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@Product_Group_ID@1.aspx

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