Effectiveness and safety of manufactured Chinese herbal formula for cervical radiculopathy: Protocol for a systematic review with meta-analysis and trial sequential analysis (Preprint)

Résumé fourni par la source

BACKGROUND Background Manufactured Chinese herbal formula(MCHF) is a kind of traditional Chinese medicine preparation, which takes traditional Chinese medicine as raw material and is processed into a certain dosage form according to the prescribed prescription and preparation process in order to prevent and treat diseases. It is a kind of commercialized traditional Chinese medicine preparation approved 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. OBJECTIVE Objective The aim of this meta-analysis was to assess and compare the efficacy of MCHF with conventional oral drug for the treatment of CR. METHODS Methods 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 5.3, 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 results, and conduct TSA (Trial Sequential Analysis) for the primary outcome measures. RESULTS Discussion This predefined protocol aims to reduce bias in the analysis and interpretation of results, with the objective of generating reliable evidence on the efectiveness and safety of MCHF in treating cervical radiculopathy. CONCLUSIONS Discussion This predefined protocol aims to reduce bias in the analysis and interpretation of results, with the objective of generating reliable evidence on the efectiveness and safety of MCHF in treating cervical radiculopathy. CLINICALTRIAL This study protocol has been registered in PROSPERO (# CRD42024605787).

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