Clinical Study on Qinghuo Qibi Decoction Combined with Rehabilitation Training in the Treatment of Autism Spectrum Disorder of Heart-liver Fire Hyperactivity Pattern

Abstract

Objective: To observe the clinical efficacy of Qinghuo Qibi Decoction combined with rehabilitation training in the treatment of autism spectrum disorder (ASD) of heart-liver fire hyperactivity pattern and its effects on inflammatory cytokines. Methods: A randomized controlled trial (RCT) was conducted. A total of 140 children with ASD of heart-liver fire hyperactivity pattern who attended our hospital and the Affiliated Hospital of Shaanxi University of Chinese Medicine between February 2022 and February 2025 were enrolled and divided into a study group and a control group according to a random number table, with 70 cases in each group. The control group received routine rehabilitation training (applied behavior analysis [ABA] and structured education), and the study group additionally received oral Qinghuo Qibi Decoction, with both groups treated for 12 weeks. The clinical efficacy, the Childhood Autism Rating Scale (CARS) and Psychoeducational Profile (Third Edition) for children with autism (C-PEP-3) scores before and after treatment, and changes in TNF-α, IL-1β, IL-6, IL-10 and lymphocyte subsets were compared between the two groups, and adverse reactions were recorded. Results: Three cases in the study group and four cases in the control group dropped out, and 133 cases were finally included. The total effective rate of the study group was 88.1%, which was higher than that of the control group (71.2%), with a statistically significant difference (P<0.05). After treatment, the C-PEP-3 scores of both groups increased and the CARS scores decreased compared with those before treatment, and the study group was superior to the control group (P<0.05). After treatment, the serum TNF-α and IL-6 levels in the study group were lower than those in the control group, while the IL-10 level was higher, with all differences statistically significant (P<0.05). No serious adverse reactions occurred in either group. Conclusion: Qinghuo Qibi Decoction combined with rehabilitation training can improve the clinical efficacy, alleviate core symptoms and reduce inflammatory responses in children with ASD of heart-liver fire hyperactivity pattern, with good safety.