Efficacy and safety of Bu Jing Yi Shi tables for high myopia: A protocol of systematic review and meta-analysis

BACKGROUND: High myopia is a kind of ametropia with diopter more than −6.00D or axial length ≥26 mm. With the change of the modern environment, the incidence rate is increasing year by year. At present, the pathogenesis of high myopia is not clear. Some current studies indicate that it may be related to the environment and genetics. A Chinese patent medicine named Bu Jing Yi Shi Tablets (BJYST) has many functions including anti-oxidation, expansion of blood vessels, anti-inflammatory, immune regulation, inhibition of retinal photoreceptor cell apoptosis, and promotion of retinal repair. A large number of existing studies have shown that this prescription can relieve the clinical manifestations of high myopia and its complications, but its true efficacy and safety are still unclear. To certify this point, a protocol for a systematic review and meta-analysis of BJYST for high myopia will be performed. METHODS AND ANALYSIS: Articles that have been identified by electronically searching of 9 English and 5 Chinese databases from their inception to December 4, 2020 will be incorporated into the study. This study only adopts Chinese and English. Two researchers will take charge of completing the selection of research, the extraction of data as well as the assessment of research quality independently. The primary outcomes will be an average change in refractive error measured in diopters and an average change in axial length measured in millimeters. Data analysis will be performed via the RevMan 5.3 software, and Grading of Recommendations Assessment, Development, and Evaluation (GRADE) will help to assess the evidence level. RESULTS: The results of this study will be published in a peer-reviewed journal. CONCLUSION: This study will conclude whether BJYST is safe and effective in treating high myopia on the basis of evidence-based medicine. REGISTRATION: The Open Science Framework (OSF) registration number is osf.io/dpk5b.