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A REVIEW OF VITAMIN THERAPY AS A TREATMENT FOR AUTISM

A REVIEW OF VITAMIN THERAPY AS A TREATMENT FOR AUTISM. Kelly Patchell Caldwell College. 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?

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A REVIEW OF VITAMIN THERAPY AS A TREATMENT FOR AUTISM

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  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?v=wdIWkym4dAA&feature=related

  7. Where can these products be found? • http://www.brainchildnutritionals.com/Brainchild_Nux.html • http://www.kirkmanlabs.com/ViewProductDetails@Product_ID@274@Product_Group_ID@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/ARIsupport/) • 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 child’s 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?v=Qklqdq_yCWk&feature=related

  14. 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?

  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, Children’s 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:831 465 0104

  27. 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)

  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 • 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)

  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/EnforcementStory/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….DOESN’T 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.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).

  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

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