenous secretin (which was given as part of a

diagnostic endoscopy test) in three autistic patients with gastrointestinal

complaints, including persistent vomiting in one case. In that report,

improvement was noted particularly in areas of eye contact, alertness, and

language capacities.

The previous reports were uncontrolled case series.[10,12] In our

current proposal, the effects of secretin were investigated in a

double-blind, placebo-controlled, crossover design. Because of the

debilitating nature of autistic disorder, the possibility of a relatively

safe medication that might improve the core symptoms of the disorder

deserved a thorough, controlled investigation. In addition, since the

Horvath (1998) report, it is our understanding that hundreds, if not

thousands, of children with autistic disorder have been exposed and continue

to be exposed to this potential treatment under uncontrolled conditions.

Therefore, an appropriately controlled assessment of the efficacy of

secretin is very timely from a public health perspective.

The goal of the study was to evaluate the impact of secretin on the

core symptoms of autism (social and communication deficits and stereotyped

behaviors and interests). This protocol was designed to test the hypothesis

that in 3- to 12-year-old children with autistic disorder, treatment with 2

clinical units per kilogram (CU/kg) of intravenous secretin would result in

a significant change from baseline in core symptoms of autistic disorder

relative to placebo.

[For the continuation of this article, go to web address below (all on one

line):

http://www.medscape.com/Medscape/GeneralMedicine/journal/1999/v01.n10/mgm100

6.owle/mgm1006.owle-02.html

* * *

Rollens Reports on Autism Epidemic

I just had breakfast with Verlin Wooley, the executive director of

California's Inland Regional Center. Inland is one of 21 regional centers in

California that serves people with developmental disabilities. Each regional

center has a catchment area, for Inland it is Riverside and San Bernadino

counties. California has 58 counties. Inland has a reputation for being one

of the most conservative centers both on strict diagnostic criteria and

fiscal policy.

Verlin told me that Inland is currently adding 150 NEW CASES OF FULLY

DIAGNOSED DSM 4 AUTISM to his caseload EVERY MONTH. This is just one

of the 21 centers. Keep in mind that prior to 1977-79, California was adding

between 100 and 200 new cases for the entire state for ONE YEAR! So Inland,

one of 21, is adding more new cases in one month that the entire new

caseload, pre 1977-79, for an entire year for the entire state of

California!

Also keep in mind that DSM 4 came into exsistence in 1988, 10 years

AFTER the rapid, unexplained increase had already begun in California. I

sincerely hope that this latest evidence of the growing autism epidemic will

be shared on

Tuesday with members of Congress.

-Rick Rollens RRollens@...

____________________________________________________________

editor: Lenny Schafer east coast editor: , Ph.D.

schafer@... CIJOHN@...

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