Efficacy and safety of traditional Chinese medicine injections in the treatment of chronic obstructive pulmonary disease: A protocol for systematic review and network meta-analysis

Abstract

Background: Chronic obstructive pulmonary disease (COPD) is a widespread, heterogeneous disease characterized by chronic inflammation of the airway and the gradual blockage of air flow due to bronchial obstruction. At present, a large number of traditional Chinese medicine injections (TCMIs) has been applied in the clinical treatment of COPD. However, there is insufficient evidence of evidence-based medicine of the interaction between them. Therefore, the purpose of this study is through the network meta-analysis to evaluate the efficacy and safety of the different TCMIs treatment of COPD, offering reference and evidence for clinical application.

Methods: We will search 7 databases for randomized controlled trials of TCMI for the COPD, including PubMed, the Cochrane Library, EMbase, China National Knowledge Infrastructure, China Biological Medicine, Chinese Scientific Journals Database, and Wan-fang databases, from the date of the establishment of each database to October 31, 2021. The network meta-analysis will be implemented through Aggregate Data Drug Information System 1.16.8 and Stata 13.0 software. Pulmonary function included forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and FEV1/FVC will be the primary outcomes, FEV1 as a percentage of the estimated value (FEV1%pred), maximal voluntary ventilation (MVV), MVV as a percentage of the estimated value (MVV%pred), 6 minutes walking distance, The St. George's Respiratory Questionnaire score, and safety/adverse event will be evaluated as secondary outcomes. Mean differences or odds ratios will be used for statistical analysis. We will ensure the reliability of the results through node-split model and heterogeneity analysis. In addition, methodological quality will be evaluated based on the Cochrane Collaboration's tool, and the quality of evidence will be evaluated according to the Grading of Recommendations Assessment, Development and Evaluation system.

Results: This study will provide reliable evidence for the clinical selection of TCMI in the treatment of COPD.

Conclusion: The results of this study will evaluate the efficacy and safety of TCMI in the treatment of COPD, and provide decision-making references for future clinical and scientific research.