CM E

Scientifically Unsupported Therapies

in the Treatment of Young Children with
Autism Spectrum Disorders
Merryl A. Schechtman, MD

A
utism spectrum disorders
(ASD) are among the most
puzzling forms of develop-
mental disability. This term refers to
a spectrum of pervasive developmen-
tal disorders sharing deficits in three
major domains: social relatedness and
interactivity, communication, and re-
stricted interests and/or stereotypic or
repetitive behaviors with difficult tran-
sitions. Studies have investigated ge-
netic factors, neurologic, immunologic,

CM E EDUCATIONAL OBJECTIVES

1. Identify the domains of comple-

mentary and alternative therapy.
2. Describe the basis for the brain-gut
connection hypothesis in autism
spectrum disorders.
3. Discuss sensory issues in children
with autism and sensory integra-
tion therapy.

Merryl A. Schechtman, MD, is Assistant

Clinical Professor of Pediatrics, Albert Ein-
stein College of Medicine, Infant Preschool
Unit, Childrens Evaluation and Rehabili-
tation Center, Rose F. Kennedy Center.
Address correspondence to: Merryl A.
Schechtman, MD, 1410 Pelham Parkway
South, Bronx, New York 10461; fax 718-
892-2296.
2007/Jupiter Images/Corbis

Dr. Schechtman has disclosed no rel-

evant financial relationships.

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3709Schechtman.indd 639 8/30/2007 10:09:46 AM

 and early environmental TABLE. The prevalence of com-
insults. ASD are lifelong, plementary and alternative
often severe disorders Types of Complementary therapy usage in children
impacting all facets of and Alternative Medicine with chronic illness, de-
individual, family, and Domain Examples velopmental disabilities,
community function. Re- Alternative medicine systems Chinese medicine, acupuncture and emotional problems
lationships are disrupted, Mind-body interventions Meditation
is high.1-3 These treat-
and socially inappropri- ments are often promoted
Biologically-based medicine Megavitamins, elimination diets
ate behaviors are promi- commercially. They also
nent. Often these children Body-based therapies Sensory integration therapy generally lack objective,
do not cope well with Energy therapies Magnet therapy evidence-based studies to
change, making it diffi- support their claims of ef-
cult for families to go out
in public places. Children may become
SIDEBAR.
aggressive, self-injurious, or resort to
self-stimulatory behaviors, which serve Biologically-based Therapies
to calm them. Although the underlying
Elimination diets: Feingold diet, gluten- and casein-free diet, ketogenic diet
causes of ASD have not been clarified,
Vitamins and supplements: Vitamins A, B6, B12, C, folate, magnesium, dimethylglycine,
several promising interventions have omega 3 fatty acids
been developed utilizing behavioral Neurosecretory agents: Secretin, oxytocin
techniques, educational programs, and Famotidine (Pepcid)
pharmacotherapy to address the symp- Immunologically-based therapies:
toms of this disorder. The prognosis for Antibiotics: vancomycin
truly normal function is guarded, even Antivirals
with availability of standard therapies, Antifungals based on the theory of yeast overgrowth (nystatin, fluconazole)
a factor often leading to parental des- Intravenous immunoglobulin G
peration and the willingness to invest Toxin removal: Chelation therapy based on theory of mercury toxicity
in newer approaches to treatment. Ef- Non-biologically based treatments: Sensory integration therapy, facilitated
communication therapy, auditory integration therapy, hyperbaric oxygen therapy
fective evidence-based services may
also not be available or in short supply.
Standard therapies may require much
time to see progress, and therefore modern-day medicine has been treat- ficacy, often relying upon unproven the-
some parents may be willing to grasp at ment that is evidence-based. There has ories with results that are usually based
the promise of a quick fix. been a growing trend toward the use of upon anecdotal cases. Commercial Web
Scientifically unsupported therapies scientifically unsupported approaches, sites or publications, instead of peer-re-
lack a foundation based on objective, especially within the fields of chronic viewed, scientific journals, are the ve-
controlled research, using methods illness and developmental disabilities. hicles promoting the information to the
standardized within biological or medi- In 1992, the U.S. government estab- public. Therapies reaching the attention
cal science. Therapies such as these are lished the National Center for Comple- of the media may then be sensational-
often used either in conjunction with mentary and Alternative Medicine (NC- ized, furthering their promotion. Often
evidence-based medical treatments CAM) through the National Institutes of pediatricians find themselves in a difficult
(complementary therapies) or might be Health. The NCCAM recognizes five do- position imposed by a parent requesting
used instead of the standard medical mains of complementary and alternative their endorsement of an unsubstantiated
practice (alternative therapies). Use of medicine: alternative medicine systems treatment.4 Recent studies found the use
these therapies date back to early folk (eg, Chinese medicine), mind-body inter- of CAM to range between 50% to 92% in
medicine and are often based upon be- ventions (eg, meditation), biologically- the ASD population.5,6 Within the ASD
lief systems stemming from religious based medicine (eg, megavitamin ther- population, 50% of biologically-based
faith. Although the use of non-stan- apy), body-based therapies (eg, sensory therapies utilized by parents involved
dardized home remedies for minor ill- integration therapy), and energy therapies dietary changes.7 Seventy-six percent of
nesses is widespread, the emphasis in (eg, magnet therapy) (see Table). parents using dietary modifications felt

