Aim: We aimed to evaluate the clinical efficacy and safety of Shenqu Xiaoshi Oral Liquid in the treatment of functional constipation in children. Methods: A comprehensive literature search was conducted from inception to 20 October 2025, across PubMed, Embase, Scopus, Web of Science, the Cochrane Library, Chinese VIP Information Database, China National Knowledge Infrastructure (CNKI), and Wan Fang Med Database. For quantitative analysis, the mean difference (MD) was used for continuous outcomes and the risk ratio (RR) for dichotomous outcomes. The methodological quality of the included studies was assessed using the Cochrane risk of bias tool. Statistical analyses were performed using RevMan 5.3 and Stata 13 software. Results: Eight studies involving 692 pediatric patients were included (Shenqu Xiaoshi Oral Liquid group: 345; control group: 347). Compared to the control group, Shenqu Xiaoshi Oral Liquid demonstrated superior clinical effectiveness RR = 1.36, 95% CI: (1.25, 1.47); z = 7.11, p < 0.00001 and a lower recurrence rate RR = 0.49, 95% CI: (0.26, 0.93); z = 2.18, p = 0.03. Both the post-treatment WMD = −0.91, 95% CI: (−0.97, −0.86); z = 31.94, p < 0.00001 and post-recurrence WMD = −1.49, 95% CI: (−1.56, −1.41); z = 40.12, p < 0.00001 defecation intervals were shorter in the Shenqu Xiaoshi Oral Liquid group. No significant difference was observed in the incidence of adverse reactions between the two groups RR = 0.67, 95% CI: (0.35, 1.29); z = 1.20, p = 0.23. Furthermore, serum levels of motilin WMD = 41.66, 95% CI: (34.17, 49.16); z = 10.90, p < 0.00001 and gastrin WMD = 23.74, 95% CI: (7.30, 40.19); z = 2.83, p = 0.005 were significantly higher in the Shenqu Xiaoshi Oral Liquid group. Conclusions: Shenqu Xiaoshi Oral Liquid shows favorable clinical efficacy and an acceptable safety profile for treating functional constipation in children. However, these outcome measures are influenced by the limited sample size and potential heterogeneity of the included studies, warranting cautious interpretation of the results.
Li et al. (2026) studied this question.