Children with autistic spectrum disorders. I: Comparison of placebo and single dose of human synthetic secretin
Aims: To examine the effect of a single dose of human synthetic secretin (HSS) on behaviour and communication in children with autism spectrum disorder (ASD) using an objective measure of communication and social reciprocity and standardised rating scales. Methods: Randomised, crossover, double blin...
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description | Aims: To examine the effect of a single dose of human synthetic secretin (HSS) on behaviour and communication in children with autism spectrum disorder (ASD) using an objective measure of communication and social reciprocity and standardised rating scales. Methods: Randomised, crossover, double blind, and placebo controlled trial of a single intravenous dose of human synthetic secretin (HSS) 2 CU/kg. The 62 subjects (3–8 years) were assigned to group 1 (saline placebo/HSS) or group 2 (HSS/saline placebo). Diagnosis was confirmed by ADI-R (Autism Diagnostic Interview–Revised) algorithm. Severity of symptoms was rated using the CARS (Childhood Autism Rating Scale). Outcome measures included Communication and Symbolic Behavior Scale (CSBS), Ritvo Real-life Rating Scale, weekly Global Rating Scale (GBRS) by parents and teachers, and daily log of gastrointestinal symptoms. The communication subscale of the CSBS, specifying communication function, reciprocity, and social-affective signalling was videotaped and scored by a blinded, trained observer. Results: Sixty one children completed the study. After randomisation, there were no significant differences in gender, race, age, and parent and teacher GBRS and Ritvo Scale between the two groups. Compared with placebo, secretin treatment was not associated with significant improvement of CSBS standard scores from baseline to 2 or 4 weeks post-infusion. Five children showed clinical improvement in standard scores: two after HSS and three after placebo. There were no significant changes in gastrointestinal symptoms after HSS or saline placebo. Conclusions: A single dose of intravenous human secretin is not effective in changing behaviour and communication in children with ASD when compared to placebo. |
doi_str_mv | 10.1136/adc.88.8.731 |
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I: Comparison of placebo and single dose of human synthetic secretin</title><source>MEDLINE</source><source>EZB-FREE-00999 freely available EZB journals</source><source>PubMed Central</source><source>Alma/SFX Local Collection</source><creator>Levy, S E ; Souders, M C ; Wray, J ; Jawad, A F ; Gallagher, P R ; Coplan, J ; Belchic, J K ; Gerdes, M ; Mitchell, R ; Mulberg, A E</creator><creatorcontrib>Levy, S E ; Souders, M C ; Wray, J ; Jawad, A F ; Gallagher, P R ; Coplan, J ; Belchic, J K ; Gerdes, M ; Mitchell, R ; Mulberg, A E</creatorcontrib><description>Aims: To examine the effect of a single dose of human synthetic secretin (HSS) on behaviour and communication in children with autism spectrum disorder (ASD) using an objective measure of communication and social reciprocity and standardised rating scales. Methods: Randomised, crossover, double blind, and placebo controlled trial of a single intravenous dose of human synthetic secretin (HSS) 2 CU/kg. The 62 subjects (3–8 years) were assigned to group 1 (saline placebo/HSS) or group 2 (HSS/saline placebo). Diagnosis was confirmed by ADI-R (Autism Diagnostic Interview–Revised) algorithm. Severity of symptoms was rated using the CARS (Childhood Autism Rating Scale). Outcome measures included Communication and Symbolic Behavior Scale (CSBS), Ritvo Real-life Rating Scale, weekly Global Rating Scale (GBRS) by parents and teachers, and daily log of gastrointestinal symptoms. The communication subscale of the CSBS, specifying communication function, reciprocity, and social-affective signalling was videotaped and scored by a blinded, trained observer. Results: Sixty one children completed the study. After randomisation, there were no significant differences in gender, race, age, and parent and teacher GBRS and Ritvo Scale between the two groups. Compared with placebo, secretin treatment was not associated with significant improvement of CSBS standard scores from baseline to 2 or 4 weeks post-infusion. Five children showed clinical improvement in standard scores: two after HSS and three after placebo. There were no significant changes in gastrointestinal symptoms after HSS or saline placebo. Conclusions: A single dose of intravenous human secretin is not effective in changing behaviour and communication in children with ASD when compared to placebo.