Department of Respiratory, Shandong Chest Hospital, Jinan, 250013, China.
Department of Gastroenterology, The General Hospital of Jinan Military Command, Jinan, 250031, China.
Chin J Integr Med. 2019 Aug;25(8):625-630. doi: 10.1007/s11655-018-2846-0. Epub 2018 Aug 30.
To evaluate the effect of Zhizhu Kuanzhong Capsules (, ZKC) for functional dyspepsia (FD) through meta-analysis.
Online databases, including PubMed, EM base, China National Knowledge Infrastructure, Wanfang Data, VIP database and Cochrane Library, were searched for randomized controlled trials (RCTs) of ZKC for FD from the inception to April, 2016. Trials were selected according to inclusion criteria and were evaluated with quality assessment standards in the Cochrane Handbook for Systematic Reviews of Interventions and Jadad scale. RevMan 5.3 and GRADEprofiler 3.6 were used for statistical analysis and evidence quality assessment.
Twenty-three trials with 2,496 patients were included and most of them were of poor methodological quality. ZKC alone or ZKC combined with routine Western medicine (WM) showed a better clinical effect rate compared with the control group of WM [odds ratio (OR)=3.32, 95% confidence interval (2.66, 4.15), P<0.00001]. No serious adverse reactions were reported.
ZKC alone or ZKC combined with routine WM could significantly improve the clinical effective rate in the treatment of FD. The quality of the evidence is low, so it is necessary to design multicenter, strictly randomized and double-blind controlled trials with large samples to validate the conclusions.
通过荟萃分析评价枳术宽中胶囊（ZKC）治疗功能性消化不良（FD）的疗效。
计算机检索PubMed、EMbase、中国知网、万方数据知识服务平台、维普数据库和 Cochrane Library，搜集 ZKC 治疗 FD 的随机对照研究（RCT），检索时限均为建库至 2016 年 4 月。根据纳入和排除标准筛选文献，采用 Cochrane 系统评价手册和 Jadad 量表评价文献质量，然后用 RevMan 5.3 和 GRADEprofiler 3.6 软件进行统计分析和证据质量评价。
共纳入 23 个 RCT，包含 2496 例患者，均为低质量研究。ZKC 单药治疗或联合常规西药（WM）治疗与 WM 对照组相比，临床有效率更高[比值比（OR）=3.32，95%可信区间（2.66，4.15），P<0.00001]。未报道严重不良反应。
ZKC 单药治疗或联合常规 WM 治疗可显著提高 FD 的临床有效率，但纳入研究质量均较低，需要设计更多大样本、多中心、严格随机、双盲的 RCT 来验证上述结论。
