To explore the clinical effect of Shugan Jieyu Xiaopi Prescription（疏肝解郁消痞方）in the treatment of functional dyspepsia（FD）of liver-stomach disharmony syndrome complicated with insomnia.

A total of 96 patients with FD of liver-stomach disharmony syndrome combined with insomnia admitted to the hospital from August 2021 to August 2023 were selected and divided into observation group（48 cases）and control group（48 cases）according to random number table method.The control group was given routine intervention，the observation group combined Shugan Jieyu Xiaopi Prescription.The course of treatment in both groups was 1 month.The clinical effect of the two groups was compared.Before treatment and 1 month after treatment，traditional Chinese medicine（TCM）syndrome scores，Nipin dyspepsia Symptom Index（NDSI），Nipin dyspepsia Life Quality Index（NDLQI），Pittsburgh Sleep Quality Index（PSQI），gastrointestinal hormones［motilin（MLT），gastrin（GAS），ghrelin］，neurotransmitters［5-hydroxytryptamine（5-HT），norepinephrine（NE）γ-aminobutyric acid（GABA）］and inflammatory factors［interleukin-6（IL-6），tumor necrosis factor-α（TNF-α）］were recorded and compared between the two groups.The occurrence of adverse reactions in the two groups was recorded.

The total effective rate of observation group was significantly higher than that of control group（P<0.05）.After treatment，the TCM syndrome scores of both groups were significantly decreased（P<0.05），and the score of the observation group was significantly lower than that of the control group（P<0.05）.After treatment，NDSI and PSQI scores of both groups were significantly decreased，and the scores of the observation group were significantly lower than those of the control group（P<0.05）.NDLQI scores of both groups were increased，and the score of the observation group was significantly higher than that of the control group（P<0.05）.After treatment，the levels of MLT and GASwere significantly decreased in both groups，and the levels of the observation group were significantly lower than those of the control group（P<0.05），the levels of ghrelin were increased in both groups，and the level of the observation group was significantly higher than that of the control group（P<0.05）.After treatment，the levels of NE in both groups were significantly decreased，and the level of the observation group was significantly lower than that of the control group（P<0.05）.The levels of 5-HT and GABA in both groups were increased，and the levels of the observation group were significantly higher than those of the control group（P<0.05）.After treatment，the levels of IL-6 and TNF-αwere significantly decreased in both groups，and the levels of the observation group were significantly lower than those of the control group（P<0.05）.There was no significant difference in the total incidence of adverse reactions between the two groups（P>0.05）.

Shugan Jieyu Xiaopi Prescription has a high efficacy in FD of liver-stomach disharmony syndrome complicated with insomnia.It can reduce the symptoms of patients，improve their sleep quality，gastrointestinal hormone and neurotransmitter levels，inhibit inflammation，and have a high safety.