</description><identifier>ISSN: 0003-9888</identifier><identifier>EISSN: 1468-2044</identifier><identifier>DOI: 10.1136/adc.88.8.731</identifier><identifier>PMID: 12876177</identifier><identifier>CODEN: ADCHAK</identifier><language>eng</language><publisher>London: BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health</publisher><subject>ADI-R ; adverse event ; Anatomy ; ASD ; Autism ; Autism Diagnostic Interview-Revised ; Autism Spectrum Disorders ; Autistic children ; Autistic Disorder - drug therapy ; Autistic Disorder - psychology ; autistic spectrum disorder ; Behavior ; Behavior Rating Scales ; Biological and medical sciences ; Biomarkers - analysis ; Brain ; Care and treatment ; CARS ; Cerebral Palsy ; Check Lists ; Child ; Child clinical studies ; Child Health Series ; Child, Preschool ; Childhood Autism Rating Scale ; Clinical trials ; clinical unit ; Communication ; Communication and Symbolic Behavior Scale ; Cross-Over Studies ; CSBS ; Developmental disorders ; Double-Blind Method ; Drug testing ; Expressive Language ; Eye contact ; Families & family life ; Family (Sociological Unit) ; Female ; Gastrointestinal Agents - therapeutic use ; GBRS ; Genetic Disorders ; Global Rating Scale ; HSS ; human synthetic secretin ; Humans ; Infantile autism ; Interpersonal Relations ; Interpersonal Relationship ; Male ; Mandatory drug testing ; Maternal & child health ; Medical sciences ; Motor Vehicles ; Nonverbal Communication ; Observation ; Outcome Measures ; Parents ; Parents & parenting ; PDD ; pervasive developmental disorder ; Physicians ; placebo ; Pregnancy ; Psychology. Psychoanalysis. Psychiatry ; Psychometrics ; Psychopathology. Psychiatry ; Psychotropic Drugs - therapeutic use ; secretin ; Secretin - adverse effects ; Secretin - therapeutic use ; Statistics as Topic ; Studies ; Treatment Outcome</subject><ispartof>Archives of disease in childhood, 2003-08, Vol.88 (8), p.731-736</ispartof><rights>Copyright 2003 Archives of Disease in Childhood</rights><rights>2003 INIST-CNRS</rights><rights>COPYRIGHT 2003 BMJ Publishing Group Ltd.</rights><rights>Copyright: 2003 Copyright 2003 Archives of Disease in Childhood</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b546t-7aa13308d4b9531a76161cee95c1899a153dd70c2b4d27a8c0d105dd5fcf0e313</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC1719589/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC1719589/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,727,780,784,885,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=14951936$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12876177$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Levy, S E</creatorcontrib><creatorcontrib>Souders, M C</creatorcontrib><creatorcontrib>Wray, J</creatorcontrib><creatorcontrib>Jawad, A F</creatorcontrib><creatorcontrib>Gallagher, P R</creatorcontrib><creatorcontrib>Coplan, J</creatorcontrib><creatorcontrib>Belchic, J K</creatorcontrib><creatorcontrib>Gerdes, M</creatorcontrib><creatorcontrib>Mitchell, R</creatorcontrib><creatorcontrib>Mulberg, A E</creatorcontrib><title>Children with autistic spectrum disorders. I: Comparison of placebo and single dose of human synthetic secretin</title><title>Archives of disease in childhood</title><addtitle>Arch Dis Child</addtitle><description>Aims: To examine the effect of a single dose of human synthetic secretin (HSS) on behaviour and communication in children with autism spectrum disorder (ASD) using an objective measure of communication and social reciprocity and standardised rating scales. Methods: Randomised, crossover, double blind, and placebo controlled trial of a single intravenous dose of human synthetic secretin (HSS) 2 CU/kg. The 62 subjects (3–8 years) were assigned to group 1 (saline placebo/HSS) or group 2 (HSS/saline placebo). Diagnosis was confirmed by ADI-R (Autism Diagnostic Interview–Revised) algorithm. Severity of symptoms was rated using the CARS (Childhood Autism Rating Scale). Outcome measures included Communication and Symbolic Behavior Scale (CSBS), Ritvo Real-life Rating Scale, weekly Global Rating Scale (GBRS) by parents and teachers, and daily log of gastrointestinal symptoms. The communication subscale of the CSBS, specifying communication function, reciprocity, and social-affective signalling was videotaped and scored by a blinded, trained observer. Results: Sixty one children completed the study. After randomisation, there were no significant differences in gender, race, age, and parent and teacher GBRS and Ritvo Scale between the two groups. Compared with placebo, secretin treatment was not associated with significant improvement of CSBS standard scores from baseline to 2 or 4 weeks post-infusion. Five children showed clinical improvement in standard scores: two after HSS and three after placebo. There were no significant changes in gastrointestinal symptoms after HSS or saline placebo. Conclusions: A single dose of intravenous human secretin is not effective in changing behaviour and communication in children with ASD when compared to placebo.