A REVIEW OF VITAMIN THERAPY AS A TREATMENT FOR AUTISM

1
A REVIEW OF VITAMIN THERAPY AS A TREATMENT FOR
AUTISM

• Kelly Patchell
• Caldwell College

2
Overview

• Where I found my information
• What is vitamin therapy?
• History of vitamin therapy
• What does it claim to do?
• Is there evidence supporting this treatment?
• Is this a treatment we should recommend?

3
Sources of Information

• Search of PsychINFO
• Vitamin therapy and aut
• Vitamin therapy
• YouTube
• Google search
• Vitamin therapy for autism
• Vitamin therapy products
• Vitamin B6
• Magnesium
• Methyl B12
• Books

4
What is Vitamin Therapy?

• Biomedical treatment
• Administration of a vitamin, mineral, or
  nutritional supplement in the form of a pill,
  powder, liquid, cream, bath, or injection.
  (http//www.asatonline.org/intervention/treatments
  /vitamin.htm)
• Vitamin A
• Vitamin B6
• Vitamin B12
• Vitamin C
• Vitamin D
• Magnesium
• Dimethylglycerine (DMG)
• Calcium
• Omega 3 Fatty Acids
• (http//www.asatonline.org/intervention/treatments
  /vitamin.htm)

5
WHAT IS VITAMIN THERAPY?

• High dosages
• B6 30 to 3,000 mg
• Recommended daily value 2mg
• Magnesium 350 to 500 mg
• Recommended daily value 80 to 400 mg
• No specified end to treatment
• Life long?
• Unclear about what behaviors are affected
• (Freeman, 2007 Maurice, Green, Luce, 1996)

6
What is Vitamin Therapy?

• In the words of an Autism Specialist
  Physician.
• http//vimeo.com/10077216
• http//www.youtube.com/watch?vwdIWkym4dAAfeature
  related

7
Where can these products be found?

• http//www.brainchildnutritionals.com/Brainchild_N
  ux.html
• http//www.kirkmanlabs.com/ViewProductDetails_at_Prod
  uct_ID_at_274_at_Product_Group_ID_at_1.aspx

8
History

• Vitamin therapy available since 1968
• Bernard Rimland (1928-2006)
• Diagnosed son with autism in lates 1950s
• Founded the Autism Research Institute (ARI) in
  1967
• Aimed at finding causes and developing treatments
• Spread the word about behavior anaylsis.and
  research biomedical treatments
• One of the first researchers to propose dietary
  and supplementary treatments including Vitamin B6
• Rimland has published several articles claiming
  effectiveness of vitamin therapy for autism
• (Edelson, 2009 www.autism.com)

9
HISTORY

• Helped form group of doctors known
• as DAN doctors (Defeat Autism Now)
• in 1995
• The Defeat Autism Now! approach mostly involves
  restricted diets, nutritional supplements, and
  the removal of toxic substances (ARI Support
  Board http//health.groups.yahoo.com/group/ARIsupp
  ort/)
• Research on vitamin therapy ongoing since 1970s
• (Edelson, 2009 www.autism.com)

10
What does Vitamin Therapy claim to do?

• Vitamin B6 (Pyridoxine)
• Helps digest proteins
• Magnesium
• Involved in bone growth, muscle and cell
  maintenance, and enzyme function
• Children with autism reportedly have
• High levels of HVA in urine due to abnormal
  metabolism of dopamine
• Results in abnormal response to sound and light
  measured through Average Cortical Responses
  (Freeman, 2007, p. 205)
• Vitamins B6 and magnesium decrease metabolism of
  dopamine
• Results in less HVA produced by body
• Corrects abnormalities in the childs response
  times to sound and light. (Freeman, 2007, p.
  205)
• (Freeman, 2007 Maurice, Green, Luce, 1996)

11
SO WHAT DOES VITAMIN THERAPY DO?

• Claims to increase eye contact and speech
• What else might be responsible?
• Decrease frustration
• How is this operationally defined?
• Other improvement in behavior
• NOT SPECIFIED. RED FLAG?
• General statements can apply to everyone!
• Remember Secrets of the Psychics?
• Decreased aggression
• Increased social responsiveness (Findling,
  Maxwell, Scotese-Wojtila, Huang, Yamashita,
  Wiznitzer,1997, p. 1)
• Are all symptoms of autism being addressed?
• (Findling et al., 1997 Leaf, McEachin,
  Taubman, 2008)

12
What do the products do.?
(http//www.brainchildnutritionals.com/Brainchild_
Nux.html)
13
What does vitamin therapy do?

