A Double-Blind, Placebo-Controlled Randomized Evaluation of The Effect of Low-Level Laser Therapy on Children with Autism Spectrum Disorder.

Autism Spectrum Disorder (ASD) presents a considerable challenge; Irritability, a common symptom among children with ASD, significantly impacts their social interactions and learning. Current treatments, including behavioral therapies and medications, offer some relief, but they often have limited efficacy and undesirable side effects. This study aimed to evaluate Low-Level Laser Therapy (LLLT) as a non-pharmacological treatment for irritability and other symptoms of ASD in a randomized, double-blind clinical trial. Results showed that children receiving active LLLT exhibited significant improvements in all Aberrant Behavior Checklist (ABC) sub-scores and total scores post-treatment (p ≤ 0.05). The sham LLLT group also showed significant post-intervention improvements in some ABC subscales, including irritability and hyperactivity (p < 0.001), lethargy, social withdrawal), and total scores (p < 0.05). However, the active LLLT group consistently maintained significant improvements across all ABC subscales and total scores during follow-up, with effect sizes ranging from small to large. The sham LLLT group showed significant differences only in irritability (p = 0.001), lethargy, and social withdrawal (p = 0.02), and the total score (p = 0.01) at follow-up. No significant differences were found between active LLLT vs. Sham at post-treatment or at follow-up. Both groups showed significant improvements in the Clinical Global Impression of Change and satisfaction categories from baseline to post-intervention and follow-up, with no significant differences between groups. These results indicate that LLLT is effective in alleviating ASD-related symptoms in children, although further research with larger sample sizes is necessary. Clinical trial registration : This study was registered in ClinicalTrials.gov ( NCT04895605) First Posted: 05/17/2021