Zhongguo quanke yixue (May 2022)
Effectiveness and Safety of Changyanning Granules in the Treatment of Dyspepsia in Children: a Systematic Review and Meta-analysis
Abstract
Background 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. Objective To systematically review the effectiveness and safety of Changyanning Granules in the treatment of dyspepsia in children. Methods 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. Results 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) . Conclusion 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.
Keywords
