Abstract:

Objective To evaluate the effect of Shanpu Jianpi granules in improving the symptoms of functional dyspepsia and stagnation of spleen deficiency in children, and the safety of its clinical application.Methods  A randomized, controlled, multicenter, non-inferiority test design method was used. A total of 120 children with functional dyspepsia who were admitted to the First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Liaoning Maternal and Child Health Hospital, and Benxi Manzhou Autonomous County Traditional Chinese Medicine Hospital from February 2022 to July 2022 were chosen and randomly divided into the observation group and the control group with 60 cases in each group. The observation group was given oral administration of Shanpu Jianpi granules, while the control group was given oral administration of Bifidobacterium triple viable enteric-coated capsules. The treatment lasted for 2 weeks. After the treatment course, record the following: (1) the comprehensive total effective rate of functional dyspepsia symptom scores in the two groups; (2) the curative effect of TCM syndromes in the two groups (total effective rate); (3) the curative effect of a single symptom of functional dyspepsia in the two groups; (4) the incidence of adverse reactions in the two groups.Results  The comprehensive total effective rate of functional dyspepsia symptom in the observation group and the control group was89.83%(53/59) and 85.96(49/57), suggesting that the observation group was not inferior to the control group. There was no statistical difference in other minor indexes between the two groups, including effect on traditional Chinese medicine syndrome and the curative effect on single symptom of functional dyspepsia (P>0.05). Altogether 3 adverse events were reported, one in the observation group (1.69%，1/59) and two in the control group (3.51%,2/57), and there was no statistical difference in the incidence of adverse events between the two groups. Conclusion Shanpu Jianpi granules is not inferior to the control drug Bifidobacterium triple viable enteric-coated capsules in the treatment of FD symptoms, and can improve TCM syndromes, with good clinical safety.

Key words:

Functional dyspepsia, Stagnation, Spleen deficiency with accumulation syndrome, Shanpu Jianpi granule, Children