OBJECTIVE: To explore the clinical effects of Xiaoer Xiaoshi granules combined with Saccharomyces boulardii（S. boulardii） in the treatment of functional dyspepsia in children. METHODS: Totally 126 children with functional dyspepsia admitted into the hospital from Jul. 2019 to Jan. 2021 were extracted to be divided into the control group（63 cases

treated with S. boulardii） and the observation group（63 cases

treated with Xiaoer Xiaoshi granules combined with S. boulardiia） via the random number table. Both groups were treated for 4 weeks. Clinical efficacy

occurrence and recurrence of adverse drug reactions

levels of cytokines [interferon γ（IFN-γ）

tumor necrosis factor α（TNF-α） and interleukin-10（IL-10）]

gastrointestinal function indicators [gastrointestinal hormones casein（PYY）

motilin（MTL） and gastrin（GAS）] before and after treatment in two groups were observed. RESULTS: After treatment of 4 weeks

the total effective rate of the observation group was 93.65%（59/63）

higher than 73.02%（46/63） of the control group

the difference was statistically significant（P<0.05）. The levels of IFN-γ

TNF-α and PYY in the observation group were significantly lower than those in the control group

while the levels of IL-10

MTL and GAS were significantly higher than those in the control group

with statistically significant differences（P<0.05）. The incidence of adverse drug reactions in the observation group and control group was respectively 6.35%（4/63） and 4.76%（3/63）

with no statistically significant difference（P>0.05）. The recurrence rate of the observation group was 3.17%（2/63）

significantly lower than 19.05%（12/63） of the control group

the difference was statistically significant（P<0.05）. CONCLUSIONS: The efficacy of Xiaoer Xiaoshi granules combined with S. boulardii in the treatment of functional dyspepsia in children is significant

which can promote the improvement of gastrointestinal function and inflammatory response

and reduce the recurrence rate.