• Before and after methyl B12 shots....
• http//www.youtube.com/watch?vQklqdq_yCWkfeature
  related

14
IS THERE EVIDENCE SUPPORTING VITAMIN THERAPY?

• Endless testimonials, anecdotal reports, and
  surveys
• http//www.youtube.com/watch?vq53gWyG05nsfeature
  related
• Jenny McCarthys view of biomedical treatment
• http//www.youtube.com/watch?v4Txnuw40BGofeature
  related
• Grants story
• Did you see any warning signs for pseudoscience?

15
Autism Research Institute

• ARI Parent Rating Scale of Treatments
• http//www.autism.com/pro_parentratings.asp

16
Autism Research Institute

• http//www.autism.com/pro_b6_studies.asp
• Lists 22 studies
• 21 show positive results
• Definition of positive?
• What behavior are they measuring?
• Evoked potentials, HVA levels, urine
• Core symptoms of autism not addressed
• Do you see a pattern developing??

17
Freeman (2007)

• Freeman (2007)
• Reviewed 16 studies conducted on Vitamin
  B6/Magnesium
• 14 found positive results, 2 found no results
• 14 of the studies were conducted by same
  researchers
• Barthelemy, Martineau, and Lelord Rimland

18
Freeman (2007)

• Flaws in studies
• 1. Studies use physiological measures as
  dependent variable
• Are evoked cortical responses related to autism?
• Need a clear operational definition
• Change in physiological measure may NOT indicate
  change in behaviors
• No data to suggest that biochemical measures or
  electrophysiological measures increase or
  decrease the symptoms associated with autism.
  (Freeman, 2007, p. 207)
• (Freeman, 2007)

19
Freeman (2007)

• 2. Measure autism using behavioral scales that
  were not validated
• Created their own behavior scales
• Martineau and Barthelemy Behavior Summarized
  Evaluation Scale in several studies
• Rimland Target Symptoms Checklist that was
  untested in his 1978 study
• Should have used scales that have been validated
  such as
• Autism Behavior Checklist
• CARS
• Childhood Autism Rating Scale
• ADOS
• (Freeman, 2007)

20
Freeman (2007)

• The studies that found no results used validated
  behavioral scales
• Tolbert Ritvo-Freeman Real Life rating scale
• Findling CARS, Childrens Psychiatric Rating
  Scale
• Possible confounding variable?
• (Freeman, 2007)

21
Freeman (2007)

• 3. The raters were not blind to all conditions
• 4. Three of the studies had NO CONTROL GROUP
• 5. Significance levels unreported in 1/3 of
  studies
• Are these results important?
• How large was the difference between the group
• receiving the vitamin therapy and the group that
  was
• receiving a placebo?
• Subjective interpretation?
• (Freeman, 2007)

22

• No well-designed studies have shown that this
  treatment is effective
• 3 rigorous studies showed that it was INEFFECTIVE
• Findling et al., 1997 Kuriyama et al., 2002
  Tolbert, Haigler, Waits, Dennis, 1993
• Vitamin B6 and Magnesium---- only vitamins
  studied
• Recommendations
• Strong, well designed studies should be conducted
• Study other forms of vitamin therapy
• Professionals need to inform parents of lack of
  research support and possible side effects
• (http//www.asatonline.org/intervention/treatments
  /vitamin.htm)

