| Year | Author | Study Subjects | Controls | Type of Intervention | Study Design | Outcome Measures | Results |
| 1988 | Gillberg | 29 children with autism in the age range 2 - 13 years. | 8 normal children, 3 children with cerebral palsy and 1 with Hallevorden-Spatz disease | Analysis of endophins in cerebrospinal fluid | Controlled study | Levels of endorphins | Produced evidence of elevated levels of endorphin like substances in cerebro-spinal fluid of some people with autism. In particular elevated levels appeared in those who appeared to feel pain less than normal and who exhibited self-injurious behaviour. p < 0.05 endorphin fraction I, p < 0.01 endorphin fraction II |
| 1990 | Knivsberg et al | Fifteen autistic people aged 6 to 22. | None | Gluten free casein free diet for one year. | Single blind study | Behaviour measured on Haracopos and Kelstrup scale and urine samples were taken. Information on autistic behaviour was taken from parents before diet and after one year. | Significant reduction of peptide levels (p < 0.001). Significant increase in language (p < 0.005), social interaction (p < 0.005), structural ability (p < 0.005) and sensory motor ability (p < 0.005).There was a reduction in epileptic seizures for four children. After four years there was still a significant increase p < 0.005) in linguistic skills. Children who stopped diet after four years had substantial reductions in test scores. |
| 1990 | Shattock et al | 25 adults with autism | 20 adults | Early morning urine samples taken | Controlled study | Measured peptides in urine. | Those with autism showed different levels of peptides, but not significantly. |
| 1991 | Sponheim | Seven children with Asperger's Syndrome and five children with autism and mild mental retardation. | Six mentally retarded children. | One had gluten and casein free diet and the other six had gluten or casein reduced diets followed by a diet with gluten for at least three months. | Open study | Visual Analogue Scale and Real Life Rating Scale | Groups were of different ages, received different interventions, no separate controls. No improvement noted in six, but the other noticed considerable improvement. |
| 1995 | Lucarelli et al | 36 autistic children aged 8 to 13. | 20 non-ASD children. | Children had a casein free diet but were given casein or a placebo in capsules for 8 weeks. | Double blind, no randomisation | Behaviour Summarized Evaluation, Student's t-test and blood tests | Significantly (p < 0.001) higher levels of IgA specific antibodies to casein, lactalbumin, B-lactoglobulin and ovalbumin and high levels of IgM and IgG for casein and IgM for lactalbumin. Significant (p < 0.05) improvements in autistic isolation, verbal communication, emotional responses, concentration, perception and cognition. |
| 1998 | Knivsberg et al | Twenty children | Yes | Gluten and casein free diet for one year | Single blind study | Tests and interviews | Significant reduction in autistic traits in diet group (mean of 12.5 to mean of 5.6) but no p numbers given. |
| 1999 | Cade et al | 128 boys with autism (age 3.5 - 16 years) and 22 girls with autism (age 3.5 - 14 years). | 83 men with schizophrenia and 37 women with schizophrenia. | Gluten free casein free diet for one year. | Controlled study | IgA in blood. Parental, physician and teachers' assessment. | Significant improvement in social isolation (p < 0.001), eye control (p < 0.001), mutism (p < 0.001), learning skills (p < 0.001), hyperactivity (p < 0.001), stereotypical activities (p < 0.001), hygiene (p < 0.001), panic attacks (p < 0.001), self motivation (p < 0.001). |
| 1999 | Whiteley et al | 22 children with autism. | Controls did not have autistic spectrum disorder | A non-randomised controlled trial of gluten free diet for at least five months. | Non-randomised controlled trial. | Behaviour was measured on Behaviour Summarized Evaluation scale with cognitive ability measured on six sub tests from Kaufman's Assessment Battery for Children. Urine analyses were done. | Improvements were noted in social and communication skills, motor ability, attention, perception and cognition. One child had a major epileptic fit when gluten was reintroduced. |
| 1999 | Whiteley et al | 31 children with autism (aged 29 - 178 months) | Six children with autism with no intervention | Gluten free diet | Controlled study | Behaviour was measured on Behaviour Summarized Evaluation scale with cognitive ability measured on six sub tests from Kaufman's Assessment Battery for Children. Urine analyses were done. | Signficant increase in scores on four out of six subtests. No figures given. |
| 2002 | Cornish | 8 children with autism on gluten free casein free diet | 29 children with autism not on gluten free casein free diet | Detailed dietary information and a food diary were taken to ascertain whether levels of nutrients were adequate | Non random postal survey | Postal survey | Nutrient intakes fell below the Lower Reference Nutrient Intake in 12 children (32%) for zinc, calcium, iron, vitamin A, vitamin B12 and riboflavin in the non diet group and four children (32%) for zinc and calcium in the diet group. Fruit and vegetable intakes were higher and cereal, bread and potato consumption were lower in those children using the diet. Also, the families of those on the diet spent a lot more money and time on food and they felt socially isolated. |
| 2002 | Knivsberg et al | 10 children with autism | 10 children with autism | Gluten free casein free diet for one year. | Single blind, randomised trial | Autistic traits (measured by DIPAB), Cognitive skills (measured by Leiter International Performance Scale), Linguistic ability (measured by ITPA and Reynells Spraktest, Motor Ability (measured by Movement Assessment Batterry for Children). | Significant reduction of resistance to communication (p < 0.004). Significant reduction of social isolation (p < 0.005). Significant reduction in strange behaviour (p < 0.007). Significant decrease in autistic behaviour (p < 0.005). |
| 2002 | Vojdani et al | 40 children with autism aged 3 - 12. | 40 healthy chidren. | Using ELISA assays, sera was analysed for the presence of IgG, IgM and IgA antibodies against gliadin and cerebellar peptides. | Controlled study | Levels of antibodies. | For all 12 antigens, the differences between mean+- SD of control sera and autistic children's sera were highly significant (p < 0.001). This suggests that bacterial infections and milk antigens may modulate autoimmune responses in autism. |
| 2003 | Arnold et al | 10 children with autism on a gluten and casein restricted diet. | 26 children with developmental delays, 26 children with autism on a normal diet. | Blood samples were taken | Controlled study | Levels of amino acids in blood were measured. | Findings suggest that children with autism are at high risk for amino acid deficiencies, (p < 0.001). Those on a GFCF diet were more likely than those on normal diet to have a deficiency. |
| 2004 | Millward C et al | All reports, studies etc on the gluten free casein free diet and autism | N/A | Research | N/A | Survey | Only one, Knivsberg et al 2002, fitted reliable criteria. |
| 2004 | Vojdani et al | 50 autistic children aged 3 - 14. | 50 healthy people | Assessed the reactivity of sera to specific peptides from gliadin and the cerebellum. | Controlled study | Assessed the reactivity of sera to specific peptides from gliadin and the cerebellum | A significant (p < 0.003) percentage of autism patients showed elevations in antibodies against the dietary protein, gliadin, and cerebellar peptides simultaneously. |
| 2005 | Rimland and Edelson | 1446 children and adults | Autistic children using other interventions | Children already on a gluten free casein free diet. | Survey | Parents' opinions | 3% of the children got worse on this diet, 32% found it had no effect and 65% improved. |
| 2006 | Elder et al | 15 children aged 2 - 16 years with autistic spectrum disorder. | Yes | Children were put on gluten free casein free diet for 12 weeks. | Randomized, double blind repeated measures crossover design. | Autistic symptoms were recorded by parents based on the Childhood Autism Rating Scale and Autism Diagnostic Interview and urinary peptide levels were collected. | There were no statistically significant findings but several parents noticed improvements. |