a review of vitamin therapy as a treatment for autism kelly patchell caldwell college
TRANSCRIPT
A REVIEW OF VITAMIN THERAPY AS A TREATMENT
FOR AUTISMKelly Patchell
Caldwell College
OVERVIEW
Where I found my information
What is vitamin therapy?History of vitamin therapyWhat does it claim to do?Is there evidence supporting this treatment?
Is this a treatment we should recommend?
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
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 AVitamin B6Vitamin B12Vitamin CVitamin DMagnesiumDimethylglycerine (DMG)CalciumOmega 3 Fatty Acids
(http://www.asatonline.org/intervention/treatments/vitamin.htm)
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)
WHAT IS VITAMIN THERAPY?
In the words of an “Autism Specialist Physician”….
http://vimeo.com/10077216
http://www.youtube.com/watch?v=wdIWkym4dAA&feature=related
WHERE CAN THESE PRODUCTS BE FOUND?
http://www.brainchildnutritionals.com/Brainchild_Nux.html
http://www.kirkmanlabs.com/ViewProductDetails@Product_ID@274@[email protected]
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)
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/ARIsupport/)
Research on vitamin therapy ongoing since 1970s
(Edelson, 2009; www.autism.com)
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 child’s response times to sound and light.” (Freeman, 2007, p. 205)
(Freeman, 2007; Maurice, Green, & Luce, 1996)
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)
WHAT DO THE PRODUCTS DO….?
(http://www.brainchildnutritionals.com/Brainchild_Nux.html)
WHAT DOES VITAMIN THERAPY DO?
Before and after methyl B12 shots.... http://www.youtube.com/watch?
v=Qklqdq_yCWk&feature=related
IS THERE EVIDENCE SUPPORTING VITAMIN THERAPY?
Endless testimonials, anecdotal reports, and surveys
http://www.youtube.com/watch?v=q53gWyG05ns&feature=related Jenny McCarthy’s view of biomedical treatment
http://www.youtube.com/watch?v=4Txnuw40BGo&feature=related Grant’s story
Did you see any warning signs for pseudoscience?
AUTISM RESEARCH INSTITUTE
ARI Parent Rating Scale of Treatmentshttp://www.autism.com/pro_parentratings.asp
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??
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
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)
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)
FREEMAN (2007)
The studies that found no results used validated behavioral scales
Tolbert: Ritvo-Freeman Real Life rating scale
Findling: CARS, Children’s Psychiatric Rating Scale
Possible confounding variable?
(Freeman, 2007)
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 groupreceiving the vitamin therapy and the group that wasreceiving a placebo? Subjective interpretation?
(Freeman, 2007)
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)
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)
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)
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)
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 KingBrain Child Nutritionalsphone:831 465 0104
BRAIN CHILD NUTRITIONALS RESEARCH
Pilot Study of a Moderate Dose Multivitamin/Mineral 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)
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)
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)
BRAIN CHILD NUTRITIONALS
ADAMS AND HOLLOWAY (2004)
BRAIN CHILD NUTRITIONALS Results
Improvements in sleep and GI problems were statistically significant
Remember…these 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 (p< 0.005 and p <0.01, 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)
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)
WHAT DOES THE SAY?
http://www.fda.gov/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/ucm105955.htm
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)
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)
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
proceduresMust recommend empirically validated
treatments More studies need to be conducted before we
can consider this treatment seriously
JUST BECAUSE ITS NATURAL….DOESN’T MEAN ITS GOOD FOR YOU!
QUESTIONS?
THANK YOU!
REFERENCESAdams, 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.brainchildnutritionals.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/EnforcementStory/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).
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