Wang Liyuan, Yu Tianyang, Sun He, Liu Ruoxi, Liu Ye
Department of Ophthalmology, First Affiliated Hospital of Heilongjiang University of Chinese Medicine.
Heilongjiang University of Chinese Medicine.
Medicine (Baltimore). 2020 Jul 2;99(27):e21156. doi: 10.1097/MD.0000000000021156.
Glaucoma is a common ophthalmic neurodegenerative disease and the main cause of blindness, which seriously affects the life and work of patients, without more effective treatment for optic nerve damage. Bushen Huoxue (BSHX) method is a traditional Chinese medicine (TCM) therapy that has been widely used as an alternative therapy to treat optic nerve damage in glaucoma patients with growing beneficial effect evidence, however, there is no current systematic review has addressed its effect for glaucoma. This study will conduct a systematic review and meta-analysis of the currently published randomized controlled trials (RCTs) of BSHX method for the treatment of glaucoma, aim to assess the efficacy and safety of BSHX method for patients with glaucoma.
We will thoroughly search literatures of RCTs related to BSHX method for glaucoma in PubMed, Medline, EMBASE, Cochrane Library, China National Knowledge Infrastructure (CNKI), VIP and Wanfang database and other databases from the establishment of the database to November 2019, with no language restriction. After reviewing the title, abstract and full text, 2 reviewers will independently select the study, extract the data, after assess the risk of bias, we will conduct a meta-analysis of the data extracted from the included RCTs, including total effective rate, intraocular pressure (IOP), visual acuity, visual field, TCM syndrome score, and adverse events. The meta-analysis will be performed using Review Manager 5.3 software and the results will be based on either random effects or fixed effects models, depending on the heterogeneity. Trial sequential analysis (TSA) and Grading of Recommendations, Development and Evaluate system (GRADE) will be conduct to evaluate the reliability and quality of evidence.
The results of the study will be published in a peer-reviewed journal, and provide a reasonable and high-quality evidence for the efficacy and safety of BSHX method for glaucoma.
This study will be the first meta-analysis to evaluate the efficacy of BSHX method in the treatment of glaucoma comprehensively, and will to provide helpful evidence for the clinical treatment of this disease.
PROSPERO CRD42020159897.
青光眼是一种常见的眼科神经退行性疾病，也是失明的主要原因，严重影响患者的生活和工作，目前尚无针对视神经损伤的更有效治疗方法。补肾活血法是一种传统中医疗法，作为一种替代疗法已被广泛用于治疗青光眼患者的视神经损伤，且越来越多的证据表明其具有有益效果，然而，目前尚无系统评价探讨其对青光眼的疗效。本研究将对目前已发表的关于补肾活血法治疗青光眼的随机对照试验（RCT）进行系统评价和荟萃分析，旨在评估补肾活血法治疗青光眼患者的疗效和安全性。
我们将全面检索PubMed、Medline、EMBASE、Cochrane图书馆、中国知网（CNKI）、维普（VIP）和万方数据库等数据库中从建库至2019年11月与补肾活血法治疗青光眼相关的RCT文献，无语言限制。在审阅标题、摘要和全文后，两名审阅者将独立选择研究、提取数据，在评估偏倚风险后，我们将对纳入的RCT中提取的数据进行荟萃分析，包括总有效率、眼压（IOP）、视力、视野、中医证候评分和不良事件。荟萃分析将使用Review Manager 5.3软件进行，结果将根据异质性基于随机效应或固定效应模型。将进行试验序贯分析（TSA）和推荐分级、制定与评价系统（GRADE）以评估证据的可靠性和质量。
本研究结果将发表在同行评审期刊上，并为补肾活血法治疗青光眼的疗效和安全性提供合理且高质量的证据。
本研究将是首次全面评估补肾活血法治疗青光眼疗效的荟萃分析，并将为该疾病的临床治疗提供有益证据。
PROSPERO CRD42020159897