23
Findling, Maxwell, Scotese-Wojtila, Huang,
Yamashita, Wiznitzer (1997)

• Purpose to investigate the effects of vitamin
  B6 and magnesium on individuals with autism
• Authors wanted to conduct further research
  because of flaws cited in research supporting
  this treatment
• Participants
• individuals diagnosed with autistic disorder
• between ages 3 and 17
• Excluded if there was a history of use of
  psychotropic medicine in past 3 months
• Referred by Rainbow Autism Center in Ohio
• (Findling et al., 1997)

24
FINDLING ET AL. (1997)

• Procedures
• 10 week double blind study
• Baseline children given placebo pills for 2
  weeks
• Treatment Participants randomly assigned to
  receive Vitamin B6 and magneisum or placebo
• Received treatment for 4 weeks and then switched
• 30 mg/kg of pyridoxine and 10 mg/kg of magnesium
  oxide per day
• Participants evaluated every other week
• Assessed participants using Childhood Autism
  Rating Scale, Clinical Global Expression Scale,
  the Children's Psychiatric Rating Scale and the
  NIMH Global Obsessive Compulsive Scale
• (Findling et al., 1997)

25
FINDLING ET AL. (1997)

• Results
• Vitamin B6 and Magneisum has no statistically
  significant effect on individuals with autism
• Used more scientific methods to evaluate
  treatment
• Possible placebo effect?
• Larger controlled studies which attend to
  important methodologic considerations are
  necessary to truly define what role HDPM may have
  in the treatment of individuals with autistic
  disorder. (Findling et al., 1997, p. 476)

26
Correspondence with Brain Child Nutritionals

• Dear Kelly,
• Thank you for your inquiry and interest in our
  products.
• I have attached a study that showed improvements
  using BrainChild Nutritionals vitamins and
  minerals over a 3 month period.
• Please feel free to contact me if there are any
  additional questions or information I can assist
  you with.
• Best Regards,
• Celeste King
• Brain Child Nutritionals
• phone[phone]

27
BRAIN CHILD NUTRITIONALS RESEARCH

• Pilot Study of a Moderate Dose Multivitamin/Minera
  l Supplement for Children with Autistic Spectrum
  Disorder
• Conducted at Arizona State University
• Purpose to assess the effects of vitamin
  supplements on children with autism
• Participants 20 children with autism ages 3-8
• Design 3 month double blind study
• (Adams Holloway, 2004)

28
BRAIN CHILD NUTRITIONALS

• Procedures
• Focused on effects of vitamin B6, vitamin C, and
  alpha lipoic acid
• Advertised study by sending out mailings to
  1000 families in Arizona
• Physicians conducted physicals on the children
• Blood tests, urine samples
• Vitamins Diagnostic Laboratory took measurements
  on levels of B6 and alpha lipoic acid prior to
  study
• Did not measure Vitamin C before study began
• (Adams Holloway, 2004)

29
BRAIN CHILD NUTRITIONALS

• Procedures cont.
• Participants randomly assigned to receive vitamin
  supplements or placebo
• Parents, physicians and experimenters were all
  blind to who received the supplements
• Supplements taken for 3 months
• Dosage gradually increased
• Evaluated effects after the three month period
  using Global Impressions Scale
• Parents rated changes that they saw during the
  study
• DO YOU SEE ANY RED FLAGS???
• (Adams Holloway, 2004)

30
BRAIN CHILD NUTRITIONALSAdams and Holloway
(2004)
31
BRAIN CHILD NUTRITIONALS

• Results
• Improvements in sleep and GI problems were
  statistically significant
• Rememberthese ratings were done by the parents!
• If the data are analyzed without including the
  two twins who mistakenly took the supplements on
  an empty stomach and suffered from
  vomiting/nausea, the mean improvements in GI and
  sleep symptoms are slightly higher (average 5.2
  and 5.2) and more statistically significant (plt
  0.005 and p lt0.01, respectively). (Adams
  Holloway, 2004, pp. 1037)
• IF ONLY IT WERE THAT EASY
• Straight from the researchers mouth
• A simple parent assessment demonstrated that
  there were significant effects on sleep and GI
  problems. (Adams Holloway, 2004, pp. 1038)
• Other contributing factors?
• Are sleep and GI problems associated with the
  symptoms of autism???
• (Adams Holloway, 2004)

