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DOI: 10.1055/s-0035-1557380
Pharmaceutical treatment studies in autism and ADHD: A design based review of study quality
Subject Editor:
Publication History
18 October 2006
12 January 2007
Publication Date:
30 July 2015 (online)
Abstract
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.