</description><subject>ADI-R</subject><subject>adverse event</subject><subject>Anatomy</subject><subject>ASD</subject><subject>Autism</subject><subject>Autism Diagnostic Interview-Revised</subject><subject>Autism Spectrum Disorders</subject><subject>Autistic children</subject><subject>Autistic Disorder - drug therapy</subject><subject>Autistic Disorder - psychology</subject><subject>autistic spectrum disorder</subject><subject>Behavior</subject><subject>Behavior Rating Scales</subject><subject>Biological and medical sciences</subject><subject>Biomarkers - analysis</subject><subject>Brain</subject><subject>Care and treatment</subject><subject>CARS</subject><subject>Cerebral Palsy</subject><subject>Check Lists</subject><subject>Child</subject><subject>Child clinical studies</subject><subject>Child Health Series</subject><subject>Child, Preschool</subject><subject>Childhood Autism Rating Scale</subject><subject>Clinical trials</subject><subject>clinical unit</subject><subject>Communication</subject><subject>Communication and Symbolic Behavior Scale</subject><subject>Cross-Over Studies</subject><subject>CSBS</subject><subject>Developmental disorders</subject><subject>Double-Blind Method</subject><subject>Drug testing</subject><subject>Expressive Language</subject><subject>Eye contact</subject><subject>Families & family life</subject><subject>Family (Sociological Unit)</subject><subject>Female</subject><subject>Gastrointestinal Agents - therapeutic use</subject><subject>GBRS</subject><subject>Genetic Disorders</subject><subject>Global Rating Scale</subject><subject>HSS</subject><subject>human synthetic secretin</subject><subject>Humans</subject><subject>Infantile autism</subject><subject>Interpersonal Relations</subject><subject>Interpersonal Relationship</subject><subject>Male</subject><subject>Mandatory drug testing</subject><subject>Maternal & child health</subject><subject>Medical sciences</subject><subject>Motor Vehicles</subject><subject>Nonverbal Communication</subject><subject>Observation</subject><subject>Outcome Measures</subject><subject>Parents</subject><subject>Parents & parenting</subject><subject>PDD</subject><subject>pervasive developmental disorder</subject><subject>Physicians</subject><subject>placebo</subject><subject>Pregnancy</subject><subject>Psychology. Psychoanalysis. Psychiatry</subject><subject>Psychometrics</subject><subject>Psychopathology. Psychiatry</subject><subject>Psychotropic Drugs - therapeutic use</subject><subject>secretin</subject><subject>Secretin - adverse effects</subject><subject>Secretin - therapeutic use</subject><subject>Statistics as Topic</subject><subject>Studies</subject><subject>Treatment Outcome</subject><issn>0003-9888</issn><issn>1468-2044</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2003</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNp9kktv1DAUhSMEotPCjjWyhIANGexxEjsskErEo6iiRTyE2FiOfTPjqWOndgLtv8fDjDrAgtW1fD4dnaN7s-wBwXNCaPVcajXnfM7njJJb2YwUFc8XuChuZzOMMc1rzvlBdhjjGmOy4JzezQ7SZBVhbJb5ZmWsDuDQTzOukJxGE0ejUBxAjWHqkTbRBw0hztHJC9T4fpAhfTnkOzRYqaD1SDqNonFLC0j7CBtpNfXSoXjtxhX89gMV0sPdy-500ka4v5tH2Zc3rz837_LTs7cnzfFp3pZFNeZMSkIp5rpo65ISmdJWRAHUpSK8riUpqdYMq0Vb6AWTXGFNcKl12akOAyX0KHu59R2mtgetwI1BWjEE08twLbw04m_FmZVY-h-CMFKXvE4GT3YGwV9OEEfRm6jAWunAT1EwWuJFTTbgo3_AtZ-CS-WSF-OYp6w8UfmWWkoLwjjl3QhXo_LWwhJE6t6ciWOCK17hguDEP9vyKvgYA3Q30QkWm72LtHfBueApyabuwz_r7uHdohPweAfIqKTtgnTKxD1X1GXqUu1zpjOAqxtdhgtRMcpK8eFrI_ir7-8_nZ9_FN8S_3TLt_36_xF_AQ7z0nc</recordid><startdate>20030801</startdate><enddate>20030801</enddate><creator>Levy, S E</creator><creator>Souders, M C</creator><creator>Wray, J</creator><creator>Jawad, A F</creator><creator>Gallagher, P R</creator><creator>Coplan, J</creator><creator>Belchic, J K</creator><creator>Gerdes, M</creator><creator>Mitchell, R</creator><creator>Mulberg, A E</creator><general>BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health</general><general>BMJ</general><general>BMJ Publishing Group Ltd</general><general>BMJ Publishing Group LTD</general><scope>BSCLL</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>0-V</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88B</scope><scope>88E</scope><scope>88I</scope><scope>8A4</scope><scope>8AF</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>ALSLI</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>CJNVE</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9-</scope><scope>K9.