ARI Publication 40 – 2013 Version

ACTOS: ACTOS (pioglitazone) has multiple effects, including the ability to decrease inflammation.
An open study of ACTOS in 25 children with autism for 3-4 months found substantial improvements
in irritability, lethargy, stereotypy, and hyperactivity, with greater benefits in the younger children.
Doses were 30 mg (younger children) and 60 mg (older children).

Boris et al., Effect ofpioglitazone treatment on behavioral symptoms in autistic children, accepted in J.
Neuroinflammation 2007.

However, the ARI survey data (below) suggests that it is only rarely beneficial.

Safety Concern: The FDA has issued a “black box" warning that ACTOS may increase
the risk of congestive heart failure, fluid retention, and edema (swelling due to fluid
build-up under the skin).

Low-dose naltrexone:
Naltrexone is a medication used to block the opioid receptor in the brain, and therefore is used to
treat opioid addiction by preventing the euphoric effect of opioids like morphine and heroin. There
have been 14 clinical trials of naltrexone for children with autism. A review paper by Elchaar et al.
reported “Naltrexone has been used most commonly at doses ranging from 0.5 to 2 mg/kg/day and
found to be predominantly effective in decreasing self-injurious behavior. Naltrexone may also
attenuate hyperactivity, agitation, irritability, temper tantrums, social withdrawal, and stereotyped
behaviors. Patients may also exhibit improved attention and eye contact. Transient sedation was
the most commonly reported adverse event."

Elchaar et al., Efficacy and safety ofnaltrexone use in pediatric patients with autistic disorder.
Ann Pharmacother. 2006 Jun;40(6):1086-95. £pub 2006 May 30. Review.

It has been suggested that low-dose naltrexone, at about 3-5 mg/day (much lower than the doses
mentioned above) may be beneficial to children with autism and may improve the regulation of
their immune system. More research is needed.

ARI Survey of Parent Ratings of Treatment Efficacy:

% Worse% No Change% Better/td>Number of Reports
IVIG7%39%54%142
Actos19%60%21%140
Low-dose naltrexone11%52%38%190

Based on the ARI Survey Data, IVIG seems the most likely to be beneficial, followed by LDN, with
Actos having the lowest% better and the highest% worse. However, this is only survey data from
relatively small numbers of families. More research is needed.

TRICHURIS SUIS THERAPY: Eggs of the pig whipworm (Trichuris suis) have been used for
treatment of certain immune-system disorders including inflammatory bowel diseases, multiple
sclerosis and food allergies, due to their immunomodulatory effects (ability to modulate the immune
system). The therapy appears to generally be safe because the worms can only exist for a short
time in human digestive tracts. Some physicians have used it for patients with autism, but there is
no formal research yet on its use for individuals with autism, so it should be viewed as an
experimental therapy for autism.

Summers RW et. al., Trichuris suis therapy in Crohn ‘s disease, Gut 2005: 54:87-90;
Summer. et al.; Trichuris suis therapy for active ulcerative colitis. a randomized controlled trial
gastroenterology april 2005.
Jouvin MH, KinetJP. Trichuris suis ova: testing a helminth-based therapy as an extension ofthe
hygiene hypothesis., J Allergy Clin lmmunol. 2012 Jul;130(1):3-1O; quiz 11-2. Review.

Agape is proud to have
been involved in this study and
mentioned on page 16.

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