The effectiveness and safety of Chinese medicines for the treatment of uveitis A protocol for systematic review and meta-analysis

Background: Uveitis is an inflammatory and heterogeneous ocular disorder and has a profound impact on patients' life, work and family. There are substantial costs to the countries and individuals associated with treatment of the complications of uveitis and blindness. Conventional therapies did not lead to satisfactory outcomes for uveitis and are associated with substantial adverse events (AEs). Emerging evidences have proved the important value and potential prospect of Chinese medicines and its compound in uveitis. However, although Chinese medicines are widely used in uveitis, its therapeutic effect and safety are still controversial. It is, therefore, timely to perform an objective and normative systematic review to assess the efficacy and safety of Chinese medicines in treating uveitis on current research. Methods: The systematic review will include all of the randomized controlled trials (RCT) on the efficacy and safety of Chinese medicines for uveitis. A relevant literature search by sensitive search strategies was conducted using the following electronic databases from their inception to September 30, 2019: PubMed, Web of Science, EMBASE, the Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang Database, China Science and Technology Journal database (VIP) and Chinese Biomedical Literature database (CBM). The strategy combines treatment terms and disease: that is, "Medicine, Chinese Traditional" (e.g., "Medicine, Chinese Traditional", TCM, Traditional Chinese medicine, Zhong Yi Xue) and uveitis. We will also search registers of clinical trials, potential gray literature, and conference abstracts. There are no limits on language and publication status. The literature screening, data extraction, and quality assessment will be conducted by 2 reviewers independently. The reporting quality and risk of bias will be assessed by other two researchers. Best-corrected visual acuity (BCVA) and improvement in disease activity were assessed as the primary outcome. The secondary outcomes will include laboratory efficacy indexes, score changes in the National Eye Institute Visual Functioning Questionnaire 25 (NEI-VFQ 25), uveitis-related tissue damage or complications, concurrent requirement of corticosteroids, immunosuppressive drugs or biologics, and AEs of treatment. Meta-analysis will be performed using RevMan5.3 software provided by the Cochrane Collaboration. Results: This study will provide a comprehensive review based on current evidence of Chinese medicines treatment for uveitis in several aspects, including BCVA and improvement in disease activity, laboratory efficacy indexes, score changes in the NEI-VFQ 25, uveitis-related tissue damage or complications, etc. Conclusion: The conclusion of this study will provide evidence to determine whether Chinese medicines are an effective and safe intervention for patients with uveitis. Ethics and dissemination: It is not necessary to obtain ethical approval for this study, given that this protocol is for a systematic review. The systematic review will be published in a peer-reviewed journal, presented at conferences and will be shared on social media platforms. PROSPERO registration number: PROSPERO CRD42020153620.