Therapies for Children With Autism Spectrum Disorders

and special diets on the effects of Peptizyde but found no changes. 249 Table 21 summarizes the
results of studies of good or fair quality.
Table 21. Outcomes of RCTs of dietary supplements for the treatment of ASDs
Author, year, country Mean age, Mean IQ ± SD Key outcomes
Groups, N
enrollment/N final
Study quality
years ± SD
Munasinghe et al. 249
G1: 68.57 ± NR • No clinically significant changes noted between
2010, Australia
21.28 months
enzyme and placebo.
G1: enzyme/placebo
G2: 70.14 ±
23.66 months
• 27/43 children completed study. Four children
withdrew from study because of negative
21/11
G2: placebo/enzyme
behavioral changes perceived by parents; 5
because of difficulties with enzyme capsule
22/16
administration; 7 because of other reasons/lost to
followup.
Quality: Fair
Chez et al. 247
2002, US
G1: L-carnosine, 14/14
G2: placebo, 17/17
Quality: Fair
Kern et al. 248
2001, US
G1:dimethyl-glycine,
39(total)/18 G2:placebo,
39(total)/19
G1:
7.71 ± 2.41
G2:
7.14 ± 2.05
Overall
3-11 (mean &
SD NR)
NR • Significant difference at baseline in
communication subscale of the GARS, with
worse scores in G1 (p=0.02).
• Pre-post changes on some measures present in
the intervention group only, but the authors did
not compare the differences across groups.
NR • No significant differences on any outcomes
assessed were observed between N,Ndimethylglycine
and placebo arms.
Quality: Fair
ASDs=autism spectrum disorders; GARS=Gilliam Autism Rating Scale; G=group; IQ=intelligence quotient; NR=not reported;
RCT-randomized controlled trial; SD=standard deviation
The remainder of the studies were case series of poor quality, in which modest effects were
observed in improving sleep with iron supplementation 242 and melatonin, 244 and for affecting
general autism symptoms with magnesium and vitamin B6 243 and a combination of fish oil and
evening primrose oil. 246 Modest improvements were seen in some children with a ketogenic diet,
but drop out was high. 245
Content of the literature-other interventions. We identified eight papers from seven studies
conducted in the clinic setting that examined various other medical therapies for treatment of
ASDs in children, including ages ranging from two to 19 years; interventions included
amantadine, 251 piracetam or pentoxifylline added to a risperidone regimen, 252,253 hyperbaric
therapy, 254 oral human immunoglobulin, 64 and dimercaptosuccinic acid (DMSA). 250,255 Two
studies focused on cholinesterase antagonists, including rivastigmine tartrate 256 and donezepil
hydrochloride. 257
These studies typically examined outcomes after three to 12 weeks of therapy. 64,251-254,256,257
Seven studies reported on adverse events. 64,251-255,257 Table 16 summarizes additional study
details. Among all studies of dietary and other interventions, two were good quality, seven were
fair, and seven were poor.
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