The efficacy and safety of qiming granule in dry eye disease: Protocol for systematic review and meta-analysis

BACKGROUND: Dry eye disease is a common eye disease mainly manifests with eye fatigue, foreign body sensation, dry and astringent eyes and other symptoms. Growing evidence shows that qiming granule may have beneficial effects on the clinical treatment of dry eye disease. However, no systematic review and meta-analysis collate and assess these clinical evidences. The purpose of this study protocol is to provide a comprehensive and reliable evaluation of the clinical evidence of qiming granule in the treatment of DED. METHODS AND ANALYSIS: Three English database and 4 Chinese databases other sources will be searched. Two methodological trained researchers will read the title, abstract and full texts and independently select the qualified literature according to inclusion and exclusion criteria. After assessment of the risk of bias and data extraction, we will conduct meta-analyses for outcomes including central macular thickness, optimum corrected vision, overall effect rates and adverse effects. The heterogeneity of data will be investigated by Cochrane X(2) and I(2) tests. We build 3 hypotheses for subgroup analysis according to the guidance for a credible subgroup effect: Disease status at baseline, duration of intervention, type of concomitant medication. Sensitivity analysis will be conducted to evaluate the stability of the results. Then publication bias assessment will be conducted by funnel plot analysis and Egger test. Finally, we will use the Grading of Recommendations Assessment, Development and Evaluate system to evaluate the quality of evidence. RESULTS: The results of our research will be published in a peer-reviewed journal. CONCLUSION: Our study is the first meta-analysis to evaluate the clinical efficacy and safety of qiming granule in the treatment of DED. It will provide more options for clinical treatment of the disease. PROSPERO REGISTRATION NUMBER: CRD42018109183.