</scope><scope>LK8</scope><scope>M0P</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2P</scope><scope>M7P</scope><scope>PQEDU</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20030801</creationdate><title>Children with autistic spectrum disorders. I: Comparison of placebo and single dose of human synthetic secretin</title><author>Levy, S E ; Souders, M C ; Wray, J ; Jawad, A F ; Gallagher, P R ; Coplan, J ; Belchic, J K ; Gerdes, M ; Mitchell, R ; Mulberg, A E</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b546t-7aa13308d4b9531a76161cee95c1899a153dd70c2b4d27a8c0d105dd5fcf0e313</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2003</creationdate><topic>ADI-R</topic><topic>adverse event</topic><topic>Anatomy</topic><topic>ASD</topic><topic>Autism</topic><topic>Autism Diagnostic Interview-Revised</topic><topic>Autism Spectrum Disorders</topic><topic>Autistic children</topic><topic>Autistic Disorder - drug therapy</topic><topic>Autistic Disorder - psychology</topic><topic>autistic spectrum disorder</topic><topic>Behavior</topic><topic>Behavior Rating Scales</topic><topic>Biological and medical sciences</topic><topic>Biomarkers - analysis</topic><topic>Brain</topic><topic>Care and treatment</topic><topic>CARS</topic><topic>Cerebral Palsy</topic><topic>Check Lists</topic><topic>Child</topic><topic>Child clinical studies</topic><topic>Child Health Series</topic><topic>Child, Preschool</topic><topic>Childhood Autism Rating Scale</topic><topic>Clinical trials</topic><topic>clinical unit</topic><topic>Communication</topic><topic>Communication and Symbolic Behavior Scale</topic><topic>Cross-Over Studies</topic><topic>CSBS</topic><topic>Developmental disorders</topic><topic>Double-Blind Method</topic><topic>Drug testing</topic><topic>Expressive Language</topic><topic>Eye contact</topic><topic>Families & family life</topic><topic>Family (Sociological Unit)</topic><topic>Female</topic><topic>Gastrointestinal Agents - therapeutic use</topic><topic>GBRS</topic><topic>Genetic Disorders</topic><topic>Global Rating Scale</topic><topic>HSS</topic><topic>human synthetic secretin</topic><topic>Humans</topic><topic>Infantile autism</topic><topic>Interpersonal Relations</topic><topic>Interpersonal Relationship</topic><topic>Male</topic><topic>Mandatory drug testing</topic><topic>Maternal & child health</topic><topic>Medical sciences</topic><topic>Motor Vehicles</topic><topic>Nonverbal Communication</topic><topic>Observation</topic><topic>Outcome Measures</topic><topic>Parents</topic><topic>Parents & parenting</topic><topic>PDD</topic><topic>pervasive developmental disorder</topic><topic>Physicians</topic><topic>placebo</topic><topic>Pregnancy</topic><topic>Psychology. Psychoanalysis. Psychiatry</topic><topic>Psychometrics</topic><topic>Psychopathology. Psychiatry</topic><topic>Psychotropic Drugs - therapeutic use</topic><topic>secretin</topic><topic>Secretin - adverse effects</topic><topic>Secretin - therapeutic use</topic><topic>Statistics as Topic</topic><topic>Studies</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Levy, S E</creatorcontrib><creatorcontrib>Souders, M C</creatorcontrib><creatorcontrib>Wray, J</creatorcontrib><creatorcontrib>Jawad, A F</creatorcontrib><creatorcontrib>Gallagher, P R</creatorcontrib><creatorcontrib>Coplan, J</creatorcontrib><creatorcontrib>Belchic, J K</creatorcontrib><creatorcontrib>Gerdes, M</creatorcontrib><creatorcontrib>Mitchell, R</creatorcontrib><creatorcontrib>Mulberg, A E</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Social Sciences Premium Collection</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Education Database (Alumni Edition)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>Education Periodicals</collection><collection>STEM Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>Social Science Premium Collection</collection><collection>British Nursing Database</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>Education Collection</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest Biological Science Collection</collection><collection>Education