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3709Schechtman.indd 640 8/30/2007 10:09:48 AM

 that these had been of some benefit for
their affected child. In the category of
body-based therapies, chiropractic ther-
apy was most commonly used; however,
there was no real reported benefit. Vari-
ous therapies were reported by parents
as helpful in relaxing the child diagnosed
with ASD, and these included therapeu-
tic horseback therapy (hippotherapy),
massage, music therapy, and sensory in-
tegration therapy.
This article will focus on many of
the biologically and non-biologically
based alternative or complementary
therapies used in the treatment of ASD
(see Sidebar, page 640).
BIOLOGICALLY-BASED THERAPIES
Diets: The Brain-Gut Connection
The potential relationship between
gastrointestinal symptoms and autism
has been the basis of much investigation
in this population. Valicenti-McDermott
et al8 reported a higher than expected
frequency of gastrointestinal
symptoms and food selec-
tivity in a sample of 50
children with ASD.
Increased symptoms
such as diarrhea, re-
flux, constipation,
bloating, etc., have
been reported with
frequencies of 9%
to 50% in this popu-
lation.9 Increased lev-
els of serotonin, a primary
gut neurotransmitter, have been
found in the plasma of people with au-
tism, but it is not clear that this is linked
to the gastrointestinal symptoms.10
In a small, double-blinded, placebo-
controlled study reviewed by Erickson,11
famotidine (Pepcid) was administered
to children with ASD and gastrointesti-
nal symptoms. Improved behavior was
noted; however, four of the nine chil-
dren noted to have behavioral improve-
ment had undiagnosed gastroesophage-
PSYCHIATRIC ANNALS 37:9 | SEPTEMBER 2007
3709Schechtman.indd 641
al reflux disorder, which may have been
a factor in their improvement.
Dietary manipulation in the treat-
ment of developmental or behavioral
problems is not a new concept. The ori-
gin of this practice is beyond the scope
of this article. However, more recent
dietary practices based upon presumed
associations with nutritional excesses
and deficiencies and possible effects
on behavior evolved in the 1920s, with
the suggestion of excessive sugar con-
sumption and the development of hy-
peractivity and impulsivity. The Fein-
gold diet,12 which became popularized
in the 1970s, was largely based upon
these theories.
In the 1970s, Panskepp13 proposed
that malabsorption of casein (a milk pro-
tein) and gluten (a wheat protein) might
be responsible for manifestations of au-
tism via altered cerebral neurotransmit-
ter metabolism. The protein metabolites
from milk and wheat products were
postulated to be absorbed through a
leaky gut and to act central-
ly as endogenous opioids;
The U.S. Institute of Medicine report ...
concluded that there is no evidence linking the
MMR vaccine with autism.
however, the relationship
between opioid activity and the
development of autism remains specula-
tive. The finding of increased peptides
in the urine of children with autism14 is
controversial, as is the proposal that a
gluten- and casein-free diet can decrease
urinary peptides, resulting in increased
social interactivity among autistic chil-
dren. Despite the lack of definitive data,
the use of the gluten-/casein-free diet is
widespread with many anecdotal testi-
monials of its success.
Erickson11 also reviewed the use of
the ketogenic diet in a small population
of children with autism. Although im-
proved behavior was noted, the study
was not controlled. Dietary limitations,
such as those imposed by selective
elimination diets, may impose addition-
al stress on children and their families
and hypothetically may result in nutri-
tional deficiencies.
In 1998, Horvaths report on im-
proved developmental/behavioral func-
tion following secretin administration
to children with gastrointestinal com-
plaints and symptoms of autism added
to the growing number of theories of
brain-gut interaction based upon gas-
trointestinal proteins acting as central
neuropeptides in the brain.15 However,
