Biomedical Treatment and Diet Supplements for the Treatment of the Autism Spectrum Disorder

PICHON RIVIERE, A.; AUGUSTOVSKI, F.; GARCIA MARTI, S.; GLUJOVSKY, D.; ALCARAZ, A.; LOPEZ, A.; BARDACH, A.; CIAPONI, A; REY-ARES, L.; SPIRA, C

Documento de Evaluación de Tecnologías Sanitarias

IECS

Año: 2012 p. 1 - 30

1668-2793

The Autism Spectrum Disorder (ASD) is a range of complex neurodevelopmental disorders featured by distinctive behaviors: Difficulty in social interaction, verbal and non verbal communication problems, and lack of flexibility in reasoning and repetitive behaviors. In the United States, its total prevalence is estimated in 66 out of 10,000 children, being four times more likely to occur in males than in females. The cause of autism is unknown although some genetic and environmental factors might play a role in its development.There is no curative treatment. The common treatment for this disorder is a combination of educational programs, speech/language therapies, social capabilities support and interventions in behavior. Other treatments such as occupational therapy and physical therapy promote improvement of the comorbid difficulties usually present in these patients. "Biomedical treatment" is one of the so-called complementary and alternative (CAM) therapies proposed to treat the main symptoms of autism and its comorbidities.TechnologyThe so-called "biomedical treatment" consists in a combination of diet modifications, vitamin and mineral supplements, antibiotics, antifungal agents, probiotics, digestive enzymes, administration of essential fatty acids, antioxidants, calcium and magnesium, aminoacids and kelation, which are indicated after an individualized diagnosis.PurposeTo assess the available evidence on the efficacy, safety and issues related to coverage policies for the use of biomedical treatment and food supplements in patients with autism spectrum disorder.MethodsA bibliographic search was carried out on the main databases: DARE, NHS EED, on Internet general search engines, in health technology evaluation agencies and health sponsors. Priority was given to the inclusion of systematic reviews; controlled, randomized clinical trials (RCTs); health technology assessments and economic evaluations; clinical practice guidelines and coverage policies of other health systems.ResultsNo references were found in the scientific literature as to ?biomedical treatment?. There was individual evidence of the different components of this treatment.Three systematic reviews evaluating supplements with essential fatty acids (omega 3), gluten and casein free diet and combined administration of vitamin B6 and magnesium for the treatment of autism spectrum as well as a pilot, randomized, controlled and double blind study evaluating the effects of multivitamin and mineral supplements were found.Essential fatty acid supplements - Omega 3In 2011, a Cochrane systematic review evaluated the type omega 3 essential fatty acids in relation to the cardinal symptoms of the autism spectrum (social interaction, communication and stereotyped behaviors) and other related symptoms (aggression, hyperactivity, insomnia, self-aggression or individual and family quality of life). Two randomized and controlled studies on 37 children with diagnosis of ASD were included. The patients were randomized in groups to receive omega 3 supplements or placebo for 6 or 12 weeks. The evaluated final results included: Improvement in the social isolation/lethargy ratio, inadequate language, stereotyping, hyperactivity and irritability assessed by The Aberrant Behavior Checklist (ABC). No significant findings were observed in any of the assessed categories between both treatment groups.Vitamin and/or Mineral TreatmentsVitamin B6 with MagnesiumIn 2009, one Cochrane systematic review evaluated the efficacy of vitamin B6 with magnesium (B6-Mg) in terms of social, communicative and behavioral response in children and adults with ASD. It included three studies where 33 patients were randomized to B6-Mg for 4 to 20 weeks. The endpoints were: Verbal behavior (increased use of language), non verbal behavior (increased response to the environmental stimulus), social interaction (increased response to other people). No statistically significant differences were found for any of the assessed endpoints.Multivitamin/Mineral SupplementOne pilot, randomized, controlled, double-blind study on 20 patients with ASD published in 2004 evaluated the administration of moderate doses of multivitamin supplements (B6 and vitamin C -VC-) for 3 months. The evaluated final results included: Caregiver´s global impression assessed by the CGI-I - Clinical Global Impression Severity Score, scale 0 to 7, being the latter the most severe score; and modification of the levels of vitamin B6, vitamin C and lipoic alpha acid.As regards global impression, there were no significant differences in most of the evaluated dimensions except for sleep and gastrointestinal symptom categories, which showed a statistically significant improvement (p=0.03) when compared with the placebo group.Gluten and/or Casein-Free DietIn 2009, one Cochrane systematic review evaluated the effectiveness, adverse effects, cost and impact on quality of life of the gluten and/or casein-free diet versus a normal diet in patients with ASD; it included two RCTs on 35 patients in total.Only one of the studies showed three significant effects in favor of the diet: General number of autistic features (means difference-MD: -5.60; 95%CI -9.02 to -2.18; p=0.001); social isolation (MD=-3.20; 95%CI -5.20 to 1.20; p=0.002) and general skill to communicate and interact (MD=1.70; 95%CI 0.50-2.90; p=0.006), assessed by the DIPAB - diagnosis of Psychotic Behavior in Children questionnaire. The other endpoints (cognitive function and motor disorders) did not evidence significant differences.Both the clinical practice guideline prepared by the Ministry of Health and Social Policy of Spain and the United Kingdom´s National Institute for Clinical Excellence (NICE) consider that there is no evidence as to the effectiveness of gluten and casein-free diets, secretin, vitamin B6 associated to magnesium Omega-3 fatty acids, dimethylglycine, among others for the specific treatment of ASD.Conclusions?Biomedical treatment" has not been reported in the scientific literature as an entity in itself. When individually assessing its components, the evidence found is not enough to endorse the use of restrictive diets and/or nutritional supplements as part of the routine treatment of the autism spectrum disorder. Both the clinical practice guidelines and health coverage policies do not endorse the use because they consider them as experimental.