Dr. Ron’s Research Review – June 15, 2016

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This week’s research review focuses on clinical trials of B6 for autism.

A study used data from an earlier non-blind study to identify 16 autistic-type child outpatients who had apparently improved when given vitamin B6 (pyridoxine). In a double-blind study each child's B6 supplement was replaced during two separate experimental trial periods with either a B6 supplement or a matched placebo. Behavior was rated as deteriorating significantly during the B6 withdrawal. (Rimland et al., 1978)

A 10-week double-blind, placebo-controlled trial included 10 patients (mean age 6 years 3 months) with autism. High-dose pyridoxine (638.9 mg) and magnesium oxide (216.3 mg) was ineffective in ameliorating autistic behaviors as assessed by the Children's Psychiatric Rating Scale (CPRS), the Clinical Global Impression Scale, and the NIMH Global Obsessive Compulsive Scale. (Findling et al., 1997)

The paper by Pfeiffer, Norton, Nelson, and Shott (1995) contained many errors, omissions, and misconceptions. Space permits me to touch on but a few. Their "exhaustive computerized search" located only 12 of the 18 studies published prior to their report. A study does not cease to exist because it has been missed in one or more computer searches. The very study that Pfeiffer et al. singled out for criticism had also been singled out—for praise—by two-time Nobelist Linus Pauling. (Rimland, 1998)

Dr. Ron


 

Articles

High-dose pyridoxine and magnesium administration in children with autistic disorder: an absence of salutary effects in a double-blind, placebo-controlled study.
            (Findling et al., 1997) Download
Several reports have described salutary effects such as decreased physical aggression and improved social responsiveness being associated with the administration of high doses of pyridoxine and magnesium (HDPM) in open-labeled and controlled studies of patients with autism. Despite this fact, this intervention remains controversial. A 10-week double-blind, placebo-controlled trial was undertaken to examine both the efficacy and safety of HDPM in autism. Twelve patients were enrolled, and 10 patients (mean age 6 years 3 months) were able to complete the study. HDPM at an average dose of 638.9 mg of pyridoxine and 216.3 mg of magnesium oxide was ineffective in ameliorating autistic behaviors as assessed by the Children's Psychiatric Rating Scale (CPRS), the Clinical Global Impression Scale, and the NIMH Global Obsessive Compulsive Scale. Furthermore, no clinically significant side effects were noted during HDPM administration. A trend for a transient change on the CPRS was found that was possibly due to a placebo response. This study raises doubts about the clinical effectiveness of HDPM in autistic disorder.

The effect of high doses of vitamin B6 on autistic children: a double-blind crossover study.
            (Rimland et al., 1978) Download
The authors used data from an earlier nonblind study to identify 16 autistic-type child outpatients who had apparently improved when given vitamin B6 (pyridoxine). In a double-blind study each child's B6 supplement was replaced during two separate experimental trial periods with either a B6 supplement or a matched placebo. Behavior was rated as deteriorating significantly during the B6 withdrawal.

High dose vitamin B6 and magnesium in treating autism: response to study by Findling et al.
            (Rimland, 1998) Download

 


References

Findling, RL, et al. (1997), ‘High-dose pyridoxine and magnesium administration in children with autistic disorder: an absence of salutary effects in a double-blind, placebo-controlled study.’, J Autism Dev Disord, 27 (4), 467-78. PubMed: 9261669
Rimland, B, E Callaway, and P Dreyfus (1978), ‘The effect of high doses of vitamin B6 on autistic children: a double-blind crossover study.’, Am J Psychiatry, 135 (4), 472-75. PubMed: 345827
Rimland, B. (1998), ‘High dose vitamin B6 and magnesium in treating autism: response to study by Findling et al’, J Autism Dev Disord, 28 (6), 581-82. PubMed: 9932247