despite the initial excitement of se-
cretin as a treatment in ASD, multiple
well-controlled, peer-reviewed stud-
ies on more than 700 children did not
bear out the treatment effects initially
reported by Horvath.
In 2002, Wakefield16 reported a case
series of endoscopic studies on children
with autism and gastrointestinal symp-
toms. An increased rate of ileal lym-
phonodular hyperplasia and colitis was
reported. This article has since been re-
tracted by almost all of the authors.
The Immune System Connection
Abnormal immune function in chil-
dren with ASDs has included the find-
ings of increased antibodies, abnormal
cytokines, antibodies to myelin basic
protein, abnormal immune responses,
and a reported increased prevalence of
641
8/30/2007 10:09:48 AM
 lymphonodular hyperplasia in a previ-
ously diagnosed population of children
with ASD.16-18 Despite suspicion of im-
mune or autoimmune dysfunction in
children with ASD based upon reports of
increased gastrointestinal symptoms, ear
infections, and allergies, no increase in
the rate of either ear infections or allergic
responses, has been noted.19,20 However, a
recent report revealed a higher family his-
tory of autoimmune disorders (rheuma-
toid arthritis, celiac disease, and inflam-
matory bowel disease) in a population of
children with ASD and gastrointestinal
symptoms who had undergone language
regression, compared with those without
language regression.21
IS IT VIRAL?
Levy and Hymans 2005 review22 cited
investigational reports of evidence of early
infection, chronic inflammation, or au-
toimmune disorders as possible etiologic
factors in ASD. They commented that
prenatal and neonatal exposure to viruses
is postulated to alter brain development;
however, studies of viral exposure failed
to show an inflammatory response in the
brain. Antiviral agents have been proposed
as a treatment strategy; however, no spe-
cific virus has been identified, and no pub-
lication has addressed antiviral therapies
in terms of efficacy or safety in ASD.
In 1998, Wakefield16 reported on 12
cases of children with GI abnormalities
and lymphonodular hyperplasia, and
eight of the 12 children allegedly dem-
onstrated symptoms of autism reported
to develop soon after receipt of an MMR
vaccination. Although Wakefield did
not prove an actual causal connection
between autism and MMR, public con-
cern nonetheless exploded after this was
reported on 60 Minutes. Madsen et al23
using national-registry data on autistic
disorders in Denmark (a national cohort
study including 537,000 children) found
no association between the MMR vac-
cine and the subsequent diagnosis of au-
tism. In March 2004, 10 of Wakefields
642
3709Schechtman.indd 642
co-authors published a formal retrac-
tion of the suggestion of a link between
MMR and autism in The Lancet.24 The
U.S. Institute of Medicine report co-
sponsored by the National Institutes of
Health and the Centers for Disease Con-
trol and Prevention concluded that there
is no evidence linking the MMR vaccine
with autism.25
IS IT BACTERIAL?
Sandler et al26 used the antibiotic van-
comycin in a small study of 11 children
with autism and diarrhea whose stools
were colonized with a different clostridi-
um species than controls. It was suggested
that neurological symptoms might result
from altered gut integrity on the basis of
toxins in altered colonic flora. However,
outcome parameters of this study were
not totally blinded, and the childrens be-
haviors may have improved because of
improved bowel function alone.
IS IT FUNGAL?
In the 1980s, anecdotal reports impli-
cated overgrowth of the yeast Candida
albicans in precipitating some cases
of autism. Crook27 suggested the over-
growth of yeast to be secondary to anti-
biotic use or ingestion of processed sug-
ars. Candidal overgrowth was, however,
not documented by endoscopic study.16
The yeast theory popularized the use of
treatments to reduce yeast colonization,
which included the use of probiotics (ac-
idophilus, lactobacillus), dietary modifi-
cation (reduction of refined sugars), and
