Liang Xiao, Wen Lihong, Wu Yifang, Hao Yanmin, Wang Shaobo, Hu Xiaoyu
Department of Infectious Diseases, Hospital of Chengdu University of Traditional Chinese Medicine.
National Integrative Medicine Clinical Base for Infectious Diseases, Chengdu 610072.
Medicine (Baltimore). 2020 Oct 2;99(40):e22517. doi: 10.1097/MD.0000000000022517.
Hepatic encephalopathy (HE) is one of the common complications of many serious liver diseases. Western medicine treatment is mainly symptomatic treatment such as neutralizing blood ammonia and protecting liver, which has poor curative effect, easy repetition and high mortality. Retention enema with traditional Chinese medicine (TCM) has been used on treatment of HE in China for many years. And it has been clinically proved that retention enema with TCM is effective and safe. But there is absent convincing evidence-based medicine to confirm the efficacy of retention enema with TCM for HE. Thus, we aimed to conduct this meta-analysis to summarize the efficacy of retention enema with TCM in patients with HE.
The study only selects clinical randomized controlled trials of retention enema with TCM for HE. We will search each database from the built-in until December 31, 2020. The English literature mainly searches Cochrane Library, Pubmed, EMBASE, and Web of Science. While the Chinese literature comes from CNKI, CBM, VIP, and Wanfang database. Meanwhile, we will retrieve clinical trial registries and gray literature. Two researchers worked independently on literature selection, data extraction and quality assessment. The dichotomous data is represented by relative risk (RR), and the continuous is expressed by mean difference (MD) or standard mean difference (SMD), eventually the data is synthesized using a fixed effect model (FEM) or a random effect model (REM) depending on the heterogeneity. The total effective rate, blood ammonia and the total bilirubin were evaluated as the main outcomes. While several secondary outcomes were also evaluated in this study. The statistical analysis of this Meta-analysis was conducted by RevMan software version 5.3.
This study will synthesize and provide high-quality evidence based on the data of the currently published retention enema with TCM for the treatment of HE.
This meta-analysis aims to evaluate the benefits of retention enema with TCM for the treatment of HE reported in randomized controlled trials, and provide more options for clinicians and patients with HE.
INPLASY202080107.
肝性脑病（HE）是多种严重肝脏疾病的常见并发症之一。西医治疗主要是诸如中和血氨、保肝等对症治疗，疗效欠佳，易复发且死亡率高。中药保留灌肠治疗HE在中国已应用多年。临床已证实中药保留灌肠治疗HE有效且安全。但尚无令人信服的循证医学证据证实中药保留灌肠治疗HE的疗效。因此，我们旨在进行此项荟萃分析，以总结中药保留灌肠治疗HE患者的疗效。
本研究仅选取中药保留灌肠治疗HE的临床随机对照试验。我们将检索自建库至2020年12月31日的各个数据库。英文文献主要检索考克兰图书馆、PubMed、EMBASE及科学网。中文文献来自中国知网、中国生物医学文献数据库、维普资讯和万方数据库。同时，我们将检索临床试验注册库及灰色文献。两名研究人员独立进行文献筛选、数据提取及质量评估。二分类数据以相对危险度（RR）表示，连续性数据以均数差（MD）或标准化均数差（SMD）表示，最终根据异质性采用固定效应模型（FEM）或随机效应模型（REM）对数据进行合成。将总有效率、血氨及总胆红素作为主要结局指标进行评估。本研究还评估了多个次要结局指标。本荟萃分析的统计分析采用RevMan 5.3版软件进行。
本研究将基于目前已发表的中药保留灌肠治疗HE的数据进行合成并提供高质量证据。
本荟萃分析旨在评估随机对照试验中报道的中药保留灌肠治疗HE的益处，并为临床医生及HE患者提供更多选择。
INPLASY202080107。
