Mechanism of Qihuang needle therapy in the management of tic disorders: a clinical trial protocol

Yuyuan Tang; Jun'e Wu; Zhirui Xu; Baochao Fan; Xiangli Li; Bingxu Jin; Chunzhi Tang

doi:10.3389/fneur.2023.1036453

Mechanism of Qihuang needle therapy in the management of tic disorders: a clinical trial protocol

Front Neurol. 2023 Apr 20:14:1036453. doi: 10.3389/fneur.2023.1036453. eCollection 2023.

Authors

Yuyuan Tang^#¹, Jun'e Wu^#², Zhirui Xu¹, Baochao Fan¹, Xiangli Li³, Bingxu Jin⁴, Chunzhi Tang¹

Affiliations

¹ Clinical Research and Big Data Laboratory, South China Research Center for Acupuncture and Moxibustion, Medical College of Acu-Moxi and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.
² Department of Reproductive Health, The Fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen, China.
³ Department of Traditional Chinese Medicine, Guangzhou First People's Hospital, Guangzhou, China.
⁴ Department of Rehabilitation, Panyu Hospital of Chinese Medicine, Guangzhou, China.

^# Contributed equally.

Abstract

Background: Qihuang needle therapy is a newly developed acupuncture therapy to treat tic disorders in clinical practice. However, the mechanism to reduce tic severity remains unknown. Changes in intestinal flora and circulation metabolites are perhaps the potential pathogenesis of tic disorders. As a result, we present a protocol for a controlled clinical trial using multi-omics analysis to probe the mechanism of the Qihuang needle in managing tic disorders.

Methods: This is a matched-pairs design, controlled, clinical trial for patients with tic disorders. Participants will be allocated to either an experimental group or a healthy control group. The main acupoints are Baihui (GV20), Yintang (EX-HN3), and Jueyinshu (BL14). The experimental group will receive Qihuang needle therapy for a month, while the control group will receive no interventions.

Expected outcomes: The change in the severity of the tic disorder is set as the main outcome. Secondary outcomes include gastrointestinal severity index and recurrence rate, which will be calculated after a 12-week follow-up. Gut microbiota, measured by 16S rRNA gene sequencing; serum metabolomics, assessed via LC/MS; and serum zonulin, assessed by enzyme-linked immunosorbent assay (ELISA), will be used as biological specimen analysis outcomes. The present study will investigate the possible interactions between intestinal flora and serum metabolites and the improvement of clinical profiles, which may elucidate the mechanism of Qihuang needle therapy for tic disorders.

Trial registration: This trial is registered at the Chinese Clinical Trial Registry (http://www.chictr.org.cn/). Registration number: ChiCTR2200057723, Date: 2022-04-14.

Keywords: Qihuang needle therapy; acupuncture; clinical trial protocol; multi-omics analysis; tic disorders.

Grants and funding

The study was supported by the National Natural Science Foundation of China (82174527), the Innovation Team and Talents Cultivation Program of the National Administration of Traditional Chinese Medicine (ZYYCXTD-C-202004), the special project of Lingnan Modernization of Traditional Chinese Medicine within the 2019 Guangdong Provincial Research and Development Program (2020B1111100008), and the Project of First Class Universities and High-Level Dual Discipline for Guangzhou University of Chinese Medicine (2021xk22). The funding organization has no role in designing and analyzing the study.