the use of antifungal agents like nystatin
and fluconazole.
IS IT PRIMARY
IMMUNODEFICIENCY?
Levy and Hyman22 reviewed three
small case series of ASD with equivo-
cal results after intravenous immu-
noglobulin G (IVIG) administration.
However, because of the small risk of
blood-borne infection and side effects
of IVIG, they recommended that this
agent be used for diseases where there
was documented benefit.
IS IT HEAVY METAL TOXICITY?
Bernard et al28 drew attention to sim-
ilarities between symptoms of autism
and mercury toxicity, suggesting a con-
nection between environmental sourc-
es of mercury and the development of
autism. However, mercury poisoning is
characterized by severe movement dis-
orders and peripheral nerve damage,
none of which is typically found in
children with ASD. Nonetheless, me-
dia reports led to requests for mercury
testing because of growing concerns
of possible toxicity. Mercury, a heavy
metal found in the environment, accu-
mulates in internal organs. Therefore,
blood and urine assays do not always
reveal mercury exposure. Hair trace
analysis, which has not been standard-
ized, is not considered to be a reliable
assay for mercury toxicity because of
differing rates of hair growth, variable
hair composition, and because sham-
poos, hair products, exposure to sun,
and drying all serve to leach substances
from hair. Thimerosal, an ethyl-mer-
cury based preservative once used in
many vaccines in the United States (in-
cluding the MMR vaccine), was sug-
gested as a possible cause of autism
in a subpopulation of immunized chil-
dren. Other sources of mercury such as
that contained in thermometers, mer-
cury amalgams in tooth fillings, and
some fish came under scrutiny in the
search for environmental precipitants
of autism symptoms. Pregnant women
were issued warnings against exces-
sive fish consumption, and amalgam
removal was even suggested. Madsen
et al23 examined the use of thimerosal-
containing vaccines and ASD in Den-
mark, where thimerosal was removed
from vaccines in 1992. This study
demonstrated that despite removal of
thimerosal from vaccines, the numbers
of autism cases continued to rise at
PSYCHIATRIC ANNALS 37:9 | SEPTEMBER 2007
8/30/2007 10:09:50 AM
 the same rate as prior to its removal.
Studies of children who received heavy
metal chelation failed to demonstrate
improved neurodevelopmental func-
tion on follow-up.29 More ominous
was the documentation of two deaths
in children in the United States (one of
whom had autism) because of
hypocalcemia and cardiac
arrest after undergo-
ing chelation thera-
py.30 The American
Academy of Pedi-
atrics (AAP) and
the Public Health
Service published
a statement in 2001
indicating the lack of
a decrease in the prev-
alence of autism despite
the removal of thimerosal.31
Although there is no evidence for
mercurys role in causing ASD, chela-
tion therapy has been utilized as a de-
toxification procedure, with occasion-
ally disastrous results.
VITAMINS AND NUTRITIONAL
SUPPLEMENTS
Nutritional supplements have also been
popularized in the treatment of symptoms
in children with ASD. Megavitamin ther-
apy gained popularity in the 1960s with
Linus Paulings theory linking mental ill-
ness and inborn errors of metabolism.32 A
variety of vitamins (vitamins A, C, B6-
magnesium complex, folic acid, B12) and
minerals have been advocated.
Vitamin B6-magnesium complex has
been the most heavily promoted of the
vitamin therapies for ASD. Vitamin B6
(pyridoxine) has been advocated because
of its cofactor role in the production of
the neurotransmitters: serotonin, norepi-
nephrine, epinephrine, dopamine, and
GABA. Magnesium may have an addi-
tive effect on this. Rimland33 reported
decreased behavioral outbursts in autism
with vitamin B6-magnesium supple-
mentation, based on more than a dozen
PSYCHIATRIC ANNALS 37:9 | SEPTEMBER 2007
3709Schechtman.indd 643
studies at that time, many of which were
not blinded or adequately controlled. In
a review of the literature in 2002, Nye
and Brice34 concluded that no recom-
mendation could be made for this treat-
