Dyspepsia (namely, the functional dyspepsia) in children, is a common pediatric disease that has a high recurrence rate. Severe dyspepsia will affect the nutritional intake of children, and may further impair their physical development and even mental health.

To systematically review the effectiveness and safety of Changyanning Granules in the treatment of dyspepsia in children.

We searched databases of CNKI, WanFang Data, CQVIP, and SinoMed for randomized controlled trials (RCTs) in Chinese and searched databases of PubMed, The Cochrane Libarary, EMBase, Web of Science for relevant RCTs in English from inception to May 2021. Regarding children with dyspepsia treated by Changyanning Granules or Changyanning Granules in combination with routine western treatment〔Live Combined Bifidobacterium and Lactobacillus Tablets (LCBLT) or Motilium Tablets (MT) 〕 (experimental group) compared with those treated with Xiaoer Xishi Pian (a Chinese patent medicine) or routine western treatment (LCBLT or MT) regardless of dosage, administration route and duration of treatment. We used response rate as the primary outcome indicator, and incidence of adverse reactions and clinical symptoms disappearing time as secondary outcome indicators. We used the Cochrane Handbook for Systematic Reviews of Interventions (Version 5.1) and RevMan 5.3 for conducting the meta-analysis.

Six RCTs were included, involving 1 150 cases (575 in the experimental group and 575 in the control group) . Meta-analysis showed that Changyanning Granules were superior to Xiaoer Xishi Pian in terms of overall response rate〔RR=1.57, 95%CI (1.27, 1.94) , P<0.000 1〕 with lower incidence of adverse reactions〔RR=0.18, 95%CI (0.09, 0.37) , P<0.000 01〕. Compared with LCBLT or MT, Changyanning Granules with LCBLT or MT produced higher overall response rate〔RR=1.60, 95%CI (1.13, 2.26) , P=0.008〕, and shortened the clinical symptom disappearing time (P<0.05) , but showed no significant difference in the incidence of adverse reactions (P>0.05) .

For children with dyspepsia, available evidence has demonstrated that using Changyanning Granules alone, or in combination with LCBLT or MT, could improve the overall response rate, shorten the clinical symptoms disappearing time with relatively low incidence of adverse reactions. However, due to low quality of included RCTs, our conclusion needs to be further verified by RCTs meeting the international standards with a large sample size, and rigorous design.

小儿消化不良（即小儿功能性消化不良）是儿科临床常见病症，复发率较高，严重的小儿消化不良会影响儿童营养摄入，进而影响儿童身体生长发育乃至心理健康。

对肠炎宁颗粒治疗小儿消化不良的有效性和安全性进行系统评价。

计算机检索中文数据库：中国知网、万方数据知识服务平台、维普网、中国生物医学数据库，外文数据库：PubMed，The Cochrane Libarary，EMBase，Web of Science；检索时间从建库起至2021年5月，筛选出肠炎宁颗粒治疗小儿消化不良的随机对照试验（RCT），试验组使用肠炎宁颗粒或肠炎宁颗粒联合西医常规治疗（金双歧或吗丁啉）；对照组为中成药常规治疗（小儿喜食片）或西医常规治疗（金双歧或吗丁啉），且不含肠炎宁颗粒，用药剂量、给药方式和疗程不限；主要结局指标为显效率，次要结局指标为不良反应发生率、临床症状消失时间。应用Cochrane Handbook 5.1评价标准和RevMan 5.3评价软件对最终纳入的研究进行Meta分析。

共纳入6项研究进行Meta分析，包含1 150例患儿，试验组575例，对照组575例。Meta分析结果显示：肠炎宁颗粒治疗小儿消化不良的显效率高于中成药常规治疗〔RR=1.57，95%CI（1.27，1.94），P<0.000 1〕；肠炎宁颗粒+西医常规治疗小儿消化不良的显效率高于西医常规治疗〔RR=1.60，95%CI（1.13，2.26），P=0.008〕；肠炎宁颗粒治疗小儿消化不良的不良反应发生率低于中成药常规治疗〔RR=0.18，95%CI（0.09，0.37），P<0.000 01〕；肠炎宁颗粒联合西医常规治疗小儿消化不良的不良反应发生率与单用西医常规治疗比较，差异无统计学意义（P>0.05）；肠炎宁颗粒联合西医常规治疗小儿消化不良临床症状消失时间短于单用西医常规治疗（P<0.05）。

基于现有数据和方法，肠炎宁颗粒单用或联合西医常规治疗可提高显效率、缩短临床症状消失时间，且不良反应发生率相对较低。但由于纳入研究质量不高，欲得到更有力的证据，还需采用大样本、设计严谨、符合国际规范的临床试验方案提高证据质量级别。