STUDY PROTOCOL article
Front. Neurol.
Sec. Neuromuscular Disorders and Peripheral Neuropathies
Volume 16 - 2025 | doi: 10.3389/fneur.2025.1608095
Efficacy and safety of manufactured Chinese herbal formula for cervical radiculopathy: Protocol for a systematic review with meta-analysis and trial sequential analysis
Provisionally accepted
- 1Guangxi University of Chinese Medicine, Nanning, Guangx, China
- 2First Affiliated Hospital of Guangxi University of Chinese Medicine, Nanning, China
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Background: Manufactured Chinese Herbal Formula (MCHF) are Chinese patent medicine preparations formulated with Chinese herbal ingredients. They are processed into specific dosage forms in accordance with defined prescriptions and manufacturing procedures, and are intended for the prevention and treatment of diseases. As a type of commercialized Chinese patent medicine, MCHFs are listed and marketed in China upon approval by the National Medical Products Administration (NMPA). MCHF can be used to treat cervical radiculopathy (CR) and alleviate symptoms, but how the efficacy of MCHF compares with that of conventional oral drug for the treatment of CR has not been thoroughly explored. The aim of this meta-analysis was to assess and compare the efficacy of MCHF with conventional oral drug for the treatment of CR.The meta-analysis will be conducted according to the Cochrane Handbook and the Preferred Reporting Items for systematic review and Meta-Analysis Programme (PRISMA-P) checklist. Full searches will be conducted in PubMed, Excerpta Medica Database (EMBASE), Cochrane Central Register of Controlled Trials (CENTRAL), and three Chinese electronic databases, including National Knowledge Infrastructure (CNKI), Wanfang Digital Periodicals (WANFANG), Chinese Science and Technology Periodicals (VIP) database. We limited the type of literature included to RCT, and there was no language restriction. Two independent reviewers will use the NoteExpress tool to screen studies, extract data, and assess study quality. The global VAS pain score after completing the duration of treatment was the primary outcome. Secondary outcomes will include NDI, JOA, SF-36 and adverse events. If feasible, a meta-analysis will be conducted in Review Manager 5.4, otherwise we will conduct a descriptive analysis. Using the recommended grading of recommendations assessment, development, and evaluation (GRADE) approach to assess the evidence level of the meta-analysis primary outcome measure and all secondary outcome measures, and conduct TSA (Trial Sequential Analysis) for the primary outcome measures.Discussion: This predefined protocol is intended to enhance transparency, avoid future duplication of efforts, and generate reliable evidence regarding the efficacy and safety of MCHF in the treatment of cervical radiculopathy.
Keywords: Cervical radiculopathy, Manufactured Chinese herbal formula, Meta-analysis, protocol, efficacy, Safety
Received: 08 Apr 2025; Accepted: 08 Aug 2025.
Copyright: © 2025 Bao, HUANG, Li, 甘, Li, Xu, Zhang and Tang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Bin Tang, First Affiliated Hospital of Guangxi University of Chinese Medicine, Nanning, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.