Efficacy of Sini SAN combined with Sijunzi decoction in tic disorder, and intestinal microbiota in children

Abstract

Purpose: To evaluate the efficacy of Sini SAN and Sijunzi decoction in tic disorder, and intestinal microbiota in children. Methods: This study enrolled 100 children with tic disorder from April 2020 to January 2023 in First Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, China. The control group (n = 45) was administered tiapride hydrochloride 50 mg daily, (gradually increased to thrice daily over 1 - 3 months, then reduced to once daily for 1 month, with a total treatment duration of 6 months). On the other hand, the study group (n = 55) received tiapride hydrochloride in addition to traditional Chinese medicine (TCM), including Sini San and Sijunzi decoction with specific herbs (Radix pseudostellariae, white peony), for 6 months. Efficacy, TCM syndrome scores, Yale Global Tic Severity Scale (YGTSS) scores, amino acid neurotransmitter levels, and α-diversity of intestinal microbiota were assessed in both groups before treatment and at 4th and 8th weeks after commencement of treatment. Results: There was no significant difference in baseline characteristics between the study and control groups, indicating comparability (p > 0.05). The study group had a significantly higher total effectiveness/efficacy (p < 0.05). It exhibited greater improvements in Traditional Chinese Medicine (TCM) syndrome scores and YGTSS scores in the 4th and 8th week of treatment compared to control group (p < 0.05). Additionally, the study group exhibited significant decrease in glutamate and aspartate levels and a significant increase (p < 0.05) in α-diversity of intestinal microbiota except for Simpson index (p > 0.05). Conclusion: The combination of TCM and tiapride hydrochloride improves efficacy, modulates neurotransmitter levels, alleviates symptoms, and improves α-diversity of intestinal microbiota.