Year Author Study Subjects Controls Type of Intervention Study Design Outcome Measures Results
1978 Rimland, Callaway and Dreyfus 16 autistic children Yes 75mg - 3000mg B6, mostly 300mg - 500mg Double blind placebo crossover Behaviour measured on TSCL ratings by parents and teachers Eleven of 15 improved (p < 0.05)
1981 Lelord et al - study 1 44 children with autistic symptoms No 600mg - 1,125mg /day B6 and 400mg - 500mg/day magnesium Open trial to identify responders Behaviour on Brettonneau II (18 items), HVA in urine 21 of the 44 children improved and these were put forward to the second study. The other 23 children were the controls.
1981 Lelord et al - study 2 21 children selected from above 44 23 children from above 44 not selected. 600mg - 1,125mg /day B6 and 400mg - 500mg/day magnesium, for 14 days Double blind placebo crossover comparing responders and non-responders. Behaviour on Brettonneau II (18 items), HVA in urine 15 of 44 improved noticeably, in 14 of 15 the improvement disappeared by 3 weeks of the cessation of the treatment (p =< 0.01). HVA levels (n=37) also improved (p < 0.01). 14% improved considerably, 33% improved, 41% no improvement, 11% worsened.
1984 Jonas et al 8 adults with autism Yes Received B6 and magnesium for 42 day periods 42 days apart. Double blind crossover trial Behaviour was measured on a rating scale. Levels of HVA, dopac, dopamine and GABA were measured in the urine. Significant clinical improvement on scores for affective responses and communication.
1988 Martineau et al 11 autistic children aged 4 - 8 Yes 30mg/kg/day B6, 10mg/kg/day magnesium. Eight weeks of treatment followed by a no treatment period. Open non-blind controlled study Behaviour Summarized Evaluation (20 items), urinary HVA, AEP. The B6 group showed a significant behavioural improvement (p < 0.02) , normalisation of evoked potential and a drop in dopamine levels. The behaviours returned to the baseline when the treatment was discontinued. Significant decrease in uDA (p < 0.02).
1993 Tolbert 15 students in a residential school with ASD and mental retardation aged 6 - 18. Yes 200mg/70kg B6 and 100mg/70kg magnesium Double blind placebo controlled assymetric crossover after 10 week baseline data. Ten week study. Objective (Ritvo Freeman Real Life Rating Scale). No effect, lower dose used to avoid toxicity. There was a slight reduction in symptoms in all students including controls and subjects.
1995 Pfeiffer et al Twelve published studies on autism No Comparing and analysing the different studies that have taken place on B6 and magnesium N/A Methodology review and summary of outcomes. It is considered that much of the research done in this area has errors and inconsistencies and although the indications are that B6 and magnesium will often ease the symptoms of autism, some larger scale studies need to be done.
1997 Findling et al 10 autistic children, outpatients Yes 30mg/kg B6 and 10mg / kg magnesium, no washout period, no test of compliance Double blind placebo crossover, 4 week trials Children's Psychiatric Rating Scale, Clinical Global Impression Scale, NIMH Global Obsessive Compulsive Scale, Conners Teach and Parent Scale. The authors claim that there was no benefit seen, but they were unable to produce data.
2002 Kuriyama 8 children aged 6 - 16 diagnosed with pervasive developmental delay Yes 200mg/day B6, no magnesium 4 week randomised double blind placebo controlled study IQ test. The subjects on B6 showed an 11.2 verbal IQ point improvement, the placebo group showed 6 points. This was statistically significant (p = 0.01)
2004 Adams and Holloway Twenty children with autistic spectrum disorders Yes Three month, moderate dose multivitamin and mineral Randomised double blind placebo controlled study Blood tests to ascertain levels of B6 and questionnaire. Evaluation before found that autistic children had substantially elevated levels of B6 (p < 0.0000001). This is consistent with the recent theory about low levels of pyridoxal - 5 - phosphate and low activity pyridoxal kinase. Pyridoxal is only poorly converted to pyridoxal - 5 - phosphate and therefore explains the need for high doses of B6. Significant improvement in sleep (p = 0.03) and gastrointestinal symptoms (p = 0.03).
2005 Rimland and Edelson 5780 autistic children and adults Autistic children taking other interventions. The dosages of B6 and magnesium were decided by parents. Parental questionnaire. Parents' judgement of behaviour. Parents rated 85 biomedical interventions as to safety and efficacy. B6 and magnesium were rated 'helpful' in 47%, 'no effect' in 49% and 'made worse' in 4%.
2006 Nye and Brice All research on the use of B6 and magnesium with children with autism N/A Dosages of B6 and magnesium Survey N/A Whilst the one research report that they felt contained everything necessary for a reliable study showed significant improvement, they considered it not enough to prove that this a a valid method.
2006 Adams et al 35 autistic children aged 3 - 9. 11 typical children No supplements given Single blind controlled study Microbiological assay used to measure level of vitamin B6 Children with autism had a 75% higher B6 level than controls (p = 0.00002). This supports the theory of low conversion of pyridoxal and pyridoxin P5P. P5P is the active cofactor for 113 well known enzymatic reactions including for formation of many key neurotransmitters.