Cheng Kai, Chi Nan-Nan, Liu Jun-Dong
Second Ward of Gastroenterology Department.
Department of Pharmacy, First Affiliated Hospital of Jiamusi University, Jiamusi, China.
Medicine (Baltimore). 2019 Apr;98(15):e15117. doi: 10.1097/MD.0000000000015117.
Previous clinical studies suggested that green tea extract (GTE) may benefit patients with a variety of cancers. However, its efficacy is still inconclusive. Thus, the objective of this study will systematically collate the clinical studies testing its efficacy and safety for cancers.
We will perform a systematic review of clinical studies assessing the efficacy of GTE in variety of cancers. We will search Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, MEDILINE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Allied and Complementary Medicine Database (AMED), and Chinese Biomedical Literature Database (CBM) using a comprehensive strategy. We will also screen the reference lists of relevant studies to identify any additional studies for potential inclusion. All databases will be searched up to February 1, 2019. All eligible case-control studies and randomized controlled trials will be included in this study. Two independent authors will review all searched literature. Upon inclusion of trials, we will extract data by using a predefined standardized form. The risk of bias assessment will be evaluated by using Cochrane risk of bias tool. We will use RevMan 5.3 software to pool the data and carry out meta-analysis.
The primary outcome includes overall response rate. The secondary outcomes comprise of overall survival, progression-free survival, the disease control rate, and any adverse events.
The results of this study will contribute to the understanding of the efficacy of GTE in the setting of cancers and promote future research of GTE in patients with cancers.
The results of this systematic review are expected to be published through peer-reviewed journals. This study does not need ethic approval, because it does not utilize individual patient data.
PROSPERO CRD42019125111.
先前的临床研究表明，绿茶提取物（GTE）可能对多种癌症患者有益。然而，其疗效仍不明确。因此，本研究的目的是系统整理测试其对癌症疗效和安全性的临床研究。
我们将对评估GTE在多种癌症中疗效的临床研究进行系统评价。我们将使用综合策略检索Cochrane对照试验中心注册库（CENTRAL）、EMBASE、MEDILINE、护理学与健康相关文献累积索引（CINAHL）、补充与替代医学数据库（AMED）以及中国生物医学文献数据库（CBM）。我们还将筛选相关研究的参考文献列表，以确定任何可能纳入的其他研究。所有数据库将检索至2019年2月1日。所有符合条件的病例对照研究和随机对照试验都将纳入本研究。两名独立作者将审查所有检索到的文献。纳入试验后，我们将使用预定义的标准化表格提取数据。将使用Cochrane偏倚风险工具评估偏倚风险。我们将使用RevMan 5.3软件汇总数据并进行荟萃分析。
主要结局包括总缓解率。次要结局包括总生存期、无进展生存期、疾病控制率以及任何不良事件。
本研究结果将有助于了解GTE在癌症治疗中的疗效，并促进未来对癌症患者使用GTE的研究。
本系统评价的结果预计将通过同行评审期刊发表。本研究不需要伦理批准，因为它不使用个体患者数据。
PROSPERO CRD42019125111
