Pilot RCT Using Homeopathic Medicines in ASD

Autism spectrum disorders (ASD) are lifetime neurodevelopmental disorders with challenges across functional domains. Despite availability of various treatment modalities and diagnostic tools, it's pathophysiology still remains poorly understood even through 8 decades of it's discovery. This pilot study compares psychometrics and parental reported outcome monitoring, behavioral and developmental outcomes, co-occurring breadth of concerns for children with ASD along with co-morbidities, with and without homeopathic treatment.

Methodology: Initial screening was done using Autism Behavior Checklist (ABC). Utilizing a randomized-controlled design and parental informed consent, this study compared children aged 3 to 12 years, divided into an experimental group receiving individualized homeopathic treatment alongside occupational/speech therapies (HG), and a control group receiving only latter (CG) .

The treatment group received homoeopathic medicines daily with frequency being once per day along with daily occupational / speech therapy sessions for 1 hour each. The control group received homoeopathic medicine look alike placebo daily with frequency being once per day along with daily occupational / speech therapy sessions for 1 hour each. Follow ups were done every 3 months and the data were combined and stored for each year separately for seven-years. The data was initially collected and then analyzed through standardized behavioral assessments [Childhood Autism Rating Scale, CARS] , speech-language assessments [Social Responsiveness Scale, SRS], parental-questionnaires for reporting emotional regulation, anxiety-related behaviors, co-morbidities [Neuro Developmental Parent Report for Outcome Monitoring, ND-PROM] and observational methods in both the groups. The treatment effectiveness was assessed using Autism Treatment Evaluation Checklist (ATEC).

Inclusion criteria

• A confirmed diagnosis of Autism Spectrum Disorder (ABC score ≥ 67)
• Age range of 2 to 12 years

Exclusion criteria

• Children with other significant comorbid psychiatric conditions that could confound the results. [eg. a brain injury; fragile X syndrome or other syndromes resulting from known genetic defects or inherited metabolic diseases; other diagnosed conditions involving impairments in social and communication abilities, such as intellectual disability without ASD, global developmental delay, language disorders and social communication disorder]
• Children with irregular follow ups.
• Children with poor medical compliance.