32
BRAIN CHILD NUTRITIONALS

• This study does not demonstrate effectiveness of
  vitamin supplements as a treatment for autism
• It weakly shows that the parents noticed slight
  changes in sleep and gastrointestinal problems,
  but we cannot say what caused these changes
• Limitations of study
• Small number of participants
• Parent assessment
• No clear definition of behavior changes
• Sleep and GI problem are NOT core symptoms of
  autism
• (Adams Holloway, 2004)

33
What does the say?
http//www.fda.gov/ICECI/EnforcementActions/Enforc
ementStory/EnforcementStoryArchive/ucm105955.htm
34
Is Vitamin Therapy a Worthwile Treatment?

• No!
• The studies conducted have not demonstrated
  effectiveness
• Do not address core symptoms of autism
• Potentially life long treatment
• Expensive!
• Freeman (2007) says it best
• Considering that research on Vitamin B6 and
  Magnesium Therapy has been available since 1968,
  and there has not been even one independent
  replication of these studies a good thirty-eight
  years later, you might want to consider waiting
  until an indepdent replication of this research
  is published otherwise, you are engaging in pure
  experimentation. (Freeman, 2007, p. 212)

35
Possible Harmful Side Effects

• High doses can be dangerous
• Possible nerve damage
• Reduced heart rate
• Weakened reflexes
• Neurological toxicity
• The real question is
• Do the treatment benefits outweigh the side
  effects?
• (Leaf et al., 2008)

36
Should we recommend this treatment?

• NO!!!
• The Right to Effective Behavioral Treatment (Van
  Houten, Axelrod, Bailey, Favell, Foxx, Iwata,
  Lovaas, 1988)
• Right to most effective treatment procedures
• Must recommend empirically validated treatments
• More studies need to be conducted before we can
  consider this treatment seriously

37
JUST BECAUSE ITS NATURAL.DOESNT MEAN ITS GOOD
FOR YOU!
38
Questions?
THANK YOU!
39
References

• Adams, J. B., Holloway, C. (2004). Pilot study
  of a moderate dose of multivitamin/mineral
  supplement for children with autistic spectrum
  disorder. The Journal of Alternative and
  Complementary Medicine, 10(6), 1033-1039.
• Association for Science in Autism Treatment.
  Summaries of Scientific Research on Interventions
  on Autism. In Association for Science in Autism
  Treatment. http//www.asatonline.org/intervention/
  treatments/vitamin.htm
• Brainchild Nutritionals. http//www.brainchildnutr
  itionals.com/Brainchild_Nux.html
• Edelson, S. M. (2009). Bernard Rimland
  (1928-2006). Journal of Autism and Developmental
  Disorders, 39, 821-822.
• FDA. Enforcement Story Archives
  http//www.fda.gov/ICECI/EnforcementActions/Enforc
  ementStory/EnforcementStoryArchive/ucm105955.htm
• Findling, R. L., Maxwell, K., Scotese-Wojtila,
  L., Huang, J., Yamashita, T., Wiznitzer, M.
  (1997). High-dose pyridoxine and magnesium
  administration in children with autistic
  disorder An absence of salutary effects in a
  double-blind, placebo-controlled study. Journal
  of Autism and Developmental Disorders, 27(4).

40
REFERENCES

• Freeman, S. K. (2007). The complete guide to
  autism treatments A parent's handbook Make sure
  your child gets what works. Lynden, WA SKF
  Books.
• Leaf, R., McEachin, J., Taubman, M. (2008).
  Sense and nonsense in the behavioral treatment of
  autism It has to be said. New York DRL Books
  Inc.
• Maurice, C., Green, G., Luce, S. C. (Eds.).
  (1996). Behavioral interventionfor young children
  with autism. Austin, TX Pro-Ed.
• Van Houten, R., Axelrod, S., Bailey, J. S.,
  Favell, J. E., Foxx, R. M., Iwata, B. A.,
  Lovaas, O.I. (1988). The right to effective
  behavioral treatment. Journal of Applied Behavior
  Analysis, 381-384.
• www.autism.com