Lin Haixiong, Wang Xiaotong, Du Xiuting, Wang Junyue, Li Yusi, Zhang Ren
The First School of Clinical Medicine, Guangzhou University of Chinese Medicine, Guangzhou Shenzhen Bao'an Traditional Chinese Medicine Hospital Group, Guangzhou University of Chinese Medicine, Shenzhen The Second School of Clinical Medicine The College of Fundamental Medical Science, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China.
Medicine (Baltimore). 2018 Feb;97(6):e9731. doi: 10.1097/MD.0000000000009731.
Functional dyspepsia (FD) is a gastrointestinal disorder affecting people in the globe. Spleen-deficiency syndrome is one of its basic syndromes. Zhizhu Kuanzhong capsule was the most frequent Chinese herbal formula used in the spleen-deficiency researches. We aim to assess the effectiveness and safety of Zhizhu Kuanzhong capsule on FD.
A systematic literature search for randomized controlled trials (RCTs) from their inception until December 31, 2017 will be conducted using 7 databases: PubMed, Cochrane Library, Embase, VIP Database, Chinese National Knowledge Infrastructure, Wanfang Data, and Chinese BioMedical Database. Inclusion the trials of Zhizhu Kuanzhong capsule which evaluate motilin level, clinical syndrome, and side effect in people with FD. The primary outcome measures will be motilin level, clinical syndrome integral, and clinical total effective rate. Data extraction and risk of bias assessments will be performed by 2 reviewers independently. Methodological and reporting quality of included studies will be assessed by the consolidated standards of reporting trials for Chinese herbal medicine formulas. All statistical analyses will be conducted using RevMan V.5.3 software. Funnel plots, Begg's test, and Egger's test will be developed to evaluate reporting bias.
This review will assess the effect of Zhizhu Kuanzhong capsule on clinical total effective rate, symptom remission rate, plasma motilin level, and safety of FD in patients.
The conclusion of our study will provide updated evidence to judge whether Zhizhu Kuanzhong capsule is an effective intervention for patients with FD.
功能性消化不良（FD）是一种影响全球人群的胃肠道疾病。脾虚证是其基本证型之一。枳术宽中胶囊是脾虚证研究中最常用的中药方剂。我们旨在评估枳术宽中胶囊治疗FD的有效性和安全性。
将使用7个数据库进行系统的文献检索，以查找从开始到2017年12月31日的随机对照试验（RCT）：PubMed、Cochrane图书馆、Embase、维普数据库、中国知网、万方数据和中国生物医学数据库。纳入评估枳术宽中胶囊对FD患者胃动素水平、临床证候及副作用的试验。主要结局指标将为胃动素水平、临床证候积分及临床总有效率。数据提取和偏倚风险评估将由2名评价者独立进行。纳入研究的方法学和报告质量将采用中药方剂报告试验的统一标准进行评估。所有统计分析将使用RevMan V.5.3软件进行。将绘制漏斗图、Begg检验和Egger检验以评估报告偏倚。
本综述将评估枳术宽中胶囊对FD患者临床总有效率、症状缓解率、血浆胃动素水平及安全性的影响。
我们研究的结论将为判断枳术宽中胶囊是否为FD患者的有效干预措施提供最新证据。