ment based upon the scant data available.
Caution is advised because excessive in-
take of pyridoxine is associated
with peripheral neuropathy.
Although there is no evidence for mercurys
role in causing ASD, chelation therapy has been
utilized as a detoxification procedure, with
occasionally disastrous results.
Excessive magnesium
concentrations are associated
with the development of seizures.
Vitamin A, such as that found in
cod liver oil, is promoted as improv-
ing immune function and vision in
children with autism; however, no
data are available. Excessive use of
Vitamin A can lead to hepatotoxicity
and increased intracranial pressure.
Vitamin C (ascorbic acid) was
reported in one trial to decrease ste-
reotypic behaviors significantly in a
study of residential students with au-
tism; however, this study was never
replicated.35 Vitamin C in excessive
doses has the potential to cause diar-
rhea and renal stones.
Vitamin B12 treatment was recom-
mended based upon data from a small,
controlled study of 20 children with
autism found to have lower plasma con-
centrations of the antioxidants methio-
nine, homocysteine, total glutathione,
cysteine, and S-adenosylmethionine as
compared with controls.36 Administra-
tion of subcutaneous vitamin B12 and
oral folinic acid to patients with ASD
is based on the premise that these indi-
viduals have compromised antioxidant
defenses with an inability to detoxify
environmental contaminants. This study
suggested that as plasma concentrations
of the antioxidants increased, behaviors
were noted to improve; however, further
studies have not replicated this data.
Dimethylglycine (DMG, a nutritional
supplement) is metabolized to the excit-
atory neurotransmitter, glycine, within the
liver. There have been reports of an old
Russian study, which suggested enhanced
language skills in developmentally disabled
children who were administered DMG;
however, two well-controlled and blinded
studies in ASD failed to demonstrate a dif-
ference between DMG and placebo.37,38
Omega-3 fatty acids or polyunsatu-
rated fatty acid (PUFA) 39 is a popular
treatment for a variety of developmental
problems including attention-deficit/hy-
peractivity disorder, dyslexia, develop-
mental coordination disorder, and ASD.
The results of controlled treatment trials
have been mixed and are hard to inter-
pret because of differing formulations
of the essential fatty acids and different
populations treated. Larger clinical trials
are needed to corroborate the findings of
a few reports of improved behaviors.
Oxytocin intranasally and intrave-
nously may have significant positive
effects on repetitive behaviors and so-
cial cognition in adult autism patients;
however, the significance of these re-
sults needs further investigation as
studies on adults cannot be general-
ized to children.40
Other Supplements
Levy and Hyman reviewed data on
other supplements such as tryptophan,
643
8/30/2007 10:09:50 AM
 tyrosine, cyproheptadine, D-cycloser-
ine, and carnosine. There is need for
additional research to support the use
of these supplements.22
NONBIOLOGICAL INTERVENTIONS
Sensory Integration Therapy
Ayres, an occupational therapist, pos-
tulated in 1979 that children with ASD
have deficits in the brain areas responsi-
ble for processing sensory input (visual,
tactile, auditory, gustatory, vestibular,
and proprioceptive) and motor output.41
Sensory integration activities include
jumping on trampolines, swinging, spin-
ning the body, rolling the body, riding a
scooter board, balance activities, appli-
cation of brushes to the body, the wear-
ing of weighted vests, smooshing a
child between pads or pillows, and play-
ing with textured toys. Oral motor activ-
ities may be used as well. Manipulation
of the environment is central to sensory
integration therapy; therefore, the fabric
(texture) of clothing or sheets may be
changed. Labels and tags are removed
from clothing, and class sizes are limited
to decrease distraction. Within the class-
room, a quiet corner is established to pro-
