Abstract：Objective To evaluate the clinical effect of Zhiqiao Chenpi Decoction on functional dyspepsia (FD) with liver-stomach disharmony. Methods Ninety-four FD patients with liver-stomach disharmony who attended the Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine from July 2020 to March 2022 were selected as study subjects, and they were divided into experimental group and control group by random number table method, with 47 cases in each group. The experimental group was given Zhiqiao Chenpi Decoction Herbal Granules, and the control group was given Zhiqiao Chenpi simulated granules. The course of medication for each group was four weeks. The clinical effect, FD subtype score and total symptom score, traditional Chinese and medicine syndrome effect, quality of life score, and psychopsychological score were compared between the two groups. Results After the trial, six cases fell off in the experimental group and 41 cases remained, five cases fell off in the control group and 42 cases remained. The clinical effect of experimental group was better than that of control group, the difference was statistically significant (P＜0.05). After treatment, the total scores of postprandial distress syndrome, epigastric pain syndrome and FD symptoms in two groups were lower than before treatment, and the experimental group was lower than the control group, the differences were statistically significant (P＜0.05). After treatment, the score of postprandial fullness of the two groups was lower than that before treatment, and the experimental group was lower than the control group(P＜0.05), and the score of early fullness of the experimental group was lower than that before treatment (P＜0.05), there was no statistical significance in the scores of upper abdominal pain and upper abdominal burning between the two groups compared with that before treatment and between the two groups (P＞0.05). The curative effect of traditional Chinese and medicine syndrome in experimental group was better than that in control group, the difference was statistically significant (P＜0.05). After treatment, there was no significant difference in physical health score, mental component score, short from 36 scores, self-rating depression scale and self-rating anxiety scale scores between the two groups compared with those before treatment and between the two groups (P＞0.05). No clinically significant abnormalities of safety indicators or serious adverse events were observed in all patients. Conclusion Findings in our study suggest that Zhiqiao Chenpi Decoction has good curative effect and high safety on liver-stomach disharmony syndrome in patients with FD.
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