Database</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Science Database</collection><collection>Biological Science Database</collection><collection>ProQuest One Education</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Archives of disease in childhood</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Levy, S E</au><au>Souders, M C</au><au>Wray, J</au><au>Jawad, A F</au><au>Gallagher, P R</au><au>Coplan, J</au><au>Belchic, J K</au><au>Gerdes, M</au><au>Mitchell, R</au><au>Mulberg, A E</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Children with autistic spectrum disorders. I: Comparison of placebo and single dose of human synthetic secretin</atitle><jtitle>Archives of disease in childhood</jtitle><addtitle>Arch Dis Child</addtitle><date>2003-08-01</date><risdate>2003</risdate><volume>88</volume><issue>8</issue><spage>731</spage><epage>736</epage><pages>731-736</pages><issn>0003-9888</issn><eissn>1468-2044</eissn><coden>ADCHAK</coden><abstract>Aims: To examine the effect of a single dose of human synthetic secretin (HSS) on behaviour and communication in children with autism spectrum disorder (ASD) using an objective measure of communication and social reciprocity and standardised rating scales. Methods: Randomised, crossover, double blind, and placebo controlled trial of a single intravenous dose of human synthetic secretin (HSS) 2 CU/kg. The 62 subjects (3–8 years) were assigned to group 1 (saline placebo/HSS) or group 2 (HSS/saline placebo). Diagnosis was confirmed by ADI-R (Autism Diagnostic Interview–Revised) algorithm. Severity of symptoms was rated using the CARS (Childhood Autism Rating Scale). Outcome measures included Communication and Symbolic Behavior Scale (CSBS), Ritvo Real-life Rating Scale, weekly Global Rating Scale (GBRS) by parents and teachers, and daily log of gastrointestinal symptoms. The communication subscale of the CSBS, specifying communication function, reciprocity, and social-affective signalling was videotaped and scored by a blinded, trained observer. Results: Sixty one children completed the study. After randomisation, there were no significant differences in gender, race, age, and parent and teacher GBRS and Ritvo Scale between the two groups. Compared with placebo, secretin treatment was not associated with significant improvement of CSBS standard scores from baseline to 2 or 4 weeks post-infusion. Five children showed clinical improvement in standard scores: two after HSS and three after placebo. There were no significant changes in gastrointestinal symptoms after HSS or saline placebo. Conclusions: A single dose of intravenous human secretin is not effective in changing behaviour and communication in children with ASD when compared to placebo.</abstract><cop>London</cop><pub>BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health</pub><pmid>12876177</pmid><doi>10.1136/adc.88.8.731</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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subjects | ADI-R adverse event Anatomy ASD Autism Autism Diagnostic Interview-Revised Autism Spectrum Disorders Autistic children Autistic Disorder - drug therapy Autistic Disorder - psychology autistic spectrum disorder Behavior Behavior Rating Scales Biological and medical sciences Biomarkers - analysis Brain Care and treatment CARS Cerebral Palsy Check Lists Child Child clinical studies Child Health Series Child, Preschool Childhood Autism Rating Scale Clinical trials clinical unit Communication Communication and Symbolic Behavior Scale Cross-Over Studies CSBS Developmental disorders Double-Blind Method Drug testing Expressive Language Eye contact Families & family life Family (Sociological Unit) Female Gastrointestinal Agents - therapeutic use GBRS Genetic Disorders Global Rating Scale HSS human synthetic secretin Humans Infantile autism Interpersonal Relations Interpersonal Relationship Male Mandatory drug testing Maternal & child health Medical sciences Motor Vehicles Nonverbal Communication Observation Outcome Measures Parents Parents & parenting PDD pervasive developmental disorder Physicians placebo Pregnancy Psychology. Psychoanalysis. Psychiatry Psychometrics Psychopathology. Psychiatry Psychotropic Drugs - therapeutic use secretin Secretin - adverse effects Secretin - therapeutic use Statistics as Topic Studies Treatment Outcome |
title | Children with autistic spectrum disorders. I: Comparison of placebo and single dose of human synthetic secretin |
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