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A Randomized Controlled Trial of Yizhi Kaiqiao Formula Combined With Repetitive Transcranial Magnetic Stimulation on
Dongling Yin1, Linlin Fan1, Ke Huang1
1Department of Child Health Care, Zhongshan Sixth People's Hospital (Torch Development Zone People's Hospital), Zhongshan, Guangdong, China.
Insights
Combining Yizhi Kaiqiao formula with repetitive transcranial magnetic stimulation (rTMS) significantly improved neurocognitive function and social outcomes in children with autism spectrum disorder (ASD). This combined therapy offers a more effective approach than rTMS alone for behavioral rehabilitation.
Area of Science:
- Neuroscience
- Pediatrics
- Integrative Medicine
Background:
- Autism spectrum disorder (ASD) presents significant challenges in neurocognitive function and social interaction in preschool children.
- Current therapeutic strategies often require combination approaches to address the multifaceted nature of ASD symptoms.
- Repetitive transcranial magnetic stimulation (rTMS) shows promise, but its efficacy may be enhanced by complementary therapies.
Purpose of the Study:
- To evaluate the efficacy of Yizhi Kaiqiao formula combined with rTMS for preschool children with ASD.
- To compare the combined therapy's effects against rTMS monotherapy on neurocognitive and social outcomes.
- To assess impacts on symptom severity, neuroinflammation, and quality of life.
Main Methods:
- A randomized controlled trial involving 178 preschool children with ASD.
- Participants were assigned to either Yizhi Kaiqiao formula + rTMS or rTMS-only groups for a 3-month intervention.
- Evaluations included symptom severity (TCM, ADOS-2, CARS), inflammatory markers (IL-6, TNF-α), neurocognition (MMN, DCCS), social ability (SRS), and quality of life (PedsQL 4.0).
Main Results:
- The combined therapy group demonstrated significantly greater improvements in ASD symptoms, neuroinflammation, neurocognitive function, social ability, and quality of life compared to the rTMS-only group (p < 0.05).
- Both interventions were well-tolerated, with comparable and low rates of adverse events between the groups.
- Yizhi Kaiqiao formula plus rTMS proved superior to rTMS alone as an adjuvant therapy for behavioral rehabilitation in ASD.
Conclusions:
- The combination of Yizhi Kaiqiao formula and rTMS is a relatively effective strategy for improving behavioral rehabilitation in preschool children with ASD.
- This integrated approach offers enhanced benefits for neurocognitive function, social outcomes, and overall quality of life.
- Further research can explore long-term effects and optimal treatment protocols for this combined therapy.
Abstract:
This paper aimed to unravel the effects of Yizhi Kaiqiao formula combined with repetitive transcranial magnetic stimulation (rTMS) on neurocognitive function and social outcomes in preschool children with autism spectrum disorder (ASD). In this randomized controlled trial, 178 preschool children with ASD recruited between January 2022 and February 2024 were randomly assigned to a combined group (Yizhi Kaiqiao formula + rTMS) or an rTMS-only group (n = 89 each). Both groups received a 3-month intervention. Pre- and post-intervention, TCM and Western medicine symptom severity (TCM syndrome scores, ADOS-2, CARS), inflammatory indicators (IL-6, TNF-α), neurocognitive function (MMN amplitude and latency, DCCS), social ability (SRS), and quality of life (PedsQL 4.0) were compared. Adverse event incidence was also recorded. Nine children in the combined group and seven in the rTMS-only group dropped out, leaving 80 and 82 completers, respectively. Post-intervention, the combined group showed greater improvements than the rTMS-only group in symptoms (TCM, ADOS-2, CARS), neuroinflammation/oxidative stress (IL-6, TNF-α), neurocognition (MMN, DCCS), social ability (SRS), and quality of life (PedsQL 4.0) (p < 0.05). Adverse event rates were low and comparable between groups (3.75% vs. 1.22%, p > 0.05). On the basis of conventional treatment, compared with rTMS adjuvant therapy alone, Yizhi Kaiqiao formula combined with rTMS is a relatively effective strategy for enhancing behavioral rehabilitation adjuvant therapy. https://www.chictr.org.cn/index.html.