vide an area with decreased stimulation.
Occupational therapists commonly pro-
vide sensory integration therapy, which
may take place in differing venues, such
as in the home or school. Anecdotal evi-
dence for efficacy of sensory integration
therapy is widespread, and there is great
interest in establishing an evidence-base
for these therapies.
There is ongoing research evaluating
the use of water therapy (aquatherapy),
horseback riding (hippotherapy), music
(music therapy), massage, and other
therapies, which claim to calm and im-
prove behavioral symptoms in children
with ASD and other disabilities.
Facilitated Communication
Facilitated communication (FC) refers
to an intervention utilizing either a com-
644
3709Schechtman.indd 644
puter or typewriting device in which an-
other individual, the facilitator, guides the
hand of a nonverbal individual. This tech-
nique was originally used to assist physi-
cally disabled individuals.42 Numerous
controlled and blinded studies have failed
to demonstrate FC as replicable or valid.
In 1998, the AAP issued a statement from
the Committee on Children with Disabili-
ties highlighting the lack of scientific data
to show FC to be effective.43
Auditory Integration Training
Auditory integration training (AIT)
is a technique conceived by a French
ENT specialist, Dr. Guy Berard, in
the 1960s. It consists of acoustically
modified music played to a child for 10
hours in two 30-minute sessions each
day from a CD player attached to box
(AIT device) that is wired to modify the
signal, presumably to reduce the vol-
ume for frequencies to which the child
is hypersensitive. It was publicized as a
method to retrain the auditory system
in children with auditory sensitivities
and became popularized by the book
The Sound of a Miracle by Stehli.44
Gravel45 stated that there was no scien-
tific evidence for the type of peripheral
hearing abnormalities that Berard orig-
inally reported. In addition, the sound
pressure levels produced by some of the
AIT devices were potentially unsafe.
The 1998 statement of the AAP, which
addressed Facilitated Communication,42
also indicated the lack of scientific evi-
dence and potential danger of Auditory
Integration Training, recommending its
use in experimental protocols only.
Hyperbaric Oxygen Therapy
A review of hyperbaric oxygen ther-
apy (HBOT) indicates successful use of
this therapy in improving perfusion and
healing in wounds (diabetes), carbon
monoxide poisoning, and decompres-
sion illness in sports divers.46 HBOT has
been used for the treatment of cerebral
palsy, fetal alcohol syndrome, traumatic
brain injury, and ischemic brain injury.
It was postulated that decreased blood
perfusion to several areas of the brain,
in particular the temporal regions and
auditory processing and language areas,
correlate with many of the behaviors as-
sociated in autism.47 However, scientific
evidence is lacking for the use of HBOT
in developmental disabilities.
SUMMARY
Our understanding of ASD has
changed over the past decades, and di-
agnostic tools have assisted in earlier
identification and referral for interven-
tion. Appropriate intervention appears
to impact positively on overall outcome
for a pervasive developmental disorder
for which there is currently no known
cure. Novel and controversial thera-
pies will come and go, and therefore
physicians should familiarize them-
selves with these interventions, as ad-
vice about these alternative approaches
will be sought. Discussions of nontra-
ditional therapies should include the
placebo effect, possibly undesirable,
or potentially dangerous outcomes of a
treatment, and the importance of scien-
tifically sound research studies of that
treatment. Addressing the use of com-
plementary and alternative therapies in
families with medically compromised
or developmentally disabled children
is crucial to providing complete care to
the patient.
A note from the editors:
This article originally appeared in
Pediatric Annals, a SLACK Incorporat-
ed publication.
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