TY - JOUR
T1 - Pharmaceutical treatment studies in autism and ADHD
T2 - A design based review of study quality
AU - Wisniewski, Tami
AU - Brimacombe, Michael B.
AU - Ming, Xue
PY - 2007
Y1 - 2007
N2 - The overall design quality of studies conducted on psychotropic substances prescribed to autism spectrum disorder and attention deficit hyperactivity disorder children is reviewed. Searches were conducted on Medline and Cochrane Controlled Trials Register. Peer-reviewed, published studies, written in English were included. Only studies that focused on children, had a minimal sample size of ten participants, and were conducted between 1994 and 2004 were included in the review. Two hundred and eighty one studies were identified and reviewed with 184 (65.5%) focused primarily on methylphenidate, with the remaining 97 studies examined stimulants, antipsychotics, antidepressants, alpha agonists, anxiolytics, and mood stabilizers. Of these, 152 (54.1%) did not employ optimal double blind placebo controlled design and 106 (37.7%) were conducted with less than 30 participants. The upper quartile for median study duration across all medications examined was 9.75 weeks for double-blinded studies and 16 weeks for all studies. Many pharmacotherapy studies conducted on children with autism spectrum disorder and attention deficit hyperactivity disorder are of limited duration, weak quality design and may be seriously underpowered. The issue of follow-up is rarely adequately addressed. These findings raise both safety and efficacy questions that have yet to be adequately studied.
AB - The overall design quality of studies conducted on psychotropic substances prescribed to autism spectrum disorder and attention deficit hyperactivity disorder children is reviewed. Searches were conducted on Medline and Cochrane Controlled Trials Register. Peer-reviewed, published studies, written in English were included. Only studies that focused on children, had a minimal sample size of ten participants, and were conducted between 1994 and 2004 were included in the review. Two hundred and eighty one studies were identified and reviewed with 184 (65.5%) focused primarily on methylphenidate, with the remaining 97 studies examined stimulants, antipsychotics, antidepressants, alpha agonists, anxiolytics, and mood stabilizers. Of these, 152 (54.1%) did not employ optimal double blind placebo controlled design and 106 (37.7%) were conducted with less than 30 participants. The upper quartile for median study duration across all medications examined was 9.75 weeks for double-blinded studies and 16 weeks for all studies. Many pharmacotherapy studies conducted on children with autism spectrum disorder and attention deficit hyperactivity disorder are of limited duration, weak quality design and may be seriously underpowered. The issue of follow-up is rarely adequately addressed. These findings raise both safety and efficacy questions that have yet to be adequately studied.
KW - ADHD
KW - Autism
KW - Design quality
KW - Pharmacotherapy
UR - http://www.scopus.com/inward/record.url?scp=34547634440&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=34547634440&partnerID=8YFLogxK
U2 - https://doi.org/10.1055/s-0035-1557380
DO - https://doi.org/10.1055/s-0035-1557380
M3 - Article
SN - 1304-2580
VL - 5
SP - 189
EP - 197
JO - Journal of Pediatric Neurology
JF - Journal of Pediatric Neurology
IS - 3
ER -